General requirements for the competence of calibration and testing laboratories
Some standard content:
GB/T15481—1995
The International Organization for Standardization Committee on Conformity Assessment (ISO/CASCO) has formulated a number of guidelines on laboratory accreditation, which have been approved and issued by ISO and IEC: With the development of international trade and technical cooperation, countries attach great importance to the review, accreditation and supervision of laboratories. my country has already started the review and accreditation of laboratories. In order to standardize this work and align it with international practices, ISO/IEC Guides 25, 43 and 58 have been adopted and formulated into a series of national standards in my country, which are completely consistent with the original guidelines in terms of technical content and writing format.
This series of national standards includes:
GB/T 15481-1995 General requirements for the competence of calibration and inspection laboratories GB/T15483-1995 Development and operation of laboratory competence comparison tests GB/T15186—1995 General requirements for the operation and recognition of calibration and inspection laboratory accreditation systems This standard is equivalent to ISO/IEC Guide 25 and formulated into a national standard in my country. This standard was proposed by the State Administration of Technical Supervision. This standard is under the jurisdiction of the National Technical Committee for Quality Management and Quality Assurance. The main drafting units of this standard are: China Institute of Standardization and Information Classification and Coding, Supervision and Management Department of the State Administration of Technical Supervision, Guangzhou Electric Science Research Institute, China Electrical Equipment Testing Institute, Boiler and Pressure Vessel Testing Research Center of the Ministry of Labor. The main drafters of this standard are: Chen Zhitian, Zhou Haozhi, Gu Yanjun, Li Qiang, Jiang Hongfu, Yao Zhenzhi, Chu Fei. ISO/IEC Foreword
ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) together form a worldwide standardization system. ISO and IEC have established corresponding technical committees to deal with technical activities in specific fields, and national groups participate in the formulation of international standards through these technical committees. The technical committees of ISU and IEC cooperate in areas of mutual interest. Other international organizations that maintain contact with IS) and IEC, whether official or non-official, are also called participants in this work. At the request of the International Laboratory Accreditation Conference 1988 (ILAC 1988), the international laboratory accreditation conference held in Auckland (New Zealand) from 17 to 21 October 1988, the ISO Committee on Conformity Assessment (CASCO) has prepared this Guide, the fourth edition of ISO/IEC Guide 25. This Guide was approved by the Council of IEC in October 1990 and by the Council of ISO in December 1990. Unless consensus can be reached within a committee recognized by the Council of ISO and IEC, these documents prepared by CASCO are issued as Guides in accordance with the general rules for the preparation and publication of ISO and IEC standards. The work of ISO/CASCO in compiling Guides is the basis for third-party certification systems, which should be based, to the extent possible, on internationally recognized standards and procedures. Recognizing the primary role of the manufacturer in the declaration of conformity through the common manufacturer/customer relationship, Council resolutions have emphasized the need for guidance documents on third-party conformity assessment procedures to enable national systems to be compatible and to promote bilateral and multilateral collaboration.
These documents provide guidance, but it is expected that countries will adopt them without modification. Considering that some countries may adopt these guidelines directly, some words such as "shal1" are used in the guidelines to indicate those contents that are expected to be mandatory. The purpose of this document to provide guidance remains unchanged.
National Standard of the People's Republic of China
General requirements for the competence ofcalibration and testing laboratoriesCB/T15481—1995
Since the last revision of ISO/IEC Guide 25 in 1982, the use of quality systems in laboratories has increased significantly. Many countries use ISO/IEC Guide 25 as the basis for establishing quality systems in laboratories and recognizing their competence (e.g. through accreditation). In recent years, the field of quality assurance has developed rapidly, and a number of new and more complete guidelines and standards have been developed, and it is necessary to revise ISO/IEC Guide 25 to reflect these changes.
During this revision, the focus was on the activities of both calibration laboratories and test laboratories, and some other requirements for laboratory competence were taken into account, such as the Good Laboratory Practice (GLP) of the Organization for Economic Cooperation and Development (OFCI) and the requirements for laboratory competence in the ISO9000 series of quality assurance standards.
