The reason is that we are a kind of medical device importer and distributor, sort of related with ISO 13485 requirement even it is not a mandatory requirement from Health Canada. Clause 8.5.1 in ISO 9001:2015 is correspond to 7.5.1 Control of production and service provision in ISO 9001:2000 įinally, I connect ISO 9001:2000 with ISO 13485:2000. Then I find the migration map between ISO 9001: 20. You could image that nobody knows what I am asking for, the feedback is that the questions is too general, especially it is hard to determine who should I ask for. I will give the example for ISO 9001:2015 Clause 8.5.1 - Control of production and service provision.Ĭan you show me controlled conditions for the use, and control of suitable infrastructure and process environment?Ĭan you show me controlled conditions for the implementation of products and services release and delivery? The main reason is that ISO 9001 has the new version of 2015 and I have to focus on the process, not the checklist we used as before.Īnyway, I will share how I did to initiate the first internal audit within the company, hope my idea could give you some help also hopeful could get feedback from you. When I make the internal audit plan this year, I realize it is really tough.
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