Fundamentals of ISO 13485 Medical Device Manufacturers’ Standard DocumentationPosted by certification consultancy on August 12th, 2023 According to ISO 13485:2016, a company must be able to deliver medical devices and related services that consistently meet customer and regulatory criteria. The system must meet certain requirements. The design and development, production, storage, distribution, installation, or servicing of a medical device, as well as the provision of related services like technical assistance, are all fields in which these organizations may be active at any number of stages of the life cycle. It is also possible for suppliers or outside parties to apply ISO 13485:2016 when offering these organizations' products or services connected to quality management systems. Companies know they can expect a tonne of documentation when it comes to ISO certifications. It is particularly true for certification to ISO 13485 for medical device quality management, as medical device manufacturers must produce comprehensive documentation as proof of the safety of their products—and the efficiency of their quality systems. A Quality Management System (QMS) that conforms with the standard and all relevant regulatory criteria is required to obtain the ISO 13485 certification. In addition to the documentation required by the jurisdiction, ISO necessitates documentation that includes like:
Documenting Management Participation A growing focus on managerial responsibility is something we notice in international standards everywhere. In terms of managing management participation, what are ISO auditors looking for?
Employee Training Records Manufacturers require a documented employee awareness training program that outlines procedures for evaluating team members' knowledge and competency. A fully integrated QMS that can push and pull data from other systems like human resources (HR) would make it simpler to keep track of records and other personnel information. Infrastructure and Maintenance ISO 13485 requires documentation of organization requirements for quality assurance. Documenting standardized maintenance methods and keeping records of any maintenance or repairs is a significant focus here. Contamination Control According to the standard, medical device manufacturers must record information about things like:
Product Realization Several documentation requirements are covered in ISO 13485's Product Realisation Clause 7. These cover the following subjects:
Supplier Documentation Typically, medical device manufacturers collaborate with several vendors and contract manufacturers. The ISO 13485 standard includes demands to proactively address supplier quality because of the magnitude of risk that suppliers might provide to products. Structured supplier quality agreements are particularly mentioned as necessary in the standard. Another best practice suggested by the FDA is the use of supplier quality agreements, which aid in establishing official standards for product requirements and supplier behaviour. Documenting Measurement and Monitoring Monitoring and analysis are essential components of the ISO approach, and ISO 13485 standard is not an exemption. ISO 13485 Clause 8 goes into a wide range of monitoring requirements, including documentation and records of processes such as:
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