5.12 Quality Manual Sequences

5.12 Quality Manual Sequences

5.12.1 Four Possible Quality Manual Sequences

The actual structure of the manual depends on the nature of the enterprise and the manner in which we intend to propagate information within the QMS. At least four basic configurations for the manual are compliant with the Standard's requirements (as long as the relationship to each section and clause of the Standard is clearly defined by means of either cross-reference charts or references within the text.):

1. Direct sequence based on the Standard's sequence (i.e., Sections 4.0, 5.0, 6.0, 7.0, and 8.0) is compliant. This is also the cut-and-paste method, in that the ISO 9001:1994 manual is edited into an ISO 9001:2000 format.

2. Shewhart cycle sequence (i.e., plan, do, check, act discussed earlier—the direct sequence approximates this sequence) is compliant.

3. Operational cycle sequence (e.g., marketing and sales, engineering, production control, purchasing, receiving, kitting, assembly, test, shipping, customer service—here again the direct sequence, especially Section 7.0, approximates this sequence) is compliant.

4. Another Standard's sequence (e.g., either FDA/CGMP, or EN 46001, which are presently based on the ISO 9001:1994 Standard), or the direct revision of the present ISO 9001:1994 Quality Manual (i.e., keeping the 20 ISO 9001:1994 sections and adding the additional ISO 9001:2000 requirements) is also compliant.

5.12.2 Direct Sequences

The pertinent clauses (SHALLS) of the Standard are located in five sections numbered consecutively from 4.0: Quality Management System to 8.0: Measurement, Analysis, and Improvement. As it was for the 1994-version quality manuals, it is already very common to find manuals configured in this fashion for the 2000 version (i.e., as sections that correspond directly with the numbering system of the Standard). We find this to be true for quality manuals that have been upgraded from the 1994 version to the 2000 version, and for those who have created their initial quality manual for their first ISO certification. We will now describe the methods required in manual creation for both situations.

Manual labels by configuration are as follows:

• An ISO 9001:2000 manual that uses the Standard's numbering system will be termed manual:2000 (i.e., numbered Sections 4 through 8).

• An ISO 9001:2000 manual that uses the 1994 numbering system will be termed manual:2000(20) (i.e., numbered Sections 1 through 20).

• The present ISO 9001:1994 manual will be termed manual:1994.

Figure 5.4 is a pictorial view of the several configurations that can occur when an available manual:1994 is upgraded into either the manual:2000 or manual:2000(20) configurations. Notice that in both cases there are a number of additional 2000 requirements that must be addressed to bring the 1994 manual in conformance with the Standard. The difference in effort between the two configurations is the cut-and-paste effort required for the manual:2000, which takes approximately one to two days sitting in front of a computer (this means about two weeks for the average overloaded ISO 9000 management representative). Adding the additional requirements afterwards realistically takes a month of effort and is independent of which configuration is chosen. The toughest sections are 4.0 and 5.0 ^[22].

Figure 5.4: Configurations for upgraded 1994 manuals (first view).

The key advantage of the manual:2000 configuration is the ease of auditing the system—because an elaborate cross-reference chart is not required—and the use of the more logical operations format of the Standard. Both ways require modifications to the lower tier documents.

I strongly prefer the manual:2000 configuration for the upgrade effort because it is an easier configuration to audit and it directly reflects the process orientation of the Standard.

5.12.2.1 Ground Floor Manual:2000 Creation

In this situation, the organization creates their first manual:2000 based on the Standard's numbering system. This is the path usually traveled for those who have not yet been certified.

The process required to create the initial manual:2000 is as follows:

1. The manual:2000 is formatted into the five directly sequenced sections of the Standard (i.e., Sections 4.0 through 8.0).

2. Quality policy statements are written against every SHALL of the Standard on a 1:1 correspondence with the Standards, numbering system (e.g., Section 4.0 contains all of the requirements for 4.1: General Requirements, 4.2.1: General Documentation Requirements, 4.2.2: Quality Manual, 4.2.3: Control of Documents, and 4.2.4: Control of Records).

3. In the case of regulatory or statutory Standards (e.g. FDA/CGMP 320 or EN46001), be sure to include all of those requirements within the manual:2000. This can be done by either placing the pertinent paragraphs within the four to eight sections or by creating a new section (e.g., "Section 9—Regulatory Affairs," or "Section 10—Security").

We have discovered that the creation of a first manual:2000 depends heavily on whether the consultant has previously written a manual:1994. If everyone is pure of heart, the manual:2000 tends to look very much like the process charts in the Standard. When the consultant has experience on a manual:1994, the manual:2000 tends to reflect the documentation structure of the 1994 version, and there may be a multitude of leftover 1994 typos. Both approaches work just fine!

However, the experienced consultant who uses 1994 documentation structure has little trouble with the trap set in Par. 4.2.1(d) that requires that the QMS contain documents needed by the organization to ensure the effective planning, operation, and control of its processes. Version 1994 requires a wide variety of procedures (i.e., process descriptions) that cover this requirement almost automatically.

5.12.2.2 1994 Upgrade Manual:2000 Creation

In this situation, the organization creates a manual:2000 based on the Standard's numbering system by first cutting and pasting the present manual:1994 into the manual:2000.

Those who have upgraded their 1994 quality manuals soon discover that all of the 1994 quality manual can be cut and pasted into the new format (e.g., 4.5: Document and Data Control:1994 and 4.16: Control of Quality Records: 1994 paste directly into Section 4.0:2000; 4.17: Internal Quality Audits: 1994 and 4.14: Corrective and Preventive Action:1994 paste directly into Section 8.0:2000).

This is true because all of manual:1994 is either just as meaningful in the process of maximizing QMS effectiveness, or, in some cases, is beyond the 2000 version requirements. Don't throw anything away! We will need to enhance the 1994 version but will not want to waste any of it.

5.12.2.3 Cut-and-Paste Technique

The cut-and-paste technique is a relatively painless way to create a substantial part of manual:2000 from what already exists in manual:1994. It is usually done as follows:

1. Manual:2000 is formatted into the five directly sequenced sections of the Standard (i.e., Sections 4.0 through 8.0).

2. Each clause of manual:1994 is cut and pasted into the manual:2000 template, as appropriate, based on the Standard's Appendix B, which describes in detail the correspondence between ISO 9001:2000 and ISO 9001:1994.

3. Each section of manual:2000 is audited against the Standard to determine where manual:2000 created from manual:1994 does not comply with the Standard (e.g., in Section 4.0, there will be significant additional effort over the 1994 quality policy statements needed to respond to 4.1: General Requirements, 4.2.1: General Documentation Requirements, and 4.2.2: Quality Manual, although 4.2.3: Control of Documents and 4.2.4: Control of Records will be in very close conformity with the Standard, including already documented procedures). See Table 5.7.

