issue 39 hkas21 - itc

June 2005

Issue No.

39H o n g K o n g A c c r e d i t a t i o n S e r v i c e

news

36/F., Immigration Tower,7 Gloucester Road, Wan Chai, Hong Kong.

Tel: 2829 4840 Fax: 2824 1302E-mail: [email protected]

Website: http://www.itc.gov.hk/hkas

First laboratory accredited by HKAS formedical testing

Preparation for medical laboratoryaccreditation by HOKLAS

– Experience sharing from the VirologyDivision, Public Health LaboratoryServices Branch, Centre for HealthProtection, Department of Health,

HKSAR Government

Bridging scheme for medicallaboratories holding other accreditations

Accreditation of Gemstone TestingLaboratories

HKAS Assessor Seminar

Designation of HOKLAS accreditedlaboratories as Conformity Assessment

Bodies under APEC Tel MRA

APLAC Workshop on ReferenceMaterial Producer Accreditation

HOKLAS-HKIAS Liaison meeting

Meeting with Certification Bodies

ISO/IEC 17025:2005 Published

APLAC General Assembly and Meetings

APLAC ISO/IEC 17011 Workshop andMRA Council Meeting

ILAC Laboratory Survey on Conversionto ISO/IEC 17025:1999

ILAC and IAF General Assemblies andMeetings

ILAC ARC Meeting

IAF-ILAC-ISO Joint Working GroupMeeting

IAF cross frontier policy

Accreditation update

Proficiency Testing update

New and Revised Published Documents

Upcoming Training Courses

Change of HKAS Website Address

First laboratory accredited by HKAS formedical testing

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Press Release on 8 March 2005A Department of Health laboratory had become the first to be accredited under themedical programme of the Hong Kong Laboratory Accreditation Scheme (HOKLAS)operated by the Hong Kong Accreditation Service (HKAS) under the Innovation andTechnology Commission (ITC).

The HKAS today (March 8) presented an accreditation certificate to the Virology Divisionof the Public Health Laboratory Services Branch under the Centre of Health Protection,Department of Health, to give accreditation on its technical competence in clinicalmicrobiology and infection under the HOKLAS medical testing test category.

HOKLAS is a voluntary scheme open to Hong Kong laboratories performing objectivetesting and calibration within the scope of the scheme and meet the HOKLAS criteriaof competence. The area of medical testing was added to the scope of accreditationby HOKLAS in February, 2004. Laboratories accredited by HOKLAS are recognised astechnically competent in this field by accreditation bodies in 40 economies worldwideunder mutual recognition arrangements with HKAS.

“Public and private clinical pathology laboratories providing diagnostic testing servicesin five pathology disciplines – anatomical pathology, chemical pathology, clinicalmicrobiology and infection, haematology and immunology – can seek accreditationunder HOKLAS,“ an ITC spokesman said.

“Accreditation criteria are based on the new international standard for medicallaboratories, ie, ISO 15189:2003 ‘Medical laboratories – Particular requirements forquality and competence’. Hong Kong is among the pioneers in adopting this newstandard to accredit medical laboratories. Laboratories seeking accreditation undergorigorous onsite assessments by experts in the medical testing field and they mustparticipate in proficiency testing programmes and achieve satisfactory results.”

“This accreditation was granted after rigorous on-site assessments carried out byoverseas experts in accordance with the ISO 15189: 2003. HKAS congratulates thelaboratory of their success in obtaining accreditation.”

“Medical laboratory testing underpins the quality of medical services. The accreditationprogramme for medical laboratories contributes to the upgrading of the service standardof medical testing laboratories and will benefit the community.”

“There is an increasing need for medical laboratories to demonstrate that they are up tointernational standards and accreditation is one way of meeting this need. Theaccreditation programme on medical testing provides an opportunity for medicallaboratories to demonstrate their competence through a third party – HOKLAS,” thespokesman said.

6/3/05, 6:44 PM

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HOKLAS was launched in 1985 and currently has 122laboratories accredited for a wide range of testing fieldsincluding electrical and electronic products, textiles andgarments, toys and children’s products, food, calibrationservices, environmental, construction materials, chemicaltesting, Chinese medicine, physical and mechanical testingand medical testing.

Preparation for medical laboratory accreditation by HOKLAS- Experience sharing from the Virology Division, Public Health Laboratory ServicesBranch, Centre for Health Protection, Department of Health, HKSAR Government

Details of the accreditation programme on medical testingand relevant application documents are available on the HKASwebsite at www.info.gov.hk/itc/hkas. Laboratories interestedin the programme may contact HKAS on 2829 4837.App l ica t ions can be submi t ted to the HKAS a t36/F Immigration Tower, 7 Gloucester Road, Wan Chai,Hong Kong.

The following article is contributed by the Virology Division,Public Health Laboratory Services Branch, Centre forHealth Protect ion, Department of Health, HKSARGovernment. This laboratory is the first medical testinglaboratory accredited by HKAS.

Much like testing in other laboratories, quality assurance isof utmost importance to medical testing laboratory to ensureoutput is consistent, reproducible, traceable and efficaciousfor patient management. In recent years, there is an increasingpressure for medical laboratories to be accredited to meetdemands for conforming to or adopting international standardsso as to ensure consistency of laboratory practice for trainingof personnel, satisfying service expectation as well as meetingthe requirements of clinical trials and research.

Delivery of quality service has been our principal goal all along,and various measures and steps have been incorporatedin multiple facets of our day-to-day work to ensure qualityoutput. In fact, for many years, as World Health OrganizationNational Laboratory for Polio, we have been following the WHOsystem and accredited through documentation of laboratorypractice, output measurement and on site inspection.However, to be accredited by HOKLAS, it is necessary toreview and compile all the quality components in accordancewith the accreditation criteria.

In preparing for laboratory accreditation, the most importantaspect was to let all staff understand accreditation is for thebenefit of the service and patient care. For many years, seniorstaff were encouraged to attend HOKLAS courses on “Qualitymanagement in Laboratories” and “Internal audits”. Variousin-house training course and lectures on quality practice werealso organized for all staff to familiarize them with the conceptsand requirements of quality system.

Planning for accreditation began with a thorough study of theHOKLAS requirements. A framework of the quality systemwas subsequently devised to incorporate all the elements inthe standard. The framework was then gradually built uponby incorporating procedures for each element, followed bytheir implementation. The first element to be tackled wasdocument control. After the document control system hadbeen implemented, other documents including managementprocedures such as organization of the quality system, internal

auditing and continual improvement programme, and technicalprocedures such as standard operating procedures for varioustests, specimen reception, reporting of test results andequipment maintenance programme were compiled to formthe quality manual.

Having the quality manual in place was only the beginning.Implementation in accordance with what was documented,together with keeping of the necessary records, wascontinuous processes. In order to verify and ensure theeffective implementation of the quality system, internal auditingand the continual improvement programme play importantroles. Although in the year 2003, the new internationalstandard for medical laboratories, ISO 15189, was issued,the basic requirements for the quality system were similar toISO 17025, and only minor modifications to the system werenecessary to fulfil the requirements.

Having gone through the accreditation process, our staff haveacquired a renewed perspective on the importance of qualityto the provision of the service. The accreditation of ourlaboratory by HOKLAS should be regarded as a bonus forassuring quality patient care, and as one of the milestones inour continuous journey on improving quality.

Back row (left to right) :Dr. K.F. Wong (Chair of the AAB Working Party for medical

testing), Dr. Vered Agmon (Assessor),Dr. Dominic Dwyer (Assessor),

Dr. Derek Wong (Department of Health)Front row (left to right) :

Mr. Louis Tong (Department of Health), Ms. Bella Ho (HKAS),Dr. Wilina Lim (Head of Virology Division, Department of

Health), Ms. Angie Yuen (HKAS),Dr. Janice Lo (Department of Health).