This standard provides a mechanism to increase confidence in calibration and test laboratories to prove that laboratory work meets common requirements. Mutual acceptance of calibration and test results between countries will help eliminate non-tariff trade barriers. The use of this standard will facilitate cooperation between laboratories and other institutions, promote the exchange of information and experience, and the coordination of standards and procedures. This standard applies to calibration laboratories and test laboratories. Laboratories that meet the requirements of this standard comply with the relevant requirements of GB/T19000-ISO9000 series standards in terms of common calibration and test activities, including the requirements of the model described in GB/T19002-ISO90002 when they provide calibration and test results as suppliers. For laboratories working in special fields, such as the chemical field (see the OECD's Good Laboratory Practice Guidelines) or the information technology field, the requirements of this standard should be supplemented and explained in accordance with GB/T 15486 General Requirements for the Operation and Recognition of Accreditation Systems for Calibration and Inspection Laboratories.
1 Scope
1.1 This standard specifies the general requirements for laboratories. If a laboratory wants to be accredited as having the ability to perform specific calibrations or inspections, it must demonstrate that its work complies with these general requirements. 1.2 In order to assess the technical competence of a laboratory or determine whether it meets other criteria, the organization or authority granting accreditation may specify some additional requirements and information to be provided based on the characteristics of the laboratory's tasks, but these additional requirements and information to be provided must be published. 1.3 This standard can be used by calibration and inspection laboratories when establishing and implementing their quality systems; it can also be used by accreditation bodies, certification bodies and other organizations related to laboratory competence. 2 Referenced standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. When this standard is published, the versions shown are valid. All standards will be revised. All parties using this standard should explore the possibility of using the latest versions of the following standards. GB/T6583-1994 Quality Management and Quality Assurance Terminology (idt1SO8402:1994) GH/T1900.1:1994 Quality Management and Quality Assurance Standards Part 1: Selection and Use Guide (idtIS0900 (1- State Technical Supervision Bureau 1995-02-14 approved 1995-10-01 implementation
1:1994)
GB/T 19001-1994
9001:19941
GB/T 15481—1995
Quality system - Quality assurance model for design, development, production, installation and service (idtISO GB/T 19002-1994 Quality system - Quality assurance model for production, installation and service (idt[S09002.1994) GB/T 19003—1994 Quality system - Quality assurance model for final inspection and testing (idIS09003:1994) Quality management and quality system elements - Part 1: Guidelines (idtIS09004-1.1994) GB/T 19004.1—1994
Basic terms and definitions for standardization and related activities TSO/IEC Guide 2:1991
International Basic Terms of Metrology (VIM), 1984. Published jointly by BIPM (International Bureau of Weights and Measures), IEC, ISO and OIML (International Organization of Legal Metrology).
3 Definitions
The relevant definitions in ISO/IEC Guide 2, GB/T 6583 and the International Basic Terms of Metrology (VIM) apply to this standard. The most relevant definitions are cited below and some other definitions applicable to this standard are listed. 3.1 Laboratory luboratory
A body engaged in calibration and/or verification.
1 If a laboratory is only part of an organization that performs other activities in addition to calibration and verification, the term "laboratory" only refers to that part of the organization that performs calibration and verification. 2 The term "laboratory" in this standard means a body that performs calibration or verification work in the following cases: at or from a fixed location,
at or from a temporary facility,or
in or from a movable facility
3. 2 Testing laboratory testing laboratory a laboratory engaged in testing work.
3.3 Calibration laboratory calibration laboratory a laboratory engaged in calibration work.
3.4 Calibration calibration
the set of operations that determine the relationship between the indication of a measuring instrument, a measuring system or the value represented by a physical measure and the corresponding known value of the measurand under specified conditions.
