survey report 2015 (online)...

Supporting information from theNational Accreditation Bodiesfor the European Commission

Initiative on Breast Cancer

Aslı Ulutürk, Silvia Deandrea, Donata Lerda, Jesús López Alcalde, Luciana Neamtiu, Zuleika Saz-Parkinson

2015

J R C S C I E N C E A N D P O L I C Y R E P O R T

Report EUR 27382 EN

and conformity assessmentReport of a survey on accreditation

in the field of breast cancer in Europe

European CommissionJoint Research Centre

Institute for Health and Consumer Protection (IHCP)

Contact informationDonata Lerda

Address: Joint Research Centre, IHCP, Public Health Policy Support

Via Enrico Fermi 2749, TP 127, 21027 Ispra (VA), Italy

E-mail: [email protected]

Tel.: +39 0332 78 6201

Fax: +39 0332 78 9059

https://ec.europa.eu/jrc/en/institutes/ihcp

https://ec.europa.eu/jrc/en

Legal NoticeThis publication is a Science and Policy Report by the Joint Research Centre, the European Commission’s in-house science service. It aims

to provide evidence-based scientific support to the European policy-making process. The scientific output expressed does not imply a policy

position of the European Commission. Neither the European Commission nor any person acting on behalf of the Commission is responsible

for the use which might be made of this publication.

JRC92204

EUR 27382 EN

ISBN 978-92-79-50318-4 (pdf)

ISBN 978-92-79-50334-4 (print)

ISSN 1831-9424 (online)

ISSN 1018-5593 (print)

doi:10.2788/15049

Luxembourg: Publications Office of the European Union, 2015

© European Union, 2015

Reproduction is authorised provided the source is acknowledged.

AbstractBackground: The objective of this survey was to collect information from the National Accreditation Bodies in collaboration with European

Cooperation for Accreditation on the accreditation status of the countries. Methods: The survey included two questionnaires and a data

protection form distributed by e-mail. The participants were the members of EA. Results: Twenty-five out of 35 contacted countries re-

sponded, corresponding to a response rate of 71%. The most applied standard resulted to be ISO 15189 and the most covered stage of care

diagnosis. Conclusions: Accreditation status is diverse across Europe; some countries don’t harbor accredited/certified organisations on

breast cancer care, and others use different standards in different stages of care. A harmonisation in quality benchmarking would enhance

equality in patients’ care.

https://ec.europa.eu/jrc/en/institutes/ihcp

https://ec.europa.eu/jrc/en

Supporting information

from the National Accreditation Bodies

for the European Commission

Initiative on Breast Cancer

Aslı Ulutürk, Silvia Deandrea,

Donata Lerda, Jesús López Alcalde,

Luciana Neamtiu,

Zuleika Saz-Parkinson

2015

and conformity assessmentReport of a survey on accreditation

in the field of breast cancer in Europe

Report EUR 27382 EN

Table of contents | 3

List of abbreviations 4Glossary 5Foreword 6Executive summary 7 1. Introduction to the European Commission Initiative on Breast Cancer 9 2. Introduction to the accreditation and conformity assessment terminology 11 3. Scope of the survey 13 4. Survey organisation 14 Method 14 Timeframe 16 Participants 16 5. Survey results 19 General overview 19 5.1. Section 1: Contact details and area of competence 19 5.2. Section 2: Gate questions 20 5.3. Section 3: The standards in use 21 5.3.1. ISO 15189:2012 24 5.3.2. ISO/IEC 17020:2012 25 5.3.3. ISO/IEC 17021:2011 25 5.3.4. ISO/IEC 17025:2005 25 5.3.5. Clinical Pathology Accreditation standard (CPA) 25 5.3.6. Imaging Services Accreditation Scheme (ISAS) 26 5.3.7. Quality Management System Standards 26 5.4. Section 4: The stages of breast cancer care and transversal items covered by the standards 27 5.4.1. The screening stage 28 5.4.2. The diagnosis stage 29 5.4.3. The treatment stage 29 5.4.4. The survivorship and management of recurrence stage 30 5.4.5. Transversal items 31 6. Conclusions 33 7. Acknowledgements 35 8. Bibliography 35 9. Useful links 35Annex I: Data protection form and questionnaire 37Annex II: E-mail communications 61Annex III: Tables 67

Table of contents

4 | Accreditation, conformity assessment and quality assurance of breast cancer care in Europe

BCS Breast Cancer ServiceCPA Clinical Pathology AccreditationEA European co-operation for Accreditation EC European CommissionECIBC European Commission Initiative on Breast CancerJRC Joint Research CentreJRC-IHCP Joint Research Centre - Institute for Health and Consumer ProtectionISO International Organization for StandardizationNAB National Accreditation BodyQA Quality AssuranceEUR Euratom, a number of JRC cataloguing, a series unique for JRC (JRC was formerly called)

List of abbreviations

Glossary | 5

Breast Cancer Care: Any kind of healthcare intervention aimed at preventing, diagnosing or treating breast cancer, including the follow-up of any other condition caused by the disease or the treatment itself. It may include primary prevention when the intervention is specifically targeted to breast cancer (e.g. dietary recommendations for high-risk women).

Breast Cancer Services: Comprises all services covering, in continuum, the full extent of management of breast cancer, from screening to follow-up and in some cases end-of-life care. These services may involve both primary care and a range of high speciality services including but not limited to screening, diagnostic imaging, pathology, surgery, radiation and medical oncology.

Stages of Breast Cancer Care: These stages imply the steps of cancer care which a patient goes through in the pathway of cancer care. In ECIBC, breast cancer care is divided into five stages: (1) screening, (2) diagnosis, (3) treatment, (4) rehabilitation and (5) follow-up. These stages should be distinguished from clinical breast cancer stages defining the extent of disease which are usually expressed in numbers 0 through 4. In this report, rehabilitation and follow-up stages are combined into one stage (survivorship and management of recurrence) to make the data more easily conveyed and interpreted.

Transversal items: This term refers to the horizontal aspects of breast cancer care that may be used in more than one stage or all through the care and for different diseases other than cancer (in other documents transversal items might be mentioned as ‘horizontal aspects’).

Glossary


The European Commission’s Joint Research Centre (JRC) has been assigned the task of steering and coordinating the European Commission Initiative on Breast Cancer. This includes the development of a Euro-pean quality assurance scheme underpinned by accreditation and the establishment of a platform of evidence-based guidelines, in-cluding a new version of the European guide-lines for breast cancer screening and diagnosis.

Developing a single European quality assur-ance scheme in order to assure competence and quality of European breast cancer ser-vices is very complex. In order to map out the situation in Europe and understand the differences in healthcare systems settings and quality assurance schemes within each country, a series of surveys were launched. The outcomes of the first survey were de-scribed in the Report of a European survey on the organisation of breast cancer care services.1 A second survey was conducted on the accredi-tation and conformity assessment standards in use in the Member States and other Euro-pean countries and it was the first survey to be conducted among the National Accredi-tation Bodies in the healthcare area. The re-sults are reported in this document.

These two survey reports, along with the JRC report on review and analysis of external quality assessment of breast cancer services in Europe (soon to be published) allow us to map similarities and differences across coun-

1. http://bookshop.europa.eu/en/report-of-a-european-survey-on-the-organisation-of-breast-cancer-care-services-pbLBNA26593/.

tries and sometimes also highlighting dis-crepancies within countries (e.g. for data held by different entities like the Health Authori-ties and the National Accreditation Bodies). JRC also detected diverse interpretations of the term ‘accreditation’ depending on the respondent’s profile (healthcare service or accreditation service) and future reports will address these glossary divergences so as to create a common base of understanding for all stakeholders’ profiles.

I highly value and support our coordination role in this initiative and its mandate to sup-port countries and stakeholders in improving healthcare quality for all European citizens.

This EUR report, being based on the infor-mation provided by many National Accred-itation Bodies on several healthcare topics, is a reference for subsequent stages of the JRC project and provides publicly available information for other projects in the field. I warmly encourage all stakeholders to care-fully read the report and to provide their feed-back on its potential use and impact. You are also invited to provide any additional information (not covered by this survey) as the JRC may organise further surveys.

Last but not least, I wish to express my grati-tude to all National Accreditation Bodies’ delegates, who contributed to the survey and we look forward to collaborating with them in the future.

Krzysztof Maruszewski Director, JRC-IHCP

Foreword

http://bookshop.europa.eu/en/report-of-a-european-survey-on-the-organisation-of-breast-cancer-care-services-pbLBNA26593/


Executive summary | 7

The JRC, the European Commission’s in-house science service, was assigned in De-cember 2012 with the tasks of (i) developing a new version of the European guidelines for breast cancer screening and diagnosis (in the following mentioned as ‘the new European Guidelines’) and of (ii) developing a volun-tary European Quality Assurance scheme for breast cancer services based on the Euro-pean legislative framework on accreditation (defined in Regulation (EC) No 765/2008) (in the following mentioned as European QA scheme). Those tasks, among others, are part of the European Commission Initiative on Breast Cancer (ECIBC).

With the scope of building up the knowl-edge base for the ECIBC and in view of designing a QA scheme flexible enough to adapt and embrace the differences in stand-ards use in different countries, a survey was conducted to gather information about the use of standards issued by the International Organization for Standardization (ISO) and ISO CASCO, the ISO committee that de-velops standards and addresses issues related to conformity assessment.

The survey targeted the National Accredita-tion Bodies (NAB), which are full members of the European co-operation for Accredi-tation (EA). The countries covered include Euro pean Union (EU) Member States plus Iceland, Montenegro, Norway, the former Yu-goslav Republic of Macedonia, Turkey, Serbia and Switzerland. Contact persons for each NAB were identified with the support of EA.

Twenty-five of the 35 contacted countries re-sponded to the survey, corresponding to a response rate of 71%. The primary findings are as follows:

• Nineteen of the 25 responding countries (76%) have at least one healthcare organisa-tion in the breast cancer care pathway which includes accredited conformity assessment activities or which is holding an accredited conformity assessment certificate.

• In 15 of these 19 countries (79%) the men-tioned healthcare organisation(s) take part in the diagnosis or treatment of breast cancer at any stage of care (from screen-ing to follow-up).

• Four ISO standards are in place for either accrediting the laboratories within the mentioned organisations or for accredita-tion of Conformity assessment bodies to assess these organisations: ISO 15189:2012, ISO/IEC 17020:2012, ISO/IEC 17021:2011, and ISO/IEC 17025:2005. Only UK re-ports the use of national standards be-sides ISO standards, which are mapped on ISO standards.

• ISO 15189:2012 and ISO/IEC 17021:2011 were the standards used in most countries (14 and 11, respectively). ISO 15189 can be applied directly in breast cancer services to accredit their laboratory (diagnostic ac-tivities) units. The ISO 17021 standard is in-stead used to accredit a certification body, which will as such certify the management system of the breast cancer service.

• Among different stages of breast cancer care (hereinafter, those stages will be re-

Executive summary


ferred to as stages of care), the diagnosis stage was most widely addressed with the standard in place. Laboratory tests, quality management and personal competence re-quirements were the items most addressed.

• Six countries do not have a healthcare or-ganisation in the breast cancer pathway which is running accredited laboratory activities or holding an accredited certifi-cate of conformity.

1. Introduction to the European Commission Initiative on Breast Cancer | 9

In 1987, the European Commission initiated the ‘Europe against cancer programme’. This programme was instrumental in funding the actions to develop the European guidelines for quality assurance in breast cancer screening and diagnosis.

In 2003, the European Council issued a re-commendation 2 to the Member States to of-fer evidence-based cancer screening through a systematic population-based approach with quality assurance at all appropriate levels and in accordance with the Euro pean guidelines for quality assurance in breast cancer screening and diagnosis (now in their fourth edition since 2006). This was followed by the Council’s conclusions in 2008 which invited the Euro-pean Commission to explore the potential for developing a European pilot quality as-surance scheme for breast cancer screening and follow-up, based on European guidelines for breast cancer screening and diagnosis and on other evidence-based guidelines for the nec-essary follow-up (other stages of care).

The ECIBC, underway at the Joint Research Centre’s Institute for Health and Consumer Protection (JRC-IHCP), is aimed at setting up one single system for defining, estab-lishing and auditing/monitoring a mini-mum set of quality requirements for breast

2. Council Recommendation of 2 December 2003 on cancer screening (2003/878/EC): http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:327:0034:0038:EN:PDF.

cancer healthcare across Europe. The project has two main pillars:

1. to develop the new European Guidelines based on new knowledge and evidence;

2. to develop a voluntary European QA scheme, which will fulfil the European legal frame for Accreditation and therefore will be in fact a European QA scheme for Breast Can-cer Services based on the EU legislative framework on accreditation, as defined in the Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accredi-tation and market surveillance 3 and by a set of evidence-based guidelines.

This initiative is in response to the Council Conclusions on reducing the burden of cancer 4 and it aims to minimize the risks connected to poor quality of care. Its concept foresees that all stages of care, i.e. screening, diag-nosis, treatment, rehabilitation, and fol-low-up (including surveillance and, where necessary, management of recurrences); in addition, other aspects such as psychologi-cal support and palliative care, which are essential for a patient-centred concept of

3. Regulation (EC) No 765/2008, OJ L 218, 13.8.2008, p. 30: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0030:0047:en:PDF.4. Council of the European Union: Council Conclusions on reduc-ing the burden of cancer, 2876th Employment, Social Policy, Health and Consumer Affairs Council meeting, Luxembourg, 10 June 2008: http://www.eu2008.si/en/News_and_Documents/Council_ Conclusions/June/0609_EPSCO-cancer.pdf.

1. Introduction to the European Commission Initiative on Breast Cancer

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:327:0034:0038:EN:PDF

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:327:0034:0038:EN:PDF

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0030:0047:en:PDF



http://www.eu2008.si/en/News_and_Documents/Council_Conclusions/June/0609_EPSCO-cancer.pdf

http://www.eu2008.si/en/News_and_Documents/Council_Conclusions/June/0609_EPSCO-cancer.pdf


quality, are also covered. It foresees that a person’s centred and multidisciplinary ap-proach will be applied.

The processes involved in the development of this European QA scheme will rely on infor-

mation gathered through bilateral meetings, workshops and a series of past, on-going and future surveys and studies. The reports partially or totally derived from surveys are listed below.

The European QA scheme will be based on the new European Guidelines (and, if neces-sary, on the selection of existing guidelines and recommendations for other stages and

aspects of care not covered in the new Euro-pean Guidelines). A more detailed description of the ECIBC is available on the JRC Sci-ence Hub.5

5. https://ec.europa.eu/jrc/en/research-topic/healthcare-quality.

Name of the report Scope of the report Timing

Report of a European survey on the organi-sation of breast cancer care services

To collect information from the countries involved in the ECIBC on the organisation of breast cancer services and to map out the organisation of breast cancer care and screening across Europe

Report published

Report of a survey on accreditation and conformity assessment in the field of breast cancer care in Europe (this one)

To understand the wide picture of accreditation and conformity assessment of breast cancer care path-way across Europe

Report published

Review and analysis of external quality assessment of breast cancer services in Europe

To describe current QA schemes in place in Europe that are affecting the breast cancer pathway

Report published

Project workshops report Includes the narration of the two workshops, the conclusions derived and their impact on the planning of activities for meeting the requirements of the two tasks.

Report published

Events’ report A summary of the meetings JRC embarked with a wide range of stakeholders, experts and concerned authorities at the national level.

Report published

https://ec.europa.eu/jrc/en/research-topic/healthcare-quality






http://bookshop.europa.eu/en/a-voluntary-accreditation-scheme-for-breast-cancer-services-the-further-development-of-european-breast-cancer-guidelines-pbLBNA26032/

http://bookshop.europa.eu/en/european-commission-initiative-on-breast-cancer-ecibc-pbLBNA26591/

2. Introduction to the accreditation and conformity assessment terminology | 11

In this document, the relevant terminol-ogy follows the strict European legislative framework in place for accreditation, which is detailed in Regulation (EC) No 765/2008 6 and Decision (EC) 768/2008 7 and might differ from the use of that terminology in healthcare or other areas.

