ISO 13485 2003TRANSLATED INTO PLAIN ENGLISH ISO 13485 is a Quality Management Standard for Medical Devices |
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The following material translates the
ISO 13485 2003 standard into Plain English.
However, this material is both general and selective. It is, therefore,
incomplete.
If you need a detailed and complete version, please consider
purchasing
our Title 45:
ISO 13485 2003 Translated into Plain
English.
Or contact Praxiom Research Group
for more information.
Also see our ISO 13485 INTERNAL AUDIT PROGRAM
Please note
that ISO presents requirements in sections 4 to 8 of
ISO 13485.
Therefore, the following material begins with section 4. Sections 1 to 3
cover
a variety of introductory and explanatory topics. These additional topics
are
discussed in our Title 45: ISO 13485 2003 Translated into Plain English.
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ISO 13485 2003 IN PLAIN ENGLISH |
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ISO 13485 2003 MEDICAL DEVICE STANDARD IN PLAIN ENGLISH |
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ISO 13485 |
4. Systemic Requirements |
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4.1
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Develop a quality management system for medical devices.
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Implement a quality management system for medical devices.
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Maintain your medical device quality management system.
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4.2 |
4.2.1 Develop quality management system documents.
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4.2.2 Prepare quality management system manual.
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4.2.3 Control quality management system documents.
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4.2.4 Maintain quality management system records.
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ISO 13485 2003 MEDICAL DEVICE STANDARD IN PLAIN ENGLISH |
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ISO 13485 |
5. Management Requirements |
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5.1 |
Promote the importance of quality.
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Develop a quality management system.
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Implement your quality management system.
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Maintain your quality management system.
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5.2 |
Identify customer requirements.
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Meet customers requirements.
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5.3 |
Define your quality policy.
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Manage your quality policy.
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5.4 |
5.4.1 Formulate quality objectives.
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5.4.2 Plan quality management system.
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5.5 |
5.5.1 Define responsibilities and authorities.
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5.5.2 Appoint management representative.
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5.5.3 Support internal communications.
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5.6 |
5.6.1 Review quality management system.
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5.6.2 Examine management review inputs.
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5.6.3 Generate management review outputs.
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ISO 134852003 MEDICAL DEVICE STANDARD IN PLAIN ENGLISH |
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ISO 13485 |
6. Resource Requirements |
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6.1 |
Identify quality management system resource requirements.
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Provide quality management system resources.
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6.2 |
6.2.1 Use competent personnel.
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6.2.2 Support competence.
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6.3 |
Identify infrastructure needs.
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Provide needed infrastructure.
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Maintain your infrastructure.
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6.4 |
Identify needed work environment.
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Implement needed work environment.
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Manage needed work environment.
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PAGE 1 OF 2 |
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This
page summarizes ISO 13485.
It highlights the main points. It does not present
detail. If you need a detailed and complete
interpretation of ISO
13485, please consider
purchasing
our
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Our Title 45 provides a detailed, accurate, and complete
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| How to Order | Detailed Site Map | Alphabetical Index | |
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| OTHER ISO 13485 WEB PAGES |
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Introduction to ISO 13485 Quality System Standard for Medical Devices |
| Definitions for ISO 13485 Quality Standard for Medical Devices |
| Plain English Overview of ISO 13485 2003 Quality Standard |
| How to Develop an ISO 13485 Quality Management System |
| ISO 13485 2003 Internal Audit Program |
| ISO 13485 is a Quality Management Standard for Medical Devices |
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