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ISO 17025 Audit requirements

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Guest user Created:   Jun 05, 2023 Last commented:   Jun 05, 2023

ISO 17025 Audit requirements

1. We are QC testing laboratory for lubricant oil & samples are inhouse only as we have our manufacturing plant now we are planning to get 17025 certification. I want to know what all documents are needed

2. Also I need guidance to make the format of scope

3. We already have quality manual & policy as per ISO 9001 45001 & 14001. Do we need to make new for ISO 17025

4. Also if you can guide regarding which documents should be in hard copy format or all documents in soft format is okay

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Tracey Evans Jun 05, 2023

You asked

"1. We are QC testing laboratory for lubricant oil & samples are inhouse only as we have our manufacturing plant now we are planning to get 17025 certification. I want to know what all documents are needed

The mandatory processes and procedures apply to all laboratories implementing ISO 1705. Then depending on your scope (for example is the laboratory responsible for sampling or not), you reduce and modify what is put into place and stated in your documents. For information, see the article Checklist 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/ and download the complimentary checklist at https://info.advisera.com/17025academy/free-download/checklist-of-mandatory-documents-required-by-iso-17025?

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2. Also I need guidance to make the format of scope

The laboratory will typically add this directly or as a linked record to the quality manual. Have a look at the Q&A post Scope of accreditation at https://community.advisera.com/topic/scope-of-accreditation/

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3. We already have quality manual & policy as per ISO 9001 45001 & 14001. Do we need to make new for ISO 17025

You can integrate your manuals and ISO 17025 clause 8 requirements, however, if different people are responsible for the ISO 9001, 45001, and 14001 certifications, it would be beneficial to keep a separate manual for ISO 17025. Either way, for efficiency, ensure your approach to management system requirements, such as handling complaints and Noncorformances is common.

For more information on integrating ISO 17025 with a certified management system, see the Q&A post and links from the Q&A post Merging ISO 9001 & ISO 17025 at https://community.advisera.com/topic/merging-iso-9001-iso-17025

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4. Also if you can guide regarding which documents should be in hard copy format or all documents in soft format is okay

ISO 17025 requires the laboratory to document processes to the extent necessary. The operational need will determine whether hard or soft copy documents, forms, and records are most appropriate. ISO 17025 does not specify.

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Jun 05, 2023

Jun 05, 2023

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