This part of GB/T 15000 specifies the general requirements for the competence of standard sample producers to produce standard samples. This part is applicable to the establishment and operation of the quality system of standard sample producers, and is also applicable to accreditation bodies, certification bodies and other relevant bodies that assess the competence of standard sample producers. This part specifies the quality system requirements that the production of standard samples should comply with, which should be an integral part of the overall quality assurance (QA) program of standard sample producers. GB/T 15000.7-2001 Guidelines for the work of standard samples (7) General requirements for the competence of standard sample producers GB/T15000.7-2001 Standard download decompression password: www.bzxz.net
This part of GB/T 15000 specifies the general requirements for the competence of standard sample producers to produce standard samples. This part is applicable to the establishment and operation of the quality system of standard sample producers, and is also applicable to accreditation bodies, certification bodies and other relevant bodies that assess the competence of standard sample producers. This standard specifies the quality system requirements that the production of reference materials should comply with and should be an integral part of the overall quality assurance (QA) program of the reference material producer.

ICS01.120
National Standard of the People's Republic of China
GB/T15000.7—2001
Replaces GB/T15000.7-1997
Directives for the work of reference materials (7)
General requirements for the competence of reference material producers (ISO Guide 34: 2000. IDT)
2001-09-06 Issued
People's Republic of China
General Administration of Quality Supervision, Inspection and Quarantine
2002-01-01 Implementation
ISO Foreword
Normative references
Terms and definitions
Organization and management requirements
Quality system requirements
Organization and management
Document and information control
Applications, tenders and contracts
Selection of partners
Service provider ||tt| |Preventive measures
Internal audit
Management review·
Technical and production requirements
Management, personnel and training·
Collaborators
Production planning
Production control
Handling and storage of materials
Service after release
Material preparation
Evaluation of homogeneity and stability
Measurement methods
Measuring equipment
Traceability and validation
Data evaluation
Determination of characteristic values ​​and their uncertainties
Certificates and information provided to users
GB/T15 000.7—2001
GB/T15000.7-2001
Appendix A (Informative Appendix)
A.1 Concept of tide source
A.2 Determination of standard sample value
A.3 Example
References·
Example of traceability of characteristic value of standard sample
GB/T15000 is divided into 7 parts under the general title of "Guidelines for working with standard samples", namely: GB/T15000.1—1994
Guidelines for working with standard samples (1)
GB/T15000.2—1994
GB /T15000.3-1994
GB/T15000.4—1994
GB/T15000.5—1994
GB/T15000.6--1996
GB/T15000.7—2001
Guidelines for working on standard samples (2)
Guidelines for working on standard samples (3)
Guidelines for working on standard samples (4)
Guidelines for working on standard samples (5)
Guidelines for working on standard samples (6)
Guidelines for working on standard samples (7)
This part is Part 7.
GB/T 15000.7-2001
General provisions for stating standard samples in technical standards Common terms and definitions for standard samples
General principles and statistical methods for determining the value of standard samples Provisions for the content of standard sample certificates
General technical rules for standard samples of chemical composition
General rules for packaging of standard samples
General requirements for the competence of standard sample producers This part is equivalent to ISO Guide 34:2000 "General requirements for the competence of standard sample producers", and is revised from GB/T15000.7-1997 "Guidelines for the work of standard samples Quality system of standard sample producers". GB/T15000.7-1997 is equivalent to ISO Guide 34:1996 version, which only stipulates how to implement the interpretation of ISO/IEC Guide 25 and ISO9000 family standards in standard samples, and does not list the general requirements for production capacity in ISO/IEC Guide 25 and ISO9000 family standards. ISO Guide 34:2000 stipulates that standard sample producers must prove that their production capabilities meet the general requirements of the quality system operation according to the requirements of standard sample development and production development. Therefore, this part timely adopts ISO Guide 342000.
Compared with GB/T15000.7-1997, the main changes of this part are as follows: Chapter 4 "Organization requirements" is changed to "Organization and management requirements", and the content adds "Organization and management", "Document and information control", "Application, bidding and contract review", "Service and supply acquisition", "User feedback", "Control of non-conforming standard samples", "Corrective measures", "Preventive measures", "Internal audit", "Management review" and other related provisions, and "Environment", "Management, personnel and training", "Material disposal and storage", "Post-issuance service" and other items are adjusted and listed in Chapter 5. Chapter 5 "Production Control" is changed to "Technology and Production Requirements". Appendix A of this part is an informative appendix.