   Table 5.7: Required Additional Quality Policy Statements (QPSs) When a Manual:1994 Is Available—Used When Adding Additional ISO 9001:2000 QPSs to a Manual:2000 Formed from Cut-and-Pasted ISO 9001:1994 QPSs or a Manual:1994

   ISO 9001:1994 Element	Associated ISO 9001:2000 Element(s)	Additional or Expanded Quality Policy Statements Required To Bring 1994 Requirements in Conformance with the Standard: Description of the Policy Adopted or Methods Used	Potential Impact on Documents
   4.1.1: Quality Policy	8.2.1: Customer Satisfaction	Monitor information related to customer perception Apply customer perception information as one way to measure QMS performance	Tiers II–IV
   	5.1: Management Commitment	Continually improve QMS effectiveness through the following: Communicating the importance in meeting customer requirements, including statutory and regulatory requirements Establishing the quality policy Ensuring that quality objectives are established Conducting management review(s) Ensuring resource(s) availability	Specifications and reports
   	5.3: Quality Policy	Ensure that the quality policy does the following: Reflects the organization's purpose appropriately Includes a commitment to comply with the QMS' requirements based on the Standard Includes a commitment to continually improve the QMS Provides a framework in which to establish and review quality objectives Is reviewed for continuing suitability	Quality policy statement
   	5.4.1: Quality Objectives	Ensure that the quality objectives are as follows: Established to meet product requirements Established at relevant organizational functions and levels Measurable Consistent with the quality policy	Executive memo
   	5.5.3: Internal communication	Ensure that appropriate communication processes are established Ensure that communication takes place with regard to QMS effectiveness	Tier II
   4.1.2.1: Responsibility and Authority	5.5.1: Responsibility and Authority	Ensure that responsibilities and authorities are communicated within the organization	Executive memo
   4.1.2.2: Resources	6.1: Provision of Resources	Ensure that the resources needed to continually improve QMS effectiveness is determined and provided Ensure that the resources needed to enhance customer satisfaction is determined and provided	Budgets and business plans
   	6.2.1: General	Ensure that personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills, and experience	Tier IV
   4.1.2.3: Management Representative	5.5.2: Management Representative	Ensure that the needed processes are established, implemented, and maintained Report to top management on any need for QMS improvement Ensure the promotion of awareness of customer requirements throughout the organization	Tier II posters
   4.1.3: Management Review	5.6.1: General Management Review	Review the QMS at planned intervals to ensure its adequacy Assess opportunities for improvement Assess the need for QMS changes including changes to the quality policy and quality objectives	Reports
   	5.6.2: Review Input	Include the following management review inputs: Results of audits Customer feedback Process performance and product conformity Corrective and preventive action (CAPA) status Follow-up actions from previous reviews Changes that could affect the QMS Recommendations for improvement	Reports
   	5.6.3: Review Output	Include management review outputs with regard to decisions and actions to do the following: Improve the QMS effectiveness and its processes Improve product against customer requirements Provide needed resources	Reports
   	8.5.1: Continual Improvement	Continually improve QMS effectiveness via use of the following: Quality policy Quality objectives Audit results Analysis of data CAPA Management review	Reports
   4.2.1: General	4.1: General Requirements	Implement the QMS Continually improve its effectiveness Identify the processes needed for the QMS Identify how the processes are applied within the organization Determine the sequence and interaction of the processes Determine criteria and methods needed to ensure process operation and control is effective Ensure the availability of resources and information to support process operation and monitoring Implement actions necessary to achieve planned process results Implement actions necessary to achieve continual process improvement Manage the organization in conformance with the Standard Control outsourced processes	Tier II
   4.2.2: Quality System Procedures	4.2.1: General	Include documented statements of a quality policy Include documented statements of quality objectives Include documents needed to ensure effective planning in the operation and control of the processes	Tiers II–IV
   4.2.3: Quality Planning	5.4.2: QMS Planning	Ensure that quality objectives are planned Ensure that QMS integrity is maintained when QMS changes are planned and implemented	Business plans
   	7.1: Planning of Product Realization	Plan and develop QMS consistent product realization processes Determine product quality objectives and requirements Determine the need for processes Determine the need to verify, validate, and monitor product performance against product acceptance criteria	Business plans and quality/control plans
   4.3.2: Review	5.2: Customer Focus	Determine customer requirements Enhance customer satisfaction Monitor information related to customer perception Apply customer perception information as one way to measure QMS performance	Tier II
   	7.2.1: Determination of Requirements Related to the Product	Determine specified customer requirements related to post-delivery activities Determine nonstated customer requirements but also necessary for the specified and/or intended use Determine statutory and regulatory requirements Determine any additional requirements the organization feels is required	Tier II
   	7.2.2: Review of Requirements Related to the Product	Maintain actions arising from the requirements review Note include internet sales reviews, if pertinent	Tier II
   	7.2.3: Customer Communication	Determine and implement effective arrangements for customer communication with regard to the following: Product information Customer feedback, including customer complaints	Tier II
   4.4.2: Design and Development Planning	7.3.1: Design and Development Planning	Review, verify, and validate each design and development (D&D) stage Determine D&D authorities	Tier II
   4.4.3: Organizational and Technical Interfaces	7.3.1: Design and Development Planning	Ensure effective interface communication Ensure clear assignment responsibility	Tier IV
   4.4.4: Design Input	7.2.1: Determination of Requirements Related to the Product	Determine specified customer requirements related to post-delivery activities Determine nonstated customer requirements but also necessary for the specified and/or intended use Determine any additional requirements the organization feels is required	Tier II
   	7.3.2: Design and Development Inputs	Maintain records Include functional and performance requirements Include, where applicable, information derived from previous similar designs Include other requirements essential for D&D	Tier II
   4.4.5: Design Output	7.3.3: Design and Development Outputs	Provide appropriate information for purchasing, production, and service provision	Tier II
   4.4.6: Design Review	7.3.4: Design and Development Review	Evaluate the ability of the results to fulfill requirements Identify any problems and propose necessary actions	Tiers II and IV
   4.4.7: Design Verification	7.3.5: Design and Development Verification	Maintain a record of necessary actions that result from verification	Tier IV
   4.4.8: Design Validation	7.3.6: Design and Development Validation	Validate product performance prior to delivery or implementation, wherever practicable Maintain records and any necessary actions that result	Tier IV
   4.4.9: Design Changes	7.3.7: Control of Design and Development Changes	To maintain records of D&D changes with necessary actions included Verify and validate D&D changes, as appropriate Evaluate the effect of the changes on constituent parts Evaluate the effect of the changes on product already delivered	Tier II
   4.5.2: Document Data Approval Issue	7.2.3: Control of Documents	To reapprove documents Ensure legibility and ready identification Ensure unintended use of obsolete documents retained for any purpose	Tier II
   4.6.2: Evaluation of Subcontractors	7.4.1: Purchasing Process	Ensure that subcontractors are reevaluated Maintain records of necessary actions that result from subcontractor evaluation	Tiers II and IV
