QMS for Medical Devices

Quality Management Systems (QMS)

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.

EN ISO 13485:2012 Medical devices — Quality management systems — Requirements for regulatory purposes

In March 2012, BS EN ISO 13485:2012 was published, following European publication in February. This version will only be applicable within Europe and is expected to be harmonised by the end of summer 2012. For the rest of the world, ISO13485:2003 will remain the applicable standard.

What is the difference between EN ISO 13485:2012 and ISO 13485:2003?

The only changes to the new 2012 standard are within the forward and Annex Z’s. There has been no change to the Normative Text, i.e. the requirements of the standard remain unchanged from the 2003 version.

The revision to the (informative) Annex Z’s was made to provide greater clarity on the applicability and alignment of clauses of ISO 13485 with the quality systems requirements of each of the three Medical Device Directives (AIMD, MDD and IVD). The new Annex Zs each cover a different Annex (Conformity Assessment Route) within one of the Medical Directives.  For example, Annex ZB of BS EN ISO 13485 shows the relationship between the Medical Device Directive 93/42/EEC Annex II, Full Quality Assurance and the clauses of EN ISO 13485.

Quality Management Standards

EN ISO 13485:2012 and ISO13485:2003, are based on the ISO9001:2000 process model approach. These standards provide a good base Quality Management Systems model for compliance with the following:

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

Registration to ISO13485 takes place when an accredited third party such as BSI visits an organization, performs assessment of 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 accredited by UKAS

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 ISO 13485 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 ISO 13485.
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. 

• Medical devices: ISO 13485 and ISO 9001 - The book takes the reader through the clauses of both ISO 13485 and ISO 9001 as well as providing essential information on quality management system auditing.
• 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