You are conducting an ISO 13485:2016 audit in a medical device manufacturing firm. The next activity on
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Question:
You are conducting an ISO 13485:2016 audit in a medical device manufacturing firm. The next activity on your audit plan is the organisation’s final product testing laboratory. Outline in a checklist how you will perform this audit by developing a series of ten audit checkpoints.
For each checkpoint, identify examples of the audit evidence you would want to gather and give the appropriate ISO 13485:2016 reference.
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Auditing and Assurance Services Understanding the Integrated Audit
ISBN: 978-0471726340
1st edition
Authors: Karen L. Hooks
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