Transcript Slide 1
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; and participate in the free trade of goods and service WTO Agreements 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 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
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 party 2nd party 3rd 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
Conformity assessment
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
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 on the customer's requirements, the level of risk associated with the product/service and regulatory requirements
Mechanisms for conformity assessment
Conformity Assessment activities can be characterized as: 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
Mechanisms for conformity assessment
Conformity Assessment activities can be characterized as: Third party –
performed by a body that is
independent of the organization
provides the product and is
not a user
of the product that for example an independent certification body certifies that another organization conforms with ISO 9001 and issues it with a certificate to this effect
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 Accreditation Mutual 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 17025:2005 General
requirements for the competence of
testing and calibration
laboratories .
ISO 15189:2007 Medical 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 Accreditation Mutual 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 aim
to reduce risk to the buyer, owner, user or consumer of the item being inspected
ISO/IEC 17020
General 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 registration NOTE 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 Accreditation Mutual 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 or management system conforms to specific requirements “Certification” and “registration” are interchangeable Use 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
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 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
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 chosen
Will depend on the level of risk to the consumer as well as other factors For a very low risk product you may have a once-off type test For 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 Accreditation Mutual 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
Conformity 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 Accreditation Mutual recognition & Peer assessment Supplier's declaration of conformity
Mechanisms for conformity assessment
Mutual Recognition Agreements (MRA's) 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
Mechanisms for conformity assessment
ISO/IEC Guide 68: 2002 Arrangements 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 Accreditation Mutual 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 17040:2005
Conformity assessment accreditation bodies — General requirements for peer assessment of conformity assessment bodies and
Mechanisms for conformity assessment
Supplier's declaration of conformity (SDoC)
ISO/IEC 17050 – 1:2004
Supplier's declaration of conformity - Part 1: General requirements
Testing Inspection Certification Accreditation Mutual recognition & Peer assessment Supplier's declaration of conformity
Mechanisms for conformity assessment
Marks of Conformity 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
Mechanisms for conformity assessment
Selection Confidence in safety, health, environment, fair commerce Regulations based on risk Choice of activities Testing Inspection 0
accreditation
Verification of competence
SDOC Certification Accreditation
certification
3 rd party conformity assessment supplier’s declaration 1 st party conformity assessment 10
Independence and Rigor of Conformity Assessment
0
What is Conformity Assessment?
Thank you for your attention
D. Iain Muir [email protected]