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The Decision 115/2008/qd-Bnn: Temporary Regulations On Requirements For Laboratory Quality Agriculture And Forestry Aquatic Products

Original Language Title: Quyết định 115/2008/QĐ-BNN: Ban hành quy định tạm thời về yêu cầu đối với phòng kiểm nghiệm chất lượng nông lâm thủy sản

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The DECISION issued a temporary regulation on requirements for laboratory quality agriculture and forestry fisheries _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ the MINISTER of AGRICULTURE and RURAL DEVELOPMENT, pursuant to the law of standards and technical regulation No. 69/2006/QH11 baske reachable through POKER lock Assembly on 29/6/2006 and is from January 1, 2007;
Pursuant to the law, the quality of goods and products s stain 2007/QH12 baske reachable through XII Congress on 21/11/2007 and is from July 1, 2008 Ordinance base food safety; The Decree 163/2004/ND-CP of June 7, 2004 Regulation DD ịnh details the implementation of some articles of the Ordinance on food hygiene and safety;
Pursuant to Decree No. 01/2008/ND-CP dated 3 January 2008, take the Government functions, tasks, powers and organizational structure of the Ministry of agriculture and rural development;
At the suggestion of Director quality management products and aquatic products, the decision: article 1. Attached to this decide temporary rules about the requirements for laboratory quality agriculture and forestry aquatic products.
Article 2. This decision takes effect after fifteen (15) days from the date The report.
Article 3. Chief of the Department, Director of quality management products and fisheries, Director of the science, technology and the environment, the Director of the Department of agriculture and rural development, the provinces and cities under central, heads of units, organizations and individuals concerned is responsible for the implementation of this decision.
 


Ministers (signed) high Release interim RULES of the German requirements for laboratory quality agriculture and forestry fisheries (attached to decide No. 115/2008/QD-BNN on December 3, 2008 of the Ministry of agriculture and rural development) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 1.
GENERAL PROVISIONS article 1. Scope this regulation lays out the requirements for the laboratory has the ability to analyze the test in the field of biology, chemistry, serves the State management of the quality of the food safety and hygiene in the scope of management of the Ministry of agriculture and rural development.
Article 2. The object to apply the applicable object of this regulation is the laboratory in the various economic sectors including interference the Organization's laboratory, foreign individuals placed in Vietnam (hereinafter referred to as the laboratory).
Article 3. Explain the term 1. The quality management system of laboratory: the personnel management system, equipment, infrastructure and quality of the manual system, the records and documents in order to ensure the quality of the test results.
2. laboratory quality manual: a document regulating the quality management system of the laboratory.
3. Approval test method: active reviews LLY (accuracy, speed does not guarantee measure, ...) in order to confirm the level of reliability and applicability of the method.
4. proficiency testing: the performance of the test on the same sample by two or more laboratory according to predetermined conditions to assess the ability to perform that test of the laboratory.
5. Compare the Union: is the assessment of the quality of test results between 2 or more of the laboratory by comparing analytical results on the m ẫu are identical to the common values of the set of results obtained from the laboratory participate in proficiency testing.
6. Corrective action: action to eliminate the cause of the mismatch was detected or other undesired condition.
Chapter 2.
MANAGEMENT REQUIREMENTS article 4. The Organization 1. Laboratory or laboratory organization, must have legal personality has the function responsible for Arab kh.
2. the laboratory is responsible for performing the activity of testing to meet the requirements of this Regulation as well as the requirements of the Agency can humidity.
3. where the laboratory is a Department in a larger organization, the organizational arrangements to ensure the Department has the conflict of interests such as the production, marketing or finance will not cause other adverse effects to the fit of the laboratory according to the regulations of asks.
4. the laboratory must have the mandate or the commitment of the authorities to ensure that the staff of the laboratory not be any pressure on trade, financial or other affiliate l pressure can affect reliability, independence of the decision and the integrity of the test results are displayed.
