Practical approach to ISO - Quality Systems Review

PharmOut will work with the clients ISO project team members to complete an ISO 9001 / ISO 13485 audit of the current operations to identify additions and changes required for ISO registration.

The consultant (1) documents and reviews the list of changes to be added to the MS Project Plan and assigned to various project team members or areas of the organization; and (2), provides sample templates and techniques suitable for addressing the required changes.

PharmOut will provide technical assistance as needed to project members as they prepare assigned documentation (quality manual, policies, procedures, flow charts, etc.). PharmOut’s consultant will conduct a review of the completed documentation and indicates the required corrections.

PharmOut will provide a report on the progress and to update the MS Project Plan as needed. This report will be circulated to senior management at an agreed frequency.

Back to Practical Implementation of ISO 9001 and 13485.