5.5 SHALL Analysis

5.5.1 Definition of SHALL

The definition for SHALL is not located in the ISO 9000:2000 vocabulary, but is offered in the form of terminology guidelines ^[16].

The term SHALL is defined as follows:

SHALL (SHALL NOT): Used to indicate a requirement strictly to be followed in order to conform to the Standard and from which no deviation is permitted. Do not use "may" or "may not" as alternatives.

Thus, both the SHALLS found in the Standard and the normative vocabulary definitions define the mandatory requirements for the Standard and establish the foundation for quality policy.

In a similar manner, the term should (should not) is also defined in the terminology guidelines and is used in guideline documents. It is "[u]sed to indicate that among several possibilities one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action is depreciated but not prohibited. (See ISO Directives Part 3:1997, Annex E.)" ^[17].

5.5.2 Appropriate Response to the SHALLS

Unless we answer the question, Within the QMS documentation system, where do we place the prescriptive responses to the descriptive SHALL requirements? we cannot define the nucleus of an effective documentation structure. As we noted previously, the Standard makes this decision neither obvious nor easy. A logical argument is required.

To reach a logical conclusion, we first need to examine what the Standard tells us about the quality manual. To begin with, there must be a quality manual. In addition, the quality manual must include the scope of the quality management system. Fortunately, the term scope is defined in the terminology guideline and agrees with common usage. For example, one dictionary's primary definition of scope is "1. extent or range of view, outlook, application, operation, effectiveness, etc.: an investigation of wide scope" ^[18]. The terminology guideline defines scope as "The range or extent of action, main purpose, intention." This definition implies that the quality manual is to contain a discussion of the entire structure of the QMS. We are then left with the question, "What is the intent of those who created the Standard with regard to what this discussion should look like and sound like?"

The determination of intent turns out to be the easier part of the argument. If we examine ISO 10013:1995(E), Guidelines for Developing Quality Manuals, Annex C, Example of a Section of a Quality Manual, we find that the committee's intent is to have each descriptive SHALL of the Standard addressed with prescriptive statements in the quality manual. This may not be your conclusion because the issue of the SHALL response remains in the realm of interpretation. However, in practice, many ISO 9000 practitioners support this conclusion inadvertently when they repeat/copy directly (paraphrase) the Standard with minor changes and declare that document to be the manual. Their act of paraphrasing includes every SHALL! This spirit with regard to prescriptive statements has carried over into ISO 9001:2000 with the addition of far more prescriptive statements than in the previous versions ^[19].

Although I abhor this blatant paraphrasing practice, it does indicate that my logic is acceptable as a reasonable resolution to the issue of SHALL response. In other words, if you don't think that we should respond to every SHALL, why do you copy every SHALL into the manual, even when they are not applicable? In short, if we can agree with this supposition, we have the nucleus for an effective QMS documentation structure. All we have to do is turn the duplicated SHALLS into prescriptive statements about what is really going on within the organization.

In this regard, we have found that the most intense areas of interpretive conflict center on the following:

What needs to be expressed as policy (policy scope)?
The level of detail expressed within the policy statements.

We will first discuss the scope of the policy statements.

5.5.3 Scope of Effort

Based on a relatively small sample of 12, it is already common to find ISO 9001:2000 manuals written in a sequenced form that corresponds directly to the Standard's sections and clauses (i.e., a manual with eight main sections and an appendix). All of the paragraph labels that deal with Sections 4 through 8 use the same nomenclature as the Standard so that there is a one-to-one correlation between the Standard's structure and the quality manual's structure:

Cover pages/table of contents/document control;
Section 1—History of the Enterprise;
Section 2—Scope of the QMS Certification;
Section 3—Quality Policy Statement;
Section 4—Quality Management System;
Section 5—Management Responsibility;
Section 6—Resource Management;
Section 7—Product Realization;
Section 8—Measurement, Analysis, and Improvement;
Appendixes.

Our rules require that Sections 4 through 8 should respond in detail to each SHALL within the corresponding element/clauses of each section. We now wish to determine just how many SHALLS there are so that we can estimate the scope of our documentation effort.

5.5.4 Effective Number of SHALLS

To estimate the number of SHALLS it is necessary to expand each SHALL statement in the Standard into all of its explicit and implicit requirements. The manner in which this is accomplished is discussed a little later in the text. As a matter of reference, we see in Table 5.3 that there are 135 explicitly stated SHALLS, and there are actually 364 expanded SHALLS (after the SHALL analysis) that require a response.