6/3/05, 6:45 PM

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Bridging scheme for medical laboratories holdingother accreditations

A bridging scheme for medical laboratories holdingaccreditation of other accreditation bodies was launched on1 January 2005 for a period of two years to facilitatelaboratories accredited either to ISO/IEC 17025 or otherstandards, to participate in the local scheme and to leveragetheir effort for attaining current accreditation. A briefing sessionon the bridging scheme was held on 3 December 2004 forthese laboratories. A total of 25 participants from laboratoriesholding other accreditation attended the session. Enthusiasticresponses were received from the participants.

as laboratory safety, pre-examination procedures, post-examination procedures, determination of critical/alertintervals, turnaround times, etc. For other standards, manyof their requirements are also similar to those of ISO 15189.HKAS recognises this, and for those medical laboratories thathave already been assessed by other accreditation bodiesagainst their respective accreditation criteria, HKAS couldfocus on those elements which have not yet been covered.HKAS will take into consideration the assessment findings ofother accreditation bodies and it is felt that a repetition ofassessment on areas already assessed by other accreditationbodies may not be necessary. Similarly, since the qualitysystem and operation procedures of these laboratories aremore or less in conformity with ISO 15189, it is also envisagedthat a much reduced effort is sufficient for these laboratoriesto upgrade their quality system and documentation to meetthe requirements of HOKLAS. HKAS will determine theassessment time needed on a case-by-case basis. Theduration of the on-site assessment for laboratories which areaccredited by other accreditation bodies could be shorter and,as a consequence, the cost of assessment wouldcorrespondingly be reduced. To maintain the standard ofaccreditation, there must be evidence that all the requirementsof ISO 15189 have been assessed, either throughassessments by other accreditation bodies, or by HKAS inthe initial assessment.

Medical laboratories accredited to ISO/IEC 17025 or otherstandards interested in this bridging scheme should apply toHKAS before 31 December 2006. Initial assessment musttake place before their current accreditation expires.

Since the launching of the new accreditation service forgemstone testing in early 2005, four laboratories have beenaccredited for performing physical tests for identificationof jadeite jade. They are:

1. Asian Gemmoligical Institute and Laboratory Limited(Registration No. HOKLAS 151)

2. China Gems Laboratory Limited (Registration No.HOKLAS 152)

3. Hong Kong Jade and Stone Laboratory (RegistrationNo. HOKLAS 153)

4. SGS Hong Kong Limited (Registration No. HOKLAS 9)

Some other applications are being processed.

Accreditation of Gemstone Testing Laboratory

Gemstone testing is a test area under the “Physical andMechanical” tests category. The tests covered include:

25 representatives from laboratories holding accreditation withother accreditation bodies attended the briefing session.Enthusiastic responses were received from the attendees.

The scheme aims to provide a means for medical laboratoriesto migrate from compliance with ISO/IEC 17025 or otheraccreditation standards in medical testing to ISO 15189. Thisis possible because ISO 15189 is based on ISO/IEC17025but with specific requirements for medical laboratories such

Tests are performed in accordance with “Standard Methods for

1. Shape and Cut Identification of Jadeite Jade2. Measurement of Dimensions of Jadeite Jade3. Measurement of Weight of Jadeite Jade4. Identification of Transparency of Jadeite Jade5. Identification of Colour of Jadeite Jade6. Jadeite Jade Polariscope Examination7. Determination of Refractive Index of Jadeite Jade8. Determination of Specific Gravity of Jadeite Jade9. Examination of Fluorescence of Jadeite Jade10. Chelsea Colour Filter Examination11. Jadeite Jade Spectroscopic Examination12. Jadeite Jade Magnification Examination13. Jadeite Jade Infrared Spectrum Examination

6/3/05, 6:45 PM

Mr. Chan delivering the opening speech.

Testing Jadeite Jade for Hong Kong” published by theGemmological Association of Hong Kong (GAHK) earlier this year.

As part of the gemstone testing accreditation programme,reference jadeite jades for different degrees of transparency,ultraviolet fluorescence, chelsea colour filtering, polariscopicidentification and refractive index, etc. have been established(See pictures of two examples of reference jadeite jades). Aproficiency test (PT) on the 13 standard jadeite jade tests hasbeen organised. The outcome of the PT indicated that mostparticipating laboratories are performing satisfactorily and areable to produce accurate and reliable test results. (See pictureof the eight artefacts jadeite jade used in the proficiency test)

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On 8 March 2005, a record number of assessors andtechnical experts gathered at the YMCA Hotel for this year’sHKAS Assessor Seminar. We were also honoured to haveProfessor P C Ching, Chairman of the Accreditation AdvisoryBoard (AAB) as well as other AAB members including Dr K FWong, Dr T L Ting, JP, Dr Wilina Lim, JP, Professor H S Lau,Mr C Y So and Mr C C Tse attending this annual event.

Mr S S Chan, Executive Administrator, HKAS welcomed allattendees to the seminar and gave a talk on the recentdevelopment of HKAS. He highlighted that the number ofaccredited laboratories had increased steadily over the past20 years and reached 121 at the end of last year. The numberof accredited inspection bodies and certification bodiesremained quite steady at 8 and 9 respectively in the past twoyears. Recently, HOKLAS has extended to cover medical testingand gemstone testing accreditation and, in the future, HKAS isconsidering extending HOKLAS to cover reference materialproducer and proficiency testing provider accreditation whilstHKCAS will extend to cover consumer product certification soon.Mr Chan further explained the challenges facing HKAS andthe direction of HKAS development. He expressed his gratitudeto the members of AAB, technical assessors and technicalexperts for their staunch support over the years.

HKAS Assessor Seminar

Picture 3. Reference jadeite jades for various degrees of transparency(Transparent T1, Translucent T2 and opaque T3)

Picture 1. An assessment of gemstone laboratory.

Picture 2. Eight different variety of jades (numbered from J, K, L, M,N, O, P, and Q) including natural, dyed, resin impregnated, enhancedand treated jadeite jades are used as artefacts in the proficiency testsfor all the 13 tests stated above.

Picture 4. Reference jadeite jades for various degrees of ultravioletfluorescence (Strong UV1, Medium UV2, Faint UV3and Inert UV4)

Following Mr Chan’s talk was a presentation ceremony of theCertificate of Accreditation to the first accredited medicaltesting laboratory. The medical testing programme waslaunched in 2003 and the first medical testing laboratory thathas successfully achieved accreditation is the Virology Divisionof the Public Health Laboratory Services Branch, Centre ofHealth Protection, Department of Health. Professor C P Ching,Chairman of AAB, presented the Certificate of Accreditationto Dr Wil ina Lim,Head of the PublicHealth LaboratoryServices Branch,D e p a r t m e n t o fHealth. Following ist h e s p e e c h o fProfessor Ching givenat the presentationceremony.

Today, apart from gathering together to share experience, Ihave the honour to present the accreditation certificate tothe first medical laboratory accredited under the medicalprogramme of HOKLAS. This laboratory is the VirologyDivision of the Public Health Laboratory Services Branch

The accreditation of the gemstone testing laboratory forperforming jadeite jade physical tests is the first stage of thegemstone testing accreditation programme. Extension of theprogramme to cover jadeite authenticity verification anddiamond identification and grading and colour gemstonesidentification is being studied.

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under the Centre of Health Protection, Department of Healthof the Hong Kong SAR Government.

The HOKLAS medical programme was launched in Februarylast year. The new international standard ISO 15189 is usedas the accreditation criteria. This standard is gaining wideacceptance in many economies since its publication. HongKong is among the pioneers in adopting this standard.

