ISO 13485: Quality Management Systems for Medical Devices
IQA – Portland, Oregon ISO 13485 Standards Training & Consultant Company
Worth noting is that for ISO conformance,documentation is not the objective, it is a means to an end. Proof: read ISO 9001: 2008 and notice it requires only 8 documented procedures, which by the way are not related to the design, manufacturing and testing of products or services.
To focus onfor ISO and to be a lot more effective than most organizations:
- Demonstration of process control at all levels of the organization:
- Use of key performance indicators (KPIs) can be helpful here. Include KPIs for processes such as corrective and preventive action, internal and external audits etc,
- If your process is under control you have the right mix of competency, documentation, instrumentation, materials etc. You should however remain vigilant for identification of opportunities for improvement.
- Team work instead of well intended solo activities:
- Corrective and preventive actions shall be addressed by a team rather than by a quality manager. These actions bring the largest opportunity for improvement and should be taken seriously. A brief weekly meeting between managers from the various departments can greatly improve root cause analysis and this enhance the effectiveness of the solutions provided.
- For any problem, devise a solution and an alternative solution
Committees wrote these ISO standards, and although common-sense and non-bureaucratic in nature, they are not easy to understand without some guidance.
We will be happy to put you on the right track. Contact IQA by phone: 503 522 9456, or you can Email Us.
More About ISO 13485 Standards (Source: Wikipedia)
A good source of information is the ISO website:
High level information regarding these standards is available through Wikipedia:
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 [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 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.