ISO 10013 1995 Standard in Plain English

Guidelines for Developing an ISO 9001 Quality Manual

ALSO SEE  ISO 9001 2008 AND ISO 9004 2009 IN PLAIN ENGLISH

ISO 10013: 1995

• Document your quality system. Consider using 
  the following document hierarchy:

  • Level A: Quality Manual

  • Level B: Quality Procedures

  • Level C: Detailed Quality Documents

  ISO says this is a "typical" way to organize documents. However, 
  you don't have to follow their advice. You can do it your way.

ISO 10013: 1995

• Develop your quality system manual. It should:

  • Address all quality system elements.

  • Contain or refer to your quality procedures.

• ISO distinguishes between three types of manuals:

  • The quality management manual. This type of manual 
    is for internal use and often contains confidential 
    or proprietary information.

  • The quality assurance manual. This type of manual 
    is for external use and does not contain confidential
    or proprietary information. It may be used by external 
    auditors and customers.

  • The quality manual. This type of manual can be 
    used for both internal and external purposes.

• If you intend to have both a quality management manual and 
  a quality assurance manual, make sure they don't conflict.

ISO 10013: 1995

• Your quality manual can serve several purposes. 
  Its purpose could be to:

  • Describe your quality system.

  • Describe your quality policy and procedures.

  • Define the quality standards that will be used.

  • Explain how quality requirements will be met.

  • Prove that your quality system is documented.

  • Control quality work practices and activities.

  • Teach people about your quality requirements.

  • Guide the implementation of your quality system.

  • Serve as a stable definition of your quality system.

  • Show that your quality system meets requirements.

ISO 10013: 1995

• Organize your manual any way you like. 
  But make sure that you:

  • Divide your manual into manageable sections and 
    cross-reference each section to an ISO standard.

  • Discuss your:

    • Quality system

    • Quality policy

    • Quality programs

    • Quality objectives

    • Quality definitions

    • Quality management

    • Quality requirements

    • Quality procedures

    • Quality plans

  • Cross-reference your quality manual to all relevant
    manuals, policies, procedures, standards, forms,
    publications, or other documents that might be
    helpful to your users.

ISO 10013: 1995

• Assign the responsibility for developing your manual to
  a team. Your quality manual development team should:

  • Clarify your quality policy or
    prepare a plan to develop one. 

  • List quality system objectives or
    prepare a plan to develop them. 

  • List your quality procedures or
    prepare a plan to develop them. 

  • Define the format, structure, and
    outline of your quality manual. 

  • Select the quality system elements
    that must be in the manual. 

  • Collect documents that describe
    your current quality system. 

  • Use interviews to identify and
    define current quality practices. 

  • Use questionnaires to identify
    current quality system practices. 

  • Delegate the actual writing to
    someone who knows how to write. 

  • Plug existing documents and
    references into the outline.

  • Ensure that final manual is
    complete, accurate, and organized. 

  • Ensure that final manual is well
    written and easy to understand.

ISO 10013: 1995

• Develop a quality manual. Your manual should:

  • Have a title.

  • Include a table of contents. 

  • Specify the scope of the manual. 

  • Provide an overview of the manual. 

  • Introduce your organization. 

  • Present your quality policy.

  • List your quality objectives.

  • Present procedures or specify where they are.

  • Describe your organizational structure.

  • Define any terms that are used in a special way.

  • Describe the elements that define the quality system.

  • Develop an index to look up quality manual topics. 

ISO 10013: 1995

• Introduce your manual. Your quality manual should have an
  introductory section that provides an overview of the manual. 
  This section should:

  • Show who reviewed and approved the 
    quality manual for distribution and use.

  • Identify the manual's version status, including 
    when the current version was approved and issued.

  • Describe how manual changes and revisions should 
    be initiated, prepared, approved, and distributed.

  • Indicate whether the manual is for internal use 
    only, or whether it can be distributed to outsiders.

ISO 10013: 1995

• Introduce and describe your organization. Your quality 
  manual should introduce your company by:

  • Stating its name, address, phone, and fax numbers.

