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ISO 9001 Process Approach

What is the definition of a process?

A "Process" can be defined as a "Set of interrelated or interacting activities, which transforms inputs into outputs". These activities require allocation of resources such as people and materials.

What is the definition of the ‘process approach’?
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”.

The processes are managed as a system, by creating and understanding a network of the processes and their interactions (see figure 2). The consistent operation of this network is often referred to as the "system approach" to management
.
The performance of an organization can be improved through the use of the process approach.

What are the characteristics of processes?
Processes are the foundation upon which your quality management system (QMS) must be developed. Let’s understand some basics about processes. 

Figure 1 - All work generally involves a process - things go in (inputs); get worked upon (conversion); and come out differently (output). The value-adding conversion activity within a process transforms inputs into outputs, e.g. takes raw materials (the input) and manufactures (the value-adding conversion activity using various resources) a product (the output).
Process inputs and outputs can be tangible (raw materials or finished product) or intangible (information - e.g. computerized drawing or specification).

Figure 2 - All process has a supplier and a customer. These suppliers and customers may be internal processes or external to your organization. Each process must have an accountable owner, i.e., having defined responsibility and authority to operate, control and improve their process.

All processes require the use of resources, e.g. - people, equipment, materials, technology etc. These resources can be used as inputs (raw materials or information such as a customer specification) as well as for the value-adding conversion activity (e.g. use of machinery, equipment, computers, technology, people, etc.) to transform raw material (input) into finished product (output).

The purpose of the process approach is to enhance an organization's effectiveness and efficiency in achieving its defined objectives. Process effectiveness and efficiency can be assessed through internal or external review processes.

All processes must also meet (customer, organizational and applicable regulatory) requirements. The performance of all processes can be monitored and measured. Gather performance data that can be analyzed to determine process effectiveness and whether any corrective action or improvement is needed.

What are the characteristics of the process approach?
A major advantage of the process approach, when compared to other approaches, is in the management and control of the interactions between these processes and the interfaces between the functional structure of the 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. (See types of processes below).

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?

What benefits does the process approach provide?
The process approach:
 
  • Focuses on integrating, aligning and linking processes effectively to achieve planned goals and objectives  
  • Allows the organization to focus on improving process effectiveness and efficiency.  
  • Facilitates consistent performance which in turn provides assurance to customers about the organization’s quality and capability.  
  • Promotes the smooth and transparent flow of operations within the organization.  
  • Contributes to lower costs and shorter cycle times, through the effective use of resources.  
  • Focus on continual improvement of processes results in improved, consistent and predictable results.  
  • Facilitates the involvement and empowerment of people and the clarification of their responsibilities.  

How is the process approach different from a departmental approach?
The process approach is an effective way to organize and manage business activities to create value for the customer and other interested parties.
Organizations are often structured into a hierarchy of functional departments.

These departments are usually managed vertically, with responsibility for the intended outputs being divided among functional units. The end customer or other interested party is not always visible to all involved. Consequently, problems that occur at the interface between departments are often given less priority than the short-term goals of the departments. This leads to little or no improvement to the customer, as actions are usually focused on the departmental functions, rather than overall benefit to the organization.

The process approach introduces horizontal management of activities, by removing the barriers between different departments and focusing their collective effort to the main goals of the organization.
 


How can QMS processes be grouped or categorized?
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 and measurement and monitoring activities. 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 strategic planning, 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.

· 
Quality 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) - These are COP’s or SOP’s that are performed by a function or organization outside the ownership or managerial control of your facility. They may be performed onsite or off-site. These processes include - heat treating; painting; welding, calibration; testing; sort; HR; etc.

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◦  clause 7.1.2 -People
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Understanding ISO 9001:2008