ISO 14971 AND ICH Q9 IN RELATION TO QUALITY RISK MANAGEMENT

Ritesh Chintakuntla

ISO 14971 and ICHQ9 comparison

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ISO 14971 and ICHQ9 comparison

  As you can see there is no much difference between ICH Q9/Q10 and ISO 14971 other then the arrangement. Since ISO 14971 is optional in US and is mandatory across the world and due to subtle changes (as per me) in the documents FDA considers ISO 14971 as a good compliance with its Risk Management regulations.

  Also another thing to note here is since ISO 13485 refers to ISO 14971 in section 7.1 it is generally considered that being ISO 13485 certified is adequate, but increasing number of Medical device and Pharmaceutical companies are seeing this opportunity as a marketing strategy to improve the growth and market share.

Helpful Risk management tools during lifecycle of the product line

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Helpful Risk management tools during lifecycle of the product line   As you can see form the previous slide there is no single tool which

can help efficacy of the Quality Risk Management system instead several tools like Quality function deployment (QFD), Preliminary Hazard analysis during Design input which looks at previous product risks along with Design FMEA and Process FMEA and Fault Tree Analysis have to be used for a robust Risk Management System. Also during post production phase any CAPA implementation has to be associated with a strong rationale of its impact on the already validated QRM.

  Also Post market surveillance, Customer feedback all have to act as a continuous feedback to the living Document of QRM of any product lifecycle.

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