1 The result of calibration can be used to assess the indication error of a measuring instrument, a measuring system or a physical measure, or to give the value of a mark on any scale. 2 Calibration can also be used to determine other metrological characteristics. 3 The results of calibration may be recorded in a document usually called a calibration certificate or calibration report. 4 The results of calibration are sometimes expressed as a calibration factor or a series of calibration factors in the form of a calibration curve. LVIM—6.13
3.5 Inspection
Technical operation performed in accordance with specified procedures to determine one or more characteristics or performances of a given product, material, equipment, organism, physical phenomenon, process or service.
Note that inspection results are usually recorded in a document called an inspection report or inspection certificate. ISO/IEC Guide 2—12.1, as amended 13.6 Calibration method Technical procedure specified for calibration. 3.7 Test method
Technical procedure specified for testing. 3.8 Verification
GB/T15481-1995
Confirmation by examination and provision of evidence that specified requirements have been met. Note: In order to link with the management of measuring equipment, verification (verification) provides a method to check the deviation between the indication of the measuring instrument and the corresponding known value, and make the total value less than the maximum allowable error specified in the management standards, procedures and specifications of the relevant measuring equipment. Based on the verification (verification) results, the decision to restore to use, adjust, repair, degrade or report the quality is made. In all cases, a complete written record of the verification (verification) is required in the dedicated record of the measuring instrument. 3.9 Quality system quality system
The organizational structure, responsibilities, procedures, processes and resources for implementing quality management. [GB/T 6583-[ISO 8402~-3.8, excluding Notes] 3.10 Quality manual quality manual
The document that describes the quality policy, quality system and quality practices of an organization. Note: The quality manual may list other documents related to the laboratory's quality work. 3.11 Reference standard reference standard refers to the standard with the highest metrological characteristics available at a given location, from which the measurements made at that location are derived. [VIM - Clause 6.08]
3.12 Reference material A material or substance having one or more sufficiently well-established properties used for calibrating instruments, assessing measurement methods or assigning values to materials.
[ISO Guide 30 - Clause 2.1]
3.13 Certified reference material (CRM) A reference material having one or more property values identified by a technically valid method and accompanied by or traceable to a certificate or other document issued by an accreditation body.
[ISO Guide 30.2.2]
3.14 Traceability The property of enabling measurement results to be related to a related standard (usually an international or national reference) by a continuous chain of comparisons. VIM - Clause 6.12 1
VIM The Note to this definition applies only to the French version. 3.15 Proliriency testing The use of inter-laboratory comparisons to judge the calibration or testing work of a laboratory [ISU/IEC Guide 2 - Article I2.6, as amended] 3.16 Requirement
To be able to identify and assess an entity, the need for its characteristics is converted into a series of quantitative or literary specifications. 4 Organization and management
4.1 The laboratory shall have a clear legal status. It shall be organized and carry out its work in such a way that its fixed, temporary and mobile facilities meet the requirements of this standard.
4.2 The laboratory shall: a) have management personnel who have the authority and resources necessary to perform their duties; b) have measures to ensure that personnel are free from any commercial, financial or other pressures that may affect the quality of their work; c) be organized in a way that ensures that the independence and integrity of their judgment are maintained at all times; d) define and document the responsibilities, authority and photo relationships of all management, execution and verification personnel that affect the quality of calibration and inspection; e) be supervised by personnel who are familiar with the calibration or inspection methods and procedures, understand the calibration or inspection process and understand the review of results. The ratio of supervisory personnel to non-supervisory personnel should be to ensure that the supervision work is carried out normally: GR/T 15481--1995
