ISO 9001 applies to all types of organizations. It doesn’t matter what size they are or what they do. It can help both product and service oriented organizations achieve standards of quality that are recognized and respected throughout the world.
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ISO 9001:2000 has replaced the old ISO 9001:2000 standard. If we’re now ISO 9001 certified, we’re going to have to update our quality system in order to meet the new ISO 9001:2008 requirements.
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The following are the important steps to be followed while implementing ISO 9001:2008 QMS:
1. Identify the goals we want to achieve:
Typical goals may be:
(i) Be more efficient and profitable
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(ii) Produce products and services that consistently meet customer requirements
(iii) Achieve customer satisfaction
(iv) Increase market share
(v) Maintain market share
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(vi) Improve communications and morale in the organization
(vii) Reduce costs and liabilities
(viii) Increase confidence in the production system
2. Identify what others expect of us:
These are the expectations of interested parties (stakeholders) such as:
(i) Customers and end users
(ii) Employees
(iii) Suppliers
(iv) Shareholders
(v) Society
3. Obtain information about the ISO 9000 family:
For more detailed information, see ISO 9000:2005, ISO 9001:2008 and ISO 9004:2008. 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 9000family of standards in our management system:
Decide if we are seeking certification that our quality management system is in conformance with ISO 9001:2008 or if we are preparing to apply for a national quality award. Use ISO 9001:2008 as the basis for certification and observe the following things:
Use ISO 9004:2008 in conjunction with our 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:
(i) ISO 10006 for project management
(ii) ISO 10007 for configuration management
(iii) ISO 10012 for measurement systems
(iv) ISO 10013 for quality documentation
(v) ISO/TR 10014 for managing the economics of quality
(vi) ISO 10015 for training
(vii) ISO/TS 16949 for automotive suppliers
(viii) ISO 19011 for auditing
6. Establish our current status; determine the gaps between our quality management system and the requirements of ISO 9001:2008
We may use one or more of the following:
(i) Self assessment
(ii) Assessment by an external organization
7. Determine the processes that are needed to supply products to our customers
Review the requirements of the ISO 9001:2008 section on Product Realization to determine how they apply or do not apply to your quality management system including;
(i) Customer related processes
(ii) Design and/or development
(iii) Purchasing
(iv) Production and service operations
(v) 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 9001:2008 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 we need to demonstrate conformance?
If yes, go to step 12
If no, go to step 13
We may need or wish to show conformance (certification/registration) for various purposes, for example:
(i) Contractual requirements
(ii) Market reasons or customer preference
(iii) Regulatory requirements
(iv) Risk management
(v) To set a clear goal for our 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 9001:2008.
13. Continue to improve your business:
Review the effectiveness and suitability of your quality management system. ISO 9004:2008 provides a methodology for improvement.