Quality Risk Management ISO 14971 / ICH Q9

Quality Risk Plans are now an essential part of our pharmaceutical operations, in fact in the EU these are a regulatory requirement for all drug products registered after the 1sy July 2008.

Risk assessments have long been a requirement for Medical Devices, more recently ISO 14971:2007 has been updated.

If you would like more information why not download the ICH Q9 document or buy the ISO 14971 standard?

Alternatively you may wish to ask one of our consultants discuss your needs or your may wish to attend one of our training courses , click our training page.

ISO 14971-2007 Medical devices — Application of risk management to medical devices

PharmOut offers ISO 14971:2007 training and consulting services on this standard.

This International Standard was developed specifically for medical device/system manufacturers using established principles of risk management.

For other manufacturers, e.g., in other healthcare industries, this International Standard could be used as informative guidance in developing and maintaining a risk management system and process.

The standard deals with processes for managing risks, primarily to the patient, but also to the operator, other persons, other equipment and the environment.

As a general concept, activities in which an individual, organization or government is involved can expose those or other stakeholders to hazards which can cause loss of or damage to something they value.

Risk management is a complex subject because each stakeholder places a different value on the probability of harm occurring and its severity. It is accepted that the concept of risk has two components:

a) the probability of occurrence of harm;

b) the consequences of that harm, that is, how severe it might be.

The concepts of risk management are particularly important in relation to medical devices because of the variety of stakeholders including medical practitioners, the organizations providing health care, governments, industry, patients and members of the public.

ICH Q9 Quality Risk Management guideline:

As with all ICH documents this guideline is the product of a tripartite harmonised ICH guideline.

This guideline provides principles and examples of tools of quality risk management that can be applied to all aspects of pharmaceutical quality including development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances and drug (medicinal) products, biological and biotechnological products, including the use of raw materials, solvents, excipients, packaging and labelling materials.