Operational Clauses

The seven areas that will need to be addressed under operations are the following, which are outlined in the draft of ISO 9001:2015:

1. Operational planning and control

2. Determination of requirements for products and services

3. Design and development of products and services

4. Control of externally provided products and services

5. Production and service provision

6. Release of products and services

7. Control of nonconforming process outputs, products, and services

Quality Control Plan

The operational process area for planning requires the organization to address the risks it has identified and put in place controls to manage and meet the specific management system requirements you have integrated (conformity of goods and services – Quality-ISO 9001, prevention of pollution – Environment-ISO 14001, prevention of injury – Occupational Health & Safety-OHSAS 18001, etc.). A “risk plan” can be utilized for this purpose, outlining all your process areas and the risks associated with each. Many organizations have utilized quality control plans to monitor and control suitable parameters and product characteristics to ensure products meet specified requirements.

Documented information needs to be maintained and should describe the characteristics of the goods and services, the activities to be performed, and results to be achieved. These records are maintained for objective evidence during inspections and tests, and analysis needs to be done to identify nonconformances.

The quality control plans outlined the process areas and identification of control areas: what had to be made and the quantity, how it was made, equipment, measurement and monitoring tools; what to inspect, etc. The control plan, however, did not include what the risks were associated with the tasks. Many organizations will need to spend time to identify the risks for their process areas, making the quality control plan a good tool when modified to include the risks as well.

The identification of individuals responsible for executing control for the providers of the tasks, whether they are for your employees, suppliers, or contractors, would be on your plan.

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