ISO 9001: 2000 Quality Management System Design
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3.3 Mandatory Documentation Requirements
The creation of a QMS—based on the Standard—requires a fully compliant documentation system (i.e., a QMS in which each SHALL of the Standard is clearly documented).
The desire to integrate business and quality objectives, so that they are transparent, is a repetitive theme throughout the Standard and its associated guidelines (see Figure 3.4) [11].
In the ISO 9000:2000 schema, the documents are intended for the following:
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ISO 9004:2000, entitled "Quality Management Systems—Guidelines for Performance Improvements" is to be used to design the QMS.
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ISO 9001:2000 (Standard), highlighted in the center, is to be used for all contractual agreements.
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ISO 9000:2000, entitled "Quality Management Systems—Fundamentals and Vocabulary" is to be used as part guideline and part standard because the terms and definitions given in the document apply to the Standard. This important point is often overlooked by practitioners.
3.3.1 Accreditation Impact on Guidelines
Contrary to common belief, guideline documents are sometimes specified by the Accreditation Boards—via the Registrars—as strict requirements for certification, either as a constraint on the Registrar or on the organization. Two typical examples are as follows:
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ISO 19011: in process—guidelines on quality and/or environmental management systems auditing;
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EN 45012: September 95—general criteria for certification bodies operating quality system certification (e.g., Clause 18 requires the supplier to keep a record of all customer complaints and corrective actions taken in regard to such complaints). The European Normal (EN) series consists of many supplementary ISO documents.
The ISO 9000 family of documents focuses its guidance and requirements on satisfying the customer, and this motif is exemplified in the guidelines by stipulating that the organization's leadership should actually create a customer-oriented organization [12]. Thus, we have a clear indication of the concept of a unified business/quality imperative as a prime directive of the Standard's intent.
It is not by accident that the Standard stresses the unification of quality and strategic business objectives. The development of the eight quality management principles is a result of a concerted effort by the United States ISO TC 176 technical committee to create a unified set of principles based on research using quality-related documents from all over the world. The Standards analyzed include the Baldrige award.
Scott Madison Paton notes that, "From 1990 to 1999, the publicly traded recipients [of the Baldrige Award], as a group, outperformed the Standard & Poor's 500 by 4.2 to 1, achieving a 685.26% return compared to a 163.11% return for the S&P 500" [13]. Paton's analysis is another indication of the bottom-line focus of ISO 9000 [14].
The similarity to the Baldrige National Quality Program 2002 is striking, and this fact has been noted by several authors [15]. An interpretation is offered in Table 3.3 in which we compare the Baldrige sections with both the eight quality management principles and the pertinent sections of the Standard. As you can see, the correlation in theme and intent is obvious.
| Baldrige Section | ISO: Eight Quality Management Principles | ISO: Standard's Requirements by Section |
|---|---|---|
| 1.0 Leadership | b) Leadership f) Continual Improvement | 5.0 Management Responsibility |
| 2.0 Strategic Planning | e) System Approach to Management | 5.0 Management Responsibility 6.0 Resource Management |
| 3.0 Customer and Market Focus | a) Customer Focus | 5.0 Management Responsibility 7.0 Product Realization 8.0 Measurement, Analysis and Improvement |
| 4.0 Information and Analysis | g) Factual Approach to Decision Making e) System Approach to Management | 5.0 Management Responsibility 7.0 Product Realization 8.0 Measurement, Analysis and Improvement |
| 5.0 Human-Resources Focus | c) Involvement of People | 6.0 Resource Management |
| 6.0 Process Management | d) Process Approach h) Mutually Beneficial Supplier Relationships | 4.0 Quality Management System 7.0 Product Realization 8.0 Measurement, Analysis and Improvement |
| 7.0 Business Results | g) Factual Approach to Decision Making | 5.0 Management Responsibility 8.0 Measurement, Analysis and Improvement |
| Source: [a]. | Source: [b] | Source: [c]. |
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[a]Baldrige National Quality Program 2002, "Criteria for Performance Excellence," NIST, Technology Administration, Department of Commerce, Gaithersburg, MD, at http://www.qualilty.nist.gov.
[b]American National Standard, Quality Management Systems—Fundamentals and Vocabulary, ISO 9000:2000, American Society for Quality, Milwaukee, WI, December 13, 2000, p. ix, at http://qualitypress.asq.org
[c]American National Standard, Quality Management Systems—Requirements, ISO 9001:2000, December 13, 2000. | ||
To fully appreciate the Standard's umbrella-documentation complexity, it is necessary to summarize all of the mandates so that a proper analysis can be achieved. The requirements are summarized in Table 3.4. The 1994 clauses are indicated in italics. I have found such cross-references to ISO 9001:1994 most useful in upgrading 1994 quality manuals to the 2000 version. (For an illustration of the concept of tiers, see Figure 4.1.)
