ISO 9001 Training
Understanding ISO 9001:2008
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ISO 9001 TrainingUnderstanding ISO 9001:2008
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0.2 Process approach This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”. An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction. When used within a quality management system, such an approach emphasizes the importance of: a) understanding and meeting requirements, b) the need to consider processes in terms of added value, c) obtaining results of process performance and effectiveness, and d) continual improvement of processes based on objective measurement. The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level. |
Process Approach Continued:
ISO 9001 Training Key Explanation Points and
Tips:
An organization’s QMS processes may be grouped or categorized
in many ways. One
logical way would include the following:
Customer Oriented Processes (COP’s) - These are product realization processes (see clause 7) that determine customer requirements
(inputs), design, make, deliver and service product (outputs) to customers and determine customer satisfaction.
These processes generally have the greatest degree of interaction with external customers. COP’s include -
marketing and sales; design and development; production; shipping; packaging; servicing/ warranty; customer
satisfaction; etc., whether performed onsite or off-site.
Support
Oriented Processes (SOP’s) - These processes provide the
necessary resources to COP’s to facilitate product realization. These processes generally have the greatest degree
of interaction at an operational level with COP’s and to a lesser degree with other internal QMS processes. SOP’s
include - human resources; information technology; purchasing and receiving; laboratory; maintenance; tooling;
facility management; etc, whether performed onsite or off-site. See clause 6 and 7.
Management Oriented Processes (MOP’s) - These processes provide the commitment, leadership, resources, review and decision-making
by top management (see clause 5). These processes generally interact with all QMS processes at the QMS
planning and review level. MOP’s include - business planning; management review; quality planning; resource
planning; communication, etc., whether performed offsite or on-site.
ÞQuality Management Processes (QMP’s) to document, measure, analyze
and improve all processes - These processes provide quality
management support to and interact with all QMS processes. QMP’s include - document control; records control;
monitoring and measurement of processes and product; internal audits; control of nonconforming product; corrective
and preventive action; continual improvement; etc whether performed onsite or off-site. See clause 4 &
8.
Outsourced Processes (OP’s) - an “outsourced
process” is a process that the organization has identified as being needed for its quality management system (QMS),
but one which it has chosen to be carried out by an external party outside the managerial control of your facility
and not subject directly to the controls of your QMS. (more on this under clause 4.1). Outsourced processes
may include MOP’s, COP’s or SOP’s. They may be performed onsite or off-site. These processes may include -
strategic planning done at head office; purchasing or design done at head office or another location for a
subsidiary or satellite facility; heat treating; painting; welding, calibration; testing; sort; HR; etc., done by
an outside (associated or independent) organization.
Your QMS is
made up of a network of
these value-adding processes that link, combine and
interact with one another to collectively provide product or service
(See Figure 2). These processes are inter-dependent and can be defined by complex
interactions. For example, any of the COP processes, could interact with some or all of the MOP’s,
SOP’s;QMP’s. Also note that resources (SOP’s) and QMP’s may also be applied to all other
processes.
Interactions
between QMS processes may occur at any of the three process stages (input, output or conversion activity). The
interaction may occur in many different ways - physical, documentary, verbal, electronic, etc. For each process, we
must identify these interactions; assess the risks of problems that may occur and implement appropriate controls to
prevent them, e.g., if orders are communicated verbally by sales personnel to production, what is the risk that
production errors will occur?