Medical laboratory testing underpins the quality of medicalservices. The accreditation programme for medicallaboratories contributes to the upgrading of the local healthcare system and will benefit the community. With the grantingof accreditation to the first medical laboratory, we are movingone step closer to these goals. Through accreditation,laboratories can raise the standard of their service anddemonstrate their competence. Accreditation also providesa convenient means for the public to identify competentservice providers.

It is great challenge to be the first laboratory to participate ina new programme. It takes much determination andmanagement’s commitment, and effort from staff to set upa quality system that meets the requirement of ISO 15189within just one year and to face the rigorous on-siteassessment carried out by overseas experts. We invitedDr. Dominic Dwyer, a renowned virologist from theWestmead Hospital of Australia and Dr. Vered Agmon, theHead of the Israel Government Public Health Laboratory toconduct this first assessment. Both assessors wereimpressed with the quality system set up at the laboratoryand the competence demonstrated by the laboratory staffduring the assessment. The laboratory well deserves theaccreditation and I would like to congratulate the laboratoryfor their success.

Prof. Ching presenting the certificate of accreditation toDr. Lim, Head of the Virology Division of the Public HealthLaboratory Services Branch, Centre of Health Protection,Department of Health, The Government of the HKSAR.

Prof. Ho talking about the contributions of a technicalassessor to the welfare of the general public.

Open discussion forum.

A record number oftechnical assessors

and technical expertsattended the seminar.

Prof. Ching, Chairman ofAccreditation Advisory

Board, delivering a speechat the presentation

ceremony of the firstHKAS accredited medical

testing laboratory.

The theme of this year’s seminar is continual improvement ofassessment process and we were delighted to have two veryexperienced technical assessors to share their experience withother assessors. The first speaker, Dr W M Kwok shared hisexperience in conducting assessments and ways to improvethe assessment process. He outlined the general timeallocated to each aspect of the assessment and providedvaluable insights into the challenges faced by assessors andgave practical advice on how to deal with them.

The second speaker was Professor S L Ho. He is a veryexperienced technical assessor in electrical testing. He talkedabout the contributions of a technical assessor in preventingaccidents, some of them were fatal ones, and improving thesafety of the general public through assessments oflaboratories to ensure that testing of electrical appliances wasproperly conducted. This is one of his main driving forcesbehind being a technical assessor for HKAS and pleadedother technical assessors to offer their support to HKAS.Professor Ho also shared his experience in assessment andpointed out that one of the most important elements toensure proper testing was staff competence. To concludehis talk, he urged fellow assessors to continue update andupgrade their professional knowledge.

Dr. Kwok sharing hisexperience in

conducting assessmentsand ways to improve the

assessment process.

6/3/05, 6:45 PM

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Group for chemical testing relating to construction materials

The discussion was led by Dr. K. C. Pang, SeniorAccreditation Officer. The ten attendees are assessors for airquality monitoring, asbestos testing or chemical analysis ofconstruction materials. Assessors’ feedback on last year’sassessor seminar, including suggestions for HKAS futureactivities, was discussed. The nature of non-conformitiesidentified during on-site laboratory assessments in 2004 wasreviewed and summarised with breakdown figures forindividual management and technical aspects. The groupalso discussed the HOKLAS requirements for appointmentsof lead assessors and technical experts, the roles andresponsibilities for lead assessors acting as assessment teamleaders and the basis for evaluation of performance of leadassessors and technical experts. Other relevant aspects,including reporting of findings, selection of documents for

21 assessors and technical experts attended the group forchemical and environmental testing.

Group for chemical and environmental testingTwenty-one assessors and technical experts attendedthis group which was led by Mr. W W Wong. We were alsopleased to have Dr T L Ting, JP, Government Chemist andmember of AAB joining this group. He provided us withvaluable insights into many of the issues discussed. Thediscussion started with a presentation by Mr Wong on thefeedback received from attendees of last year’s seminar andthe approved amendments made to ISO/IEC 17025 whichwill be published. When this new edition is published, thecriteria for laboratory accreditation will be revised accordinglyand, since there are no major changes, it is expected thatassessments will not be affected significantly. Assessors werebriefed on the major amendments.

A system for grading of non-conformities was introduced inJanuary last year. Recent feedback from laboratoriesindicated that they were general satisfied with this system.To refresh the basis of this grading system and to furtherharmonise the grading of non-conformities amongstassessors, examples were given to the participants fordiscussion. Assessors generally found the examples usefulfor clarifying some grey areas which they sometimesencountered during assessments.

Another area where assessors often need guidance is theminimum requirement for participation in proficiency testingprogrammes. Mr Wong highlighted the requirements givenin HKAS 002, HOKLAS 003 and relevant HOKLASSupplementary Criteria and explained that proficiency testingwas a means to provide evidence on the competence of alaboratory to perform specific tests. As such, it is sometimesnecessary to interpret the requirement in the context of thetest concerned. For example, a successful participation in aproficiency testing programme on pH in drinking water mayindicate a laboratory’s competence to perform the same test

in sea water. On the contrary, successful participation in aproficiency testing programme on metals in drinking watermay not indicate a laboratory’s competence to determinemetals in sea water. Similarly, for multi-analyte tests,successful participation in some of the analytes maysometimes indicate competence of the laboratory to performthe other analytes, depending on the actual test procedureand the analytes concerned. Hence it is important to exerciseprofessional judgement when interpreting the proficiencytesting results, and there is no hard and fast rule that can beapplied to this requirement. Mr Wong further explained somefacts and myths of proficiency testing and stressed thatparticipation in proficiency testing programme could notsubstitute routine internal quality control programmes.

Dr. Pang responding to a question raised by an assessor.

examination and tests to be witnessed as well as choice ofcheck samples, were also covered.

Other topics discussed include estimation of measurementuncertainty and the feedback received from laboratorieson assessments. Assessors and technical experts werepleased to note that some very encouraging feedback hasbeen received.

After the talks and presentation ceremony, assessors weredivided into five groups according to their disciplines for more

in-depth discussions on technical issues related specificallyto their respective disciplines.

6/3/05, 6:45 PM

Group for Calibration Services, Electrical & ElectronicProducts Testing, Physical & Mechanical Testing, Textiles& Garments Testing and Consumer Products Inspection

In this group, two HKAS officers, Mr. K.W. Chen andMr. W.L. Shum, discussed with 20 assessors. The groupcovered the approach to grading of non-conformities,issues relating to calibration and verification of equipment,and the implementation of the IAF/ILAC Guidance on theApplication of ISO/IEC 17020.

A number of observations recorded in previous HOKLAS/HKIAS assessments were presented for discussion.Part icipants were invited to determine whether theobservations were non-conformities, and if they were, tograde them accordingly. Assessors actively participatedin the discussion and generally agreed to a harmonisedapproach to the grading of non-conformities. Assessorswere reminded to record assessment findings in sufficientdetail so that the assessed organisations could identify theroot causes of the non-conformities and take appropriatecorrective actions accordingly.

Assessors were briefed about the difference betweencalibration and verification of a measuring instrument. Ingeneral, calibration of an instrument is an operation toestablish the relation between the values of quantity realisedby the reference standard and the corresponding valuesindicated by the instrument under specified conditions whileverification of an instrument is a confirmation throughexamination of the instrument and provision of objectiveevidence that it fulfils specified requirements. Calibration

emphasizes measurement traceability whilst verificationemphasizes functionality. Assessors were advised to referto the ISO International Vocabulary of Basic and GeneralTerms in Metrology (VIM) for further information.

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About twenty assessors participated in the discussionof this group. They came from various backgroundincluding government departments, tertiary educationinstitutes, consultants and commercial laboratories. Thegroup was led by Mr. C. K. Cheung and Mr. Francis C. C.Wong, Senior Accreditation Officers and Mr. S. F. Yip,Accreditation Officer, HKAS.

Assessors were briefed on the following latest development:

Group for construction materials testing

Mr. Cheungexplaining the

latestdevelopment in

constructionmaterials testing.

