Some standard content:
ICS03.120.10
National Standard of the People's Republic of China
GB/T19015—2008/IS010005:2005 replaces GB/T19015—1996
Quality management systems
Guidelines for quality plans
Quality management systemsGuidelines for quality plans (ISO10005:2005IDT)
Issued on October 29, 2008
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaStandardization Administration of the People's Republic of China
Implementation on May 1, 2009
GB/T19015—2008/ISO10005:2005Foreword
Normative references
3 Terms and definitions Definition
Development of a quality plan
Identification of the need for a quality plan
Inputs to the quality plan
Scope of the quality plan
Preparation of a quality plan
Contents of the quality plan
Inputs to the quality plan
Quality objectives
Management responsibilities
Control of documents and information
Record control
Customer communication
Design and development||tt ||Purchasing·
Production and Service Provision
Identification and Traceability
Customer Property
Product Protection.
Control of Nonconforming Product
Monitoring and Measurement
Review, Acceptance, Implementation and Revision of the Quality Plan6.1
Review and Acceptance of the Quality Plan
Implementation of the Quality Plan
6.3 Revision of the Quality Plan
6.4 Feedback and Improvement·||t t||Appendix A (Informative Appendix)
Appendix B (Informative Appendix)
References
Example of Quality Plan Format
Comparison between GB/T19015-2008 and GB/T19001-200010
GB/T19015-2008/1S010005.2005 This standard is equivalent to 1SO10005:2005 "Guide to Quality Plan of Quality Management System". This standard is a component of the GB/T19000 family of standards: and is consistent with it. This standard replaces GB/T19015-1996 "Guide to Quality Plan of Quality Management System". The main changes of this standard compared with GB/T19015-1996 are as follows: The structure has changed, aiming to maintain consistency with the 2000 version of the GB/T19000 family of standards. a)
b) Many new contents have been added, mainly: 1) The original 4.1 content has been expanded into a chapter to describe the process of quality plan formulation in detail; 2) The content of Chapter 5 is listed according to the terms of GB/T19001-2000; 3) The quality plan example in the appendix has been adjusted. The title has also been modified accordingly to reflect the changes in the GB/T19000 family of standards and better express the intention of this standard. c)
Appendix A and Appendix B of this standard are both informative appendices. This standard was proposed and managed by the National Technical Committee for Standardization of Quality Management and Quality Assurance (SAC/TC151). The drafting units of this standard are: China National Institute of Standardization, China Quality Association, Nuclear Industry Standardization Institute, Dongfeng Motor Corporation, and China United Certification Center.
The main drafters of this standard are: Li Jing, Wang Xiaosheng, Xu Wenzheng, Zhu Xiaoli, and Zhou Yuqing. This standard was first issued in 1996, and this is the first revision. GB/T19015—2008/IS010005:2005 Introduction
This standard is developed to provide guidance on how to use quality plans in the establishment of a quality management system or a separate management activity. In addition, the quality plan provides a working method and procedure that supports product realization in relation to the specified requirements of the process, product, project or contract. The quality plan should be coordinated with other related plans. The benefits of developing a quality plan are to increase confidence in meeting requirements, to ensure that the process is under control, to guide the initiative of relevant personnel, and to provide opportunities for understanding and grasping improvements. This standard does not replace the guidance given in GB/T19004 or other industry specifications. When quality plans need to be applied in a project, this standard supplements the guidance provided in GB/T19016. According to the process model shown in Figure 1, quality management system planning applies to the entire model. The quality plan is mainly applicable starting from customer requirements, through product realization and products, until customer satisfaction. Continuous improvement of the quality management system
Management responsibilities
Illustration:
Value-added activities
Information flow
Resource management
Measurement,
and improvement
Realization
Figure 1 Output of the process-based quality management system model
1 Scope
GB/T19015-—2008/IS010005:2005 Guide to quality plans
Quality management system
This standard provides guidance on the development, review, acceptance, implementation and revision of quality plans. This standard applies to organizations that have or have not established a quality management system that meets the requirements of GB/T19001. This standard applies to quality plans for processes, products, projects or contracts in any industry and any product category (hardware, software, process materials and services).
