QMS for Medical Devices

In accordance with Annex II or V of the Medical Devices Directive.  Many companies apply the ISO 13485 standard to achieve QMS compliance or Annex VI for Class IIa.

BSI offers a full range of quality management assessment services for manufacturers of medical devices (and suppliers/subcontract manufacturers) to satisfy both regulatory and voluntary requirements.

Currently there is one published standards to consider for registration, ISO13485:2003.

ISO13485:2003, published in July 2003, is based on the ISO9001:2000 process model approach. This standard will fully replace ISO13485:1996 and ISO13488:1996 by the summer of 2006.  These standards provide a good base model for compliance with the following:

1. EU CE marking medical device directives
2. Health Canada CMDCAS
3. Taiwan Medical device Regulations
4. Plus other international requirements.

Registration to ISO13485 takes place when an accredited third party such as BSI visits an organization, assesses the quality management system and if satisfactory issues a certificate confirming that the organization’s quality management system meets the requirements of the Standard.

So your BSI quality management systems certificate is objective, accredited, recognized evidence of your company’s commitment to quality and helps you demonstrate this to customers.

BSI is accredited by UKAS (the United Kingdom Accreditation Service) and its USA and Canadian equivalents for ISO 9001 and ISO13485. ISO13485:2003 is becoming widely accepted as the international standard to address medical device regulations around the world.

In addition to assessing quality management systems to the ISO13485 standards, BSI also offers the full range of complementary assessment services such as ISO9001:2000, ISO14001 and ISO18001. BSI can also assess special processes such as sterilisation using appropriately qualified microbiologists and the sterilisation standards.  BSI also offers a series of medical device training courses covering an Introduction to ISO 13485, Medical Devices CE Marking, CE Marking for the In Vitro Diagnostics Directive and Medical Device auditor courses (ISO 13485).

Why do I need registration?

Gaining registration to ISO13485:1996, ISO13488:1996 or ISO13485:2003 through BSI will help your organization do business in this highly regulated sector. Whether you are looking to operate internationally or to expand locally to accommodate new business, ISO13485 will help you demonstrate to customers and regulators that you are committed to quality.

The regular assessment process will ensure that your processes are continually checked for effectiveness and provide the opportunity to avoid unpleasant regulatory surprises.

Registration can improve overall performance, remove uncertainty and widen market opportunities.

Six steps to achieving registration with BSI:

1. Establish a quality management framework as identified in the appropriate standard
   (ISO 13485, ISO 13488 or ISO 13485:2003).
2. BSI will then provide an estimate of costs and time-scales for formal assessment.
3. Submit a formal application to BSI.
4. BSI will undertake an on-site pre-audit to review of the Quality Manual and the Quality Systems. This will then identify any weaknesses and omissions in your quality management system that need to be resolved and your readiness for the main assessment.
5. BSI will then conduct an on-site initial assessment and make recommendations.
6. On successful completion of the audit, a certificate of registration is issued which clearly identifies the scope of the Registered Quality Management System. This certificate is supported by continual assessments visits and normally no re-certification assessment is required.
   

Guidance notes and documents

The free guidance documents below are available for immediate download. 

• What is ISO 13485:2003? - This guidance document explains in simple, easy to understand terms, the fundamental points of ISO 13485:2003.
• Practical Guide to Understanding ISO 13485:2003 - BSI has developed this guidance document in order for you to have a basic knowledge of the details within the ISO 13485:2003 standard.
• Medical Device Guidance (MEDDEV's) - Official guidance documents produced by the European Commission
• Medical Device Notified Body Recommendations (NB-Med's) - Recommendations on the Directives from the European Notified Bodies Medical Devices Group 
• Consensus Statements - Agreed interpretations from the European Notified Bodies Medical Devices Group
• Other Helpful Documents - A collection of other documents that are of interest to medical devices manufacturers