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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.
ISO 9001
| ISO 13485
| | The ISO 9001 Standard requires maintaining documentation to describe the QMS, its scope, required quality procedures, and procedures required to realize the product. Documentation shall include: | The ISO 13485 Standard requires maintaining documentation to describe the QMS, its scope, required quality procedures, and procedures required to realize the medical device. Documentation shall include: | A documented statement regarding the quality management system including the quality objectives.
| A documented statement regarding the quality management system including the quality objectives.
| A Quality manual
| Quality manual
| Documented procedures as required by the ISO 9001 Standard.
| Documented procedure as required by the ISO 13485 Standard.
| Any kind of documentation that ensures effective planning and operations.
| Any kind of documentation that ensures effective planning and operations.
| Records required by the ISO 9001 Standard.
| Records required by the ISO 13485 Standard.
| | | Any kind of additional documentation (such as procedures or records) required by any regulatory requirement (national or international).
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The main distinction between the ISO 9001 Standard and the ISO 13485 Standard are additional requirements of any regulatory requirements for documentation. That means that any kind of regulation that specifies any kind of documentation to maintain is considered just like any requirement made in chapter 4.2. You are required to implement and maintain it.
The ISO 13485 Standard requires all the same but with Documents that are required by national or regional regulations.
For example, if you are a factory that produces medical devices and the office of health (in your country or region) requires to maintain any kind of licenses (like a business license that authorizes you to operate a business) - you would be required to include the license in the list of your required quality management records (control of records) and present this licenses (valid, of course) when required (in an external audit, for example). The ISO organization is aware that there are many regulations for producing medical devices throughout the world and the ISO 13485 Standard gives them the same scale as for any standard requirement for documentation.
Plus (it's not over), for any kind of medical device - the organization must maintain a file describing the documents specifying the medical device (including manufacturing specifications) and documents required by the QMS. This way anyone can trace any documents at any stage of the realization processes related to the medical device. This file may include: - Technical specifications
- Work instructions
- Intended use requirements
- Quality requirements
- Customers' applications (of any kind)
View the next article about the Quality manual requirements of the ISO 13485.
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