This standard mainly provides guidance on quality plans for product realization, rather than on the planning of the organization's quality management system. This standard is a guidance document and is not intended for certification purposes. Note: To avoid excessive repetition of the words "process, product, project or contract", this standard uses the term "specific circumstances" (see 3.10). 2 Normative references
The clauses in the following documents become clauses of this standard through reference in this standard. For dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this standard, however, parties to agreements based on this standard are encouraged to investigate whether the latest versions of these documents can be used. For undated references, the latest versions apply to this standard. GB/T19000—2008 Quality Management System Fundamentals and Vocabulary 3 Terms and Definitions
The terms and definitions established in GB/T19000--2008 and the following terms and definitions apply to this standard. Some of the following definitions are directly quoted from GB/T19000-2008, but in some cases the "Note" is omitted or supplemented. 3.1
Objective evidenceobjectiveevidence
Data supporting the existence or authenticity of something [GB/T19000--2008, definition 3.8.1]
procedureprocedure
The prescribed way to carry out an activity or process (3.3) Note 1: A procedure may or may not be documented Note 2: When a procedure is documented, it is usually called a "written procedure" or "documented procedure". The document containing the procedure may be called a "procedure document". [GB/T19000-2008, definition 3, 4.5]
processprocess
A set of interrelated or interacting activities that transform inputs into outputs Note: Rewritten from the definition in 3.4.1 of GB/T19000-2008 (note not included) 3.4
product
result of the process (3.3)
Note 1: There are four general product categories: services (e.g. transport);
software (e.g. computer programs, dictionaries); GB/T19015—2008/ISO10005.2005Hardware (e.g. mechanical parts for an engine);
Process materials (e.g. lubricants).
Many products are made up of components belonging to different product categories, and their attributes as services, software, hardware or process materials depend on the dominant component of the product. For example: the product "car" is made up of hardware (e.g. tires), process materials (e.g. fuel, coolant), software (e.g. engine control software, driver's manual) and services (e.g. operating instructions given by a salesperson). Note 2 to entry: Services are intangible and are the result of at least one activity being performed at the interface between the supplier and the customer. The provision of services may involve, for example: activities performed on a tangible product provided by the customer (e.g. a car in need of repair); activities performed on an intangible product provided by the customer (e.g. a profit and loss statement required to prepare a tax return); the delivery of an intangible product (e.g. the provision of information in the context of knowledge transfer); the creation of an atmosphere for the customer (e.g. in hotels and restaurants). Software consists of information and is usually an intangible product and may exist in the form of methods, reports or procedures (3.2). Hardware is usually a tangible product and its quantity has the characteristic of being counted. Process materials are usually tangible products whose quantities have continuous characteristics. Hardware and process materials are often referred to as goods,
[GB/T19000--2008, definition 3.4.2]] 3.5
Project
A unique process (3.3) consisting of a set of coordinated, controlled activities with start and end dates that achieves results that meet specified requirements including time, cost and resource constraints. Note 1: A single project can be a component of a larger project structure. Note 2: In some projects, as the project progresses, its objectives become clearer and product characteristics are gradually determined. Note 3: The result of a project can be a single or multiple products (3.4). [GB/T19000-2008, definition 3.4.3]
Quality management systemqualitymanagementsystemThe management system that directs and controls the organization in terms of quality［GB/T19000-2008, definition 3.2.3］3.7
Quality objectivequalityobjective
The daily goals pursued in terms of quality
Note 1: Quality objectives are usually formulated in accordance with the organization's quality policy. Note 2: Quality objectives are usually set for the relevant functions and levels of the organization. [GB/T9000--2008, definition 3.2.5] 3.8
quality planqualityplan
document that specifies who and when to apply the specified processes (3.3), procedures (3.2) and related resources to meet the requirements of a specific project (3.5), product (3.4), process or contract Note 1: These procedures usually include those quality management processes and product realization processes involved Note 2: Usually, the quality plan refers to parts of the quality manual or procedure documents. Note 3: The quality plan is usually one of the results of quality planning. 3.9
recordrecord
document that states the results achieved or provides evidence of the activities performed Note: Rewritten from the definition of 3.7.6 in GB/T19000-2008 (note not included) 2
Specific casespecificcase
Object of the quality plan (3.8)
