Some standard content:
ICS03.120.10
National Standard of the People's Republic of China
GB/T19017—2020/IS010007:2017 replaces GB/T19017—2008
Quality management
Guidelines for technical status management
Quality management--Guidelines for configuration management(ISO10007.2017IDT）
Official account
2020-11-19Release
State Administration for Market Regulation
National Standards Administration Committee
Release
2021-06-01Implementation
Foreword
Introduction
Scope
2 Normative references
3 Terms and definitions
Technical status management responsibilities
4.1 Responsibilities and authorities
4.2 Technical status management organization
5 Technical status management process
General
Technical status management planning| |tt||Technical status identification
Change control
Technical status record
Technical status audit
Appendix A (Informative Appendix) Structure and content of the technical status management plan A.1
General
A.2 Introduction
Policy
A.4 Technical status identification
A.5 Change control
A.6 Technical status record
A.7 Technical status audit
References
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GB/T19017—2020/1S010007:2017 This standard is one of the GB/T19000 family standards. Foreword
This standard was drafted in accordance with the rules given in GB/T1.1—2009. GB/T19017—2020/IS010007:2017 This standard replaces GB/T19017—2008 "Guidelines for Technical Status Management of Quality Management Systems". Compared with GB/T19017—2008, this standard has the following major technical changes, in addition to editorial changes: In the scope of the standard, the statement "not intended for certification purposes" in the original standard has been deleted; in the terminology of the standard, 5 terms in the original standard have been retained and the definitions of these terms have been modified accordingly, and 4 terms such as change control, concession, technical status management, and management agency have been deleted; in the content of the standard, "product technical status information" has been modified, no longer limited to products, but applicable to the technical status of products or services; the focus of technical status management activities has been expanded from the customer in the previous version to "customers and relevant stakeholders", and the meaning of "supplier" has been expanded to include the two categories of suppliers and external providers in the past. In addition, the record documents in the process of technical status management are collectively referred to as documented information, which is consistent with the definition of documented information in GB/T19000-2016. This standard uses the translation method equivalent to IS010007:2017 "Guidelines for Technical Status Management of Quality Management". This standard is proposed and managed by the National Technical Committee for Standardization of Quality Management and Quality Assurance (SAC/TC151): Drafting units of this standard: China National Institute of Standardization, the Fourth Institute of China Electronics Technology Group Corporation, Shanghai Jiezhineng Software Technology Co., Ltd., the Second Institute of China Aerospace Science and Industry Corporation, China Aviation Industry Corporation, Aviation Industry Shenyang Aircraft Design Institute, Beijing Electronic Engineering General Research Institute.
The main drafters of this standard: Wu Fang, Li Jing, Kang Jian, Li Wen'an, Liang Jun, Yang Zhiguo, Geng Jinfeng, Sun Zhibin, Wang Zhongwen, Wang Lizhi, Liu Kouzhen, Yuan Delun.
The previous versions of the standards replaced by this standard are: GB/T19017-1997, GB/T190172008. m
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GB/T19017—2020/IS010007:2017 Introduction
This standard aims to enhance people's understanding of technical status management, promote the use of technical status management, and help organizations apply technical status management to improve their performance.
Before describing the technical status management process, this standard includes technical status management planning, technical status identification, change control, technical status record and technical status review, and lists the responsibilities and authorities of technical status management. Technical status management is an activity to manage the technical status identification and status, as well as the relevant product and service technical status information throughout the life cycle of products and services by using technical and management means. Technical status management is to document the technical status of products or services, and provide identification and traceability, the realization of their physical and functional requirements and obtain accurate information at all stages of their life cycle. Organizations can implement technical status management according to their size and the complexity and nature of their products or services to reflect the needs of specific life cycle stages.
