Top management shall ensure that

Its time to decide what your intentions are with the level of quality you desire for the organization and outline a plan as to how you're going to achieve those intentions and it will be helpful to review clauses 4.1 (General requirements) and 4.2 (Documentation) again.

The plan doesn't have to be complex-many organizations choose to create a couple of pages, similar to an executive summary of what and how things happen in the organization related to quality. Issues you should consider include continual improvement, resource needs, the identification of processes and their interactions and change in the organization.

The last element is something new in ISO 9001:2000 (5.4.2.b). Because businesses of all types and sizes are in a constant state of change, TC 176 felt that managing change to maintain the integrity of the system and the organization was an important concept to consider and understand. In other words, if your organization enters into a new line of business, requiring you to hire more people to spur growth, or if the economy plunges into a recession, forcing you to halt production and lay off employees, significant change will occur at every level. But no matter what happens, you still need to meet your customers' requirements. Your customers must not suffer because your organization is experiencing change-if they do, you won't have them as customers very long.

So the new standard simply requires that you consider change during the planning stage. You should have a process that addresses any type of change in the organization, which could include a restructuring of the organization, personnel turnover, new products or services or the downsizing of products or services and any process improvement. Also, any change should be addressed during a management review.

Be sure to understand the terminology in this section when dealing with the "quality plan" and "quality planning." They are related, but the plan is the result of the planning process. Clause 5.4.2 relates to "system" level planning to satisfy the requirements of clause 4.1 (which address the system and its processes). Later, clause 7.1 will cover "product" level planning for the product realization processes.