Decision No. 115/2008/QD-BNN Issuing Temporary Provisions on Requirements for Agricultural, Forestry, and Aquatic Product Quality Testing Laboratories

Pursuant to …;

Issuing temporary regulations on requirements for quality testing laboratories in agriculture, forestry, and fisheries

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THE MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT

Pursuant to the Law on Technical Standards and Regulations No. 68/2006/QH11 adopted by the 11th National Assembly on June 29, 2006, which took effect from January 1, 2007; Pursuant to the Law on Product Quality and Goods No. 05/2007/QH12 adopted by the 12th National Assembly on November 21, 2007, which took effect from July 1, 2008;

Pursuant to the Ordinance on Food Safety and Hygiene; Decree No. 163/2004/NĐ-CP dated September 7, 2004 detailing certain provisions of the Ordinance on Food Safety and Hygiene;

Pursuant to Decree No. 01/2008/NĐ-CP dated January 3, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Issued herewith are the Temporary Regulations on Requirements for Quality Testing Laboratories in Agriculture, Forestry, and Fisheries.

At the proposal of the Director of the Directorate of Quality Assurance for Agriculture, Forestry and Fisheries Products,

Pursuant to …;:

Article 1. These Regulations shall take effect fifteen (15) days from the date of publication in the Official Gazette.

Article 2. The Heads of the Office of the Ministry, Directors of the Department of Quality Management of Agricultural and Aquatic Products, Heads of the Science, Technology, and Environment Departments, Directors of Provincial Departments of Agriculture and Rural Development, Heads of units, organizations, and individuals concerned are responsible for implementing these Regulations.

Article 3. Dao Duc Phat

 

REGULATIONS

Issued together with Decision No. 115/2008/QĐ-BNN dated December 3, 2008 of the Ministry of Agriculture and Rural Development

(Chapter I. These Regulations set out requirements for laboratories capable of conducting biological and chemical tests to support state management of food safety and hygiene quality within the purview of the Ministry of Agriculture and Rural Development.)

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hChapter II. Scope of Application

GENERAL PROVISIONS

3. Amend Clause 3 Article 2 as follows:PointThis Decree applies to organizations and individuals in Vietnam, and foreign individuals related to foreign motor vehicles driven by foreigners to participate in traffic in Vietnam for tourism purposes.

The scope of application of these Regulations includes laboratories under various economic sectors, including those of foreign organizations and individuals located in Vietnam (hereinafter referred to as laboratories).

3. Amend Clause 3 Article 2 as follows:PointArticle 4. Organization

1. Laboratories or organizations with laboratories must have legal personality and be able to bear legal responsibility.

Article 3. Explanation of Terms

2. Laboratories are responsible for performing testing activities that meet the requirements of these Regulations as well as those of competent authorities.

3. In cases where laboratories are part of larger organizations, organizational arrangements must ensure that conflicting interest departments such as production, marketing, or finance will not adversely affect the compliance of laboratories with the requirements of these Regulations.

4. Laboratories must have provisions or commitments from authorized persons to ensure that laboratory staff are not subjected to any commercial, financial, or other pressures that may impact the reliability, independence of decisions, and the integrity of test results.

5. Laboratories must:

a. Have managerial and technical staff with the authority and resources necessary to perform their duties, including implementing, maintaining, and improving the quality management system.

b. Ensure that all members of the laboratory are not subject to any internal or external pressure that may affect the quality of their work.

Chapter 2.

c. Define responsibilities, authorities, and working relationships of all employees (managers, performers, or inspectors) who influence the quality of testing.

3. Amend Clause 3 Article 2 as follows:Pointd. Conduct appropriate supervision of testing personnel, including trainees, through personnel familiar with testing methods and procedures, as well as the purpose of each test, and by evaluating test results.

Article 5. Quality Management System

1. Laboratories must establish, implement, and maintain a quality management system appropriate to their scope of operations. Laboratories must document necessary procedures and guidelines to ensure the quality of test results.