This part replaces GB/T15000.7-1997 from the date of implementation. This part is proposed and managed by the National Technical Committee for Standard Samples. Drafting unit of this part: Secretariat of the National Technical Committee for Standard Samples. Main drafters of this part: Chen Bainian, Gao Liangcai, Zhang Guangwei, Lin Zhuoran, Wu Qiansi, Ma Qihe. This part was first published in 1997.
GB/T15000.7—2001
ISO Foreword
ISO and IEC constitute a specialized system for worldwide standardization. National organizations of ISO or IEC members participate in the formulation of international standards by participating in the activities of technical committees. As stipulated in the International Standards Ordinance, technical committees are composed of interested organizations participating in a specific technical field. ISO and IEC technical committees collaborate in technical fields of common interest. Other international organizations (official and non-official) that maintain liaison with ISO and IEC may also participate in the preparation of international standards.
Guides are drafted in accordance with the rules of Part 3 of the ISO/IEC Directives. Draft guidelines prepared by the appropriate committee or working group are circulated to national bodies for voting. A guide is approved for publication only after it is approved by at least 75% of the national members who voted. Please note that some elements of this guide may be subject to patent rights. ISO and IEC are not responsible for determining these patent rights. ISO Guide 34 was prepared by ISO/REMCO. After the publication of this edition, the 1996 edition was published The first edition of the Guidelines is abolished. This edition is a revised version of the 1996 edition. Appendix A in the guide is an informative appendix.
GB/T15000.7--2001
The use of standard samples makes it possible to transfer "measured values" or "assigned quantity values" between inspection, analysis and measurement laboratories. Standard samples are widely used in the calibration of measuring instruments and the evaluation or confirmation of measurement methods. In some cases, the use of standard samples can make it convenient to express characteristics in arbitrary units. With the increasing number of standard sample producers, in order to ensure the quality of standard samples, it has become a basic requirement to provide proof of the scientific and technological capabilities of the producers. At the same time, in the field of science and technology, due to the improvement of the precision of measuring instruments and the need for more reliable and accurate data The demand for new, high-quality reference standards is increasing. Some previously acceptable reference standards may no longer meet these more stringent requirements, so reference standard producers need not only to provide information about the reference standards in the form of reports, certificates and instructions, but also to demonstrate their ability to produce reference standards of acceptable quality. The 1996 edition of ISO Guide 34 specifies how to implement the interpretation of ISO/IEC Guide 25 and the ISO 9000 family of standards in the production of reference standards, but does not include the general requirements of ISO/IEC Guide 25 and the ISO 9000 family of standards. Since the first edition of ISO Guide 34 was published in 1996, developments have reached the point where the assessment of the competence of reference standard producers has become a priority. Therefore, the 2000 edition specifies that reference standard producers must demonstrate that their operations meet all general requirements. Pharmacopoeia standards and medicines established and distributed by pharmacopoeial authorities may follow the general principles of this standard. However, it should be noted that pharmacopoeial authorities use different methods to provide users with the information given by certificates of analysis and validity periods. Furthermore, the uncertainty of the assigned value need not be stated, since it is negligible compared with the limits determined by the specific analytical methods specified in the pharmacopoeia. 1 Scope
Guidelines for Standard Sample Work (7)
General Requirements for the Competence of Standard Sample Producers GB/T15000.7—2001
1.1 This part of GB/T 15000 specifies the general requirements for the competence of standard sample producers to produce standard samples. 1.2 This part applies to the establishment and operation of the quality system of standard sample producers, and also applies to accreditation bodies, certification bodies and other relevant organizations that assess the competence of standard sample producers. 1.3 This part specifies the quality system requirements that the production of standard samples should comply with, which should be an integral part of the overall quality assurance (QA) program of the standard sample producer.
2 Normative references
The clauses in the following documents become the clauses of this part through reference in this part of GB/T 15000. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this part. However, parties to an agreement based on this part are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest version of the document applies to this part.