GB/T19015-2008/ISO10005:2005 NOTE: This term is used to avoid repeating "process, product, project or contract" in this standard. Development of the quality plan
Identify the need for a quality plan
The organization shall identify the need for a quality plan. There are many situations in which a quality plan is useful or necessary, for example: to show how the organization's quality management system is applicable to a specific situation; a
to meet statutory, regulatory or customer requirements;
to develop and validate new products or processes;
to demonstrate internally and/or externally how quality requirements are met; to organize and manage related activities to meet quality requirements and achieve quality objectives; f)
to optimize the use of resources in meeting quality objectives; to minimize the risk of not meeting quality requirements; g)
as a basis for monitoring and evaluating conformity with quality requirements: in the absence of a documented quality management system. NOTE: A quality plan may or may not be necessary for a specific situation. An organization that already has a quality management system may be able to meet all the needs of a quality plan under its existing system, so it is not necessary for the organization to develop a separate quality plan. 4.2 Inputs to the quality plan
Once the organization decides to develop a quality plan, it should identify the inputs to the quality plan, such as: requirements for specific situations;
Requirements for the quality plan, including customer requirements, laws, regulations and industry specifications: c
Requirements for the organization's quality management system;
Risk assessment for specific situations;
Resource requirements and available resources;
Information needed by personnel involved in the activities involved in the quality plan: Information needed by other interested parties using the quality plan; h) Other related quality plans;
i) Other related plans, such as: other project plans, environmental management plans, health and safety management plans, information security management plans. 4.3 Scope of the quality plan
The organization should determine the scope covered by the quality plan and other documents to avoid unnecessary duplication. The scope of the quality plan will depend on several factors, including: the unique processes and quality characteristics of the specific situation that need to be included in the quality plan; a) the requirements of customers or other interested parties (internal or external) for generic processes to be included in the specific situation, but it is necessary to demonstrate that their b) requirements will be met;
the extent to which the quality plan is supported by the documented quality management system. c) where quality management procedures are not documented, these may need to be supplemented to support their quality plan. It may be beneficial to review the scope of the quality plan with customers or other interested parties, for example, to facilitate their use of the quality plan for monitoring and measurement.
4.4 Preparation of the quality plan
4.4.1 Start
The organization shall determine the person responsible for preparing the quality plan. The quality plan shall be prepared with the participation of personnel within the organization involved in the specific situation and, where appropriate, personnel from outside the organization.
When preparing the quality plan, the quality management activities applicable to the specific situation should be determined. Documentation should be done when necessary. 4.4.2 Documentation of the quality plan
The quality plan can indicate directly or by reference to appropriate documented procedures or other documents (such as project plans, work instructions, checklists, computer application software, etc.) how the required activities are carried out. When a requirement leads to a deviation from the organization's management system, the deviation should be justified and authorized. Many of the required common documents may already be included in the organization's quality management system documents, including the quality manual and documented procedures. These documents may need to be selected, rewritten and/or supplemented. The quality plan should indicate how the organization applies common documented procedures directly or after selective modification to the quality plan, or ignores these common procedures. The quality plan can be part of a document or some documents. For example: the project quality plan is usually included in the project management plan (see GB/T19016).
4.4.3 ResponsibilitiesbzxZ.net
When preparing the quality plan, the organization shall determine and agree upon the roles, responsibilities and obligations of the relevant parties, both internally and with customers, management or other interested parties. The organization implementing the quality plan shall ensure that the personnel involved understand the quality objectives and any specific quality issues or required control measures in the quality plan. 4.4.4 Consistency and Compatibility
The content and format of the quality plan shall be consistent with its scope, the inputs to the plan and the needs of the intended users. The level of detail of the quality plan shall be consistent with all agreed customer requirements, the way the organization operates and the complexity of the activities performed. The organization shall also consider the need for compatibility with other plans.
