ISO 13485 - QMS FOR MEDICAL DEVICES
ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices [1][clarification needed]. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488(also 1996).
While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained.
Other specific differences include:
- the promotion and awareness of regulatory requirements as a management responsibility. An example of market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States.
- controls in the work environment to ensure product safety
- focus on risk management activities and design transfer activities during product development
- specific requirements for inspection and traceability for implantable devices
- specific requirements for documentation and validation of processes for sterile medical devices
- specific requirements for verification of the effectiveness of corrective and preventive actions
Compliance with ISO 13485:2005 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485 and ISO 14971 by a Notified Body. The result of a positive assessment is the certificate of conformity allowing the CE marking and the permission to sell the medical device in the European Union.
This standard adopted by CEN as EN ISO 13485:2003/AC:2007 is harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC.[2]
Cooperating for the safety, quality and performance of medical devices
Introduction to the Global Harmonisation Task Force (GHTF) for Medical Devices, an informal platform for regulatory authorities and representatives of industry from Europe, the United States of America, which goal is to provide a forum for national regulatory authorities and industry representatives in the field of medical devices to promote international convergence in regulatory requirements and practices.
Health care and medical devices
ISO 13485 certification helps Beckman Coulter meet regulatory deadline for medical devices. Beckman Coulter, Inc., implemented ISO 13485 to meet a new medical device regulation requiring registration to the standard.
Quality management systems for the medical device industry
ISO has just published a standard to facilitate implementation of quality management systems based on ISO 9001:2000 by the medical device industry.
Why Quality Foundation – Kolkata
Consultants of Quality Foundation follow a Structured approach (Process flow diagram for System Development) for developing ISO/TS 13485:2009 : Quality management systems—application of ISO 9001:2015 for Medical Devices, through consultancy and training services, involving all concerned personnel, there by developing the competence in application of the standard in true sense and thereby continually improve during & after completion of consultancy, training and handholding services.
Consultants of Quality foundation are the Only Senior consultant registered with National Board of Quality Promotion /Quality Council of India, in the eastern region, Kolkata for QMS, Strongly believes in Value addition, Provides Customized Solutions. Possess Expertise in Diversified sectors. Quality Foundation have dedicated consultants having in depth knowledge and experience in Management systems consulting & Training. Have consulted and trained for More than 200 + Clients across India on various ISO Standards.
See also
References
Related standards
- ISO/TR 14969:2004
Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003 - ISO 13485:2003
Medical devices -- Quality management systems -- Requirements for regulatory purposes - More standards
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