质量管理表现改善的系统–指南(1).docx

Quality management systems – Guidelines for performance improvements

1 Scope
This International Standard provides guidelines beyond the requirements given in ISO 9001 in order to consider both the effectiveness ad efficiency of a quality management system, and consequently the potential for improvement of the performance of an organization. When compared to ISO 9001, the objectives of customer satisfaction and product quality are extended to include the satisfaction of interested parties ad the performance of the organization.

This International Standard is applicable to the processes of the organization and consequently the quality management principles on which it is based can be deployed throughout the organization. The focus of this International Standard is the achievement of ongoing improvement, measured through the satisfaction of customers and other interested parties.
This International Standard consists of guidance and recommendations and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001.

2 Normative reference
The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.
ISO 9000:2000, Quality management systems – Fundamentals and vocabulary.

3 Terms and definitions
For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.
The following terms, used in this edition of ISO 9004 to describe the supply-chain, have been changed to reflect the vocabulary currently used:

supplier organization customer (interested parties )

Throughout the text of this International Standard, wherever the term “product” occurs, it ca also mean “service”.

4 Quality management system
4.1 Managing systems and processes
Leading and operating an organization successfully requires managing it in a systematic and visible manner. Success should result from implementing and maintaining a management system that is deigned to continually improve the effectiveness and efficiency of the organization’s performance by considering the needs of interested parties. Managing an organization includes quality management, among other management disciplines.
Top management should establish a customer-oriented organization
a) by defining systems and processes that can be clearly understood, managed and improved in effectiveness a well as efficiency, and
b) by ensuring effective and efficient operation and control of processes and the measures and data used determine satisfactory performance of the organization.
Examples of activities to establish a customer-oriented organization include
- defining and promoting processes that lead to improved organizational performance,
- acquiring and using process data and information on a continuing basis,
- directing progress towards continual improvement, and
- using suitable methods to evaluate process improvement, such as self-assessments and management review.
Examples of self-assessment and continual improvement processes are given in annexes A and B respectively.
ISO 9001:2000, Quality management systems – Requirements
4 Quality management system
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

The organization shall
a)identify the processes needed for the quality management system and their application throughout the organization,
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring o these processes,
e) monitor, measure and analyse these processes, and
f) implement actions necessary to achieve planned results and continual improvement of these processes.

These processes shall be managed by the organization in accordance with the requirements of this International Standard.
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.

NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.

4.2 Documentation

Management should define the documentation, including the relevant records, needed to establish, implement and maintain the quality management system and to support and effective and efficient operation of the organization’s processes.
The nature and extent of the documentation should satisfy the contractual, statutory and regulatory requirements, and the needs and expectations of customers and other interested parties and should be appropriate to the organization. Documentation may be in any form or medium suitable for the needs of the organization.
In order to provide documentation to satisfy the needs and expectations of interested parties management should consider
- contractual requirements from the customer and other interested parties,
- acceptance of international, national ,regional and industry sector standards,
- relevant statutory and regulatory requirements,-decisions by the organization,
- decisions by the organization,
- sources of external information relevant for the development of the organization’s competencies, and

- information about the needs and expectations of interested parties.

The generation, use and control of documentation should be evaluated with respect to the effectiveness and efficiency of the organization against criteria such as
- functionality (such as speed of processing),
- user friendliness,
- resources needed,
- policies and objectives
- current and future requirements related to managing knowledge.
- benchmarking of documentation systems, and
- interfaces used by organization’s customers, suppliers and other interested parties.
Access to documentation should be ensured for people in the organization and to other interested parties, based on the organization’s communication policy.

ISO9001:2000, Quality management systems – Requirements

4.2 Documentation requirements

4.2.1 General

The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by this International Standard,
d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and
e) records required by this International Standard.
NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.

NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
a) the size of organization and type of activities,
b) the complexity of processes and their interaction, and
c) the competence of personnel.
NOTE 3 The documentation can be in any form or type of medium.

4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions,
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.
4.2.3 Control of documents
Documental required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained or any purpose.
4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retention time and disposition of records.

4.3 Use of quality management principles
To lead and operate an organization successfully, it is necessary to manage it in a systematic and visible manner. The guidance to management offered in this International Standard is based on eight quality management principles.

These principles have been developed for use by top management in order to lead the organization toward improved performance. These quality management principles are integrated in the contents of this International Standard and are listed below

a) Customer focus
Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

b) Leadership

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.
c) Involvement of people
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
d) Process approach
A desired result is achieved more efficiently when activities and related resources are managed as a process.
e) System approach to management
Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.
f) Continual improvement
Continual improvement of the organization’s overall performance should be a permanent objective of the organization.
g) Factual approach to decision making
Effective decisions are based o the analysis of data and information.
h) Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
Successful use of the eight management principles by an organization will result in benefits to interested parties, such as improved monetary returns, the creation of value and increased stability.

5 Management responsibility
5.1 General guidance

5.1.1 Introduction

Leadership, commitment and the active involvement of the top management are essential for developing and maintaining an effective and efficient quality management system to achieve benefits for interested parties. To achieve these benefits, it is necessary to establish, sustain and increase customer satisfaction. Top management should consider actions such as
- establishing a vision, policies and strategic objectives consistent with the purpose of the organization,
- leading the organization by example, in order to develop trust within its people,
- communicating organizational direction and values regarding quality and the quality management system,
- participating in improvement projects, searching for new methods, solutions and products,
- obtaining feedback directly on the effectiveness and efficiency of the quality management system,
- identifying the product realization processes that provide added value to the organization.
- creating an environment that encourages the involvement and development of people, and
- provision of the structure and resources that are necessary to support the organization’s strategic plans.

Top management should also define methods for measurement of the organization’s performance in order to determine whether planned objectives have been achieved.
Methods include
- financial measurement,
- measurement of process performance throughout the organization,
- external measurement, such as benchmarking and third-party evaluation,
- assessment of the satisfaction of customers, people in the organization and other interested parties,
- assessment of the perceptions o customers and other interested parties of performance of products provided, and
- measurement of other success factors identified by management.
Information derived from such measurements and assessments should also be considered as input to management review in order to ensure that continual improvement of the quality management system is the driver for performance improvement of the organization.
5.1.2 Issues to be considered
When developing, implementing and managing the organization’s quality management system, management should consider the quality management principles outlined in 4.3.
On the basis of these principles, top management should demonstrate leadership in, and commitment to, the following activities:
- understanding current and future customer needs ad expectations, in addition to requirements;
- promoting policies and objectives to increase awareness, motivation and involvement of people in the organization;
- establishing continual improvement as an objective for processes of the organization;
- planning for the future of the organization and managing change;
- setting and communicating a framework for achieving the satisfaction of interested parties.
In addition to small-step or ongoing continual improvement, top management should also consider breakthrough changes to processe