An important point is that, while auditing you should be impartial and provide the right feedback about the system, so when you are doing it by yourself this would not be possible. If you are a small business with a few employees within your company, taking the service of a consultant is the right solution, because you cannot audit something that you have worked on and processed yourself. This is mainly one of the biggest questions, because a lot of people think that they have to hire some external body or external organization to do that but NO it’s not mandatory. In order to perform your internal audit effectively you can go through the guideline for better understanding. It also tells you the good practices to perform an audit. It explains how you can select your team, how you can audit, what is the scope of the audit. There is more information available on the ISO 13485 and on the FDA 21 CFR part 820 section 22, mentioning specifically how you can comply to the internal audit process for your quality management system.īut there is also a guideline available with ISO 19011, which is the way to audit quality system for your organization.
Manufactures should verify by themselves, and not wait for a third-party audit to do that for them. Because the internal audit is the tool that is helping you to verify that your Quality management system is compliant, efficient and maintained.
If you are following the ISO 13485 or the 21 CFR part 820 it is clearly mentioned that you need to perform an internal audit. So, now if you audit your own organization by yourself or with the support of a consultant prior to your third-party audit to make sure your Quality management system (QMS) is compliant, this is known as an internal audit. We all know that an audit is an official inspection of a company, typically done by an independent body.
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