   4.6.4: Verification of Purchased Product	7.4.3: Verification of Purchased Product	Establish and implement inspection or other activities required to ensure that purchased product meets specifications Ensure that when your customer performs source inspection we have stated the verification arrangements and method of product release in the purchasing information	Tier II
   4.7: Control of Customer Supplied Product	7.5.4: Customer Property	Identify, protect, and safeguard customer property Note include intellectual property in this control	Tier II
   4.8: Product Identification and Traceability	7.5.3: Identification and Traceability	Identify product status with respect to monitoring and measurement Control the unique identification of the product Note include configuration management within this control, if appropriate	Tiers III and IV
   4.9: Process Control	6.3: Infrastructure	Determine, provide, and maintain an infrastructure designed to achieve conformity to product requirements, consider the following: Buildings, workspaces, and associated utilities Process equipment (both hardware and software) Supporting services such as transport or communication	Tiers II–IV
   	6.4: Work Environment	Determine and manage the work environment required to achieve conformity to product requirements	Tiers II–IV
   	7.5.1: Control of Production and Service Provision	Include controlled conditions, as applicable, for the following: Information that describes product characteristics Work instructions, as necessary Monitoring and measuring devices Implementation of monitoring and measurement Implementation of release, delivery and postdelivery activities	Tiers II–IV
   	7.5.2: Validation of Processes for Production and Service Provision	Validate the ability of special processes to achieve planned results Revalidate special processes Show approval of equipment	Tiers III and IV
   4.10.2-4.10.5: Inspection and Testing	8.2.4: Monitoring and Measurement of Product	Monitor and measure the characteristics of the product Indicate in the records the person(s) authorizing release of the product Release product and service delivery until planned arrangements are completed or otherwise approved by a relevant authority and, where applicable, by the customer	Tiers III and IV
   4.10.1: General	7.1: Planning of Product Realization	Determine the need to verify, validate, and monitor product performance against product acceptance criteria	Tier II
   4.10.1: General	8.1: General	Plan and implement the monitoring, measurement, analysis and improvement processes needed to continually improve the effectiveness of the QMS	Tier II
   4.10.2: Receiving Identification and Traceability	7.4.3: Verification of Purchased Product	State intended verification arrangements and methods of product release in the purchasing information when the organization or its customer intends to perform source inspection	Tiers III and IV
   4.10.5: Identification and Traceability Records	7.5.3: Identification and Traceability	Identify product status with respect to monitoring and measurement requirements	Tier IV
   4.11.1-4.11.2: Control of Inspection, Measuring, and Test Equipment	7.6: Control of Monitoring and Measuring Devices	Determine the monitoring and measurement to be undertaken Establish processes for this purpose Calibrate or verify at specified intervals or prior to use Adjust or readjust devices as necessary Protect devices from damage and deterioration during maintenance Ensure that when equipment that was used out of calibration is found, the organization takes appropriate action on the equipment and any product affected Ensure that the ability of computer software to satisfy the intended application is confirmed. Confirmation is to occur prior to initial use and reconfirmed as necessary	Tiers II–IV
   4.12: Identification and Traceability Status	7.5.3: Identification and Traceability	Identify product status with respect to monitoring and measurement requirements	Tier IV
   4.13: Control of Nonconforming Product	8.3: Control of Nonconforming Product	Ensure that release or acceptance under concession is by a relevant authority, and, where applicable, by the customer Maintain records of the nature of the nonconformities and any subsequent actions taken, including concessions obtained	Tiers II–IV
   4.14: CAPA	8.5.2: Corrective Action	Ensure that actions are taken to eliminate the cause of nonconformities in order to prevent recurrence	Tier II
   4.14: CAPA	8.5.3: Preventive Action	Ensure that actions are taken to eliminate the causes of potential nonconformities in order to prevent their occurrence Ensure that preventive actions are appropriate to the effects of the potential problems Maintain records of the results of actions taken	Tiers II and IV
   4.15: Handling, Storage, Preservation, Packaging, and Delivery	7.5.5: Preservation of Product	Apply preservation to the constituent parts of a product	Tiers III and IV
   4.15.6: Delivery	7.5.1: Control of Production and Service Provision	Ensure that postdelivery activities are controlled	Tiers II and IV
   4.17: Internal Quality Audits	8.2.2: Internal Audit	Define the audit criteria, scope, frequency, and methods Select auditors and conduct audits such that objectivity and impartiality are ensured in the audit process Ensure that auditors do not audit their own work	Tiers II and IV
   	8.2.3: Monitoring and Measurement of Processes	Ensure that the methods used to monitor and measure the QMS processes have the ability to achieve planned results Ensure that when planned results are not achieved correction and corrective action is taken as appropriate	Tiers II and IV
   4.18: Training	6.2.1: General	Demonstrate that personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills, and experience	Tiers III and IV
   	6.2.2: Competence, Awareness, and Training	Determine the necessary competence for personnel performing work affecting product quality Provide training or take other steps to satisfy training needs Evaluate the effectiveness of the training Ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives	Tiers II and IV
   4.19: Servicing	7.5.1: Control of Production and Service Provision	Ensure the availability of the following: Product characteristic information Work instructions, as necessary Suitable equipment Monitoring and measuring devices	Tiers II–IV
   4.20.1: Identification of Need	8.1: General	Determine the extent to which statistical techniques are to be used	Tier II
   4.20.1: Identification of Need; 4.20.2: Procedures	8.2.3: Monitoring and Measurement of Processes	Apply suitable methods to do the following: For monitoring and, where applicable, measurement of the QMS processes To demonstrate the ability of the processes to achieve planned results	Tiers II and IV
   	8.2.4: Monitoring and Measurement of Product	Monitor and measure (M&M) the characteristics of the product to verify conformance to requirements Carry out M&M of characteristics at appropriate stages of product realization Maintain evidence of conformity with the acceptance criteria	Tiers II and IV
   	8.4: Analysis of Data	Determine, collect, and analyze appropriate data to do the following: Demonstrate the suitability and effectiveness of the QMS Evaluate where continual improvement of QMS effectiveness can be made Include data generated as a result of M&M and from other relevant sources Analyze data to provide information relating to do the following: Customer satisfaction Conformity to product requirements Characteristics and trends of process and products including opportunities for preventive action Suppliers	Tiers II and IV
   Alert: The cut-and-paste transformation of the manual:1994 into manual:2000 does have some difficulties because the 1994 clauses are mixed about within the 2000 sections in some novel ways (e.g., the 4.10: Inspection & Test:1994 clauses are distributed in Section 7: Product Realization:2000 and Section 8: Measurement, Analysis, & Improvement:2000. To make things a bit more complex, pertinent 4.10 clauses appear in the five new Clauses 7.1, 7.4.3, 7.5.3, 8.1, and 8.2.4. However, the Standard has worked diligently to make the cut-and-paste operation as smooth as possible via a cross-reference chart between the clauses (refer to pp. 19–22 of the Standard). In particular, if you follow Table B.1—Correspondence between ISO 9001:1994 and ISO 9001:2000, on pp. 19 and 20 of the Standard, your cut-and-pasting exercise should take less than 2 days of work.

