Clients

  • Dodhys Medical Ltd.
  • Rely BTL Production & Services
  • AKG Engineering & Construction Group
  • Consulting Key Management (CKM)
  • ACA Alliance
  • Elecnor S.A. Co. Abu Dhabi
  • Hadid International Services FZE
  • ALMADION International LLC
  • Qatari Industrial Equipment WLL
  • Beaver Gulf Group

ISO ISO 13485 Certification
Home - ISO Certications - ISO 13485: 2004 (Environmental Management Certification)

ISO 13485 is an international standard that specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of Medical Devices. This standard can also be used by international and external parties, including certification bodies, for assessment of the organization's ability to meet customer and regulatory requirementsapplicable to Medical Devices and related services.

The primary objective of ISO 13485:2003 is to facilitate harmonized 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. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

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

Find out how much ISO 13485 certification could cost your business.

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Certifications

  • ISO 9001 -
    Quality Management
  • ISO 50001-
    Energy Management
  • ISO 9001-
    Quality Management for Small Businesses
  • ISO 28000 Security- Management for the Supply Chain
  • ISO 14001-Environmental Management
  • ISO 13485-
    Medical Devices
  • OHSAS 18001- Occupational Health and Safety
  • ISO 80079- Equipment for Explosive Areas
  • ISO 22000-
    Food Safety
  • ISO 3834-
    Welding Technical Requirements
  • ISO 9004-
    QMS Performance Improvement
  • EN 15224-
    Health Care
  • ISO 10002-
    Customer Satisfaction
  • GxP HACCP-
    Hygiene in Practices
  • ISO 10006-
    QM Management in Projects
  • HACCP-
    Hygiene in Practices
  • ÖNR 49001-
    Risk Management
  • WHO-
    HACCP Food
  • ISO 12100-
    Safety of Machinery
  • 2012/83/EC-
    Good Sales Practice GDP
  • ISO 15378-
    Primary Packaging GMP
  • GMP-
    Good manufacturing Practice
  • ISO 22716 -Cosmetics GMP
  • EN 15221-
    Facility Management
  • ISO 26000-
    Social Responsibility
  • EU 333/2011-Criteria for Scrap Down
  • SA 8000-
    Social Accountability System Certification
  • CE Marking

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