Guest user Created: Jun 17, 2017 Last commented: Jun 17, 2017

ISO 9001 document requirements for a repair shop

I was wondering what the requirements would be for documentation (SOP, WI, etc.) for a repair shop with technicians who mainly use their training and work experience to fix equipment. Could I provide training records to show competency, or do I need to documents with steps that are taken in diagnosing and repairing of various lab equipment, which would be a huge task since we deal with many different types of instruments.

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Strahinja Stojanovic Jun 17, 2017

Thank you for any help you can offer.

Answer:

The requirements for document and records are the same regardless of the size of the company, but this new version of ISO 9001 allows you to decrease the amount of documentation. There are no requirements for SOPs and WI, so you can decide by yourself what SOP and WIs are worth documenting. I would suggest you to document them only for activities and processes that are complex and have higher chances of nonconformities. The more competent employees you have, the less documents you need.

For more information, see: Deciding Which Procedures to Document in QMS https://advisera.com/9001academy/blog/2013/11/26/deciding-procedures-document-qms/

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Jun 16, 2017

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