Healthcare organisations may undergo ex-ternal assessments for various purposes such as improving safety and quality or demon-strating the achievement of certain require-ments (Shaw 2013). These assessment modal-ities are normally outside the European legal framework for Accreditation (henceforth mentioned as the European legal framework) and may lead to an organisation obtaining a ‘certificate’ attesting their compliance with performance requirements which might contain the words ‘accreditation’, ‘certifica-tion’, ‘designation’ or others but with a dif-ferent legal meaning than what is proposed in the European legal framework. To avoid confusion arising from possible different meanings, the definition of the terminology according to Regulation (EC) No 765/2008 was used in this report as given below.

6. OJ L 218, 13.8.2008, p. 30: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0030:0047:en:PDF.7. OJ L 218, 13.8.2008, p. 82: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0082:0128:en:PDF.

• National accreditation body: the sole body in a Member State that performs accreditation with authority derived from the State (Regula-tion (EC) No 765/2008).It is agreed that each Member State will appoint one National accreditation body (NAB) or address the NAB of another Member State. The NABs operate on a non-profit basis and the Member State is expected to provide the appropriate finan-cial and personnel resources. They are in charge of assessing, accrediting and moni-toring conformity assessment bodies and are able to restrict, suspend or withdraw the given accreditation certificates in case of a breach.The NAB can accredit conformity assess-ment bodies. If a breast cancer service in-cludes a laboratory or performs tests which can be considered as a laboratory activity, these activities can be accredited by the NAB. However a NAB is not allowed to provide certification or inspection services and they generally are not allowed to pro-vide those services they accredit.Each NAB must be a member of the Euro-pean cooperation for accreditation (list of members: http://www.european-accredi-tation.org/ea-members).

• Accreditation: an attestation by a national accreditation body that a conformity assess-ment body meets the requirements set by har-monised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a spe-

2. Introduction to the accreditation and conformity assessment terminology





http://www.european-accreditation.org/ea-members

http://www.european-accreditation.org/ea-members


cific conformity assessment activities (Regula-tion (EC) No 765/2008).This term has gained different meanings among different professional groups (Shaw 2000). In this document, accreditation is strictly interpreted as defined above.The accreditation procedure, if the evalu-ated organisation is found to be compe-tent, ends with an accreditation certificate being issued. This certificate is subject to be restricted, suspended or withdrawn.

• Conformity assessment body: a body that performs conformity assessment activities in-cluding calibration, testing, certification and inspection (Regulation (EC) No 765/2008) upon accreditation from the NAB.As an example, a conformity assessment body (CAB) can verify compliance of radiotherapy services to specific require-ments derived from healthcare guidelines.

• Conformity assessment: the process dem-onstrating whether specified requirements re-lating to a product, process, service, system, person or body have been fulfilled (Regulation (EC) No 765/2008).Conformity assessment can be applied to a product, a process (such as surgery, psy-chosocial care or survivorship support of-fered to cancer patients), a system, a body and includes activities such as testing, in-spection and certification of management systems, products or services and persons.

• Notified body: is a conformity assessment body which is granted an accreditation certificate and notified to the Commis-sion by the relevant Member State its ability to carry out third-party conform-ity assessment services (Decision (EC) No 768/2008).

• Certification: it is the process of provi-sion of a certificate by an independent body that the product, process, service or system in question meets specific require-ments.

• Inspection: inspection describes the regu-lar checking of a product, a service or a system to make sure it meets specified cri-teria. For example some diagnostic equip-ment needs to be inspected regularly to ensure their efficacy and safety.

• European co-operation for Accreditation (EA) (http://www.european-accreditation. org/home): according to Regulation (EC) No 765/2008, every NAB appointed by a Member State is required to be a mem-ber of EA, which is formally appointed as the body responsible for the European accreditation infrastructure in the same regulation. EA is given the task of coop-eration with all stakeholders and the Euro-pean Commission and provides peer eval-uation services to its members.

http://www.european-accreditation.org/home

http://www.european-accreditation.org/home

3. Scope of the survey | 13

In 2012, a contact person responsible for co-ordinating responses at country level was identified for each of the full members of EA. The survey consisted of a data protec-tion form and two questionnaires. The first questionnaire included gate questions about the presence of a healthcare organisation which is running an accredited laboratory or holding an accredited conformity assessment certificate for activities part of or relevant for breast cancer care. The second questionnaire (annexed to the first questionnaire) covered information on the standards used in the pathway, including details on the stages of care and transversal items (e.g. quality man-agement) covered by each standard.

The survey was organised primarily to un-derstand the wide picture of accreditation and conformity assessment in the field of breast cancer care across Europe. The infor-mation requested is crucial to set-up a Euro-pean QA scheme which will fulfil the European legal framework and therefore will be in fact an accreditation and conformity assessment scheme taking into account the significant experiences already built in the use of ISO standards for breast cancer care.

This report should be considered comple-mentary with the JRC report Review and analysis of external quality assessment of breast cancer services in Europe in providing a better insight of the European situation in qual-ity assurance. The two reports, together with the Report of a European survey on the organisa-tion of breast cancer care services, will describe the origins of different data received from different sources and provide countries a better insight of the connections between the different involved authorities.

It should be highlighted that the initiative aims to encourage application of evidence-based guidelines and harmonised operating procedures. The research JRC conducted so far, was functional for optimising the Euro-pean QA scheme design and, consequently, enhancing impact of evidence-based health-care on outcomes of women affected by breast cancer.

3. Scope of the survey


Method

The Adobe LiveCycle Designer® tool was used to design, distribute and manage the infor-mation provided (using the distribute form and collect answers tools). This tool allows the creation of interactive forms with an automatic submission (e.g. via e-mail) and a functional mail-box ([email protected]), accessible to all group members, that was used to communicate with the designated respondents. In this way, full-time assistance and support could be provided to all participants.

Participants in the survey received three PDF forms: a data protection form and two questionnaires–the core form and the an-nex form. All documents used are visible in Annex I.

The core form included two sections, the contact and affiliation details and the gate questions. If the first gate question was re-plied positively, reflecting the presence of organisations accredited or holding accred-ited certificates of conformity for activities part of or relevant for breast cancer care in the country, the participants were asked to fill in the second questionnaire, the annex form.

For each of the ISO/ISO CASCO standards in place, an annex form had to be filled in. It was divided into five sections:

1. Name of the ISO/ISO CASCO standard.2. Where the standard ISO/IEC 17021 was

mentioned, additional information about the quality management system standard used was asked.

3. The stages of care addressed by the stand-ard.

4. Transversal items of breast cancer care ad-dressed by the standard (e.g. safety, and other items covering the whole process of breast cancer care).

5. Additional comments.

All the questions were mandatory, except for those in section 5 and the additional in-formation part (free text) at the end of each section.

Upon receipt of all the questionnaires, the data were collated into a database, a manual data cleaning procedure was performed and inconsistencies and/or missing data were re-ported for each participating country.

The data protection form included a privacy statement and asked for consent to use the data provided in this survey for the devel-opment of the European QA scheme and for research purposes. As this report will be publicly available, a Request of Consent for Publication was sent to all participating countries which provided information (see e-mail in Annex II).

4. Survey organisation

mailto:jrc-cancer-policy-support%40ec.europa.eu?subject=

mailto:jrc-cancer-policy-support%40ec.europa.eu?subject=

4. Survey organisation | 15

Table 1: ISO codes of countries.

Countries Twere coded according to the In-ternational Organisation of Standardisation (ISO) 3166 standard (reported in Table 1 and

available at: (https://www.iso.org/obp/ui/# search).

Country Name ISO Code Country Name ISO Code

Austria AT Lithuania LT

Belgium BE Luxembourg LU

Bulgaria BG Latvia LV

Switzerland CH Montenegro ME

Cyprus CY The former Yugoslav Republic of Macedonia MK

Czech Republic CZ Malta MT

Germany DE Netherlands (the) NL

Denmark DK Norway NO

Estonia EE Poland PL

Spain ES Portugal PT

Finland FI Romania RO

France FR Serbia RS

Greece GR Slovenia SI

Croatia HR Slovakia SK

Hungary HU Sweden SE

Ireland IE Turkey TR

Iceland IS United Kingdom UK

Italy IT

https://www.iso.org/obp/ui/#search

https://www.iso.org/obp/ui/#search


Timeframe

All nominated contact persons were con-tacted by e-mail via the functional mailbox.

1. The survey was launched on 9 August 2013 and the deadline for completion was 15 September 2013.

2. By the deadline, 16 countries had sent back a completed questionnaire. For all the others, an individual reminder e-mail was sent on 20 September 2013.

3. After an intense period of follow-up, the last questionnaire was received on 19 Jan-uary 2014.

4. A request for clarifications was sent out starting from 4 March 2014.

5. Upon a second follow-up phase, the last clarifications were received on 2 June 2014.

6. On 5 June 2014 respondents were asked to approve the proposal of JRC for the summary tables of the individual data, as they would have been published (and ap-pear in this document at Annex IV). Sev-enteen of the countries approved the data within the deadline. The last approval was received on 12 August 2014 after several communications.

7. Between 6 and 8 August 2014, participat-ing countries, who already had approved their individual data, were asked to pro-vide their consent for publication of the data with the information, that in the absence of a reply before August 15th, the ‘Silence gives consent’ statement (con-sent is assumed when there’s no evidence of disagreement) would be applied and it would be recorded as a consent. The countries which had not sent the approval in time were sent a reminder mail to both approve their individual data and to pro-vide their consent for publication of this data.

8. All the NABs finally approved their indi-vidual data.

Participants

In Table 2, the nominated contact persons from the 35 countries contacted are listed. Twenty-five of them responded and the non-responding countries are shaded in grey. In two countries (BE and CY), the contact per-son was replaced between the questionnaire in 2013 and the follow-up in 2014.

4. Survey organisation | 17

Table 2: List of participants.

Country Nominated contacts Other collaborators Accreditation body

AT Johanna STAMPLER - Akkreditierung Austria

BEVeerle NOTEN (2013)Nicole VANLAETHEM (2014)

- BELAC: Belgian Accreditation Organization

BG Elza JANEVA - BAS: Bulgarian accreditation service

CH Rolf STRAUB - SAS: Swiss Accreditation Service

CYKyriakos TSIMILLIS (2013)Antonis IOANNOU (2014)

- CYS-CYSAB: Ministry of Health, Nicosia

CZ Martina BEDNAROVA - CAI: Czech Accreditation Institute

DE Uwe ZIMMERMANN - DAkkS: Germany’s National Accreditation Body

DKHenrik Lykkegaard JØRGENSEN

-DANAK: Danish Accreditation and Metrology Fund

EE Kaire TÕUGU - EAK: Estonian Accreditation Centre

ES Isabel de la VILLA - ENAC: Spanish National Accreditation Body

FI Tuija SINERVO - FINAS: Finnish Accreditation Service

FR Hélène MEHAY - COFRAC: French Accreditation Committee

GR Aliki STATHOPOULOU - ESYD: Hellenic Accreditation System

HR Dragica KRIZANEC - HAA: Croatian Accreditation Agency

HU Rozsa RING - NAT: Hungarian Accreditation Board

IE Marie O’MAHONY - INAB: Irish National Accreditation Board

IS Sigurlinni SIGURLINNASON - ISAC: Icelandic Board for Technical Accreditation

IT Filippo TRIFILETTI - ACCREDIA: Italian National Accreditation Body

LT Danutė JANULIONIENĖ - LA: Lithuanian National Accreditation Bureau

LU Ferrand DOMINIQUE Monique JACOBYOLAS: Luxembourg Accreditation and Surveillance Office

LV Zinaida GORINA - LATAK: Latvian National Accreditation Bureau

MK Dragan VELEVSKI -IARM: Institute for Accreditation of the Republic of Macedonia

MT Claudio BOFFA -NAB-Malta: National Accreditation Board of Malta

ME Ranko NIKOLIC - ATCG: Accreditation Body of Montenegro


Table 2: (cont.)

Country Nominated contacts Other collaborators Accreditation body

NL Jan C. van der POEL - RVA: Dutch Accreditation Council

NO Cecilie LAAKE - NA: Norwegian Accreditation

PL Eugeniusz ROGUSKI Malgorzata OLCZAK-WASIK PCA: Polish Centre for Accreditation

PT Leopoldo CORTEZ - IPAC: Portugal Accreditation Institute

RO Cristian NICHITA - RENAR: Romanian Association for Accreditation

RS Ljubinka GLIGIC - ATS: Accreditation Body of Serbia

SE Annika LYDÉN -SWEDAC: Swedish Board for Accreditation and Conformity Assessment

SI Bostjan GODEC - SA: Slovenian Accreditation

SK Tibor CZOCHER - SNAS: Slovak National Accreditation Service

TR Gokhan BIRBIL - TURKAK- Turkish accreditation Agency

UK Lorraine TURNER Jane BEAUMONT UKAS: United Kingdom Accreditation Service

5. Survey results | 19

Countries which did not respond to the sur-vey were not included in the following ta-bles, but they are visible on every map.

In all the descriptions, response rates are rounded to the closest whole number and expressed in relation to the 25 countries re-sponding (for instance, 84% of the countries means that this was the response of 21 coun-tries out of 25).

A standard may be applied to more than one stage of care or a stage of care may be addressed by more than one standard. For example when a stage of care is addressed by two different standards in a country, they are considered as two diverse applications. Therefore the total number of applications may exceeds the number of countries. To provide a clearer view, data will be displayed in terms of numbers of applications where needed.

General overview

Twenty-five countries out of the 35 contacted responded to the questionnaire, which cor-responds to a response rate of 71%. HU, IS, LV, MT, NO, PT, RO, SK, CH and TR did not respond to the survey, therefore, no in-formation is available for these countries. In Figure 1 the contacted countries are depicted in different colours according to their reac-tion to the questionnaire.

The ideal response rate could be higher; however, taking into account that this was the first approach to the NABs for a survey on the healthcare system, the achieved 71% was considered as sufficient to draw a reli-able picture of the current European situa-tion in terms of accreditation and conform-ity assessment in breast cancer care.

Figure 1: Country participation map.

5.1. Section 1: Contact details and area of competence

All the respondents were employed by the corresponding NABs. In all cases, due to the procedure applied for identifying respond-ents, they were the responsible staff mem-

5. Survey results

Responded

Not responded

IS

NO

SE

FI

EE

LV

LTBY

RU

UA

MD

RO

TR

CY

BGRS

MEMK

GRAL

BA

HU

SK

PL

CZ

DE

AT

SI HR

NLBE

LU

CHFR

IT

MT

AD

ESPT

UKIE

DK


Existing

Not existing

IS

NO

SE

FI

EE

LV

LTBY

RU

UA

MD

RO

TR

CY

BGRS

MEMK

GRAL

BA

HU

SK

PL

CZ

DE

AT

SI HR

NLBE

LU

CHFR

IT

MT

AD

ESPT

UKIE

DK

Not responded

bers within their organisations for the spe-cific area of activity (healthcare). They were considered responsible for the information provided for the whole of their country.

The fact that most of the persons responsible for the questionnaire compilation were em-ployees of and nominated by the respective NABs provides a high degree of reliability to the information received. In the following, when a response typology is attributed to a country it means that the information was provided by the respective NAB.

Figure 2a: Existence of a healthcare organisation with accredited laboratories or holding accredited certificates of conformity in the breast cancer care

pathway.

