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tcmc QMS | tcmc-qms.blogspot.com Reviews

https://tcmc-qms.blogspot.com

Blog with articles on improving business process quality for increased profitability. Improve QMS to be lean, efficient, effective, profitable

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1

tcmc QMS: Is ISO 13485:2016 applicable to distributors of medical devices?

http://tcmc-qms.blogspot.com/2016/09/is-iso-134852016-applicable-to.html

Tcmc Quality Management Services. Friday, 23 September 2016. Is ISO 13485:2016 applicable to distributors of medical devices? A question I have been asked is: To what extent is ISO 13485:2016 applicable to distributors of medical devices? They import devices and sell them locally as is. The answer to this question depends on answers to the following questions. Are you marketing the medical devices that you sell? Are you providing after-sales support of any kind? How do you track and handle recalls? What ...

2

tcmc QMS: October 2015

http://tcmc-qms.blogspot.com/2015_10_01_archive.html

Tcmc Quality Management Services. Wednesday, 28 October 2015. ISO 13485 question on advisory notices. A LinkedIn user asked the following question:. Can we claim an (ISO 13485) exemption to the requirement for a procedure for issuing advisory notices? We are not a finished medical device manufacturer, but we will supply components to customers who will assemble them into finished medical devices. Links to this post. Corrective and Preventive Action. Subscribe to: Posts (Atom). See our main web site:.

3

tcmc QMS: August 2015

http://tcmc-qms.blogspot.com/2015_08_01_archive.html

Tcmc Quality Management Services. Tuesday, 25 August 2015. Kaizen: If a thing is worth doing, it is worth doing badly. G K Chesterton. Credit. Just today, an old friend reminded me of this G. K. Chesterton saying that I used to quote more frequently and could profitably start using more frequently again. Our conversation was in the context of ' Kaizen. Where I wrote: Even if it ain't broke, it can - and must - be improved. On the American Chesterton Society web site. Links to this post. Links to this post.

4

tcmc QMS: July 2016

http://tcmc-qms.blogspot.com/2016_07_01_archive.html

Tcmc Quality Management Services. Friday, 8 July 2016. Risk Based Thinking (RBT) in ISO 9001:2015. What is risk based thinking as required in ISO 9001:2015? How do you implement it? This 17 minute presentation expands on the guidance provided by TC 176. Links to this post. Subscribe to: Posts (Atom). See our main web site:. Tcmc Quality Management Services. Tweets by @tcmc quality. Risk Based Thinking (RBT) in ISO 9001:2015.

5

tcmc QMS: ISO 14001 - What is it? An Overview

http://tcmc-qms.blogspot.com/2016/04/iso-14001-what-is-it-overview.html

Tcmc Quality Management Services. Wednesday, 20 April 2016. ISO 14001 - What is it? My latest training video on YouTube (just 9 minutes long) gives a high level overview of all the requirements in this well-reputed international standard for environmental management systems. ISO 14001 - What is it? Subscribe to: Post Comments (Atom). See our main web site:. Tcmc Quality Management Services. Tweets by @tcmc quality. ISO 14001 - What is it? What is ISO 13485 for Medical Devices?

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Tcmc Quality Management Services. Friday, 23 September 2016. Is ISO 13485:2016 applicable to distributors of medical devices? A question I have been asked is: To what extent is ISO 13485:2016 applicable to distributors of medical devices? They import devices and sell them locally as is. The answer to this question depends on answers to the following questions. Are you marketing the medical devices that you sell? Are you providing after-sales support of any kind? How do you track and handle recalls? What ...

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tcmc QMS Simplify Clarify Control

We provide training to equip your staff with the quality tools they need to create and maintain efficient and effective processes. Whether it is Quality Management, Environmental Management or Medical Devices, we view compliance as an opportunity to help make your business more effective, efficient, accountable, and profitable. We help you identify and monitor Key Performance Indicators to use the information in your system to drive strategic and operational goals and objectives. ISO 13485 - ISO 14001.

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