ISO 9001 - Understanding ISO 9001 Requirements

0.2 Process Approach - Continued

ÞAn organization’s QMS processes may be grouped or categorized in many ways. One logical way would include the following:

ÞCustomer 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.

ÞSupport 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.

ÞManagement 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.

ÞOutsourced 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 to the your QMS. These could 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; heat treating; painting; welding, calibration; testing; sort; HR; etc., done by an outside organization.

ÞYour 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.

ÞInteractions 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?



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