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5.4.2 QMS Planning
Top management must:
a)Ensure QMS planning is carried out in order to meet both, the requirements of clause 4.1 as well as the quality objectives
b)Maintain the integrity of QMS when changes to system are planned and implemented
Key Explanation Points and Tips:
ÞIt is the responsibility of top management to provide direction, authorization and, resources and review for QMS planning.
ÞWhen developing your QMS process controls (for determining customer requirements, design, development, manufacture, delivery and customer support), you must focus on meeting customer and regulatory requirements as well as the planned QMS objectives established in clause 5.4.1.
ÞAs I had mentioned earlier, clause 4.1 is the backbone of ISO 9001 as well as ISO 9001. It provides direction on how to put together the framework of your QMS, i.e. your QMS plan. Your QMS planning requires you to identify all your QMS processes and describe their sequence and interaction. The criteria and methods for planning, operation and control of these processes come from the rest of the ISO requirements as well as your customer and your own organization. So if you have developed your QMS following the steps explained under clause 4.1, you have addressed clause 5.4.2a.
ÞThe continuity and effectiveness of your QMS must be substantially maintained in the event of significant changes in your QMS or organization, e.g. management, ownership, relocation, technology, product, shift in customer base, etc. Changes must be carefully planned so as not to disrupt your organizations ongoing capability and responsibility to effectively meet customer and regulatory requirements
In such instances, change control would require:
Þ careful planning of the nature and timeline for the changes;
Þ determining the impact or outcome of such changes;
Þ ensuring adequate resources are available to implement the change;
Þ top management authorization
Þ change deployment and follow-up
Þ review of the QMS by top management after changes are effected.
ÞQMS planning could be a part of business planning or treated as an independent process depending on organizational structure and responsibilities. The management representative (see clause 5.5.2) typically facilitates QMS planning with the various process owners. The process owners must take responsibility for implementation, maintenance and improvement of their processes. The management representative may provide training and technical assistance as needed. Top management through business planning must provide leadership, resources and review of QMS performance.
ÞPerformance indicators to demonstrate effective QMS planning could include - achievement of quality objectives; improved customer satisfaction ratings; reduced number and seriousness of internal/external audit nonconformities.