4. In the case of regulatory or statutory Standards (e.g., FDA/CGMP 320 or EN46001) be sure to cut and paste all of those requirements within the manual:2000. If they were already in manual:1994, and you have fully cut and paste every clause, this issue will automatically have been resolved.

5. Fill in the additional quality policy statements that are required above and beyond the 1994 requirements. This process is reciprocal to the fourth technique in which we keep the 1994 version numbering system and add the additional 2000 requirements. See Figure 5.5.

   
   Figure 5.5: Upgrading a 1994 manual to a 2000 version manual.

Table 5.8 is a cut-and-paste at-a-glance chart that provides a simplified overview of the issues (i.e., the clauses that need to be broken up into their appropriate quality policy statements and placed within the Standard's five sections). For example, the five clauses of 4.1: Management Responsibility:1994 end up in nine different clauses and in three different sections in the 2000 version. By contrast, 4.4: Design Control:1994 is found only in Clause 7.3: Design and Development:2000.

Table 5.8: ISO 9001:1994 Cut-and-Paste-at-a-Glance Chart (Use When a 1994 Quality Manual Already Exists and a 2000 Manual Is Formatted)

1994 Clauses	ISO 9001:1994 Titles[1,].			Manual:2000 Sections [2].
		4.0: QMS	5.0: Management Responsibility	6.0: Resource Management	7.0: Product Realization	8.0: Analysis, and Improvements
4.1	Management Responsibility		5.1, 5.3, 5.4.1, 5.5.1, 5.5.2, 5.5.3 (new), 5.6.1	6.1, 6.2.1		8.5.1
4.2	Quality System	4.1, 4.2.1, 4.2.2	5.4.2 (Planning)		7.1 (Planning)
4.3	Contract Review		5.2 (Customer Focus)		7.2.1, 7.2.2, 7.2.3	8.2.1 (new)
4.4	Design Control				7.2.1, 7.3
4.5	Document and Data Control	4.2.3
4.6	Purchasing				7.4.1, 7.4.2, 7.4.3
4.7	Control of Customer Supplied Product				7.5.4
4.8	Product Identification and Traceability				7.5.3
4.9	Process Control			6.3, 6.4	7.5.1, 7.5.2
4.10	Inspection and Testing				7.1, 7.4.3, 7.5.3	8.1, 8.2.4
4.11	Control of Inspection, Measuring, and Test Equipment				7.6
4.12	Inspection and Test Status				7.5.3
4.13	Control of Nonconforming Product					8.3
4.14	Corrective and Preventive Action					8.5.2, 8.5.3
4.15	Handling, Storage, Packaging, Preservation and Delivery				7.5.1, 7.5.5
4.16	Control of Quality Records	4.2.4
4.17	Internal Quality Audits					8.2.2, 8.2.3
4.18	Training			6.2.2
4.19	Servicing				7.5.1
4.20	Statistical Techniques					8.1, 8.2.3, 8.2.4, 8.4
Source: [a]. Alert: Neither 5.5.3 or 8.2.1 is assigned in the Standard's cross references.
[1,].Cut and paste these clauses into the appropriate manual:2000 sections. [2]Paste appropriate1994 clauses into these sections. [a]ANS/ISO/ASQ Q9001-2000 Standard, pp. 19 and 20—refer to those pages for all 1994 clauses.

5.12.2.4 The Fill-In Process

After you have cut and pasted the 1994 clauses into manual:2000, the hard part starts because we must now fill in the quality policy statements that are dictated by the Standard above and beyond the 1994 requirements. Table 5.7 summarized to a high degree of exactitude what must be added to manual:2000 to make it conform in detail with the Standard. Reciprocally, it is also the differences between ISO 9001:1994 and the Standard that must be added to manual:2000(20) to make it conform with the Standard.

Example of Tier I Response Table 5.7 includes a final column that addresses the "Potential Impact on Documentation" caused by the additional 2000 requirements. For example, Clause 8.2.1 of the Standard adds the need to describe a policy with regard to monitoring information as it relates to a customer's perception of the company's service. In this case, the quality policy statement in manual:2000 might sound something like this:

8.2.1 Customer Perception of Excellent: Customer perception of Excellent's performance is monitored and measured rigorously by means of weekly sample interviews with key customers by the national sales manager; monthly reviews by quality assurance with the executive committee on customer complaints and customer commendations; and monthly customer service reports on all aspects of service performance. Metrics are established for each of these activities (refer to Doc. #MS3-08 entitled, "Marketing and& Sales Customer Metrics").

Potential Tier II Impact This response would probably require a modification to, let's suppose, the present tier II document #MS2-001 entitled, "Marketing and Sales Procedures," the creation of the new tier III document #MS3-08, and the creation of a new tier IV form #MS4-009 entitled "Marketing and Sales Metric Performance."

As indicated in Table 5.7, there are about 170 possible quality policy statement enhancements needed to bring the 1994 requirements in conformance with the Standard. As noted, these modifications can ripple through the lower level documents and have the potential to cause multiple revisions throughout the QMS documentation.

For those readers who have been blessed with aggressive auditors—who have constantly pushed the envelope of your quality system to consider all of your core competencies—the amount of revision will be reasonable. For others who are not so fortunate, the amount of revision could be daunting. Allow yourself plenty of time to work on your upgrades.

Many clients are giving themselves a year or so and are timing their upgrades to a surveillance assessment (e.g., carry out the document review three months before the surveillance, the preassessment two months before the surveillance, and the upgrade assessment at the same time as the surveillance audit). Unfortunately, many upgraders are waiting until the last minute to upgrade, which could cause a serious scheduling problem among registrars ^[23].

5.12.2.5 Assessment Implications for Directly Sequenced Manuals

ISO 9001:2000 auditors commonly assume the existence of a directly sequenced manual ^[24]. Furthermore, they generally assume a one-to-one correspondence with each clause in the element. The form of the certification assessment generally takes on the form shown in Table 5.9 ^[25].

Table 5.9: ISO 9001:2000 Certification Assessment for Excellent, Inc.

Time	Activities	Auditors/Location		Initial Auditee(s)
Day One
8:15 A.M.	Arrive on site	Team	Corporate conference room	Core group
8:30	Opening meeting chaired by the lead auditor
9:00	Tour of the plant	Team	Quick walk of facility	Management representative
9:30	Top-management process: 5.1, 5.3, 5.4.1, 5.5.1, 5.5.2, 5.5.3, 5.6.1, 6.1, 6.2.1, 8.5.1	Team	Conference room	Core-group management
11:00	QMS structure: 4.1, 4.2.1, 4.2.2, 5.4.2, 7.1	Lead	Quality-assurance office	Management representative
11:00	Marketing and sales process: 5.2, 7.2.1,2,3, 8.2.1	Auditor 2	Marketing and sales	V.P. of marketing and sales
Noon	Lunch	Team	Fast food	Management representative
1:00	Internal audit process: 8.2.2,&3	Lead	Quality-assurance office	Quality-assurance manager
1:00	Design and development process: 7.2.1(Reg), 7.3	Auditor 2	Engineering area	V.P. of engineering
2:00	Corrective and preventive action process: 8.5.2,3	Lead	Quality-assurance office	Quality-assurance manager
3:00	Analytical process: 8.1, 8.2.3, 8.2.4, 8.4	Lead	Quality-assurance office	Quality-assurance manager
3:00	Purchasing process: 7.4	Auditor 2	Purchasing	Purchasing manager
3:30	Prepare for daily review	Team	Prep office
4:00	Daily review—chaired by lead auditor	Team	Conference room	Core group
4:30	Exit site	Team
Day Two
8:30 A.M.	Review of previous day's findings	Team	Conference room	Core group
9:00	Document control process: 4.2.3	Lead	DC office	DC coordniator
9:00	Production control process: 6.3, 6.4, 7.5.1, 2 plus control of nonconforming product: 8.3	Auditor 2	Manufactuting areas	V.P. of operations
10:00	Training process: 6.2.2	Lead	HR office	HR manager
10:30	Identification and traceability process: 7.5.3	Auditor 2	Manufacuring areas	V.P. of operations
11:00	Control of monitoring and measuring devices process: 7.6	Lead	Metrology	Calibration supervisor
11:00	Monitoring and measuring of product process: 7.1, 7.4.3, 7.5.3, 8.1, 8.2.4	Auditor 2	Manufactuting and quality-assurance areas	V.P. of operations. and quality-assurance manager
11:30	Preservation of product processes: 7.5.1, 7.5.5	Auditor 2	Manufactuting areas	V.P. of operations
12:00	Lunch	Team	Fast food	Management representative
1:00	Control of records process: 4.2.4	Lead	Quality-assurance office	Quality-assurance manager
1:00	Customer property process: 7.5.4 plus service provision process: 7.5.1	Auditor 2	Customer service	Customer-service manager
2:00	Auditors prepare for closing meeting	Team	Prep office
4:00	Closing meeting chaired by lead auditor	Team	Conference room	Core group
4:30	Auditors exit site	Team

