IV Conformance
Conformity assessment is "any activity concerned with determining directly or indirectly that relevant requirements are fulfilled" (ISO/IEC Guide 2: 1996)
Overview and Structure
Conformity assessment is the process of deciding whether or not a product or system conforms to a standard and/or complies with a regulation. There are three main types of conformity assessment: testing, inspecting and certifying.
Over recent years, the international conformance structure has evolved as a hierarchy (see Conformity Assessment Structure ). The implementation of the World Trade Organisation's TBT and SPS Agreements (see Technical Requirements for Export ) have encouraged this. Most WTO member countries are now developing similar structures in order to facilitate trade. The basic structure is as follows:
Government
Governments have a role in ensuring that systems are in place to meet the requirements of international agreements within the WTO and within regional organisations such as Asia Pacific Economic Co-operation (APEC). The national system must be scientifically rigorous, and the processes transparent and reliable. This enables our trading partners to have confidence and trust in any conformance decisions made in New Zealand. Similarly, the New Zealand government must be confident that decisions made overseas are accurate and reliable and that imported products will not place New Zealand citizens at risk.
Accreditation
Accreditation is: "a procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks." Governments establish or endorse technical accreditation bodies. Accreditation is voluntary but provides confidence in results. Accreditation bodies check that those doing the actual testing, inspecting and certification are competent and reliable. The parallel in the education sector is the New Zealand Qualifications Authority that accredits educational institutes as competent to issue trade training certificates or award degrees.
Testing, Inspecting, Certifying
The actual conformity assessment is undertaken by private organisations on a commercial basis. Specialist laboratories undertake tests or check measurements and issue test or calibration reports. Inspection bodies undertake various types of professional inspections and issue inspection reports. Certification bodies license products or audit quality or environmental management systems and issue certificates of conformity.
Mutual Recognition
Mutual Recognition Arrangements (MRAs) are based on conformity assessment: whether the authorities in one country can trust a decision made in another country. MRAs are agreed after rigorous peer evaluation to ensure that each partner is using the same or equivalent standards or specifications and undertaking checks using the same methods.
Conformity Assessment Structure
International Accreditation New Zealand
626 Great South Road, Greenlane
(Private Bag 28 908, Remuera), Auckland
Telephone: 09-525 6655
Website: www.ianz.govt.nz
Mission: "To underpin and facilitate domestic commerce and external trade through appropriate national conformity assessment and training."
International Accreditation New Zealand (IANZ) is the national authority for accrediting technical professional services. Its primary role is the accreditation of testing and calibration laboratories and inspection bodies. It also accredits specific professional activities, including radiology services and pharmacies.
Accreditation ensures that the government, consumers and the public can have confidence in the quality and competence of New Zealand's testing, inspection and other assessment services. Reliable technical services contribute directly to improved business efficiency and to the international competitiveness of New Zealand's industry and technology.
Accreditation is in the voluntary sector; i.e. there is no legal requirement for facilities to be accredited. Regulators and other government authorities are, however, increasingly using formal accreditation to international standards as a reliable measure of competence to undertake some government-funded services.
Recent cases of fatal errors by non-accredited medical laboratories, for example, have led health funders to require laboratories seeking government medical testing contracts to have current IANZ accreditation.
IANZ advises government on conformance issues and technical barriers to trade, and participates in the standards and conformance aspects of trade negotiations.
Structure
IANZ is the operating arm of the Testing Laboratory Registration Council, a statutory body established by Act of Parliament in 1972. The Council has nine appointed members from various technical disciplines and sectors of industry, and reports to Parliament through the Minister of Commerce. IANZ is entirely user-funded and does not receive any government funding. IANZ has a staff of 35 based in Auckland, and undertakes accreditation assessments throughout New Zealand.
All recommendations to grant IANZ accreditation are referred to Professional Advisory Committees, consisting of invited external technical experts who contribute on a voluntary basis. This ensures that the process is independent, objective and transparent. The relevant Advisory Committee also considers recommendations for suspension or withdrawal of accreditation.
IANZ relies on a pool of over 200 technical experts who act as technical assessors for peer reviews of laboratories or inspection bodies in their specialist field.
IANZ itself is subject to regular peer evaluations by counterpart accreditation authorities from Europe, North America and the Asia Pacific region. This ensures that its competence and procedures remain consistent with international practice. IANZ participates in similar peer evaluations of its overseas counterparts.
