5 min reading time

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Perry Mykleby
Customer Activation, Engagement & Retention
ISO13485 is a quality standard that helps assure that customers get well-designed, needed, products that operate safely and as advertised, and that systematic feedback about the product will later result in future improvements.

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.

Tammy Nguyen
SQE at Powerwave Technologies
Hello everyone,

I reviewed the ISO 13485, and I agreed with Robert Packard comment.

Tammy

Lucy Watkins, BA (Hons), ACIM
Head of Fundraising at Birmingham St Mary’s Hospice
We are running an event on ISO 13485 in Birmingham, UK on 14 November which will explain in simple terms the standard requirements, the approval process and key do’s and don’ts.
[http://www.medilinkuk.com/events/key-iso-standards-medical-devices|leo://plh/http%3A*3*3www%2Emedilinkuk%2Ecom*3events*3key-iso-standards-medical-devices/KsN4?_t=tracking_disc]

Kanwal Jit Singh
Public Actions in Sustainability, Finance, Law etc
I think there is a difference between a Quality standard (QS) and a quality management standard (QMS). ISO 13485 is a QMS and not a QS.

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.

Bruce Grayson
Strategic Business Development – Enterprise and Mobile Software – Clinical Applications and Medical Devices
Quality standards in isolation are often more difficult to understand than when they are placed in the context of their supporting ecosystem of standards. Reading one standard at a time makes it hard to see how things all fit together. Unfortunately this is how many of us are exposed to new processes or standards.

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.

[http://blog.cm-dm.com/post/2011/11/01/ISO-and-IEC-standards-explained-to-software-engineers-and-quality-managers|leo://plh/http%3A*3*3blog%2Ecm-dm%2Ecom*3post*32011*311*301*3ISO-and-IEC-standards-explained-to-software-engineers-and-quality-managers/zjim?_t=tracking_disc]

Bottom line – it is better to see how all the cogs inter-mesh within the standards than to try to understand each in isolation.
Bruce

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.
B

Kanwal Jit Singh
Public Actions in Sustainability, Finance, Law etc
My two cents.
ISO 13485 provides a framework
1. for designing medical devices with the design parameters in consonance with the regulatory environment of the market where they are to be used; and
2. for producing them as per the approved design in a consistent manner; and
3. for the installation and use of the medical devices
4. to alleviate medical conditions of the patients without compromising the health of the user(s) and the environment

Robert Houghland
CEO at Hanover Pen Corp., Hanover, PA
In layman’s terms there are five steps to ISO 13485; say, do, check, record and improve. Say what you are going to do and how you are going to do it. Do what you say needs to be done. Check that the outcome of your actions is what you expected. Record what was done and checked. Improve the first four steps through corrective and preventive actions. You can go into great detail describing how each of these five steps are used throughout the process of designing and making a medical device but it all boils down to say, do, check, record and improve.
Robert Houghland

Pratyesh S.
Senior Executive – Regulatory Affairs at Meril Life Sciences India Pvt Ltd
Hello Joe,

Slides provided provided by GHTF which includes case studies, too. You may find it suitable.

[http://www.ghtf.org/meetings/conferences/4thapec/4_APEC_SG3_ISO13485%20Introduction%20KL%202008-Gunter%20Frey-Hideki%20Asai.pdf|leo://plh/http%3A*3*3www%2Eghtf%2Eorg*3meetings*3conferences*34thapec*34_APEC_SG3_ISO13485%2520Introduction%2520KL%25202008-Gunter%2520Frey-Hideki%2520Asai%2Epdf/FZxx?_t=tracking_disc]

Rob Packard
510(k), CE Marking & Quality System Consultant
Great comments from everyone!

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.

Michelle Bonn
President, Guideline Medical
A simple description of ISO 9000 standards vs. ISO 13485 standards (with regards to manufaturing).

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
Regulatory Affairs Specialist.
I found what looks like a helpful overview in plain English:
[http://www.praxiom.com/iso-13485.htm|leo://plh/http%3A*3*3www%2Epraxiom%2Ecom*3iso-13485%2Ehtm/DFEf?_t=tracking_disc]

This training module on FDA QS requirements, while not describing ISO 13485, might also help:
[http://www.fda.gov/training/cdrhlearn/ucm162015.htm#qsr|leo://plh/http%3A*3*3www%2Efda%2Egov*3training*3cdrhlearn*3ucm162015%2Ehtm%23qsr/RUK6?_t=tracking_disc]

Steve Coulter
General Manager Regulatory Compliance Associates Inc.
To make it very simple…ISO 13485 provides a company that wants to develop medical devices a basis structure that ensures a thorough, systematic development processes resulting in safe and effective products.

Waqaas Ahmad Butt
Production Manager at Accuray Surgicals Ltd, Lakson Group of Companies
” The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for Quality Management System.’

www.aboutsurgicalinstruments.wordpress.com

Souraya Verhaegen-Sakhri
Senior Quality & Regulatory Manager at Philips Innovation Services
Actually Sarah did really well, nothing to add!!!

Sarah H. Stec
Senior Counsel, Medical Device Regulatory Law at Johnson & Johnson
Adel is right – ISO 13485 is a standard for Quality Management Systems for medical device manufacturers. It’s based on ISO 9001, although it contains specifics for medical device manufacturers (taking into account the inherent riskiness of manufacturing medical devices over manufacturing less risky items). According to the standard itself, it “…specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.”

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
go on …

Adel Qashmari
Student at ahwaz jondishapour university of medical science
ISO 13485 is a Quality Management Standard for Medical Devices.