Become ISO 14971 and ICH Q9 Compliant – Knowhow of the Regulations

  • Date: April 05, 2010
  • Source: Admin
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ISO 14791 and ICH Q9 – Why Needed for Your Company

Injuries caused by defective or dangerous medical appliances, equipment, organ transplants, prosthetic devices, surgical implants, surgical equipment, hospital supplies, diagnostic equipment, and hearing and visual aids can call for severe lawsuits. Therefore, ensuring a minimum level of risk is the obligation of the manufacturer.

US FDA and UK MDD are two agencies working proactively to ensure best quality food and medical products to its users by eliminating associated risk and increasing safety and quality of the product. To achieve the quality level dictated by the FDA or MDD, following ISO 14971 or ICH Q9 is perhaps the best option in case you are in medical device production as both these guidance help to minimize error and risks and improve quality.

ISO 14791 – Most Preferred Regulation forBoth FDA and MDD

Medical device manufacturing and risks are perhaps interwoven. Thus, managing risk is of great importance for the manufacturer. And to develop a risk management system, following ISO 14971:2007 can give unparallel results.

While the FDA considers ISO 14971:2007 as an efficient and acceptable risk management model, EU has made this model mandatory for the production of medical devices.  Even when the manufacturers do not intend to implement the model, they are still required to conduct and document a risk management process.

Requirement of ISO 14971:2007

According to ISO definition, ISO 14971 is “Systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, and controlling risk”.

What Risks Can be Associated

In medical de vice manufacturing, risk or hazard refers to any potential source of harm that can affect patient or consumer. Risk means an amalgamation of the probability of the harm and severity of the same. Therefore, controlling risk means implementing protective measures for reducing or minimizing risks.

Process of ISO 14971

  • To follow the standard, manufacturers are required to
  • Identify the hazards associated with production of medical devices
  • Identify Clinical Hazards
  • Identify potential contributing factors/causes
  • Evaluate Risk
  • Control Risk
  • Identify and implement risk control measures

What ISO 14971:2007 Provides

ISO 14791compliance provides questions to medical device manufacturers which they can use to identify medical device characteristics that could have an impact on safety. Other than questions, examples of hazards, foreseeable sequences of events and hazardous situations are also provided in the compliance.


Adopted at step 4 at the ICH Steering Committee meeting on 9 November 2005, the ICH Q9, or the tripartite harmonized ICH guideline is a document on Quality Risk Management. Function of ICH Q9 is to ensure a common understanding of QRM by both industry and regulators. By ensuring a common understanding, ICH Q9 aims at reaching a “Desired State”, and improves communication and transparency within the organization.

Principles of ICH Q9

As stated in the ICH Q9 guideline, principles of the guideline are:

  • “The evaluation of the risk to quality should be based on scientific knowledge and ultimately link back to the protection of the patient; and
  • The level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk.”

What ICH Q9 explains

  • A common language and process
  • Potential methodologies for QRM
  • How Can ICH Q9 be Helpful for Your Company
  • Q9 will offer broad risk concepts and principles
  • Provides elements of Risk Assessment/Management Processes
  • You no more depend on a single tool, rather it provides you “The Right Tool for the Job” approach
  • Helps you with the principles for implementation
  • Risk Management Tools
  • High-level  (Ideas and Concepts)
  • Mid-Level  (Quantitative and Qualitative)
  • Low-Level (Real numbers and real time)

Can Blending ISO 14971 and ICH Q9 give you a Better Result?

Yes, of course blending of the two compliances promise you an escalating result in terms of managing risks. You will achieve major business benefits by regular use of the Risk Management File / Report in training, marketing, validation, root cause analysis, CAPA activities and failure investigations, as well as the obvious, reduced liability.

To learn more about how to blend these two regulations and how to implement them effectively, join the webinar, ISO 14971:2007 and the CE-Mark, organized by ComplianceOnline on 9th April, 2010. Speaker John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 28 years experience in U.S. FDA-regulated industries.

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