IANZ Operations
- Testing and calibration laboratory accreditation (ISO/IEC 17025)
- Inspection body accreditation (ISO/IEC 17020)
- Radiology service accreditation (ISO/IEC 17025 adapted)
- Pharmacy accreditation (ISO/IEC 17025 adapted)
- Proficiency testing programme accreditation (ISO/IEC Guide 43)
- Registration of OECD GLP Compliant Laboratories
- Designating Authority for approval of laboratories and inspection bodies for CE marking (see Agreement between New Zealand and the European Community for Mutual Recognition of Conformity Assessment (NZ/EU MRA) - for CE Marking)
- Assessment of Ministry of Health food safety system (HACCP) auditing bodies
- Assessment of MAF meat industry laboratories
- Development of accreditation programmes and technical criteria
- Technical information and advice
- Input to development of international standards relating to testing, inspection and accreditation
- Training courses in a range of technical areas, including laboratory quality management, measurement, testing and auditing skills. Specific courses cover accreditation requirements for medical testing, radiology and inspection services
- Advisory service for developing country accreditation authorities
The accreditation process follows international accreditation standards. Assessors check both the technical competence of the organisation and its quality management system. This includes checking that staff are properly qualified and experienced and that their knowledge is up-to-date. It covers test or inspection methods, environment and equipment, recording and all other aspects that could affect the result.
The specific tests or inspections that meet accreditation requirements are listed in the organisation's Scope of Accreditation. Accredited organisations are entitled to put the IANZ logo on reports of tests or inspections within their scope.
Laboratory Accreditation
IANZ accredits laboratories against the international standard: ISO/IEC 17025: General Requirements for the Competence of Testing and Calibration Laboratories.
Laboratories are currently accredited in the following fields:
- Biological and microbiological
- Chemical
- Dairy products
- Electrical
- Gas cylinders
- Mechanical
- Medical
- Metrology and Calibration
- Applied physics
- Wool
Inspection Body Accreditation
IANZ accredits Inspection Bodies against the international standard: ISO/IEC 17020, General Criteria for the Operation of Various Types of Bodies Performing Inspection. At present, IANZ is the only provider of Inspection Body accreditation in New Zealand.
Inspection bodies undertake a range of activities, from inspection of agricultural products to boilers, cranes and ski lifts. The government Quarantine Service is gaining Inspection Body accreditation for its border control services. The Ministry of Health is using criteria based on ISO/IEC 17020 to ensure the technical competence of food safety inspection services.
Radiology Service and Pharmacy Accreditation
Radiology services (x-ray and other imaging) and pharmacies offering prescription services are accredited against Codes of Practice based on ISO/IEC 17025, and developed in close consultation with the relevant professional bodies.
Proficiency Testing
Proficiency testing programmes check the consistency of procedures between laboratories and the reproducibility of test results (whether an identical test will always give the same result). Identical samples or artefacts are sent to laboratories for testing or calibration. Results are analysed by statisticians and studied by technical consultants, expert in the field being tested. A report is returned to each participating laboratory on its performance and indicating any remedial action needed. All IANZ-accredited laboratories are required to participate in proficiency testing programmes.
Public Database of IANZ Accredited Organisations
IANZ maintains a database of its accredited organisations and their scopes of accreditation. This is accessible through the IANZ website .
International Role
IANZ assists in reducing technical barriers to trade through Mutual Recognition Arrangements (MRAs) with counterpart accreditation authorities in New Zealand's major export markets. MRA partner accreditation authorities will accept test, measurement and inspection reports from New Zealand if they bear the IANZ accreditation logo.
IANZ currently has MRAs for laboratory accreditation with 40 accreditation authorities in 29 of New Zealand's major overseas markets, including Europe, North America, Australia and a number of developed Asian countries. These will be added to as new accreditation authorities meet the stringent peer evaluation requirements for MRA status.
International Involvement
IANZ is a founding member of the international grouping of laboratory accreditation authorities, International Laboratory Accreditation Co-operation (ILAC) which was established in 1978 and currently has 58 members from over 50 countries. IANZ is also a founding member of the regional grouping, Asia Pacific Laboratory Accreditation Co-operation (APLAC), which is recognised by APEC as a Specialist Regional Body.
IANZ represents New Zealand in ILAC and APLAC, and on the OECD Panel on Good Laboratory Practice. These responsibilities are recognised by the New Zealand Government through a Memorandum of Understanding.
IANZ staff provide input into a number of international committees, including the ISO Committee on Conformity Assessment (CASCO), and participate in meetings of other regional groupings of importance to New Zealand, such as European co-operation for Accreditation (EA).
