The set of ISO 13485 Audit Checklist and guide includes introductory description, how to apply and use the audit checklist, brief introduction to audit requirements, discerning minor verses of major or critical non-conformities, and how to summarize the respective findings and rate the overall performance.
So, before conducting a Quality management system audit to ISO 13485 for medical devices, you may be looking for some kind of an ISO 13485 audit checklist. The ISO 13485 audit checklist is a systematic, documented verification process of objectively obtaining and evaluating audit evidence to determine whether an organization’s QMS conforms to the QMS audit criteria, and the results of this process to the client. The QMS audit criteria are defined as the policies practices procedures or requirements.
The audit checklist of ISO 13485 is a very useful & important document for auditors, who are new or experienced. The ISO 13485 Audit checklist helps auditors to organize, plan, conduct and report audit observations in a consistent manner. The definition of ISO 13485 audit checklists is such a list of tasks that must be completed as part of ISO 13485 audit is an integral part of the evaluation process for the internal audit plan. Medical device manufacturer has to plan and carry out regular internal audits, for the requirement purpose of ISO 13485 audit checklists, which is essentially a list of tasks that must be completed during implementation.
As per the organization’s processes, and the requirements of the audit for ISO 13485 standard; the format of this Audit checklist encourages the ISO 13485 auditor to document objective evidence. The ISO 13485 audit checklist is created as well as managed by the ISO 13485 lead auditors.
Purpose of an ISO 13485 Audit Checklist is:
- To assist memory-nothing is missed inadvertently;
- To ensure comprehensive coverage of all applicable element ;
- To ensure continuity/repeatability/consistency of the audit;
- To manage time;
- To organize note taking; and subsequent review by auditors.
- Can become part of an Audit report.
The ISO 13485 Audit should focus on the quality objectives and action plans of the organisations to allow problem areas to be identified so that remedial action can be taken. Generally, the audit is a means of assisting managers at all levels to improve the performance of the operations under their control. There is no such kind of checking on how well people are doing their job!
Or we can say, within the overall quality management system for medical devices, ISO 13485 audit checklists are used to determine whether quality management activities conform to the stated program, whether these activities are effectively implemented system, and how effective the Quality management system is in fulfilling the quality policy.
The ISO 13485:2016 Audit Checklist for Quality management system certification of medical devices contains ISO 13485:2016 clause-wise as well as department-wise audit questionnaires. Punyam Academy’s Online ISO 13485 Auditor Training Course fulfils all the requirements of ISO 13485 audit and become a certified ISO 13485:2016 Auditor.
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ISO 13485 Certification Requirements 
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