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  • Home
  • About
    • About John
    • John’s Approach to Quality and Environmental Management Systems
    • Testimonials
  • Services
    • ISO 9001 Consultancy
    • ISO 14001 Consultancy
    • OHSAS 18001 Consultancy
    • ISO 13485 Consultancy
    • ISO 17025 Consultancy
    • ISO 27001 Consultancy
    • PAS 99 Consultancy
    • Chain of Custody Certification
    • Training
      • ISO 9001 Training for Internal Auditors
      • IRCA Auditor Training
  • FAQs
  • Contact

ISO 13485 Consultancy

Home ISO 13485 Consultancy
Medical Device Management Systems

ISO 13485 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485 is to facilitate harmonised medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. The two notable exclusions are; proactive monitoring of customer satisfaction and the requirement to demonstrate continual improvement of the quality management system. Because of these exclusions, organisations whose quality management systems conform to ISO 13485 cannot claim conformity to ISO 9001 unless their quality management system conforms to all the requirements of ISO 9001.

Interested in becoming ISO 13485 certified? Talk to John today!

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John E Jeffery
15 Lower Heyshott
Petersfield
Hampshire
GU31 4PZ
United Kingdom

Tel : +44 (0) 1730 302 280
Fax : +44 (0) 1730 302 294

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