5. Laboratory must: a. have the management and technical staff was given the authority and resources necessary to implement the tasks include implementing, maintaining and improving the quality management system.
b. arrangements to ensure all members of the room is not solely any pressure of internal or outside influence the quality of their work.
c. regulations responsibility, powers and relationships of all employees (managers, make or check the work) that can affect the quality of the tests.
d. implement appropriate monitoring to test employees, including employees who are the files, through the employees understand the methods, testing procedures, as well as the purpose of each test and by evaluating the test results.
Article 5. Quality management system 1. Laboratory should establish, implement and maintain the quality management system consistent with the scope of activities. Laboratory must document the procedures and guidelines necessary to ensure the quality of the test results.
2. Laboratory to build a quality manual included or cited to support procedures including technical procedures, quality manual have to take out the structure of the documentation system used in the quality management system.
Article 6. Document control 1. Laboratory should establish and maintain procedures to control all documents in the quality management system (internal or materials originating from the outside).
2. All documents must be issued before the competent person review and approval.
3. document control procedure must ensure that: a. all appropriate documents have been approved are always available in all the places made the operation of the laboratory;
b. documents are periodically reviewed and, where necessary, be revised to ensure that they continue to conform and comply with the applicable requirements;
c. all of the invalid document or obsolete must be recovered promptly thờivà the appropriate mark to avoid accidental use;
d obsolete documents are kept due to legal requirements or for the purposes of storing the information must be marked appropriately.
4. documentation of the quality management system must be clearly recognizable. The identification must include the date issued, l section reviewed, the page number, the total number of pages, the authority issued.
5. The review and approval of changes to browse documents by the Department to perform considering ban air-conditioner proceed unless indicated specially. Specified parts must have access to the appropriate information as a basis for the review and approval.
6. Laboratory must establish procedures that describe how to perform and control the changes of guava document is stored in the computer system.
Article 7. In considering the proposal, and asks the contract 1. Laboratory should establish and maintain procedures for considering the request, the bid proposal and contract. And th policy brewing procedures to decide on testing contract must ensure that: a. the requirements, including the method of use, fully defined, established and well understood;
b. the laboratory had the capacity and resources to meet the requirements;
c. store the appropriate th method is selected and has the ability to meet the requirements of the customer;
d. any difference between ask and the contract must be settled before the start of the work.
e. the client should be informed of any changes compared to the contract.
2. The review must also apply for every job in the subcontract of the laboratory.
Article 8. Extra contracts on testing 1. If the laboratory uses the extra contract for work, they must choose qualified subcontractors. Subcontractors are qualified as subcontractors to comply with the requirements of this regulation or meeting the requirements of the ISO standard ISO/IEC 17025:2007.
2. the laboratory shall inform the client about the text positions b laboratory that uses sub-contractors and the consent of the customer, preferably in writing.
3. the laboratory must have a list of all the subcontractors on testing and must have proven the th extra customer consistent with this regulation or meeting the requirements of the ISO standard ISO/IEC 17025:2007.
Article 9. Buy services and supplies test 1. Laboratory to have the procedure about choosing and buying services and test widgets that can affect the quality of the test.
2. the laboratory shall ensure that the map provides materials and reagents, consumed is purchased that affect the quality of the test would not be used until they come along and check out the ANC or confirmed is accordance with standards or requirements that are specified in the method of th relevant otherwise. Records of operation check the suitability must be kept.
3. Encourage laboratory reviews vendor material consumption, supply and services chart primarily affects the quality of the test. Laboratory must maintain records reviews, purchase contract, a list of approved suppliers.
Article 10. The control test is not accordance 1. Laboratory procedures and to build must apply when there are any inconsistent would related online implementing the procedures, methods, instructions of the laboratory. This procedure should ensure: a. the responsibility and authority to manage the job mismatch, the action (including work pauses, holding back test report if necessary) are defined and implemented when the job is not suitable;
b. the evaluation of the level of work is inconsistent;

c. The remedy conducted in time with every decision about the possibility of accepting inappropriate work;
d. When necessary, the mismatch is to notify the customer and results are not suitable to be recovered;
e. authority to allow continued work.
