ISO 9001 Compliance
A Core Business Solutions article in the ISO Explained series
September 01, 2006
5.4 Management Planning
Setting a direction
by scott dawson
WHAT'S THE POINT?To some, the point of ISO 9001 registration is a certificate. While important to convince customers that certain procedures are in place, a certificate can be a very expensive piece of paper if that is the only benefit realized by the organization. To others, the point of IS0 9001 is measured performance improvement for the organization, and the certificate is merely a confirmation of an effective quality management system (QMS). This results-focused view of ISO 9001 is confirmed by the growing number of companies pursuing "compliance through self-certification" instead of a formal registrar-certification of their QMS.
The framers of new standard also saw performance improvement as the central point of the standard. The expanded top management responsibilities make clear who must lead the charge toward measurable results.
Top management shall ensure that quality objectives are established within the organization. (ref. 5.4.1)
The quality system must be planned and implemented by top management:
in order to meet the quality objectives. (ref. 5.4.2)
"The point of IS0 9001 is measured performance improvement for the organization."
Many ISO 9001 professionals believe the establishment of meaningful, measurable quality objectives toward which the entire QMS is directed is a very important part of the ISO 9001 standard. For it is in the setting and achieving of business-essential objectives that a real return-on-investment (ROI) can be found.
So, as top management sits down to discuss quality objectives, they must define quality for their organization and its customers. Surely the quality of products and services should be included. Certainly measures of customer satisfaction would be on the list of key objectives. But what about other drivers of a quality organization such as:
We could name a dozen additional measures of a quality company, but the determination of "quality objectives" may not be much different from setting "business performance targets" as part of strategic planning. While a (surprisingly) few measures are mandated in the ISO standard, it is left to the organization's management to set objectives most useful to the organization and its customers.
BREAKING DOWN THE STANDARDThe section entitled "Planning" (5.4) starts with a mandate for senior management:
Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. (ref. 5.4.1)
The primary responsibility for the establishment of quality objectives cannot be delegated, though involving the rest of the organization can help ensure the objectives are realistic with a high degree of buy-in. Top management must determine performance targets for the organization as a whole, and then break them down into smaller sub-objectives that can be assigned to divisions, departments, teams or individuals, as appropriate.
As is stated, the objectives must include required product quality goals as specified in section 7.1, Planning of Product Realization:
In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product (ref. 7.1)
The additional objectives set are left to the judgment of management based on the organization's size, market, product mix, complexity, etc. It is typical that the organization limit the number of objectives to those most vital to the organization's success.
DEFINING MEASURABLE OBJECTIVESThe objectives must also be measured:
The quality objectives shall be measurable and consistent with the quality policy. (ref. 5.4.1)
This would eliminate "motherhood-and-apple-pie" statements that are mere slogans espousing a general desire for quality. By stating that objectives must be "measurable", an objective set of data gathered, reported and analyzed should be able to clearly indicate whether or not specific objectives have been reached.
In establishing measurable objectives, many companies define the following for each:
Objective Statement of the performance area to be achieved.
While this format is not specified by the ISO 9001 requirements, an organization might want to consider including many of these elements in their quality objectives planning.
It is also required that all quality objectives are "consistent with the quality policy" (see 5.3). That means there must be logical relationship between the performance targets of the organization and top management's statement of intention that it intends to achieve quality as a result of the company's operation (see the ISO Explained article on "The Quality Policy" available from www.9000world.com for more information on how to establish a quality policy). The consistency between the quality policy and quality objectives must be clear to third-party auditors as well as those more familiar with the company.
GENERAL QMS PLANNINGIn addition to setting quality objectives, management is responsible for planning the overall QMS.
Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and
First, the QMS must be planned (and implemented) to be sure the requirements listed in the "General Requirements" for the QMS (ref. 4.1) are met. These requirements are summarized below:
So, the QMS planning must incorporate all of the requirements found in section 4.1, and compliance with these requirements must be maintained.
Second, the QMS must deliver results. It is expected that top management monitor the company's performance against its stated quality objectives and take necessary actions to be sure these objectives are met. Third-party auditors will certainly be looking to see a strong pattern of meeting stated objectives.
Third, the QMS planning process must respond to significant organizational changes by making necessary adjustments to policies, procedures, quality objectives, etc. Changes that could require QMS modifications might include new product lines, customers with new requirements, marked organizational growth or downsizing, acquisition or divestiture of company facilities, management reorganizations, etc.
THE POINT OF IT ALLThis brief set of management "planning" requirements has huge implications for any organization seeking ISO 9001 compliance or registration. Senior management must "direct the ship" by steering the organization toward clearly stated, consistently measured and carefully analyzed quality objectives. It is through the use of quality objectives that top management can keep the organization focused on what is most important to the company and its customers, ensuring improving results that deliver real, demonstrable quality throughout the company.