There is a technical supervisor (regardless of the number) responsible for technical work and a quality supervisor (regardless of the title) responsible for the quality system and its implementation. He or she can directly communicate with the top management and technical supervisor responsible for the laboratory's quality policy and resource decisions. In some laboratories, the quality manager may also be the technical manager or his/her deputy; h) In the absence of the technical or quality manager, a deputy should be appointed! i) Where appropriate, there should be documented policies and procedures to protect the confidential information and proprietary rights of the client: when appropriate, sign and add laboratory comparison and capability comparison test plans. 5 Quality system, audit and review
5.1 The laboratory shall establish and maintain a quality system that is appropriate to the type, scope and amount of calibration and inspection work it undertakes. The elements of the quality system shall be documented and the quality documents shall be made available to laboratory personnel. The experimental plan shall clearly state the policies, objectives and commitments to achieve a good level of work and the quality of calibration or inspection services. The laboratory manager shall ensure that these policies and objectives are included in the quality manual and that all relevant personnel in the laboratory are aware of, understand and implement them. The quality manager shall be responsible for maintaining the current effectiveness of the quality manual. 5.2 The quality manual and related quality documents shall describe the policies and procedures established by the laboratory to meet the requirements of this standard. The quality manual and related quality documents shall include: a) the quality policy statement of the top management, including goals and commitments; b) the laboratory's organizational and management structure and its position in any parent organization and the corresponding organizational chart; d) the relationship between management work, technical work, support services and the quality system; e) job descriptions of key personnel and job descriptions of other personnel involved; f) identification of the laboratory's authorized signatories (when this concept is applicable); g) the laboratory's procedures for achieving measurement traceability; h) the scope of regular calibration and/or inspection; ensure that the laboratory reviews all new work 1) Measures to ensure that the laboratory has appropriate facilities and resources before starting new work: j) Calibration, verification (validation) and/or inspection procedures used; k) Procedures for handling calibration and inspection samples; 1) Major equipment and reference measurement standards used; m) Calibration, verification (validation) and maintenance procedures for equipment; 2) Inspection (validation) activities: including inter-laboratory comparisons, proficiency comparison inspection plans, use of standard materials and internal quality control programs; 3) Feedback and corrective action procedures to be followed when inspection discrepancies or deviations from documented policies and procedures are found; 4) Management measures for exceptions to documented policies and procedures or standard specifications; 5) Procedures for handling delays: 6) Confidentiality protection for all suggestions! 7) Audit and review procedures.
5.3 The laboratory should regularly audit its work to verify that its operation can continue to meet the requirements of the quality system. Such audits should be undertaken by trained and qualified personnel, and the auditors should have nothing to do with the work being audited. When the audit finds that the accuracy or effectiveness of the laboratory's calibration or test results are questionable, the laboratory should immediately take corrective measures and notify in writing all clients that may have been affected. 5.4 The manager should review the quality system established to meet the requirements of technical standards at least once a year to ensure its continued applicability and effectiveness, and make all necessary changes and improvements. 5.5 Problems found in audits and reviews and the resulting corrective measures should be documented. The person responsible for quality should ensure that these corrective measures are completed within the agreed time.
5.6 In addition to regular audits, the laboratory should also ensure the quality of the results provided to the client by implementing inspections and reviewing these inspection methods. If applicable, the following include (but not limited to): GB/T 154811995
a) Internal quality control programs that use statistical techniques as much as possible; b) Participation in capability comparison tests or comparisons by other laboratories; c) Regular use of certified reference materials and/or use of secondary reference materials in internal quality control; d) Repeated tests using the same or different methods; e) Re-testing of retained samples;
f) Correlation of test results of different characteristics of a sample. 6 Personnel