2. Laboratories must develop a quality manual including or referring to supporting procedures, including technical procedures, the quality manual must outline the structure of the documentation used in the quality management system.

Article 6. Control of Documents

1. Laboratories must establish and maintain procedures to control all documents within the quality management system (internal or external origin).

2. All documents must be reviewed and approved by authorized persons before issuance.

3. Document control procedures must ensure that:

a. All approved documents are always available at all locations where laboratory activities are performed;

b. Documents are periodically reviewed, and when necessary, revised to ensure they remain relevant and comply with applicable requirements.

3. Amend Clause 3 Article 2 as follows:Pointu 5. Quality Management System

1. The laboratory must establish, implement, and maintain a quality management system appropriate to its scope of activities. The laboratory must document all necessary procedures and guidelines to ensure the quality of testing results.

2. The laboratory must develop a quality manual including or referring to supporting procedures, including technical procedures, and the quality manual must outline the structure of the documentation used in the quality management system.

3. Amend Clause 3 Article 2 as follows:Pointu 6. Document Control

1. The laboratory must establish and maintain procedures for controlling all documents within the quality management system (both internal and external origin).

2. All documents must be reviewed and approved by authorized personnel before issuance.

3. The document control procedure must ensure that:

a. All appropriate approved documents are always available at all locations where laboratory activities are performed;

b. Documents are periodically reviewed, and when necessary, revised to ensure they remain suitable and comply with applicable requirements.

c. All obsolete or outdated documents must be promptly retrieved and appropriately marked to prevent accidental use.

d. Documents retained due to legal requirements or for information archiving purposes must be appropriately marked.

4. Quality management system documents must be clearly identifiable. Such identification shall include the date of issuance, review date, page number, total number of pages, and authority issuing the document.

5. The review and approval of document changes must be conducted by the original reviewing department, unless otherwise specifically designated. The designated department must have access to appropriate information to serve as the basis for review and approval.

6. The laboratory must establish procedures describing how to implement and control changes to documents stored in computer systems.

3. Amend Clause 3 Article 2 as follows:Point7. Reviewing requirements, proposals, and contracts

1. The laboratory must establish and maintain procedures for reviewing requirements, tender proposals, and contracts. Policies and procedures for reviewing to decide on testing contracts must ensure that:

a. Requirements, including the methods to be used, are fully defined, documented, and understood;

b. The laboratory has the capability and resources to meet the requirements;

c. Suitable testing methods are selected and capable of meeting customer requirements;

d. Any discrepancies between requirements and contracts are resolved before work commences;

e. Customers are notified of any changes to the contract.

2. The review process also applies to all sub-contract works performed by the laboratory.

3. Amend Clause 3 Article 2 as follows:Point8. Subcontracting for Testing

1. If the laboratory uses subcontractors for work, it must select competent subcontractors. A competent subcontractor is one that complies with the requirements of this regulation or meets the requirements of the TCVN ISO/IEC 17025:2007 standard.

2. The laboratory must notify the customer in writing about the use of subcontractors and obtain the customer's consent, preferably in writing.

3. The laboratory must maintain a list of all testing subcontractors and must have documentation proving that these subcontractors comply with this regulation or meet the requirements of the TCVN ISO/IEC 17025:2007 standard.

3. Amend Clause 3 Article 2 as follows:Point9. Procurement of Testing Services and Materials

1. The laboratory must have procedures for selecting and purchasing services and materials that affect test quality.

2. The laboratory must ensure that supplies, reagents, and consumable materials purchased and affecting test quality will not be used until they are tested or confirmed to meet standards or specified requirements in relevant testing methods. Records of conformity testing activities must be kept.

3. It is encouraged for the laboratory to evaluate suppliers of consumable materials, supplies, and major services affecting test quality. The laboratory must maintain evaluation records, acceptance certificates, and approved supplier lists.

