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5 min reading time
That’s reeeaally top-level and oversimplified…just trying to make the definition as layperson-esque as possible. I’ll leave the details to the experts like Robert.
I reviewed the ISO 13485, and I agreed with Robert Packard comment.
Lucy Watkins, BA (Hons), ACIM
Kanwal Jit Singh
QS are product specific and define the safety and performance requirements of the product, while QMS are generic and also bring in focus the production, post production and regulatory framework in which the product is to be used.
ISO 9001 is a general QMS, with ISO 13485 being sector specific QMS for medical devices. There are other sector specific QMS – all of them incorporate specific requirements of the sector into the broad framework of ISO 9001. And IEC 62304 is QMS specific for software as a medical device or in a medical device.
ISO 14971 is referenced in ISO 13485 – hence is automatically linked and becomes part of the QMS.
Analogous to the game where you take a closeup picture of an item and try to guess what it might be, looking at a standard on its own leaves the average person wondering what parts are important and how it can apply to their day to day activities. I liked the slide set provided by Pratyesh but more context would be better.
Whenever possible find examples of the standard in context..
For example, here is an easy to read link for those creating software based devices and want to understand how ISO13485 fits in relation to ISO14971 and IEC 62304.
Bottom line – it is better to see how all the cogs inter-mesh within the standards than to try to understand each in isolation.
PS back to the original question -Can you describe ISO:13485 in a way everyone can understand? – the answer is “probably not! ” since every role will require a slightly different focus. Oversimplification of complex standards leads to leaving out important concepts (like risk) as Robert noted above.
Kanwal Jit Singh
Slides provided provided by GHTF which includes case studies, too. You may find it suitable.
Another one of our group members sent me an email earlier today where she said that she attended a course where ISO 13485 was treated as a slight variant on ISO 9001, and the topic of risk management did not even get its own slide. It is so important to understand the difference, so I feel compelled to add a little more.
In 1994 the ISO 9001 Standard was developed as a systematic approach to managing quality. In 1996 a similar standard was created for the Medical Device Industry (i.e. – ISO 13485). The ISO 13485 Standard is similar in structure to the ISO 9001 Standard, but the fundamental purpose is different. ISO 9001 is about providing customer satisfaction and continuous improvement, while ISO 13485 is about meeting customer requirements, regulatory requirements and maintaining effectiveness.
With all that jargon, I think an example is needed…
Company ABC makes a super bandage to stop bleeding that works great on deep cuts. Customers want the super bandage to be made available over-the-counter (OTC). ABC also has complaints about the bandage being both too sticky and not sticky enough.
In a 9001 system, ABC makes new products that are OTC with both stronger adhesive and for sensitive skin with less aggressive adhesive. In a 13485 system, ABC must make sure that their product claims are allowed by the local and national regulations (OTC products may only be advertised for minor cuts and scrapes–not “deep cuts”). Also, ABC will need to perform specific performance and safety testing before submitting the two new versions of the bandage to the FDA.
The type of procedures and controls you need for a 9001 vs. a 13485 Quality Management System are quite different due to these different requirements.
ISO 9000 standards are based on improving factory performance through leadership and management practices. These improvements are generally guided and managed by following Quality Management Systems.
ISO 13485 standards are based on improving the performance of medical devices, business services, and regulatory compliance. The main purpose is to meet customers’ needs for producing quality medical devices & meeting regulatory compliance. Current Good Manufacturing Practices (CGMP, enforced by the FDA) can fall under the umbrella of ISO 13485 standards to help med-device manufacturing facilities prevent product and manufacturing defects.
Jean Bigoney, RAC, CQE
This training module on FDA QS requirements, while not describing ISO 13485, might also help:
Waqaas Ahmad Butt
Sarah H. Stec
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