Monthly Archives: June 2018 »
ISO 13485:2016 Standard- Table of contents
The book is organized like the standard itself, the table of contents is identical to the ISO 13485 Standards table of contents making it user friendly, familiar, and unintimidating. Each chapter contains the information,
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Why choose the book ISO 13485:2016 – A Complete Guide to Quality Management in the Medical Device Industry
Why choose the book ISO 13485:2016 – A Complete Guide to Quality Management in the Medical Device Industry over other menu scripts? When you’ve done as much as I have in the quality management
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Introducing the project ISO 13485:2016 – A Complete Guide to Quality Management in the Medical Device Industry
The quality management world of the medical device industry has gone through a significant change represented by the publication of the new revision of the ISO 13485 Standard, the 2016 revision. This revision brings
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ISO 13485 Standard:2016 – 8.5.2 Corrective Action
Corrective action is one of the foundation elements of quality management and is essential for sustaining improvement of the QMS. The main concept of corrective action promotes a systematic analysis of quality problems that
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ISO 13485:2016 Standard – 8.2.1 Feedback
The ISO 13485 standard requires the evaluation of feedback regarding the use of the medical device; the organization is to continually and systematically evaluate whether the medical device meets the requirements throughout its life-cycle:
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ISO 13485:2016 Standard – 7.5.8 Identification
The ISO 13485 Standard demands the organization establish and maintain a systematic identification of its business activities and process results throughout the material flow. The identification shall be according to specifications: medical device specifications
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ISO 13485:2016 Standard – 7.5.6 Validation of processes for production and service provision
Process validation is next control required by the ISO 13485 Standard, and an effective process validation contributes significantly to ensuring the quality of the medical device. Validation means testing that expected results and objectives
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