The difference between ISO and ICH primarily lies in their scope, focus, and the specific examples and tools they provide for risk management, especially within the context of medical devices and pharmaceuticals.
ISO vs. ICH: A Comparative Overview
While both ISO (International Organization for Standardization) and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) develop standards and guidelines, they serve different industries and purposes. Here's a breakdown focusing on their approaches to risk management:
Risk Management Focus
- ISO 14971: Specifically focuses on the application of risk management to medical devices.
- ICH: Provides guidelines for pharmaceuticals, including aspects of quality risk management as seen in ICH Q9.
Tools and Examples
This is where a key difference appears in the provided reference:
- ISO 14971: Includes extensive examples (65 pages) to aid the industry in performing risk management, but does not include risk management tools in diagram form.
- ICH Guidance: Dedicates 14 pages at the end of the document to examples of risk management activities and tools.
Summary Table
| Feature | ISO 14971 (Medical Devices) | ICH (Pharmaceuticals) |
|---|---|---|
| Industry Focus | Medical Devices | Pharmaceuticals |
| Risk Management Examples | Extensive examples (65 pages), no diagrams | Examples in the guidance document (14 pages), includes some tools. |
| Diagrammatic Tools | No diagrammatic risk management tools included | Some risk management tools provided. |
Practical Insights
- ISO 14971's extensive examples help medical device manufacturers tailor risk management practices to their specific products.
- ICH's risk management guidelines, particularly ICH Q9, assist pharmaceutical companies in making science and risk-based decisions related to product quality.
In essence, while both provide guidance for risk management, ISO focuses on medical devices and offers detailed examples, while ICH focuses on pharmaceuticals and integrates risk management principles into quality standards. The formats of examples and the inclusion of diagrammatic tools also differ.
