ISO 13485 Clause 8: Measurement, Analysis, and Improvement

Clause 8 of ISO 13485:2016 gives the requirements for measurement analysis and improvements of these processes including:

  • 8.1 General
  • 8.2 Monitoring and Measurement
  • 8.3 Control of nonconforming product
  • 8.4 Analysis of data
  • 8.5 Improvement

8.1 General

All organizations are required to create a plan and then apply to the monitoring, measurement, analysis and improvement processes needed in order to meet the conformity needs of the product, to ensure the conformity of the QMS, and maintain the effectiveness of the QMS.

8.2 Monitoring and Measurement

As part of the requirements each organization is required to monitor and measure a variety of information in order to improve their process and meet customer needs this includes:

  • Customer Feedback
  • Complaint Handling
  • Reporting to Regulatory Authorities
  • Internal Audit
  • Monitor and Measure processes and products

8.3 Control of nonconforming product

Organizations are required to react to any product that is not conforming to product requirements. Organizations need to identify and control these products to ensure that they are not used and distributed further. This process needs to be documented and maintained. Corrective and Preventive Action (CAPA) processes is an important part of the ISO 13485:2016 Quality Management System, it helps to correct non-conformances requires doing something different than the action that caused them. Learn more about CAPA

8.4 Analysis of Data

The organization needs to collect and analyze appropriate data to determine the efficiency of the QMS. The procedures to determine this need to include data collection and analysis, including statistics to help understand the extent of the QMS productivity. The analysis needs to include at a minimum: feedback; conformity to product requirements; characteristics and trends of processes and products; suppliers; audits; service reports.

8.5 Improvements

Improvements are a crucial part of the quality management system. ISO 13485:2016 requires all organizations to focus on continually improving. Overall, the organization needs to identify and implement any changes necessary to maintain the effectiveness of the QMS, and the medical device safety and performance. Organizations need to do this by quality policy, quality objectives, audit results, post-market surveillance, analysis of data, corrective actions, preventive actions, and management review.


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