J
Rooch
ISO 9001 2K Clause 7.3.2 Requires that product requirements are to be determined and records are maintained. As an auditor I look for documented evidence that there are defined design inputs for current and completed projects and that the record contains evidence that these inputs have been reviewed and approved.
Record associated with this clause would be design project files. The files should contain input documents including customer, industry, regulatory and statutory requirements that are applicable. Most organizations then clearly state in a recorded form (letter, form or memo) the concise input requirements related to the product the organization intends to supply. These records must clearly indicate that a review was performed and that the output (inputs into 7.3.3) were approved by the organization.
I good document to use as a reference to the requirements of ISO 9001 is ISO 9004 2K. 9004 is a guideline for process improvement but in many cases it is very useful in clarifying the intent of ISO 9001 clause.
Hope this helps
ISO 9001 2K Clause 7.3.2 Requires that product requirements are to be determined and records are maintained. As an auditor I look for documented evidence that there are defined design inputs for current and completed projects and that the record contains evidence that these inputs have been reviewed and approved.
Record associated with this clause would be design project files. The files should contain input documents including customer, industry, regulatory and statutory requirements that are applicable. Most organizations then clearly state in a recorded form (letter, form or memo) the concise input requirements related to the product the organization intends to supply. These records must clearly indicate that a review was performed and that the output (inputs into 7.3.3) were approved by the organization.
I good document to use as a reference to the requirements of ISO 9001 is ISO 9004 2K. 9004 is a guideline for process improvement but in many cases it is very useful in clarifying the intent of ISO 9001 clause.
Hope this helps