3. Amend Clause 3 Article 2 as follows:Point10. Control of Nonconforming Testing

1. The laboratory must develop and apply procedures when there is any nonconformity related to the implementation of laboratory procedures, methods, or guidelines. These procedures must ensure:

a. Management responsibilities and authorities for handling nonconformities, actions (including stopping work, retaining test reports if necessary) are identified and implemented upon discovery of nonconformities;

b. An assessment of the degree of nonconformity;

c. Immediate corrective action taken along with decisions regarding the acceptability of nonconformities;

d. When necessary, the nonconformity is reported to the customer and nonconforming results are withdrawn;

e. Authority to continue work.

2. When an assessment indicates that nonconformities may recur or there is doubt about the conformity of laboratory activities with procedures, the laboratory must immediately implement corrective action procedures as stipulated in Article 11.

3. Amend Clause 3 Article 2 as follows:Point11. Corrective Actions

1. The laboratory must establish procedures and delegate appropriate authority to implement corrective actions when nonconformities or deviations from quality management system procedures or technical activities are discovered.

2. Corrective action procedures must begin with an investigation to determine the root cause of the problem.

3. When corrective actions are required, the laboratory must propose possible corrective actions and implement the most suitable one to eliminate the existing issue and prevent its recurrence.

4. Corrective actions must be considered in relation to the importance and risk level of the problem.

5. The laboratory must document and implement any changes resulting from the investigation into corrective actions.

6. The laboratory must monitor the results to ensure that the corrective actions taken are effective.

7. If necessary, a follow-up assessment must be conducted after implementing corrective actions to determine their effectiveness. The assessment must ensure that appropriate areas of activity are evaluated according to Article 13.

3. Amend Clause 3 Article 2 as follows:Point12. Record Control

1. The laboratory must establish and maintain procedures for identifying, collecting, classifying, accessing, filing, storing, maintaining, and disposing of quality and technical records.

2. All records must be clear, preserved, and stored in a manner that ensures easy retrieval and maintained in an appropriate environment to prevent damage, deterioration, or loss. Retention periods for records must be specified.

3. The laboratory must retain records of original measurements, processed data, and necessary information, calibration records, employee records, and a copy of each issued test report for a specified period of time. Each test record must contain sufficient information to identify factors affecting measurement uncertainty and to allow the test to be repeated under conditions as close as possible to the initial conditions. Records must include identification information about the person responsible for sample collection, the performance of each test, and the verification of results.

4. When errors are found in the records, they must be marked with a line through the error, not erased so as to make reading difficult, and the correct value must be recorded next to it. All changes in the records must be confirmed by the person making the correction with their signature or initials. In cases where records are stored in electronic form, appropriate measures must be taken to prevent loss or alteration of original data.

3. Amend Clause 3 Article 2 as follows:PointChapter 13. Internal Evaluation

1. The laboratory must periodically conduct internal evaluations of its activities according to a planned schedule and procedure to check and confirm whether its activities continue to comply with the requirements of the quality management system and this regulation. This evaluation must be carried out by trained and qualified personnel, if resources permit, these individuals must be independent from the activity being evaluated.

2. When the evaluation detects doubts about the effectiveness of operations or the accuracy and validity of test results, immediate corrective actions must be taken, and customers must be notified in writing if an investigation shows that the laboratory's results may be affected.

3. Records of the evaluated field of activity, findings during the evaluation, and corrective actions arising from the evaluation must be retained.

4. The laboratory must verify the activities following internal evaluation and document the implementation and effectiveness of the corrective actions taken.

hChapter 3.

TECHNICAL REQUIREMENTS

3. Amend Clause 3 Article 2 as follows:PointChapter 14. General Requirements

1. There are many factors that determine the accuracy and reliability of tests conducted by the laboratory. These factors include:

a. Human factors;

b. Facilities and environmental conditions;

c. Testing methods and method efficacy;

d. Equipment;

e. Measurement traceability;

f. Sampling;

g. Test sample management and calibration.

