Implementing your quality management system

Implementing your ISO 9001:2000 quality management system 

1. Identify the goals you want to achieve

Typical goals may be:

• Be more efficient and profitable
• Produce products and services that consistently meet customer requirements
• Achieve customer satisfaction
• Increase market share
• Maintain market share
• Improve communications and morale in the organization
• Reduce costs and liabilities
• Increase confidence in the production system

2. Identify what others expect of you

These are the expectations of interested parties (stakeholders) such as:

• Customers and end users
• Employees
• Suppliers
• Shareholders
• Society

3. Obtain information about the ISO 9000 family

• For general information, look to this brochure
• For more detailed information, see ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000
• For supporting information, refer to the ISO Web site
• For implementation case studies and news of ISO 9000 developments worldwide, read the ISO publication ISO Management Systems.

4. Apply the ISO 9000 family of standards in your management system.

Decide if you are seeking certification that your quality management system is in conformance with ISO 9001:2000 or if you are preparing to apply for a national quality award.

• Use ISO 9001:2000 as the basis for certification
• Use ISO 9004:2000 in conjunction with your national quality award criteria to prepare for a national quality award

5. Obtain guidance on specific topics within the quality management system

These topic-specific standards are:

• ISO 10006 for project management
• ISO 10007 for configuration management
• ISO 10012 for measurement systems
• ISO 10013 for quality documentation
• ISO/TR 10014 for managing the economics of quality
• ISO 10015 for training
• ISO/TS 16949 for automotive suppliers
• ISO 19011 for auditing

6. Establish your current status, determine the gaps between your quality management system and the requirements of ISO 9001:2000

You may use one or more of the following:

• Self assessment
• Assessment by an external organization

7. Determine the processes that are needed to supply products to your customers

Review the requirements of the ISO 9001:2000 section on Product Realization to determine how they apply or do not apply to your quality management system including;

• Customer related processes
• Design and/or development
• Purchasing
• Production and service operations
• Control of measuring and monitoring devices

8. Develop a plan to close the gaps in step 6 and to develop the processes in step 7

Identify actions needed to close the gaps, allocate resources to perform these actions, assign responsibilities and establish a schedule to complete the needed actions. ISO 9001:2000 Paragraphs 4.1 and 7.1 provide the information you will need to consider when developing the plan.

9. Carry out your plan

Proceed to implement the identified actions and track progress to your schedule

10. Undergo periodic internal assessment

Use ISO 19011 for guidance in auditing, auditor qualification and managing audit programmes

11. Do you need to demonstrate conformance?

If yes, go to step 12
If no, go to step 13

You may need or wish to show conformance (certification/registration) for various purposes, for example:

• Contractual requirements
• Market reasons or customer preference
• Regulatory requirements
• Risk management
• To set a clear goal for your internal quality development (motivation)

12. Undergo independent audit

Engage an accredited registration/certification body to perform an audit and certify that your quality management system complies with the requirements of ISO 9001:2000.

13. Continue to improve your business

Review the effectiveness and suitability of your quality management system. ISO 9004:2000 provides a methodology for improvement.