Documentation of the Process Approach

The ISO 9001 Standard requires documentation of the process, operations, and activities that comprise
the QMS. I promote it as part of standardization in organizations; the documentation of the process
approach creates a system for designing, analyzing, and implementing processes. The extent and level of
details of the documentations shall be determined by the organization according to its needs. But bear in
mind that you will have to justify it. If you decided to maintain a low detailed documentation during an
audit, you must show how this documentation is sufficient. Documentation is divided into two levels:
• The organization shall define how processes, operations, and activities shall be documented. Here the standard
refers to process diagrams, procedures, work instructions, and so on.
• The organization shall define which process outputs must serve as evidence and be
maintained in the form of records of processes, operations, and activities.
The methods and basics of defining and maintaining documented information is discussed thoroughly in
chapter 7.5—Documented information.
Visualization of the Process Approach
I prepared a very basic diagram that illustrates all the ideas and requirements that were discussed in this
chapter. You may use it as a concept when developing and planning your processes.
The first diagram (Figure 4.3) illustrates how of the general processes are planned.
The second diagram (Figure 4.4) is a detailed demonstration of the process approach elements and aspects
that must be considered when designing a process. The diagram includes references to all requirements
mentioned in this chapter:
Sequence
Input from supplier
Process 1 Process 2
Process 3
Process 4
Outputs to customer
Figure 4.3 Definition of sequences between processes.
38 ISO 9001:2015—A Complete Guide to Quality Management Systems
Inputs from a supplier to the process
Process 1
Activity 3
Verifications/
validations: the examination of evidence against criteria
Evaluations of planned results
Output
to customer
How much? The measurement and analysis of a process: criteria, methods, key indicators
Necessary actions were carried out, all outputs are accepted, results are desirable and meet specifications, and undesirable results are prevented
Who is responsible to operate and monitor the process
Management review
Supplier’s evaluation
Managem QM
ent of controls—
Customer resources, Doc.
satisfactio trainings, informatio
n and n,
knowledg planning,
e etc.
Measurement, analysis, and improvement of processes
Activity 1: What and how to
execute
Activity 2
Knowledge
The means with which the process will be accomplished
Specifications
Documentation
Resources
Infrastructures
Proc. owner
Figu