4.4.5 Form and structure
The quality plan may take any of the following forms. For example: a simple text description, a diagram, a document matrix, a process map, a work flow chart or a manual. Any of the above forms can be in electronic or hard copy. Note: An example of a quality plan is provided in Appendix A. The quality plan can be divided into several documents, each of which is responsible for a different aspect. The control of the interfaces between the different documents needs to be clearly defined. These aspects include design, procurement, production, process control or special activities (such as acceptance testing). If the organization wishes to prepare a quality plan consistent with the requirements of ISO 9001, it can refer to the cross-reference table provided in Appendix B. 5 Contents of the quality plan
5.1 General
The examples and lists given in this standard should not be considered comprehensive or limiting. Where appropriate, the quality plan for a specific situation should cover the following clauses to be checked. Some clauses in this standard may not apply, for example: when design and development are not included.
5.2 Scope
The quality plan shall clearly state its scope, including: a brief statement of the purpose and expected results for the specific situation; a)
b) the various aspects of the quality plan that apply to the specific situation, including any special limitations on its applicability; the conditions under which the quality plan is valid (e.g. spatial extent, temperature range, market conditions, availability of resources or certification status of the quality management system).
5.3 Inputs to the quality plan
For convenience, it may be necessary to list or describe the inputs to the quality plan (see 4.2), for example: references to input documents according to the users of the quality plan; checks on consistency with input documents during the maintenance of the quality plan; identification of changes to input documents in the quality plan that may require review. 4
5.4 Quality objectives
GB/T19015-—2008/IS010005:2005The quality plan shall state the quality objectives for the specific situation and how they will be achieved. Consider establishing quality objectives for the following areas, for example:
Quality characteristics of a specific situation:
Matters that are important to satisfying the customer or other interested party; Opportunities for improving work methods.
Quality objectives should be expressed in measurable terms. 5.5 Management responsibilities
The quality plan shall identify the individuals within the organization who are responsible for: a) ensuring that the activities required by the quality management system or the contract are planned, implemented and controlled, and for monitoring their progress; b) determining the sequence of processes applicable to the specific situation and their interactions; c) communicating requirements to all relevant departments, functions, subcontractors and customers, and resolving problems that arise at the interface between these groups;
reviewing all audit results;
authorizing requests for exemptions from the organization's quality management system requirements; controlling corrective and preventive actions;
reviewing and authorizing changes or deviations to the quality plan. Reporting lines during the implementation of the quality plan may be given in the form of a flow chart. 5.6 Control of documents and information
For documents and information applicable to specific situations, the quality plan should describe: a) How to identify documents and information;
Who reviews and approves documents and information;
To whom documents are distributed, or how to obtain these documents; c)
How to select available documents and information. d)
5.7 Control of records
The quality plan should describe what records need to be established and how to maintain them. These records may include: design review records, inspection and test records, process measurements, work orders, drawings and meeting minutes. The following should be considered: how records are kept, where they are kept, and for how long; a)
What are the contractual, statutory and regulatory requirements and how these requirements are met; on what media (e.g. paper or electronic); how requirements for record clarity, retention, retrieval, disposal and confidentiality are determined and met; what methods are used to ensure that records are available when needed; when and how records are provided to customers; in what language, where applicable; and the disposal of records.
5.8 Resources
5.8.1 Provision of Resources
The quality plan should determine the type and amount of resources required to successfully implement the plan. These resources may include materials, human resources, infrastructure and work environment.
Where individual resources are limited, the quality plan needs to identify which requirements should be met from several concurrent products, projects, processes or contracts.
5.8.2 Materials
When the required materials [raw materials and/or components] have specified characteristics, it should be stated or indicated in the quality plan that the materials must comply with the specifications and standards of 5
GB/T19015-2008/ISO10005:2005.
