» The relationship between ISO/IEC 17065 and ISO/IEC 17067, and the acceptance of product schemes.
15 August, 2013
A new standard, ISO/IEC 17067: 2013 - Conformity assessment -- Fundamentals of product certification and guidelines for product certification schemes, was published by ISO on 31st July 2013. This standard cancels and replaces ISO Guide 67: 2004, which has been technically revised.
This Bulletin is to confirm UKAS’ current view and approach on the use of this document within accredited product certification. We are looking to discuss this further with our European and international accreditation colleagues to ensure a harmonised approach and therefore our position may change as a consequence of the outcome of these discussions
ISO/IEC 17067 provides the fundamentals for the design and content of product certification schemes; it forms a key part of the overall infrastructure for product certification but does not contain any actual requirements. This guidance is referred to in ISO/IEC 17065 as a note under clause 3.9 (the definition of Certification Scheme); 7.1 (Process Requirements – General) and 7.9.1 (Surveillance).
With regard to the content and applicability of schemes, ISO/IEC 17065 requires that the certification body “shall operate one or more certification scheme(s) covering its certification activities” (7.1.1). The definition of certification scheme is provided in clause 3.9 as “certification system related to specified products, to which the same specified requirements, specific rules and procedures apply”. Clearly for a certification scheme to consistently deliver the required certification it will need to be robust and contain all information necessary to ensure consistent and meaningful assessment of requirements. Therefore the standard refers in notes against both of these clauses to ISO/IEC 17067. However, as this is through a note there is no direct requirement that all schemes will meet the requirements of ISO/IEC 17067.
Informative Annex A.1 of ISO/IEC 17065 also states that “the overall aim of certification is to give confidence to all interested parties”. Although this is an informative annex, and therefore not a direct requirement, confidence cannot be given if the scheme is not robust.
Therefore the UKAS expectation is that there is a product certification scheme in place and that the requirements of this scheme are defined such that the operational requirements of ISO/IEC 17065 can be met. For example, that there is a defined certification scheme; it meets the definition in clause 3.9; it was developed with input from the person having overall responsibility for the development of certification requirements (5.1.3 e); and is suitably robust to ensure consistent application.
Certification Bodies should also consider how the impartiality mechanism has been involved in the development and adoption of such schemes.
Findings will not be directly raised against the lack of use of ISO/IEC 17067 or against any specific clause of that guidance document. However UKAS may refer to the guidelines within ISO/IEC 17067 when assessing this requirement and when raising any subsequent findings against ISO/IEC 17065.
Should you require any clarification to the above please contact Kevin Belson - Technical Manager.