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Medical Devices Certification – ISO 13485:2003

“A Quality Management System standard helping organisations to consistently demonstrate regulatory and customer requirements in delivering medical devices and related services”
Overview of Scheme

ISO 13485:2003 – Medical Devices relates to all Quality Management Systems in the field of Medical Devices, including IVD (In Vitro Diagnostic).
The standard can be used for your business in regards to: design, development, production, installation and servicing of medical devices as well as design, development and provision of related services.

Comparing ISO 9001 & ISO 13485

  • ISO 13485 is based on ISO 9001; but remains highly specific to medical devices and excludes some elements of ISO 9001
  • Organisations certified to ISO 13485, cannot also claim ISO 9001 certification without meeting additional requirements
The key principle of ISO 9001:2008 include:

  • A Customer Focus
  • Business Leadership: Helping you and your business
  • Involvement of People
  • Process Approach
  • System Approach to Management
  • Continual Improvement
  • Factual Approach to Decision Making
  • Mutually Beneficial Supplier Relationship
Benefits To Your Business
  • SC Certification of ISO 13485 delivers enhanced opportunities by ensuring you meet global accreditation requirements, reaching more global markets in the Medical sector.
  • ISC monitor, manage and enhance quality across all operations – helping you mitigate risks and manage all compliance domestically and internationally
  • ISC is a signatory to multilateral, bi-lateral and other agreements with numerous global certification bodies so that medical products can be accepted globally.

ISC clients attaining ISO 13485 certification reported positive business results across all facets of the business including:

  • Management
  • Profitability and Financial Performance
  • Service Delivery
  • Operational Excellence
  • Product Development
  • Sales and Marketing
Benefits to ISC Certification
  • Access to global research and insight analysis to help your businesses grow
  • A distinct understanding of your business, how your business best profits through ISO 13485 certification
  • A process driven outcome to certification
  • Feedback and value addition from our experienced auditors and staff
  • Approachable and flexible team
  • Gap assessment
  • Access to professionals with decades of experience across a wide array of industries – who understand your business and how ISO 13485 can help you achieve competitive advantage
  • 20+ years of operations & 10,000+ global certifcations
  • Exensive working knowledge in ISO 9001 Certification having established, implemented and managed Australia’s first 3rd party Quality Management Systems certification program from 1985 to 1995
  • Access to the best global auditors – ISC invests in recruiting and developing the best auditors including incentivising, training and satisfaction scoring to enhance our processes, approach and focus
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