ISO 13485
Encyclopedia
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 device
s . 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:
Compliance with ISO 13485 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.
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
s . 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 managementRisk managementRisk management is the identification, assessment, and prioritization of risks followed by coordinated and economical application of resources to minimize, monitor, and control the probability and/or impact of unfortunate events or to maximize the realization of opportunities...
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 actionCorrective and preventive actionCorrective action and preventive action are improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice...
s
Compliance with ISO 13485 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
ISO 14971
ISO 14971 is an ISO standard, of which the latest revision was published in 2007, that represents the requirements for a risk management system for medical devices....
by a
Notified Body
Notified Body
A Notified Body, in the European Union, is an organisation that has been accredited by a Member State to assess whether a product meets certain preordained standards. Assessment can include inspection and examination of a product, its design and manufacture...
. 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.
See also
- System suitability test
- List of ISO standards
- ISO 14969
- ISO 14971ISO 14971ISO 14971 is an ISO standard, of which the latest revision was published in 2007, that represents the requirements for a risk management system for medical devices....
- ISO 690ISO 690ISO 690 is an ISO standard for bibliographic referencing in documents of all sorts. It includes electronic documents, and specifies the elements to be included in references to published documents, and the order in which the elements of the reference should be stated...