ISO/IEC 17025:2017 offers in article 8.3 the opportunity that a laboratory that has established and maintains a management system, in accordance with the requirements of ISO 9001, and that is capable of supporting and demonstrating the consistent fulfilment of the requirements of Clauses 4 to 7, also fulfils at least the intent of the management system requirements specified in 8.2 to 8.9.
Within ILAC P15 (with respect just to Inspection Bodies) recommends in article 8.1.3b that However, when determining the extent of required assessment, the accreditation body should take into consideration whether the inspection body has been certified against ISO 9001 by a certification body accredited by an accreditation body which is a signatory to the IAF MLA, or to a regional MLA, for the certification of management systems.
In note 2 of article 5.5 of ISO/IEC 17000:2004 is written that Certification is applicable to all objects of conformity assessment except for conformity assessment bodies (2.5) themselves, to which accreditation (5.6) is applicable.
Does this mean that article 5.5 (incl. its note) means that a quality management system due to ISO 9001 of a CAB (like a laboratory) can not be certified by an accredited certification body because that would appear like an accreditation which is reserved for the NABs?
8 January 2021
There is no clause in ISO/IEC 17021-1 that would prevent a Certification Body from certifying the management system of a Laboratory or Inspection Body. Such a possibility is recognised in some related documents, for example, ILAC P-15: Application of ISO/IEC 17020:2012 for the Accreditation of Inspection Bodies, clause 8.1.3b, which states that ‘Option B does not require that the inspection body’s management is certified to ISO 9001. However, when determining the extent of required assessment, the accreditation body should take into consideration whether the inspection body has been certified against ISO 9001 by a certification body accredited by an accreditation body which is a signatory to the IAF MLA, or to a regional MLA, for the certification of management systems.’
However there are justifyable concerns regarding the possibity of such an accredited certification being confused in the market place with accreditation to ISO/IEC 17025 and that there are specific risks of the CB covering aspects normally covered by the Accreditation Body.
Therefore it is the opinion of the EA CC that:
- It is valid for a Certification Body to certify the management system of a Laboratory or Inspection Body, however:
- The CBs Risk management system must identify any impartiality risks and how they are mitigated/managed (ISO/IEC 17021-1: 5.2.3).
- The Scope of the ISO 9001 certification is clear that it is for the Magement System supporting the operation of the Laboratory/Inspection Body.
- The scope of the ISO 9001 certification must be different to the scope of the ISO/IEC 17025/ISO/IEC 17020 accreditation.
- The certification must in no way infer compliance with ISO/IEC 17025 or ISO/IEC 17020.
- The certification Body’s marks and logos must not be used by the certified laboratory / inspection body in any way that infers that that they are indicating compliance with ISO/IEC 17025 or ISO/IEC 17020.
- A certification body shall not permit its marks to be applied by certified clients to laboratory test, calibration or inspection reports or certificates (ISO/IEC 17021-1: 8.3.2.)