6.1 The inspection laboratory should have sufficient personnel, who should have received education and training appropriate to the tasks they undertake and have the corresponding technical knowledge and experience:
6.2 The inspection laboratory should ensure that its personnel can receive timely training. 6.3 The laboratory should keep records of the qualifications, training, skills and experience of technical personnel. 7 Facilities and Environment
7.1 The laboratory facilities, calibration and inspection areas, energy, lighting, heating and ventilation should facilitate the normal operation of calibration or inspection. 7.2 The environment in which calibration or inspection is carried out should not affect the validity of the results or have an adverse effect on the required measurement accuracy. This should be particularly noted when calibration and inspection are carried out in non-fixed locations. 7.3 Where appropriate, the laboratory should be equipped with facilities for effective monitoring, control and recording of environmental conditions. Factors that affect calibration or inspection, such as biological sterilization, dust, electromagnetic interference, humidity, power supply voltage, temperature, sound and vibration levels, should be given due attention. 7.4 When work in adjacent areas is not compatible, effective isolation measures should be taken. 7.5 Access to and use of all areas that affect the quality of work should be regulated and controlled. 7.6 Appropriate measures should be taken to ensure good housekeeping in the laboratory. Note: Compliance with relevant health and safety requirements is the responsibility of the laboratory, but this is beyond the scope of this standard. 8 Equipment and Standard Materials
8.1 The laboratory shall be equipped with all equipment (including standard materials) required for correct calibration and verification. If equipment outside the permanent control of the laboratory is to be used, it shall be ensured that the relevant requirements of this standard are met. 8.2 All equipment shall be properly maintained and the maintenance procedures shall be documented. If any equipment is overloaded or operated incorrectly, or the results displayed are questionable, or it is shown to be defective through verification (validation) or other means, it shall be immediately removed from use and clearly marked. If possible, it shall be stored in a specified place until it is repaired and calibrated, verified or tested to show that it operates satisfactorily. The laboratory shall check the impact of such defects on past calibrations or tests. 8.3 Each equipment (including standard materials) shall indicate its calibration status by appropriate grades, marks or other identification methods. 8.4 Records of each equipment and standard materials that are important for calibration and verification shall be kept. The record contents shall include: a) Name of the equipment; b) Manufacturer's name, model, serial number or other unique identification; c) Date of receipt and date of commissioning; d) Current location (if applicable); e) Condition upon receipt (e.g. new, used, modified); f) Copy of the manufacturer's instruction manual (if any); 3) Date and results of calibration and/or verification (validation) and date of next calibration and/or verification (validation); 4) Details of maintenance performed to date and future maintenance plans; 5) History of damage, failure, modification or repair; 6) Traceability of measurement and calibration CB/T 15481.-1995 9.1 All measuring and inspection equipment that may affect the accuracy or effectiveness of calibration or inspection shall be calibrated and/or verified (validated) before being put into use. The laboratory shall establish a plan for the calibration and verification (validation) of measuring and testing equipment. 9.2 An overall plan for the calibration and/or verification (validation) and confirmation of equipment shall be established and implemented to ensure that (where applicable) the laboratory's measurements are traceable to existing national measurement standards. The calibration certificate shall indicate (where applicable) the traceability to the national measurement standard and shall provide the measurement results and the associated measurement uncertainty and/or a statement of compliance with approved metrological specifications. 9.3 If it is not possible to trace back to the national measurement standard, the laboratory shall provide satisfactory evidence of the relevance of the results: for example, participation in an appropriate inter-laboratory comparison or capability comparison test program. 9.4 Measurement reference standards owned by the laboratory may only be used for calibration and not for other purposes unless it can be demonstrated that their performance as measurement reference standards will not be compromised.
