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#ISO 13485 INTERNAL AUDIT CHECKLIST ISO#

#ISO 13485 INTERNAL AUDIT CHECKLIST ISO#

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.

Define audit objectives, scope, and criteria.

If you work for a small company, that might be you! This person will be responsible for all phases of the audit. The first basic step is to figure out who will lead the audit team. However, the process of initiating the audit is vital to the audit’s success. When planning an audit, it is tempting to skip some of the steps below and go immediately to creating a checklist and schedule. A similar one could be developed to plan your supplier audits for the year.Ī typical ISO 13485:2016 internal audit will generally cover 2-4 areas of the organization each month throughout the year, depending on the size of the company. An example of a master internal audit schedule is shown below.

Individual audit leaders will construct the individual audit plans to meet the schedule. Determine whether or not the QMS has been properly maintained.ĭeveloping Your Overall ISO 13485 Audit Schedule A well-planned audit schedule will ensure that audits are performed regularly, are conducted according to the importance of the process and address the results of previous audits.ĭeveloping a master audit schedule is the first step toward planning audit activities for the year.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 the QMS 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. Confirming that the organization has implemented and is maintaining the QMS documentation – commonly called an on-site audit.Confirming that the organization’s QMS documentation conforms to the standard and any applicable regulatory requirements – commonly called a documentation audit.ISO 13485 talks about two main components of internal audits (section 8.2.4): Basic Types of ISO 13485 AuditsĪudits are planned, systematic processes carried out according to prepared working documents and audit plans.

The emphasis is on the QMS processes and the effectiveness of the entire system in meeting defined requirements and objectives. A QMS audit is NOT intended to evaluate the quality of products, nor does it focus on the performance of people. In other words, you are trying to assess whether the organization’s system says what it needs to say, that you’re doing what you say you’ll do, and that what you’re doing is working to produce the outcomes you need. The Real Purpose of the Medical Device QMS AuditĮven though it seems obvious, it’s worth repeating that the purpose of conducting an audit is to determine whether the QMS conforms to specified requirements and is effective in enabling your organization to meet quality objectives. Want to learn more about ISO 13485 auditing? Consider our ISO 13485 Lead Auditor Training – available in person or as a virtual instructor-led training.