Quality Management System
All departments of our company start to create their procedures. All prepared procedures review by department heads and then approved by the company director. For the ready procedure, they give a number, rev. and an effective date. Finally, they submit to the QA department to establishing on master document register.
My question that, what is QA/QC role in this process?
Is it required to re-approved by the Quality manager for conformity of procedure to standard requirements? if required how to proceed?
If not, how the Quality team be ensuring that procedure suitable for ISO 9001 standard requirements.
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First, that is a great example of what can become a quality management system owned by many people in an organization. Normally, there is great resistance to participate in this way.
What I would recommend is that before starting to create procedures people should have some basic training in ISO 9001 requirements associated with each department. Now, you cannot go back in time. So, I recommend performing departmental internal audits where internal auditors can check implementation and also conformance according to ISO 9001 requirements.
The following material can provide more information:
- ISO 9001 internal auditor training: Is it for me? - https://advisera.com/9001academy/blog/2015/06/02/iso-9001-internal-auditor-training-is-it-for-me/
- Free webinar on demand - How to perform an ISO 9001:2015 internal audit - https://advisera.com/9001academy/webinar/how-to-perform-an-iso-9001-2015-internal-audit-free-webinar-on-demand/
- Free online training ISO 9001:2015 Internal Auditor Course: https://advisera.com/training/iso-9001-internal-auditor-course/
- Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
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Oct 27, 2020