ISO 13485 Consultants

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[Shaleen]

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ISO 13485 is an International Organization for Standardization standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the International Organization for Standardization13485 published in 1996 and International Organization for Standardization13488 (also 1996).


Specific differences include:
the promotion and awareness of regulatory requirements as a management responsibility.

Examples of market-specific regulatory requirements include 21 CFR 820,

the Quality System Regulation for medical devices sold in the United States,

enforced by the U.S. Food and Drug Administration (FDA), or

the Medical Devices Directive 93/42/EEC, required for doing business in the European Union
controls in the work environment to ensure product safety

focus on risk management activities and design control activities during product development


specific requirements for verification of the effectiveness of corrective and preventive actions

specific requirements for inspection and traceability for implantable devices

specific requirements for documentation and validation of processes for sterile medical devices

BENEFITS OF CERTIFICATION
Customer satisfaction –
Through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements

Reduced operating costs –
Through continual improvement of processes and resulting operational efficiencies

Improved stakeholder relationships –
Including staff, customers and suppliers

Legal compliance –
By understanding how statutory and regulatory requirements impact the organisation and its customers

Improved risk management –
Through greater consistency and traceability of products and use of risk management techniques

Proven business credentials –
Through independent verification against recognised standards

Ability to win more business –
Particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.