5.8.3 Human Resources
When necessary, the quality plan should specify the special capabilities required for the duties or activities of personnel in specific situations. The quality plan should determine the training and other activities required for personnel. It should include:
a) The need for new personnel and their training;
b) Training of existing personnel on new or modified operating methods. At the same time, the development and motivation strategies required or applicable to the team should be considered. Note: 5.13 mentions personnel qualifications and 6.2 mentions training in the process of implementing the quality plan. 5.8.4 Infrastructure and Work Environment
The quality plan shall describe the special requirements for the specific situation, such as manufacturing or service equipment, workplaces, tools and equipment, information and communication technology, supporting services and transportation equipment, which are necessary to successfully complete the plan. Where the work environment has a direct impact on product or process quality, the quality plan needs to specify special environmental characteristics. Examples are: a)
Air particle content in cleanrooms;
Protection against electrostatic sensitive devices;
Biohazard protection;
Temperature distribution in ovens;
Environmental lighting and ventilation.
5.9 Requirements
The quality plan shall include or reference the requirements to be met for the specific situation. A brief summary of these requirements may include information to help users understand the context of their work, such as a project brief. In other cases, a comprehensive list of requirements may need to be compiled from input documents. The quality plan shall describe when, by whom and how the requirements specified for the specific situation will be reviewed. The quality plan shall also describe how the results of the review will be recorded and how conflicts and ambiguities in the requirements will be resolved. 5.10 Customer Communication
The quality plan shall describe:
a) Who is responsible for communicating with customers in specific situations: the means of communicating with customers;
When applicable, the channels and contact points for communicating with specific customers or functional departments; c)
The maintenance of records of communication with customers;
The follow-up process for receiving customer feedback or complaints. e
5.11 Design and Development
5.11.1 Design and Development Process
The quality plan shall include or reference the design and development plan. The quality plan shall take into account applicable regulations, standards, specifications, quality characteristics and statutory and regulatory requirements, as appropriate. It shall determine the criteria for accepting design and development inputs and outputs, and at what stage, by whom, and how the outputs are reviewed, verified and validated. Design and development is a complex process, and consideration should be given to seeking guidance from various appropriate information sources, including the organization's design and development procedures.
Note: GB/T19004 provides general guidance for the design and development process, and ISO/IEC90003 provides specific guidance for the software field. 5.11.2 Control of design and development changes
The quality plan should describe:
a) How requests for design changes are controlled; b)
Who is authorized to make change requests;
How changes are reviewed based on their impact:
d) Who is authorized to approve or reject changes;
e) How the implementation of changes is verified. GB/T19015—2008/IS010005:2005In some cases, there may be no requirements for design and development. However, existing design changes still need to be managed. 5.12 The purchasing
quality plan shall determine:
the key characteristics of purchased products that have an impact on the quality of the organization's products;a
how these characteristics are communicated to suppliers so that they are adequately controlled throughout the product or service life cycle; methods for evaluating, selecting and controlling suppliers; requirements for and reference to supplier quality plans or other plans, as appropriate;d)
the methods used to meet relevant quality assurance requirements, including legal and regulatory requirements applicable to purchased products, and how the organization verifies that purchased products conform to specified requirements;f
g) outsourcing of equipment and services.
Note: Guidance on "outsourcing" can be found at iso.org/tc176/sc2. 5.13 Production and service provision
Production and service provision, together with the associated monitoring and measurement processes, normally form the main part of the quality plan. The processes included will vary depending on the nature of the work. For example, a contract may involve manufacturing, installation and other post-delivery processes. The relationships between the various processes can be clearly represented by process maps or flow charts. Inspections of production and service processes may be necessary to ensure the ability to deliver products as required. Such inspections should always be carried out if the output of a process cannot be verified by subsequent monitoring or measurement. The quality plan should identify the inputs, implementation activities and outputs required for production and/or service provision. Where appropriate, the quality plan should include or relate to:
Process steps:
b) Relevant documented procedures and work instructions;c
Tools, techniques, equipment and methods to achieve the specified requirements, including details of any necessary material, product or process certification;
Conditions that need to be controlled to meet the planned arrangements;e
Management methods to determine compliance with such conditions, including any specified statistical methods or other process control methods; details of any necessary personnel qualifications and/or certification;g)
Skill assessment criteria or service delivery criteria;h)
Applicable legal and regulatory requirements;
Industry regulations and practices.