1. Problems encountered in the construction materialslaboratories on concrete cube testing and foundationtesting.

2. Accreditation for expression of opinion in passive fireproduct assessments in lieu of testing.

3. New test areas in construction materials testing – pipetesting required and active fire fighting equipment testing.

4. New test areas in physical & mechanical testing –gemstone and dangerous goods packaging testing.

5. Construction product inspection accreditation to ISO/IEC17020 – water pipe & other water facilities inspectionrequired.

6. Construction product certification accreditation to ISO/IEC 65 – ready mix concrete (QSPSC), passive fireprotection products, manhole covers (EN 124) and otherdrainage facilities.

7. Setting of new local standards on aggregate, cement,concrete, steel infrared thermography, radar detection,echo sounder and time domain reflectometry, etc.

Mr. Chen and Mr. Shum with their group

With effect from 1 January 2005, all inspection bodiesaccredited under HKIAS have to comply with the IAF/ILACGuidance on the Appl icat ion of ISO/ IEC 17020.Participants were briefed on the requirements of thisdocument and the corresponding revis ions to theaccreditation criteria for consumer product inspection.

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At the 14th APLAC MRA Council meeting, it was resolvedthat a workshop be held in Hong Kong to discuss issuesrelated to a possible extension of the APLAC MutualRecognition Arrangement (MRA) to cover accreditation ofreference material producers (RMPs). The workshop washeld on 11 and 12 March 2005 and was attended by 20

Office of the Telecommunications Authority (OFTA) hasrecently published a revised Information Note “Asia-PacificEconomic Cooperat ion (APEC) Mutual Recognit ionA r r a n g e m e n t f o r C o n f o r m i t y A s s e s s m e n t o fTelecommunications Equipment (APEC Tel MRA)” on itswebsite. The purpose of the Information Note is to updatethe general public and interested parties with the fact thatHong Kong has entered into arrangement with the US forthe implementation of Phase I (mutual recognition of testreports) and Phase II (mutual recognition of equipmentcertification) procedures of APEC Tel MRA since April 2005.Before that, Hong Kong had already made simi lararrangements with Australia, Canada, Singapore and

Chinese Taipei for the implementat ion of Phase IProcedures. A testing laboratory which is accredited underHOKLAS for specific telecommunications equipment testsor EMC tests in the test category of “Electrical andElectronic Products” may be designated by OFTA asconformity assessment bodies (CAB’s) under APEC TelMRA. So far, OFTA has designated some local testinglaboratories as CAB’s and the test reports produced bythem wil l be accepted by the corresponding APECeconomies as those produced by CAB’s in their economies.Any testing laboratory or certification body who is interestedin becoming CAB may access OFTA’s website http://www.ofta.gov.hk/en/tec/main.html for more details.

Designation of HOKLAS accredited laboratories asConformity Assessment Bodies under APEC Tel MRA

Group for Medical Testing

Ms. Ho givingan introduction

on grading ofnon-

conformities.

Participants of the APLAC Workshop on Reference MaterialProducer Accreditation.

Mr. W.W. Wong,convener of the

APLAC workinggroup on referencematerial producers

highlighted theAPLAC MRA

Council resolutionsand the expecteddeliverables from

the workshop

There were 55 participants in this group. They includepathologists, scientific officers and a number of experiencedmedical technologists from both the public and the privatesectors, and their expertise covered different medicallaboratory disciplines, viz anatomical pathology, chemicalpathology, microbiology and haematology.

The discussion focussed on the grading of non-conformitiesfor medical testing. It began with a brief introduction byMs. Bella Ho on the grading of non-conformities, and thenfollowed by an exercise on grading of 22 observations indifferent medical testing discipl ines. Each of theseobservations and the grading assigned were subsequentlydiscussed with enthusiasm.

This exercise served to illustrate that, although assessors areexperts in their own discipline, subjective opinion may affect

the grade assigned to a non-conformity. The discussionhelped to achieve consistent application of the grading system.Participants also agreed that the grading of a particularobservation might depend on other factors as well as on theactual situation of the laboratory at the time of assessment.All participants enjoyed this exchange of ideas and manyexpressed that they would l ike to have more suchexperience sharing sessions in future.

representatives from 14 APLAC accreditation bodies from12 economies. A representative from InterAmericanAccreditation Cooperation (IAAC) also attended theworkshop. The workshop was divided into four sessions,each dedicated to a specific topic and led by a facilitator.Three facilitators were invited. They were:

APLAC Workshop on Reference Material Producer Accreditation

6/3/05, 6:46 PM

The fifth HOKLAS-HKIAS liaison meeting was held on16 December 2004. Eight representatives from accreditedlaboratories or inspection bodies attended the meeting.Mr S. S. Chan, Mr. W. W. Wong and Mr. C. K. Cheungrepresented HKAS at the meeting. Following are some ofthe issues discussed.

1. HKAS Executive has recently conducted a review of thegrading system launched on 26 January last year fornon-conformities identified in assessments of laboratoriesand inspection bodies. The review indicates that, notonly has the system been proved useful according to thefeedback from the assessors and the organisationsassessed, both the granting and reaff irmation ofaccreditation have also been expedited. The average timetaken for granting accreditation is substantially reducedfrom 96 days to 56 days for initial application and from129 days to 79 days for extension, while that forreaffirmation is also cut by 4 days, from 86 days to 82days. Based on these favourable f ind ings, theAccreditation Advisory Board has endorsed, at its seventhmeeting, the continuation of the grading system for futureassessments of laboratories and inspection bodies.Laboratory and inspection body representatives to theliaison meeting were invited to give their views andsuggestions to HKAS for improving this system.

2. A revised procedure for dealing with changes in name andownership of an accredited organisation was implemented.In gist, accreditation will be granted under the name of thelegal entity which owns the business or firm that performsthe activities accredited. For the name change of anaccredited organisation, accreditation may be continuedprovided that there are no other changes which may affectthe conformity of the organisation with the accreditationcriteria. As for any changes in ownership of an accreditedorganisation which is not, by itself, a legal entity, theaccreditation granted under the name of the original ownerwill be terminated when the change takes effect. If the newowner wishes to maintain accreditation under the newownership, it needs to apply anew to HKAS Executive.

3. The revised system for submission of information and

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documents to HKAS Executive and technical assessorswas implemented on 1 December 2004. Accreditedlaboratories and inspection bodies were briefed on thissystem on 15 November 2004. Representatives to theliaison meeting were invited to provide HKAS Executivewith their views and feedback on the revised system.

4. Laboratory representatives were informed that thesecond edition of ISO/IEC 17025 would be publishedvery soon. However, there will be no major change apartfrom, for example, the requirement for continualimprovement. It is anticipated that most accreditedlaboratories would not have major problems complyingwith the new standard. Similarly, inspection bodyrepresentatives were informed that the IAF/ILACGuidance on application of ISO/IEC 17020 had beenpublished and could be obtained from the IAF website.The implementation date for this guidance documentwas January 2005. This guidance is mandatory toaccredited inspection bodies. A major change is thatinspection body should witness every inspector at leastonce during the normal accreditation cycle in performingevery field of inspection he/she has been authorised bythe inspection body.

5. To understand their need better, HKAS Executive isconsidering improving the liaison with representatives ofend users of laboratory and inspection body services.Laboratory and inspection body representatives were invitedto identify and suggest to HKAS Executive any of their majorclients who might wish to take part in the liaison.

6. The current accreditat ion regulat ions a l low thereinstatement of a suspension immediately uponconfirmation that the cause of the suspension has beenrectified. This may lead to an abuse of the system therebyan accredited organisation voluntarily suspends itsaccred i ta t ion upon ident i f i ca t ion o f a c r i t i ca lnon-conformity, but ask for re-instatement immediatelyor shortly thereafter. This issue was discussed. Somerepresentatives of accredited organisations agreed thatthere should be a minimum period for suspension butothers expressed reservations about it.