9.5 Measurement references Calibration of standards should be carried out by bodies that can provide traceability to national measurement benchmarks. A plan should be prepared for the calibration and verification (validation) of metrological reference standards. 9.6 When traceable, reference standards and measuring and test equipment should be subjected to in-service inspections between calibrations and verifications. 9.7 Whenever possible, standard materials should be traceable to national or international measurement bases, or traceable to national or international standard reference materials. 10 Calibration and Verification Methods
10.1 The laboratory should prepare and document instructions for the use and operation of all equipment, the handling and preparation of samples for calibration and/or verification work, if the lack of instructions may endanger the calibration or verification work. All instructions, standards, manuals and reference data related to laboratory work should be current and readily available to personnel. 10.2 Laboratory The laboratory shall use appropriate methods and procedures for all calibration or verification and related activities within its scope of responsibility including sample collection, handling, transfer and storage, preparation, estimation of measurement uncertainty and analysis of calibration and/or verification data. These methods and procedures shall be consistent with the required accuracy and the relevant calibration or verification standards and specifications. 3. When calibration and verification methods are not specified: the laboratory shall choose methods that have been published in national standards, by well-known technical organizations or in relevant scientific literature or journals. 10.4 When methods that have not yet been established as standards must be used, these methods shall be agreed with the client, fully documented and approved for use by the client and other recipients of the report. 10.5 When sampling is part of the inspection method, the laboratory shall use documented procedures and appropriate statistical techniques to select samples. . 10.6 Calculations and data conversions should be properly checked. 10.7 When using computers or automated equipment to collect, process, calculate, record, report, store or retrieve calibration or test data, the laboratory should ensure that:
1) Comply with the requirements of the standards;
b) 1 Computer software should be documented and meet the requirements for use: ) Develop and implement procedures to protect data integrity, which should include (but not limited to) the integrity of data input or collection, data storage, data transmission and data processing;
1) Maintain computers and automated equipment to ensure correct function and provide the environment and working conditions necessary to ensure the integrity of calibration and test data:
e) Develop and implement appropriate procedures to ensure data security, including preventing unauthorized personnel from accessing and modifying computer records without authorization. 10.8 The laboratory shall establish procedures for the purchase, acceptance and storage of consumable materials used in its technical work. 11 Disposal of calibration and test samples
11.1 The laboratory shall have a unique documented system for identifying calibration or test samples to ensure that the identification of samples is not confused at any time. bZxz.net
CB/T15481--1995
11.2 When receiving calibration or test samples, their status shall be recorded, including whether they are abnormal or deviate from the standard status described in the corresponding calibration or test method. If there is any doubt as to whether the sample is suitable for the next calibration or test, or the sample does not conform to the instructions provided, or the required calibration or test is not fully specified, the laboratory shall ask the client before the work begins and ask for further explanation. The laboratory shall determine whether all necessary preparations have been completed for the sample or whether the client requires the laboratory to prepare or arrange for the preparation of the sample.
11.3 The laboratory shall have documented procedures and appropriate facilities to prevent deterioration or damage of samples used for calibration or inspection during storage, handling, preparation and calibration or inspection, and comply with any relevant instructions provided with the samples. If samples must be stored or handled under specific environmental conditions, these conditions shall be maintained, monitored and recorded (if necessary). When calibration and inspection samples or parts thereof need to be properly preserved (for example, for reasons of record, safety or value or for later inspection of calibration or inspection), the laboratory shall have storage and safety facilities to protect the condition and integrity of these samples or parts thereof that need to be properly preserved. 11.4 The laboratory technician shall prepare documented procedures for the receipt, storage or safe disposal of calibration or inspection samples, including any provisions necessary to maintain the integrity of the laboratory.
12 Records
12.1 The laboratory shall have a record keeping system appropriate to its circumstances and in compliance with any applicable regulations. All original observation records, calculated and derived data, calibration records, and copies of calibration certificates, test certificates, and test reports shall be filed and retained for an appropriate period of time. The record of each calibration and test shall contain sufficient information to ensure its reproducibility. The record shall include the identification of the personnel involved in the sampling, sample preparation, calibration, or test.
12.2 All records (including those relating to calibration and test equipment listed in 8.4), certificates, and reports shall be stored securely, properly maintained, and kept confidential by the client.