GB/T3935.1 General terminology in standardization and related fields Part 1: Basic terminology GB/T19000 Fundamentals and terminology of quality management system GB/T15000.2 Guidelines for standard sample work (2) Common terms and definitions of standard samples GB/T15000.3 Guidelines for standard sample work (3) General principles and statistical methods for determining the value of standard samples GB/T15000.4 Guidelines for standard sample work (4) Provisions on the contents of standard sample certificates GB/T15481 Competence of calibration and testing laboratories General requirements GB/T 19022.1 Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment VIM International basic terminology for metrology (published by ISO, IEC, BIPM, IFCC, IUPAC, IUPAP and OIML) 3 Terms and definitions
Terms and definitions established by GB/T 3935.1, GB/T 15481, GB/T 15000.2, GB/T 19000.VIM and the following terms and definitions apply to this part of GB/T 15000.
Reference material producer A technically competent institution (organization or company, public or private) that shall be fully responsible for the standard values ​​or other characteristic values ​​of reference materials it produces and supplies in accordance with GB/T 15000.3 and GB/T 15000.4. 3.2
Collaborator
A technically competent organization (organization or company, public or private) that performs the production or measurement of standard samples (certified standard samples) for the standard sample producer on a contractual or voluntary basis. 1
GB/T15000.7—2001
4 Organization and management requirements
4.1 Quality system requirements
4.1.1 General
The standard sample producer shall establish, implement and maintain a quality system suitable for its scope of work, including the type, scope and number of standard samples to be produced.
It should be clearly recognized that the measurement of a standard sample is mainly to achieve the required level of accuracy (i.e., appropriate measurement uncertainty) for its intended purpose. The standard sample producer shall define a procedure for determining the quality of the material and make the procedure an integral part of the overall quality system.
The standard sample producer shall define their scope according to the application of the standard sample, the measurement method (used in the homogeneity, stability and determination study) and the limitations of the material matrix. 4.1.2 Quality policy
The standard sample producer shall define the quality policy, objectives and commitment, and document it to ensure and maintain the quality of all aspects of the standard sample production, including material quality (such as homogeneity and stability), determination (such as equipment calibration and confirmation of measurement methods), determination of characteristic values ​​(such as application of appropriate statistical procedures) and material handling, storage and transportation procedures. Where necessary, the quality policy shall include the use of laboratories with vitality and capabilities in their respective measurement fields for inter-laboratory determination studies. Therefore, the policy should include a commitment to cooperate with the corresponding industries in the testing technology community to avoid working alone. The policy should also include a commitment to produce standard samples that meet the definition of GB/T15000.2, and to determine the characteristic values ​​according to the requirements specified in GB/T15000.3 and to evaluate them using acceptable statistical techniques. When necessary, the quality policy should also include a commitment to provide relevant information to users in accordance with the provisions of GB/T15000.4 on certificates. It is important that the quality policy should state the intended use of standard samples to ensure that the standard sample producer fully informs the user of what type of application a certain standard sample can be used for. 4.1.3 Quality system
The standard sample producer shall establish, implement and maintain a documented quality system. The system shall be adapted to the type, scope and batch of standard samples it undertakes to produce. The standard sample producer shall document the necessary contents such as his quality policy, system, plan, procedure, operating instructions, research results, etc., so that the producer can ensure the quality of the standard samples produced. The documents used in the quality system should be understood, communicated, used and implemented by all relevant personnel. In particular, the producer should have a quality record system that includes the following: a) planning to ensure the appropriate selection of technical parameters of candidate standard samples (e.g. concentration range, particle size range, etc.); b) preparation procedures; c) obtaining the required uniformity of the standard samples; d) stability assessment of the standard samples, including real-time assessment of stability when necessary; e) measurement procedures; f) reproduction of traceability to national or international measurement standards; g) determination of characteristic values, including the preparation of certificates or instructions in accordance with GB/T15000.4; h) ensuring the arrangement of appropriate storage facilities; i) determining appropriate identification, labeling, packaging facilities, packaging and distribution procedures and after-sales service; j) compliance with GB/T15000.2, GB/T15000.3, GB/T15000.4 and the relevant requirements of this standard. The documented quality system should specify the activities carried out by the producer of standard samples and the activities of collaborators. The quality system should also include the policies and procedures adopted by the producer of standard samples to ensure that the activities carried out by collaborators conform to this standard. The documented quality system shall define the responsibilities and roles of the technical and management responsible, including their accountability for ensuring conformity to the requirements of this International Standard.