Table 5.3: Effective SHALLS per ISO 9001:2000 Section and Elements/Clauses
ISO 9001:2000 Sections	ISO 9001:2000 Elements	The Number of Explicit SHALLS	The Number of SHALLS After Expansion
4.0 QMS	4.1 General Requirements	5	20
	4.2.1 Documentation Requirements—General	1	8
	4.2.2 Quality Manual	1	2
	4.2.3 Control of Documents	3	14
	4.2.4 Control of Records	3	12
Subtotal 4.0		13	56
5.0 Management Responsibility	5.1 Management Commitment	1	5
	5.2 Customer Focus	1	1
	5.3 Quality Policy	1	7
	5.4 Planning—Quality Objectives—QMS Planning	3	5
	5.5 Responsibility, Authority and Communication	414
	5.6 Requirements—Management Review	5	17
Subtotal 5.0		15	49
6.0 Resource Management	6.1 Provision of Resources	1	8
	6.2 HR—Competence, Awareness, and Training	2	5
	6.3 Infrastructure	1	3
	6.4 Work Environment	1	2
Subtotal 6.0		5	18
7.0 Product Realization	7.1 Planning of Product Realization	4	15
	7.2 Customer Related Processes	8	21
	7.3 Design and Development	22	49
	7.4 Purchasing	9	18
	7.5 Production and Service Provision	14	41
	7.6 Control of Monitoring and Measuring Devices	9	17
Subtotal 7.0		66	161
8.0 Measurement, Analysis and Improvement	8.1 General	2	13
	8.2 Monitoring and Measurement	18	25
	8.3 Control of Nonconforming Product	6	9
	8.4 Analysis of Data	3	12
	8.5 Improvement	7	21
Subtotal 8.0		36	80
Totals		135	364

The expansiveness versus the Standard's explicitness is one of the more subtle and difficult parts of manual creation process. One often wonders, Where in the world did the assessor come up with that question? An experienced assessor simply goes through all 364 expanded SHALLS specified in the Standard, one at a time, consciously or unconsciously. As you can see, there really is what seems to be an endless progression of interview questions. By the fourth or fifth surveillance, the depth of questions even surprises the assessor who introduces them.

Of course, the exact number of expanded SHALLS is not the point and the exact number is subject to all-night debates. It is the awareness of the completeness and underlying subtleties of the Standard that is significant. We believe, that the Standard, when fully responded to, establishes a powerful platform for the TQM scenarios discussed in this book.

As indicated in Table 5.3, this expansive nature of the Standard occurs in numerous elements. The use of this table becomes a useful guide when internal audit checklists are created.

For the sake of comparison, we note that the total number of expanded SHALLS for the 1994 version was calculated to be 320. It is interesting to note that a number of the additional 44 SHALLS of the Standard's calculated 364 occurs in design and development. For example, one of the new requirements is that the design output is to include information with regard to the purchase of production material, the actual production process, and the required after-sales activities, thus exemplifying the stress on total process not apparent in the 1994 version. The emphasis on customer satisfaction has also added additional SHALLS as part of the Customer Related Processes clauses. On the other side of the field, there has been a decrease of SHALLS in other areas (e.g., for the Control of Monitoring and Measuring Devices that tends to compensate for some of the newer SHALLS).

It is easy to get side tracked on this subject and miss the point that one is not to take the SHALLS at face value, but to look deeply into their implications and act accordingly. In this regard, we will now examine just how one can account for all of the requirements, explicit and implied.

5.5.5 Method to Count SHALLS

Because of its umbrella-like nature, we will analyze the first sentence of Part 4.1: QMS General Requirements of the Standard to demonstrate how we counted this expansive statement of SHALLS. Notice that there is only one explicit SHALL in the clause. However, also notice that the clause expands into five directives that require a response (not just one, that is). We are to do the following:

Establish a QMS;
Document a QMS;
Implement a QMS;
Maintain a QMS;
Continually improve its effectiveness.

Because of its major importance in QMS structural definition, we will illustrate this technique further through the analysis of Clause 4.2.1: QMS Documentation Requirements—General.

4.2.1 Analysis In this case we have one explicit SHALL. However, when we expand the SHALL we get eight; that is, the QMS documentation is to include the following:

Documented statements of a quality policy;
Documented statements of quality objectives;
A quality manual;
Documented procedures;
Documents needed to ensure the effective planning;
Documents needed to ensure the effective operation;
Documents needed to ensure the effective control;
Records.

6.1 Analysis The analysis can get tricky. For example here is the SHALL analysis for Clause 6.1: Provision of Resources. (There is only one SHALL.) The organization is to do the following:

Determine the resources needed to implement the QMS;
Provide the resources needed to implement the QMS;
Determine the resources needed to maintain the QMS;
Provide the resources needed to maintain the QMS;
Determine the resources needed to continually improve its effectiveness;
Provide the resources needed to continually improve its effectiveness;
Determine the resources needed to enhance customer satisfaction;
Provide the resources needed to enhance customer satisfaction.

In this example, one SHALL yields eight expanded SHALLS.

This straightforward exercise, in practice, permits the reader to grasp for the first time the nuances of the Standard. What at first appears to be a document in which every sentence looks the same and is undifferentiated from any other sentence suddenly takes on the appearance of a good mystery novel as we start to look for the plot. We assume, of course, that you enjoy mystery novels. Better yet, it would really be helpful if you happen to be a Talmudic scholar.

^[16]"ISO Guidance on the Terminology Used in ISO 9001:2000 and ISO 9004:2000," Quality Systems Update, Vol. 11, No. 2, February 2001.

^[17]Refer to "QS-9000 Quality System Requirements," obtainable from AIAG, (810) 358-3003 for a sector specific definition and usage of "shall" and "should."

^[18]Webster's Encyclopedic Unabridged Dictionary of the English Language, New York: Gramercy Books, 1996.

^[19]Par. 5.6 Management Review.