|
ISO 13485 Standard documentation requirements - Quality manual requirements |
 |
|
4.2.2 Quality manual ISO 13485 Standard documentation requirements - Quality manual requirements
ISO 9001
| ISO 13485
| The ISO 9001 Standard requires maintaining a quality manual that describes the scope of the quality management, the procedures established for the quality management system and the relations between the processes and the QMS.
The quality manual shall include:
| The ISO 13485 Standard requires maintaining a quality manual that describes the scope of the quality management, the procedures established for the quality management system and the relations between the processes and the QMS.
During the exclusion chapter -the ISO 13485 Standard requires also to mention the activities that are not applicable during the product realization.
The quality manual shall include:
| The scope of the quality management system
| The scope of the quality management system. | List of exclusions.
| List of exclusions and/or non applications.
| The procedures established for the quality management system.
| The procedures established for the quality management system.
| A description of the relations between the processes and the QMS.
| A description of the relations between the processes and the QMS.
| | | The quality manual shall describe the structure of the documentation used by the quality management system.
|
The main requirements are the same. The quality manual shall include: - The scope of the quality management system - which services or products are included under the quality management system
- List of excluded chapters (for more about this read the next article).
- List of procedures that the QMS includes
- A description of the relation between the process (mentioned above) and the quality management activities.
The additional requirement is for the application of the standard. List of exclusion is a simple matter. If there are any requirements during chapter 7 (product realization) that are not applicable tov your organization, following the product character - the organization can exclude them and mention it within the quality manual. But, if there are any requirements during chapter 7 that are not being performed in the organization but has an affect on the product (out sourcing for example) - you must include them in the quality manual because according to the ISO 13485 documents control requirements, you are still responsible and those activities must be performed under your QMS. In other words, you are required to control these activities as well. The quality manual must include the documentation structure in the organization. I suggest to provide some kind of explanation (textual or a drawing) that explains the relations and interrelations between the documents throughout your QMS. So as well as a list of procedures, forms, records that you use to manufacture the device (normally required by the ISO 9001 Standard), the ISO 13485 Standard requires describing which drawings, Bill of Materials and packaging specifications (just for the example) are included in the quality management system. View the next article about the documents control requirements of the ISO 13485. aaa aaa |