Notice the way that certain processes precede other processes in the audit flow:

• Top management process precedes QMS structure as a way to achieve an umbrella perspective of the management style and motivation before an audit of detailed operations;

• Marketing and sales process precedes design and development process because it is the marketing requirements documentation that drives design engineering;

• Customer property process precedes service provision process for customer in the application of that clause to service functions because, for example, returned goods often belong to the customer during the repair process.

Such audit patterns are designed to capture the concomitant relationships of one Standard's element to another. In addition, registrar assessors and other third-party or second-party auditors tend to gravitate towards this type of element alignment because it is an efficient way to do audits against very stringent time constraints.

In a certification audit, the assessor must keep moving along and cover all of the elements within the time frames noted in the far left column. There is very little opportunity to go back and check out an observation later on in the audit. In fact, it is best to tell the auditee(s) exactly when the audit is frozen and not drive them crazy with sudden appearances at the last minute to decide on a nonconformance report. My policy has always been to tell the client, for example, "We will end the audit at 4:00 P.M.!" and make that time within plus or minus one minute. I seldom miss.

Table 5.10 summarizes what I have found to be the most difficult implementation issues for those either upgrading or initializing a QMS based on the Standard. Unfortunately, the changeover to the Standard is moving slowly, and this analysis is based on only 10 ISO 9001:2000 certifications. However, inputs from other assessors point to the same issues. The setting of objectives and implementation of audits are the two most difficult tasks.

Table 5.10: ISO 9001:2000 Most Difficult Critical Issues (in Order of Difficulty)

Element(s)	Title of Clause	Degree of Difficulty
5.4.1 + 7.1(a)	Quality Objectives (ability to define objectives, metrics, and goals)	Most
	Planning of Product Realization (quality objectives for the product)	Most
8.2.2	Internal Audit (coverage of all processes against appropriate SHALLS)	Most
4.1	General Requirements (creation of appropriate process documents)	High
4.2.1(d)	General Documentation Requirements (other documents other than procedures)	High
4.2.3	Control of Documents (methods of control and use of electronic media)	High
8.5.3	Preventive Action (interpretation of what constitutes a preventive action)	High
8.5.2(a) + 8.2.1	Customer Complaints (completeness of coverage and closure/follow up)	High
	Customer Satisfaction (or dissatisfaction)	High
8.5.2	Corrective Action (closure—e.g., follow-up actions)	Moderate
4.2.4	Control of Records (what is a record and how long need they be kept?)	Moderate
5.5.2(c)	Management Representative (ensuring promotion of quality awareness)	Moderate

5.12.2.6 Checklist

If the direct-sequence method is chosen, a convenient checklist can be generated to track manual progress as part of an extensive quality manual desk audit. An example of such a checklist is shown in Table 5.11.

Table 5.11: Excellent's ISO 9001:2000 Quality Manual Status—Direct Sequence Manual

Activities	Percentage Found in Text Actual/Plan	Nonconformances Issued	Comments (End of Week 12)
ISO 9001:2000 Clauses (1994)
Quality manual cover page	95/90		Ready for PA-1
Table of contents	95/90		Ready for PA-1
Section 1.0: History of excellent	95/90		Ready for PA-1
Section 2.0: Scope of the certification	80/90		Firm up wording
Section 3.0: Quality policy statement	80/90		Needs posting
Section 4.0: Quality management system	80/90		Clean up NCRs
4.1 General requirements-QMS (4.2.1)	85	NCR001	Minor: open
4.2.1 General document requirements (4.2.2)	85	NCR002	Minor: open
4.2.2 Quality manual (4.2.1)	80		Need control stamp
4.2.3 Control of documents (4.5)	75	NCR003	Major: open, distribute?
4.2.4 Control of records (4.16)	75	NCR004	Minor: open, master?
Section 5.0: Management Responsibility	90/90
5.1 Management commitment (4.1.1)	90		Ready for PA-1
5.2 Customer focus (4.3.2)	90		Ready for PA-1
5.3 Quality policy (4.1.1)	90		Get posters up
5.4.1 Quality objectives (4.1.1)	85	NCR005	Minor: open, goals
5.4.2 QMS Planning (4.2.3)	85		Rewrite late
5.5.1 Responsibility and authority (4.1.2.1)	90		Ready for PA-1
5.5.2 Management representative (4.1.2.3)	95		Ready for PA-1
5.5.3 Internal communication (new)	85	NCR006	Minor: closed
5.6 Management review (4.1.3)	90	NCR007	Minor: closed, report?
Section 6.0: Resource management	90/90
6.1 Provision of resources (4.1.2.2)	95		Ready for PA-1
6.2 Human resources (4.18, 4.1.2.2)	95	NCR008	Minor: closed, great job
6.3 Infrastructure (4.9)	90		Ready for PA-1
6.4 Work Environment (4.9)	80		Screen room issue
Section 7.0: Product Realization	84/90
7.1 Planning of Product Realization (4.2.3, 4.10.1)	90		Ready for PA-1
7.2.1 Det. of Rqts. related to Product (4.3.2, 4.4.4)	90		Ready for PA-1
7.2.2 Review of Requests related to product (4.3)	85	NCR009	Minor: open, engineering?
7.2.3 Customer communication (4.3)	85		Rewrite late
7.3 Design and development (4.4)	80	NCR010	Minor: open, beta tests
7.4 Purchasing (4.6 w/4.10.2 and 7.4.3)	80	NCR011	Minor: open, PM
7.5.1 Control of production and service provision (4.9, 4.15.6, 4.19)	75	NCR012	Minor: open, D/B due
7.5.2 Val. of processes production and service provision (4.9)	95		Ready for PA-1
7.5.3 Identification and traceability (4.8, 4.10.5, 4.12)	80		Receiving W/I issue
7.5.4 Customer property (4.7)	85		Need better example
7.5.5 Preservation of product (4.15)	75	NCR013	Minor: open, ESD issue
7.6 Control monitoring and measuring devices (4.11)	85		In-house cal. late
Section 8.0: Measurement, analysis and improvement	78/90
8.1General MA&I (4.10.1, 4.20.1,2)	75		Clarity an issue
8.2.1 Customer satisfaction (new)	80		Dissatisfaction?
8.2.2 Internal audit (4.17)	70	NCR014	Major: open, incomplete
8.2.3 Monitoring and measurement of processes (4.17,4.20.1,2)	75		Process definition?
8.2.4 Monitoring and measurement of product (4.10 and 4.20 w/o procedures)	85		In-process issue
8.3 Control of nonconforming product (4.13)	95	NCR015	Minor: open, scrap?
8.4 Analysis of data (4.20.1,2)	80		Where are the charts?
8.5.1 Continual improvement (4.1.3)	80		Same as above
8.5.2 Corrective Action (4.14.1, 4.14.2)	70	NCR016	Major: open, closure
8.5.3 Preventive Action (4.14.1, 4.14.3)	65	NCR017	Major: open, teams?

