What is ISO 13458? This is the easy part; ISO 13485 specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical device
development and related services that consistently meet customer and applicable regulatory requirements (from ISO.org). Any company can have a quality management system, but certification
involves being accredited by an outside organization such as BSI or TÜV, including yearly audits of all aspects of the design and development process in which the company participates.
An annual ISO 13485 audit can make even a seasoned quality manager pause and take stock of their company’s QMS system. The yearly cycle of maintaining a certified Quality Management System
culminates in that audit and involves activities throughout the prior twelve months. This demands commitment of time, effort, thoughtful considerations of the entire staff, and sometimes a bit of worry.
With all the work that goes into maintaining a certified quality system, it begs the question, “is it worth it?” Can I just maintain a QMS system without a certifying body and be “Compliant?” This article explores the value that certification brings, both to the design and development firms that maintain certification and to the clients that benefit from them.
Included in this whitepaper:
- Value to a design firm’s clients
- Value to a contract Product Design & Development Firm
- Compliance vs Certified
- Creativity & Efficiencies in Early Stage Companies
- Conclusion