4.2 Organization and Management
4.2.1 The producer of reference materials (or part of an organization) shall have a defined legal status. 4.2.2 The producer of reference materials shall be organized and operated in such a way that all the requirements of this International Standard are met, regardless of whether its work (including that of collaborators) is performed in permanent facilities or in temporary, non-permanent facilities. 4.2.3 The producer shall:
GB/T15000.7—2001
a) have management personnel supported by technical personnel who shall have the necessary authority and resources to perform their duties and, when a deviation from the quality system or procedure for the production of standard samples is found, have the right to take measures to prevent or minimize such deviation;
b) have arrangements to ensure that management and personnel are not influenced by any commercial, financial and other internal or external pressures that would affect the quality of their work;
c) have policies and procedures to protect user confidential information and proprietary rights; d) have policies and procedures to avoid any risk that could reduce the producer's credibility in terms of competence, impartiality, judgment or operational integrity activities; e) Use an organizational chart to specify the organizational and management structure of the standard sample producer, its position in the overall organization, and the relationship between management, technical operations, support services, partners and the quality management system; f) For all personnel engaged in management, execution or verification work that affects the quality of standard sample production, their responsibilities, authorities and relationships should be specified:
g) There is a technical management personnel who is fully responsible for the technical operation and the required resources to ensure that each process of standard sample production meets the required quality;
h) Designate a staff member as the quality manager (regardless of the name), regardless of the staff member’s other duties, and specify the responsibilities and authorities he should have to ensure that the requirements of this standard are always implemented and followed. The quality manager should communicate directly with the highest person in charge to obtain decisions about production policies or resources; i) When necessary, appoint deputies for key managers (such as technical and quality managers). 4.3 Document and information control
4.3.1 General
The manufacturer of reference materials shall establish and maintain a procedure for the control of all documents (both internally and externally developed) and other information that form part of the quality documentation, including documents from external bodies, such as standards, guidelines, test or calibration methods, and technical specifications, work instructions and manuals related to the reference materials produced. NOTE Documentation in this context means all information or work instructions, including tables of policy, textbooks, procedures, technical specifications, calibration tables, charts, software, etc. This information may be recorded on any medium, whether hard or electronic, and may be digital, analog, graphic or written. 4.3.2 Approval and release of documents
4.3.2.1 All documents (including documented procedures) issued to personnel as part of the quality system shall be controlled, including review and approval for use by authorized personnel prior to release. A list identifying the current revision status of quality system documents shall be established and readily available to prevent the use of invalid or obsolete documents. 4.3.2.2 The procedures adopted should also ensure that:
a) the valid version of the relevant documents is available at the main workplaces where the effective production of standard samples is carried out; b) the documents are reviewed regularly and revised as necessary to ensure the continued applicability of the documents and meet the requirements for use; c) invalid or obsolete documents are promptly withdrawn from all places of issuance or use, or otherwise ensured that they are no longer in use; d) obsolete documents retained for legal or informational purposes should be appropriately marked. 4.3.3 Changes to documents
4.3.3.1 Unless otherwise specified, changes to documents (including documented procedures) should be reviewed and approved by the person originally authorized to perform this function. The authorized person should have access to relevant background information on which the approval is based. 4.3.3.2 Where applicable, the nature of the change should be identified in the document by an appropriate attachment. 4.3.3.3 If the document control system of the standard sample producer allows documents to be modified manually before re-issuance, the procedures and authority for such changes should be specified, and it should be ensured that the changes are signed and dated. Documents amended by hand should be marked, signed and dated and formally reissued as soon as possible.
4.3.3.4 Procedures should be established for how to change files maintained in computer systems. 3
GB/T15000.7--2001
4.4 Application, bid and contract review
4.4.1 Each application, bid and contract for the production of standard samples should be reviewed by the standard sample producer to ensure that: a) all requirements are fully specified, documented and fully understood; b) the standard sample producer has the ability and resources to meet these requirements; c) in the case of external contracts, differences between the contract order requirements and those in the bid document are resolved to the satisfaction of both the standard sample producer and the user.
Application, bid or contract review should be conducted in a practical and efficient manner. Financial, legal and scheduling issues should also be considered.
Note 1: Competence means that the producer of standards has the necessary equipment, intellectual resources and information resources and that its personnel have the necessary skills and expertise for the standards to be produced. The review of competence may include the assessment of previous production of standards and/or the organization of an interlaboratory measurement program (using samples with similar composition to the standards to be produced). Note 2: The contract for the provision of stock or custom standards to users may be an oral or written agreement. 4.4.2 Records of such reviews (including any changes), discussions with users about their requirements, and the results of work performed during the contract or subcontract shall be maintained.
