ISO 10013 Standard in Plain English

Guidelines for Developing an ISO 9001 Quality Manual

ISO 10013 1995 is now OBSOLETE.

SEE  ISO 9001 2015 AND ISO 9004 2009.

This web page is based on the ISO 10013:1995 Quality Standard 
published by the International Organization for Standardization
It presents a comprehensive interpretation of this standard 
using language that is clear and easy to understand.

>>>  ISO 10013 1995 is now OBSOLETE <<<

Document your
quality system 
  • 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.

 
Develop your
quality manual
  • 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.

 
Clarify
your quality
manual's
purpose 
  • Your quality manual can serve several purposes.  Its purpose could be to:                                

    • Describe your quality management 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.

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

    • Divide your manual into manageable sections.

    • 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.                                    

 
Prepare to
develop your
quality manual 
  • 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.                        

 
Develop your
quality manual 
  • 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. 

 
Introduce your
quality manual
  • 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.

 
Introduce your
organization 
  • 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.

 
Introduce your
quality policy
and objectives 
  • 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.                                                             

 
Describe your
organizational
structure
  • 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.

 
Develop quality
procedures 
  • 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.                                

 
Describe your
quality system
elements 
  • 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.

 
Review and
approve your
quality manual 
  • 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 authorize its use.

 
Develop
methods to
control manual
distribution 
  • 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. 

 
Control your
quality manual
changes
  • 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.

 
Special note While ISO 9001 does expect you to develop a Quality Manual, 
this is not your primary mission.  Your primary mission is to  develop a Quality Management System that meets ISO's  requirements. Writing a manual is only one small part  of this mission. Your manual and your system are two  very different things.                                                 
 

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Updated on November 29, 2014. First published on June 6, 1997.

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