quality industry national conference “empowering future quality professionals” what is...

QUALITY INDUSTRY NATIONAL CONFERENCE“EMPOWERING FUTURE QUALITY PROFESSIONALS”

What is Conformity Assessment?D. Iain Muir

Senior Manager: Compliance Management SABS

Member of the Quality Management and Conformity Assessment Chamber

Conformity assessment in context

Corporate, Public and Trade Policy

Industry association, Government Ministry or

Department

Require technical infrastructure to:

manage risk;be economically efficient;incorporate ‘externalities’

and protect against market failure;

ensure the public's confidence in the economy;

andparticipate in the free trade

of goods and service

WTO Agreements

Metrology (measurement and physical standards)

Legal metrology

(weights and measures)

Scientific measurement (microbiological, chemical

and non legal physical properties) -

Generally a mixture of government owned or

private laboratories and research interests

International organisations

(BIPM and OIML)

Regional bodies

Documentary standards

A range of organisations

may develop documentary standards. In the ISO system each

country has one national standards representative

In some sectors

government Ministries or Departments make and

define documentary standards

Regional bodies

Conformity assessment in context

Claims of conformity and certification

This is the process by which a

person or company claims their product or service conforms to a

standard or technical specification

1st party2nd party3rd party

After a claim of conformity or

certification, at any level, marks of conformity can be issued to the

product or service

Testing and inspection activities

Peer assessment and accreditation services

Further activity to ensure

confidence, consistency and competence

Often government or quasi-government bodies

These bodies have formed regional and international

organisations to ensure there is consistency on how peer

assessment and accreditation is performed (IAF, ILAC and IEC Schemes) and is the basis for

MRAs

Conformityassessment

Introduction to Conformity Assessment

Why Conformity Assessment?

Purpose

to help companies beginning to explore the possibility of obtaining certification for themselves or their products in order to trade, market or win contracts.

to help customers who are seeking clarification of the various certification claims they encounter.

For conformity assessment practitioners and bodies.

Introduction to Conformity Assessment

Governments want to be sure that a countries technical infrastructure is adequate and comparable in order to accept goods

Technical infrastructure can be seen in terms of “hardware” and “software”

Technical “software” Technical “hardware”

SANS, ISO/IEC CASCO standards

and guides

(provide the “rules” for the hardware)

National Measurement Laboratories

National Standards Institutes

Laboratories

Certification Bodies

Accreditation Bodies

Mechanisms for conformity assessment

Testing

Inspection

Certification Management system Personnel Product Accreditation

Mutual recognition & Peer assessment

Supplier's declaration of conformity

The decision to use one type of conformity assessment, depends onthe customer's requirements,

the level of risk associated with the product/serviceand regulatory requirements

First party –

technical term used when conformity assessment to a standard, specification or

regulation is carried out by the supplier organization itself it is a self-assessment

known as a supplier's declaration of conformity.

Second party –

performed by the customer of the organization

for example the manufacturer would allow his customer to do an assessment of the product against the requirements

Conformity Assessment activities can be characterized as:


Third party –

performed by a body that is independent of the organization that provides the product and is not a user of the product

for example an independent certification body certifies that another organization conforms with ISO 9001 and issues it with a certificate to this effect

Conformity Assessment activities can be characterized as:


Testing - Definition

Determination of one or more characteristics of an object of conformity assessment, according to a procedure.

NOTE “Testing” typically applies to materials, products or processes.

ISO/IEC 17000:2004 (4.2)

Testing Inspection

Certification

AccreditationMutual recognition & Peer assessment



Common form of conformity assessment

Provides the basis for other types of conformity assessment like inspection

and product certification

Product is tested against a specified set of criteria

Used to make decisions on the performance of the product

Depending on specific requirements from customers and the risk associated

with the product, the testing laboratory may choose to be accredited

ISO/IEC 17025:2005General requirements for the competence of testing and calibration laboratories.

ISO 15189:2007Medical laboratories - Particular requirements for quality and competence


Inspection - Definition

Examination of a product design, product, process or installation

and determination of its conformity with specific requirements or,

on the basis of professional judgement, with general requirements

NOTE: Inspection of a process may include inspection of persons,

facilities, technology and methodology

ISO/IEC 17000:2004 (4.3)

Testing Inspection

Certification




Inspection bodies

Examine a huge range of products, materials, installations, plants, processes, work procedures and services, in the private as well as the public sector, and report on such parameters as quality, fitness for use and continuing safety in operation

Overall aimto reduce risk to the buyer, owner, user or consumer of the item being inspected

ISO/IEC 17020General criteria for the operation of various types of bodies performing inspection


Certification - Definition- Third party attestation related to products, processes, systems or persons”

ISO/IEC 17000:2004 (5.5)

NOTE 1 Certification of a management system is sometimes also called registrationNOTE 2 Certification is applicable to all objects of conformity assessment except for conformity assessment bodies themselves, to which accreditation is applicable

Attestation – “Issue of a statement based on a decision following review that fulfillment of specified requirements have been demonstrated”

ISO/IEC 17000:2004 (5.2)

Testing Inspection

Certification




What is Certification?When a third party gives written assurance that:

product (including services),process,personnel,organization ormanagement system

conforms to specific requirements

“Certification” and “registration” are interchangeableUse of one over the other is largely dependant on the geographical region