4.4.3 The review shall include the content of the work that the producer of standards must perform under the subcontract. 4.5 Selection of collaborators
4.5.1 The producer of standards shall establish and maintain a procedure to ensure that all collaborators perform work that complies with the technical requirements specified by the producer of standards. The producer of standards shall also ensure that collaborators comply with the provisions of this standard that are relevant to their tasks. 4.5.2 The standard sample producer shall select collaborators based on their ability to meet the subcontract requirements, including technical competence and specific quality assurance requirements. The technical requirements that collaborators need to meet are equivalent to those specified in Chapter 5. 4.5.3 The standard sample producer shall maintain a register of all collaborators in the production process, including records of their evaluation of their ability to perform subcontracts in accordance with the requirements of the technical standard.
The standard sample producer shall always ensure that the capabilities of the collaborators are competent. At the same time, the collaborators shall be able to demonstrate that they can meet the requirements of this standard when undertaking subcontract work. 4.6 Procurement of services and supplies
4.6.1 The standard sample producer shall have a policy and procedure for the selection of services and supplies that affect the quality of its standards. 4.6.2 The standard sample producer shall only use services and supplies with appropriate specifications to ensure the quality of the standards. 4.6.3 When formally recognized service and supply quality cannot be obtained, the standard sample producer shall have procedures to ensure that the purchased materials and services meet the specified requirements and shall maintain records of all measures taken. 4.6.4 The standard sample producer shall ensure that the purchased instruments and consumable materials are not put into use until they have been inspected, calibrated or otherwise verified to meet the requirements specified in the standard specifications or specifications for the production, determination and valuation of standard samples. 4.6.5 The standard sample producer shall maintain records of the main suppliers and collaborators of supplies required for the production of standard samples. These records shall include the quality assurance that the suppliers and collaborators have been recognized for. 4.7 User Feedback
The standard sample producer shall establish policies and procedures to resolve complaints and feedback from users and other groups. All records of complaints and the research conducted by the standard sample producer and the corrective actions taken shall be kept. 4.8 Control of non-conforming standard samples
4.8.1 The standard sample producer shall establish policies and procedures to be implemented when any production activity fails to conform to the prescribed production procedures. The policy and procedures shall ensure:
a) specify the responsibilities and authority of the management personnel of non-conforming products; b) when non-conforming standard samples are confirmed, the measures that must be taken and the system to ensure the implementation of these measures shall be specified; c) the impact of non-conforming products shall be evaluated; d) when necessary, production shall be stopped and certificates shall be withheld; e) remedial measures shall be taken within the specified time frame; f) when necessary, the results of non-conforming standard samples that have been distributed to users shall be recalled; g) the responsibilities for authorizing resumption of work shall be specified.
GB/T15000.7—2001
Note: The identification of non-conforming standard samples or problems related to the quality system or valuation activities shall be carried out in all links of the quality system. For example, user complaints, quality control, inspection of consumable materials, observation or supervision of personnel, inspection of certificates, management review, internal and external audits. 4.8.2 When the assessment finds that the supply of non-conforming standard samples may occur again, or when the standard sample producer doubts whether the production complies with its own policies and procedures, the corrective action procedure in 4.9 shall be immediately followed to find out the cause and eliminate it. 4.9 Corrective Action
4.9.1 General
The reference standard producer shall establish policies and procedures and provide appropriate authority for implementing corrective actions when nonconforming reference standards or deviations from the quality system policies and procedures occur. Corrective actions taken to eliminate the cause of the nonconformance or deviation shall be commensurate with the magnitude of the problem and the risks that may result. The reference standard producer shall document and implement the modifications to the operating procedures as a result of the corrective actions. NOTE: Problems in the quality system and technical operations can be identified through various activities within the quality system. Examples include controls on nonconforming reference standards, internal and external audits, management reviews, and feedback from user or staff observations. 4.9.2 Cause Analysis
The corrective action procedure shall include an investigation process to determine the cause of the problem. This is sometimes the most difficult, yet critical, part of the corrective action procedure.
