The regulatory requirements vary across markets. Quality record documentation is performed to show that the QMS is executed and followed. It also provides the sequences, interactions and resources required to do business with a medical device company. What QMS consists of: The QMS consists of the fundamental set of policies, procedures, forms, and work instructions. The following section will take you through the major sections of the ISO 13485:2016 and provide action items and best practices to help you apply them in your medical device company.ĭefinition: "A formal system that documents the structure, processes, roles, responsibilities and procedures required to achieve effective quality management." (ASQ, a Quality Management System). There is a greater emphasis on risk-based approaches to quality and safety as compared to the ISO 13485:2003.Ĭompliance with ISO 9001:2016 requires companies to demonstrate that risk is taken into account for the entire organization's Quality Management System (QMS) processes that include aspects shown in the following figure.Ĭompliance with ISO 9001:2016 requires companies to demonstrate that risk is taken into account for the entire organization's Quality Management System (QMS) processes However, it requires risk-based approaches for quality and safety protection just like the requirement that is mentioned over a dozen times in the ISO 9001:2016 standards. The ISO 13485 standard does not have a high-level Annex SL structure that's found in the other ISO 9001:2015 standards. Greater emphasis on risk-based approaches to quality and safety. The update to ISO 13485:2003 helps in aligning with the regulatory requirements with respect to Documentation, Complaint management, and reporting issues to regulators. Many Global Regulatory bodies are including ISO 13485 into their requirements making the product suitable for companies to market internationally.
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