Clause 8.1 Management system requirements

Clause 8.1 does not require a procedure. It specifies the need to establish a management system and document it to the extent necessary so that the laboratory can achieve the requirements of ISO 17025. This means it is more applicable to apply clause 8.1 to a policy statement. e.g. State as a policy “The laboratory is committed to establishing,  documenting and maintaining a management system to meet the general, structural, resource, process and management requirements of ISO 17025”. This is typically documented in the Quality Manual, not as a procedure. If the laboratory does not have a system already established in accordance with ISO 9001, then state that the Option A applies, where the clause 8 management requirements are addressed as part of ISO 17025. If the laboratory does have a system already established in accordance with ISO 9001, then state that the Option B applies, where the clause 8 management requirements are addressed as part of ISO 9001, including laboratory activities. This means that, for example how complaints and corrective action are handled, fall under the ISO 9001 activities and evidence can be shown of laboratory activities being included.You can link this clause 8.1 to your overall project planning to implement ISO 17025:2017.

Have a look at the ISO 17025 toolkit document templates for some more insight:  

• Quality Policy at https://advisera.com/17025academy/documentation/quality-policy/;  and
• Quality Manual at https://advisera.com/17025academy/documentation/quality-manual/
• Project Plan for ISO/IEC 17025 implementation at https://info.advisera.com/17025academy/free-download/project-plan-for-iso-17025-implementation

The following articles may be of interest :

• List of mandatory documents required by ISO 17025:2017 at https://advisera.com/17025academy/blog/2019/08/30/list-of-mandatory-documents-required-by-iso-170252017/ 
• Clause-by-clause explanation of ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025/