Generally, the root cause is not obvious, so a careful analysis of the potential causes of the problem is required. Potential causes include: the nature of the reference standard and its specifications, the determination method and procedure, the technical skills and training of personnel, and the materials and instruments (and their calibration) used in the production process.
4.9.3 Corrective Actions
The standard sample producer shall identify possible causes and corrective measures that can be taken. The selected measures shall eliminate the existing problems and prevent them from recurring.
4.9.4 Monitoring of Corrective Actions
After implementing the corrective action plan, the standard sample producer shall monitor its effects to ensure that the measures taken can effectively overcome the originally identified problems.
4.9.5 Effects
The effects of the corrective actions shall be submitted to management for review. 4.10 Preventive Actions
4.10.1 All operating procedures shall be reviewed regularly and systematically to identify all potential nonconformities and opportunities for improvement, both technical and related to the quality system. Preventive action plans shall be developed, implemented and monitored to reduce the occurrence of similar nonconformities and to take advantage of improvement opportunities.
Note 1: Preventive action is a proactive process to find opportunities for improvement rather than a reaction to problems or complaints that have already occurred. Note 2: Tools used in total quality management (TQM), such as brainstorming, flow charts, mind-mapping and parieto diagrams, can assist this process. Www.bzxZ.net
4.10.2 After implementing preventive actions, the master sample producer shall monitor the results to confirm the reduction of defects or other improvements within its operating range to establish the effectiveness of the preventive actions. 4.10.3 The results of the preventive actions shall be submitted to management review. 4.11 Records
4.11.1 General
4.11.1.1 The standard sample producer shall establish and maintain a procedure for the identification, collection, retrieval, access, storage, custody and handling of quality and technical records.
GB/T15000.72001
a) Quality records are records that provide objective evidence of the effectiveness of the quality system operation or the degree to which quality requirements are met. For example, it includes internal audit and management review reports, as well as corrective and preventive action records. b) Technical records are the accumulation of data and information obtained from the execution of inspection and calibration procedures. It shows that the specified quality or process parameters have been achieved. Technical records include forms, contracts, work log sheets, work manuals, inspection log sheets, control charts/diagrams, calibration reports/certificates and papers, reports and certificates issued to users. The standard sample producer shall ensure that the information required in the event of a dispute in the future has been recorded. 4.11.1.2 All records shall be legible and shall be stored and maintained in such a manner that they are easily retrievable and in a facility that provides an appropriate environment to prevent damage, deterioration or loss. The retention period for records shall be specified and documented.
Note: Records may be in any form of media, such as hard copy or electronic media. 4.11.1.3 All records shall be securely maintained and, where necessary, confidential to the user. 4.11.1.4 The producer of the standard shall have a procedure to protect electronically stored data and to prevent unauthorized access to or modification of such data. 4.11.2 Records and Reports
The producer of the standard shall establish and maintain a record system that is appropriate to the circumstances and complies with all applicable regulations. Taking into account the validity period of the standard, the producer of the standard shall specify that all independent basis observations, appropriate calculations and their resulting data (such as statistical treatments and estimates of uncertainty), calibration records and preparation reports shall be retained for a certain period of time after which they shall no longer be referenced. The results of each calibration or measurement (or group of calibrations) performed by the reference standard producer (and his collaborators, if necessary) shall be reported clearly and objectively in accordance with the work instructions for the calibration or characterization method. Such results shall normally be reported in the form of a "calibration or measurement report". The report shall include all the information necessary to interpret the calibration or measurement results and a summary of the methods used. This procedure applies to the internal reports of reference standard producers and should not be confused with the value reports and analysis certificates provided to users with reference standards.
4.12 Internal Audit
4.12.1 The reference standard producer shall conduct internal audits of its activities on a regular basis according to the prescribed schedule and procedures to verify that its operations comply with the requirements of this International Standard and the requirements of the quality system. The internal audit plan shall cover all quality elements of the quality system, including the technical and production activities leading to the completion of reference standards. The responsibility of the person responsible for quality is to plan and organize the audits according to the schedule and management requirements. Such audits shall be conducted by trained and qualified personnel who, when resources permit, shall be independent of the audited activities. Auditors should not audit their own activities unless there is a real need and they can prove that an effective audit has been conducted. Under normal circumstances, internal audits should be completed within one year. 4.12.2 When the audit finds that the effectiveness of the quality system operation or the correctness or effectiveness of the standard samples need to be corrected, the standard sample producer should take corrective measures in a timely manner and notify those users who may be negatively affected in writing. 4.12.3 All audit results and corrective measures taken for this should be recorded. The management of the standard sample producer should ensure that these measures are implemented within an appropriate and recognized time interval. 4.13 Management Review
4.13.1 The senior management of the standard sample producer should regularly review the quality system and production processes to ensure the continued suitability and effectiveness of the quality and benefit system and make necessary modifications or improvements. The review should consider the reports of management and supervisory personnel, the latest internal audit results, the assessment of external organizations, and user feedback (including complaints and other relevant factors). The management review cycle is once a year. The evaluation results should be fed back into the planning plan and should include the goals, objectives and activity plans for the next year.