2. When the assessment indicates that the work does not fit may recur or have doubts about the suitability of the laboratory activity compared with the procedures, the laboratory must immediately implement corrective action procedure referred to in article 11.
Article 11. Corrective action 1. Laboratory must build procedure and delivery of appropriate powers to implement corrective action when the job does not match or the other discrepancies compared with the procedures in the quality management system or technical operations.
2. procedures regarding corrective action must begin with an investigation to determine the cause of your main problem.
3. When should have corrective action laboratory must take out the corrective action may be to choose and implement the most appropriate corrective action to eliminate the problem exist and prevent problems that recur.
4. The corrective action must be reviewed to correspond with the level of importance and the danger of the issue.
5. Laboratory must establish and apply any changes be required arise from the investigation study on the corrective action.
6. Laboratory must monitor the results to ensure corrective action has been taken is in effect.
7. When needed, must perform additional reviews do next after corrective action to determine the effectiveness of the corrective action. The assessment must ensure that the appropriate areas of activity must be judged according to the provisions of article 13.
Article 12. Control of records 1. Laboratory should establish and maintain procedures for identification, collection, classification, access, file, store, maintain and liquidate the h Oh engineering and quality profile.
2. All the records must be clear, must be preserved and stored in a way to ensure easy access and stored in a proper environment to prevent damage or degradation as well as to prevent loss. The retention time must be specified for the profile.
3. Laboratory must keep records of the original observation, data was processed and the necessary information, calibration records, employee records and a copy of each of the test reports issued in a given time. The profile for each test must be kept full of information containe can if can help to identify the factors affecting speed ensure measure and allow repeat the test in conditions closest to the initial conditions. Records must include information about who is responsible for sampling, performed each test and the test results.
4. When in the h Oh profile error, wrong, error up to the ANC not to come along and erase makes it hard to read, to write the correct value. All changes in the records must be the main repair sign or abbreviated name. In the case ờng case records are stored as electronic data, there must be corresponding measures to avoid loss or change the original data.
Article 13. Internal evaluation 1. Laboratory must perform periodic internal reviews of the activities of the laboratory according to a plan and a defined procedure to check and confirm the operation of the laboratory still continues to comply with the requirements of the quality management system and of this regulation or not. This review of incompatible must be trained and who have the expertise to implement, if resources permit, these people must be independent of the activity being assessed.
2. When evaluating the findings cast doubt on the validity or correctness, of the test results must immediately implement corrective action and to notify in writing to the customer if the investigation shows the results of the laboratory take out can be affected.
3. To store the profile fields are evaluated, the active player when reviews and corrective actions arising from the evaluation.
4. the laboratory should confirm the activities after the internal review and record the implementation and effectiveness of corrective action already taken.
Chapter 3.
TECHNICAL REQUIREMENTS article 14. General requirements 1. There are many factors that determine the proper speed and reliability of the test performed by the laboratory. These factors include: a. human factors;
b. facilities and environmental conditions;
c. methods of th store experience and the effect of the method;
d. equipment;
e. Computer link measurement standards;
f. sampling;
g. sample management testing and calibration.
2. The extent to which the above factors contributed to create speed ensure measure synthesis of the different measurement value for listed between the type of test. Laboratory must take into account these factors when building methods and testing procedures, the training and qualifications of staff as well as in the selection and calibration equipment that laboratory use.
Article 15. HR 1. Leadership laboratory must ensure all those who operate the equipment, perform testing, reviews results and signed test report must have the capacity. When the laboratory used the staff are to be trained must be supervised like defined. The staff performs specific duties must be based on the level of training, appropriate experience or demonstrated skills as required.
2. the laboratory should have procedures to identify training needs and training organization for employees, the training program must be consistent with the current and future tasks of the laboratory, the effectiveness of training activities must be evaluated.
3. the laboratory must maintain a current job description of a Manager, technical staff and support staff participated in the experiment.
4. Leadership is a specific responsibility for the implementation of the sampling, testing, the test certificates, people give comment and interpretation and those who operate special equipment. Laboratory must maintain records of the powers, competencies, education, qualifications, skills and experience of all the appropriate technical staff including contract staff. The information must always be available and keep Affairs now n days.
