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What do we mean by control of record and what are the major active in ISO 9001:2015?
I would like to ask one concern for How we defining or identify acceptance criteria for calibration? Could you please suggest us?
I need to understand if the acceptance in derogation by the customer must always be formalized by the supplier? I recently did an audit, I saw that the NCs are kept, etc ... while the request in derogation is not ... (otherwise by email, etc.) subsequent actions taken.
Usually, our suppliers open their own internal NC, with their own form and send it to us with the request in derogation. For the less serious ones, they send us a simple email (they already know that they are simple reports).
How would you conduct an organization and stakeholders context analysis?
The company I work for is a biotechnology company and we hold ISO 9001 certification. We keep records as required by ISO, however, I was wondering if the quality department needs to perform a secondary review on all or some of the records.
I'm totally new to ISO 9001 standards but I'm assigned to prepare a quality manual and quality management system. Kindly guide me about the basic procedure and standards to read and understand.
Can a waste collection service exclude clause 8.3 for its scope?
If ISO 9001:2015 does not require a QMS Manual then what should be in its place
Who exactly is the "top management" when implementing ISO 9001?
Can I have more details of the context of Organisation, and Risks, and Opportunities?