5.12.2.7 Readiness Concept

As a rule, when a section is rated at 90% or higher, it is ready for the initial systems assessment (i.e., certification assessment sometimes called the "A-1"). That means that, alternately, we are ready to do the preassessment (PA-1) to fine tune the system prior to the certification audit.

Some companies choose to go directly to the certification audit. However, my experience with over 100 certifications in the United States and Canada is that a preassessment is a very good idea ^[26]. All of the open nonconformance reports (NCRs) should be rigorously responded to and considered closed by the organization prior to the PA-1. There must be no majors anywhere in the system at that point, so that it will be possible to truly judge the status of the QMS with all of the documentation in place. This rule also holds after the PA-1 and prior to the certification assessment so that it will be possible to judge the effectiveness of the QMS with all the documentation and implementation in place and operational. Most companies are able to accomplish this task with a good deal of hard work. This means that all of management must be part of this commitment to excellence.

The comments in Table 5.11 indicate what type of specific action item is required to complete the task and whether a specific NCR has been written against the section during an internal quality audit. There were 17 NCRs written against the system with only two closed at the moment. There are four open majors.

5.12.3 Shewhart Sequence

The Shewhart cycle of continuous improvement (i.e., plan-do-check-act) can also be used to configure the manual, especially as the Standard has attempted to follow this pattern to a high degree. Table 5.12 provides some idea on how the five sections of the Standard are distributed across the Shewhart cycle.

Table 5.12: Approximate Shewhart Cycle for ISO 9001:2000

ISO 9001:2000 Sections	ISO 9001:2000 Elements	Plan	Do	Check	Act
4.0: Quality Management System (QMS)	4.1: General Requirements		4.1(a), (b), (c), (d)	4.1(e)	4.1(f)
	4.2.1: Documentation Requirements —General	4.2.1(a)	The rest
	4.2.2: Quality Manual	4.2.2(a)	The rest
	4.2.3: Control of Documents		All
	4.2.4: Control of Records		All
5.0: Management Responsibility	5.1: Management Commitment		All
	5.2: Customer Focus		All
	5.3: Quality Policy	Rest		5.3(e)
	5.4: Planning; Quality Objectives; QMS Planning	5.4.2	5.4.1
	5.5: Responsibility, Authority and Communication		All
	5.6: Requirements—Management Review			All
6.0: Resource Management	6.1: Provision of Resources		All
	6.2: HR—Competence, Awareness, Training		The rest	6.2.2(c)
	6.3: Infrastructure		All
	6.4: Work Environment		All
7.0: Product Realization	7.1: Planning of Product Realization	All
	7.2: Customer Related Processes		All
	7.3: Design and Development	7.3.1	7.3.2,3	7.3.5,6	7.3.4,7
	7.4: Purchasing		All
	7.5: Production and Service Provision	7.5.1	The rest	7.5.2
	7.6: Control of Monitoring and Measuring Devices		The rest	7.6(a)
8.0: Measurement Analysis and Improvement	8.1: General	Split	Split
	8.2: Monitoring and Measurement	Audits	8.2.3,4	8.2.1,2	8.2.3
	8.3: Control of Nonconforming Product		Split	Split	Split
	8.4: Analysis of Data		Split	Split
	8.5: Improvement		8.5.1		8.5.2,3
The rest = the remaining clauses.

As illustrated in Table 5.12, the clauses of the Standard can be organized into explicit plan-do-check-act Shewhart Cycle categories (refer to Chapter 3). A manual structured in this fashion would need a cross-reference chart to indicate exactly how the reader was to locate the specific Standard's clauses for either reference or audit purposes.

This approach is perhaps the most logical sequence to follow but it does have a number of problem areas (e.g., design and development and monitoring and measurement), where a split of the clauses might not be the most efficient way to discuss those processes.

We have yet to observe this method used in either a manual:1994 or manual:2000, but I have incorporated the concept into a combined TQM/ISO program ^[27]. In that approach, the relationship between the Standard's elements and the Shewhart Cycle varies with the TQM concept. Table 5.13 demonstrates this method. The original certification was based on the 1994 version and we have transformed the numbering system to meet the Standard's nomenclature as part of an anticipated upgrade requirement ^[28].

Plan Cycle—Goals/Marketing and Sales/Estimating and Supplemental Control

Section 5.0: Management Responsibility (all clauses)

Section 4.0: Quality Management System (all clauses)

Clause 7.1: Planning of Product Realization

Clauses 7.2.1: Determination of Requirements Related to Product, 7.2.2: Review of Requirements Related to Product, 7.2.3: Customer Communication, 8.2.1: Customer Satisfaction

Clause 7.3: Design and Development

Clause 8.5.1: Continual Improvement

Do Cycle—Purchasing and Project Coordination/Manufacturing

Clause 7.4: Purchasing

Clause 7.5.4: Customer Property

Clause 7.5.3: Identification and Traceability

Clauses 6.1: Provision of Resources, 6.3: Infrastructure, 6.4: Work Environment, 7.5.2: Validation of Processes for Production and Service Provision

Clause 8.2.4: Monitoring and Measurement of Product

Clause 7.6: Control of Monitoring and Measuring Devices

Clause 7.5.5: Preservation of Product

Check Cycle—Job Costing and Cash Flow Control

Clause 8.2.2: Internal Audit

Clause 7.5.1: Control of Production and Service Provision

Clause 8.1: General Measurement, Analysis, and Improvement

Clause 8.2.3: Monitoring and Measurement of Processes

Clause 8.4: Analysis of Data

Act Cycle—Financial Feedback and Cost of Quality

Clause 6.2: Human Resources

Clause 8.3: Control of Nonconforming Product

Clauses 8.5.2: Corrective Action with Customer Complaints, 8.5.3: Preventive Action

For example, in the plan cycle, the TQM model includes goals, marketing, estimating, and supplemental control.

A directly integrated TQM/ISO program is designed to gain the full advantage of both quality management concepts. We will cover this topic no further because there are many books available on TQM ^[29].

5.12.4 Operational Sequence

Another manual layout method is to configure the manual in terms of the actual organization's manufacturing or service processes. We have seen several attempts made at this approach in the 1994 version, but they were eventually rejected due to the correlation difficulty with the Standard's sections. However, as illustrated in Figure 5.6, the Standard's five sections more readily lend themselves to an operational flow ^[30].

Figure 5.6: The ISO 9001—2000 QMS value chain.

We have applied this approach to the 1994 version by means of a tier II, manufacturing process manual. This type of document is essentially a quality plan because it begins with marketing and sales and flows through to after sales servicing. Its use permits the reader to more readily sense the operational flow as the quality policy manual is read. It's application to the 2000 version would be even more appropriate.

The manufacturing process manual is generally created with flow charts and supplementary text. When flow charts are used, the entire manufacturing process can be posted in key areas of the facility and their presence is an impressive display for visitors.

