The Importance of a QMS Audit for Medical Device Companies

Yes, we all know those third parties (Government Regulators, Notified Bodies, Registrar’s) require you to conduct internal audits of your QMS each year. They also strongly encourage you to use supplier audits to assure your critical supplier’s quality. However, how a company “embraces” these requirements often get relegated to a “necessary activity” that needs a checkmark in a checkbox to say “we did it” to the auditor. The implementation and ongoing support of a effective Quality Management System (QMS) is crucial for ensuring compliance to the regulations applicable to the country/region you are targeting, maintaining product quality (identify and fix errors that could lead to malfunctions, misdiagnoses and other problems), and gaining/maintaining market access. Each region has specific regulations and standards medical device manufacturers, pharmaceutical companies, and other regulated industries must adhere to.

Efficient/effective product development process

Taking a product idea to the commercialization stage requires an understanding of customer needs, translating them into design specifications, verifying/validating the design to both your and the regulator’s satisfaction and then establishing the manufacturing processes to consistently produce that product is

Compliance

Ensures Medical Devices comply with the proper regulatory agency (e.g., FDA, Health Canada, UK, and EU) requirements.

• Support certification
• Help prepare for regulatory body inspections/audits
• Are usually mandatory per the QMS standard/regulation being implemented

Patient safety

Ensures that medical devices are safe for patients when used as intended.

Risk mitigation

Identify and fix errors that could lead to misdiagnoses and other problems.

Continuous Improvement

Identifies opportunities to optimize processes and reduce risks.

Awareness (within the Company)

A QMS impacts practically all company functions. All employees are trained to one or more aspects of the QMS (at minimum the Quality Policy).

Auditing clarifies the responsibilities to the various organizational functions regarding their obligations to the processes and procedures that govern their work and identify gaps/discrepancies between the common practices and the requirements.

The audit results provide management an opportunity to review and evaluate the performance of their organization, after all, the quality standards and regulations provide tools and guidance for the basic processes any R&D and manufacturing organization should have.

Consider a non-regulated product, what systems/processes would you implement to ensure customer satisfaction and safety?