13 Certificates and Reports
13.1 The results of each calibration or test performed by the laboratory shall be reported accurately, clearly, unambiguously, and objectively in accordance with the specifications of the calibration or test method. These results are normally reported in the form of a calibration return, inspection report or test certificate, which should include all the information necessary to describe the calibration or test results and all the information required by the applicable law. 13.2 Each certificate or report should include at least the following information: a) title, such as "Calibration Certificate", "Verification Report" or "Test Certificate"; b) name and location of the laboratory where the calibration or test was carried out (if different from the laboratory address); c) unique identification of the certificate or report (such as a serial number) and identification of each and all parts; d) name and address of the client (if applicable); e) description and unambiguous identification of the sample being calibrated or tested; f) identity and condition of the calibration or test sample; h) date of receipt of the calibration or test sample and date of the calibration or test (if applicable); h) a description of the calibration or test sample used; Identification of the calibration or test method, or a clear statement of any non-standard methods used: i) the sampling procedure involved (if applicable); ii) any deviations, additions or subtractions from the calibration or test method and any other information relevant to the specific calibration or test, such as environmental conditions; k) the results of measurements, inputs and outputs (supported by tables, diagrams, sketches and photographs as appropriate), and their demonstrated validity; 1) a statement of the estimated uncertainty of the calibration or test result (if applicable); m) the signature, position or title of the person responsible for the contents of the certificate or report (regardless of how it was formed), and the date of issue; 2) if applicable, a statement that the results are valid only for the calibrated or tested samples; 3) a statement that the certificate or report may not be reproduced (except in full) without the written approval of the laboratory. 13.3 If the certificate or report contains the calibration or test results performed by a subcontractor, this should be clearly indicated. GB/T 15481—1995
13.4 Special care and attention should be paid to the layout of certificates and reports, especially the expression of calibration or test data should be easy for readers to understand. The format of each type of calibration or test report should be carefully designed one by one, but the titles should be standardized as much as possible. 13.5 Major revisions to issued calibration certificates, test reports or inspection certificates can only be made in the form of another document, or in the form of a data modification notice including the statement "Supplement to the calibration certificate (or test report or inspection certificate) with serial number ×××× (or other identification method)" or in the form of an equivalent text description. Such revisions should comply with all the corresponding requirements of Clause 12 of this standard.
13.6 When circumstances such as defects in the measuring or inspection equipment are discovered, which cast doubt on the validity of the results given in any calibration certificate, test report, inspection certificate or amendment to the report or certificate, the laboratory shall immediately notify the client in writing. 1 3.7 When the client requires the transmission of calibration or test results by telephone, telex, fax or other electronic or electromagnetic means, the laboratory shall ensure that its staff follows documented procedures that ensure that the requirements of this standard are met and confidentiality is maintained. 14 Subcontracting of calibration or test work
14.1 If the laboratory subcontracts any part of the calibration or test work, this part of the work shall be arranged to be performed in a laboratory that meets the requirements of this standard. In terms of subcontracted work, the laboratory shall ensure and be able to confirm that its subcontractor is capable of completing the undertaken work and can meet the same competence criteria. The laboratory shall notify the intention to subcontract any part of the test work to another unit in writing. Client. 14.2 The laboratory shall record and maintain detailed information on the investigation of the subcontractor's capability and compliance, and maintain a register of all subcontracting matters.
15 External support services and supplies
15.1 When the laboratory seeks external services and supplies not covered by this standard to support its calibration or inspection, it shall only use external support services and supplies that can fully guarantee the quality of the laboratory's calibration or inspection. 15.2 If there is no independent quality assurance of the external support services or supplies, the laboratory shall establish procedures to ensure that the purchased equipment, materials and services meet the specified requirements. Whenever possible, the laboratory shall ensure that the purchased equipment and consumables are tested and maintained as required by the corresponding calibration or inspection requirements before use. 15-3 The laboratory shall maintain records of all suppliers who provide support services or supplies for calibration or inspection. 16.1 The laboratory shall have documented policies and procedures for handling complaints from clients or other parties regarding the laboratory's work, and shall record and maintain all complaints and their handling. 16.2 When any concern or other matter raises doubts about the laboratory's compliance with its policies or procedures, or with the requirements of this standard, or about other matters related to the laboratory's calibration or inspection quality, the laboratory shall ensure that these scopes of work and related responsibilities are promptly reviewed in accordance with the requirements of Section 5.3 of this standard.6 The laboratory shall promptly notify the client in writing if any doubt arises as to the validity of the results given in any calibration certificate, test report, inspection certificate or amendment to a report or certificate, such as the discovery of a defect in the measuring or inspection equipment. 13.7 When the client requires the transmission of calibration or inspection results by telephone, telex, fax or other electronic or electromagnetic means, the laboratory shall ensure that its personnel follow documented procedures which ensure that the requirements of this standard are met and confidentiality is maintained. 14 Subcontracting of calibration or inspection work
14.1 If the laboratory subcontracts any part of the calibration or inspection work, this part of the work shall be arranged to be performed by a laboratory that meets the requirements of this standard. In the case of subcontracted work, the laboratory shall ensure and be able to verify that its subcontractors are capable of carrying out the work undertaken and meet the same competence criteria. The laboratory shall notify the client in writing of its intention to subcontract any part of the inspection work to another party. 14.2 The laboratory shall record and maintain details of investigations into the competence and compliance of subcontractors and shall maintain a register of all subcontracting matters.