HOKLAS-HKIAS Liaison meeting

• Dr Ed de Leer, Chair of International Advisory Group onReference Materials (IAGRM) and Director of Science ofNMi Van Swinden Laboratorium, Dutch NationalMeasurement Standards Institute;

• Dr Robert Watters, Chief, Analytical Measurement Division,National Institute of Standards and Technology, and

• Mr Alan Squirrell, ILAC Secretary.

Mr Tony Russell, Chair of APLAC also attended the workshop.Mr W W Wong of HKAS is the convener of the APLAC WorkingGroup on Reference Material Producers. He explained thepurpose and expected deliverables of the workshop. Theworkshop identified a number of issues and action items. Theworkshop also recommended that the APLAC MRA shouldbe extended to cover accreditation of RMPs. A report on theworkshop was presented to the APLAC MRA Council in April.

Meeting with Certification BodiesAfter attending the International Accreditation Forum (IAF)Technical Committee meeting in February 2005 in Taiwan,

China, Mr. Tommy Fung, Senior Accreditation Officer, HKAS,held a meeting with representatives from the 9 HKCAS

6/3/05, 6:46 PM

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The second edition of ISO/IEC 17025 was published on 15May 2005. According to an ILAC resolution, accreditedlaboratories have to implement this new edition two yearsafter the publication of the standard. HKAS is working on a

The annual Asia Pacific Laboratory Accreditation Cooperation(APLAC) General Assembly and other meetings including Boardof Management meeting, Training Committee meeting,Proficiency Testing Committee meeting, Public InformationCommittee meeting and Mutual Recognition ArrangementCouncil meeting, were held in Hanoi, Vietnam during the period5 to 10 December 2004. Mr S. S. Chan and Mr W. W. Wongattended the meetings. Some points worth noting are:

1. The Proficiency Testing Committee approved HKAS, incollaboration with the Government Laboratory, HongKong, to organise a proficiency testing programme on

ISO/IEC 17025:2005 Publishedtransitional plan which will be announced soon. In themeantime, accredited laboratories are advised to study thenew standard carefully and prepare to implement thenecessary changes to their management system.

pesticide residues in herbal medicine under the auspicesof APLAC in 2005.

2. The Mutual Recognition Arrangement (MRA) signatorystatus of CNAL, China, KAN, Indonesia, and BoA,Vietnam was extended to include inspection.

3. Mr Tony Russell of NATA, Australia was elected as Chairof APLAC whilst Mr S. S. Chan, Executive Administratorof HKAS, was elected as Chair of the MRA Council.Mr Yoshinobu Uematsu of IAJapan was elected as Chairof the Technical Committee.

An APLAC lead evaluator and ISO/IEC 17011 workshopwas held on 22-24 April 2005 in Tokyo, Japan. A total of43 participants from 31 accreditation bodies and 22economies attended this workshop. The need of thisworkshop arose from the publication of ISO/IEC 17011Conformity assessment – General requirements foraccreditation bodies accrediting conformity assessmentbodies in September 2004. Signatories to the APLAC MRAare required to comply with the requirements of thisstandard by 31 December 2005. The purpose of thisworkshop was two-fold. Firstly, current APLAC leadevaluators need to be updated on the requirements of thisstandard. Secondly, accreditation bodies need to be awareof the new requirements, and their applications, in order tofacilitate transition to this new standard.

The workshop was coordinated by Mr Peter Unger of A2LA,who was assisted by three moderators, viz., Mr S. S. Chanof HKAS, Mr Barry Ashcroft of IANZ and Dr Pannada Silvaof DMSc. Each requirement of ISO/IEC 17011 wasdiscussed with special emphasis placed on the differencesbetween the old standards (ISO/IEC Guide 58 and ISO/IEC TR 17010) and this new standard. Vivid discussionswere held and interpretations of the requirements wereclarified. Several key differences between the existing and

the new standards were identified. Mr W. W. Wong, HKAS,attended this workshop.

Immediately following the workshop was a two-day APLACMRA Counci l meeting. Main decisions and issuesdiscussed include:

1. The MRA status of International Accreditation ServiceInc. (IAS) of USA has been extended to cover calibration.

2. It was decided that the APLAC MRA be extended to coveraccreditation of reference material producers.

3. All signatories to the APLAC MRA are required to complywith ISO/IEC 17011 by 31 December 2005. A leadevaluator will be appointed to evaluate the informationprovided by accreditation bodies on their conformity withISO/IEC 17011. A MRA Council meeting will be held inmid-2006 to hear the reports from the lead evaluators.

4. The Council discussed the desirability of separatingmedical testing into a distinct entry in the APLAC MRA.The Working Group for studying effectiveness of theAPLAC MRA has been asked to study the issue andreport to the Council at its November meeting.

APLAC ISO/IEC 17011 Workshop and MRA Council Meeting

APLAC 2004 General Assembly and Meetings

accredited certification bodies (CBs) on 28 February 2005.CBs were informed of the recent developments at internationallevel and in HKAS. Issues discussed at this meeting mainlyrelated to the operation and competence of CBs. CBs indicatedthat transition from ISO 14001:1996 to ISO 14001:2004

certification had been in accordance with the Joint ISO-IAFCommunique and the IAF Transition Plan for Accredited EMSCertification. The Communique and the Transition Plan areavailable on the IAF website < http://www.iaf.nu/>. Expiry dateof accredited certificates to ISO 14001:1996 is 15 May 2006.

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ILAC Laboratory Survey on Conversion to ISO/IEC 17025:1999Following is an extract of a survey on the conversion fromISO/IEC Guide 25:1990 to ISO/IEC 17025:1999 by accreditedlaboratories conducted by the ILAC Laboratory Committeein 2003. In this survey, some very interesting information wasidentified, and in view of the publication of the second editionof ISO/IEC 17025:2005, the results of the survey could serveas valuable experience on which the conversion to the secondedition of ISO/IEC 17025 could be based. A full report isavailable from the website of ILAC at http://www.ilac.org.

ISO/IEC 17025:1999 was published after extensiveconsultation with stakeholders. There were quite a numberof “new” and “revised” requirements with which accreditedlaboratories need to comply. The transition period endedon 31 December 2002. In 2003, the ILAC LaboratoryCommittee decided that a survey should be undertaken totest the extent to which there were on-going problems facedby laboratories in relation to the conversion. More than 2000responses from 51 economies were received representinga return rate of over 10 per cent. Considering the extentof the changes in the laboratory accreditation standard, itis remarkable that the laboratory community generallyconsidered that the transition was smooth.

The issue that was ranked as the most problematic bylaborator ies was the est imat ion of measurementuncertainty. 64% of the respondents indicated that theyhad had issues or were still having issues with estimationof measurement uncertainty. HKAS was aware of this sincethe publication of the standard in 1999 and has identifiedthat estimation of measurement uncertainty, particularly fortesting, as one of the areas where training was most neededby laboratories as well as technical assessors. Accordingly,HKAS has organised training courses dedicated to eachspecified field, e.g. chemical analysis, construction materialtesting, microbiological testing, etc., since 2001. A trainingcourse dedicated to technical assessors in chemicalanalysis was held in June 2001. A one-day advancedworkshop course on estimation of measurement uncertaintyin chemical testing was orgnaised since 2002. Thesetraining courses are being organised on an on-going basis.It should also be noted that training courses on estimationof measurement uncertainty in calibration have beenorganised by HKAS for many years.