2. The degree to which these factors contribute to the overall measurement uncertainty varies significantly between different types of tests. The laboratory must consider these factors when developing testing methods and procedures, training and qualifications of staff, as well as in selecting and calibrating equipment used by the laboratory.

3. Amend Clause 3 Article 2 as follows:PointChapter 15. Personnel

1. Laboratory leadership must ensure that all individuals operating equipment, performing testing tasks, evaluating results, and approving test reports have the necessary capability. When the laboratory uses trainees, there must be appropriate supervision. Staff performing specific tasks must be qualified based on appropriate training, experience, or demonstrated skills.

2. The laboratory must have procedures to determine training needs and organize training for staff, training programs must be suitable for current and future laboratory tasks, and the effectiveness of training activities must be evaluated.

3. The laboratory must maintain current job descriptions for managers, technical staff, and support staff involved in testing.

4. Leadership must assign specific responsibilities to those collecting samples, conducting tests, issuing test certificates, providing comments and interpretations, and operating special equipment. The laboratory must maintain records of the authority, capability, education, expertise, skills, and relevant experience of all technical staff including contract employees. Information must always be available and dated when responsibilities are assigned.

3. Amend Clause 3 Article 2 as follows:PointChapter 16. Facilities and Environmental Conditions

1. Laboratory facilities serving testing include (but are not limited to) energy sources, lighting, and environmental conditions that must be ensured to accurately perform testing.

2. The laboratory must ensure that environmental conditions do not affect results or adversely impact the quality of any measurement. The laboratory must pay particular attention when sampling and testing are performed at locations other than the fixed location of the laboratory. The laboratory must document technical requirements for facilities and environmental conditions that may affect test results.

3. The laboratory must monitor, control, and record environmental conditions as required by technical regulations, methods, procedures, or places where environmental conditions may affect result quality.

4. The laboratory must effectively separate adjacent areas with incompatible activities. The laboratory must implement cross-contamination prevention measures.

5. The laboratory must establish industrial hygiene measures. Procedures must be established if necessary.

3. Amend Clause 3 Article 2 as follows:PointChapter 17. Testing Methods and Method Approval

1. General Requirements

a. The laboratory must use appropriate procedures and methods for all tests. This includes sample collection, storage, transportation, retention, and preparation for testing. Testing methods must meet the minimum reporting limit (MRPL) or detection limit (LOD) requirements set by the importing country's regulatory authority or Vietnam.

b. The laboratory must provide user and operation manuals for all related equipment, as well as sample storage guidelines. All guides, standards, handbooks, and reference data related to work must be updated and readily available for staff use.

c. Any changes to the testing method may only be applied when such changes have been documented in writing, proven technically correct, permitted for use, and accepted by the customer.

2. Selection of Methods

a. The laboratory must use testing methods, including sampling methods, that meet the customer's requirements and are appropriate for the test. Priority should be given to using methods published in the form of international, regional, or national standards. The laboratory must ensure the use of the latest version of the standard unless this version is not suitable or cannot be implemented.

b. When the customer does not clearly specify the method to be used, the laboratory must select an appropriate method published in international, regional, or national standards or issued by reputable technical organizations, or specified by the equipment manufacturer. Laboratory-established or accepted methods may be used if they are suitable for the intended purpose and approved. The customer must be informed about the method used. The laboratory must confirm its capability to correctly apply the standard method before commencing testing.

c. The laboratory must notify the customer when requested methods are unsuitable or outdated.

3. Methods Developed by the Laboratory

a. Introducing testing methods developed by the laboratory for internal use must be a planned activity and must be assigned to competent staff with necessary resources provided.

b. Plans must be updated during development, and the laboratory must ensure effective information exchange among all involved personnel.