IANZ provides consultancy services for developing accreditation authorities, particularly in the Asia Pacific region, and provides training for their staff, both offshore and in New Zealand. IANZ also regularly hosts overseas delegations keen to learn from the extensive experience IANZ has gained in competency-based accreditation, proficiency testing and co-operation with regulators.
Joint Accreditation System of Australia and New Zealand
22 The Terrace (PO Box 708), Wellington
Telephone: 04-474 3348
Website: www.jas-anz.com.au
Mission: "To ensure the JAS-ANZ accreditation process enhances New Zealand/Australia and international trade and achieves international recognition of the excellence of Australian and New Zealand goods and services."
The Joint Accreditation System of Australia and New Zealand (JAS-ANZ) accredits inspection bodies, bodies that certify management systems or auditor training courses or personnel and bodies that license products. JAS-ANZ also provides accreditation programmes for regulators and industry specific schemes using criteria modelled on international standards and guidelines.
Increased trade and greater competition from imported products has brought into focus the need for quality in products, processes and services
JAS-ANZ accredits third party certification bodies as competent to carry out independent audits of management systems and to issue certificates of compliance. Accredited bodies may issue certificates for a quality management system (ISO 9001:2000 - or QS 9000 for the automotive industry), an environmental management system (ISO 14001) or other management systems with specified criteria. Accreditation of the body issuing the certificate provides companies with assurance that their management systems have been audited in line with international practice and that their ISO 9001:2000 or ISO 14001 certificates will be recognised by their customers.
JAS-ANZ also accredits inspection bodies to the international standard ISO/IEC 17020: General Criteria for the Operation of Various Types of Bodies Performing Inspection.
Auditors qualified to undertake various competence assessments, including management systems audits, are registered by personnel certification bodies. JAS-ANZ accredits the personnel certifiers as competent to assess auditors' qualifications and industry knowledge and to issue the appropriate registration. JAS-ANZ also accredits organisations that provide auditor training courses.
Products that conform to specific requirements can be licensed to use product certification markings. JAS-ANZ accredits the bodies that certify these products to the international standard ISO/IEC Guide 65: General Requirements for Bodies Operating Product Certification Systems.
JAS-ANZ also provides accreditation services for a range of other specialist technical activities.
Structure
The Joint Accreditation System of Australia and New Zealand (JAS-ANZ) is an international organisation established by a formal treaty between the governments of Australia and New Zealand. The treaty was signed on 30 October 1991. The organisation operates on a self-funding, non-profit basis.
JAS-ANZ is controlled by a Governing Board comprising ten members, six of whom are appointed by the Australian Government and three by the New Zealand Government. The Chief Executive of JAS-ANZ is the tenth member. A senior official from MED represents the New Zealand Government on the Governing Board. A secretariat, located in Canberra and headed by the Chief Executive, handles the day-to-day functions of JAS-ANZ.
Bodies seeking accreditation have to satisfy the requirements of the accreditation criteria published by the JAS-ANZ Governing Board. These criteria are based on international standards and guidelines. This process facilitates international mutual recognition of accredited certificates.
Accreditation is based on assessments undertaken on behalf of the Governing Board. All recommendations to grant accreditation are subject to approval by the Accreditation Review Board, appointed by and operating under delegated authority from the Governing Board. Recommendations for suspending or withdrawing accreditation are also subject to Board approval.
Operations
JAS-ANZ is responsible for:
- Maintaining a joint accreditation system that will give users in Australia and New Zealand confidence that goods, services and personnel certified by accredited bodies meet established standards
- Supporting trade by obtaining and maintaining overseas acceptance of product certificates and management systems certificates issued in New Zealand and Australia
- Establishing links with relevant bodies in the areas of conformity assessment services and recognition of standards in relation to goods and services
- Obtaining mutual recognition and acceptance of certificates of conformity with relevant bodies in other countries
JAS-ANZ also provides advice to the government on conformance issues and participates in standards and conformance aspects of trade negotiations.