15 External Support Services and Supplies
15.1 When seeking external services or supplies not covered by this standard to support its calibration or inspection, the laboratory shall only use external support services and supplies that can fully guarantee the quality of the laboratory's calibration or inspection. 15.2 If there is no independent quality assurance for external support services or supplies, the laboratory shall establish procedures to ensure that the purchased equipment, materials and services meet the specified requirements. Whenever possible, the laboratory shall ensure that the purchased equipment and consumables are inspected, calibrated or verified (validated) according to the standard specifications required for the corresponding calibration or inspection before use. 15-3 The laboratory shall keep records of all suppliers who provide the support services or supplies required for calibration or inspection. 16 Complaints
16.1 The laboratory shall establish documented policies and procedures to deal with complaints raised by clients or other units regarding the laboratory's work, and record and preserve all complaints and their handling methods. 16.2 When any concern or other matter raises doubts about the laboratory's compliance with its policies or procedures, with the requirements of this International Standard, or with other matters concerning the laboratory's calibration or inspection quality, the laboratory staff shall ensure that these areas of work and related responsibilities are promptly reviewed in accordance with the requirements of Section 5.3 of this International Standard.6 The laboratory shall promptly notify the client in writing if any doubt arises as to the validity of the results given in any calibration certificate, test report, inspection certificate or amendment to a report or certificate, such as the discovery of a defect in the measuring or inspection equipment. 13.7 When the client requires the transmission of calibration or inspection results by telephone, telex, fax or other electronic or electromagnetic means, the laboratory shall ensure that its personnel follow documented procedures which ensure that the requirements of this standard are met and confidentiality is maintained. 14 Subcontracting of calibration or inspection work
14.1 If the laboratory subcontracts any part of the calibration or inspection work, this part of the work shall be arranged to be performed by a laboratory that meets the requirements of this standard. In the case of subcontracted work, the laboratory shall ensure and be able to verify that its subcontractors are capable of carrying out the work undertaken and meet the same competence criteria. The laboratory shall notify the client in writing of its intention to subcontract any part of the inspection work to another party. 14.2 The laboratory shall record and maintain details of investigations into the competence and compliance of subcontractors and shall maintain a register of all subcontracting matters.
15 External Support Services and Supplies
15.1 When seeking external services or supplies not covered by this standard to support its calibration or inspection, the laboratory shall only use external support services and supplies that can fully guarantee the quality of the laboratory's calibration or inspection. 15.2 If there is no independent quality assurance for external support services or supplies, the laboratory shall establish procedures to ensure that the purchased equipment, materials and services meet the specified requirements. Whenever possible, the laboratory shall ensure that the purchased equipment and consumables are inspected, calibrated or verified (validated) according to the standard specifications required for the corresponding calibration or inspection before use. 15-3 The laboratory shall keep records of all suppliers who provide the support services or supplies required for calibration or inspection. 16 Complaints
16.1 The laboratory shall establish documented policies and procedures to deal with complaints raised by clients or other units regarding the laboratory's work, and record and preserve all complaints and their handling methods. 16.2 When any concern or other matter raises doubts about the laboratory's compliance with its policies or procedures, with the requirements of this International Standard, or with other matters concerning the laboratory's calibration or inspection quality, the laboratory staff shall ensure that these areas of work and related responsibilities are promptly reviewed in accordance with the requirements of Section 5.3 of this International Standard.
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