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At suitable stages of the design and the development, the organization must review it. The review must be systematic and defined. The review must also be a part of the design and the development plan. While reviewing the development, the organization must refer to the next issues:
ISO 9001
| ISO 13485
| The review must evaluate to competence of the development to the requirements. The evaluation would be based on the outputs presented.
| The review must evaluate to competence of the development to the requirements. The evaluation would be based on the outputs presented.
| The review must identify problems occurred during the development and suggest appropriate and required ways to deal.
| The review must identify problems occurred during the development and suggest appropriate and required ways to deal.
| The participants of the review are to be the relevant parties that has (or had) affected the design and the development.
| The participants of the review are to be the relevant parties that has (or had) affected the design and the development. These functions and their duties are to be defined and documented.
| | The organization must keep records of the design and the development review. These records must be defined as quality records within your records control procedure as mention in paragraph 4.2.4 – control of records. | The organization must keep records of the design and the development review. These records must be defined as quality records within your records control procedure as mention in paragraph 4.2.4 – control of records.
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The purpose of the design and the development review is: - Evaluating the ability to meet the requirements
- Control over the design and development processes
The level of formality and complexion of the review would be defined according to the nature of the product. The review shall be planned. The plan must include the issues, the schedules, and the type of the review (demonstration, presentation, accusation – whatever suits your organization). During the review, relevant parties that take part in the design and the development process or has affected would participates; developers, scientists, researchers, production managers, quality representative, customers' delegates, etc. Now lays the additional requirement. While the ISO 9001 Standard requires only that the relevant parties shall attend the review, the ISO 13485 Standard requires definition of the parties requested during the review. The definition can be documented in various way; job description, development plan, procedure or work instruction. The organization shall also define measures to detect non conformity occurred during the design and the development and suggest ways to solve these non conformities. Further development activities shall be approved only after all nonconformities are eliminated or referred. The output of the review shall be planned and documented as well (You guessed it, everything is to be documented) .You shall plan the required outputs; meeting summary, tasks, decisions etc. you are required to define the method of follow-ups. How do you intend to validate your outputs and verify the execution. It is pretty complicated to develop under the ISO 13485 Standard requirements. We mentioned that at the beginning. Didn’t we?
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