1. Problem of application of PDCA model for management system
1.1 Difference between continual improvement process and management process
1.1.1 Distinguishing between management system and product realization system
ISO9001: 2000 has been structured systematically

About b), provision of resources is an activity to support efficient product realization activities. Therefore it is one of management activities. I wonder why TC176 does not include this activity in (a). No need to separate and make independent from (a). Only the confusion remains.

About c), product realization activities are not management ones and to make product realization process efficiently management activities may necessary. Quality management activities done by its system are complementary to product realization

analyze a system and find wasteful support functions to improve. Product realization processes or core processes are processes with basic function of an organization.
There are often wastes in product realization processes but management must take leadership to improve them with people who are doing core activities like Toyota does.
1.1.3 Lacks of the conceptual distinction among some titles of ISO9001: 2000 clauses
So the titles of ISO9001: 2000 clauses have not careful considerations for the distinction. �g6. Resource management�h is no problem, because it is up to management�fs responsibility. But the title of �g7 Product realization �g is not good. It should be �g7 Supporting activities for production realization processes�h or �g7 Production realization management�h. Likewise, �g 7.3 Design and development�h should be �g 7.3 Supporting activities for design and development�h or �g7.3 Design control�h. Designers do design and development and their activities differ by products and industries. ISO9001: 2000 has not direct involvement with such technical matters.
1.1.4 Relations between PDCA cycle and management steps

Figure1. Relation with PDCA and management process

PDCA cycle has been called Deming cycle in Japan for about fifty years. Deming introduced the device to process analysis and improvement. The device originally developed by Walter Shewhart, Bell Laboratories physicist who was Deming�fs friend and mentor. As Figure 1. shows, PDCA processes include both management processes and core processes (product realization processes). Be careful when you apply PDCA model to management processes.
1.1.5 Relations between management steps and core activities
When you consider management steps, you must have clear understanding of sequential relations between management steps and core activities.
You must be careful that the cycle was developed for improvement, not for a management process, because the cycle includes �gDo�h in the steps. �g Do�h symbolizes activities of a core system. When activities of a core system are performing, its management system does �g controlling�h activities. I have made the simple following chart model using the PDCA model to make clear the difference between management processes and production realization processes (core processes). The following chart simply shows the concept of the both activities.

Figure2 Management steps
1.2 Difference between a process approach and a functional approach

�gWhilst most organizations are still managed by means of functional, hierarchical structures, products and services are produced, sold and delivered by business processes which operate cross-functionally. These processes take inputs from a number of sources, and blend, or transform them (add value) to produce desired outputs. The ISO9000: 2000 standards are restructured on a business process model which more accurately represents the way organizations actually operate than the linear 20-cause structure of the 1994 standard�h.

The concept of process approach has the same meaning with a key word of �gprocesses�h in �gReengineering�h.
I have made the simple chart that shows relations between a process approach and a functional approach.
I name the structure as a lattice one. The new concept for an efficient production developed by Toyota production system can be clearly explained the above model.
Traditionally focus of production efficiency was place on deleting wastes in each function (on the horizontal arrow lines). It leads to large lot size production in production.
But Toyota invented various techniques to delete wastes on processes (on the vertical arrow lines), like zero stocks, cell system. They have made lead-time shorten. It leads to small lot size production. Thus it has made total cost largely decreased and its quality has been enhanced.

Figure3 Relation with process approach and functional approach

1.3 Relations with other management system
Systematic relations among quality management, environmental management, occupational health and safety management, financial management and risk management are necessary.
1.3.1 Definition of Management and Quality management
ISO9000: 2000 has the definition of Management. It has also conceptual diagrams about Management and its family words.
According to the diagrams, Quality management comes under Management. Therefore it seemed to me that Management is the super ordinate to Quality management. Then what are coordinates (sibling) of Quality management? Production management? Cost management? Schedule management? Tool management? It is a very important question to make the definition of Quality management clear from a viewpoint of the total system of an organization. But ISOIS9000: 2000 shows no concern about the matter.
When a manager has to do decision-making about how to do work to satisfy customers needs, he or she generally consider all phases of a work; quality,

1.3.2 Management and its three steps
Three steps of management are planning, control and evaluation (measurement).
These are coordinates of Management from the viewpoint of system thinking.
When we want to make a good working plan, we will think quality, delivery date and cost altogether. And when we want to do effective control of works, we will also think quality, delivery date and cost altogether. The same thing can be said to evaluation.
If we have only think of quality, it sometimes may result in sub-optimization, like heavy documentation that leads to wasteful cost increase to an organization.
Therefore, Quality management is not independent from other management. To achieve customer satisfaction effectively, it should be avoided to think of product quality only.

Figure 4. Classification concept of various management aspects

1.3.3 How to measure management effectiveness
The purpose of Management is to support to achieve the purpose of core activities of business. The purpose of core activities that are essential to do business is to meet customers�f demands (quality and delivery date) with least cost.

