Posts Tagged ‘ISO 14971’

Risk Management in AS9100C

Friday, April 3rd, 2009

In the new revision of the AS9100 standard, an emphasis is being placed on clause 7.1.2 – Risk Management. This is a new requirement to implement a risk management process applicable to the product and organization covering responsibility, criteria, mitigation, and acceptance. The purpose of adding risk management in clause 7.1.2 is to provide additional focus on product risk during product realization.

Unlike ISO/TS 16949 which makes a reference to the Failure Mode and Effects Analysis (FMEA) process or ISO 13485 which references ISO 14971 for guidance on risk analysis, AS9100 is less prescriptive about how this should be done. This lack of specificity should not be interpreted as a simple suggestion for risk analysis, but rather as a flexible mandate that allows an organization to choose the best method of analysis appropriate to the product.

For more information on AS9100 Rev C, contact today!

Moving from ISO 9001 to ISO 13485? There’s more to it than a few “add-ons”!

Friday, March 13th, 2009

An ISO 9001 quality management system is a great start for a company looking to get into the medical device industry, but it may be only the beginning. A transition to ISO 13485 could be required based on the type of product to be manufactured. It is easy to make the mistake of thinking that a transition to ISO 13485 will be an easy task since a quality system foundation is in place. When implementing the additional requirements, it is very important to be aware of (and focus on) the key differences between the two standards.

ISO 13485:2003 is a standard specifically for the medical device industry. It contains a majority of the requirements of ISO 9001, but the differences require substantial changes to an existing ISO 9001 quality management system. The standard, which was revised in 2003, supersedes earlier european and international documents such as EN 46001:1997, EN 46002:1997, ISO 13485:1996 and ISO 13488:1996.

One of the key differences between the standards is that ISO 9001 requires an organization to demonstrate continual improvement. There is a heavy emphasis on this throughout ISO 9001 which can make the transition to ISO 13485 a little difficult. In the ISO 13485 standard, the emphasis is on maintaining the effectiveness of the quality system.

Another area of focus is the promotion and awareness of regulatory requirements, such as United States Quality System Regulation (QSR) 21 CFR 820. Depending on where the device may be sold and used around the globe, additional requirements from other nations or international bodies must be examined.

Other differences include many additional procedures that must be documented and implemented. Risk analysis must be considered throughout product realization (ISO 14971 provides guidance on this subject). Product safety, sterility, inspection and traceability are emphasized along with various additional requirements for documentation, product validation and verification of the effectiveness of corrective and preventive actions.

If you need help with the transition process, contact G3 Solutions today. Visit our full website at today!

ISO 13485 makes a reference to ISO 14971 for risk analysis – what is it?

Tuesday, January 27th, 2009

One requirement in the medical device standard ISO 13485 is for risk management to be conducted throughout product realization (reference the last paragraph in ISO 13485 section 7.1 and also Note 3 for that section). ISO 14971 is a guidance document that gives direction for performing risk analysis. The document makes reference to various quality tools such as Fault Tree Analysis (FTA), Failure Mode and Effects Analysis (FMEA) and Failure Modes Effects, and Criticality Analysis (FMECA). These tools are often used in many other ISO 9001-based standards such as ISO/TS 16949 and AS9100. Integrating these tools as part of the product planning process will provide a solid foundation for the engineering and production of medical devices.

For more information on ISO 13485 and ISO 14971, contact G3 Solutions at 810-632-9850.