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A: Begin by deciding if registration to the ISO 9001 standard makes good sense for your organization. To determine this consider:
If you are seriously consider seeking, registration, then you must understand in depth what the standard requires of an organization. You can begin by reading our summary of the ISO 9001:2000 requirements. Then read one of the books listed in the bibliography that describes in depth what the standard is and what it actually requires. Alternatively you could take a course that describes the standard and the registration process. See the list of training resources to find a suitable course.
To determine the amount of effort required to comply will require assessing the maturity of your quality management system. If the organization already has a good understanding of product and service requirements, if you are already using effective procedure documents, if you have a quality policy, and quality objectives, if executive management regularly reviews reports of defects and customer complaints, if the competency needs are known for each job position, and if you monitor customer satisfaction, then you may be well on your way toward gaining registration. If your quality system is absent or immature, it will require much more effort to become compliant. You can do this assessment yourself, once you understand the Standard, or you can hire a consultant or registration agency to lead a "preassessment." A convenient summary of this preassessment is a table listing each area of the organization as a column, and each element of the Standard as a row. The cell entries can then show the readiness of each area to comply. This will provide a graphic summary of the work that needs to be carried out.
Design and implement the quality system to comply with the requirements of ISO 9001. This will typically require:
ISO 9001 relies on a system of audits to provide assurance that the organization is meeting the requirements of the standard. An audit includes an inspection of the documents and records that make up your quality system. Most importantly it is an inspection of the way the people in the organization work and the knowledge they have about the operation of the quality management system. It is required that the organization carry out scheduled and planned internal audits of the quality management system. This in itself in not sufficient, however, to obtain registration.
Only a "third party registration agency" is accredited to issue a certificate attesting that your organization meets the requirements of the ISO 9001 standard. Select this registration agency carefully. Guidance in selecting a registrar is provided in many books listed in the bibliography. Choose the registration agency early in the project so that you can learn in detail what they require before granting a registration.
Although registration requirements vary, it is typical to have a "preassessment" followed by a "registration audit" At both the preassessment and the registration audit, an comprehensive audit of the organization is performed. When the auditor identifies a discrepancy between the work that is being performed and the requirements of ISO 9001, the "nonconformance" will be written up. If only a few minor nonconformances are found during the registration audit, the agency will issue a certificate stating that your organization complies with the requirements of the ISO 9001 standard.. This certificate typically expires after three years. Also, the registration agency typically requires surveillance audits at six months intervals to maintain the currency of the certificate.
At this point, you deserve to celebrate your accomplishments!
The action planning checklist provides a more detailed list of steps to follow, once the decision to seek registration has been made.
A more detailed description of the steps involved, including a complete interpretation of each element of the ISO 9001 standard, is presented in the book ISO 9001, The Standard Interpretation.
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