Best-known Management System certifications - ISO 9001 & ISO

14001

More than 1 000 000 organizations worldwide certified to ISO 9001

and/or ISO 14001

Management certification is not carried out by ISO

ISO does not control the certification bodies

ISO does contribute to best practice and consistency of certification

bodies through the development of standards and guides


Sector specific standards – have their basis in ISO/IEC 17021 only differ in those areas which are deemed absolutely

necessary and relate specifically to the discipline covered example, food safety and ISO/TS 22003

General standard –ISO/IEC 17021:2006 General requirements for bodies providing audit and certification of management systems is applicable for all types of management systems generally


Product certification may consist of:

initial product testing with assessment of the quality management system

followed up by testing of samples from the factory and/or the open market

initial testing and surveillance testing

type testing : testing of a sample product

The type of product certification scheme chosenWill depend on the level of risk to the consumer as well as other factorsFor a very low risk product you may have a once-off type testFor a high risk product you may have a scheme which has type testing, requires an ISO 9001 management system in place with regular product testing from the factory and also products taken from the outlets for testing


ISO/IEC Guide 65:1996 General requirements for bodies operating product certification systems [Draft = ISO 17065] can be used in combination with a number of related product

standards and guides to demonstrate that a product complies with specified criteria


Other standards and guides in this family ISO/IEC Guide 23:1982 (Reconfirmed in 2003)

– Methods of indicating conformity with standards for third-party certification systems

ISO/IEC Guide 28:2004– Conformity assessment - Guidance on a third-party certification

system for products ISO/IEC Guide 53:2005

– Conformity assessment - Guidance on the use of an organization's quality management system in product certification

ISO/IEC Guide 67:2004– Conformity assessment - Fundamentals of product certification


Objectives of certification of personnel

Achieving and promoting a globally accepted benchmark for

organizations operating certification of persons

Certification of persons is one means of providing assurance that the

certified person meets the requirements of the certification scheme

Confidence in the respective conformity assessment schemes is

achieved by means of a globally accepted process

Conformity Assessment Auditor competence: General = ISO 19011

Conformity Assessment Auditor competence: Third party = ISO

17021-Part 2 (Still in draft)


ISO/IEC 17024:2003 (Under Revision)Conformity assessment - General requirements for bodies operating certification of persons Requirements for a body certifying persons against

specific requirements, including the development and maintenance of a certification scheme for personnel


Accreditation - Definition

Third-party attestation related to a conformity assessment body conveying

formal demonstration of its competence to carry out specific conformity

assessment tasks

ISO/IEC17000:2004 (5.6)

Testing Inspection

Certification




Accreditation is the procedure

by which an authoritative body gives formal recognition that a body

or person is competent to carry out specific tasks

Management System Accreditation

indicates to the client of the certification body that its competence to

do the certifications has been independently confirmed

Accreditation of testing laboratories, product certification and

inspection bodies

is independent verification that they are competent to perform the

activities for which they are accreditedISO/IEC 17011Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies


Mutual/Multilateral arrangement/agreement

Arrangement or agreement whereby more than two parties

recognize or accept one another’s conformity assessment results

ISO/IEC 17000:2004 (7.9)

Testing Inspection

Certification




How can confidence be achieved?

Through cross-border cooperation among conformity assessment

bodies and also among accreditation bodies

What do MRA’s achieve ?

Reduce the multiple conformity assessment that products, services,

systems, processes and materials may need to undergo, especially

when they are traded across borders

Contribute to the efficiency of the international trading system by

facilitating the acceptance of goods and services everywhere on the

basis of a single assessment in one country,

Benefit suppliers and customers alike

Mutual Recognition Agreements (MRA's)


ISO/IEC Guide 68: 2002Arrangements for the recognition and acceptance of conformity assessment results


Peer assessment - Definition

assessment of a body against specified requirements by

representatives of other bodies in, or candidates for, an

agreement group

ISO/IEC 17000:2004 (4.5)

agreement group

bodies that are signatories to which an arrangement is based

ISO/IEC 17000:2004 (7.10)

Testing Inspection

Certification




Peer Assessments are useful

To demonstrate competence

To ensure quality

To create and keep mutual confidence

Peer assessment process

Carried out by peers or by agreement groups of accreditation bodies

or conformity assessment bodies

Other certification bodies, other laboratories,etc

Parties with similar experiences, training, competence

ISO/IEC 17040:2005Conformity assessment — General requirements for peer assessment of conformity assessment bodies and accreditation bodies


Testing Inspection

Certification



ISO/IEC 17050 – 1:2004Supplier's declaration of conformity - Part 1: General requirements

Supplier's declaration of conformity (SDoC)


Purpose of ISO/IEC 17030:enable a uniform approach to the use of third-party marks of conformity

to address potential problems arising from different uses of third-party marks of conformity

ISO/IEC 17030 concentrates on third party marks of conformity but may also be used as guidance for other applications of marks of conformity

ISO/IEC 17030 is based on market feedback and demands from various users and issuers of marks of conformity assessment

Marks of Conformity


Confidence in safety, health, environment, fair commerceRegulations based on riskChoice of activities

TestingInspectionSDOCCertificationAccreditation

Independence and Rigor of Conformity Assessment

accreditationVerification of competence

Per

ceiv

ed R

isk

supplier’s declaration1st party conformity

assessment

certification3rd party conformity

assessment

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Selection

What is Conformity Assessment?

D. Iain [email protected]

Thank you for your attention

quality industry national conference “empowering future quality professionals” what is...

Documents

type of conformity assessment

claim of conformity

marks of conformity

context claims of conformity

quasi government bodies

goods technical infrastructure

technical specification

various certification