Iso 9001 Case Analysis

3 The requirements of ISO 9001

Being a quality management standard, ISO 9001:2015 defines a set of quality management requirements. These requirements are available in the following seven clauses of the standard.

4. Context

5. Leadership

6. Planning

7. Support

8. Operations

9. Evaluation

10. Improvement

These seven clauses of ISO 9001:2015 can be summarized as follows.

3.1 Context

The standard asks you to understand your organization 's context (business environment) before you develop a quality management system for your organization. You need to understand your organization’s external environment, its culture, values, performance and needs & expectations of the interested parties and how they affect customer requirements as well as statutory

This requires you to,

• Define the quality policy of your organization.

• Establish quality objectives for the organization.

• Define roles, responsibilities & authorities of your staff

• Communicating the above

3.3 Planning

Under this clause, you need to plan for the development of your QMS. You need to address risks & opportunities which could influence the QMS ensuring that the QMS is not disturbed in anyway.

This requires you to,

• Identify risks & opportunities that could influence the performance of the QMS

• Define what actions to be taken to address them

• Develop plans to achieve quality objectives

• Evaluate the results of quality objectives

• Define the process of making changes to the QMS when required ( by considering purpose of the change, availability of resources, responsibilities, consequences and ensuring integrity of the QMS)

3.4

Review the related records & inform the customer on any changes

• Establish a process to design & develop your products (applicable only if you are designing your products by yourself)

• Monitor & control of external processes/products/services that you use for your operations (Includes determination of criteria to select, evaluate & monitor external service providers, evaluating the adequacy of controls implemented by external providers for their processes/products & clarifying your requirements to external service providers)

• Manage & control production & service provision activities (Establishing controls for production & service process, Identify the out put throughout production & service process, protect property owned by customers & external service providers, preserve outputs during production & service process, comply with all post delivery requirements, control changes in production & service process, verify products at each stage & plan for its release, identify, evaluate & take corrective action for any non conforming outputs & document them)

3.6 Evaluation

The standard requires you to monitor, measure, analyze and evaluate the performance of your organization’s established