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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:
Mechanisms for conformity assessment
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:
Mechanisms for conformity assessment
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
Supplier's declaration of conformity
Mechanisms for conformity 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
Mechanisms for conformity assessment
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
AccreditationMutual recognition & Peer assessment
Supplier's declaration of conformity
Mechanisms for conformity assessment
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
Mechanisms for conformity assessment
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
AccreditationMutual recognition & Peer assessment
Supplier's declaration of conformity
Mechanisms for conformity assessment
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
Mechanisms for conformity assessment
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
Mechanisms for conformity assessment
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
Mechanisms for conformity assessment
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
Mechanisms for conformity assessment
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
Mechanisms for conformity assessment
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
Mechanisms for conformity assessment
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)
Mechanisms for conformity assessment
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
Mechanisms for conformity assessment
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
AccreditationMutual recognition & Peer assessment
Supplier's declaration of conformity
Mechanisms for conformity assessment
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
Mechanisms for conformity assessment
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
AccreditationMutual recognition & Peer assessment
Supplier's declaration of conformity
Mechanisms for conformity assessment
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)
Mechanisms for conformity assessment
ISO/IEC Guide 68: 2002Arrangements for the recognition and acceptance of conformity assessment results
Mechanisms for conformity assessment
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
AccreditationMutual recognition & Peer assessment
Supplier's declaration of conformity
Mechanisms for conformity assessment
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
Mechanisms for conformity assessment
Testing Inspection
Certification
AccreditationMutual recognition & Peer assessment
Supplier's declaration of conformity
ISO/IEC 17050 – 1:2004Supplier's declaration of conformity - Part 1: General requirements
Supplier's declaration of conformity (SDoC)
Mechanisms for conformity assessment
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
Mechanisms for conformity assessment
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
10 0
0
Mechanisms for conformity assessment
Selection
What is Conformity Assessment?
D. Iain Muiriain@sabs.co.za
Thank you for your attention