In selecting the audit team members, consider which competencies are needed, how long your audit will last, the scope of the audit, and time constraints. Select the audit team. If your company is small, you may comprise the “team” If your company has more than, say, 150 employees, insources design, makes high risk-products, etc., it is possible that you may need 2+ auditors on your team.Will you have adequate cooperation from auditees? Are any of the people involved working on a major deadline that would take away from their participation? Will any of them be on vacation? Is there adequate time and budget to conduct the audit? Will all the information you need be made available to you? Don’t assume. Determine the feasibility of the audit. You need to ensure that you will be able to conduct the audit as planned.Defining the audit criteria (i.e., ISO 13485:2016) and additional applicable regulatory requirements (e.g., 21 CFR 820 and/or EU Medical Device Regulation 2017/745) are also imperative. You need to define which facilities and/or departments are involved and which processes will be audited and clearly identify those areas that may be excluded. Define audit objectives, scope, and criteria. This is an important step.If you work for a small company, that might be you! This person will be responsible for all phases of the audit. Appoint the lead auditor. The first basic step is to figure out who will lead the audit team.However, the process of initiating the audit is vital to assure the audit process is comprehensive and successful. When planning an audit, it is tempting to skip some of the steps below and go immediately to creating a checklist and schedule. Determine whether or not the QMS has been properly maintained.Determine if the QMS has been effectively implemented.Determine whether or not the QMS has been documented in accordance with applicable requirements also known as audit criteria (e.g., ISO standard, applicable regulations, contracts).Determine the extent to which the QMS has been established.The focus of the documentation audit centers on whether the QMS has been established and documented, while the on-site audit looks at whether there is sufficient objective evidence within the QMS to confirm it has been implemented and maintained. The difference between the two usually is in the approach and depth to which each of these audit components is conducted. A thorough QMS audit includes both components. While documentation and on-site audits may seem like two entirely different animals, they are not. ![]()
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