5.11 Pyramid for a Manual


5.11 Pyramid for a Manual

In a similar fashion we can describe the hierarchal content of the manual as illustrated in Figure 5.3.

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Figure 5.3: The four phases of the ISO 9001—2000 Quality Manual (direct sequence with Standard's sections).

We indicate in Figure 5.3 that the manual contains the entire set of organizational quality policies (defined as phase 1). We have chosen to indicate five directly sequenced sections to cover the five operating sections of the Standard (defined as phase 2). This set of definitions is valid for any form of manual sequences or configurations.

Phases 3 and 4 are somewhat more difficult to define because they are parallel processes in that each SHALL of the Standard (phase 4) is responded to with a quality policy statement (phase 3). It is this four-phase process that transforms a descriptive ISO 9001:2000 requirement into a set of prescriptive quality policy statements.

We can clarify the language used in this graphic by a review of previous statements and definitions.

5.11.1 Quality Policy

Policies are by their nature time-independent (i.e., they do not describe movement, but rather define position), whereas processes and procedures are time dependent (i.e., they describe flow, continuity, and movement). A policy is basically a rule of the house set up by top management. They are prescriptive (have specific direction and/or instruction) and indicate method of approach.

5.11.2 Total Quality Policy

The total quality policy consists of our response to all of the Standard's quality policy requirements as described in the quality manual.

5.11.3 Elemental Policies and Specific ISO 9001:2000 Requirements

There are five major sections in the Standard, which contain approximately 364 descriptive requirements in the form of either explicitly stated or implicitly directed SHALLS. In the case chosen, we have assumed that the requirements will be in the manual in five sections on a one-to-one basis with the Standard. More sections can be added as necessary (e.g., to meet regulatory, security, or safety requirements, although such requirements can be readily enclosed within one of the five sections).

All 364 requirements need to be addressed with prescriptive quality policy statements written into the text against their pertinent elements. Regulatory, security, and safety requirements would add more SHALLS to this number but are to be treated in the same prescriptive manner.

5.11.4 Quality Policy Statement Examples

We have maintained that each SHALL must be addressed if the manual is to clearly define the overall structure of the documented system and its effective implementation. We have previously discussed the requirements for documentation that are to be effectively implemented. This set of documents is somewhat complex and distributed throughout the Standard in Sections 4 through 8.

Thus, a quality policy statement is required by the supplier in response to each SHALL. The quality policy statement is intended to be prescriptive and to delineate authority/responsibility.

Some examples of quality policy statement are illustrated in Table 5.6. Appendix B addresses several more areas of the Standard not already addressed in the main text. Notice how specific each statement is and how authority and responsibility is clearly stated. In just these few sentences, it is possible to begin to visualize the Excellent Corporation's management structure and commitment to quality.

Table 5.6: Examples of Quality Policy Statements

Standard Clause

Standard's SHALL(s)

Quality Policy Statement(s)

5.2: Customer Focus

Top management is to ensure that we have determined and met customer requirements to enhance customer satisfaction.

The executive committee of the Excellent Corp. has assigned the vice president of marketing and sales to ensure that customer requirements are fulfilled—as described in the Marketing and Sales Process document—and that customer satisfaction is measured by means of several sales and marketing objectives, metrics, and goals summarized in the document entitled "Annual Business Objectives and Status." More discussion on this subject can be found in Sections 7.2.1 and 8.2.1 of this manual.

5.5.1: Responsibility and Authority (R&A)

Top management is to ensure that responsibility and authority for the various QMS activities are defined and communicated throughout the enterprise.

The executive committee of the Excellent Corp. has defined responsibility and authority by means of:

An organizational chart (Re: Appendix A);

Job descriptions (Re: Job Description Manual);

Assignments summarized in tier I and II documents;

Master R&A lists maintained by department managers.

7.4.1: Purchasing Process [last sentence]

The organization is to keep records of the results of supplier evaluation and any actions that result from such evaluations.

The purchasing manager establishes and maintains the approved critical vendor list (ACVL), which contains all class A subcontractors (i.e., critical suppliers).

Class B and C suppliers are used at the full discretion of the buyers and are recorded separately in the maintenance, repair, and operations (MRO) master list.

Supplier evaluations and surveys are recorded in the vendor history files.

Specific operational actions taken with regard to suppliers are documented on supplier corrective action reports (SCARs) or receiving inspection reports (RIRs).

We conclude that unless each SHALL of the Standard is addressed clearly within the manual—in the form of quality policy statements—there is a high probability that key sections of the three ISO 9000 pillars (i.e., documentation, implementation, and demonstration of effectiveness) will be trivialized and undermine the integrity of the entire Standard.




ISO 9001(c) 2000 Quality Management System Design
ISO 9001: 2000 Quality Management System Design
ISBN: 1580535267
EAN: 2147483647
Year: 2003
Pages: 155

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