Technical status management can be used in full
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Product and service identification and traceability requirements. 1 Scope
Quality management
GB/T19017—2020/IS010007:2017 Technical status management guide
This standard provides guidance for technical status management within an organization. This standard applies to all stages from concept to disposal of products and services. 2 Normative references
The following documents are indispensable for the application of this document. For any dated referenced document, only the dated version applies to this document. For any undated referenced document, its latest version (including all amendments) applies to this document. GB/T19000—2016 Quality Management System Fundamentals and Vocabulary (ISO9000:2015, IDT) 3 Terms and definitions
The terms and definitions defined in GB/T19000—2016 and the following terms and definitions apply to this document. 3.1
configuration
interrelated functional and physical characteristics of a product or service as specified in the configuration information (3.5)3.2
configuration baselineconfiguration baseline approved configuration information (3.5) that establishes the characteristics of a product or service at a certain point in time and serves as a reference for activities throughout the life cycle of the product or service
configuration item
object within a certain configuration (3.1) that satisfies an end-use function3.4
configuration status record accounting formal records and reports of configuration information (3.5), the status of proposed changes, and the status of implementation of approved changes 3.5
configuration information requirements for the design, implementation, verification, operation and support of products or services 4 Responsibilities for configuration management
4.1 Responsibilities and authorities
The organization shall determine, describe and assign responsibilities and authorities for the configuration management process, including accountabilities, taking into account: a) the complexity and nature of the product or service; b) the needs at different stages of the product or service life cycle; 1
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GB/T19017-—2020/IS010007.2017c)
interfaces between the activities directly related to the configuration management process; d)
other relevant interested parties involved (or need to be involved) inside and outside the organization; determination of the responsible body for verification implementation activities; e
determination of the management body.
4.2 Technical Status Management Organization
Before approving a change, the management organization shall verify that: a) the proposed change is necessary and the results are acceptable; b) the change has been appropriately documented and classified; c
the activities planned to implement the change into documented information, hardware and/or software are sufficient. 5 Technical Status Management Process
5.1 General
The organization shall establish, implement and protect
Technology Fast Management
Management Processes shall
State Management Process activities to make them effective. (Customers may have product or service requirements as well as applicable legal and regulatory requirements, and
The technical status shall specify the environment in which the technical support activities will occur.| |tt||Project-specific documented information and its usage should be considered!
Technical status management planning
Technical status management planning
Effective planning Able to coordinate technical medical association
Competitor specific products or services
Respect the basics
Management process
Technical skin status
Fly into files and get||tt ||Controlled;
Approval
My status
Determine the technical status management documented information to be used; c)
d) Use the organization's relevant documented information as much as possible ; The entire product
planning
and insert the product or service life cycle
life cycle in a specific environment,
status management plan
regulations The resources, as well as the responsibilities and authorities (including responsibilities) required to carry out technical status management during the life cycle of the product or service.
The technical condition management plan can be a separate document, or a part of other documents, or composed of several documents. In some cases, the technical condition management plan can be provided by an external provider. The organization may retain it as a separate document or as part of its own technical status management plan.
See Appendix A for the structure and content of the technical status management plan. 5.3 Technical status identification
5.3.1 Selection of product structure or service capabilities and technical status items The selection of technical status items and their interrelationships should be able to describe the product structure or service capabilities. The organization shall determine technology status items based on established selection criteria. The organization should select as technical status items those objects whose functional and physical characteristics can be managed independently to obtain the overall end-use performance of the technical status item. Selection criteria should consider:
a) life cycle of the state of the technology;
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b) applicable legal and regulatory requirements;
key risk and safety aspects extent;
d) new or improved technology, design or development; e) interfaces with other technical status items,
f) purchasing conditions;
g) support and service .
GB/T19017-2020/ISO10007:2017 The number of technical status items selected should be considered to optimize the organization's ability to control the product or service as much as possible. The selection of technical status items should be carried out as early as possible in the product or service life cycle. As the product or service progresses, technical status items should be reviewed. 5.3.2 Technical status information
Technical status information includes definition and usage information. They usually include: requirement specifications, design drawings, parts lists, data models, test specifications, operating manuals (for commissioning, maintenance and operation), and all specific requirements regarding decommissioning and disposal. Technical status information should be relevant and traceable. . The organization shall determine a unique naming and numbering scheme to ensure appropriate control of each technical status item, data and technical status item associated with it, and shall take into account the organization's existing naming and numbering scheme, as well as change control information, For example, the version revision status
5.3.3 technical status baseline
the technical status baseline represents the game or server
property
represents the currently valid ||tt| |Accurate changes
During the product or service life cycle
seek to determine the baseline.
