Welcome to the ISO 13485 Standard - Quality management medical devices knowledge center
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Let us talk a bit About the ISO 13485 Standard and this website |
| | The ISO 13485 Standard is a special standard for quality management systems for manufacturers for medical devices (and services) where the primary goal is to protect the public's health and safety based on the medical device and its use.
The ISO 13485 Standard puts the international, national or/and regulatory requirements for medical devices at the first priority. After these requirements come all the rest. So, his objectives (it's still a standard for quality management system) is to harmonize regulatory requirements with quality management system requirements. Utopia! |
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ISO 13485 Standard quality management system general requirements |
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| The main processes of the quality management system are to be documented within the quality manual or procedures. This is the main idea of any quality manual. In any case, do yourself a favor and present within the quality manual a list of the processes included under the quality management system. It would save some explanations during the Audits. The relations and sequences between the main processes must be defined, documented and implemented. First let's understand the basics |
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ISO 13485 Standard documentation requirements - General requirements |
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Paragraph 4.2.1 General requirements - is a general paragraph that presents the main documentation requirements of the quality management system rregarding your QMS – Policies, Processes, work instruction, requirements for records (Forms etc.) and the records themselves. . The specific requirements are mentioned during the next paragraphs. In this article we will review the general requirements for documentation of the ISO 13485 with reference to the ISO 9001 Standard. |
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ISO 13485 Standard Control of Nonconforming Product requirements |
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| As soon as Nonconformity is detected within the organization, it must be recorded. It must be written somewhere. The ISO 9001 Standard requires that any non conforming product would be identified and controlled. The purpose is to prevent using this product or delivering it to your customers. The process of identifying and controlling shall be documented within a procedure. The documentation of the treatment must include authorities and responsibilities. So far, his cousin the ISO 13485 Standard requires pretty much the same. But of course with some additional requirements. Otherwise we wouldn't be here…
When dealing with nonconforming products, the organization must refer to the next issues |
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ISO 13485 Monitoring and Mesruement - Internal Audit requirements |
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| One of the most effective acts that organization may conduct in order to monitor, analyze control and improve is the internal audit. I am a big fan of it. This article would last too long if I had to go into most specific details about its significance.
The audit main goal is to give a status report. The tactic of an audit (external or internal) is to evaluate the organization's performances with reference to the requirements. In plain words, it is required from your organization to maintain several activities. The audit evaluates whether the activities are performed and how well they are performed.
The organization is required to perform the internal audit in defined periodical intervals in order to assess the quality management system and to confirm that:
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ISO 13485 Human Resources Requirements |
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The importance of training as part of a quality management system 
| The employees are the ones who produce the medical devices. The employees are the ones who are sitting in front of the machines, in front of the computers, in front of your customers, or assembling the products in the manufacturing halls. Industries and services today are becoming more and more different than before. The products and services supplied to customers are more complex. The organization must combine the two together: the human resources and the knowledge. The purpose of the training is to give your employee the opportunity to perform his job like it is planned.
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ISO 13485 Work Environment requirements |
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 | The ISO 13485 Standard requires that the organization will manage its infrastructures, resources and the working environment which are related to the realization process and the product. Like we said before in our recent articles: the ISO organization doesn't like to leave anything open for any questions! |
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