品质管理系统要求.doc

Quality management systems – Requirements

1 Scope

1.1 General

This International Standard specifies requirements for a quality management system where an organization

a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.

NOTE In this International Standard, the term “product” applies to the product intended for, or required by, a customer.

1.2 Application

All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Were any requirement(s) of this international Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unlessacceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.

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 9000:2023, 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 items, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:

supplier → organization → customer

The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.

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

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 (see 1.2),

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 of these processes,

e) monitor, measure and analyseanalyze 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 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 (see 4.2.4)

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 the organization and type of activities,

b) the complexity of processes and their interactions, and

c) the competencies 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 (see1.2.),

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

Documents 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 version 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 for 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, retrieval, retention time and disposition of records.

5 Management responsibility

5.1 Management commitment

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by

a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,

b) establishing the quality policy,

c) ensuring that quality objectives are established,

d) conducting management reviews, and

e) ensuring the availability of resources.

5.2 Customer focus

Top management shall ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).

5.3 Quality policy

Top management shall ensure that the quality policy

a) is appropriate to the purpose of the organization,

b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,

c) provides a framework for establishing and reviewing quality objectives,

d) is communicated and understood within the organization, and

e) is reviewed for continuing suitability.

5.4 Planning

5.4.1 Quality objectives

Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

5.4.2 Quality management system planning

Top management shall ensure that

a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and

b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

Top management shall ensure that the responsibilities, authorities are defined and communicated within the organization.

5.5.2 Management representative

Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes

a) ensuring that processes needed for the quality management system are established, implemented and maintained,

b) reporting to top management on the performance of the quality management system and any need for improvement, and

c) ensuring the promotion of awareness of customer requirements throughout the organization.

NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.

5.5.3 Internal communication

Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.

5.6 Management review

5.6.1 General

Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

Records from management review shall be maintained (see 4.2.4).

5.6.2 Review input

The input to management review shall include information on

a) results of audits,

b) customer feedback,

c) process performance and product conformity,

d) status of preventive and corrective actions,

e) follow-up actions from previous management reviews,

f) changes that could affect the quality management system, and

g) recommendations for improvement.

5.6.3 Review output

The output from the management review shall include any decisions and actions relate to

a) improvement of the effectiveness of the quality management system and its processes,

b) improvement of product related to customer requirements, and

c) resource needs.

6 Resource management

6.1 Provision of resources

The organization shall determine and provide the resources needed

a) to implement and maintain the quality management system and continually improve its effectiveness, and

b) to enhance customer satisfaction by meeting customer requirements.

6.2 Human resources

6.2.1 General

Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.

6.2.2 Competence, awareness and training

The organization shall

a) determine the necessary competency for personnel performing work affecting product quality,

b) provide training or take other actions to satisfy these needs,

c) evaluate the effectiveness of the actions taken,

d) 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, and

e) maintain appropriate records of education, training, skills and experience (see 4.2.4).

6.3 Infrastructure

The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable

a) building, workspace and associated utilities;

b) process equipment (both hardware and software), and

c) supporting services (such as transport or communication).

6.4 Work environment

The organization shall determine and manage the the work environment needed to achieve conformity to product requirements.

7 Product realization

7.1 Planning of product realization

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).

In planning product realization, the organization shall determine the following, as appropriate:

a) quality objectives and requirements for the product;

b) the need to establish processes, documents, and provide resources specific to the product;

c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance

d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).

The output of this planning shall be in a form suitable for the organization’s method of operations.

NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.

NOTE 2 The organization may also apply the requirement given in 7.3 to the development of product realization processes.

72 Customer-related processes

7.2.1 Determination of requirements related to the product

The organization shall determine

a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,

b) requirements not stated by the customer but necessary for specified or intended use, where known,

c) statutory and regulatory requirements related to product, and

d) any additional requirements determined by the organization.

7.2.2 Review of requirements related to the product

The organization shall review the requirements related to the product. This review shall be conducted prior to the organization’s commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that

a) product requirements are defined,

b)