Secretariat of ISO/TC 176/SC 2 Date: 17 May 2001
ISO 9000 Introduction and Support Package:
Guidance on the Process Approach to quality management systems
In conjunction with the publication of the International Standards ISO 9001:2000 and
ISO 9004:2000, ISO/TC 176/SC 2 has published a number ofguidance modules:
– Guidance on ISO 9001:2000 clause 1.2 'Application'
– Guidance on the Documentation requirements of ISO 9001:2000
– Guidance on the Process Approach to quality management systems
– Guidance on the Terminology used in ISO 9001:2000 and ISO 9004:2000 _1)
(1) This module was developed jointly with ISO/TC 176/SC1/WG2. ISO/TC 176/SC1 was responsible for the development ofISO 9000:2000 Quality management systems - Fundamentals and vocabulary)
Together these are being made available as the ISO/TC 176/SC 2 'ISO 9000 Introduction and Support Package.
Feedback from users of the standards will be used to determine whether additional modules should be developed, or if these published modules should be revised.
The modules, and further information on the year 2000ISO 9000 standards, may be downloaded from web site:
for BSI Secretariat
ISO/TC 176/SC 2
This guidance document is intended to help users of the ISO 9000:2000 series of standards to understand the concepts and intent of the “process approach” to quality management systems. It is not limited to the requirements of ISO9001:2000, and is not intended to provide guidance for conformity assessment purposes. It should not be interpreted as a source of additional requirements to those contained in ISO 9001:2000.
The new ISO 9000:2000 standards promote the adoption of a process approach when developing, implementing and improving a quality management system (QMS). The process approach is reflected in the structure ofISO 9004:2000 (“Quality Management Systems – Guidelines for performance improvement”), and also in ISO 9001:2000 (“Quality management systems – Requirements”). The “20 element” structure of ISO 9001:1994 has been replaced by this process-based quality management system, which is shown schematically in Figure 1, below.
Figure 1 – Model of a process-based quality management system (Taken from ISO9000:2000)
This guidance document seeks to explain, in simple language, what is meant by a process, how processes can interact within a system, and how the Plan-Do-Check-Act (PDCA) cycle can be used to manage those processes. Examples of quality management system processes are given, as well as guidance on the implementation of the process approach in relation to ISO 9001:2000 requirements.2) Understanding the Process Approach
One of the eight quality management principles on which the ISO 9000:2000 series of standards is based relates to the “Process Approach” as follows:
Process Approach: a desired result is achieved more efficiently when activities and related resources are managed as a process.
ISO 9000:2000 clause 3.4.1 defines a “Process” as:
“Set of interrelated orinteracting activities which transforms inputs into outputs
NOTE 1 Inputs to a process are generally outputs of other processes.
NOTE 2 Processes in an organization (3.3.1) are generally planned and carried out under controlled conditions to add value.”
Inputs and outputs are generally products that may be tangible and/or intangible. Examples of inputs and outputs may include equipment,materials, components, energy, information and financial resources, among others. To perform activities within the process appropriate resources have to be allocated. A measurement system can be used to gather information and data to analyse process performance and/or input and output characteristics.
Fig 2 – Schematic representation of a Process
ISO 9001:2000 stresses the importance for...