The results of the internal audit are then clearly available. Conduct quality audits and verify that they are compliant with the ISO 13485 standard.For this purpose, a GAP analysis or a readiness audit can be used. Identify the current status of the quality management system, as well as risks and opportunities for improvement.Identify the specific areas addressed by the ISO 13485 standard through research.Establish a team of QMS experts to ensure compliance with the standard through regular audits.In addition, responsible personnel may take the following actions: It can be used to directly check and enter the following information: The internal 13485 audit checklist is a great support for quality management teams.
For this purpose, the checklist contains the basic audit questions for all standard requirements of the current ISO 13485:2016 and supports companies in meeting the individual requirements. The template should be structured in such a way that all areas can be processed step by step without omitting important aspects. The audit checklist should include all relevant standard requirements of ISO 13485 and, in the best case, additionally the provisions of the Medical Devices Regulation 2017/745/EU (MDR) and/or the Medical Devices Directive (93/42/EEC).
The best way to do this is with an ISO 13485 audit checklist, which should be designed as a questionnaire for the professional conduct of an audit. With an internal ISO 13485 audit, medical device manufacturers and providers prepare for external certification of their QM system. gain competitive advantage through independent certification.communicate their high quality standards.companies confirm that they meet the aspects of the requirements of relevant guidelines for medical devices covered by the standard.With certification to EN ISO 13485 by an independent certification body: This can lead to delays in market entry and, consequently, to lost sales. Medical devices manufactured or offered by companies that do not have a certified ISO 13485 quality management system are usually denied access to important markets. App & software for obtaining ISO 13485:2016 certification The preparation for an ISO 13485:2016 certification auditģ. The relevance of ISO 13485 certificationĢ. However, such a checklist can also be used by internal quality management teams to prepare for the external ISO 13485 audit.ġ. Using an ISO 13485 checklist, external inpectorsĭetermine whether a company’s QM system complies with the standard’s requirements and is thus suitable for certification.
However, it contains additional requirements for medical devices and reformulates some of the requirements of ISO 9001 for its own purposes. In substance, ISO 13485 is similar to the ISO 9001 standard. In addition to QMS requirements, the standard also includes customer requirements and the regulatory requirements of the European Union (EU), Canada, and other major markets worldwide. For this reason, national and international regulatory agencies require medical device manufacturers and providers to demonstrate that they have a quality management system (QMS) that has been audited and certified by an external body.Ĭertification bodies generally base their audits on the EN ISO 13485 standard “Medical devices: Quality management systems – Requirements for regulatory purposes.” This addresses the requirements that medical device manufacturers and suppliers must meet in developing, implementing, and maintaining quality management systems. The quality and effectiveness of medical devices affect the safety of patients, users and others more than many other products. Why use checklist to audit for ISO 13485 certification?