In the technical status baseline, the
5.4 Change Control
5.4.1 General Provisions
technical status baseline and its approval are determined on a daily basis
's technical status information is composed of
establishing a level of detail
status baseline for technical
services to enable subsequent
Specific Requirements
Required Control Ideas
All changes to technical status information after initial release should be controlled. The potential consequences of the change, customer requirements and the technical status baseline will affect the degree of control required to handle proposed changes or concessions. The process for controlling changes should be documented and should include the following: a) Description, rationale for the change Produced and documented information Category of change based on complexity, resources and schedule b)
Evaluation of the results of the change;
Details of how the change will be handled:
e) How to implement and Verify the details of the change. Note that some organizations use terms such as "exception release" or "deviation" instead of "concession". 5.4.2 Proposal, identification and documentation of change requirements Changes may be initiated by the organization, the customer or an external provider. All proposed changes shall be identified and retained as documented information before submission to the governing body (see 4.2) for evaluation. Change proposals usually include the following information:
a technical status items that need to be changed and related information, including their names and details of the current version revision status; b) measures for the proposed changes; ||tt| |-rKaeerkAca-
GB/T19017-2020/IS010007:2017 Details of other technical status items or information that will be affected by the change; c
d) Relevant parties who proposed the change and the proposed Date; e)
Reason for change:
Category of change.
The status of change processing, related decisions and dispositions should be retained as documented information. To facilitate identification and traceability, the typical method of documenting changes is to use a standard form that gives a unique identification number. 5.4.3 Evaluation of changes
5.4.3.1
The organization shall evaluate proposed changes and retain them as documented information. The scope of the evaluation should be consistent with the complexity of the product or service and the category of the change, and should include the following content: Auditor Test Preparation Center
a) The technical benefits of the proposed change;
b) and The risks associated with the proposed changes;
c) the potential consequences on the contract, schedule and cost; d) the potential impact of the proposed changes not being approved. 5.4.3.2
When determining the consequences of changes, the following factors should also be considered: applicable relevant legal and regulatory requirements;
The interchangeability of technical status items and the need to re-identify them;b
Interfaces between technical status items;
Manufacturing, testing and inspection methods;
Inventory and purchasing;
Delivery activities;
Customer support requirements .
5.4.4 Processing of changes
A process for handling changes should be established, implemented and maintained, and its management organization (see 4.2) should be identified for each proposed change, and the category of the proposed change should be considered.
After the proposed change has been evaluated, the governing body shall review the evaluation and make a decision on the handling of the change. The processing of changes should be retained as documented information and notification of the processing should be distributed to relevant internal and external parties. 5.4.5 Implementation and verification of changes
Implementation of approved changes usually includes:
a) changes to technical status information that has been released to relevant parties; b) internal and external parties affected by the change Measures taken by relevant external parties. After a change is implemented, its conformance to the approved change should be verified. This verification should be retained as documented information to facilitate traceability.
5.5 Technical status records
5.5.1 General
Technical status recording activities form documented information and reports related to products or services and their technical status information. The organization shall conduct technical status recording activities throughout the life cycle of the product or service to support and make the technical status management process effective.
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5.5.2 Documented information
GB/T19017-2020/IS010007:20175.5.2.1 During the technical status identification and change control activities, technical status records will be generated Written information. This documented information takes into account visibility and traceability, as well as efficient management of the evolving state of the technology. They typically include details of: a) technical status information (e.g. identification number, title, effective date, version revision status, change history and their inclusion in any baseline);
b) product or the technical status of the service (for example: part number, product design or manufacturing status); c) the status of the release of new technology status information; d) the processing of changes.
5.5.2.2 The evolving technical status information should be retained as documented information in a manner that allows identification of the reports that provide the requirements (see 5.5.3 for required cross-references and linkages). 5.5.2.3 In order to protect the integrity of the technical status information and provide a basis for change control, it is recommended that technical status items and related information be stored in an environment that: a) conforms to the required conditions (for example, conditions required for computer hardware, software, data, documented information, drawings); b) provides protection against loss of integrity or unauthorized change; and provides restore capabilities when and where required; d) allows retrieval.
