ISO 13485:2016 requires leadership, assistance

Organizations are required to demonstrate company-wide, measurable performance improvement. They must implement risk management, document corrective actions (internal, customers, and suppliers), and ensure they are currently within their due date. They must also follow corrective and preventive action (CAPA) to identify risk level (high, moderate, or low).

The CEO is required to lead the operations/manufacturing team by reporting the findings of the supply chain auditor to top-level management review team for immediate action.

There are many standards and laws that shape a quality system for a medical device company – ISO 13485 and FDA 21CFR820 being the most prominent. The main components of a quality management system (QMS) are the following, with CAPA being priority one.

1. Management responsibility
2. Design controls
3. Purchasing controls
4. Risk management
5. CAPA – A concept within good manufacturing practice (GMP), and numerous ISO business standards that focuses on the systematic investigation of the root causes of identified problems or identified risks in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).
6. Production and process controls
7. Record management
8. Post-market surveillance and improvements

One problem is that standards, guidance, and law are descriptive but not prescriptive – leading to confusion within most organizations on how to implement and integrate these components into their QMS. Here’s where a plastics industry specialist, supply chain auditor, can help. (See sidebar.)

Risk concept

One of the major items introduced in ISO 13485:2016 is the concept of risk, and the use of identified risks as part of evaluating and monitoring suppliers.

ISO 13485:2016 will not only review requirements and expectation of the FDA and European Notified Bodies for supplier management, but also guide you on how to incorporate these into your supplier management process. This will help you save significant efforts and resources, potentially saving millions of dollars by learning actionable approaches with improved awareness and familiarity.

ISO 13485:2016 will provide valuable assistance and guidance to all regulated companies. The following job titles/positions will benefit from CEO guidance with assistance from the supply chain auditor: quality managers, quality engineers, supplier managers, supplier engineers, internal quality auditors, and supplier auditors – including, first-, second-, and third-party auditing systems.

Building partnerships with your suppliers helps you meet FDA and ISO 13485 requirements and can add value to your quality management system and your company as well.

About the author: Lewis Yasenchak is the founder/owner of P&Y Management Resources, specializing in ISO compliance/certification, quality training, and related management issues for the plastics industry. Yasenchak can be reached at lewis.yasenchak@windstream.net or 706.694.2977.