The “Secret” ISO Standards
The International Standards Organization (ISO) has many supporting standards which are used in conjunction with the ISO 13485 series. While some are more specific, the emphasis on many is to bring forth in a business environment, the best practices for producing consistently quality services and products.
While we profile a couple in this article, you can go to our listing page and find many more such as:
- ISO 13485 – 2003 – Medical devices – Quality management systems – Requirements for regulatory purposes
- ISO 13485/Cor1:2009 Medical devices – Quality management systems – Requirements for regulatory purposes – Corrigendum 1
- ISO 15189 – 2007 – Medical Laboratories – Particular Requirements for Quality and Competence
- ISO 15378 – 2006 – Quality Management Systems – Primary Packaging Materials for Medicinal Products – Particular Requirements for the Application of ISO 9001:2000, with Reference to Good Manufacturing Practice (GMP)
- ISO 9001 – 2008 – Quality Management Systems Requirements
- ISO 14971 – 2019 – Medical devices – Application of risk management to medical devices
- ISO Guide 73 – 2009 – Risk management – Vocabulary
- ISO/TR 14969 – 2004 – Medical devices – Quality management systems – Guidance on the application of ISO 13485: 2003
- ISO/TR 16142 – 2006 – Medical Devices – Guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of Medical Devices
- ISO/TS 20993 – 2006 – Biological Evaluation of Medical Devices – Guidance on a Risk Management Process
These standards are distributed by us through Techstreet, a standards publishing partner. Their vast inventory opens up many new avenues to learn about these tools to support your overall ISO certification efforts
If You Buy, Use, Create Or Update Medical Software, You Need TIR36:2007, Validation of Software for Regulated Processes
If you’ve been certified under ISO 13485, it states a need for software validation since it drives so many of the operations that the general standard covers. But the medical device community felt the standard needed more specificity, so enter TIR36:2007 It helps explain how to ensure the quality levels for software that is used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, and complaint handling or to automate any other aspect of the quality system
In addition, the standard applies to software used to create, modify, and maintain electronic records and to manage electronic signatures that are subject to the validation requirements. So it applies to software:
- Employed in the production of a device
- Used in implementation of the quality system of the device manufacturer
But doesn’t apply to software that is:
- Essentially a component, part, or accessory of a medical device
- That is itself a medical device
The value of TIR36:2007 is that it is not tied to a specific software type, platform or application. It really promotes good general use and practices with respect to ensuring software quality, consistency and control. This is even amid the dizzying changes and updates and the myriad of ways it can and will be used. It’s sort of a port of best practices in the storm of software change.
Don’t Even Think About Hiring A Quality Consultant Without Consulting ISO 10019:2005
It’s our stance that you don’t need to hire often costly consultants for many phases of the ISO registration process. But there are times when it becomes necessary to outsource and in those cases, ISO has provided some guidance on finding the right attributes when selecting a consultant in their ISO 10019:2005 guidelines for the selection of quality management system consultants and use of their services. Under this advisory, ISO covers a number of issues that apply to the actual selection of a quality management system (QMS) consultant such as:
- The type and scope of input that should be solicited internally and externally as an aide to the selection process to the selection process
- Must have areas of competency for the consultant and to some extent the organization that supports them
- How to avoid conflicts of interest and other ethical considerations
- How to best apply the services from a consultant to create, manage and improve your quality management system
- Guidelines for crafting the contract between the consultant and your organization
There is a myriad of other useful considerations for engaging a quality management consultant and using his or her services in ISO 10019:2005. Get this important advisory before you start the process. You’ll be glad you did.
And The List Goes On
If we have peaked your interest, here’s a partial list of standards, all of which can make you and your company more valuable from just about any perspective.