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ISO 13485 is a set of international standards that help organizations identify, control, and prevent quality problems. It's important for businesses to be compliant with these standards because it shows they are taking their quality management seriously.
The ISO 13485:2016 standard establishes a framework for the quality management system (QMS) requirements for healthcare products and services. ISO 13485 requirements checklists help assess whether a company is ready to undergo an ISO 13485 certification audit by a third party. A certification audit involves conducting an in-depth evaluation of a company's QMS to determine its compliance with specific standards. This provides assurance that your organization meets global safety and quality standards so that you can maintain customers' trust and protect your business reputation.
To prepare for an ISO 13487 auditing process, it is important to have baseline information about your organization's QMs already in place. An ISO13485 audit checklist can be used as part of this process. A QMS will typically include processes and procedures for analyzing the quality of products and services, managing risk related to quality issues, maintaining records of performance (including corrective actions), and training employees on how to use the system.
Use this ISO 13485 checklist to determine whether your company's QMS meets the ISO standards and take corrective actions.
Please note that this checklist template is a hypothetical appuses-hero example and provides only standard information. The template does not aim to replace, among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.