Reports
5.5.3
To achieve technical status management
the entire product or service
generally, the report includes:
the technical status contained in a particular technical status base and the status baseline clearing b)
such
full information list
the current version revision status and details of the change history; e)
d) change and step status report;
to cover individual technical status items or
delivered technical status and details of the maintained technical status (such as parts, traceability numbers and their version revision status). e)
5.6 Technical status audit
The technical status audit shall be carried out based on the documented information to determine whether the product or service meets the requirements and is consistent with the technical status information. There are generally two types of status audits:
Functional status audit. This is a formal review to verify that the status item has achieved the functional and performance characteristics specified in the status information a).
Physical status audit. This is a formal review to verify that the status item has achieved the physical characteristics specified in the status information b).
A status audit may be required before formal acceptance of the status item. This audit is not intended to replace other forms of verification, review, testing or inspection, but it may be affected by the results of these activities. 5
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GB/T19017—2020/IS010007:2017 Appendix A
(Informative Appendix)
Structure and content of the status management plan A.1 General
The preparation structure of the status management plan should include the contents of the headings A.2 to A.7 and form corresponding chapters. A.2 to A.7 also provide guidance on related content.
A.2 Introduction
The technical configuration management plan shall include an introduction, which provides overview information. The introduction normally includes content on the following topics: the purpose and scope of the technical configuration management plan; a)
a description of the products or services and technical configuration items to which the plan applies; b)
a schedule to provide guidance for the preparation of a timetable for significant technical configuration management activities; d)
a description of the technical configuration management tool;
relevant documented information (e.g., technical configuration management plans from suppliers); a list of relevant documented information and their interrelationships. A.3 Policy
The technical configuration management plan shall detail the technical configuration management policy that has been agreed with customers and suppliers. It should provide the basis for the technical status management activities within the scope of the contract, such as: a) the policy on technical status management and the implementation of related management activities; b) the organization, responsibilities and authorities of relevant interested parties; c)
qualification and training:
d)
criteria for the selection of technical status items;
frequency, distribution and control of reports;
terminology.
4 Technical status identification
The technical status management plan shall detail:
the breakdown structure, specifications and other documented information of technical status items; a)
the naming and numbering method used for specifications, drawings, concessions and changes; b)
the identification method of version revision status;
the technical status baseline, schedule plan to be established and the type of technical status information to be included; d)
the use and allocation of sequence numbers or other traceability identification; documented information that determines the process for publishing technical status information (including any related procedures). rKaeerKAca-
Change Control
The Technical Status Management Plan shall detail:
The relationship between the management body of the organization (see 4.2) and other relevant interested parties; a)
GB/T19017—2020/IS010007:2017 Documented information on change control before the technical status baseline specified in the contract is established; b)
The methods for handling changes (including those proposed by customers or suppliers) and concessions. Technical Status Records
The Technical Status Management Plan shall detail:
The methods for collecting, recording, processing, maintaining and archiving the data necessary to generate the documented information of the technical status records; a)
The definition of the content and format of all technical status record reports. b
Technical status audit
The technical status management plan should detail:
The list of technical status audits required and their arrangement in the project schedule, a
The documented information of the technical status audit to be used; b)
The responsibilities and authorities of relevant internal and external stakeholders; The provisions of the format of the technical status audit report. Official account:
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GB/T19017—2020/ISO10007:2017[]
References
GB/T19001—2016Quality Management System RequirementsGB/T19004
GB/T19016
Guidelines for Quality Management Organizations to Achieve Sustained SuccessQuality Management SystemProject Quality Management Guidelines Official account: Auditor Preparation Center
-irKaeerkAca-2 Introduction
The configuration management plan shall include an introduction, which shall provide general information. The introduction shall normally include the following topics: the purpose and scope of the configuration management plan; a)
a description of the products or services and the configuration items to which the plan applies; b)
a schedule to provide guidance for the preparation of a timeline of significant configuration management activities; d)
a description of the configuration management tool;
relevant documented information (e.g., configuration management plans from suppliers); a list of relevant documented information and their interrelationships. A.3 Policy
The configuration management plan shall detail the configuration management policy that has been agreed upon with the customer and supplier. It should provide the basis for the technical status management activities within the scope of the contract, such as: a) the policy on technical status management and the implementation of related management activities; b) the organization, responsibilities and authorities of relevant interested parties; c)
qualification and training:
d)
criteria for the selection of technical status items;
frequency, distribution and control of reports;
terminology.
