Welcome to the ISO 13485 Standard - Quality management medical devices knowledge center
Welcome to the ISO 13485 Standard - Quality management medical devices knowledge center

Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in this website. Written by an experienced industry professional, this practical methods and suggestions provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing.
Filled with examples drawn from the author’s experience and spanning different sectors and fields of the medical device industry, the websites translates the extra ordinary requirements and objectives of the standard into feasible activities and tasks. It provides you a full analysis of each clause and sub clause trough quality perspectives: the implications on an organization, its processes, management, human resources, infrastructures, work environment, control and effectiveness, documentations and records.  It is organized like the standard itself — the table of contents is identical to the ISO 13485 Standard’s table of contents — making it user friendly, familiar, and unintimidating. Use it as a consulting session — read it, explore it ,extract ideas — and draw on the information and knowledge that suits you and your organization, and then apply it effectively to your quality management system and processes.

 

 
ISO 13485 Standard - 4.2.3 Control of Documents E-mail
ISO 13485 control of docuements
Documents must be controlled. This is a key element of a quality management system. In order to achieve document control, a method must be maintained. The main idea is to provide control over the documents under the quality management system and to eliminate any confusions and mixups of different documents from different sources. This method must be one of the organization’s quality procedures

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ISO 13485 Standard - 8.2.1 Feedback E-mail
ISO 13485 customers feedbackThe organization is to continually and systematically evaluate whether the medical device meets the requirements throughout its life cycle, and that residual risks are controlled constantly. While the ISO 9001 standard demands the evaluation of customer satisfaction, the ISO 13485 standard does not, but requires the evaluation of feedback regarding the use of the medical device:
  • Does the medical device meet the intended use requirements?
  • Does the medical device meet the regulatory requirements?
  • Are residual risks still controlled and have new risks been identified?

 

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ISO 13485 Standard - 8.2.2 Internal Audit E-mail
ISO 13485 internal audit
One of the most effective activities that organizations may implement in order to monitor, analyze, control, and improve its quality management system (QMS) is the internal audit.
The audit’s main goal is to give a status report regarding your quality management system. The tactic of an audit (external or internal) is to evaluate the organization’s performances with reference to any kind of requirements. Your organization is required to maintain several activities. The audit evaluates whether the activities are performed and how well they are performed.

 

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