5.2. Section 2: Gate questions

In this section, participants were firstly asked to report if in their country there is at least one healthcare organisation (such as a hospital, outpatient clinic, local health authority, laboratory, etc.), which is either accredited or holding an accredited cer-tificate of conformity for all or part of the breast cancer care pathway. And, secondly, if such an organisation exists, they were asked whether that organisation is treating breast cancer patients before, during or after diagnosis (e.g. screening, biopsy, treatment).

Nineteen of the 25 responding countries (76%) reported having an accredited labora-tory in a healthcare organisation or having an organisation holding an accredited cer-tificate of conformity. Out of these 19, one country stated that these healthcare organi-sations are not carrying out activities related to breast cancer care, two countries noted that this information is not known, one did not respond to this question and 15 coun-tries stated that the organisation(s) take part in breast cancer care either before or after the diagnosis.

The responses to the gate questions are mapped in Figure 2a and the aggregated data are shown in Figure 2b.


Figure 2b: When such an organisation exists, involve - ment of this organisation in breast cancer treatment.

5.3. Section 3: The standards in use

The 19 countries which reported either hav-ing at least one healthcare organisation’s laboratory accredited and/or that at least one healthcare organisation held an accredited certificate of conformity in the first ques-tionnaire, were asked to complete a second questionnaire (one per each of the standards applied).

In the second questionnaire, the countries were asked to note all the standards in place in their country and give details for each standard, including the stages of care and transversal items addressed. Breast cancer care was divided into the following stages of care:

1. The whole breast cancer pathway.2. Screening.3. Diagnosis.4. Treatment.5. Survivorship and follow-up.

The individual answers of the countries are reported in Tables 1 to 7 in Annex III.

Out of the 19 countries, 11 (52%) declared one standard running in the country, three coun-tries (CZ, DE, FR) reported two standards, four countries (ES, FI, GR, SE) reported three and one country (UK) reported five accreditation standards in place.

With the sole exception of UK, standards reported by the countries included only ISO or ISO CASCO. UK reported, besides three ISO standards, two national standards which are both based on ISO standards: Clinical Pathology Accreditation Standard and Imaging Services Accreditation Scheme.

ISO 15189:2012, ISO/IEC 17020:2012, ISO/IEC 17021:2011, and ISO/IEC 17025:2005 were used as accreditation standards. Where ISO/IEC 17021 is in place, ISO 9001:2008, ISO/IEC 27001:2013, ISO 13485:2003, ISO 14001:2004 and ISO/IEC TR 18001:2004 were reported as the management system standards.

Details of the mentioned ISO standards’ scope are shown in Table 3.

15

31

Involved in treatment of cancer

Not involved in treatment of cancer

Not known or not reported


Table 3: ISO standards used by the NABs in the covered countries.

* ICS: International Classification for Standards. In grey are the certification standards.

Figure 3: Number of NABs using each standard.

Standard name Field (according to ICS* Specifications

ISO 15189:2012Laboratory medicine in general.Quality management and quality assurance

Medical laboratories–Requirements for quality and competence

ISO/IEC 17020:2012Product and company certification. Conformity assessment

Conformity assessment–Requirements for the operation of various types of bodies performing inspection


Conformity assessment–Requirements for bodies providing audit and certification of management systems


General requirements for the competence of testing and calibration laboratories

ISO 9001:2008 Quality management and quality assurance Quality management systems–Requirements

ISO/IEC 27001:2013 Character sets and information codingInformation technology–Security techniques–Information security management systems–Requirements

ISO 13485:2003Quality management and quality assurance.Medical equipment in general

Medical devices–Quality management sys-tems–Requirements for regulatory purposes

ISO 14001:2004 Environmental managementEnvironmental management systems– Requirements with guidance for use

ISO/IEC TR 18001:2004 Character sets and information codingInformation technology–Radio frequency identification for item management–Applica-tion requirements profiles

ISO 15189:2012 ISO/IEC 17020 ISO/IEC 17021:2011 ISO/IEC 17025:2005

Num

ber

of c

ount

ries

usi

ng t

he s

tand

ard

Standard in use


Figure 4: Total number of applications of each standard by all NABs and for all stages of care.

Figure 5: Total number of applications of each standard by all NABS and per stage of care.


Tota

l num

ber

of a

pplic

atio

ns

Standard in use

Survivorship

Treatment

Diagnosis

Screening

The whole pathway

ISO 15189:2012

ISO/IEC 17020

ISO/IEC 17021:2011

ISO/IEC 17025:2005


The most commonly used standard among countries was ISO 15189:2012, used by 14 countries out of 19 (74%) indicating the ten-dency of the NABs to directly audit the lab-oratories in healthcare organisations (ISO/IEC 17025:2005 can be used in alternative).

The second most common standard used by NABs was ISO/IEC 17021:2011 with 11 countries (58%); this is the standard used by NABs to accredit certification bodies.

A brief explanation of the standard and an overview on how the countries applied each standard is reported below. Ratios are given with respect to the 19 countries using at least one standard. While discussing the stand-ard, only the stage of care which it addresses most frequently is detailed. For all the other stages of care, details of individual answers are available in Tables 4-7, Annex IV.

5.3.1. ISO 15189:2012

ISO 15189:2012 is used by the accreditation bodies to assess and to accredit medical laboratories and provides recognition of the medical laboratory’s competence in both its management system and technical practice. It covers the requirements for medical labo-ratories to ensure the quality and compe-tence of their services, and their consistency in delivering technically valid test results. It is the translation of ISO/IEC 17025:2005 for the medical field.

This standard was the most addressed one, reported by 14 countries (74%). As the stand-ard is to be used in the laboratory field, 13 of

these 14 (92%) countries addressed the diag-nosis phase. Seven countries addressed the transversal items and each of the screening, treatment and survivorship and follow-up stages were addressed by three countries.

The wide usage of this standard shows that in breast cancer care, the services most fre-quently seeking accreditation are linked to measurement and testing activities (e.g. lab-oratories and, more in general, diagnostics) and this may be explained by the fact that diagnostic activities were historically one of the first areas covered by accreditation in the medical field. Another important reason for targeting the diagnostic stage is the im-pact of diagnosis results for all the following stages of care and; hence the importance of a high degree of quality assessment imple-mentation.

Figure 6: Total number of applications of ISO 15189:2012 per stage.

Of the 13 countries using this standard in the diagnosis phase, the aspiration of fluid and subsequent testing item was covered in eight; biopsy and tissue histology item in nine. Five countries declared that the stand-ard was also used to address some molecular bio logy tests (such as HER2/neu tests).

Screening

Diagnosis

Treatment

Survivorship13

3

43

ISO 15189:2012


5.3.2. ISO/IEC 17020:2012

ISO/IEC 17020:2012 is used to assess inspec-tion bodies for the impartiality, competence and consistency of their inspection activities. Inspection bodies provide information to their clients about the conformity of inspect-ed items with regulations, standards, specifi-cations, inspection criteria or contracts.

This standard was reported only by DE and FR. DE addressed the biopsy and tissue his-tology item of the diagnosis stage. FR report-ed addressing accreditation of inspection bodies for medical devices and external qual-ity control by the standard.

5.3.3. ISO/IEC 17021:2011

This standard is intended for use by accredi-tation bodies to assess certification bod-ies which provide audit and certification of management systems (e.g. using ISO 9001). Accredited bodies will grant certification of applicants after a successful audit and provid-ed that the criteria of the respective standard, as e.g. the ISO 9001 standard, are fulfilled.

Figure 7: Total number of applications of ISO/IEC 17021:2011 per stage.

Eleven countries out of 19 (58%) reported hav-ing this standard in place. Four of these coun-tries (ES, IT, PL and SE) reported to address the whole breast cancer pathway. With this standard, the screening stage was addressed by five countries, the diagnosis and treatment stages by four countries, and the survivorship and follow-up stage by one country.

Nine countries out of the 11 (82%) addressed some transversal items using this standard. The items mostly covered were quality man-agement (nine countries), mammography (eight countries), ultrasonography, informa-tion systems and personal competence re-quirements (seven countries each).

5.3.4. ISO/IEC 17025:2005

This standard is applied to laboratories per-forming testing/calibration activities to rec-ognize their competency in these activities. These also can include laboratories where testing and/or calibration are a part of in-spection and product certification.

Four countries had this standard in place: ES, FE, GR and SE. It addresses the diagno-sis stage in three countries, treatment stage and transversal items in two, screening and survivorship and follow-up stages in only one country.

5.3.5. Clinical Pathology Accreditation standard (CPA)

This standard is a national one only reported by UK. It has been in use for accreditation of medical laboratories for over 20 years.

The whole pathway

Screening

Diagnosis

Treatment

Survivorship

ISO/IEC 17021:20115

8

4

9

8


The laboratories are now undergoing transi-tion to UKAS accreditation with ISO 15189.

Diagnosis and survivorship and manage-ment of recurrence stages are covered by this standard as well as some transversal items.

5.3.6. Imaging Services Accreditation Scheme (ISAS)

Similar to CPA, this standard is a national one and only reported by UK. It has been mapped on ISO 17020 and ISO 15189, de-signed to be applied to all current imaging modalities and to interventional radiology services.

The standard covers items related to imag-ing studies in the diagnosis stage, the sur-vivorship and management of recurrence stage and among the transversal items. Pop-ulation based breast screening services are not covered by the standard.

5.3.7. Quality Management System Standards

These standards are used by the accredited certification bodies to audit and certify the management systems of organisations. They provide a model to achieve more efficient use of resources and improved risk manage-ment.

In this survey, the following (quality) man-agement system standards used by the certifi-cation bodies were reported: ISO 9001:2008, ISO/IEC 27001:2013, ISO 13485:2003, ISO 14001:2004 and ISO/IEC TR 18001:2004.

• ISO 9001:2008: specifies requirements for a quality management system where an organization needs to demonstrate its ability to deliver products that meet the expected requirements. It is applicable to organizations of all types and size.

• ISO/IEC 27001:2013: specifies the require-ments for an organisation’s information security management system. It also in-cludes requirements for the treatment of information security risks tailored to the needs of the organization.

• ISO 13485:2003: sets out the requirements for a quality management system for an organization providing medical devices and related services. It aims to facilitate harmonized medical device regulatory re-quirements for quality management sys-tems of producers of medical devices.

• ISO 14001:2004: provides requirements for an environmental management sys-tem where an organization demonstrates that their policy takes into account legal requirements and company specific re-quirements to improve environmental aspects.

• ISO/IEC TR 18001:2004: consists of the results of three surveys on the applica-tions for radio frequency identification and provides classification of these appli-cations and recommendations for areas of standardization based on these surveys.


Figure 9: Total number of applications of standards in each stage.

5.4. Section 4: The stages of breast cancer care and transversal items covered by the standards

While in section three the total frequency of standards application was reported, in this section, the standards used in health-care systems are evaluated and reported in a stage-wise approach. The data included be-low are derived from the 19 countries which addressed breast cancer care with at least one standard.

Figure 8: Number of NABs addressing each stage.

For the ease of classifying, the stages of care are divided into screening, diagnosis, treat-ment and survivorship and management of recurrence. Each stage includes some sub-stages which are discussed in the relevant sections below. The transversal items are also included in the questionnaire in addi-tion to the stages of care.

The wholepathway

Screening Diagnosis Treatment

Num

ber

of c

ount

ries

Breast cancer care stage

Survivorshipand follow-up

ISO/IEC 17025:2005

ISO 15189:2012

ISO/IEC 17020

ISO/IEC 17021:2011

SurvivorshipScreening Diagnosis TreatmentThe whole pathway


Figure 10: Number of NABs addressing the screening stage by each standard.

In general, the standards were mostly ad-dressing the diagnosis stage. This is in cor-relation with the result that ISO 15189:2012 which is used to accredit medical laborato-ries such as pathology laboratories, is the most widely used standard.

The survivorship and follow-up stage was the least addressed by countries and least covered by a standard.

5.4.1. The screening stage

Screening includes asymptomatic healthy women in a certain age range undergoing screening mammography at specified in-tervals for early diagnosis of breast cancer. Screening can be organised or opportunistic. In organised screening programmes, women are invited to attend a population breast cancer screening programme. If they are pre-scribed a screening mammography by their general practitioner or gynaecologist, it is de-fined as opportunistic screening.

Countries were asked whether the screen-ing stage was addressed by a standard. The ones addressing this stage were further asked if the screening is an organised one and if not, to provide a detailed description of the screening.

In 11 of the 19 countries (58%), this stage was addressed by at least one standard and in the remaining eight countries it was not ad-dressed at all. The most widely used stand-ard for this stage was ISO/IEC 17021:2011, reflecting that the management systems are crucial in screening programmes.

Seven of the 11 countries (63%) addressing the screening stage declared that screening is an organised one, three informed that the situa-tion was not known. The remaining country did not respond to this question.


Num

ber

of c

ount

ries

Standard in use

No standards


Figure 11: Number of NABs addressing the diagnosis stage by each standard.

5.4.2. The diagnosis stage

Women with signs or symptoms in their breast or women with a positive screening mammography undergo a diagnostic as-sessment in order to get a final diagnosis. This assessment can involve aspiration or a biopsy and the samples will then be assessed by subsequent tests. Diagnosis stage and its standardisation are of great importance as the future decisions and patterns of care de-pend on it.

Countries were asked whether the diagno-sis stage is addressed by a standard. If the stage was covered, they were further asked to specify if two items–aspiration and sub-sequent testing and biopsy and tissue histol-ogy–were covered.

This was the stage of care most covered by any standard, being addressed in 14 out of the 19 countries (74%). ISO 15189:2012 was the standard most used to cover this stage, used in 13 of these 14 (93%) countries.

Among the 28 cases where this stage was ad-dressed by a standard, the aspiration of fluid and subsequent testing item was addressed in 19 and biopsy and tissue histology item was addressed in 23.

5.4.3. The treatment stage

Women diagnosed with breast cancer then undergo a treatment which may include, depending on multiple factors such as the stage of the disease, a surgical removal of the mass, a part of or the entire breast, radio-therapy, chemotherapy, hormonal therapy. Plastic reconstructive breast surgery is fre-quently proposed to these women.


Num

ber

of c

ount

ries

Standard in use

No standards


Figure 12: Number of NABs addressing the treatment stage by each standard.

When the country addressed this stage, it was asked to detail the inclusion of the items: sur-gery, breast reconstruction, radiotherapy and chemotherapy, and hormonal therapy.

Eleven countries out of 19 (58%) addressed this stage and most of them (eight countries) applied ISO/IEC 17021:2011. Like in the screening stage, quality management systems were the first undergoing quality assessment.

In the 13 applications of this stage, surgery was covered in nine, reconstruction in five, radiotherapy in nine and chemotherapy and hormonal therapy in eleven.

5.4.4. The survivorship and management of recurrence stage

Women with a malignant lesion who un-dergo relevant treatment procedures are en-rolled to follow-up in order to detect and manage possible recurrences and metastasis

at an early phase. During this stage, the sur-vivors may also benefit from psychosocial and other support therapies. Palliative care can be provided at every step of the treat-ment (e.g. pain control) and in case of a negative outcome, end-of-life care could be delivered.

Where the standards cover this stage, the country is asked to detail if it covers these four items: follow-up and management of recurrence, psychosocial care, survivorship support, palliative care and end-of-life care.

This stage of care was covered in eight coun-tries making it the stage least addressed by a standard.

In the 10 cases where this stage is addressed, ISO/IEC 17021:2011 was utilized in five, ISO 15189:2012 was utilized in four and ISO/IEC 17025:2005 in one.


Num

ber

of c

ount

ries

Standard in use

No standards


Figure 13: Number of NABs addressing the survivorship and management of recurrence stage by each standard.

Among these 10 cases, follow-up and man-agement of recurrence was covered in eight, psychosocial care and palliative care and end-of-life care in four, and survivorship support in three countries.