When there is a requirement for installation or commissioning, the quality plan should describe how the product will be installed and which characteristics must be verified and confirmed at that time.
In When specific circumstances include after-sales services (such as maintenance, support or training services), the quality plan should describe how the organization ensures compliance with applicable requirements, such as:
a) laws and regulations;
b) industry regulations and practices;
c) personnel competence, including personnel receiving training; d) the effectiveness of initial and ongoing technical support within the agreed period. Note: GB/T 19016 provides guidance on project process management within this clause. 5.14 Identification and traceability
Where product identification is appropriate, the quality plan should determine the method to be used. When traceability is required, the quality plan should determine its scope and extent, including how to identify the products involved. 7
GB/T19015—2008/ISO10005.2005 The quality plan should describe: ||tt| |a) How to identify and reference contractual, statutory and regulatory traceability requirements in working documents; b) What records of traceability requirements are generated, how are they controlled and distributed; c) Specific requirements and methods for identifying the inspection and test status of products. Note: Identification and traceability are part of technical status management. For guidance on technical status management, see GB/T 19017. 5.15 Customer property
The quality plan should describe:
&) How to identify and control products provided by customers (such as materials, process equipment, test equipment, software, data, information, intellectual property or services):
The methods used to verify whether the products provided by customers meet the specified requirements; b)
How to control nonconforming products provided by customers; c
d) How to control damaged, lost or unsuitable products. Note: ISO/IEC 17799 provides guidance on information security. 5.16 Product Protection
The quality plan shall describe:
a) the requirements for handling, storage, packaging and delivery of the product and how these requirements are met; and b) (if the organization is responsible for delivery of the product) how the product is delivered to the specified location in a manner that does not degrade the required characteristics of the product.
5.17 Control of Nonconforming Product
The quality plan shall determine how nonconforming product will be identified and controlled to prevent its misuse until appropriate disposition or acceptance with concessions is completed. The quality plan may specify specific limitations, such as the extent or type of rework or repair permitted and how such rework or repair is authorized. 5.18 Monitoring and Measurement
The monitoring and measurement processes provide the means of obtaining objective evidence of conformity. In some cases, the customer requires only a monitoring and measurement plan (often called an “inspection and test plan”) as the basis for monitoring conformity to specified requirements, and no other quality plan information is required. The quality plan shall identify:
the monitoring and measurement to be used for processes and products; a)
the stages of application;
the quality characteristics to be monitored and measured at each stage; e
the procedures and acceptance criteria to be used;
any statistical process control procedures to be applied; when inspection or testing is required to be witnessed or performed by management and/or customers, for example: f
a test or series of tests (sometimes called "type tests") to determine whether the design meets the requirements of the product specification for design approval;
including acceptance field tests;
product verification;
product validation.
g) when, where and how third parties are to be used for inspection or testing, whether the organization desires or the customer or regulatory authority requires; h) the criteria for product release.
The quality plan shall identify the controls for the monitoring and measuring equipment to be used in the specific situation, including their calibration confirmation status. NOTE 1: ISO 9022 provides guidance on measurement management systems. Note 2: GB/Z19027 provides guidance on the selection of statistical methods. 5.19 Audit
Audit can be used for several months, for example:2005The quality plan shall describe:
a) How the contractual, statutory and regulatory traceability requirements are identified and referenced in the work documents; b) What records of traceability requirements are generated, how they are controlled and distributed; c) Specific requirements and methods for identifying the inspection and test status of the product. Note: Identification and traceability are part of technical status management. For guidance on technical status management, see GB/T19017.5.15 Customer property
The quality plan shall describe:
&) How the products provided by the customer (such as materials, process equipment, test equipment, software, data, information, intellectual property or services) are identified and controlled:
The methods used to verify whether the products provided by the customer meet the specified requirements; b)
How to control nonconforming products provided by the customer; c
d) How to control damaged, lost or unsuitable products. Note: ISO/IEC17799 provides guidance on information security. 5.16 Product Protection
The quality plan shall describe:
a) the requirements for handling, storage, packaging and delivery of the product and how these requirements are met; and b) (if the organization is responsible for delivery of the product) how the product is delivered to the specified location in a manner that does not degrade the required characteristics of the product.
