1. It must be the top management who’s responsible for the quality planning.
Quality planning shall always be coordinated and led by the top management. I have seen organizations which do the quality planning just by the management representative, who’s often the head of the quality department. In such organizations, the quality planning can seldom be effective. The quality management system must be well integrated into the organization’s business operation to make it effective and become a value adding system to the company. So the person leading the quality planning must fully understand the company’s strategy and the direction that the organization wants head to. This person must have integrated knowledge of the company’s overall performance, so that he/she can have a good perspective for what is expected to be achieved from the quality planning. So this role can hardly be replaced by anyone else.
2. Following things shall be done in quality planning according to ISO9001:2015
- Understand the internal and external issues of the organization;
- Understand the needs and expectations of the interested parties;
- Establish the quality scope;
- Identify the processes in the quality management system, establish the requirements and control of each process, and define the roles and responsibilities of each position in the processes;
- Establish the quality policy;
- Identify the risks and opportunities in the quality management system and propose actions to address these risks and opportunities;
- Establish the quality objectives (the objectives for the whole organization, for each department, for each quality process, for the effectiveness evaluation of actions taken to address the risks and opportunities, etc.);
- Propose the actions to ensure the achievement of the above objectives and allocate the necessary resources to support the effective implementation of these actions.
Understanding of the internal and external issues of the organization, understanding of the needs and expectations of the interested parties, and risk & opportunities identifications can be done together, as explained in another article. Identification of processes is discussed here. Requirements and controls which shall be established for each process can also be found in my other blog.
It must be emphasized here again that quality management system shall be integrated with the overall business operation of the company. So when doing the above planning, it shall not be a stand-alone event. It must serve for the achievement of the organization’s business targets. For example, when setting up quality objectives, the top management shall consider how the achievement of these quality objectives can help the achievement of the organization’s business targets. Otherwise, the quality objectives are meaningless.
3. Quality planning is not once a year event
Quality planning shall not just be done once a year. An organization usually has multiple ways to review the effectiveness of its quality management system, such as management review, internal audit, customer satisfaction study, etc. Whenever such review is done, planning shall be done again, to see whether all the things done previously are effective, suitable and adequate, and to see whether objectives shall be adjusted and new actions shall be proposed.
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