This data shows that this stage, especially psychosocial care, palliative care and end-of-life care and survivorship support fields are highly neglected.

5.4.5. Transversal items

These aspects or items include elements of breast cancer care that are used in several stag-es of care throughout the pathway and cover:

• Mammography.• Ultrasound.• Magnetic Resonance Imaging.• Pathology.• Laboratory tests.• Medication management.• Communication.• Information systems.• Quality management.• Proficiency testing.• Personnel competence requirements.• Hygiene.• Safety.• Research.

Countries were asked to report whether these items were covered.


Num

ber

of c

ount

ries

Standard in use

No standards


Figure 14: Number of applications of standards to each transversal item.

Standards were applied to laboratory tests and quality management items in 20 cases and to personnel competence requirements

in 19 cases, making these three items the most addressed ones. Research, with seven cases, was the least covered item.

Mammog

raph

y

Ultras

ound MRI

Patho

logy

Num

ber

of a

pplic

atio

ns

Transversal item addressed by the standard

Rese

arch

Labo

ratory

tests

Medica

tion

Commun

icatio

n

Inform

ation

syste

ms

Quality

man

agem

ent

Profic

iency

testi

ng

Perso

nnel

compe

tence

Hygien

e

Safet

y

6. Conclusions | 33

Even if this survey does not cover the data from all the contacted NABs, a response rate of 71% can draw a reliable picture of the current European situation in terms of the accreditation and conformity assessment of breast cancer care. All the respondents are active within their respective NABs, ensur-ing a high level and up-to-date knowledge and therefore, reliable information.

The data collected in this survey were very important and relevant to design a European QA scheme for Breast Cancer Services (BCS). The JRC report Review and analysis of exter-nal quality assessment of breast cancer services in Europe will help to provide a more detailed map of the European situation.

The following conclusions can be derived from the results of the survey:

• Nineteen of the 25 responding countries (76%) have at least one healthcare organi-sation in the breast cancer care pathway which is accredited or holding an accred-ited certificate of conformity. This leaves 24% having no such healthcare organisa-tion and reflects the need for enhance-ment and unification of quality assurance in breast cancer care services throughout Europe.

• Four ISO and ISO CASCO standards were applied for accrediting the men-tioned organisations: ISO 15189:2012, ISO/IEC 17020:2012, ISO/IEC 17021:2011, and

ISO/IEC 17025:2005. Only UK reported the use of national standards besides ISO standards.

• ISO 15189:2012 and ISO/IEC 17021:2011 were the most used standards (14 and 11 times, respectively). ISO 15189:2012 speci-fies requirements for medical laborato-ries, and the wide usage of this standard is coherent with the result that the diag-nosis stage is the one most addressed by a standard. ISO/IEC 17021:2011 addresses the certification bodies auditing the man-agement systems and is mostly used in screening programs according to norma-tive criteria; ISO 9001:2008 is the stand-ard applied by certification bodies.

• Among different stages of care, diagnosis was the most widely addressed with any standard. This is coherent with the impor-tance of this stage for the following care decisions.

• Laboratory tests, quality management and personal competence requirements were the transversal items most addressed.

• None of the responding countries re-ported using the standard ISO/IEC 17065 for product or process certification, even though this standard could be envisioned to potentially address quality management within all the stages and aspects (or items) of breast cancer diagnosis and care. How-ever, this would require the establishment of criteria that certification bodies, accred-ited according to ISO/IEC 17065, would have to apply when certifying BCS.

6. Conclusions


These data reflect the heterogeneity in the accreditation status of breast cancer care ser-vices throughout Europe. The implementa-tion of the European QA scheme would foster a unification of the accreditation and con-formity assessment, and thus the implemen-tation of the scheme by the BCS across Eu-rope will have positive consequences on the quality of provided services.

Although this report provides detailed in-formation about accreditation and con-formity assessment of breast cancer care in Europe, the number of accredited/certified institutions is not discussed, therefore the information on the geographical prevalence and distribution of these standards cannot be derived through this survey.

7. Acknowledgements | 8. Bibliography | 9. Useful links | 35

We would like to thank Thomas Facklam (EA chair) for his input and support in an-nouncing the survey and in providing the list of contacts; Jane Beaumont (The United Kingdom Accreditation Service), for her ac-curate revision of the draft survey. We are also grateful to Hanspeter Ischi (former member of the Swiss NAB-SAS) for his very

valuable review and Manuel Florensa-Molist (JRC) for providing the design of the final product.

Most of all, we would like to express our gratitude to all those responding to the sur-vey and for the extremely valuable informa-tion they provided.

7. Acknowledgments

8. Bibliography

1. Shaw CD, Braithwaite J, Moldovan M, Nicklin W, Grgic I, Fortune T, et al. Profiling health-care accreditation organi-zations: an international survey. Int J Qual Health Care. 2013 Jul;25(3):222-31.

2. Shaw C, Groene O, Mora N, Sunol R. Accreditation and ISO certification: do they explain differences in quality man-agement in European hospitals? Int J Qual Health Care. 2010 Dec;22(6):445-51.

9. Useful links

1. http://www.iso.org/iso/home.html2. http://www.european-accreditation.org3. http://www.cen.eu/Pages/default.aspx

4. http://www.iec.ch5. https://standardsdevelopment.bsigroup.

com

http://www.iso.org/iso/home.html

http://www.european-accreditation.org

http://www.cen.eu/Pages/default.aspx

http://www.iec.ch

https://standardsdevelopment.bsigroup.com

https://standardsdevelopment.bsigroup.com

Annex I: Data protection form and questionnaire | 37

Annex I: Data protection form and questionnaire


1. Data protection form


2. Questionnaire Form 1–Core Form


3. Questionnaire Form 2–Annex Form

Annex II: E-mail communications | 61

Annex II: E-mail communications


From: JRC CANCER POLICY SUPPORTSent: 09 August 2013 12:02Subject: Ares(2013)2784082: Survey on accreditation and certification of breast cancer care in EuropeAttachments: NABs_CORE FORM_distributed.pdf; NABs_ANNEX FORM_distributed.pdf; NABs_ DATA PROTECTION_distributed.pdf

Ares(2013)2784082

Dear Madam, dear Sir,

you may already be aware of the discussions that have been taking place with the EA Chair, Dr Thomas Facklam, about the role of National Accreditation Bodies (NABs) in a very important project prompted by the European Council’s invitation to the Commission to explore the possibility of developing a voluntary accreditation scheme for breast cancer screening and care.

As a follow up of an earlier survey to Member States on how breast cancer services are being delivered across Europe, now we are directly approaching NABs in order to go into more details in the identification of ISO accreditation and/or certification/inspection standards which have an im-pact on breast cancer care and might be in place in different countries. This survey is being carried out to ensure that all EA NABs have the opportunity to provide information to the project coordina-tors, European Commission Joint Research Centre (JRC) in Ispra (Italy). The information required concerns the accreditation work that has already been undertaken in each Member State and that may contribute to supporting any or all aspects of the breast cancer care pathway.

The survey is enclosed (first two attachments) in this mail and the third attachment is the data privacy statement.

As regards the survey, please note the following important points:

1) The survey consists in two different forms: CORE and ANNEX. CORE form should be filled in as first because it includes the gate questions that determine the necessity to compile the ANNEX one. The number of ANNEX forms to be filled in is variable and depends to the answers given in the CORE form. Further instructions are available in the form itself.

2) The survey can be saved at any stage of the process. It does not therefore need to be completed in one go.

3) The survey can be partially completed and then sent to someone else for further completion. The form will automatically save all the answers.


4) Once the form is completed, it can be submitted by clicking on the button Submit by Email (Please always use the option “Desktop Email application”): this will send the survey response directly to us. Note however that this operation will not succeed if any of the mandatory questions have been left unanswered.

As regards the privacy statement and the agreement of consent of use of data, please check the appropriate box and then click on the button Submit by Email (Please always use the option “Desk-top Email application”): this will send the data protection form directly to us. Note that you can change/revoke your choice at any time. All you need to do is to send us an e-mail informing us of your change and we will reply with confirmation.

Please note that the deadline for submission of survey responses is 15/09/2013.

If you should need any further information, please do not hesitate to contact us at this e-mail box or via the phone numbers listed in the questionnaire and/or visit our webpage:http://ihcp.jrc.ec.europa.eu/our_activities/public-health/cancer_policy_support.

We would like to thank you and your collaborators in advance for dedicating your time to complet-ing this questionnaire. Since the information you provide will be important to design the accredita-tion scheme that must be implementable in all EU Member States and in the other participating countries, we kindly ask you to provide as much information as possible.

Best regards,

Silvia DEANDREAon behalf of Healthcare Quality group_______________________________________

SILVIA DEANDREAMD, PhD

European CommissionDG Joint Research Centre (JRC)Institute for Health and Consumer ProtectionPublic Health Policy Support UnitVia E. Fermi 2749I-21027 Ispra (VA)/ItalyPhone: +39 0332 [email protected]

http://ihcp.jrc.ec.europa.eu/our_activities/public-health/cancer_policy_support

mailto:silvia.deandrea%40ec.europa.eu?subject=


From: JRC CANCER POLICY SUPPORTSent: 05 June 2014 09:15Subject: Approval of data in “Survey on accreditation and certification of Breast Cancer Care”

Dear Sir/Madam,

Thanks to the efforts and cooperation of you and the other survey participants, we are finalising a report on Survey on accreditation and certification of Breast Cancer Care.

In the file enclosed you can find the data that you have provided showed in a tabular representation; due to confidentiality issues, you see only the row corresponding to your country. As these tables correspond to what will be actually published in the final report, we suggest that you carefully check the content. An official request for consent to publication will immediately follow your data approval.

In order to make this data available to European citizens and stakeholders as soon as possible, we would ask to provide an answer by June 17th. As for the previous step of the survey, we are fully available for any support or clarification needed.

We would like to thank you again for the time you dedicated for contributing to such an important collection of information and to the final document derived.

With grateful greetings by the JRC team on Healthcare Quality,

Asli Uluturk

DG Joint Research CentreInstitute for Health and Consumer ProtectionPublic Health Policy SupportBuilding 58AVia Enrico Fermi 274921027 Ispra (VA)ITALY+39 [email protected]

mailto:Asli.ULUTURK%40ec.europa.eu?subject=


From: JRC CANCER POLICY SUPPORTSent: 06 August 2014 14:29Subject: Publication of the “Survey on accreditation and certification of Breast Cancer Care”

Dear Sir/Madam,

Thanks to the efforts and cooperation of you and other survey participants, we are now finalising the “Survey on accreditation and certification of Breast Cancer Care” and we envisage having it published within few weeks.

We are coming back to you in order to ask your consent for the publication of the data that you provided last year and that you confirmed with your last e-mail on DD/MM/YYY: this can be done by simply replying YES to this e-mail. If we do not hear from you by 13/08/2014, we will apply the rule “Silence gives consent” (consensus is assumed when there’s no evidence of disagreement).

With kindest regards,

Asli ULUTURK

We are recruiting: http://recruitment.jrc.ec.europa.eu/?type=GH.

DG Joint Research CentreInstitute for Health and Consumer ProtectionPublic Health Policy SupportBuilding 58AVia Enrico Fermi 274921027 Ispra (VA)ITALY+39 [email protected]

http://recruitment.jrc.ec.europa.eu/?type=GH

mailto:Asli.ULUTURK%40ec.europa.eu?subject=

Annex III: Tables | 67

Annex III: Tables


Table 1. ISO standards used in countries and stages of breast cancer care addressed by the standard.

Gate questions:

• Are there any organisations accredited or holding accredited certification/inspection for activities part of or relevant for breast cancer care?

• Are these organisations treating breast cancer either before (e.g. screening, early diagnosis, biopsy, analysis) or after the diagnosis?

Questions on the standards for Breast Cancer Care:

• Name of the standard(s) used.• Breast cancer stages addressed by the standard in the healthcare institutions present in the

country.• Transversal items addressed by the standard in the healthcare institutions present in the

country.


Table 1. (cont.)

Coun

try

Is th

ere

an a

ccre

dite

d/

cert

ified

org

anis

atio

n Is

thi

s or

gani

sati

on

diag

nos i

ng o

r tr

eati

ng

brea

st c

ance

r

Whi

ch s

tand

ards

are

in p

lace

Whi

ch b

reas

t ca

ncer

sta

ges

are

add

ress

ed b

y th

e st

anda

rdW

hich

tra

nsve

rsal

item

s

are

addr

esse

d by

the

stan

dard

ATYe

sYe

sIS

O/IE

C 17

021:

2011

(und

er IS

O

9001

:200

8)Sc

reen

ing

Dia

gnos

isTr

eatm

ent

BEYe

sYe

sIS

O 1

5189

:200

7D

iagn

osis

–bi

opsy

and

tiss

ue

hist

olog

y, m

olec

ular

test

ing

to

dete

ct a

ny m

utat

ions

cau

sing

br

east

can

cer o

r infl

uenc

ing

trea

tmen

t (fo

r exa

mpl

e: H

ER2/

neu

FISH

: if

posi

tive,

a tr

eat-

men

t with

her

cept

in w

ill b

e st

arte

d).

Path

olog

y, la

bora

tory

test

s,

med

icat

ion

man

agem

ent,

qual

-ity

man

agem

ent,

pers

onne

l co

mpe

tenc

e re

quire

men

ts

BGYe

sN

oIS

O/IE

C 17

021:

2011

(und

er IS

O

9001

:200

8)Sc

reen

ing

Dia

gnos

is

Trea

tmen

t Su

rviv

orsh

ip a

nd m

anag

e-m

ent

of r

ecur

renc

e

CYN

oN

R*–

––

CZYe

sYe

sIS

O 1

5189

:201

2D

iagn

osis

–bio

psy

and

tissu

e hi

stol

ogy

Path

olog

y, la

bora

tory

test

s

ISO

/IEC

1702

1:20

11 (u

nder

ISO

90

01:2

008,

ISO

134

85:2

003,

IS

O/IE

C 27

001:

2013

)

Scre

enin

g–

orga

nise

d sc

reen

-in

g fo

r asy

mpt

omat

ic w

omen

, sc

reen

ing

of c

olor

ecta

l car

ci-

nom

a, c

arci

nom

a ce

rvic

is u

teri,

ca

rcin

oma

of th

e pr

osta

te g

land

Dia

gnos

is–

aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bio

psy

and

tissu

e hi

stol

ogy

Trea

tmen

t–su

rger

y, b

reas

t re

cons

truc

tion,

radi

othe

rapy

, ch

emot

hera

py, P

ET c

ente

rsSu

rviv

orsh

ip a

nd m

anag

emen

t of

recu

rren

ce–f

ollo

w-u

p an

d m

anag

emen

t of r

ecur

renc

e, p

al-

liativ

e ca

re a

nd e

nd-o

f-lif

e ca

re

Mam

mog

raph

y, u

ltras

ound

s,

MRI

, Inf

orm

atio

n sy

stem

, qua

l-ity

man

agem

ent


Table 1. (cont.)

