FAQ32

What is the importance of the quality manual (or whatever the document is called) and are there fixed items which it is mandatory to cover in it? Considering that the standard ISO 9001:2015 no longer requires its existence, does this mean that if an IB uses Option B it is not mandatory to have a quality manual, while an IB which uses Option A must have a quality manual, or is it voluntary in both cases?

STANDARD: ISO/IEC 17020  ·  CLAUSE: 8.1.3  ·  TOPIC: Management system documentation 

Answer:

ISO/IEC 17020 only refers to “manual” in the 1st bullet of clause 8.1.2. Here it is referenced as a type of “management system documentation”. Therefore, whether option A or B is chosen, there is no requirement to have a “manual”. What is required in both cases is to have a “management system” capable of achieving the consistent fulfilment of the requirements of ISO/IEC 17020.

FAQ10

While some clauses in ISO/IEC 17020 refer to ”documented procedures”, other clauses refer to ”established procedures” or just ”procedures”. What is the difference between ”documented procedures”, ”established procedures” and ”procedures”?

STANDARD: ISO/IEC 17020  ·  CLAUSE: 8.2.4  ·  TOPIC: Documenting the management system 

Answer:

Where ISO/IEC 17020 requires a “documented (or written) procedure’ then those procedures shall be documented. Where the standard refers to a ‘procedure’, then there is no requirement in the Standard for that procedure to be documented (or written). Where the standard requires an “established ‘procedure”, again there is no requirement in the standard to document those established procedures. However, it is noted that clause 5.1.2 of ISO/IEC 17011:2004 states that to establish procedures means to ensure they are documented, implemented and maintained. The terms “documented” and “established” should not be understood to be limited to written descriptions of activities. Procedures could be in the form of pictures, flow charts, video recordings, audio recordings or in other formats and media. As stated in the Introduction to the standard, ISO/IEC 17020 can be used as a requirements document for accreditation. Therefore, from accreditation point of view accreditation bodies may agree with inspection bodies the extent to which procedures should be documented to enable accredited inspection bodies to demonstrate competence, impartiality and consistency of their inspection activities. To this end ILAC application documents or guidance documents may also identify specific procedures that require documenting for the purpose of accreditation. There is also a requirement in clause 8.2.1 of ISO/IEC 17020 for the inspection body’s top management to establish, document and maintain policies and objectives for fulfilment of ISO/IEC 17020. Therefore, the extent to which procedures should be documented in order to effectively implement documented policies and achieve documented objectives and to consistently fulfil the requirements of the standard, other than those mandated by the standard or by ILAC documents, is a matter for the inspection body to agree with the accreditation body.