Once I visited a factory, where I could see fine monthly quality reports. The quality manager of the factory was proud of the reports. But I could not find data of decrease of defective units in each report so far. So I commented that the reports showed no effective Quality management activities in the factory. The quality manager did manage to make fine reports and did not manage core activities by supporting improvement of their work methods.

1.3.4 Documentation of procedures and cost
Basic documents are necessary to do work correctly. But people who know unnecessary documents never read the documents, because to read them is waste of time and lack of considerations to cost. They see through what are wasteful documents.
To keep good quality, we should design a method of a work to be easily done (that means low cost) and with fast flowing (that means a quick response to customers demands) together. Thus the work makes

ISO9000 has no requirements about production management, such as making a master schedule, doing parts explosion to make work instructions or purchasing orders, setting standard time to calculate workload and leveling of the load, etc. These are main managing factors for core activities that generate customer satisfaction in practice.
I am afraid that handling of Quality management independently from other Management will finally lead interested parties to a bog.

2.Problem of assessment of quality management system (QMS)
2.1 Inherent characteristics of management standards
The flexibility allowed in ISO9001: 2000 makes various alternatives in adopting each specific company. The characteristic has been explained as follows in ISO9000 family.
2.1.1 ISO900-1: 1994 clause 4.3
�g International Standards in ISO9000 family, both guidance and requirements, are written in terms of the quality system objectives to be satisfied. These International Standards do not prescribe how to achieve the objectives but leave that choice to the management of the organization.�h
2.1.2 0.1 clause of Introduction in ISO9001: 2000
�gThe design and implementation of an organization�fs quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management system or uniformity of documentation.�h
2.1.3 In the explanation for 4.4.3 Control of documents of [ISO9001 for Small Businesses: What to do: Advice from ISO/TC176]
�gBy taking advantage of the flexibility allowed in the clause and adopting the simplest and most practical methods, unnecessary bureaucracy and costs can be

Therefore each company should design its own quality management system. In general, even designs are bad or good, if they satisfy the given objectives of ISO9001: 2000, the systems have no problem for their assessments. But for companies, quality of designed systems (especially efficiency) is vitally important. Some companies often have piles of wasteful documents and some others have not.
ISO9000 consultants must first survey clients�f characteristics and create adequate system. The consultants should have creative design skills. But often they only show model procedures.

2.2 Assessment problems caused by the flexibility allowed in Standards
ISO9001: 2000 requires objectives (�gends�h) and a company designs �gmeans�h to satisfy the ends, considering efficiency. Then there are many means among companies, which install ISO9001: 2000. And what an assessor check are means that each company has selected.
Therefore, an assessor should be eligible to understand various alternatives, because companies chose their own adequate systems from various alternatives. But it is often difficult to confront with such an assessor in actual assessment scenes.
I will explain it by the following example.
2.2.1 Essential items required by ISO9001: 2000 to be recorded.
8.2.4 clause in ISO9001: 2000 requires that evidence of conformity with the acceptance criteria shall be maintained and records shall indicate the person(s) authorizing release of product. Thus there are no specific requirements about items to be recorded except person(s) authorizing release of product. Therefore the selection of specific items is up to the choice by each company.
2.2.2 Example alternatives of items to be recorded
Figure 5 shows some of alternatives, each of which covers 8.2.4 clause in the ISO9001: 2000 requirements.

All of three alternatives satisfy the ISO9001: requirement. Where traceability is a requirement, Lot No. is an essential item. For small businesses, generally persons authorizing release of product is also an inspector. Therefore the both items can be integrated. An inspection done processed products and processes were done according to job cards. Therefore, the integration with job cards is the most efficient alternative like C.
2.2.3 An actual problem happened in an assessment scene
Company A had received a preliminary assessment and the assessor pointed out that inspection record should include measured data, because the company took the system of C (refer to Fig. 4). The assessor had in mind a uniform system of B. Therefore he cannot understand other alternatives.

��: Essential items to be recorded �Z: Items recorded
�¢: Transcribed items from prescribed documents
Figure 5. Sample of alternatives

3 How to solve the problems
3.1 Clear establishment of concept of a core system with its complementary management system
Core system has the same meaning with production realization system. Its supporting system is management system.
3.2 Clear establishment of management system and their relation with core processes
Various management systems have each own aspect with core system. And the large classification of management should be three steps: planning, control and evaluation. And the next grouping should be quality, schedule and environment.
3.3 Design skills for ISO9001 system for companies and consultants
The consultants should learn and experience at least Industrial Engineering, Value engineering and Toyota production system (or KAIZEN).
3.4 Effective training of understanding of alternatives for an assessor
The assessors also should learn and experience at least Industrial Engineering, Value engineering and Toyota production system (or KAIZEN).