Understanding The ISO/TS 16949:2002 Standard 

4.2.2 Quality Manual  

Establish and maintain quality manual & include: 

a)    Scope of the QMS including details of and justification for any exclusions 

b)    Procedures (or references to the procedures) 

c)    Description of interaction between QMS processes 

Key Explanation Points and Tips: 

Þ      The quality manual is a special type of document that describes your QMS. Besides describing your QMS, your quality manual could provide information on organizational background and capabilities. It may be used by customers, regulatory bodies, suppliers and company personnel for a variety of purposes. There are many acceptable ways to document your quality manual. 

Þ      You must define the scope of your QMS in your quality manual. Your QMS scope should include – facilities (manufacturing and support locations), products, processes, your agreement to conform to TS 16949 and other business management standards, etc. Customers will want to know the extent of your capabilities and the Registrar will want to determine the time and effort needed to audit your organization. 

Þ      Provide details of any clause exclusions from your scope, e.g. 7.3 Product Design and Development, and justification for it, i.e. no OEM customer has designated your organization as being design responsible. 

Þ      You have flexibility in whether or not to include your procedures and lower level documentation with your quality manual or organize them in some other fashion. You may include all or some of your procedures in your Quality Manual or reference them to your Quality Manual. Keep a listing or index at the front or back of your Manual showing the complete list of your procedures whether included or referenced.  

Þ      The practicality of how you organize your QMS manual and related documentation would depend, of course, on the size of your organization, complexity of products and processes; competency of personnel, media used for documentation (hard copy versus computerized); ease of use and understanding by personnel; etc. So go ahead and organize your documentation to facilitate easy of use; availability and maintainability. 

Þ      Your quality manual must include a description of the interaction of your QMS processes. This was discussed above under clause 4.1  

Þ      As a controlled document (see 4.2.1), the quality manual is subject to all of the controls in clause 4.2.3.