4. Non-standard Methods

a. When non-standard methods are required, these methods must be agreed upon with the customer and must include clear specifications regarding the customer's requirements and the purpose of the test. The developed method must be appropriately approved before use.

b. For new methods, a testing procedure must be established before conducting the test, and it must include at least the following information:

(i) Scope of application

(ii) Description of sample types tested

(iii) Parameters or quantities and their ranges

(iv) Equipment and devices, including technical features

(v) Required primary standards and reference materials

(vi) Environmental conditions and stability periods required

(vii) Criteria and requirements for acceptance/rejection

(viii) Recorded data, analysis methods, and data presentation

(ix) Uncertainty or estimation procedures for measurement uncertainty

(x) Procedures described include:

+ Sample storage, transportation, retention, and preparation;

+ Pre-test checks performed before starting work;

+ Checks to ensure equipment operates correctly, and when necessary, calibration and adjustment of equipment before each use;

+ Recording observation and results methods;

+ All safety measures to be followed;

5. Approval of Testing Methods

a. Approval involves confirming through inspection and providing objective evidence that specific requirements for use have been met.

b. The laboratory must approve non-standard methods, methods developed by the laboratory, standard methods used outside their intended scope, and modifications or expansions of standard methods to confirm that the method is suitable for the intended use. This approval must be comprehensive enough to meet the application requirements or fields of application defined. The laboratory must record the results obtained, the approval procedures used, and announce that the method is suitable for the intended use.

c. The range and accuracy of values obtained from the approved method must be consistent with the customer's requirements when evaluating the intended use (e.g., result uncertainty, detection limit, method selectivity, linearity, resistance to external influences, repeatability/reproducibility limits).

6. Evaluation of Measurement Uncertainty

a. Laboratories performing internal calibration must have and apply procedures for evaluating measurement uncertainty for all calibrations.

b. The laboratory must have and apply procedures for evaluating measurement uncertainty. In certain cases, the nature of the testing method may limit strict calculation of measurement and statistical uncertainty. In such cases, the laboratory must at least identify components of measurement uncertainty, conduct a reasonable evaluation, and ensure that the reporting format does not mislead about measurement uncertainty. A reasonable evaluation must be based on knowledge of the method's characteristics and the field of measurement and must use, for example, previous experience and valuable data.

c. When evaluating measurement uncertainty, all significant components of uncertainty in specific situations must be considered using appropriate analytical methods.

7. Data Control

a. Calculations and data transmission must be suitably checked in a systematic manner.

b. When computers or automated equipment are used to collect, process, report, store, or retrieve test data, the following must be ensured:

(i) Computer software used by users must be fully documented, detailed, and approved as suitable for use;

(ii) Procedures for protecting data must be established and applied, which must include (but are not limited to) the ability to protect data integrity and confidentiality when entering or collecting data, storing data, transmitting and processing data;

(iii) Computers and automated equipment must be maintained to ensure good operation under environmental and operational conditions necessary to maintain the integrity of test data.

3. Amend Clause 3 Article 2 as follows:Pointu 18. Equipment

1. The laboratory must be equipped with all necessary devices to take samples, measure, and conduct tests required to accurately perform testing work (including sampling, preparing test samples, processing and analyzing test data).

2. Equipment and software used for testing and sampling must have the capability to achieve the necessary accuracy and must comply with relevant technical regulations related to corresponding testing. Calibration programs must be established for significant quantities or values of equipment when these characteristics significantly affect the results. Before being put into use, equipment (including sampling equipment) must be calibrated or tested to confirm that the equipment meets the technical requirements stipulated by the laboratory and complies with the technical regulations of corresponding standards.

3. Only authorized personnel may use the equipment. The laboratory must always have updated user and maintenance manuals available (including equipment instruction manuals provided by manufacturers) for suitable laboratory staff to use.

4. All items of equipment and equipment software used for testing that are important to the results must be clearly identified.

