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:
- Quality policy and objectives: Organisations must have written policies that outline both their commitment to quality and the specific goals that will enable them to achieve it.
- Quality manual: The scope of the QMS and references to established quality processes should be included in the quality manual.
- Computer software validation procedure: Medical device makers are required by the U.S. Food and Drug Administration (FDA) to validate any software used in the creation, production, packaging, labelling, storage, installation, and maintenance of finished products.
- Quality procedures and records: These must include instructions for ISO 13485 documents and records control as well as all other operations.
- Medical device file: Both the technical documentation for the device and its device master record are referred to in this document.
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?
- In the documentation, specify roles and responsibilities in detail
- keeping track of the dates for QMS reviews and other preparatory activities
- keeping records of planning sessions and evaluations
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:
- How to keep the quality of final products from being impacted by environmental factors
- personnel attire or hygiene considerations
- the steps to take when handling contaminated products
Product Realization
Several documentation requirements are covered in ISO 13485’s Product Realisation Clause 7. These cover the following subjects:
- Process and outcomes of the customer requirements review
- A process for contacting customers
- Plans, outputs, and files related to design and development
- Verification of raw materials and products from third parties
- Traceability
- Installation and calibration documents
- records of computer validation
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:
- Complaint Handling and customer feedback
- Regulatory reporting
- Internal audits
- Nonconforming product
- Corrective and preventive action
- Reporting
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