Chapter 21: QMS Documentation and Implementation Design Rules

21.1 Design Rule Tables

We have now treated each element of QMS design in some detail and are in a position to summarize the set of design rules—that if applied by authors to the QMS creative process—should resolve all of the issues under consideration (see Table 21.1). The table is arranged in terms of the applied design rule and resultant benefits of the approach.

Table 21.1: ISO 9001:2000 QMS Design Rules

QMS Design Rules	Benefits of Approach
Integrate business strategy with quality management—by means of a total business and quality policy format	Forms the basis of a well-informed organization Supports the organization's information technology imperatives Caters to decision making
Cleary define all of the organization's core competencies in terms of processes (e.g., marketing and sales, engineering, manufacturing, quality assurance, finance, and customer service)	Will be the framework for the process-oriented QMS design
Comply exactly with the Standard's requirements Respond positively with a quality policy statement to each SHALL, and adhere to the spirit of the ISO 9001:2000 requirements and guidelines	Ensures compliance with the Standard Enhances the inherent continuous/continual improvement cycle Enhances the possibility of payback
Utilize stewardship management with cross-functional teams Use experts to write sections	Ensures that top management is committed to the complete documentation, implementation, and demonstration of effectiveness of the program Partially satisfies the affective part of QMS design
Analyze all processes of the organization prior to the specific design decision Use flow charting methods if possible—otherwise tables and charts	Greatly enhances the development of the quality manual and provide an outstanding base for the hub documents
Formally declare the specific sequence pattern for the QMS layout (e.g., direct sequence with ISO 9001:2000 elements) and intensively train team members in the approach Select from four possible sequences: direct ISO 9001:2000, Shewhart cycle, operational cycle, and another standard's	Team members will work towards clear linkage to lower level documents Team members will concentrate on operational flow and the continuous/continual improvement cycle
Formally declare the specific manual configuration (e.g., stand-alone), and intensively train team members in the approach Select from either stand-alone or integrated configurations Be consistent with the placement of quality policy statements
Evolve online in the shortest possible time Put level I and II documents online as early as possible Appeal directly to the customer/client's perspective	Leads to significant gains in document control and revision control Lowers distribution and maintenance costs Ensures clarity for all readers Caters to the new customer
Clearly place all quality policy statements in the quality manual Avoid redundant statements in lower level documents State the quality policy statements once	Creates a fully compliant manual that is clear and precise with regard to the organization's rules, methods, and business strategies
Include sufficient detail in the quality policy statements Allow the reader to understand how the organization actually works	Provides all readers, especially decision makers, with worthwhile pertinent organizational information Provides a highly effective document for the new customer
Provide user-friendly navigation tools A four-tier structure Hub documents	Significantly increases the probability of effective implementation by all employees Tends to minimize the number of documents Clarifies linkage
Avoid paraphrasing	Removes the trivialization of the Standard that is anathema to the quest for continuous/continual improvement where completeness and clarity are mandatory
Use effective styles such as the following: Simple declarative sentences in the active voice and present tense Avoid redundancy Clear labels Useful TOC Minimize jargon Stress clarity Define terms Effectively link Avoid "ing" usage Use bullets Don't rely on the spell checker Use graphics	Enhances information flow Increases rate of understanding Increases training retention time Increases rate to find documents
Use the same design rules for sector-specific requirements	The exact same benefits apply
Use as many words and charts as is needed to produce the organizational image that is desired	A little long May be too strong— But it ain't wrong Terse is worst!
Utility—documents should be as follows: Worth reading Contain industry familiar phrases Relatively easy to obtain	Enhanced communication A common training vocabulary Propagates the quality policy directive to all employees
Online considerations: Use user-friendly entrance icons to the QMS documentation structure (e.g., ISO 9000 QMS link) Keep separate directories for each department, core competency, or process document Use the manual cover page as a hub document with hyperlinks to lower tier documents Provide a controlled desk reference chart on how to enter and navigate the QMS documentation structure Make certain that all terminals are provided with the proper software applications and that all terms are compatible with the network Be sure to create a procedure that covers security/password control, backup, and configuration management details for the QMS online system; remember to validate software when appropriate	Employees tend to get confused immediately when asked to find a specific file unless they can quickly enter a master list of documents Lowers user anxiety through familiarity and is a quick entrance to a master documentation list A very easy and effective technique for QMS documentation navigation Removes user anxiety—a simple cheat sheet Especially important when flow charts are used Topics such as electronic signature control are to be included

Summary of Global Mandatory Requirements As a memory jogger and very handy check-off list, the following global documentation has been shown to be mandatory (although there are requirements that are partially discretionary):

• A QMS;

• A quality manual (tier I);

• Documented quality policy (tier I);

• Documented quality objectives (tier I);

• Identification of processes (tier I);

• Sequence and interaction of the processes (tier I);

• Management reviews (tier I);

• Process plans (tier II);

• Monitoring, measuring, analysis, and improvement plans (tier II);

• Six documented procedures (tier II);

• Work instructions as applicable (tier III);

• Other documents needed to ensure the effective planning, operation, and control of its processes (all tiers);

• Records as required (exist at all tier levels)—to indicate objective evidence of effective operation;

• Documents that describe product characteristics (tier III);

• Method of linkage between tiers;

• Declaration of the ISO management representative;

• Description of the organization to be certified;

• Specific description of responsibility and authority of at least the top management;

• Inter and intra organizational interfaces;

• Demonstration of the effective implementation of the system;

• The use of sensible levels of documentation;

• The effective management of customer complaints;

• Declaration of factored items (if applicable);

• Master list of current Standards and codes.