ISO 13485:2003

This is an industry specific management standard specially developed for medial devices manufacturing industry. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.

Systematic Requirement

  • Establish a quality system for medical devices
  • Document your medical device quality system

Management Requirements

  • Support quality
  • Focus on customers
  • Establish a quality policy
  • Perform quality planning
  • Control your quality management system
  • Carry out management reviews

Carry out management reviews

  • Provide quality resources
  • Provide quality personnel
  • Provide quality infrastructure
  • Provide quality environment


All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

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DBS CERT , is an Independent, Impartial and Proficient Certification Body. Each standard supports its own benefits within every industry, however the common benefits across the certifications include: widened market potential, compliance to procurement tenders, improved efficiency and cost savings, higher level of customer service, and therefore satisfaction, and heightened staff moral and motivation. By having a recognised management standard it tells your customers that you are serious about their needs.
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