5. The laboratory must maintain a record for each item of equipment and software that is important to the test performed. The record must include at least the following information:

a. Identification of the equipment item and equipment software.

b. Manufacturer's name, serial number, or other clear identification.

c. Equipment inspection in compliance with technical regulations.

d. Current location of the equipment.

e. Manufacturer's instructions (if any) or reference to where such instructions can be found.

f. Date, result, and copy of the calibration or adjustment report and acceptance criteria, next calibration date.

g. Appropriate maintenance plan and maintenance carried out according to the plan.

h. Any damage, malfunction, repair, or change to the equipment.

6. The laboratory must have procedures for storing, transporting, retaining, safely using, and planned maintenance of measuring equipment to ensure the equipment operates well and to prevent contamination or deterioration.

7. Overloaded, poorly managed, or yielding suspicious results equipment, or showing defects or exceeding permitted limits must not be used. Such equipment must be isolated or clearly labeled as not to be used until it has been repaired and testing and calibration show it performs accurately. The laboratory must check and consider the impact of defects or deviations from specified limits on previous tests and must apply procedures for managing non-conformities.

8. When interim calibration checks are necessary to maintain the reliability of the calibration status of the equipment, the interim checks must be conducted according to a prescribed procedure.

9. In cases where calibration indicates adjustments are needed, the laboratory must have procedures to ensure that versions (for example, in computer software) are accurately updated.

10. Testing equipment including both hardware and software must be protected against adjustments that could compromise the accuracy of test results.

3. Amend Clause 3 Article 2 as follows:Pointu 19. Measurement Traceability

1. All equipment used for testing work, including auxiliary measuring equipment (such as for determining environmental conditions) that significantly affects the accuracy or correctness of test results or sampling must be calibrated before use. The laboratory must develop plans and procedures for calibrating equipment.

2. When the laboratory uses external calibration services, measurement traceability must be ensured through the use of calibration services from accredited calibration laboratories capable of measuring and ensuring traceability. Calibration certificates issued by calibration laboratories must include measurement results including measurement uncertainty.

3. The laboratory must develop plans and procedures for calibrating primary standards. Primary standards must be calibrated by an organization capable of providing traceability. Laboratory-held primary standards may only be used for calibration and not for other purposes. Primary standards must be calibrated before and after any adjustments.

4. When possible, standard samples must be derived from SI units or certified standard samples. Internal standard samples must be checked to the maximum extent economically and technically feasible.

5. The laboratory must conduct interim checks according to procedures and plans to maintain the reliability of the calibration status of primary standards and standard samples.

6. The laboratory must have safety management procedures for storing, transporting, retaining, and using primary standards and standard samples to prevent contamination or damage and to protect their integrity.

3. Amend Clause 3 Article 2 as follows:Pointu 20. Sampling

1. The laboratory must have sampling plans and procedures when taking samples of substances, materials, or products for testing. Sampling plans and procedures must be available at the sampling site. Sampling plans must be rational and based on appropriate statistical methods. The sampling process must record controlled factors to ensure the validity of test results.

2. When a customer requests modifications, additions, or deletions to documented sampling procedures, these requests must be detailed recorded along with appropriate sampling data and all related documentation regarding test results must be retained and communicated to relevant parties.

3. The laboratory must have procedures for recording data and activities related to sample collection that form part of the testing activities conducted by the laboratory. These records must include the sampling procedure used, identification of the sampler, environmental conditions, and diagrams or similar methods to determine the sampling location when necessary, and, if applicable, statistical sampling procedures applied.

3. Amend Clause 3 Article 2 as follows:Pointu 21. Management of test samples and calibration

1. The laboratory must have procedures for transporting, receiving, managing, storing, protecting, archiving, or disposing of test samples, including all necessary provisions to protect the integrity of the test samples and to protect the interests of customers.

2. The laboratory must have a system for coding test samples. The coding of samples must be maintained at the laboratory throughout the time the samples exist at the laboratory. The sample coding system must ensure that samples are not confused in practice or when referred to in other records or documents.

