Understanding The ISO/TS 16949:2002 Standard 

4.2 Documentation Requirements  

4.2.1 General  

QMS documentation shall include: 

a)    Statements of a quality policy and quality objectives 

b)    A quality manual 

c)    Documented procedures required by the Standard 

d)    Documents needed by the organization (to ensure effective planning, operation, and control of QMS processes)  

e)    Records required by the Standard 

Note 1 – Where the term ‘documented procedure’ appears within the standard, this means that the procedure is established, documented, implemented, and maintained. 

Note 2 – The extent of QMS documentation may differ from one organization to another due to the: 

a)    size of organization and type of activities 

b)    complexity of processes and their interaction 

c)    competence of personnel 

Note 3 - Documentation may be in any form or type of medium 

Key Explanation Points and Tips: 

Þ      Let’s begin with some definitions. A document is information that is written or recorded on some medium such as paper or computer. A document may specify requirements (e.g. a drawing or technical specification); provide direction (e.g. quality plan); or show results or evidence of activities performed (e.g. records). 

Þ       A procedure is a specific way to perform an activity or process (methods or practice used by an organization) and it may or may not be written. If it is written, it is called a documented procedure. The same reasoning applies to work instructions which may or not be documented. 

Þ      This standard is not heavy on documented (written) procedures as was the case with previous standards. Clause 4.2.1 specifies all the different types of documentation needed for your QMS. The need to have additional documentation beyond those specified in this standard may depend upon - customer; regulatory and your own organizational requirements. Other factors to consider may include - complexity of products and processes; effect on quality; risk of customer dissatisfaction; economic risk; effectiveness and efficiency; competence of personnel; etc.  

Þ      The documents you must include in your QMS are those needed to ensure the effective planning, operation and control for QMS processes (Clause 4.2.1d). Each organization must determine what documentation is needed to achieve this based upon the factors listed above.  

Þ      Make a list of all documents required by your QMS, regardless of the media or source of the document. This list may include documents from customers; suppliers; subcontractors; outsourcers; from within your organization; industry and regulatory bodies; registrars; etc. It is this list of documents that is subject to clause 4.2.3 control requirements.  

Þ      You must have documented statements of your quality policy and objectives. These will be discussed later in clause 5. There are many ways to document your Quality Manual and would be determined by the size, structure and complexity of your organization (se note 2). Clause 4.2.2 specifies more requirements for the contents of the quality manual. 

Þ      Regardless of how you document your QMS, you must demonstrate the effective implementation of your QMS in terms of conformity to TS 16949, customer, regulatory and your own organizational requirements. 

Þ      Under TS 16949, you must have documented procedures for  - clause 4.2.3 - Control of documents; clause 4.2.4 - Control of records; clause 6.2.2.2 - Training; clause; clause 8.2.2 - Internal audit; clause 8.3 - control of nonconforming product; clause 8.5.2 -  Corrective action and clause 8.5.3 - Preventive action. Procedures are also mentioned in other clauses such as 7.3.6.3; 7.6.3.1 and 7.5.2c, but the standard does not specify that these be ‘documented’ procedures. However, it might add value to some organizations to document these requirements.  

Þ      Depending on your organizations size, complexity, competency, etc, (see note 2) you may decide to have additional procedures or carry over some or all the procedures you had under previous QMS systems. Note there are several ways to write procedures, other than the conventional narrative form. 

Þ      You may choose to include your procedures and lower level documentation in your quality manual or organize them in some other fashion. The practicality of this would depend 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; maintainability; etc. (see note 2). 

Þ      In addition to the documents specifically called out in TS 16949, clause 4.2.1d call for documents deemed necessary for effective management and control of your processes, e.g. material specifications; competence criteria, product specifications, packaging specifications, manufacturing specifications, work instructions; forms; schedules; set-up specifications, etc. See note 2 below. 

Þ      TS 16949 calls for many records to provide evidence of effective planning, operation and control of processes. Examples include – management review records; calibration records, internal audit records; corrective action records, etc. As we go through this standard, we will highlight these records. Again, your processes may call for additional records beyond those expected by TS 16949.  

Þ      Many clauses do not specifically call for documents and records, but there is a strong implication in the wording of the need to have them. This is where clause 4.2.1d and 4.2.1e as well as 4.2.4; 7.1b and 7.1d kick in. In defining your processes and controls, you must indicate what evidence you will have to demonstrate effective planning, operation and control.  

Þ      Under Note 1 above it says ‘documented procedures’ must be established, documented, implemented, and maintained. This is done by following the requirements under clause 4.2.3 control of documents 

Þ      Note 2 - provides guidance on the extent of documentation your organization must have. This will vary from organization to organization according to the criteria indicated. Other criteria that may also affect the extent of documentation may include – impact on quality; risk of customer dissatisfaction; customer regulatory, and industry requirements; workforce stability and past quality problems and nonconformities. For example, if you have a highly educated and stable workforce, then the amount of documentation needed may be significantly less than an organization that has a high turnover of its workforce and lower educational requirements. 

Any combination of media is acceptable for documents and records provided they conform to requirements specified in clause 4.2.3 control of documents and clause 4.2.4 control of records