Value Chain As mentioned previously, Figure 5.6 demonstrates this operational flow inherent in the Standard, as indicated by the central flow of activities from marketing and sales to service, install, and repair. This intrinsic operational flow is supported by a set of executive functions (e.g., management responsibility and general measurement, analysis and improvement; and control functions, such as control of documents and control of nonconforming product).

A similar diagram can be constructed for both the supplier (subcontractor) and the customer (interested parties). We can indicate the role of the organization (certified organization—you) when the value chain is extended to include this complete interorganizational flow. This unique functionality is demonstrated in Figure 5.7 (each arrow represents the set of executive functions, operational process, and control functions shown in Figure 5.6).

Figure 5.7: Value chain incorporating complete interorganizational flow.

As indicated above, the organization fulfills the role of customer, supplier, and subsupplier dependent upon where its various transactions occur in the chain. The middle diagram [perspective of the organization (you)] represents the basic terminology used in the Standard (i.e., the certified enterprise is termed the organization, those who provide resources to the organization are termed the supplier, and the customer is termed the customer).

The customer has been broadened to include interested parties that have "an interest in the performance or success of an organization" (refer to ISO 9000:2000, p. 10). Thus, the people in the organization can also be considered customers, similar to the TQM concept (i.e., anyone who receives a product).

A clarification of the terminology is offered in Table 5.14. The terminology equivalents are related to the Standard, its guidelines, and common industry usage.

Table 5.14: Typical Supply-Chain Interface Terminology (* = Standard's Terminology)

*Supplier→	*Organization→	*Customer (interested party)
Subsupplier	Supplier	Customer
Subcontractor	Organization	Customer
Vendor	Contractor	Purchaser
Who supplies you	Certified organization (you)	Who you provide product/sell to
Business first party to you (you perform second-party audits on them)	Business first party to customer and business second party to supplier (you perform first-party audits on yourself)	Business second party to you (they perform second-party audits on you)
Metrology house	Producer	Consumer
Raw materials producer	Distributor	Client
Consultants	Importer	Independent supplier and producer
Contract supplier	Assembler	OEM house
Design house	Service organization	Sister division
Component manufacturer	Software house	Joint venture partner (may be internal or external to organization)
Private label manufacturer	Manufacturer Design house (may be internal or external to organization)	Organization's employees Bankers Unions Society

5.12.5 According to Another Standard's Sequence

Unfortunately, the 1994 version was widely adopted as the baseline for other standards, such as QS-9000 and ISO 13485, and almost all of those standards will not be transformed into the 2000 format until 2003. As a result, the scenario—in which we decide to structure the manual against another standard's format—has already become a serious issue. We will deal with one such restructure because all of the other restructures are similar in form. The standard to be considered is the FDA/CGMP 820 National Standard (QSR) ^[31].

5.12.5.1 Suggested Manual Format

We suggest that the manual be created as follows:

1. Template the manual in the form of the QSR (i.e., subparts and FDA/CGMP 820.NNN nomenclature).

2. Mathematician's rule: Like any good mathematician, first attempt to formulate the problem in terms of an already known solution—in this case, we can do a one-to-one relationship between the QSR and the ISO 9001:1994 version upon which the QSR is based, then relate the QSR to the Standard. Method of integration:

   • Table 5.7 already aligns the Standard's sections against the 1994 version.

   • Table 5.15 is an example of how one might integrate the results of Table 5.7 with the QSR.

     Table 5.15: Relationship Between the QSR, ISO 9001:1994, and ISO 9001:2000 National and International Standards

     QSR Part 820 Sections	QSR 820 Titles	1994 Clauses	ISO 9001:1994 Titles	ISO 9001:2000 Clauses
     820.5 plus 820.20 (d) and 820.20 (e)	Quality System	4.2	Quality System	4.1, 4.2.1, 4.2.2 5.4.2 (planning) 7.1 (planning)
     820.20 minus 820.20 (d) and 820.20 (e)	Management; Responsibility	4.1	Management; Responsibility	5.1, 5.3, 5.4.1, 5.5.1, 5.5.2, 5.5.3(new) 5.6.1 6.1, 6.2.1, 8.5.1
     820.22	Quality Audit	4.17	Internal Quality Audits	8.2.2, 8.2.3
     820.25	Personnel	4.18	Training	6.2.2
     820.30	Design Controls	4.4	Design Control	7.2.1, 7.3
     820.40	Document Controls	4.5	Document and Data Control	4.2.3
     820.50	Purchasing Controls	4.6	Purchasing	7.4.1, 7.4.2, 7.4.3
     820.60 and 820.65	Identification; Traceability	4.8	Product Identification and Traceability	7.5.3
     820.70 and 820.75	Production and Process Controls; Process Validation	4.9	Process Control	6.3, 6.4 7.5.1, 7.5.2
     820.72	Inspection, Measuring, and Test Equipment	4.11	Control of Inspection, Measuring, and Test Equipment	7.6
     820.80	Receiving, In-process, and Finished Device Acceptance	4.10	Inspection and Testing	7.1, 7.4.3, 7.5.3 8.1, 8.2.4
     820.86	Acceptance Status	4.12	Inspection and Test Status	7.5.3
     820.90	Nonconforming Product	4.13	Control of Nonconforming Product	8.3
     820.100	Corrective and Preventive Action	4.14	Corrective and Preventive Action	8.5.2, 8.5.3
     820.120, 820.130, 820.140, 820.150, 820.160, and 820.170	Device Labeling; Device Packaging; Handling; Storage; Distribution; Installation	4.15	Handling, Storage, Packaging, Preservation and Delivery	7.5.1, 7.5.5
     820.180, 820.181, 820.184,	General Requirements: Device Master Record (DMR); Device History Record (DHR)	4.16	Control of Quality Records	4.2.4
     820.186, and	Quality System Record (QSR);	4.16	Control of Quality Records	4.2.4
     820.198	Complaint Files
     820.200	Servicing	4.19	Servicing	7.5.1
     820.250	Statistical Techniques	4.20	Statistical Techniques	8.1, 8.2.3, 8.2.4, 8.4
     Not specifically addressed	Marketing and sales protocols are not addressed.	4.3	Contract Review	5.2 (customer focus) 7.2.1, 7.2.2, 7.2.3 8.2.1 (new)
     Not specifically addressed	Usually processed in essentially the same system as noncustomer owned	4.7	Control of Customer Supplied Product	7.5.4
     Source: [a]]. Alert: Neither 5.5.3 or 8.2.1 are assigned in the Standard's cross-references.
     [a]ANS/ISO/ASQ Q9001-2000 Standard, pp. 19 and 20—refer to those pages for all 1994 clauses and FDA/CGMP 820 National Standard (QSR).

   • Law of diminishing returns: Do not seek perfection—cross reference to the degree that makes sense. Follow the law of stupidity: "If it sounds stupid, it's stupid." Works every time.

3. Complete the manual with prescriptive, quality policy statements for every requirement of the QSR.

4. Evaluate each section of the completed QSR manual against the pertinent Standard requirements summarized in Table 5.15. Add in quality policy statements to the QSR sections wherever the Standard's requirements are not met.

5. Put Table 5.15, or an equivalent, into the manual as a cross-reference chart for reference or audit purposes.

5.12.5.2 Example of the Integrated QSR/Standard Quality Policy Statement

Let us apply Table 5.15 to a section of our manual that has been formatted according to the QSR. We have chosen Section 820.60: Identification as our sample of how the manual would sound with the Standard's requirements integrated into the QSR requirements. To create this paragraph we first responded to the QSR in detail and then include quality policy statements for the Standard's requirements (note the stress on process).

