There are several ways in which the competence and impartiality of conformity assessment bodies (CABs) can be recognised, including government recognition, accreditation and peer assessment.
Recognition is based on specified requirements set out in the following documents:
- relevant laws or regulations;
- conformity assessment schemes;
- the relevant International Standards for the type of conformity assessment body; and
- supplementary documents related to the specific technical area being covered.
Governments can recognise CABs in two different ways: administrative recognition, where no consideration of technical competence is required, or technical recognition, where consideration of technical competence is required.
Consideration of technical competence should be based on the relevant International Standards, and the persons making the assessment of the CAB should be competent in the relevant International Standard and technical area. Recognition may take the form of a license to operate, admission to an approved list of CABs or a pre-qualification list of suppliers.
Where there is an urgent need for a conformity assessment approach to be set up, the regulatory authorities could decide to directly assess and appoint bodies. However, the basis of the assessment might not be clear and it could be difficult for the bodies and their certificates to gain recognition in other countries.
Accreditation is a specific conformity assessment activity involving the independent third-party assessment of CABs with specified requirements. Accreditation generally involves the use of auditing techniques by assessment teams including experts in the organizational aspects such as management systems and also in the technical activities of the body. For example, for a testing laboratory the team would include one or more experts in the types of measurement and testing being carried out.
The relevant standard for accreditation, ISO/IEC 17011, sets out the following requirements for accreditation bodies and the process of accreditation:
- accreditation body requirements, including legal responsibility, structure, impartiality, confidentiality, liability and financing and accreditation activity;
- management requirements, including requirements for the management system of the accreditation body, document control, records, nonconformities and corrective actions, preventive actions, internal audits, management reviews and complaints;
- human resource requirements, including personnel associated with the accreditation body, personnel involved in the accreditation process, monitoring and personnel records;
- accreditation process requirements, including accreditation criteria and information, application for accreditation, resource review, subcontracting the assessment, preparation for assessment, document and record review, on-site assessment, analysis of findings and assessment report, decision-making and granting accreditation, appeals, reassessment and surveillance, extending accreditation, suspending, withdrawing or reducing accreditation, records on CABs, and proficiency testing and other comparisons for laboratories;
- requirements for responsibilities of the accreditation body and the CAB, including obligations of the CAB, obligations of the accreditation body and reference to accreditation and use of symbols.
Accreditation bodies around the world have formed several international organisations of which they are the members. These bodies include the International Accreditation Forum (IAF), which focuses on issues related to consistent accreditation of certification bodies; and the International Laboratory Accreditation Cooperation (ILAC), which focuses on issues related to consistent accreditation of laboratories and inspection bodies.
IAF and ILAC produce documents which help their members provide consistent interpretation and application of the relevant International Standards on conformity assessment. This builds confidence that accredited conformity assessment activities in one country can be deemed to be equivalent to accredited conformity assessment activities undertaken in another country, and hence countries can mutually recognise each other conformity assessment results (e.g. test reports, inspection reports and certificates).
Peer assessment, also known as peer evaluation, is a conformity assessment activity used to ascertain the conformity of a person or organization with a set of specified requirements for membership of a group which the person or body wishes to join. The assessment is carried out by other members of the group, in other words the peers of the applicant. The specified requirements normally include relevant International Standards.
Requirements in the relevant standard, ISO/IEC 17040, contain:
- structural requirements;
- human resource requirements, including qualifications and selection, and languages and translation;
- information and documentation;
- peer assessment process requirements, including application for peer assessment or an extension of scope, review and acceptance of the application, preparation for the peer assessment process, appointment of peer assessment team, documentation review, on-site assessment, analysis of findings, peer assessment report, review of the peer assessment report, peer assessment in support of continuing membership of agreement group, and notification of changes;
- confidentiality requirements;
- complaints handling requirements;
- guidance on financial aspects, assessment techniques for use by peer assessment teams and information to be included in the peer assessment report.
Peer assessment practice is based on:
- competent assessors, drawn from members of the group;
- clearly specified membership criteria decided by the group;
- a methodical assessment of the candidate organization’s conformity with the criteria; and
- a report of the findings with sufficient information for the group to decide on the candidate organization’s suitability for membership.
The group will decide upon whether there is a need for periodic auditing and re-assessment of the members of the group. If so, the relevant parts of the process will be undertaken. The members of peer assessment agreement groups are generally all expert in the particular technical areas covered by the agreement and so provide a high level of technical competence for the peer assessment. On the other hand, the bodies could be in competition with each other and might not be totally impartial. The peer assessment scheme needs to be well-managed in order to maintain its effectiveness in inspiring confidence in the work of its members. One aspect of peer assessment in a multilateral arrangement is to ensure that the assessment teams are drawn from across the membership and do not involve assessors from two different members assessing each other’s organizations.
In conformity assessment, the process of peer assessment is specified in ISO/IEC 17040:2005, Conformity assessment - General requirements for peer assessment of conformity assessment bodies and accreditation bodies.
Examples of peer assessment groups for:
that are run by IEC. Several thousand testing laboratories participate in these systems and more than 1 million valid certificates have been issued to date by certification bodies holding membership with them. Each member of these systems automatically accepts the conformity certificates and reports of all the other System members.
- IECEE (System of Conformity Assessment Schemes for Electrotechnical Equipment and Components) covers safety and performance for a wide variety of equipment and components used in homes, offices, workshops, healthcare facilities and more;
- IECEx (System for Certification to Standards Relating to Equipment for use in Explosive Atmospheres) covers the highly specialized field of explosion protection associated with the use of equipment in areas where flammable gases, liquids and combustible dusts may be present;
- IECQ (Quality Assessment System for Electronic Components) ensures the safety and reliability of electronic components used in the IT industry, avionics, and more;
- IECRE (System for Certification to Standards relating to Equipment for use in Renewable Energy Applications) covers certification to standards relating to equipment for use in Renewable Energy applications.
topics on conformity assessment