HKAS a lso hosted a 3-day APLAC workshop onmeasurement uncertainty in testing, the outcomes of whichhave resulted in the publication of an APLAC Guidancedocument on estimation of measurement uncertainty intesting – APLAC TC005. This guidance document is theresult of the hard work of 47 experts from 10 economies inthe Asia Pacific Region. This document is available fromthe website of APLAC at http://www.aplac.org.

When asked if they agreed with the statement – “the key staffin our laboratory know enough about ISO/IEC 17025 tomaintain our accreditation”, the majority of laboratories (96per cent) agreed or strongly agreed. In the local context,

HOKLAS 003 Technical Criteria for Laboratory Accreditationwas revised and published in July 2000 to keep it in line withISO/IEC 17025:1999. In order to familiarise assessors as wellas laboratories with the new requirements, a one-day seminarwas held on 15 September 2000. 252 technical assessorsand laboratory representatives attended this seminar. Eachclause of the new standard was discussed and newrequirements were highlighted and the policy for estimationof measurement uncertainty was explained in detail. This isprobably one of the key factors for the successful conversionto ISO/IEC 17025:1999 in Hong Kong.

In another question, respondents were asked to rate theamount and quality of the information on issues related toISO/IEC 17025:1999 available from a range of sources(acc red i t a t i on bod ies , l abo ra to r y assoc ia t i ons ,governments, professional bodies, standards bodies, ILAC,regional bodies and academic bodies.). We are glad tonote that laboratory managers are generally very happy withthe help they received from accreditation bodies. To assistaccredited laboratories to convert to ISO/IEC 17025, agap-analysis was performed for all assessments conductedafter the publication of HOKLAS 003 until end of 2001.Non-conformities against ISO/IEC 17025:1999 were raisedas recommendations and laboratories were required toresolve these by the end of 2001, if their accreditation wasto be maintained after that date. All accredited laboratorieshave been converted to the new standard on or before thetransition period stipulated by ILAC.

The survey revealed that two issues that laboratories needmost information or training were measurement uncertaintyand method validation. Training courses on these topics wereorganised last year in October by HKAS. Similar courses willalso be organised this year.

Laboratory managers were also asked to express a viewon whether the new laboratory accreditation standard hadenhanced the distinction between laboratory accreditationand certification. A majority (67 per cent) thought that ithad, which suggests that the distinction is important tolaboratory managers. Interested readers may refer to acommunique prepared by the IAF-ILAC-ISO/CASCO JointWorking Group on Image and Integrity of ConformityAssessment to clarify the key distinctions between the twodifferent types of recognition provided separately byaccredi tat ion bodies and cert i f icat ion bodies. Areproduction of this communique was published in issuenumber 33 of HKAS News, which is available from thewebsite of HKAS at http://www.info.gov.hk/itc/hkas.

Another key finding of the survey was that most laboratoriesare happy to be accredited. Those that are not so pleasedtend to complain about the cost and inconvenience of thestandard and the accreditation process. Similarly, a strongmajorities of respondents considered that laboratoryaccreditation is a good investment and that proficiency testingand other interlaboratory comparison provide good value.

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ILAC ARC Meeting

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ILAC and IAF General Assembly and Meetings

Mr. Tommy Fung of HKAS signing the IAF Quality ManagementSystem Multilateral Mutual Recognition Arrangement. On his

right is Mr. Thomas Facklam, Chair of IAF.

The International Laboratory Accreditation Cooperation (ILAC)and International Accreditation Forum (IAF) General Assembliesand conferences were held in Cape Town, South Africa inOctober 2004. This was an annual event organised jointly byILAC and IAF. It consisted of a series of meetings, some ofthem were joint meetings of ILAC and IAF, and included, forexample, the ILAC Accreditation Policy Committee meeting,the ILAC Arrangement Committee meeting, the ILAC GeneralAssembly, the IAF Technical Committee meeting, the JointILAC-IAF Inspection Committee meeting, IAF GeneralAssembly, the joint ILAC-IAF General Assembly, etc. Mattersrelating to accreditation of laboratories, certification bodies andinspection bodies were discussed. Mr. W. W. Wong and MrTommy Fung of HKAS attended the conferences and meetings.Some of the key outcomes of this event include:

The first International Laboratory Accreditation Cooperation(ILAC) Arrangement Committee (ARC) was held on 3 and 4March 2005 in Paris, France. Mr. W. W. Wong representedHong Kong Accreditation Service to attend the meeting. TheILAC ARC replaces the Accreditation Policy Committee (APC)and its remit is to consider and formulate policies on issuesrelated to the development and maintenance of proceduresand requirements for the implementation of the multilateralmutual recognition arrangement (MLMRA), and the developmentof new dimensions and extensions to the arrangement.

Some of the key issues discussed are:

technical competence of bodies producing referencematerials with assigned values was accreditation ofconformity assessment activity and that accreditation inthis field would be conducted against harmonised criteriabased on ISO Guide 34 and ISO/IEC 17025 in combination.

4. In anticipation of the publication of the second edition ofISO/IEC 17025, it was resolved that the transition periodfor the implementation should be two years from the dateof publication of the standard.

5. It was noted that the significance of the ILAC MRA infaci l i tat ing trade was very often over looked orunderestimated by governments. In view of this, a task forcewas established to study the economic impact of the MRA.

6. To further enhance ILAC as the platform for competenceassessment activities, it was resolved that ILAC shouldpromote and foster the development of relationships withother competence assessment bodies like WorldAnti-doping Agency (WADA), Organisation for EconomicCooperation and Development (OECD), InternationalElectrotechnical Commission (IEC), etc.

7. The ILAC General Assembly agreed to use theILAC-IAF Guidance document on ISO/IEC 17020 from 1January 2005.

1. Mr. Tommy Fung represented HKAS in signing the IAFQuality Management System Mult i lateral MutualRecognition (MLA) on 9 October 2004.

Signatories to the MLA recognise the certificates issuedby certification bodies accredited by the other signatoriesto the MLA as equivalent to those issued by certificationbodies accredited by themselves.

2. The following new signatories joined the ILAC MRA:i. Department of Standards Malaysia (DSM) – extension

to calibrationii. National Accreditation Body of Indonesia (KAN) –

extension to calibrationiii. Slovenian Accreditation (SA) – testing and calibrationiv. Hellenic Accreditation Council (ESYD) – testing and

calibrationv. Romanian Accreditation Association (RENAR) – testing

Iran Accreditation System (IAS), Pakistan NationalAccreditation Council (PNAC), Assured Calibration andLaboratory Accreditation Select Services (ACLASS) of USA,and Egyptian Accreditation Council (EGAC) also joined ILACas Associates. Associates are accreditation body membersof ILAC which are not signatories to the MRA.

3. The ILAC General Assembly resolved that assessing the

1. To improve the profile of ILAC to national and internationalauthorities and to enhance the acceptance of ILACMLMRA by them, a working group was formed. Thecountries/region that this group should focus on are USA,Japan and Europe. This work may enhance theacceptance of test reports from HKAS accreditedlaboratories by regulatory authorities in these economies,which are the main trading partners of Hong Kong.

2. Investigating the economic impact of the ILAC MLMRAwas identified as a priority area. The Chief Executive of

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IAF-ILAC-ISO Joint Working Group (JWG) MeetingA meeting of the IAF-ILAC-ISO Joint Working Group (JWG)took place on 7 November 2004 in Amsterdam, theNetherlands. The JWG is a high level collaborative groupamongst the following organizations:

• International Accreditation Forum (IAF);• International Laboratory Accreditation Cooperation (ILAC);

and• International Organization for Standardization (ISO).

The JWG was established after the signing of the IAF-ILAC-ISO Memorandum of Understanding (MoU) ConcerningCooperation and Mutual Assistance on Accreditation as Partof Conformity Assessment in March 2004, and its purposeis to act as a clearinghouse for the identification, preliminaryanalysis, coordination, and division of responsibilities fordealing with issues surrounding conformity assessmentpolicy, standards development and practice as they relateto accreditation.

