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Answers to "HOW" Questions about ISO 9000


QUESTION

How many countries use ISO 9000?

ANSWER

See: The ISO Survery of Certifictions.


QUESTION

How many ISO 9000 certificates have been issued?

ANSWER

See: The ISO Survery of Certifictions.


QUESTION

How much does it cost to become ISO 9001 Certified?

ANSWER

This is one of our most popular questions. Unfortunately, there is
no simple answer. How much it costs depends on a lot of factors. It
depends on how long you take to develop your quality management
system, how many people are involved, whether you hire outside
consultants or not, and how much your registrar charges.

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 (QMS). 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

For detailed cost estimates, including daily fees, please
talk to ISO 9000 consultants and registrars in your area.


QUESTION

How long will it take to become ISO 9001 Certified?

ANSWER

In order to determine how long it will take to become ISO 9001
certified or registered, you have to figure out how long it will take
to develop or upgrade your quality management system
(QMS).  One
way of figuring this out is to start with a Gap Analysis.  A Gap Analysis
will tell you what steps you need to take to upgrade or develop your
QMS. Once you know what needs to be done, you can figure out
how long the work should take.

In general, it can take from three months to three years to develop
a complete QMS.  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 QMS, 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. You may wish
to use our ISO 9001 Compliance Audit to make sure that your quality
management is compliant before you ask your registrar to carry
out an external audit of your system.


QUESTION

How much time do we have to upgrade to ISO 9001:2008?

ANSWER

ISO published the new ISO 9001 2008 standard on November 15, 2008.
According to ISO and IAF, you had two years to upgrade to the new
standard. Therefore, the new deadline was November 15, 2010.
Your old ISO 9001 2000 certificate was obsolete on that date.

This also means that most ISO 9001 books, ebooks, web pages, and
articles published before November 15, 2008 are out-of-date, technically
obsolete, and probably inaccurate. They should, therefore, be ignored.


QUESTION

How can I get in touch with ISO Headquarters?

ANSWER

To talk to ISO in Switzerland, please use ISO's Contact Page.


QUESTION

How do I choose an ISO 9001 Registrar?

ANSWER

When choosing a registrar, we suggest that you:

  • Make sure that the registrar's ISO 9001 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 9001 certificates in your specific industry.

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

  • Clarify how the registrar performs external audits.

    • Clarify how initial assessments are performed.

    • Clarify how certification audits are performed.

    • Clarify how surveillance audits are performed.

  • Find out how the registrar handles problems.

    • Find out how nonconformities are handled.

    • Find out how the registrar handles complaints.

    • Find out 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.

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

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

  • Confirm how much the registrar will charge.

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

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

    • Confirm 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.


QUESTION

How can I become an ISO 9001 auditor?

ANSWER

If you wish to become an ISO 9001 auditor, probably the best place
to start is by contacting your country's ISO Member Body.  Your ISO
Member Body will either be able to provide training or tell you who
to contact.  ISO Registrars will also be able to provide training or tell
you who can provide training in your area. For more information,
please see our ISO Trainers page.


QUESTION

How should I format my ISO 9001 documents?

ANSWER

ISO does not specify a document format. How you format your
ISO 9001 documents is entirely up to you.  However, ISO does expect
you to control your ISO 9001 documents. For more information about
how to control your documents, please see the next question (below).


QUESTION

How should I control my ISO 9001 documents?

ANSWER

Your organization must develop and document a procedure to
control its QMS documents. Your procedure must ensure that you:

  • 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.


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OUR ISO 9001 PAGES

ISO 9001 2008 Introduction

Quality Management Definitions

Quality Management Principles

ISO 9001 2008 versus ISO 9001 2000

ISO 9001 2008 Translated into Plain English

How to Upgrade to the New QMS Standard

Quality Management Gap Analysis Tool

How to Develop a Process-based QMS

Process-based QMS Development Plan

Quality Management Audit Program

Process Approach

OUR ISO 9004 QUALITY MANAGEMENT PAGES

Introduction to ISO 9004 2009 Quality Management

Overview of the ISO 9004 2009 Quality Standard

ISO 9004 2009 Translated into Plain English

ISO 9004 2009 Compliance Audit Tool


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Updated on December 19, 2012. First published on October 24, 2001.

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