ISO 13485 & MDR Blog

How to comply with section 8.2 Monitoring and measurement in ISO 13485:2018

Monitoring and measurement focus on the quality of the product or services, which reflect the effectiveness of the Quality Management System. Simply put, it informs us about whether our products have met the expectations in terms of quality, safety, and efficacy.

The ISO 13485 standard defines the different areas in which monitoring and measurement should be emphasized. These areas are reflected in the six sub clauses in clause 8.2, namely: 8.2.1 Feedback, 8.2.2 Complaint handling, 8.2.3 Reporting to regulatory authorities, 8.2.4 Internal audit, 8.2.5 Monitoring and measurement of processes, and 8.2.6 Monitoring and measurement of product. Now, we shall briefly discuss the requirements of each sub clause and how we can comply with it.

Feedback, complaints, and reporting

Under sub clause 8.2.1 Feedback, the company is required to gather and monitor information from production and post-production activities. The objective for doing so is to ensure that product requirements are met, and also to serve as input for risk management when looking at product realization from a continual improvement standpoint. For example, ABC Medical Ltd, who is a third-party manufacturer of the XYZ Company Ltd brand heart stent, should use the process data gathered from the manufacture of the stent for three consecutive batches to demonstrate consistency in quality and meeting of the requirements of XYZ Company. From out-of-specifications results of each batch record sheet, ABC Medical Ltd can utilize any out-of-specifications results from post-production to detect early warning signs of failure of machinery, and thereby tighten the maintenance regimen.

Under clause 8.2.2 Complaint handling, the company is required to have a complaint-handling procedure to be in line with regulatory requirements. Companies can input reporting timeline and criteria into existing procedures for complaint handling. To learn more about complaint handling, read this article: How to comply with ISO 13485:2016 requirements for handling complaints.

Sub clause 8.2.3 Reporting to regulatory authorities mandates that if a complaint is deemed to meet the criteria of a field safety notice or adverse event, reporting must be done in a timely manner and documented. Similarly, companies can incorporate regulatory guidelines for field safety notices and adverse events as part of the complaint-handling procedure. For example, a field safety notice should be triggered if the trending analysis of three consecutive production batches shows out-of-specification results for the critical limit set.

Internal audit, monitoring, and measurement

Under sub clause 8.2.4 Internal audit, the company is required to have a planned and documented arrangement for the internal audit, and to ensure that any corrections and corrective actions are taken without undue delay. To comply, the internal audit team should have a documented interval for auditing the relevant area. For example, if the internal audit procedure states that the clean room should be audited in the first week of each quarter, then the internal audit team should carry out the audit accordingly. Prior to the audit, the internal audit team should also check the corrective action report for any findings that need to be addressed.

Sub clause 8.2.5 Monitoring and measurement of processes requires the company to apply a suitable method to demonstrate the ability of the process to achieve the planned results. For example, in order for the stent to achieve a sustained release formulation in the body, the coating process should be carried out for no more than 15 minutes. So, the company should look at the critical factors that will impact the coating process, such as the coating technology, the type of solvent used, the thickness of coating on the different parts of the stent, etc., in order to ensure that the stent will be coated uniformly with the drug substance.

Under sub clause 8.2.6 Monitoring and measurement of product, the company is required to measure the characteristics of the product to ensure that product requirements are met in accordance with documented arrangements and procedures at applicable stages of the product realization processes. This record should also include the person who authorized the product release, as well as the test equipment used to perform the measurement activities. Companies could conduct critical testing of the product during the pilot stage and the actual production stage, and then compare the results for verification of the specifications. To record measurement of the product, an input field can be added to indicate the test equipment used, like the model number and the service date.

The importance of having a planned and documented arrangement

Compliance with each sub clause of 8.2 only requires us to execute our daily tasks in a planned and documented arrangement. For example, in order to ensure that the company could produce the expected result of a product being sterile, there should be regular maintenance on the autoclave machines, and its records reviewed regularly, to identify any out-of-specification indicators. If any out-of-specification indicators are recorded, these could also serve as an input to the risk assessment.

Aligning internal procedures with regulatory requirements ensures that the product meets the local regulations and gives the company more clarity on handling certain quality issues. For example, the company will be able to have guidelines for how to classify a complaint and how to set the appropriate timeline for reporting or resolving an issue. The different areas in monitoring and measurement activities can help companies to improve their operations, provide valuable feedback to their risk management plan, and also to ensure that quality requirements for products and services are met.

Use this free Project Plan for ISO 13485:2016 implementation to implement all monitoring and measurement requirements in the scope of your ISO 13485 implementation.