4 Technical status identification
The technical status management plan shall detail:
the breakdown structure, specifications and other documented information of technical status items; a)
the naming and numbering method used for specifications, drawings, concessions and changes; b)
the identification method of version revision status;
the technical status baseline, schedule plan to be established and the type of technical status information to be included; d)
the use and allocation of sequence numbers or other traceability identification; documented information that determines the process for publishing technical status information (including any related procedures). rKaeerKAca-
Change Control
The Technical Status Management Plan shall detail:
The relationship between the management body of the organization (see 4.2) and other relevant interested parties; a)
GB/T19017—2020/IS010007:2017 Documented information on change control before the technical status baseline specified in the contract is established; b)
The methods for handling changes (including those proposed by customers or suppliers) and concessions. Technical Status Records
The Technical Status Management Plan shall detail:
The methods for collecting, recording, processing, maintaining and archiving the data necessary to generate the documented information of the technical status records; a)
The definition of the content and format of all technical status record reports. b
Technical status audit
The technical status management plan should detail:
The list of technical status audits required and their arrangement in the project schedule, a
The documented information of the technical status audit to be used; b)
The responsibilities and authorities of relevant internal and external stakeholders; The provisions of the format of the technical status audit report. Public account:
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GB/T19017—2020/ISO10007:2017[]
References
GB/T19001—2016Quality Management System RequirementsGB/T19004
GB/T19016
Guidelines for Quality Management Organizations to Achieve Sustained SuccessQuality Management SystemProject Quality Management Guidelines Public account: Auditor Preparation Center
-irKaeerkAca-2 Introduction
The configuration management plan shall include an introduction, which shall provide general information. The introduction shall normally include the following topics: the purpose and scope of the configuration management plan; a)
a description of the products or services and the configuration items to which the plan applies; b)
a schedule to provide guidance for the preparation of a timeline of significant configuration management activities; d)
a description of the configuration management tool;bzxZ.net
relevant documented information (e.g., configuration management plans from suppliers); a list of relevant documented information and their interrelationships. A.3 Policy
The configuration management plan shall detail the configuration management policy that has been agreed upon with the customer and supplier. It should provide the basis for the technical status management activities within the scope of the contract, such as: a) the policy on technical status management and the implementation of related management activities; b) the organization, responsibilities and authorities of relevant interested parties; c)
qualification and training:
d)
criteria for the selection of technical status items;
frequency, distribution and control of reports;
terminology.
4 Technical status identification
The technical status management plan shall detail:
the breakdown structure, specifications and other documented information of technical status items; a)
the naming and numbering method used for specifications, drawings, concessions and changes; b)
the identification method of version revision status;
the technical status baseline, schedule plan to be established and the type of technical status information to be included; d)
the use and allocation of sequence numbers or other traceability identification; documented information that determines the process for publishing technical status information (including any related procedures). rKaeerKAca-
Change Control
The Technical Status Management Plan shall detail:
The relationship between the management body of the organization (see 4.2) and other relevant interested parties; a)
GB/T19017—2020/IS010007:2017 Documented information on change control before the technical status baseline specified in the contract is established; b)
The methods for handling changes (including those proposed by customers or suppliers) and concessions. Technical Status Records
The Technical Status Management Plan shall detail:
The methods for collecting, recording, processing, maintaining and archiving the data necessary to generate the documented information of the technical status records; a)
The definition of the content and format of all technical status record reports. b
Technical status audit
The technical status management plan should detail:
The list of technical status audits required and their arrangement in the project schedule, a
The documented information of the technical status audit to be used; b)
The responsibilities and authorities of relevant internal and external stakeholders; The provisions of the format of the technical status audit report. Public account:
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GB/T19017—2020/ISO10007:2017[]
References
GB/T19001—2016Quality Management System RequirementsGB/T19004
GB/T19016
Guidelines for Quality Management Organizations to Achieve Sustained SuccessQuality Management SystemProject Quality Management Guidelines Public account: Auditor Preparation Center
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