Section 820.60 Identification (refer to the Standard's Par. 7.5.3 with regard to identification)

The Excellent Company identifies product throughout the entire manufacturing cycle to maintain the integrity of its production process. The key method for hardware identification is by means of unique part numbers for each component, subassemblies, and final assemblies. In addition, serialization is provided at specified steps in the production process for all subassemblies and final assemblies. The part numbers and serial numbers are also used as identifiers during both return material and installation activities (refer to Doc. QA-001, entitled "Product Quality Plan").

Software, both embedded and hard-disk installed, is also identified by part number and serial number. Configuration management is the responsibility of the software engineering manager (refer to Doc Eng-002, entitled "Software Design Process").

Part numbers are assigned by engineering document control during creation of the bill of materials in the design and development phase (refer to Doc. Eng-001, entitled "Engineering Design Process").

Serialization of key assemblies is the responsibility of the manufacturing test department. All printed wiring assemblies are also serialized (refer to Doc. Mnf-001, entitled "Manufacturing Process").

5.12.5.3 The Special Case of a Manual:1994 Upgrade

As we discussed earlier, Table 5.8 is to be used when you add additional ISO 9001:2000 quality policy statements to a manual:1994. In other words, we are responding to the Standard's requirements using another Standard's sequence that in this case is the ISO 9001:1994 format.

Table 5.8 indicates the additional or expanded quality policy statements required to bring 1994 requirements in conformance with the Standard. So, for example, to bring Clause 4.20.1: Identification of Need of the 1994 Standard in conformance with the Standard, we would need to describe our policy with regard to the extent that statistical techniques are used in our QMS, and then ripple on down our policy into a tier II document. The result might look like the following in the manual:2000(20).

4.20.1 Statistical Techniques: Statistical techniques are applied throughout the QMS processes. Such methods are described in document #ENG-2-005, entitled "Engineering Standards." The methods of data representation and analysis include the following:

• Risk analysis, FMEA charts, and numerous computerized quantitative methods of analysis are used in engineering design.

• Pareto and run charts are used in the analysis and actions taken with regard to quality objectives and corrective and preventive actions.

• C=0 sampling techniques are used at incoming inspection, and run charts and histograms are used for in-process and final inspection.

5.12.6 Comparison of Sequences

The comparative analysis for the four sequences is diagrammed in Figure 5.8 and characterized in Table 5.16.

Table 5.16: Comparison of Quality Manual Content Attributes

Attributes	Direct Sequence	Shewhart Cycle	Another Standard's Sequence	Operational Cycle
Linkage to Standard's clauses	Excellent	Good	Fair	Fair
Clarity of operational orientation	Excellent	Good	Good	Excellent
Continuous improvement cycle	Excellent	Excellent	Fair	Fair
Coverage of support functions	Excellent	Excellent	Excellent	Fair
Core competency clarity	Excellent	Good	Fair	Fair
Ease of auditing to Standard's clauses	Excellent	Good	Difficult	Fair
Overall	Excellent	Good	Fair	Fair

Figure 5.8: Diagram of quality manual potential sequences.

What we observe to date is that the direct sequence is the most common sequence chosen—although many previously certified suppliers have indicated that they would prefer to stay with the 1994 format discussed in Section 5.12.5.3. However, the Standard's format effectively serves to establish an operational division between structure (Section 4), management imperatives (Sections 5 and 6), the creation of product (Section 7), and the supplemental analytical functions (Section 8). This functionally elegant categorization is lost if one stays with the 1994 format (see earlier discussions of the Shewhart cycles for both the 1994 and 2000 Standards).

The Shewhart cycle is sort of a pocket-rocket approach to the direct sequence that already strongly reflects the plan-do-check-act cycle. It really doesn't offer more clarity and probably should not be considered a worthy candidate.

The operational cycle is strongly reflected in Section 7 of the Standard and, before you have accounted for all of the support and supplemental clauses, your final format will look a great deal like the Standard. So why not use a format that already exists?

Force fitting the Standard into another standard's format is readily doable with a little thought and a lot of effort. However, regardless of the other standard used, you will lose the beauty of the Standard's division of management functions into five clearly defined categories. In the case of previously created 1994 manuals, this may become the most popular approach, but it is retrogressive. In this regard, I have rated the use of the 1994 format as fair with respect to what I consider to be six prime attributes (see Table 5.16).

As for me, the direct sequence is number one on my list. It is somewhat redundant and certainly requires a great deal of interpretation. However, I feel it is the best we have for now and it provides a landscape that is unlimited in regard to core competency expression.

^[22]See Shipley, David, "Destination: ISO 9001," Quality Progress, March 2002, p. 32, for an example of how one company faced this upgrade issue.

^[23]"Top Three British Registrars Forecast Registration Push," Quality Systems Update, Vol. 11, No. 11, November 2001, and "Super Committee Tackles ISO 9000 Issues, Looks for Answers," Quality Systems Update, Vol. 12, No. 5, May 2002, at http://www.qsuonline.com.

^[24]This assumption may eventually change because many suppliers state that they would prefer to stay with the manual:1994 format. It is subject of intense discussion at this writing. My experience to date with 12 manuals indicates that the 2000 format was preferred, so once people start working the problem they may change their preference. Of 12, 3 stayed with 20 clauses.

^[25]For more information on the way a registrar views a client, see, for example, Taylor, C. Michael, "Meet the Registrar: Firsthand Accounts of ISO 9000 Success from the Registration Source," ASQ Publications, 1997, item: H0967, ISBN 0-87389-423-3.

^[26]The 90% rule is not meant to negate the desire for perfection. It does emphasize the reality of life among those who already have a full-time job in addition to their ISO functions. At any time prior to certification, during certification, and after certification, there will always be about 10% to 20% of the system under revision. That is called continuous improvement. Any attempt to beat this fact of life will be met with extreme frustration followed by rebellion. Minor nonconformities due to fine tuning are a constant of the motion in ISO.

^[27]The publication of the ANSI/ISO 14001-1996, Environmental Management Systems—Specification With Guidance for Use document is based upon the Shewhart cycle. ISO 9001:2000 then followed with its reconfiguration to essentially the Shewhart cycle.

^[28]Based on the work of Dr. Anthony F. Costonis, president and founder of Corporate Development Services, Inc., of Lynnfield, MA, http://www.corpdevelopment.com. Although the Shewhart cycle was used to certify a client a number of years before the 2000 version release, the assessors had little trouble with the QMS structure because of a detailed cross-reference chart.

^[29]See, for example, the ASQ Quality Press Publications Catalog, Fall/Winter 2001, pp. 92–95, at http://www.asq.org.

^[30]The concept of a value chain was first introduced by Michael E. Porter in a series of business text books (e.g., Competitive Advantage, New York: The Free Press, 1985). The idea of "chains" finds many outlets (e.g., Troczynski, Tom, "The Quality Chain," Quality Progress, September 1996, p. 208.

^[31]Quality System Regulation, Part VII, Department of Health and Human Services, Food and Drug Administration, 21 CFR, Part 820, Medical Devices; Current Good Manufacturing Practice; Final Rule, Monday, October 7, 1996.