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Answers to "HOW" Questions about ISO 9000

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QUESTION

So instead of trying to give you a simple answer, we'll show you how to construct your own answer. One approach is to start with a Gap Analysis. A Gap Analysis will tell you what steps you need to take to upgrade or develop your quality management system. Once you know what needs to be done, you can figure out how long the work should take, who should do it, and how much it should cost.  

With this kind of information, you can plan your system development project and prepare a budget using the following kinds of cost categories:

• Internal costs
  • Gap Analysis
  • Project planning
  • System development
  • System documentation
  • System implementation
  • Training and awareness
  • Internal quality audit
  • System modifications
• External costs
  • Services
    • Consultants
      • Professional fees
        • Gap Analysis
        • Project planning
        • System development 
        • System documentation
        • System implementation
        • Training and awareness
        • Internal audit services
        • System modifications
      • Travel and living expenses
    • Registrars
      • Professional fees
        • Application fee
        • Registration fee
        • Initial assessment
        • Certification audit
        • Surveillance audits
        • Reassessments
      • Travel and living expenses
  • Products
    • Publications
    • Software

QUESTION

In general, it can take from 3 months to 3 years to develop a complete quality management system.  How long it will actually take will depend on a lot of factors, including how many people work on the project, how knowledgeable they are, and how large your organization is. 

Once you've developed your quality management system, your registrar may want you to wait another three or more months before the certification (registration) audit is done.  This is because you need to be able to prove that your quality system is actually working, and because it takes at least three months to develop an adequate record of performance.

QUESTION

While you are encouraged to make the transition to ISO 9001:2000 as soon as possible, officially you may still become newly certified to the old ISO 9001, 9002, or 9003 standards until December 15, 2003. Of course, since you're going to have to do it all over again with the new standard, this may not make much sense.

While December 15, 2003 is the formal deadline, registrars will expect their clients to become ISO 9001:2000 well before this date. This is because they won't allow their clients to leave it all to the last minute. We suggest that you contact your registrar as soon as possible to avoid unpleasant surprises.

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QUESTION

When choosing a registrar, we suggest that you:

• Make sure that the registrar's ISO 9000 certificates are recognized and respected in your industry.

  • Make sure that your customers will be impressed with the registrar's certificate.

• Find out whether your registrar has been formally certified by a recognized accreditation body.

  • Find out whether your registrar has been authorized to issue ISO 9000 certificates in your specific industry.

    • Find out how many certificates the registrar has issued in your industry.

• Clarify how the registrar performs quality audits.

  • Clarify how initial assessments are performed.

  • Clarify how certification audits are performed.

  • Clarify how surveillance audits are performed.

• Specify how the registrar handles problems.

  • Specify how nonconformances are handled.

  • Specify how the registrar handles complaints.

  • Specify the conditions that would cause the registrar to revoke an organization's certificate.

• Ensure that the registrar's auditors are suitable.

  • Ensure that auditors have been properly trained.

  • Ensure that auditors are certified or registered.

  • Ensure that auditors know your industry.

• Confirm that suitable auditors are assigned to audits.

  • Confirm that suitable auditors will be available.

    • Confirm that suitable auditors will be available in your area or region when you need them.

  • Confirm that audit assignments will be formally discussed with you before audits are scheduled.

    • Confirm that you will have a chance to review the auditors' credentials before audits are scheduled.

• Visit the Quality Digest site to see how well the registrar scored on the latest ISO 9000 Registrar Customer Satisfaction Survey.

• Verify how much the registrar will charge.

  • Verify how much it will cost to apply for registration and to maintain your registration.

  • Verify how much it will cost for the initial assessment, for the certification audit, and for future surveillance audits and reassessments.

  • Verify how much it will cost for travel expenses.

• Ask the registrar for a list of client references.

  • Ask referees to evaluate registrar's performance.

  • Ask referees how problems were handled.

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QUESTION

QUESTION

• Approve documents before you distribute them.

• Provide the correct version of documents at points of use.

• Review and re-approve documents whenever you update them.

• Specify the current revision status of your documents.

  • Identify changes that are made to documents.

• Preserve the usability of your quality documents.

  • Preserve the identity of your documents.

  • Preserve the readability of your documents.

• Monitor documents that come from external sources.

  • Identify documents that come from the outside.

  • Control the distribution of these external documents.

• Prevent the accidental use of obsolete documents.

  • Identify obsolete documents that have been retained.