Coun

try

Is th

ere

an a

ccre

dite

d/

cert

ified

org

anis

atio

n Is

thi

s or

gani

sati

on

diag

nos i

ng o

r tr

eati

ng

brea

st c

ance

r

Whi

ch s

tand

ards

are

in p

lace

Whi

ch b

reas

t ca

ncer

sta

ges

are

add

ress

ed b

y th

e st

anda

rdW

hich

tra

nsve

rsal

item

s

are

addr

esse

d by

the

stan

dard

DE

Yes

Yes

ISO

151

89:2

012

Dia

gnos

is–

aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing

Labo

rato

ry te

sts

ISO

/IEC

1702

0:20

12D

iagn

osis

–bi

opsy

and

tiss

ue

hist

olog

yPa

thol

ogy

DK

No

NR*

––

–

EEYe

sYe

sIS

O 1

5189

:201

2D

iagn

osis

–as

pira

tion

of fl

uid

and

subs

eque

nt te

stin

g, b

iops

y an

d tis

sue

hist

olog

y, B

RCA1

an

d 2

test

s

–

ESYe

sYe

sIS

O/IE

C 17

021:

2011

(und

er IS

O

9001

:200

8)Th

e w

hole

bre

ast

canc

er

path

way

Mam

mog

raph

y, u

ltras

ound

, M

RI, p

atho

logy

, lab

orat

ory

test

s, q

ualit

y m

anag

emen

t, pe

rson

nel c

ompe

tenc

e re

quire

-m

ents

, hyg

iene

, saf

ety

ISO

151

89:2

012

Scre

enin

g–

orga

nise

d sc

reen

-in

g fo

r asy

mpt

omat

ic w

omen

Dia

gnos

is–

aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bio

psy

and

tissu

e hi

stol

ogy,

mol

ecul

ar

path

olog

y: e

.g.;

HER

2

Path

olog

y, la

bora

tory

test

ing,

in

form

atio

n sy

stem

s, q

ual-

ity m

anag

emen

t, pr

ofici

ency

te

stin

g, p

erso

nnel

com

pete

nce

requ

irem

ents

, hyg

iene

, saf

ety

ISO

/IEC

1702

5:20

05Tr

eatm

ent–

radi

othe

rapy

, the

re

is o

ne l

abor

ator

y ac

cred

ited

for c

alib

ratio

n of

the

stan

d-ar

d us

ed fo

r the

rapy

leve

ls,

Gam

ma

radi

atio

n of

Cob

alt 6

0,

0,81

Gy/

min

, CM

C=0,

8 %


Table 1. (cont.)

Coun

try

Is th

ere

an a

ccre

dite

d/

cert

ified

org

anis

atio

n Is

thi

s or

gani

sati

on

diag

nos i

ng o

r tr

eati

ng

brea

st c

ance

r

Whi

ch s

tand

ards

are

in p

lace

Whi

ch b

reas

t ca

ncer

sta

ges

are

add

ress

ed b

y th

e st

anda

rdW

hich

tra

nsve

rsal

item

s

are

addr

esse

d by

the

stan

dard

FIYe

sYe

sIS

O 1

5189

:201

2D

iagn

osis

–as

pira

tion

of fl

uid

and

subs

eque

nt te

stin

g, b

iops

y an

d tis

sue

hist

olog

y

Path

olog

y, la

bora

tory

test

ing,

co

mm

unic

atio

n, in

form

atio

n sy

stem

s, q

ualit

y m

anag

emen

t, pr

ofici

ency

test

ing,

, pe

rson

-ne

l com

pete

nce

requ

irem

ents

, hy

gien

e, s

afet

y

ISO

/IEC

1702

5:20

05D

iagn

osis

–as

pira

tion

of fl

uid

and

subs

eque

nt te

stin

g, b

iops

y an

d tis

sue

hist

olog

y

Path

olog

y, la

bora

tory

test

ing,

co

mm

unic

atio

n, in

form

atio

n sy

stem

s, q

ualit

y m

anag

emen

t, pr

ofici

ency

test

ing,

per

sonn

el

com

pete

nce

requ

irem

ents

, hy

gien

e, s

afet

y

ISO

/IEC

1702

1:20

11Sc

reen

ing

–or

gani

sed

scre

en-

ing

for a

sym

ptom

atic

wom

enTr

eatm

ent–

surg

ery,

bre

ast

reco

nstr

uctio

n, ra

diot

hera

py,

chem

othe

rapy

and

hor

mon

al

ther

apy

Mam

mog

raph

y, m

edic

atio

n m

anag

emen

t, co

mm

unic

atio

n,

info

rmat

ion

syst

ems,

qua

lity

man

agem

ent,

pers

onne

l com

-pe

tenc

e re

quire

men

ts, h

ygie

ne,

safe

ty

FR**

Yes

Not

kno

wn

ISO

151

89:2

012

Dia

gnos

is–a

spira

tion

of fl

uid

and

subs

eque

nt te

stin

g, b

iops

y an

d tis

sue

hist

olog

y

Path

olog

y, la

bora

tory

test

s

ISO

/IEC

1702

0:20

12Sc

reen

ing

–ac

cred

itatio

n of

in

spec

tion

bodi

es fo

r med

ical

de

vice

s (m

amm

ogra

phy)

Mam

mog

raph

y


Table 1. (cont.)

Coun

try

Is th

ere

an a

ccre

dite

d/

cert

ified

org

anis

atio

n Is

thi

s or

gani

sati

on

diag

nos i

ng o

r tr

eati

ng

brea

st c

ance

r

Whi

ch s

tand

ards

are

in p

lace

Whi

ch b

reas

t ca

ncer

sta

ges

are

add

ress

ed b

y th

e st

anda

rdW

hich

tra

nsve

rsal

item

s

are

addr

esse

d by

the

stan

dard

GR

Yes

Yes

ISO

151

89:2

012

Diag

nosi

s–as

pira

tion

of fl

uid

and

subs

eque

nt te

stin

g, b

iops

y an

d tis

sue

hist

olog

y , b

lood

mar

ker

test

s fo

r CA

15.3

, CA1

25, C

EA

(car

cino

embr

yoni

c an

tigen

)Tr

eatm

ent–

chem

othe

rapy

an

d ho

rmon

al th

erap

y, b

lood

ce

ll co

unts

: whi

te b

lood

cel

ls,

red

bloo

d ce

lls, h

emog

lobi

n,

hem

atoc

rit, p

late

lets

, blo

od

chem

istr

ies

: le

vels

of

liver

en

zym

es ,

leve

ls o

f po

tass

ium

, ch

lorid

e, a

nd u

rea

nitr

ogen

lev-

els,

cal

cium

leve

ls, b

lood

sug

ar

leve

ls, d

eter

min

atio

n of

dru

g le

vels

in b

lood

, blo

od m

arke

r te

sts

for C

A 15

.3, C

A125

, CEA

(c

arci

noem

bryo

nic

antig

en),

FISH

Tes

t (Fl

uore

scen

ce In

Situ

H

ybrid

izat

ion)

, mol

ecul

ar te

sts

for m

utat

ion

anal

ysis

(eg.

real

tim

e PC

R, A

RMS

PCR,

NG

S)Su

rviv

orsh

ip a

nd m

anag

e-m

ent

of r

ecur

renc

e–

follo

w-u

p an

d m

anag

emen

t of

recu

rren

ce

Labo

rato

ry te

sts,

com

mun

i-ca

tion,

info

rmat

ion

syst

ems,

qu

ality

man

agem

ent,

profi

cien

-cy

test

ing,

per

sonn

el c

ompe

-te

nce

requ

irem

ents

, hyg

iene

, sa

fety

ISO

170

21:2

011

(ISO

90

01:2

008)

Scre

enin

g–

orga

nise

d sc

reen

-in

g fo

r asy

mpt

omat

ic w

omen

Dia

gnos

is–

aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bio

psy

and

tissu

e hi

stol

ogy

Mam

mog

raph

y, u

ltras

ound

, M

RI, l

abor

ator

y te

sts,

qua

lity

man

agem

ent,

pers

onne

l com

-pe

tenc

e re

quire

men

ts, h

ygie

ne,

safe

ty

ISO

170

25:2

005

Dia

gnos

is–

Labo

rato

ry’s

equ

ip-

men

t cal

ibra

tion.

Trea

tmen

t–M

olec

ular

and

cel

l bi

olog

y te

sts

for r

esea

rch

use

only

(eg.

cel

l via

bilit

y te

st, g

ene

expr

essi

on a

naly

sis)

.

Labo

rato

ry te

sts,

qua

lity

man

-ag

emen

t, pr

ofici

ency

test

ing,

pe

rson

nel c

ompe

tenc

e re

quire

-m

ents

, res

earc

h, e

quip

men

t ca

libra

tion

and

met

rolo

gica

l tr

acea

bilit

y


Table 1. (cont.)

Coun

try

Is th

ere

an a

ccre

dite

d/

cert

ified

org

anis

atio

n Is

thi

s or

gani

sati

on

diag

nos i

ng o

r tr

eati

ng

brea

st c

ance

r

Whi

ch s

tand

ards

are

in p

lace

Whi

ch b

reas

t ca

ncer

sta

ges

are

add

ress

ed b

y th

e st

anda

rdW

hich

tra

nsve

rsal

item

s

are

addr

esse

d by

the

stan

dard

HR

Yes

Yes

ISO

151

89:2

012

Trea

tmen

t–ch

emot

hera

py a

nd

horm

onal

ther

apy

IEYe

sYe

sIS

O 1

5189

:201

2D

iagn

osis

–as

pira

tion

of fl

uid

and

subs

eque

nt te

stin

g, b

iops

y an

d tis

sue

hist

olog

y

ITYe

sN

R*IS

O/IE

C 17

021:

2011

(und

er IS

O

9001

:200

8)Th

e w

hole

bre

ast

canc

er

path

way

Mam

mog

raph

y, u

ltras

ound

, M

RI, p

atho

logy

, lab

orat

ory

test

s, m

edic

atio

n m

anag

emen

t, co

mm

unic

atio

n, in

form

atio

n sy

stem

s, q

ualit

y m

anag

emen

t, pr

ofici

ency

test

ing,

per

sonn

el

com

pete

nce

requ

irem

ents

, hy

gien

e, s

afet

y, re

sear

ch

LTYe

sN

ot k

now

nIS

O/IE

C 17

021:

2011

(und

er IS

O

9001

:200

8)Sc

reen

ing

–or

gani

sed

scre

en-

ing

for a

sym

ptom

atic

wom

enD

iagn

osis

- as

pira

tion

of fl

uid

and

subs

eque

nt te

stin

g, b

iops

y an

d tis

sue

hist

olog

yTr

eatm

ent–

surg

ery,

radi

o-th

erap

y, c

hem

othe

rapy

and

ho

rmon

al th

erap

y

Mam

mog

raph

y, u

ltras

ound

, M

RI, l

abor

ator

y te

sts,

med

ica-

tion

man

agem

ent,

com

mun

i-ca

tion,

info

rmat

ion

syst

ems,

qu

ality

man

agem

ent,

pers

onne

l co

mpe

tenc

e re

quire

men

ts

LUN

oN

R*–

––

ME

No

NR*

––

–

MK

No

NR*

––

–

NL

Yes

Yes

ISO

151

89:2

012

Dia

gnos

is–

biop

sy a

nd ti

ssue

hi

stol

ogy

Profi

cien

cy te

stin

g


Table 1. (cont.)

Coun

try

Is th

ere

an a

ccre

dite

d/

cert

ified

org

anis

atio

n Is

thi

s or

gani

sati

on

diag

nos i

ng o

r tr

eati

ng

brea

st c

ance

r

Whi

ch s

tand

ards

are

in p

lace

Whi

ch b

reas

t ca

ncer

sta

ges

are

add

ress

ed b

y th

e st

anda

rdW

hich

tra

nsve

rsal

item

s

are

addr

esse

d by

the

stan

dard

PLYe

sYe

sIS

O/IE

C 17

021:

2011

(und

er IS

O

9001

:200

8)Th

e w

hole

bre

ast

canc

er

path

way

–su

rger

y, ra

diot

hera

py,

chem

othe

rapy

and

hor

mon

al

ther

apy,

psy

chos

ocia

l car

e

Mam

mog

raph

y, u

ltras

ound

, M

RI, p

atho

logy

, lab

orat

ory

test

s, m

edic

atio

n m

anag

emen

t, co

mm

unic

atio

n, in

form

atio

n sy

stem

s, q

ualit

y m

anag

e-m

ent,

pers

onne

l com

pete

nce

requ

irem

ents

, hyg

iene

, saf

ety,

re

sear

ch

ISO

/IEC

1702

1:20

11 (u

nder

ISO

14

001:

2004

)Th

e w

hole

bre

ast

canc

er

path

way

–su

rger

y, ra

diot

hera

py,

chem

othe

rapy

and

hor

mon

al

ther

apy,

psy

chos

ocia

l car

e

Mam

mog

raph

y, u

ltras

ound

, M

RI, p

atho

logy

, lab

orat

ory

test

s, m

edic

atio

n m

anag

emen

t, co

mm

unic

atio

n, in

form

atio

n sy

stem

s, q

ualit

y m

anag

e-m

ent,

pers

onne

l com

pete

nce

requ

irem

ents

, hyg

iene

, saf

ety,

re

sear

ch

ISO

/IEC

1702

1:20

11 (u

nder

ISO

/IE

C TR

180

01:2

004)

The

who

le b

reas

t ca

ncer

pa

th w

ay–

surg

ery,

radi

othe

rapy

, ch

emot

hera

py a

nd h

orm

onal

th

erap

y, p

sych

osoc

ial c

are

Mam

mog

raph

y, u

ltras

ound

, M

RI, p

atho

logy

, lab

orat

ory

test

s, m

edic

atio

n m

anag

emen

t, co

mm

unic

atio

n, in

form

atio

n sy

stem

s, q

ualit

y m

anag

e-m

ent,

pers

onne

l com

pete

nce

requ

irem

ents

, hyg

iene

, saf

ety,

re

sear

ch


Table 1. (cont.)

Coun

try

Is th

ere

an a

ccre

dite

d/

cert

ified

org

anis

atio

n Is

thi

s or

gani

sati

on

diag

nos i

ng o

r tr

eati

ng

brea

st c

ance

r

Whi

ch s

tand

ards

are

in p

lace

Whi

ch b

reas

t ca

ncer

sta

ges

are

add

ress

ed b

y th

e st

anda

rdW

hich

tra

nsve

rsal

item

s

are

addr

esse

d by

the

stan

dard

RSYe

sYe

sIS

O 1

5189

:201

2Sc

reen

ing

–gen

etic

stu

dies

–one

la

b is

accr

edita

tion

per I

SO 1

5189

: 20

12 (e

xam

inat

ion

of m

utat

ions

in

BRC

A-1

and

Brca

-2 g

ene)

Dia

gnos

is–

biop

sy a

nd ti

ssue

hi

stol

ogy,

Cyt

opat

holo

gica

l ex

amin

atio

n of

bio

psy-

mon

-oc

lona

l ant

ibod

y (1

lab)

ISO

15

189:

2012

Trea

tmen

t–su

rger

y, ra

dio-

ther

apy,

che

mot

hera

py a

nd

horm

onal

ther

apy

Surv

ivor

ship

and

man

age-

men

t of

rec

urre

nce

Path

olog

y, la

bora

tory

test

s,

profi

cien

cy te

stin

g , p

erso

n-ne

l com

pete

nce

requ

irem

ents

, hy

gien

e, s

afet

y, re

sear

ch

SEYe

sYe

sIS

O/IE

C 17

021:

2011

(ISO

/IEC

2700

1:20

13)

The

who

le b

reas

t ca

ncer

pa

thw

ayM

amm

ogra

phy,

ultr

asou

nd,

path

olog

y, la

bora

tory

test

s,

med

icat

ion

man

agem

ent,

info

rmat

ion

syst

ems,

qua

lity

man

agem

ent,

pers

onne

l com

-pe

tenc

e re

quire

men

ts, h

ygie

ne

ISO

/IEC

1702

1:20

11 (I

SO

9001

:200

8)Th

e w

hole

bre

ast

canc

er

path

way

Mam

mog

raph

y, u

ltras

ound

, pa

thol

ogy,

labo

rato

ry te

sts,

m

edic

atio

n m

anag

emen

t, in

form

atio

n sy

stem

s, q

ualit

y m

anag

emen

t, pe

rson

nel c

om-

pete

nce

requ

irem

ents

, hyg

iene

ISO

/IEC

1702

5:20

05 a

nd/o

r ISO

15

189:

2012

Scre

enin

g–

orga

nise

d sc

reen

-in

g fo

r asy

mpt

omat

ic w

omen

Dia

gnos

is–

aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bio

psy

and

tissu

e hi

stol

ogy,

Mol

ecul

ar

biol

ogy

met

hods

, Im

mun

o hi

s-to

lgy

met

hods

, Flo

w c

ytom

etry

Surv

ivor

ship

and

man

agem

ent

of r

ecur

renc

e–

follo

w-u

p an

d m

anag

emen

t of

recu

rren

ces

Mam

mog

raph

y, p

atho

logy

, la

bora

tory

test

s, q

ualit

y m

an-

agem

ent,

profi

cien

cy te

stin

g, ,

pers

onne

l com

pete

nce

requ

ire-

men

ts


Table 1. (cont.)

