Typically, it contains general information regarding the logistics of the audit (e.g., date, scope, applicable standard(s), auditor(s), and so on). Your audit report can also be based upon what your organization is looking for. Your audit plan is more detailed and focuses on the scope of the audit that you're organization is about to conduct - processes, procedures, people to include, timing, agendas, etc. That can be a helpful visual aid to see if audits are being conducted on time - and if they're not, then it's time to have a discussion with senior leadership about why. Using a Gantt chart or even just a tracker in Excel, you can indicate when an audit is scheduled, and then change the colour to show if it's in progress, on time, delayed, cancelled, etc. Others mirror an external audit and do it all in one shot at a defined frequency. Some spread their audits out over a period of time, such as one year.
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In my example I may need to create a separate PCM for each standard, rather than make it more complicated by trying to include both 13485 and 21 CFR in the same PCMĪn audit schedule depends upon your organization, how its management system is set-up, and the culture of your organization. Then they will mark the requirements in their checklist as N/A that are not applicable and are left with the clauses that are required.
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That's were my dilemma there in lies, I am trying to match the relevant clauses to the process being audited in my PCM, therefore I want one document that an auditor can refer to and know which requirement are applicable. But what I don't understand is how you know if the requirement is applicable to that audit in the first place? In your document example "Q1" is applicable to all your standards, but how do you know if the process you are auditing needs to be audited against that requirement? This is a great way for auditors to understand whether the requirement is applicable to their audit. You have broken this down by a list of requirements and you have identified which standards are applicable to those requirements. Many thanks for your feedback! The document that you attached looks great. If anyone’s mindset differs please let me know and describe why you do not prescribe to this method of internal auditing and what you would do differently. For example, if control of documents is required the elements section should include reference to 13485:2016 4.2 and 820.40 21 CFR 820Īlso I want to ultimately make it easier on the internal auditors to complete the internal audit checklist, if they can simply review the PCM, N/A the clauses which are not applicable to their audit and carry on this will save invaluable time. In my opinion the PCM should reference all clauses for all certification on site to prove that our audits are robust and all elements are taken into consideration during the internal audit process. What I would like to know if anyone has any advice or any examples of a PCM that has a list of process and a list of elements that cover all applicable clauses to that site (Ideally if you have an example that has 13485 and 21 CFR 820 that would be great, I more so just want to see how it is laid out). Therefore the auditor needs to trawl through the audit checklist, find this element (and other applicable elements) and complete the audit. For example if an auditor were to complete an internal audit that involved the review of the change management process, The control of documents is called out as an element for review during this audit but no specific clauses are called out.
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My issue with this PCM is that the 13485:2016 and 21 CFR clauses are not specifically called out in this document. To accompany this we also have a Process Clause Matrix, however the PCM does not reference any clauses, it simply details the process on the X axis and then has a list of “elements” on the Y axis. We have an extensive audit checklist (13485 and 21 CFR 820) which is pretty much in the form of turning every clause into a question. Our site is certified to ISO 13485:2016 and 21 CFR 820. Please see below background about the company I work for: I have a question regarding the internal audit process.