EN ISO 9001
EN ISO 9001:2015 is the world's most widely used QMS standard. It is based on the PDCA cycle (Plan-Do-Check-Act) and risk-based thinking.
Core principles:
- Customer focus
- Leadership
- Engagement of people
- Process approach
- Continual improvement
- Evidence-based decision making
- Relationship management
Application: EN ISO 9001 is sector-independent and applies to organisations of any size and industry.
Distinction from EN ISO 13485:
- EN ISO 9001: general QMS, focus on customer satisfaction and continual improvement
- EN ISO 13485: sector-specific QMS for medical devices, focus on regulatory compliance and product safety, no explicit continual improvement requirement
For medical device manufacturers, EN ISO 13485 is the applicable standard. EN ISO 9001 may be used complementarily for other business areas. EN ISO 9001 certification alone does not fulfil MDR QMS requirements.
Frequently asked questions
What is the difference between EN ISO 9001 and EN ISO 13485?
EN ISO 9001 is general, focusing on customer satisfaction and continual improvement. EN ISO 13485 is sector-specific for medical devices, focusing on regulatory compliance and product safety. Medical device manufacturers need EN ISO 13485, not EN ISO 9001.
Is EN ISO 9001 certification sufficient for medical device manufacturers?
No. MDR (EU) 2017/745 requires a QMS meeting MDR requirements. EN ISO 13485 is the recognised standard for this. EN ISO 9001 certification alone does not fulfil MDR requirements.
Can an organisation be certified to both EN ISO 9001 and EN ISO 13485?
Yes. Many medical device manufacturers hold both certifications, as EN ISO 13485 incorporates many EN ISO 9001 elements but is more specific. Some accreditation bodies offer combined certification audits.