Coun

try

Is th

ere

an a

ccre

dite

d/

cert

ified

org

anis

atio

n Is

thi

s or

gani

sati

on

diag

nos i

ng o

r tr

eati

ng

brea

st c

ance

r

Whi

ch s

tand

ards

are

in p

lace

Whi

ch b

reas

t ca

ncer

sta

ges

are

add

ress

ed b

y th

e st

anda

rdW

hich

tra

nsve

rsal

item

s

are

addr

esse

d by

the

stan

dard

SIN

oN

R*–

––

UK

Yes

Yes

ISO

151

89:2

012

Dia

gnos

is–

aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bio

psy

and

tissu

e hi

stol

ogy

Surv

ivor

ship

–fo

llow

-up

and

man

agem

ent o

f re

curr

ence

s

Path

olog

y, la

bora

tory

test

s,

com

mun

icat

ion,

info

rmat

ion

syst

ems,

qua

lity

man

agem

ent,

profi

cien

cy te

stin

g, ,

pers

on-

nel c

ompe

tenc

e re

quire

men

ts,

hygi

ene,

saf

ety

ISO

/IEC

1702

1:20

11 (u

nder

ISO

90

01:2

008)

Qua

lity

man

agem

ent

ISO

/IEC

1702

1:20

11 (I

SO/IE

C 27

001:

2013

)In

form

atio

n sy

stem

s

Clin

ical

Pat

holo

gy A

ccre

dita

tion

stan

dard

(lab

orat

orie

s ar

e un

-de

rgoi

ng tr

ansi

tion

to U

KAS

ac-

cred

itatio

n to

ISO

151

89:2

012)

Dia

gnos

is–

aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bio

psy

and

tissu

e hi

stol

ogy

Surv

ivor

ship

and

man

age-

men

t of

rec

urre

nce

–fo

llow

-up

and

man

agem

ent o

f rec

urre

nces

, th

e sa

mpl

ing

and

exam

inat

ion

of

aspi

rate

s an

d bi

opsi

es d

urin

g fo

llow

-up

surv

eilla

nce

activ

ities

.

Path

olog

y, la

bora

tory

test

s,

com

mun

icat

ion,

info

rmat

ion

syst

ems,

qua

lity

man

agem

ent,

profi

cien

cy te

stin

g, p

erso

nnel

co

mpe

tenc

e re

quire

men

ts,

hygi

ene,

saf

ety


Table 1. (cont.)

Coun

try

Is th

ere

an a

ccre

dite

d/

cert

ified

org

anis

atio

n Is

thi

s or

gani

sati

on

diag

nos i

ng o

r tr

eati

ng

brea

st c

ance

r

Whi

ch s

tand

ards

are

in p

lace

Whi

ch b

reas

t ca

ncer

sta

ges

are

add

ress

ed b

y th

e st

anda

rdW

hich

tra

nsve

rsal

item

s

are

addr

esse

d by

the

stan

dard

UK

(con

t.)Im

agin

g Se

rvic

es A

ccre

dita

tion

Sc

hem

e (IS

AS) w

hich

has

be

en ‘m

appe

d’ a

gain

st IS

O/

IEC

1702

0:20

12 a

nd IS

O

1518

9:20

12

Dia

gnos

is–

Sym

ptom

atic

sc

reen

ing,

dia

gnos

tic m

amm

o-gr

aphy

, dia

gnos

tic u

ltras

ound

an

d ot

her i

mag

ing

and

inte

rven

-tio

nal r

adio

logy

ser

vice

s.Su

rviv

orsh

ip a

nd m

anag

e-m

ent

of r

ecur

renc

e–

Follo

w-u

p an

d m

anag

emen

t of r

ecur

renc

-es

, per

iodi

c im

agin

g an

d in

ter-

vent

iona

l rad

iolo

gy s

cree

ning

to

det

ect p

oten

tial r

ecur

renc

e.

Mam

mog

raph

y, u

ltras

ound

, M

RI, c

omm

unic

atio

n, in

form

a-tio

n sy

stem

s, q

ualit

y m

anag

e-m

ent,

pers

onne

l com

pete

nce

requ

irem

ents

, hyg

iene

, saf

ety,

re

sear

ch(T

he S

tand

ard

is d

esig

ned

to b

e ap

plie

d to

all

curr

ent i

mag

ing

mod

aliti

es a

nd to

inte

rven

tiona

l ra

diol

ogy

serv

ices

: gen

eral

x-

ray;

ultr

asou

nd; c

ompu

ted

tom

ogra

phy

(CT)

; int

erve

n-tio

nal r

adio

logy

(IR)

; mag

netic

re

sona

nce

imag

ing

(MRI

); du

al

ener

gy x

-ray

abs

orpt

ion

(DEX

A);

radi

onuc

lide

imag

ing

(RN

I);

sym

ptom

atic

bre

ast m

amm

og-

raph

y. N

on-i

mag

ing

aspe

cts

of N

ucle

ar M

edic

ine

(incl

udin

g ra

diop

harm

acy)

and

asy

mpt

o-m

atic

bre

ast s

cree

ning

ser

vice

s ar

e no

t cur

rent

ly in

clud

ed in

th

e sc

ope

of th

is S

tand

ard.

)

* N

R: N

ot R

epor

ted.

Rel

evan

t dat

a w

as n

ot p

rovi

ded

or th

at th

e qu

estio

n w

as n

ot re

leva

nt ta

king

into

con

side

ratio

n th

e an

swer

s to

pre

viou

s qu

estio

ns.

** I

SO/I

EC

1702

1:20

11 a

nd I

SO/I

EC

1706

5:20

12 m

aybe

in u

se b

ut th

e re

spon

dent

cho

se n

ot to

repo

rt th

e in

form

atio

n du

e to

unc

erta

in/m

issi

ng d

ata.


Table 2. Overview of the breast cancer stages addressed by the standard.

Questions:

• ISO standard used for accreditation or accredited certification/inspection for activities part of or relevant for breast cancer care.

• Countries using the standard.• The breast cancer stages covered by the standard.


Table 2. (cont.)

ISO

sta

ndar

dCo

untr

ies

usin

g th

e st

anda

rdTh

e w

hole

bre

ast

canc

er p

athw

aySc

reen

ing

Dia

gnos

isTr

eatm

ent

Surv

ivor

ship

an

d fo

llow

-up

Tran

sver

sal

Item

s

ISO

15

189:

2012

BE, C

Z, D

E, E

E, E

S,

FI, F

R, G

R, H

R, IE

, N

L, R

S, S

E, U

K

ES, S

E, R

SBE

, CZ,

DE,

EE,

ES,

FI

, FR,

GR,

IE, N

L,

RS, S

E, U

K

GR,

HR,

RS,

G

R, S

E, U

KBE

, CZ,

DE,

ES,

FR,

G

R, N

L, R

S, U

K

ISO

/IEC

1702

0:20

12D

E, F

RFR

DE

DE,

FR

ISO

/IEC

1702

1:20

11AT

¹, BG

¹, CZ

³, ES

¹, FI

, GR¹

, IT¹

, LT¹

, PL

⁴, SE

², U

K²

ES, I

T, P

L, S

EAT

, CZ,

FI,

GR,

,LT

AT, C

Z, F

I, LT

AT, C

Z, F

I, LT

CZCZ

, ES,

FI,

IT, L

T,

PL, S

E, U

K

ISO

/IEC

1702

5:20

05ES

, FI,

GR,

SE

SEFI

, GR,

SE

ES, G

RSE

SE

Clin

ical

Pat

holo

gy

Accr

edit

atio

n st

anda

rd

UK

UK

UK

UK

Imag

ing

Serv

ices

Ac

cred

itat

ion

Sche

me

UK

UK

UK

UK

1. Th

ese

coun

trie

s us

ed th

e IS

O/I

EC

1702

1:20

11 u

nder

the

man

agem

ent s

yste

m s

tand

ard

ISO

900

1:20

08.

2.

Thes

e co

untr

ies

used

the

ISO

/IE

C 17

021:

2011

und

er th

e m

anag

emen

t sys

tem

sta

ndar

ds I

SO 9

001:

2008

and

ISO

/IE

C 2

7001

:201

3.3.

C

Z u

sed

the

ISO

/IE

C 17

021:

2011

und

er th

e m

anag

emen

t sys

tem

sta

ndar

ds I

SO 9

001:

2008

, ISO

1348

5:20

03 a

nd I

SO/I

EC

270

01:2

013.

4.

PL u

sed

the

ISO

/IE

C 17

021:

2011

und

er th

e m

anag

emen

t sys

tem

sta

ndar

ds I

SO 9

001:

2008

, ISO

1400

1:20

04 a

nd I

SO/I

EC

TR

1800

1:20

04.


Table 3. Detailed description of breast cancer stages addressed by standards in each country.

Questions:


• Countries using the standard.• The breast cancer stages covered by the standard.


Table 3. (cont.)

ISO

sta

ndar

dCo

untr

ies

usin

g

the

stan

dard

The

who

le b

reas

t ca

ncer

pat

hway

Scre

enin

gD

iagn

osis

Trea

tmen

tSu

rviv

orsh

ip

and

follo

w-u

p

ISO

15

189:

2012

BEN

oN

oBi

opsy

and

tiss

ue

his t

olog

y, m

olec

ular

te

stin

g to

det

ect a

ny

mut

atio

ns c

ausi

ng

brea

st c

ance

r or

influ

enci

ng tr

eatm

ent

(for

exa

mpl

e: H

ER2/

Neu

FIS

H: i

f po

sitiv

e,

a tr

eatm

ent w

ith h

er-

cept

in w

ill b

e st

arte

d).

No

No

CZN

oN

oBi

opsy

and

tiss

ue

hist

olog

yN

oN

o

DE

No

No

Aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing

No

No

EEN

oN

oAs

pira

tion

of fl

uid

and

subs

eque

nt te

stin

g,

biop

sy a

nd ti

ssue

hi

stol

ogy,

BRC

A1 a

nd

BRCA

2 te

sts

No

No

ESN

oO

rgan

ised

scr

eeni

ng

for a

sym

ptom

atic

w

omen

Aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bi

opsy

and

tiss

ue

hist

olog

y, m

olec

ular

pa

thol

ogy:

e.g

.; H

ER-2

No

No

FIN

oN

oAs

pira

tion

of fl

uid

and

subs

eque

nt te

stin

g,

biop

sy a

nd ti

ssue

hi

stol

ogy

No

No

FRN

oN

oAs

pira

tion

of fl

uid

and

subs

eque

nt te

stin

g,

biop

sy a

nd ti

ssue

hi

stol

ogy

No

No


Table 3. (cont.)

ISO

sta

ndar

dCo

untr

ies

usin

g

the

stan

dard

The

who

le b

reas

t ca

ncer

pat

hway

Scre

enin

gD

iagn

osis

Trea

tmen

tSu

rviv

orsh

ip

and

follo

w-u

p

ISO

15

189:

2012

(con

t.)

GR

No

No

Aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bi

opsy

and

tiss

ue h

is-

tolo

gy, b

lood

mar

ker

test

s fo

r CA

15.3

, CA

125,

CEA

(car

ci-

noem

bryo

nic

antig

en)

See

Tabl

e 6

Follo

w-u

p an

d

man

agem

ent o

f re

curr

ence

HR

No

No

No

Chem

othe

rapy

and

ho

rmon

al th

erap

yN

o

IEN

oN

oAs

pira

tion

of fl

uid

and

subs

eque

nt te

stin

g,

biop

sy a

nd ti

ssue

hi

stol

ogy

No

No

NL

No

No

Biop

sy a

nd ti

ssue

hi

stol

ogy

No

No

RSN

oG

enet

ic s

tudi

es–

one

labo

rato

ry is

acc

red-

ited

(exa

min

atio

n of

m

utat

ions

in B

RCA-

1 an

d BR

CA-2

gen

e)

Aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bi

opsy

and

tiss

ue

hist

olog

y, c

ytop

atho

-lo

gica

l exa

min

atio

n of

bio

psy-

mon

oclo

nal

antib

ody

(1 la

b)

Surg

ery

, rad

ioth

erap

y,

chem

othe

rapy

and

ho

rmon

al th

erap

y, Im

-m

unoc

hem

ical

met

h-od

s (C

A 15

-3; C

EA)

(7 la

bs),

Cyto

path

o-lo

gica

l exa

min

atio

n of

bio

psy-

mon

oclo

nal

antib

ody

(1 la

b)

See

Tabl

e 7

SEN

oO

rgan

ised

scr

eeni

ng

for a

sym

ptom

atic

w

omen

Aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bi

opsy

and

tiss

ue

hist

olog

y, m

olec

ular

bi

olog

y m

etho

ds, i

m-

mun

ohis

tolo

gy m

eth-

ods,

flow

cyt

omet

ry

No

Follo

w-u

p an

d

man

agem

ent o

f re

curr

ence

UK

No

No

Aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bi

opsy

and

tiss

ue

hist

olog

y

No

Follo

w-u

p an

d m

an-

agem

ent o

f re

cur-

renc

e


Table 3. (cont.)

ISO

sta

ndar

dCo

untr

ies

usin

g

the

stan

dard

The

who

le b

reas

t ca

ncer

pat

hway

Scre

enin

gD

iagn

osis

Trea

tmen

tSu

rviv

orsh

ip

and

follo

w-u

p

ISO

/IEC

1702

0:20

12D

EN

oN

oBi

opsy

and

tiss

ue

hist

olog

y N

oN

o

FRN

oAc

cred

itatio

n of

in

spec

tion

bodi

es

for m

edic

al d

evic

es

(mam

mog

raph

y) e

x-te

rnal

qua

lity

cont

rol

No

No

No

ISO

/IEC

1702

1:20

11AT

(und

er

ISO

900

1:20

08)

No

See

Tabl

e 4

See

Tabl

e 5

See

Tabl

e 6

No

BG (u

nder

IS

O 9

001:

2008

)N

oBA

S ha

ve n

ot in

for-

mat

ion

rela

ted

BA

S ha

ve n

ot in

for-

mat

ion

rela

ted

BAS

have

not

info

r-m

atio

n re

late

d BA

S do

es n

ot h

ave

info

rmat

ion

rela

ted

to

the

topi

c

CZ (u

nder

IS

O 9

001:

2008

, IS

O 1

3485

:200

3,

ISO

270

01:2

013)

No

Org

anis

ed s

cree

ning

fo

r asy

mpt

omat

ic

wom

en, c

olor

ecta

l ca

ncer

cer

vica

l can

-ce

r, pr

osta

te c

ance

r

Aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bi

opsy

and

tiss

ue

hist

olog

y

Surg

ery,

bre

ast r

econ

-st

ruct

ion,

radi

othe

ra-

py, c

hem

othe

rapy

, PET

ce

nter

s

Follo

w-u

p an

d m

an-

agem

ent o

f re

cur-

renc

e, p

allia

tive

care

an

d en

d-of

-life

car

e

ES (u

nder

IS

O 9

001:

2008

)Th

e w

hole

bre

ast

canc

er p

athw

ay–

––

–

FI (u

nder

IS

O 9

001:

2008

)N

oO

rgan

ised

scr

eeni

ng

for a

sym

ptom

atic

w

omen

No

Surg

ery,

bre

ast r

econ

-st

ruct

ion,

radi

othe

ra-

py, c

hem

othe

rapy

and

ho

rmon

al th

erap

y

No

GR

(und

er

ISO

900

1:20

08)

No

Org

anis

ed s

cree

ning

fo

r asy

mpt

omat

ic

wom

en

Aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bi

opsy

and

tiss

ue

hist

olog

y

No

No

IT (u

nder

IS

O 9

001:

2008

)Th

e w

hole

bre

ast

canc

er p

athw

ay–

––

–

LT (u

nder

IS

O 9

001:

2008

)N

oO

rgan

ised

scr

eeni

ng

for a

sym

ptom

atic

w

omen

Aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bi

opsy

and

tiss

ue

hist

olog

y

Surg

ery,

radi

othe

rapy

, ch

emot

hera

py a

nd

horm

onal

ther

apy

No


Table 3. (cont.)