4.13.2 The results of management reviews and any corrective actions taken as a result shall be recorded. Management shall ensure that these actions are implemented at appropriate and approved intervals. 5 Technical and production requirements
5.1 Management, personnel and training1 The reference standard producer shall conduct internal audits of its activities regularly in accordance with the specified schedule and procedures to verify that its operations comply with the requirements of this International Standard and the requirements of the quality system. The internal audit plan shall cover all quality elements of the quality system, including technical and production activities leading to the completion of reference standards. The person responsible for quality is responsible for planning and organizing the audits according to the schedule and management requirements. Such audits shall be conducted by trained and qualified personnel who, when resources permit, shall be independent of the activities being audited. Auditors shall not audit their own activities unless there is a real need and they can demonstrate that an effective audit has been conducted. Under normal circumstances, internal audits shall be completed within one year. 4.12.2 When the audit finds that the effectiveness of the operation of the quality system or the correctness or effectiveness of the reference standards needs to be corrected, the reference standard producer shall take corrective actions in a timely manner and shall inform in writing those users who may be negatively affected. 4.12.3 All audit results and corrective actions taken as a result shall be recorded. The management of the reference standard producer shall ensure that these actions are implemented at an appropriate and recognized interval. 4.13 Management Review
4.13.1 Senior management of the standard sample producer shall regularly review the quality system and production processes to ensure the continued suitability and effectiveness of the quality system and make necessary modifications or improvements. The review shall consider reports from management and supervisory personnel, the latest internal audit results, assessments by external organizations, and user feedback (including complaints and other relevant factors). The management review cycle is once a year. The results of the review shall be fed back into the planning program and shall include the objectives, goals and activity plans for the next year.
4.13.2 The results of the management review and the corrective actions taken as a result shall be recorded. Management personnel shall ensure that these measures are implemented at appropriate and approved time intervals. 5 Technical and Production Requirements
5.1 Management, Personnel and Training1 The reference standard producer shall conduct internal audits of its activities regularly in accordance with the specified schedule and procedures to verify that its operations comply with the requirements of this International Standard and the requirements of the quality system. The internal audit plan shall cover all quality elements of the quality system, including technical and production activities leading to the completion of reference standards. The person responsible for quality is responsible for planning and organizing the audits according to the schedule and management requirements. Such audits shall be conducted by trained and qualified personnel who, when resources permit, shall be independent of the activities being audited. Auditors shall not audit their own activities unless there is a real need and they can demonstrate that an effective audit has been conducted. Under normal circumstances, internal audits shall be completed within one year. 4.12.2 When the audit finds that the effectiveness of the operation of the quality system or the correctness or effectiveness of the reference standards needs to be corrected, the reference standard producer shall take corrective actions in a timely manner and shall inform in writing those users who may be negatively affected. 4.12.3 All audit results and corrective actions taken as a result shall be recorded. The management of the reference standard producer shall ensure that these actions are implemented at an appropriate and recognized interval. 4.13 Management Review
4.13.1 Senior management of the standard sample producer shall regularly review the quality system and production processes to ensure the continued suitability and effectiveness of the quality system and make necessary modifications or improvements. The review shall consider reports from management and supervisory personnel, the latest internal audit results, assessments by external organizations, and user feedback (including complaints and other relevant factors). The management review cycle is once a year. The results of the review shall be fed back into the planning program and shall include the objectives, goals and activity plans for the next year.
4.13.2 The results of the management review and the corrective actions taken as a result shall be recorded. Management personnel shall ensure that these measures are implemented at appropriate and approved time intervals. 5 Technical and Production Requirements
5.1 Management, Personnel and Training
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