At the second meeting a number of items were discussedas follows:

ISO/IEC 17011 Transition periodThe JWG noted that the IAF and ILAC memberships had at theirannual General Assemblies in October 2004 resolved that allaccreditation body members should meet the requirements ofthe new ISO/IEC 17011:2004, Conformity assessment – Generalrequirements for accreditation bodies accrediting conformityassessment bodies by 1 January 2006. This date has been setin collaboration with ISO, and the JWG approved the wording ofa Joint IAF-ILAC-ISO Communique on the matter.

ISO/IEC 17011 was published on 1 September 2004, andreplaces the following accreditation documents:

• ISO/IEC Guide 58:1993, Calibration and testing laboratory

accreditation systems – General requirements for operationand recognition;

• ISO/IEC Guide 61:1996, General requirements forassessment and accreditation of certification/registrationbodies; and

• ISO/IEC TR 17010:1998, General requirements for bodiesproviding accreditation of inspection bodies.

ISO 14001 Transition periodA new edition of the standard that was published on 15November 2004 has replaced ISO 14001:1996. The JWGnoted that the IAF had resolved at their General Assemblyin October 2004 to establish a transit ion period forcertificates from accredited certification bodies. Thetransition period has been set at 18 months to allow themigration of certification based on the requirements of ISO14001:1996 to being based on the requirements of ISO14001:2004.

After this 18-month transition period expires the only validISO 14001 certificates from accredited certification bodieswill be those meeting the requirements of ISO 14001:2004.

Requirements for third party auditorsIt was agreed that an IAF-ISO Task Force should be establishedto analyse the need within the conformity assessmentcommunity for requirements that would cover the competenceof auditors of management systems. This Task Force will bringtogether the necessary experts in both organizations to assessthis issue. Once established, the Task Force is to undertake itswork and recommend further action (if necessary) to the nextmeeting of the JWG scheduled for June 2005.

In the interim the new IAF Technical Committee Working Groupto establish IAF guidance on the application of ISO 19011:2002 will continue with its preliminary work.

International Accreditation Japan (IAJapan) was appointedto convene a working group on this project.

3. A meeting amongst ISO, IAF and ILAC was held inNovember last year to discuss issue of including areference to ISO 9001 on accreditation certificates. Thefollowing statement was suggested – “This laboratory isaccredited in accordance with ISO/IEC 17025:2005.Accreditation demonstrates technical competence for adefined scope and operation of an international recognisedquality management system (see joint ISO-ILAC-IAFCommunique reference dated xxx 2005). The jointcommunique states that the management systemrequirements in ISO/IEC 17025 meet the principles of ISO9001 and are aligned with its pertinent requirements.”Once the communique is signed by ISO, ILAC and IAF,the ILAC accreditation bodies, including HKAS, may beginto use the statement on the accreditation certificates.

4. A guidance document is being written for the implementationof ISO 15189. ISO 15189 is the basis of HOKLAS 015 whichis the accreditation criteria for the medical testinglaboratories. In view of its importance, a mirror group wasformed under ARC, and Ms Bella Ho of HKAS was amember of this group.

5. A requirement on the minimum participation in proficiencytesting programmes has been approved by ILAC. Thedate of publication of this requirement is February 2005.The implementation date of this requirement was agreedto be 1 January 2006. A resolution to this effect will beput forward to the ILAC General Assembly in September2005. This will not affect HOKLAS accredited laboratoriesas the HOKLAS existing requirement already meets thenew ILAC requirement.

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IAF cross frontier policy

Survey on management system certificatesand on laboratory accreditationThe annual survey by ISO of ISO 9001 and ISO 14001certificates from accredited certification bodies was discussed.ISO invited the IAF to assist in the design and implementationof the survey in the future. Separately, ILAC agreed to workwith ISO to establish an annual ISO Survey on the globalnumbers, sectors and places of laboratory accreditations toISO/IEC 17025 and ISO 15189.

Process for handling of complaints aboutconformity assessment practiceDiscussions also took place on the most effective way forthe parties to respond to complaints about conformityassessment practice, whether the complaints were inrelation to non-accredited or accredited conformityassessment activities. A procedure will be confirmed indue course amongst the parties.

The following is an excerpt from a press release of IAF oncross frontier policy published in October 2004.

The International Accreditation Forum (IAF) MultilateralRecognition Arrangement (MLA) Management Committee(MC) adopted a number of pract ices to enhanceimplementation of IAF Guidance on Cross FrontierAccreditation during its Plenary Meeting held on October 8,2004, in Cape Town, South Africa. These include sharingbest pract ices, regu lar assessments of e ffect iveimplementation, and maintenance of up-to-date informationon critical locations.

The process was initiated in September 2003 when IAF’sGeneral Assembly approved the IAF Guidance on CrossFrontier Accreditation, the main purpose of which is tofacilitate cooperation among Accreditation Bodies (ABs) inauditing critical locations and enhance the networking andcapability of ABs worldwide. Results of a June 2004 surveyon MLA signatories showed that all signatories (exceptwhere not applicable such as operating only locally) had aplan in place to conform to the requirements and areimplementing the policy and related requirements.

Subsequently, the MLA MC chartered a Cross FrontierPractices Group (CFPG) to monitor implementation andreport suggestions for implementation. Results of a secondsurvey conducted from the perspective of the host countrysubstantiated the findings of the first survey and helpedidentify critical locations. Responding ABs indicated thatboth multilateral and bilateral arrangements were alreadyin place; in addition, ABs have arrangements to exchange

reports, work with each another as subcontractors, andact as observers and interpreters.

The CFPG made these recommendationsto the MLA MC:• Cross frontier best practices should be gather and posted

on IAF's Web site.• The MLA MC should assess implementation of the Cross

Frontier Policy at each peer evaluation, focusing on the AB’splan, proper allocation of resources within the organization,arrangements with other ABs, and evidence of theimplementation of the plan.

• As a control, ABs should require their accredited CertificationBodies to periodically supply a list of all critical offices. Thehost AB should advise the local ABs sufficiently in advanceof those offices and plan for audits using a method thatmeets the requirements of the Cross Frontier Policy.

• A seven-step process for implementation should be used:

1) Outline the plan.2) Identify the commitment to the plan.3) Identify the resources necessary to fulfil the plan.4) Assure that all needed arrangements are in place.5) Put in place the necessary operating plans, including

internal system and resources.6) Begin to implement the system.7) Apply the principles of continual improvement.

These seven steps must also be applied to other ABs withwhich the implementing AB has arrangements. The overallplan should result in the required frequency and integrity ofaudits of all critical locations.

Accreditation UpdateNew Accreditation GrantedSeven new laboratories and two new inspection bodies havebeen granted accreditation since the last issue of HKAS News.Details are given below.

HOKLASAsia Gemmological Institute and Laboratory Limited (HOKLASRegistration No. 151) is the first HOKLAS accredited laboratoryin Hong Kong for physical tests of gemstones under the testcategory of “Physical and Mechanical Testing”. The laboratoryprovides testing service to the public.

China Gems Laboratory Limited (HOKLAS RegistrationNo. 152) and Hong Kong Jade & Stone Laboratory(Registration No. HOKLAS 153) have been accredited forgemstone testing under the test category of “Physical andMechanical Testing”. The laboratories provide testing serviceto the public.

Pharmtech (Hong Kong) Limited – Quality Control Laboratory(HOKLAS Registration No. 154) has been accredited forpharmaceutical products testing under the test category of“Chemical Testing”. The laboratory provides testing service tothe public.

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Stanger Asia Limited (HOKLAS Registration No. 021) hasvoluntarily suspended all HOKLAS accredited cookingbenches and sink units tests under the test category of“Construction Materials” effective 1 November 2004.

