|
ISO 13485 Standard Normative references requirements |
 |
|
In this article we would review the ISO 13485 Standard requirements as appeared Chapter 2 – Normative references - one of the most unread chapters in the history of the ISO Standards.You must admit that I am right. But I read it and it was hard to understand...
ISO 9001
| ISO 13485
| During the ISO 9001 Standard document there are explanations and guidance that are required to express the standard's requirements.
Dated references relate only to the edition indicated. Any amendments, new additions or new publications do not apply. In any case, the right to investigate if there are new editions to dated references.
Undated references relate to the last edition published.
List of all updated international standards are to be found by the ISO/IEC organization.
ISO 9000:2000, Quality management systems - Fundamentals and vocabulary | During the ISO 13485 Standard document there are explanations and guidance that are indispensable for the standard's applications.
Dated references relate only to the edition cited.
Undated references relate to the last edition published.
ISO 9000:2000, Quality management systems - Fundamentals and vocabulary |
The bottom line of normative references is that the terminology specified during this standard is not open for interpretive discussion. So do not get creative here. This is not the place. The ISO 13485 Standard uses the ISO 9001 Standard as a normative reference. Any term appears on the ISO 9001 Standard is applicable to the ISO 13485 Standard. Move on to the ISO 13485 Standard quality management system requirements... |
