Ensuring confidence in medical device safety
ISO 13485, published in 2003, and now fully recognized in many countries, is based on the ISO 9001 process model approach. These standards provide a good base model, recognized by the Global Harmonization Task Force (GHTF), for compliance with the European Union (EU) CE marking medical device directives, Health Canada CMDCAS, Taiwan Medical Device Regulations, Japan JPAL and other international requirements.
Certification to ISO 13485 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.
Your BSI quality management systems certificate is objective, accredited, recognized evidence of your company’s commitment to quality systems and helps you demonstrate this to customers and regulators. BSI is accredited by the United Kingdom Accreditation Service (UKAS) and the Standards Council of Canada (SCC). ISO 13485 is becoming widely accepted as the international standard to address medical device requirements around the world.
The standard can be used by manufacturers to demonstrate applicable regulatory requirements, and by other organizations whose related services support medical device manufacturers.
For more information, please visit our Healthcare and medical device ISO 13485 page.
Next steps
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Gaining certification 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, ISO 13485 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. Certification can improve overall performance, remove uncertainty and widen market opportunities.
For more information, please visit our Healthcare and medical device ISO 13485 page.
Next steps
Request a quote, find out more about training courses or contact us for more details.
From a one-day introductory course to implementation training or lead auditor courses, our network of public and onsite training can help you at every stage of the process. Our experience of how organizations of all types and sizes relate to the standard is unequalled - and we can deliver the training you need for understanding, implementing, assessing and certifying your quality management systems.
We offer a comprehensive program of training courses covering every aspect of ISO 13485 for:
Students who are new to quality management systems
- Courses in understanding and implementing a new system
Students who need to audit and improve an existing system
- Courses in auditing, assessing and improving an existing system
Next steps
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There are six steps to achieving certification with BSI.
- Establish a quality management framework as identified in the appropriate standard (ISO 13485).
- BSI will then provide an estimate of costs and time-scales for formal assessment.
- Submit a formal application to BSI. Consider an optional pre-assessment.
- BSI will undertake a pre-certification 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.
- BSI will then conduct an on-site initial assessment and make recommendations.
- 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 assessment visits.
For more information, please visit our Healthcare and medical device ISO 13485 page.
Next steps
Request a quote, find out more about training courses or contact us for more details.
