Consider 7 Modifications Throughout ISO 13485 Implementation That Will Benefit the Organization

ISO 13485 is a collection of international standards for quality management systems that can assist medical device manufacturers in designing, manufacturing, and distributing quality medical devices that fulfill client needs. These seven modifications can aid in the improvement of ISO 13485 quality management systems for medical devices.

• A Risk-Based Focus: ISO 13485 placed an exceptional focus on a risk-based methodology, with over a dozen mentions of risk in the reference manual. To accomplish safety and compliance, a risk-based strategy balances the quality management operations with the probability of damage. Instead of only in product development processes, a risk-based methodology is now necessary across the entire QMS. The particular standards are less specific beyond the necessity for risk management at all stages of the product life cycle. The manufacturer is responsible for actively identifying and assessing risks in all aspects of the QMS and implementing suitable controls. There has not been any defined risk level or outline of how device manufacturers should balance risk management with efficiency. So, a simple scale can be used to convey risk assessment results Risks, for example, can be classified as low, medium, or high using predefined scales in several aspects of the QMS, such as supplier management and corrective and preventive action.
• Enhanced Documentation Control: ISO 13485 process-based document control criteria are particularly for documenting “release.” The release is a set of criteria that must be completed for  ISO 13485 documents to continue to the next stage. For example, an instrument calibration exercise may need to meet certain requirements for results and supervisory review before it is declared accomplished and released. If organizations are trying to handle release requirements on a paper-based system, the additional document control requirements can be complex and time-consuming. It’s common to lose paperwork or forget to obtain a required verification. So, enhanced documentation control can help to keep track of the document process.
• Increased Training Efficiency: Clause 6.2 of ISO 13485 includes a subtle expansion of training requirements to address the need for effective training. Specifically, the quality management system must:
  • Document processes for establishing competence
  • Provide training and ensure awareness
• Effective ISO 13485 awareness training is an important component of any QMS. However, the 13485 update makes it clear that training activities should be more rigorous.
• Enhanced Customer-Related Processes: Under 13485, device manufacturers must collect feedback during production and post-production and incorporate it into the QMS and risk management activities. ISO 13485 has continued to expand the requirements for non-conformance investigations and CAPA processes. Extra sub clauses have expanded the requirements to measure complaint handling activities and report specific complaints to regulators when required. The requirement is strongly intertwined with the risk-based approach, which is a major focus of ISO 13485. The standard is being updated to include tighter feedback mechanisms and a more progressive approach to continuous improvement. Continuously measuring a product’s ability to meet customer requirements can assist organizations in addressing unforeseen risks and avoiding quality issues that can lead to patient safety issues or product recalls.
• Improved Design-Development Correlation: Developing a system of traceability from design inputs to outputs has been established as an official requirement while being a best practice under ISO 13485:2003.  The current edition requires design verification efforts to be documented, including explicit evidence-based rationale when necessary. A planned testing activity, for example, should provide a testing sample size and explain why this sample size is statistically significant. ISO 13485 added a requirement for design transfer to manufacturing to make a comprehensive standard of product quality, which is based on strong, logical evidence.
• More rigorous supplier management: ISO 13485 established a clear requirement to evaluate the level of risk that each supplier potentially introduces. Suppliers must be monitored frequently to generate an accurate and up-to-date risk assessment. Most of all, there is a need for regular communication between manufacturers and suppliers about risk and quality issues. The frequency and depth of supplier audits can vary depending on the supplier’s potential impact on product quality.
• Improved Complaint Handling: ISO 13485 addressed complaint handling as mandatory input for management review. In addition, clause 8.2.2 defines a list of procedural requirements for medical device suppliers:
  • Comply with regulatory complaint-handling requirements
  • Make a process to receive and route information
  • Assess complaints
  • Report complaints to regulatory authorities, if needed
  • Perform a root-cause investigation
  • Handle related complaints, such as inputs or suppliers
  • Implement helpful and protective action
  • Address any third-party involvement
  • Assess servicing records, if applicable
  • Apply complaints to the risk-management lifecycle

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