Monitoring and Measurement in ISO 13485
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Monitoring and measurement focus on the quality of products and services, reflecting the effectiveness of the Quality Management System (QMS). In simple terms, it tells us whether our products meet expectations in quality, safety, and efficacy.
ISO 13485 defines several areas where monitoring and measurement should be emphasized, outlined in six sub-clauses in clause 8.2:
Feedback (8.2.1)
Complaint Handling (8.2.2)
Reporting to Regulatory Authorities (8.2.3)
Internal Audit (8.2.4)
Monitoring and Measurement of Processes (8.2.5)
Monitoring and Measurement of Product (8.2.6)
Feedback (8.2.1)
Companies must gather and monitor information from production and post-production activities. This ensures product requirements are met and serves as input for risk management from a continual improvement perspective. For instance, if ABC Medical Ltd produces heart stents for XYZ Company Ltd, they should use data from three consecutive batches to demonstrate quality consistency. This helps detect early signs of machinery failure, allowing for timely maintenance.
Complaint Handling (8.2.2)
Companies must have a complaint-handling procedure aligned with regulatory requirements. This includes reporting timelines and criteria. For more on complaint handling, see How to Comply with ISO 13485:2016 Requirements for Handling Complaints.
Reporting (8.2.3)
If a complaint meets the criteria for a field safety notice or adverse event, reporting must be timely and documented. Incorporate regulatory guidelines for field safety notices and adverse events in the complaint-handling procedure. For example, a field safety notice should be triggered if three consecutive batches show out-of-specification results for a critical limit.
Internal Audit (8.2.4)
Companies must have a planned and documented arrangement for internal audits, ensuring corrections and corrective actions are taken without undue delay. The internal audit team should follow documented intervals for auditing relevant areas and check corrective action reports for any pending issues.
Monitoring and Measurement of Processes (8.2.5)
Companies must apply suitable methods to demonstrate process capability in achieving planned results. For example, to ensure a stent achieves sustained release in the body, the coating process should be limited to 15 minutes. Critical factors affecting the coating process, such as technology, solvent type, and coating thickness, must be controlled to ensure uniform drug coating.
Monitoring and Measurement of Product (8.2.6)
Companies must measure product characteristics to ensure requirements are met at applicable stages of the product realization process. Records should include the person authorizing the product release and the test equipment used. Conduct critical testing during the pilot and production stages and compare results for specification verification. Record test equipment details like model number and service date.
Importance of a Planned and Documented Arrangement
Compliance with sub-clauses in 8.2 involves executing daily tasks in a planned and documented manner. For example, to ensure product sterility, regularly maintain sterilization equipment and review records to identify out-of-specification indicators. These indicators can serve as inputs to risk assessments.
Aligning internal procedures with regulatory requirements ensures product compliance with local regulations and provides clarity on handling quality issues. For instance, guidelines on classifying complaints and setting appropriate timelines for reporting or resolving issues are crucial. Monitoring and measurement activities help improve operations, provide valuable feedback to risk management plans, and ensure quality requirements for products and services are met.