ISO

sta

ndar

dCo

untr

ies

usin

g

the

stan

dard

The

who

le b

reas

t ca

ncer

pat

hway

Scre

enin

gD

iagn

osis

Trea

tmen

tSu

rviv

orsh

ip

and

follo

w-u

p

ISO

/IEC

1702

1:20

11(c

0nt.)

PL (u

nder

IS

O 9

001:

2008

, IS

O14

001:

2004

, IS

O/IE

C TR

180

01:2

004)

The

who

le b

reas

t ca

ncer

pat

hway

––

Surg

ery,

radi

othe

rapy

, ch

emot

hera

py a

nd

horm

onal

ther

apy

Psyc

hoso

cial

car

e

SE (u

nder

IS

O 2

7001

:201

3,

ISO

900

1:20

08)

The

who

le b

reas

t ca

ncer

pat

hway

––

––

UK

(und

er

ISO

900

1:20

08,

ISO

270

01:2

013)

No

No

No

No

No

ISO

/IEC

1702

5:20

05ES

No

No

No

Radi

othe

rapy

, the

re

is o

ne l

abor

ator

y ac

cred

ited

for c

alib

ra-

tion

of th

e st

anda

rd

used

for t

hera

py le

v-el

s, G

amm

a ra

diat

ion

of C

obal

t 60,

0,8

1 G

y/m

in, C

MC=

0,8

%

No

FIN

oN

oAs

pira

tion

of fl

uid

and

subs

eque

nt te

stin

g,

biop

sy a

nd ti

ssue

hi

stol

ogy

No

No

GR

No

No

Labo

rato

ry’s

equ

ip-

men

t cal

ibra

tion.

Mol

ecul

ar a

nd c

ell

biol

ogy

test

s fo

r re

sear

ch u

se o

nly

(eg.

ce

ll vi

abili

ty te

st, g

ene

expr

essi

on a

naly

sis)

.

No

SEN

oO

rgan

ised

scr

eeni

ng

for a

sym

ptom

atic

w

omen

Aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bi

opsy

and

tiss

ue

hist

olog

y, m

olec

ular

bi

olog

y m

etho

ds, I

m-

mun

ohis

tolo

gy m

eth-

ods,

flow

cyt

omet

ry

No

Follo

w-u

p an

d

man

agem

ent o

f re

curr

ence

s


Table 3. (cont.)

ISO

sta

ndar

dCo

untr

ies

usin

g

the

stan

dard

The

who

le b

reas

t ca

ncer

pat

hway

Scre

enin

gD

iagn

osis

Trea

tmen

tSu

rviv

orsh

ip

and

follo

w-u

p

Clin

ical

Pa

thol

ogy

Accr

edit

atio

n st

anda

rd

UK

No

No

Aspi

ratio

n of

flui

d an

d su

bseq

uent

test

ing,

bi

opsy

and

tiss

ue

hist

olog

y

No

Follo

w-u

p an

d m

an-

agem

ent o

f re

cur-

renc

es, T

he s

ampl

ing

and

exam

inat

ion

of

aspi

rate

s an

d bi

opsi

es

durin

g fo

llow

-up

sur-

veill

ance

act

iviti

es

Imag

ing

Se

rvic

es

Accr

edit

atio

n Sc

hem

e

UK

No

No

Sym

ptom

atic

scr

een-

ing,

dia

gnos

tic m

am-

mog

raph

y, d

iagn

ostic

ul

tras

ound

and

oth

er

imag

ing

and

inte

r-ve

ntio

nal r

adio

logy

se

rvic

es

No

Follo

w-u

p an

d m

an-

agem

ent o

f re

cur-

renc

es, p

erio

dic

imag

-in

g an

d in

terv

entio

nal

radi

olog

y sc

reen

ing

to d

etec

t pot

entia

l re

curr

ence


Table 4. Specific items of the screening stage addressed by the standard in place.

Questions:


• Is the screening stage addressed by the standard.• Items of the screening stage addressed by the standard.


Table 4. (cont.)

ISO

sta

ndar

dCo

untr

y us

ing

the

stan

dard

Is t

he s

cree

ning

sta

ge a

ddre

ssed

by

the

sta

ndar

dAr

e th

ese

item

s ad

dres

sed

by t

he s

tand

ard

Org

anis

ed s

cree

ning

fo

r as

ympt

omat

ic w

omen

O

ther

ISO

15

189:

2012

BE

No

NR*

–

CZN

oN

R*Co

lore

ctal

can

cer,

cerv

ix c

ance

r, pr

osta

te c

ance

r

DE

No

NR*

–

EEN

oN

R*–

ESYe

sYe

s–

FIN

oN

R*–

FRN

oN

R*–

GR

No

NR*

–

HR

No

NR*

–

IEN

oN

R*–

NL

No

Not

kno

wn

–

RSYe

sN

ot k

now

nG

enet

ic s

tudi

es-o

ne la

b is

acc

red-

ited

(exa

min

atio

n of

mut

atio

ns in

BR

CA-1

and

BRC

A-2

gene

)

SEYe

sYe

s–

UK

No

NR*

–

ISO

/IEC

1702

0:20

12D

EN

oN

R*–

FRYe

sN

R*Ac

cred

itatio

n of

insp

ectio

n bo

dies

fo

r med

ical

dev

ices

(mam

mog

ra-

phy)

ext

erna

l qua

lity

cont

rol

ISO

/IEC

1702

1:20

11AT

Yes

Not

kno

wn

–

BGN

oN

R*BA

S do

es n

ot h

ave

info

rmat

ion

rela

ted

to th

e to

pic

CZ

Yes

Yes

Colo

rect

al c

ance

r, ce

rvic

al c

ance

r, pr

osta

te c

ance

r

ES

Yes

Yes

–

FIYe

sYe

s–

GR

Yes

Yes

–


Table 4. (cont.)

ISO

sta

ndar

dCo

untr

y us

ing

the

stan

dard

Is t

he s

cree

ning

sta

ge a

ddre

ssed

by

the

sta

ndar

dAr

e th

ese

item

s ad

dres

sed

by t

he s

tand

ard

Org

anis

ed s

cree

ning

fo

r as

ympt

omat

ic w

omen

O

ther

ISO

/IEC

1702

1:20

11(c

ont.)

ITYe

sYe

s–

LTYe

sYe

s–

PLYe

sN

ot k

now

n–

SEYe

sYe

s–

UK

No

NR*

–

ISO

/IEC

1702

5:20

05ES

No

NR*

Ther

e is

one

lab

orat

ory

accr

ed-

ited

for c

alib

ratio

n of

the

stan

dard

us

ed fo

r the

rapy

leve

ls, G

amm

a ra

diat

ion

of C

obal

t 60,

0,8

1 G

y/m

in, C

MC=

0,8

%

FIN

oN

R*–

GR

No

NR*

–

SEYe

sYe

s–

Clin

ical

Pa

thol

ogy

Accr

edit

atio

n st

anda

rd

UK

No

NR*

–

Imag

ing

Se

rvic

es

Accr

edit

atio

n Sc

hem

e

UK

No

NR*

–

* N

R: N

ot R

epor

ted.

Rel

evan

t dat

a w

as n

ot p

rovi

ded

or th

at th

e qu

estio

n w

as n

ot re

leva

nt ta

king

into

con

side

ratio

n th

e an

swer

s to

pre

viou

s qu

estio

ns.


Table 5. Specific items of the diagnosis stage addressed by the standard in place.

Questions:


• Is the diagnosis stage addressed by the standard.• Items of the diagnosis stage addressed by the standard.


Table 5. (cont.)

ISO

sta

ndar

dCo

untr

y us

ing

th

e st

anda

rdIs

the

dia

gnos

is

stag

e ad

dres

sed

by

the

sta

ndar

d

Scre

enin

g

Aspi

ratio

n of

flui

d an

d su

bseq

uent

tes

ting

Bi

opsy

and

tis

sue

hist

olog

yO

ther

ISO

15

189:

2012

BEYe

sN

ot k

now

nYe

sM

olec

ular

test

ing

to d

etec

t any

mut

atio

ns

caus

ing

brea

st c

ance

r or i

nflue

ncin

g tr

eatm

ent

(for

exa

mpl

e: H

ER2/

Neu

FIS

H: i

f po

sitiv

e, a

tr

eatm

ent w

ith h

erce

ptin

will

be

star

ted)

.

CZYe

sN

oYe

s–

DE

Yes

Yes

NR*

–

EEYe

sYe

sYe

sBR

CA1,

BRC

A2 te

sts

ESYe

sYe

sYe

sM

olec

ular

Pat

holo

gy: e

.g.;

HER

2

FIYe

sYe

sYe

s–

FRYe

sYe

sYe

s–

GR

Yes

Yes

Yes

Bloo

d m

arke

r tes

ts fo

r CA

15.3

, CA1

25, C

EA

(car

cino

embr

yoni

c an

tigen

)

HR

No

NR*

NR*

–

IEYe

sYe

sYe

s–

NL

Yes

Not

kno

wn

Yes

–

RSYe

sN

R*Ye

sCy

topa

thol

ogic

al e

xam

inat

ion

of b

iops

y-m

ono c

lona

l ant

ibod

y (1

lab)

SEYe

sYe

sYe

sM

olec

ular

bio

logy

met

hods

–Im

mun

o hi

stol

gy

met

hods

–Fl

ow c

ytom

etry

UK

Yes

Yes

Yes

–

ISO

/IEC

1702

0:20

12D

EYe

sN

R*Ye

s–

FRN

oN

R*N

R*–

ISO

/IEC

1702

1:20

11AT

Yes

Not

kno

wn

Not

kno

wn

–

BGN

oN

ot k

now

nN

ot k

now

nBA

S do

es n

ot h

ave

info

rmat

ion

rela

ted

to

the

topi

c

CZYe

sYe

sYe

s–

ESYe

sYe

sYe

sYe

s

FIN

oN

R*N

R*–

GR

Yes

Yes

Yes

–


Table 5. (cont.)

ISO

sta

ndar

dCo

untr

y us

ing

th

e st

anda

rdIs

the

dia

gnos

is

stag

e ad

dres

sed

by

the

sta

ndar

d

Scre

enin

g

Aspi

ratio

n of

flui

d an

d su

bseq

uent

tes

ting

Bi

opsy

and

tis

sue

hist

olog

yO

ther

ISO

/IEC

1702

1:20

11(c

ont.)

ITYe

sYe

sYe

s–

LTYe

sYe

sYe

s–

PLYe

sN

ot k

now

nN

ot k

now

n–

SEYe

sYe

sYe

s–

UK

No

NR*

NR*

–

ISO

/IEC

1702

5:20

05ES

No

NR*

NR*

–

FIYe

sYe

sYe

s–

GR

Yes

No

No

Labo

rato

ry’s

equ

ipm

ent c

alib

ratio

n.

SEYe

sYe

sYe

sM

olec

ular

bio

logy

met

hods

–Im

mun

o hi

stol

gy

met

hods

–Fl

ow c

ytom

etry

Clin

ical

Pa

thol

ogy

Accr

edit

atio

n st

anda

rd

UK

Yes

Yes

Yes

–

Imag

ing

Se

rvic

es

Accr

edit

atio

n Sc

hem

e

UK

Yes

No

No

–

* N

R: N

ot R

epor

ted.

Rel

evan

t dat

a w

as n

ot p

rovi

ded

or th

at th

e qu

estio

n w

as n

ot re

leva

nt ta

king

into

con

side

ratio

n th

e an

swer

s to

pre

viou

s qu

estio

ns.


Table 6. Specific items of the treatment stage addressed by the standard in place.

Questions:


• Is the treatment stage addressed by the standard.• Items of the treatment stage addressed by the standard.


Table 6. (cont.)

ISO

sta

ndar

dCo

untr

y us

ing

th

e st

anda

rdIs

the

tre

atm

ent

stag

e ad

dres

sed

by

the

sta

ndar

d

Are

thes

e it

ems

addr

esse

d by

the

sta

ndar

d

Surg

ery

Brea

st

reco

nstr

ucti

onRa

diot

hera

pyCh

emot

hera

py a

nd

horm

onal

the

rapy

Oth

er

ISO

15

189:

2012

BEN

oN

R*N

R*N

R*N

R*–

CZN

oN

R*N

R*N

R*N

R*PE

T Ce

ntre

s

DE

No

NR*

NR*

NR*

NR*

–

EEN

oN

R*N

R*N

R*N

R*–

ESN

oN

R*N

R*N

R*N

R*–

FIN

oN

R*N

R*N

R*N

R*–

FRN

oN

R*N

R*N

R*N

R*–

GR

Yes

No

No

No

Yes

Bloo

d ce

ll co

unts

: w

hite

blo

od c

ells

, re

d bl

ood

cells

, he

mog

lobi

n, h

e-m

atoc

rit, p

late

lets

, bl

ood

chem

istr

y,

leve

ls o

f liv

er

enzy

mes

, le

vels

of

pot

assi

um,

chlo

ride,

and

ure

a ni

trog

en le

vels

, ca

lciu

m le

vels

, bl

ood

suga

r lev

els,

de

term

inat

ion

of d

rug

leve

ls in

bl

ood,

blo

od m

ark-

er te

sts

for C

A 15

.3, C

A125

, CEA

(c

arci

noem

bryo

nic

antig

en),

FISH

Tes

t (F

luor

esce

nce

In

Situ

Hyb

ridiz

atio

n),

mol

ecul

ar te

sts

for

mut

atio

n an

alys

is

(eg.

real

tim

e PC

R,

ARM

S PC

R, N

GS)


Table 6. (cont.)

ISO

sta

ndar

dCo

untr

y us

ing

th

e st

anda

rdIs

the

tre

atm

ent

stag

e ad

dres

sed

by

the

sta

ndar

d

Are

thes

e it

ems

addr

esse

d by

the

sta

ndar

d

Surg

ery

Brea

st

reco

nstr

ucti

onRa

diot

hera

pyCh

emot

hera

py a

nd

horm

onal

the

rapy

Oth

er

ISO

15

189:

2012

(con

t.)