Accreditation programmes are currently available for the following activities:
Accreditation of Certifiers of Management Systems
- Certification of Quality Management Systems (ISO 9000 and QS-9000 for the automotive industry)
- Certification of Environmental management systems (ISO 14001)
- Certification of Food Safety Systems based on Hazard Analysis Critical Control Point (HACCP)
- Certification of HACCP Management systems
- Certification of Occupational Health and Safety Management Systems (OH&S - AS/NZS 4801)
- Certification of Information Security Management Systems (ISMS - AS/NZS 4444)
Accreditation of Product Certifiers
- Certification of Products licensed to carry Certification Markings
Accreditation of Personnel Certifiers
- Certification of Audit Personnel
Other Accreditation Programmes
The JAS-ANZ Register
JAS-ANZ produces a Register of Accredited and Certified Organisations, in association with Standards Australia International. The Register lists all bodies accredited by JAS-ANZ, plus all the organisations and personnel certified by these accredited bodies. The register is updated monthly from information provided by the accredited certification bodies. The Register is available on the JAS-ANZ website .
International Role
A primary objective of the JAS-ANZ Board is to establish international links so that the certifications that are granted by JAS-ANZ-accredited bodies will be recognised in any international market.
JAS-ANZ is a founding member of the International Accreditation Forum (IAF), which aims to promote mutual recognition between accreditation bodies, and to be a forum for the exchange of information and ideas of common interest. The IAF was established in 1993 and now has members from over 35 countries. The main work of the IAF to date has been the development of uniform interpretative documents based on the relevant ISO/IEC accreditation and certification Guides.
A multilateral Mutual Recognition Agreement (MRA) has been signed by 29 members of the IAF, including JAS-ANZ. This MRA covers accreditation of ISO 9000 certification bodies.
JAS-ANZ is a foundation member of the International Auditor and Training Certification Association (IATCA). IATCA is establishing a mutual recognition scheme for ISO 9000 auditors and auditor training courses, based on uniform criteria and a common code of practice for the operation of auditor certification and auditor training course accreditation. A similar programme has been established for the certification of environmental management system (ISO 14001) auditors.
Regional Co-Operation
JAS-ANZ is a foundation member of Pacific Accreditation Co-operation (PAC), a specialist body within APEC. PAC promotes acceptance of certificates of conformity through mutual recognition. It encourages and supports the development of national accreditation authorities throughout the Asia Pacific region. PAC develops regional consensus among members on accreditation and certification issues to be taken to relevant international forums such as the IAF. A regional MRA covering accreditation of ISO 9000 certification bodies has been signed by members of PAC, including JAS-ANZ.
JAS-ANZ has signed an MRA with European counterparts covering accreditation of certification of environmental management systems (ISO 14001) and product certification.
Conformance: Testing and Calibration
Testing is the process of determining the characteristics of an item or material using recognised scientific methods.
Tests are carried out in laboratories and reports relate only to the sample tested. Most tests are conducted using standard test methods that specify the equipment, environment and processes required to achieve a reliable result. Microbiological testing, for example, requires a sterile environment, with staff wearing protective clothing. When non-standard test methods are used, the scientists must be able to prove that the test method is valid.
Accreditation means the laboratory and its staff are competent to undertake the specific tests listed in its Scope of Accreditation. A laboratory may be accredited to test food products for chemical residues, but not to check for microbial contamination. Or it may be competent to test building materials for ability to withstand earthquakes or to test the toxicity of paints used on coffee mugs. Test reports may only carry the accreditation logo if the laboratory is accredited for those tests.
There are over 500 accredited laboratories in New Zealand. A list of laboratories accredited for specific tests is on the IANZ website .
Calibration is the process of ensuring that measuring instruments are giving accurate results.
Measuring instruments are calibrated in calibration laboratories against reference standards that have been calibrated by MSL. This ensures that any measurements performed with the calibrated instruments will be traceable back to the national measurement standard. Calibration laboratories can be accredited to calibrate a wide range of measuring instruments, including speed cameras, analytical balances, measuring tapes, pressure gauges and electrical power meters.
Calibration reports may only carry the accreditation logo if the laboratory is accredited for those calibrations. A list of laboratories accredited for specific calibrations is on the IANZ website.
Conformance: Inspection
Inspection is the use of skill and professional judgement to determine whether technical and safety requirements are being met.
The international standard for professional inspection bodies (ISO/IEC 17020) covers designs, products, services, processes and plant. Specialist inspectors examine the technical aspects of such things as pipelines, crane designs, boilers, buildings, machinery, quarantine services or food premises.
Many inspections require the use of internationally recognised standard inspection methods to ensure that all safety aspects are checked. An example is AS/NZS 3788:1996 - Pressure Equipment - In-Service Inspection.
Accreditation assessments of inspection bodies include detailed on-site observation as well as checking of procedures, records and reports. This enables technical assessors to be confident that approved inspection body staff have the necessary skills, experience and systems to support their results. Inspection reports may only carry the accreditation logo if the inspection body is accredited for those inspections.