Change of Legal StatusBureau Veritas Consumer Products Services (Hong Kong)Limited - Kwai Chung Office (HOKLAS Registration No. 053)voluntarily terminated the accreditation for all tests in all testcategories effective 1 December 2004. The accreditationfor some tests has been granted to Bureau Veritas HongKong Limited – Kwai Chung Office under the sameRegistration Number.

Bureau Veritas Consumer Products Services (Hong Kong) Limited– Kowloon Bay Office (HOKLAS Registration No. 058) voluntarilyterminated the accreditation for all tests in all test categorieseffective from 1 December 2004. The accreditation for sometests has been granted to Bureau Veritas Hong Kong Limited –Kwoloon Bay Office under the same Registration Number.

The accreditation for all tests under the test category of“Chemical Testing” of the Macau Jockey Club – RacingLaboratory (HOKLAS Registration No. 107) was voluntarilyterminated with effect from 30 January 2005. Theaccreditation for the same tests has been granted to MacaoUniversity of Science & Technology Foundation – RacingLaboratory under the same Registration Number.

Accreditation TerminatedQA Testing Centre Limited (HOKLAS Registration No. 020)has voluntarily terminated the accreditation for all testseffective 1 December 2004.

The Hong Kong and China Gas Co. Ltd. – Tai Po Laboratory(HOKLAS Registration No. 117) has voluntarily terminated theaccreditation for all tests effective 1 April 2005.

The Chinese University of Hong Kong – Advanced Surfaceand Materials Analysis Centre (HOKLAS RegistrationNo. 132) has voluntarily terminated the accreditation for alltests effective 8 April 2005.

Proficiency Testing Update

Castco Testing Centre (Shenzhen) Limited (HOKLASRegistration No. 155) has been accredited for physical tests ofaggregates and concrete under the test category of “ConstructionMaterials”. It provides testing service to the public.

The Virology Division, Public Health Laboratory ServicesBranch, Centre for Health Protection, Department of Health(HOKLAS Registration No. 801P) is the first laboratoryaccredited by HKAS under the Medical Testing Test Category.This laboratory is directed by a pathologist. The scope ofaccreditation covers examinations in the discipline of clinicalmicrobiology and infection. It provides services to public andprivate hospitals and clinics.

Diagnostix Pathology Laboratories Ltd. (HOKLAS RegistrationNo. 802P) has been accredited for examinations in thediscipline of anatomical pathology under the test category of“Medical Testing”. The laboratory is directed by a pathologistand provides services to private hospitals and clinics.

HKIASAsia Pacific Inspection Limited (HKIAS Registration No. 009)is accredited for the pre-shipment inspection for kitchenwareunder the inspection field of “Consumer Product” and providesinspection service to the public.

ETS-Testconsult Limited (HKIAS Registration No. 010) isaccredited for welding inspection under the inspection fieldof “Construction products”. The inspection body providesservice in inspection/approval of welding procedures andinspection/approval of welder testing to the public.

Accreditation Suspended and ReinstatedETS-Testconsult Limited (HOKLAS Registration No. 022)voluntarily suspended all HOKLAS accredited physical andsite tests for concrete under the test category of “ConstructionMaterials” effective 24 December 2004. Accreditation for allthe suspended tests was reinstated on 13 April 2005.

The Hong Kong Standards and Testing Centre Ltd. (HOKLASRegistration No. 003) has voluntarily suspended all HOKLASaccredited EMC tests under the test category of “Electricaland Electronic Products” effective 29 March 2005.

Test Area Scheduled Dates StatusDiagnostic test March 2005 Report issued and– schemidt laboratories identified ashammer outliers were requested to

provide findings to HKAS.

Soil - in-situ density test May 2005 Interested parties will beby Nuclear Densometer invited to participate shortly

Aggregate June 2005 Samples distributed to– physical test laboratories for testing.

Reinforcing steel September 2005 Programme being planned– physical test and interested parties will

be invited to participatein due course.

Construction MaterialsAn update on the proficiency testing programme organsied byHKAS in 2005 is given below:

Toys and Children’s ProductsThe interim report for the APLAC T039 – Toy SafetyProficiency Testing Programme has been issued toparticipating laboratories. The preparation of the final reportby the Government Laboratory is underway.

Chinese MedicineSamples for the APLAC T043 – Herbal Medic ineProficiency Testing Programme have been distributed toparticipating laboratories and some participants havealready returned their test results. This programme isjointly organised by HKAS and Government Laboratoryunder the auspices of APLAC. Some delay of the

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New and RevisedPublished Documents

It is the policy of HKAS to review and revise criteriadocuments regular ly. The fo l lowing are new andrevised criteria documents published since the last issueof HKAS News.

programme is expected as problems in del iver ingsamples to some participating accreditation bodies havebeen encountered.

Physical and Mechanical TestingThe f inal report on jadeite jade prof iciency test ingprogramme has been issued. Laboratories identified asoutliers have been requested to undertake an investigationand to provide the findings to HKAS.

A proficiency testing programme on the determination ofthe refractive index of gemstone has been organized andis still underway.

OthersThe APLAC APM 017 proficiency testing programme – massis being organised jointly by HKAS, Hong Kong Association

of Certification Laboratories (HKACL), and KAN – the nationalaccreditation body of Indonesia.

APLAC T044 – a proficiency testing programme for textilesis being organised jointly by HKAS and Hong KongAssociation of Certification Laboratories (HKACL). Otheraccreditation bodies have been invited to nominatelaboratories for participation.

The final report on APLAC T040 – Coal Proficiency TestingProgramme has been issued. All participating laboratoriesin Hong Kong have obtained satisfactory results.

HKAS has invited accredited laboratories to participate inAPLAC T020 and APLAC T021 organised by TAF of Taiwan,China, APLAC T020 involves chemical testing of Portlandcement and APLAC T021 involves methanol and sulphurdioxide testing of alcoholic beverage.

If you wish to contribute to the next newsletteror require further information on any of the

items in this newsletter,please contact HKAS Executive,

36/F., Immigration Tower,7 Gloucester Road, Wan Chai, Hong Kong.

Tel: 2829 4840 Fax: 2824 1302Website address: http://www.itc.gov.hk/hkas

E-mail address: [email protected]

Upcoming Training Courses

September 2005

• The Quality Management in the Laboratory Workshop

• The Internal Quality System Audits Workshop

• Preparing for Accreditation in Medical Laboratories

• Medical Laboratory Quality Management Based on ISO15189

• Internal Auditing of Medical Laboratories to ISO 15189

Interested readers please note that the latestinformation on training courses is posted on our

website at www.itc.gov.hk/hkas.

HKAS published Publicationdocuments Date

HOKLAS Supplementary November 2004Criteria No. 15 Revised“Construction Materials”Test Category – Accreditation ofNon-destructive Tests for Weldingof Steel and Metal

HKAS 008 (2nd Edition) November 2004 (English version only)Guide for HKAS Lead Assessors,Assessors and Technical Experts

HKIAS 003 (2nd Edition) January 2005(English version)HKIAS Criteria for Accreditation ofInspection Bodies

HOKLAS 007 (February 2005) February 2005(English version) RevisedAssessment/ReassessmentQuestionnaire for Non-medicalLaboratories

HOKLAS Supplementary May 2005Criteria No. 22 Revised“Textiles and Garments”Test Category

The above documents are available for downloading fromour website at http://www.itc.gov.hk/hkas.

HKAS has completed its websiterevamping and the domain name of

the homepage has been changed fromhttp://www.info.gov.hk/itc/hkas to

http://www.itc.gov.hk/hkas.

HKAS has completed its websiterevamping and the domain name of

the homepage has been changed fromhttp://www.info.gov.hk/itc/hkas to

http://www.itc.gov.hk/hkas.

Change ofHKAS Website Address

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