Understand . Plan . Document . Implement . Audit . Review

The ISO 9001 Master Key

The process of establishing a quality management system as per the ISO 9001:2008 standard involves specific activities such as planning, documenting, implementing, auditing and reviewing.   This cycle is repeated throughout the lifespan of the quality management system, through which continual improvements are made, and it is based upon the Deming/Shewhart cycle of:

• Planning

  • Determining the processes needed for the quality management system and their application throughout your organization

  • Determining the sequence and interaction of these processes where you can achieve this by establishing a flowchart of your operations where the process begins and ends with your customers where the focus shall be on the planning and implementation of your product's quality plan

• Do

  • Determine the criteria and methods of operation and control of these processes

  • Ensure the availability of resources to support the operation and control of these processes

• Check

  • Monitor, measure and analyse these processes, where appropriate

  • Ensure the availability of information to support the monitoring, measurement and analysis activities

• Act

  • Implement necessary actions to achieve objectives and continual improvements of these processes.

When this PDCA cycle is applied towards a specific process, you are effectively applying the Process Approach of managing a process.  The output of your QMS planning must be translated into a Quality Manual, and thus it becomes the most important document within your QMS.  It maps out the system and its documentation.  So if you are planning your QMS or a specific process, look at its inputs, outputs and activities by applying the process approach.

Steps in the process approach

1.0  Define the purpose of the organization:

The organization should identify its customers and other interested parties as well as their requirements, needs and expectations in order to define the organization’s intended outputs.  Communicate frequently with customers and other interested parties to ensure continual understanding of their requirements, needs and expectations.

2.0  Define the policies and objectives of the organization

Based on analyses of the requirements, needs and expectations, establish the organization’s policies and objectives, top management should decide which markets the organization should address and develop relevant policies. Based on these policies, management should then establish objectives for the intended outputs.

3.0  Determine the  processes in the organization

3.1  Determine the processes needed for achieving the intended outputs.  These processes are defined by ISO 9001 as being related to:

• Management responsibility,

• Resource management,

• Product realization, and

• Monitoring, measurement and improvement. 

Identify all process inputs and outputs, along with the suppliers and customers, including applicable legal requirements.

3.2  Define the activities within the process

• Define the required inputs and outputs of the process

• Determine the activities required to transform the inputs into the required outputs

• Determine and define the sequence and interaction of the activities within the process

• Determine how each activity will be performed.

4.0  Determine the sequence of the processes

Determine how the processes flow in sequence and interaction.  Define and develop a description of the network of processes and their interaction.  Consider the following:

• The customer of each process,

• The inputs and outputs of each process,

• Which processes are interacting,

• Interfaces and what are their characteristics,

• Timing and sequence of the interacting processes,

• Effectiveness and efficiency of the sequence.

As an example, processes that result in an output (such as product delivered to a customer) will interact with other processes (such as the management, measurement and monitoring, and resource provision processes).

Methods and tools such as block diagrams, matrix and flowcharts can be used to support the development of process sequences and their interactions.

5.0  Define process ownership

Management should define individual roles and responsibilities for ensuring the implementation, maintenance and improvement of each process and its interactions. Such an individual is usually referred to as the "process owner".  To manage process interactions, it may be useful to establish a "process management team", that has an overview across all the processes, and which includes representatives from each of the interacting processes.

6.0  Define process documentation

Determine those processes that are to be documented and how.  The main purpose of documentation is to enable the consistent and stable operation of the processes.  The organization should determine which processes are to be documented, on the basis of: 

• the size of the organization and its type of activities,

• the complexity of its processes and their interactions,

• the criticality of the processes, and

• the availability of competent personnel.

When it is necessary to document processes, a number of different methods can be used such as graphical representations, written instructions, checklists, flow charts, visual media, or electronic methods.

7.0  Define the monitoring and measurement requirements

Determine where and how measuring and monitoring should be applied. This should be both for control and improvement of the processes, as well as for the intended process outputs.

Identify the measures and monitoring criteria for process control and process performance, to determine the effectiveness and efficiency of the process, taking into account factors such as: 

• Conformity with requirements,

• Customer satisfaction,

• Supplier performance,

• On time delivery,

• Lead times,

• Failure rates,

• Waste,

• Process costs,

• Incident frequency.

9.0  Define the resources needed

Determine the resources needed for the effective operation of each process.  Examples of resources include:

• Human resources,

• Infrastructure,

• Work environment,

• Information,

• Natural resources,

• Materials, and

• Financial resources.

10.0  Verify the process against its planned objectives

Confirm that the characteristics of the process are consistent with the purpose of the organization, and verify that all the requirements are satisfied. If not, consider what additional process activities are required to improve the process.

See my ISO 9001 Templates for readymade documentation.

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