3. The laboratory must record in the sample receipt record any differences or deviations from the specified conditions observed. When there is any doubt about the suitability of a sample, or when a sample does not conform to the provided description, as well as when the required test is not detailed, the laboratory must consult with the customer regarding additional guidance before proceeding and must record this consultation.

4. The laboratory must have appropriate procedures and means to prevent damage, loss, or harm to test samples during storage, preservation, and preparation. When samples must be stored under specified environmental conditions, these conditions must be maintained, controlled, and recorded.

3. Amend Clause 3 Article 2 as follows:Pointu 22. Assurance of Test Results Quality

1. The laboratory must have quality control procedures to verify the effectiveness of the tests performed. Data results must be recorded in such a way that trends in the results can be identified. This verification must be planned and include, but not be limited to:

a. Regular use of certified reference materials or internal controls through the use of secondary reference materials;

b. Participation in inter-laboratory comparison programs and proficiency testing;

c. Repeating tests using the same method or different methods;

d. Testing retained samples;

e. Correlation of results from different characteristics of a sample.

2. Quality control data must be analyzed, and corrective and preventive actions must be taken when these data fall outside established criteria, and incorrect results must be reported.

3. Amend Clause 3 Article 2 as follows:Pointu 23. Reporting Results

1. Test results performed by the laboratory must be reported accurately, clearly, specifically, objectively, and in accordance with specific instructions in the test method.

2. Information included in the test report includes, but is not limited to, the contents specified in Clause 3 of this Article. Results may be reported in a simpler manner when tests are performed for internal customers. If information listed in Clause 3 of this Article is not communicated to the customer, it must be available within the laboratory.

3. A test report must include at least the following information, unless the laboratory has a valid reason not to comply:

a. Title, for example, "Test Report";

b. Name and address of the laboratory and location where the test was conducted if different from the laboratory's address;

c. Unique identification number of the test reports and on each page, the identification number must be included to ensure that the page is recognized as part of the test report and clearly identify the end of the test report;

d. Name and address of the customer;

e. Description of the method used;

f. Description and clear identification of the tested sample;

g. Date of sample receipt and date of test completion;

h. Reference to the sampling plan and procedure used by the laboratory or another organization if relevant to the validity or application of the results;

i. Test results along with units of measurement;

j. Name, position, signature of the authorized person issuing the test report;

k. When appropriate, declaration of the validity of the results only related to the tested sample;

l. When appropriate, declaration of the estimated uncertainty of measurement, information on measurement uncertainty is necessary in test reports when relevant to the validity or application of the test results, upon customer request, or when measurement uncertainty affects compliance with a regulatory limit.

4. When providing comments and interpretations, the laboratory must establish a basis in writing for the laboratory to provide comments and interpretations.

5. When the test report contains test results performed by a subcontractor, these results must be clearly indicated. The subcontractor must report the test results in writing.

6. In cases where test results are transmitted by telex, fax, or other electronic means, the requirements of this regulation must be met.

7. Any modification or addition to the content of the test report after issuance must be made in the form of an additional document and must be accompanied by a statement "supplement to the test report, series number, or equivalent identification form." Such modifications must meet all the requirements of this regulation. When a new complete test report needs to be issued, this report must be uniquely identifiable and must refer to the original report it replaces.

3. Amend Clause 3 Article 2 as follows:Pointu 24. Improvement

The laboratory must continuously improve the effectiveness of its management system through policies, quality objectives, evaluation results, data analysis, corrective and preventive actions, and leadership review.

3. Amend Clause 3 Article 2 as follows:Pointu 25. Leadership Review

The head of the testing laboratory must periodically conduct a review of the testing laboratory management system, testing activities, and calibration to ensure that the system is appropriate, effective, and to propose necessary improvements or changes. All findings from the head's review and activities arising from this review must be recorded.