  • Explaining what it does and how it does it.

  • Summarizing its history and experience.

ISO 10013: 1995

• Your quality manual should:

  • State your quality policy.

  • List your quality objectives.

  • Explain how you ensure that your quality policy and 
    objectives are understood and applied by everyone.

• Consider developing specific quality policy statements for
  each element or section of your manual, but make sure that
  these specific statements are consistent with your general
  policy statement.

ISO 10013: 1995

• Describe your company's organizational structure. Your
  quality manual should describe the structure that governs
  and controls quality. It should:

  • Describe the functions, departments,
    sections, or groups that affect quality.

  • Specify the quality oriented responsibilities that 
    make up each function, department, section, or 
    group, and the associated distribution of authority.

  • Clarify the patterns of interaction, communication, 
    and reporting that unify the quality system.

ISO 10013: 1995

• Develop and document procedures to control how 
  quality system activities should be performed.

  • Your quality manual should either contain procedures 
    or make reference to them. Your procedures may either 
    be part of your quality manual or exist apart from it.

  • Your procedures should control people who:

    • Perform the work that influences quality.

    • Manage the work that influences quality.

    • Control the work that influences quality.

    • Verify the work that influences quality.

    • Review the work that influences quality.

• Each procedure should:

  • State its purpose or intent. 

  • Clarify the scope of its application.

  • Highlight the controls that must be applied.

  • Explain how authority has been distributed.

  • List the responsibilities that should be performed.

  • Identify who is responsible for doing the work.

  • Describe the work that should be performed.

  • Specify how and when the work should be done. 

  • List the documents and records that must be used. 

  • List the materials and supplies that must be used. 

  • List the tools and equipment that must be used. 

  • Define the patterns of interaction and the 
    relationships that should be maintained.

• Make sure that each procedure:

  • Uses exactly the same format and layout.

  • Covers a logically separate and distinct
    part of the quality system.

ISO 10013: 1995

• Describe your quality system elements. The great bulk
  of your quality manual should describe quality management
  system elements. This part of your manual should:

  • Describe and explain how each of the quality
    management system requirements is being satisfied,
    and how each of the resulting quality system elements
    will be monitored and controlled. 

  • Organize the discussion of your quality management
    system elements so that it respects the way ISO has
    arranged the discussion of its quality management
    system requirements. But, this does not mean that
    you need to use precisely the same outline. 

  • Demonstrate that your quality management system is
    complete, well organized, and thoroughly integrated.

ISO 10013: 1995

• Review and approve your quality manual. The final draft
  of your quality manual should be carefully reviewed and
  approved by:

  • Experts: those who have the knowledge and
    expertise needed to ensure that the content
    is accurate and complete. 

  • Users: those who must make regular use of the
    quality manual and who are able to determine
    whether the manual is, in fact, usable. 

  • Managers: those who are responsible for implementing
    the quality manual and who must formally authorize
    its use.

ISO 10013: 1995

• Develop methods to manage the distribution 
  of controlled copies of your quality manual.

  • Use serial numbers to control the distribution 
    of your quality manual to authorized users.

  • Distribute the entire manual or only 
    selected sections to authorized users.

  • Make sure that all authorized users 
    have easy access to your quality manual.

  • Make sure that each authorized user can 
    understand and can use your quality manual.

• Develop methods for labeling and distributing 
  uncontrolled copies of your quality manual. 

ISO 10013: 1995

• Develop methods to control changes to your manual.

  • Control how changes are initiated.

  • Control how changes are developed.

  • Control how changes are labeled.

  • Control how changes are authorized.

  • Control how changes are distributed.

  • Control how changes are incorporated.

  • Control how obsolete versions are handled.

ISO 10013: 1995

• While the preceding information should help you to prepare
  your manual, it may not be enough. If you need more help,
  try the Web. You should be able to find some examples of
  quality manuals. Try searching using key words such as:

  • quality manual

  • quality assurance manual

  • quality management manual

  • iso 9001 manual

Google, Yahoo, MSN

ISO 10013: 1995

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Updated on June 5, 2010. On the Web since May 25, 1997.