| Tier Level | 2000 Standard's Clause | Standard's Requirements Related to Documentation | X-ref to 1994 Standard |
|---|---|---|---|
| I | 4.2.1 b) | A quality manual that contains a scope and justified exclusions. | 4.2.2 |
| 4.2.1 a); 5.3 5.4.1 | Documented statements of a quality policy and quality objectives … (separate or in the quality manual) | 4.1.1 4.2.2 | |
| 4.1 a) | Identification of the processes needed by the QMS and their application throughout the organization …(separate or in the quality manual) | 4.2.1 | |
| 4.1 b) | Determination of the sequence and interaction of such processes … (separate or in the quality manual) | ||
| 4.2.2 | A description of the interaction between the processes of the QMS … (included in the quality manual). | ||
| 5.6.1 | A top-management review of the organization's QMS at planned intervals … (tier I record) | 4.1.3 | |
| II | 7.1 | The manner in which the organization plans the processes needed for product realization (quality or control plan) | 4.2.3 4.10.1 |
| 8.1 | The manner in which the organization plans the monitoring, measurement, analysis, and improvement processes needed (quality or control plan) | 4.10.1 4.20 | |
| 4.1 | Identify the control of outsourced processes | 4.6.1 | |
| 4.2.1 c) | Documented procedures required by the Standard (contained in either the quality manual or references to them) | 4.2.2 | |
| 4.2.3 |
| 4.5 | |
| 4.2.4 |
| 4.16 | |
| 8.2.2 |
| 4.17 | |
| 8.3 |
| 4.13 | |
| 8.5.2 |
| 4.14.1 4.14.2 | |
| 8.5.3 |
| 4.14.1 4.14.3 | |
| III | 7.5.1 b) | Controlled work instructions, where applicable and necessary | 4.9, 4.19 4.15.6 |
| All | 4.1 | A documented QMS | 4.2.1 |
| 4.2.1 d) | Additional documents needed by the organization to ensure the effective planning, operation, and control of its processes (This is the "sleeper" requirement that drives the creation of a multitude of documents!) | 4.2.2 | |
| 4.2.1 e) | Records required by the standard | 4.2.2 4.16 | |
| II and IV | 7.5.1 a) | Controlled information that describes the characteristics of product, where applicable | 4.9 4.19, 4.15.6 |
| 8.2.2 | Planned intervals for the Internal audits | 4.17 |
Although there are a large number of different types of documents required by the Standard, our design approach offers a highly disciplined and logical approach to QMS documentation structure. For this purpose, a clearly defined and consistent taxonomy is required that is based upon long-established guidelines on how to propagate technical information effectively. All of the required documentation is readily incorporated into this versatile documentation structure. Accordingly, the taxonomy used in this book is defined in Table 3.5. The application of this structure is described in Part 2 [16].
| Document Tier | Book's Terminology | Typical Content | Typical Record(s) |
|---|---|---|---|
| I | Quality manual (same definition as Standard) | Policies (i.e., response to SHALLS), process summaries and interactions, justification for exclusions, quality policy statement | Management reviews, management representative memo |
| II | Process documents (same definition as Standard) | Processes, standard operating procedures (SOPs), process flow charts, quality plans, control plans | Master document lists, device master record, device history record, design history files, technical files |
| III | Procedures (same definition as Standard) | Work instructions, work directions, test plans, calibration and maintenance plans | Quotes, sales orders, travelers and routers, inspection and test data, certificates of conformance and analysis |
| IV | Forms [see 4.2.1d) of Standard] | Templates and formats onto which drawings, blueprints, labels, test plans, and data are placed | CAD drawings, corrective and preventive action reports, job descriptions |
It is important to note that records are filled-in and filed forms that can occur at any documentation level. They constitute a separate document category, and a separate set of control rules are required (refer to Par. 4.2.1(e) of the Standard). Several typical records are indicated to clarify this issue. The subject of records is covered more fully in Section 8.1.
3.3.2 QMS Design Methods To Be Presented
To accomplish this goal (i.e., to produce a fully responsive QMS in compliance with the Standard—that also integrates the organization's strategic and quality objectives—this book describes a series of ISO 9001:2000 QMS design rules that prescribe methods to enhance clarity, user friendliness, and compliance). Such methods include the following:
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The integration of business strategy with quality management;
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The use of the inherent continuous/continual improvement cycle;
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The need for stewardship;
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The development of effective QMS documentation structures;
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The avoidance of paraphrasing;
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The use of different documentation media;
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The development of prescriptive quality policy statements;
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The SHALL analysis method;
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The quality manual sequence methods;
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The possible quality manual configurations;
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The sector-specific requirements prescribed by ISO 9000 accreditation boards.
The reader, armed with this set of design rules, should be able to create an ISO 9001:2000 QMS that represents the true nature of the organization and supports its competitive advantage. In that regard, the first set of design rules is presented in Part 2.
[11]The ISO 9000 Family: http://www.iso.ch/iso/en/iso9000-14000/iso9000/selection_use/iso9000family.html.
[12]Section 1.4 of ISO 9004:2000.
[13]Paton, Scott Madison, "Will the Baldrige Endure?" Quality Digest, May 2001, p. 4, at http://www.qualitydigest.com.
[14]See, for example, Hsu, Sangem "ISO 9004 Finally Measures up to Excellence," Quality Systems Update, February 2001, p. 15, and West, Jack, "ISO 9000:2000—Direction, Changes, and Opportunities," European Quality Institute, 2000, Section 8, http://www.iso9000directory.com.
[15]See, for example, Marash, Stanley A., "Fusion Management, Part One, Comparing Business Process Models," Quality Digest, June 2001, p. 22, The Memory Jogger 9000/2000, GOAL QPC, p. 157, at http://www.goalqpc.com, and Tonk, Hampton Scott, "Integrating ISO 9001:2000 and the Baldrige Criteria," Quality Progress, August 2000, p. 51.
[16]Our documentation taxonomy is based on the work of Robert E. Horn, founder of Information Mapping, Inc., Waltham, MA, at http://www. infomap.com. See, for example, "Mapping Hypertext," Lexington Institute, 1989.
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