Drugdu.com expert's response:

Non-conformities in the quality management system for medical devices refer to situations where an activity or its outcome in the quality management system activities related to medical device production, sales, and after-sales service fails to meet established requirements or standards. These requirements or standards typically originate from relevant regulations, standards, contracts, and internal quality management system documents of the enterprise. Non-conformities can manifest in various forms, including but not limited to non-conformities related to documents, products, processes, personnel, environments, records, and data.

Specifically, non-conformities in the quality management system for medical devices may involve the following aspects:

Document Non-conformity: Quality management system documents do not comply with applicable laws, regulations, standards, or contracts. For instance, there may be no documented corrective action control procedure established, no clear review of nonconformities (including customer complaints), no determination of the causes of nonconformities, no evaluation of measures needed to ensure nonconformities do not recur, and no identification and implementation of required measures.

Product Non-conformity: Products fail to meet specified quality requirements, such as issues with appearance, performance, safety, or products being released without passing inspection.

Process Non-conformity: Production processes are not carried out according to established procedures or requirements, such as not following documented procedures or lax production process control leading to unstable product quality.

Personnel Non-conformity: Relevant personnel have not undergone training or do not possess necessary skills and knowledge, or fail to perform their duties as required.

Environment Non-conformity: Production environments or facilities do not meet specified requirements, such as cleanliness, temperature, and humidity not meeting established standards.

Record and Data Non-conformity: Records are incomplete, inaccurate, or not preserved and managed as required, or data analysis is insufficient, failing to promptly identify and resolve issues.

For identified non-conformities, an auditor should write a non-conformity report and submit it to the audit team leader for review. In cases of disagreement within the audit team, the audit team leader has the final decision-making authority. At the same time, the enterprise should take corresponding corrective and preventive measures to prevent the recurrence of non-conformities and continuously improve the effectiveness of the quality management system.

In summary, non-conformities in the quality management system for medical devices are situations where quality management system activities fail to meet requirements, requiring enterprises to give them high priority and take effective measures for correction and prevention.