There are over 80 accredited inspection bodies in New Zealand. A list of accredited bodies, together with their Scope of Accreditation, is on the IANZ website .
Conformance: Certification
As the chart illustrates, there are several categories of certification. Certification bodies are accredited to specific international standards, depending on the type of certification they are competent to undertake. Certification bodies issue certificates of compliance to suppliers of goods and services.
A management system certification body may be accredited to audit and certify a quality management system (ISO 9000) or an environmental management system (ISO 14001), a health and safety system or other management systems with published standards or codes of practice. The range of standards a certification body is accredited to audit against is specified in its Scope of Accreditation.
Compliance certificates may only carry the accreditation logo if the certification body is accredited to audit against that standard. A list of certification bodies accredited for specific standards is on the JAS-ANZ website .
Note: A company is never "accredited". A third party certification body is accredited; the company it audits is certified (see Conformity Assessment Structure ).
Certification of Quality Management Systems (ISO 9001: 2000)
Quality management system (QMS) certification is the process of carrying out an independent audit of an organisation's documented management system against the requirements of the standard and of ensuring that written procedures are applied in practice. Certification bodies issue certificates of compliance.
The first international standards for quality management systems, the ISO 9000 series, were published in 1987 and revised in 1994. The current version, ISO 9001: 2000, brings together key elements of the earlier standards and places greater emphasis on continual improvement. Certification to ISO 9001: 2000 is evidence that an organisation is managing its processes in order to meet its customers' needs.
Certification of Environmental Management Systems (ISO 14001)
In 1996, the ISO 14000 series of environmental management standards was published. These standards cover a range of environmental issues, including environmental labelling (ISO 14024). The standard ISO 14001 deals specifically with environmental management systems. The principles are similar to ISO 9001:2000, with emphasis on continual improvement, but the standard also addresses technical issues relating to environmental effects. Certification to ISO 14001 is evidence that the business is making a serious effort to manage and reduce its impact on the environment.
New Zealand Association of Certification Bodies
The New Zealand Association of Certification Bodies (NZACB) is a non-profit organisation for certification bodies operating within New Zealand. NZACB members are accredited to certify quality management systems to ISO 9001: 2000 and/or environmental management systems to ISO 14001. Some members of NZACB also operate accredited laboratories or accredited inspection services.
All NZACB members are accredited by JAS-ANZ or IANZ as competent to undertake specific audits and issue certificates of compliance within their Scope of Accreditation. Some certification bodies operating in New Zealand are also accredited by overseas accreditation bodies.
The NZACB Secretariat is managed by the New Zealand Organisation for Quality. The association may be contacted via The Secretary, NZACB, P.O. Box 622, Palmerston North; telephone 06-350 5825; facsimile 06-350 5820; email quality@nzoq.org.nz . Contact addresses for members of the NZACB are available from the secretariat or the NZOQ website .
Note: NZACB groups commercial providers of certification services. It does not form part of New Zealand's standards and conformance infrastructure, but is included as a source of information for business.
Personnel Certification
Personnel certification is the process of determining that an individual has the appropriate knowledge and skills to undertake assessments against specified requirements.
Professional auditors are required to have in-depth knowledge of the industries they are auditing. They must undertake a formal training course on the standard they are to audit against and demonstrate that they have the right personal skills to be an auditor. They must also serve a period of practical training supervised by an experienced auditor.
There are several levels of registration, from Provisional to Lead Auditor. Auditors are registered as competent to audit only those industries where they have prior work experience. Registration certificates specify the standard industry codes covered by the individual's registration. Auditors must perform a minimum number of audits per year to maintain registration.
A list of certification bodies accredited to undertake personnel certification is on the JAS-ANZ website .
Product Certification
Product certification is the process of licensing manufacturers to apply a product certification marking to a line of products that comply with specified product standards and other technical requirements, e.g. labelling.
Product certification is commonly used for products with specific safety requirements. In New Zealand, the "S" mark is recognised as evidence that products such as windscreens, bicycles or toasters have passed a safety check. (NB: the "S" mark programme now operates commercially and is not currently accredited to the international standard for product certification).
Product certifiers require that a sample of the product be submitted, together with design details and other documentation. This usually includes accredited test or inspection reports. The manufacturer may also be required to have a certified quality management system in place. If all requirements are met, the manufacturer will be licensed to apply the product certification mark to all products made identical to the original design.
A list of certification bodies accredited to undertake product certification is on the JAS-ANZ website.
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