HR

Yes

NR*

NR*

NR*

Yes

–

IEN

oN

R*N

R*N

R*N

R*–

NL

No

NR*

NR*

NR*

NR*

–

RSYe

sYe

sN

ot k

now

nYe

sYe

s–

Imm

unoc

hem

i-ca

l met

hods

(CA

15-3

; CEA

) (7

labs

)–

Cyto

path

olog

ical

ex

amin

atio

n of

bi-

opsy

-mon

oclo

nal

antib

ody

(1 la

b)

SEN

oN

R*N

R*N

R*N

R*–

UK

No

NR*

NR*

NR*

NR*

–

ISO

/IEC

1702

0:20

12D

EN

oN

R*N

R*N

R*N

R*–

FRN

oN

R*N

R*N

R*N

R*–

ISO

/IEC

1702

1:20

11AT

Yes

Not

kno

wn

Not

kno

wn

Not

kno

wn

Not

kno

wn

–

BGN

oN

ot k

now

nN

ot k

now

nN

ot k

now

nN

ot k

now

nBA

S do

es n

ot h

ave

info

rmat

ion

re-

late

d to

the

topi

c

CZYe

sYe

sYe

sYe

sYe

s–

ES

Yes

Yes

Yes

Yes

Yes

–

FIYe

sYe

sYe

sYe

sYe

s–

GR

No

NR*

NR*

NR*

NR*

–

IT

Yes

Yes

Yes

Yes

Yes

–

LT

Yes

Yes

Not

kno

wn

Yes

Yes

–

PL

Yes

Yes

Not

kno

wn

Yes

Yes

–

SE

Yes

Yes

Not

kno

wn

Not

kno

wn

Yes

–

UK

No

NR*

NR*

NR*

NR*

–


Table 6. (cont.)

ISO

sta

ndar

dCo

untr

y us

ing

th

e st

anda

rdIs

the

tre

atm

ent

stag

e ad

dres

sed

by

the

sta

ndar

d

Are

thes

e it

ems

addr

esse

d by

the

sta

ndar

d

Surg

ery

Brea

st

reco

nstr

ucti

onRa

diot

hera

pyCh

emot

hera

py a

nd

horm

onal

the

rapy

Oth

er

ISO

/IEC

1702

5:20

05ES

Yes

NR*

NR*

Yes

NR*

Ther

e is

one

lab

o-ra

tory

acc

redi

ted

for c

alib

ratio

n of

th

e st

anda

rd u

sed

for t

hera

py le

vels

, G

amm

a ra

diat

ion

of C

obal

t 60,

0,8

1 Gy

/min

, CM

C=0,

8 %

FIN

oN

R*N

R*N

R*N

R*–

GR

Yes

No

No

No

No

Mol

ecul

ar a

nd c

ell

biol

ogy

test

s fo

r re

sear

ch u

se o

nly

(eg.

Cel

l via

bilit

y te

st, G

ene

expr

es-

sion

ana

lysi

s)

SEN

oN

R*N

R*N

R*N

R*–

Clin

ical

Pa

thol

ogy

Accr

edit

atio

n st

anda

rd

UK

No

NR*

NR*

NR*

NR*

–

Imag

ing

Se

rvic

es

Accr

edit

atio

n Sc

hem

e

UK

No

NR*

NR*

NR*

NR*

–

* N

R: N

ot R

epor

ted.

Rel

evan

t dat

a w

as n

ot p

rovi

ded

or th

at th

e qu

estio

n w

as n

ot re

leva

nt ta

king

into

con

side

ratio

n th

e an

swer

s to

pre

viou

s qu

estio

ns.


Table 7. Specific items of the survivorship and management of recurrence stage addressed by the standard in place.

Questions:


• Is the survivorship and management of recurrence stage addressed by the standard.• Items of the survivorship and management of recurrence stage addressed by the standard.


Table 7. (cont.)

ISO

sta

ndar

dCo

untr

y us

ing

th

e st

anda

rdIs

the

surv

ivor

ship

and

man

agem

ent

of r

ecur

renc

e st

age

addr

esse

d by

the

sta

ndar

d

Are

thes

e it

ems

addr

esse

d by

the

sta

ndar

d

Follo

w-u

p

and

man

agem

ent

of r

ecur

renc

e

Psyc

hoso

cial

ca

reSu

rviv

orsh

ip

supp

ort

Palli

ativ

e ca

re

and

end-

of-li

fe

care

Oth

er

ISO

15

189:

2012

BEN

oN

R*N

R*N

R*N

R*–

CZN

oN

R*N

R*N

R*N

R*–

DE

No

NR*

NR*

NR*

NR*

–

EEN

oN

R*N

R*N

R*N

R*–

ESN

oN

R*N

R*N

R*N

R*–

FIN

oN

R*N

R*N

R*N

R*–

FRN

oN

R*N

R*N

R*N

R*–

GR

Yes

Yes

No

No

No

–

HR

No

NR*

NR*

NR*

NR*

–

IEN

oN

R*N

R*N

R*N

R*–

NL

No

NR*

NR*

NR*

NR*

–

RSYe

sN

ot k

now

nN

oN

oN

o–

SEYe

sYe

sN

oN

oN

o–

UK

Yes

Yes

No

No

No

–

ISO

/IEC

1702

0:20

12D

EN

oN

R*N

R*N

R*N

R*–

FRN

oN

R*N

R*N

R*N

R*–

ISO

/IEC

1702

1:20

11AT

N

oN

R*N

R*N

R*N

R*–

BGN

oN

ot k

now

nN

ot k

now

nN

ot k

now

nN

ot k

now

nBA

S do

es n

ot h

ave

info

rmat

ion

re-

late

d to

the

topi

c

CZYe

sYe

sN

ot k

now

nN

ot k

now

nYe

s–

ESYe

sYe

sYe

sYe

sYe

s–

FIN

oN

R*N

R*N

R*N

R*–

GR

No

NR*

NR*

NR*

NR*

–

ITYe

sYe

sYe

sYe

sYe

s–

LTN

oN

ot k

now

nN

ot k

now

nN

ot k

now

nN

ot k

now

n–


Table 7. (cont.)

ISO

sta

ndar

dCo

untr

y us

ing

th

e st

anda

rdIs

the

surv

ivor

ship

and

man

agem

ent

of r

ecur

renc

e st

age

addr

esse

d by

the

sta

ndar

d

Are

thes

e it

ems

addr

esse

d by

the

sta

ndar

d

Follo

w-u

p

and

man

agem

ent

of r

ecur

renc

e

Psyc

hoso

cial

ca

reSu

rviv

orsh

ip

supp

ort

Palli

ativ

e ca

re

and

end-

of-li

fe

care

Oth

er

ISO

/IEC

1702

1:20

11(c

ont.)

PL

Yes

Not

kno

wn

Yes

No

No

–

SEYe

sYe

sN

ot k

now

nN

ot k

now

nN

ot k

now

n–

UK

No

NR*

NR*

NR*

NR*

–

ISO

/IEC

1702

5:20

05ES

No

NR*

NR*

NR*

NR*

–

FIN

oN

R*N

R*N

R*N

R*–

GR

No

NR*

NR*

NR*

NR*

–

SEYe

sYe

sN

oN

oN

o–

Clin

ical

Pa

thol

ogy

Accr

edit

atio

n st

anda

rd

UK

Yes

Yes

No

No

No

The

sam

plin

g an

d ex

amin

atio

n of

asp

irate

s an

d bi

opsi

es d

urin

g fo

llow

-up

surv

eil-

lanc

e ac

tiviti

es

Imag

ing

Serv

ices

Ac-

cred

itat

ion

Sche

me

UK

Yes

Yes

No

No

No

Perio

dic

imag

ing

and

inte

rven

tiona

l ra

diol

ogy

scre

enin

g to

det

ect p

oten

tial

recu

rren

ce

* N

R: N

ot R

epor

ted.

Rel

evan

t dat

a w

as n

ot p

rovi

ded

or th

at th

e qu

estio

n w

as n

ot re

leva

nt ta

king

into

con

side

ratio

n th

e an

swer

s to

pre

viou

s qu

estio

ns.


Table 8. STransversal items of breast cancer addressed by the standard in place.

Questions:


• Transversal items covered by the standard.


Table 8. (cont.)

ISO

sta

ndar

dCo

untr

y us

ing

th

e st

anda

rd

Mammography

Ultrasound

MRI

Pathology

Laboratory tests

Medication man-agement

Communication

Information sys-tems

Quality management

Proficiency testing

Personal competence requirements

Hygiene

Safety

Research

Oth

er

ISO

15

189:

2012

BEN

oN

oN

oYe

sYe

sYe

sN

oN

oYe

sN

oYe

sN

oN

oN

oN

o

CZN

oN

oN

oYe

sYe

sN

ot

know

nN

oN

oN

oN

oN

oN

ot

know

nN

ot

know

nN

oN

o

DE

NR*

NR*

NR*

NR*

Yes

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

–

EEN

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*–

ESN

oN

oN

oYe

sYe

sN

oN

ot

know

nYe

sYe

sYe

sYe

sYe

sYe

sN

oN

o

FIN

oN

oN

oYe

sYe

sN

oYe

sYe

sYe

sYe

sYe

sYe

sYe

sN

oN

o

FRN

oN

oN

oYe

sYe

sN

oN

oN

oN

oN

oN

oN

oN

oN

o–

GR

No

No

No

No

Yes

No

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

–

HR

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

–

IEN

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*–

NL

NR*

No

No

No

No

No

No

No

Not

kn

own

Yes

No

Not

kn

own

Not

kn

own

Not

kn

own

No

RSN

oN

oN

oYe

sYe

sN

ot

know

nN

oN

oN

oYe

sYe

sYe

sYe

sYe

s–

SEYe

sYe

sN

ot

know

nYe

sYe

sYe

sN

ot

know

nYe

sYe

sN

ot

know

nYe

sYe

sN

ot

know

nN

ot

know

nN

o

UK

No

No

No

Yes

Yes

No

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

ISO

/IEC

1702

0:20

12D

EN

R*N

R*N

R*Ye

sN

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*N

R*–

FRYe

sN

oN

oN

oN

oN

oN

oN

oN

oN

oN

oN

oN

oN

oN

o

ISO

/IEC

1702

1:20

11AT

Not

kn

own

Not

kn

own

Not

kn

own

Not

kn

own

Not

kn

own

Not

kn

own

Not

kn

own

Not

kn

own

Not

kn

own

Not

kn

own

Not

kn

own

Not

kn

own

Not

kn

own

Not

kn

own

–

BGN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nBA

S do

es n

ot

have

info

rma-

tion

rela

ted

to

the

topi

c


Table 8. (cont.)

ISO

sta

ndar

dCo

untr

y us

ing

th

e st

anda

rd

Mammography

Ultrasound

MRI

Pathology

Laboratory tests


Communication


Quality management

Proficiency testing


Hygiene

Safety

Research

Oth

er

ISO

/IEC

1702

1:20

11(c

0nt.)

CZYe

sYe

sYe

sN

ot

know

nN

ot

know

nN

ot

know

nN

oYe

sYe

sN

oN

oN

ot

know

nN

ot

know

nN

oN

o

ESYe

sYe

sYe

sYe

sYe

sN

ot

know

nN

ot

know

nN

ot

know

nYe

sN

ot

know

nYe

sYe

sYe

sN

ot

know

n–

FIYe

sN

oN

oN

oN

oYe

sYe

sYe

sYe

sN

oYe

sYe

sYe

sN

oN

o

GR

Yes

Yes

Yes

No

Yes

No

No

No

Yes

No

Yes

Yes

Yes

No

No

ITYe

sYe

sYe

sYe

sYe

sYe

sYe

sYe

sYe

sYe

sYe

sYe

sYe

sYe

sN

o

LTYe

sYe

sYe

sN

ot

know

nYe

sYe

sYe

sYe

sYe

sN

ot

know

nYe

sN

ot

know

nN

ot

know

nN

ot

know

n–

PLYe

sYe

sYe

sYe

sYe

sYe

sYe

sYe

sYe

sN

ot

know

nYe

sYe

sYe

sYe

s–

SEYe

sYe

sN

ot

know

nYe

sYe

sYe

sN

ot

know

nYe

sYe

sN

ot

know

nYe

sYe

sN

ot

know

nN

ot

know

nN

o

UK

(und

er

ISO

900

1)N

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nYe

sN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

nN

ot

know

n–

UK

(und

er

ISO

270

01)

No

No

No

No

No

No

Not

kn

own

Yes

No

No

No

No

No

No

No

ISO

/IEC

1702

5:20

05ES

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

NR*

–

FIN

oN

oN

oYe

sYe

sN

oYe

sYe

sYe

sYe

sYe

sYe

sYe

sN

oN

o

GR

No

No

No

No

Yes

No

No

No

Yes

Yes

Yes

No

No

Yes

Equi

pmen

t ca

libra

tion

and

met

rolo

gica

l tr

acea

bilit

y

SEYe

sN

oN

oYe

sYe

sN

oN

ot

know

nN

oYe

sYe

sYe

sN

oN

ot

know

nN

ot

know

nN

o


Table 8. (cont.)

ISO

sta

ndar

dCo

untr

y us

ing

th

e st

anda

rd

Mammography

Ultrasound

MRI

Pathology

Laboratory tests


Communication


Quality management

Proficiency testing


Hygiene

Safety

Research

Oth

er

Clin

ical

Pa

thol

ogy

Accr

edit

atio

n st

anda

rd

UK

No

No

No

Yes

Yes

No

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

Sam

plin

g an

d te

stin

g m

ay b

e do

ne

spec

ifica

lly a

s a

poin

t-of

car

e ac

tivity

Imag

ing

Se

rvic

es

Accr

edit

atio

n Sc

hem

e

UK

Yes

Yes

Yes

No

No

No

Yes

Yes

Yes

No

Yes

Yes

Yes

Yes

The

stan

dard

is

des

igne

d to

be

app

lied

to

all c

urre

ntim

agin

g m

odal

ities

and

to in

terv

entio

nal r

adio

logy

ser

vice

s: g

ener

al x

-ray

; ultr

asou

nd; c

ompu

ted

tom

ogra

phy;

inte

rven

tiona

l rad

iolo

gy; m

agne

tic

reso

nanc

e im

agin

g ; d

ual e

nerg

y x-

ray

abso

rptio

n; ra

dion

uclid

e im

agin

g; s

ympt

omat

ic b

reas

t mam

mog

raph

y. N

on-i

mag

ing

aspe

cts

of N

ucle

ar

Med

icin

e (in

clud

ing

radi

opha

rmac

y) a

nd a

sym

ptom

atic

bre

ast s

cree

ning

ser

vice

s ar

e no

t cur

rent

ly in

clud

ed in

the

scop

e of

this

sta

ndar

d

* N

R: N

ot R

epor

ted.

Rel

evan

t dat

a w

as n

ot p

rovi

ded

or th

at th

e qu

estio

n w

as n

ot re

leva

nt ta

king

into

con

side

ratio

n th

e an

swer

s to

pre

viou

s qu

estio

ns.

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European Commission

EUR 27382 EN – Joint Research Centre – Institute for Health and Consumer Protection

Title: Report of a survey on accreditation and conformity assessment in the field of breast cancer in Europe

Author(s): Aslı Ulutürk, Silvia Deandrea, Donata Lerda, Jesús López Alcalde, Luciana Neamtiu, Zuleika Saz-Parkinson

Luxembourg: Publications Office of the European Union

2015 – 102 pp. – 21.0 x 29.7 cm

EUR – Scientific and Technical Research series – ISSN 1831-9424 (online) – ISSN 1018-5593 (print)

ISBN 978-92-79-50318-4 (pdf)

ISBN 978-92-79-50334-4 (print)

doi:10.2788/15049

JRC Mission

As the Commission’sin-house science service,the Joint Research Centre’smission is to provide EUpolicies with independent,evidence-based scientificand technical supportthroughout the wholepolicy cycle.

Working in closecooperation with policyDirectorates-General,the JRC addresses keysocietal challenges whilestimulating innovationthrough developing newmethods, tools andstandards, and sharingits know-how withthe Member States,the scientific communityand international partners.

Serving societyStimulating innovationSupporting legislation

LB-NA-27382-EN

-N

doi:10.2788/15049ISBN 978-92-79-50318-4