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BS EN ISO 13485:2003 (BS EN ISO 13485:2012)

Medical devices - Quality management systems - Requirements for regulatory purposes

This Standard is aimed at companies that design, develop, produce, install or service medical devices and specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

The newly published BS EN IS013485: 2003 Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes now includes a requirement for senior management "buy-in" as specified in ISO 9001:2000.  However the primary objective 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 BS EN ISO 9001 that are not appropriate as regulatory requirements. Therefore, while BS EN ISO 13485:2003 has the same format as BS EN ISO 9001:2000 and most of the same requirements, compliance with BS EN ISO 13485:2003 does not provide conformity with BS EN ISO 9001:2000.
BS EN ISO 13485:2003 supersedes BS EN ISO 13485:2001 and BS EN 1S0 13488:2001 which was withdrawn in July 2006. To maintain their certified status all organisations within the medical devices industry must adopt BS EN 13485:2003
Major differences between BS EN IS013485: 2003  and ISO 9001:2000 are the requirement to maintain the effectiveness of the system rather than improve it; emphasis on meeting customer and regulatory requirements as against increasing customer satisfaction and a greater requirement for documented procedures which include:
  • Those documents required by regulation
  • Responsibility and authority
  • Training procedure, if required
  • Maintenance requirements
  • Health, cleanliness, clothing
  • Environmental conditions
  • Control of contaminated product
  • Risk management
  • Customer requirements
  • Design and development
  • Purchasing process including traceability records and records of verification
  • Reference materials and reference measurement procedures
  • Labelling and packaging
  • Installation and verification
  • Sterilization process validation
  • Identification and validation
  • Preserving product including shelf life
  • Monitoring, measurement and measuring devices
  • Sterilization records, servicing records, batch records, validation

Differences in research and development activities:

  • Determine design transfer activities
  • Document design planning outputs
  • Include risk management in input
  • Approve inputs
  • Document design outputs
  • Include specialist as needed in design review
  • Complete validation before delivery
  • Include clinical trial as required

Added programs to consider:

  • Clinical evaluation
  • Risk management
  • Clinical trials
  • Cleanliness of product and contamination control
  • Requirements for implantable devices
  • Communication of advisory notices

Differences between 13485:2003 and 13485:2012

The European standard EN ISO 13485:2012 Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes, has been published, after approval by CEN on 24 January 2012. This replaces EN ISO 13485: 2003. The change was made as a number of European countries objected to the inference that ISO 13485 inferred compliance to the Medical Device Directive (MDD).   To solve this problem, annexes at the beginning of the new standard have now been expanded to link the clauses of ISO 13485 to the Medical Device Directive.

It is important to note that the text of the global standard ISO 13485:2003 is unchanged. Only the foreword and annexes in the European version have been revised.

In Effect ISO 13485 2003 is the same as ISO 13485 2012 as the actual requirements have not changed.

Services Offered

Lewis Conquer Consultancy Services specialise in putting in simple uncomplicated quality management systems, that meet the requirements of the BS EN ISO 13485 medical devices standard, without unnecessary administration.


changes to BS EN ISO 13485:2003

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