5.17 Control of Nonconforming Product
The quality plan shall determine how nonconforming product will be identified and controlled to prevent its misuse until appropriate disposition or acceptance with concessions is completed. The quality plan may specify specific limitations, such as the extent or type of rework or repair permitted and how such rework or repair is authorized. 5.18 Monitoring and Measurement
The monitoring and measurement processes provide the means of obtaining objective evidence of conformity. In some cases, the customer requires only a monitoring and measurement plan (often called an “inspection and test plan”) as the basis for monitoring conformity to specified requirements, and no other quality plan information is required. The quality plan shall identify:
the monitoring and measurement to be used for processes and products; a)
the stages of application;
the quality characteristics to be monitored and measured at each stage; e
the procedures and acceptance criteria to be used;
any statistical process control procedures to be applied; when inspection or testing is required to be witnessed or performed by management and/or customers, for example: f
a test or series of tests (sometimes called "type tests") to determine whether the design meets the requirements of the product specification for design approval;
including acceptance field tests;
product verification;
product validation.
g) when, where and how third parties are to be used for inspection or testing, whether the organization desires or the customer or regulatory authority requires; h) the criteria for product release.
The quality plan shall identify the controls for the monitoring and measuring equipment to be used in the specific situation, including their calibration confirmation status. NOTE 1: ISO 9022 provides guidance on measurement management systems. Note 2: GB/Z19027 provides guidance on the selection of statistical methods. 5.19 Audit
Audit can be used for several months, for example:2005The quality plan shall describe:
a) How the contractual, statutory and regulatory traceability requirements are identified and referenced in the work documents; b) What records of traceability requirements are generated, how they are controlled and distributed; c) Specific requirements and methods for identifying the inspection and test status of the product. Note: Identification and traceability are part of technical status management. For guidance on technical status management, see GB/T19017.5.15 Customer property
The quality plan shall describe:
&) How the products provided by the customer (such as materials, process equipment, test equipment, software, data, information, intellectual property or services) are identified and controlled:
The methods used to verify whether the products provided by the customer meet the specified requirements; b)
How to control nonconforming products provided by the customer; c
d) How to control damaged, lost or unsuitable products. Note: ISO/IEC17799 provides guidance on information security. 5.16 Product Protection
The quality plan shall describe:
a) the requirements for handling, storage, packaging and delivery of the product and how these requirements are met; and b) (if the organization is responsible for delivery of the product) how the product is delivered to the specified location in a manner that does not degrade the required characteristics of the product.
5.17 Control of Nonconforming Product
The quality plan shall determine how nonconforming product will be identified and controlled to prevent its misuse until appropriate disposition or acceptance with concessions is completed. The quality plan may specify specific limitations, such as the extent or type of rework or repair permitted and how such rework or repair is authorized. 5.18 Monitoring and Measurement
The monitoring and measurement processes provide the means of obtaining objective evidence of conformity. In some cases, the customer requires only a monitoring and measurement plan (often called an “inspection and test plan”) as the basis for monitoring conformity to specified requirements, and no other quality plan information is required. The quality plan shall identify:
the monitoring and measurement to be used for processes and products; a)
the stages of application;
the quality characteristics to be monitored and measured at each stage; e
the procedures and acceptance criteria to be used;
any statistical process control procedures to be applied; when inspection or testing is required to be witnessed or performed by management and/or customers, for example: f
a test or series of tests (sometimes called "type tests") to determine whether the design meets the requirements of the product specification for design approval;
including acceptance field tests;
product verification;
product validation.
g) when, where and how third parties are to be used for inspection or testing, whether the organization desires or the customer or regulatory authority requires; h) the criteria for product release.
The quality plan shall identify the controls for the monitoring and measuring equipment to be used in the specific situation, including their calibration confirmation status. NOTE 1: ISO 9022 provides guidance on measurement management systems. Note 2: GB/Z19027 provides guidance on the selection of statistical methods. 5.19 Audit
Audit can be used for several months, for example:
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