Article 16. Facilities and environmental conditions 1. The facilities of the laboratory test service including (but not limited) to the elements: the source of energy, light and other environmental conditions requirements must ensure to perform accurate testing.
2. the laboratory should ensure the environmental conditions do not affect the results or adverse impact to the quality of any measurements. Ph total tested are particularly concerned when over-the-air sampling, testing was done at a different location with the fixed position of the laboratory. Laboratory must be made in writing to the technical requirements of facilities and environmental conditions that can affect the test results.
3. Laboratory to monitor, control and record the environmental conditions requirements as required by technical regulations, methods, procedures or where relevant brewed the environmental conditions can affect the quality of the results.
4. the laboratory should have separated is between the area near each other but not function compatible. Ph total tested must implement measures to prevent cross-contamination. Yes ng
5. Laboratory must devise measures to ensure industrial hygiene. Case of need established procedures.
Article 17. Th method otherwise and approval method 1. General requirements a. laboratory must use the procedures and method defined for all tests. This includes sampling, preservation, shipping, storing and preparation of samples for testing. Yes th method must meet analytical limited minimal analysis according to method (MRPL) or the limit of detection (LOD), ... th reachable authorities importing countries or Vietnam.
b. the laboratory must have the manual and all related equipment, as well as preserving the prototype. All instructions, standards, manuals and other reference data relating to the work must be updated and always available for employees to use.
c. changes in comparison with the experimental method is applied only when the changes have been made in writing, be proven technically is true, are allowed to use and acceptance by customers.
2. Choose the method of a. laboratory must use other methods, including experimental store th method, to meet the requirements of customers and like defined for the test. Prioritize using dd to be issued new balance men form is the international standard, the region or the country. Laboratory must ensure the use of a new standard for the Standard Edition, unless this is not accordance or not possible.
b. When customers do not define clearly ịnh DD method using laboratory must choose method defined was announced in the international standards, the region or the country or the prestigious engineering institutions issued or are prescribed equipment manufacturers. The port test ph testing method by setting or acceptable to use in case the method is defined like with the purpose of use and if this method th approval to come along. The client must be informed of the method of use. Laboratory to confirm there is enough ability to apply correct methods of hidden cycle before starting the test.
c. the laboratory must notify the client when the client request method is not accordance or outdated.
3. The method by ph total tested build a. putting the methods of th laboratory built by the store to use an internal operations plan and must be assigned to qualified personnel, provided the necessary resources.

b. The plan must be updated in d ựng and laboratory to ensure the exchange of information is between all the employees involved.
4. The method of manufacture a undigested. When the need to use methods not as methods, these methods must be agreed with the customer and must have clear regulations on the requirements of the customers and items of the test. The ANC method construction must be reachable on the appropriate approval before use.
b. new methods to establish testing procedures before performing the test, and that procedures must include at least the following information: (i) scope (ii) description of sample type tested (iii) parameters or quantities and about identify (iv) tools and equipment technical features include, (v) The main standard and standard model needed (vi) requirements for environmental conditions and the necessary stabilization period (vii) standards and requirements to approve/reject (viii) data are recorded, methods of analysis and presentation of data (ix) Speed does not guarantee or estimate mode procedure did not ensure measure (x) description of procedures including : + maintenance, shipping, storing and preparation of prototypes;
+ The inspection be done before starting work;
+ Checking device to work properly, and when needed, the calibration and correction of equipment before each use;
+ The logged method and observation of results;
+ All safety measures must comply with;
5. Approval test method a. approval is confirmed by check and provide objective evidence that the requirements defined for a specific use has been met.
b. laboratory approval test method must not target, method by ph total construction, testing the methods used outside the manufacture the range expected and expansion as well as changes to the standard methods to confirm that this method is accordance with the intended use. The approval must be broad enough to meet the applicable requirements or applicable field. Laboratory should record results there are procedures used to approve and announce that this accordance with the purpose of use.
c. scope and precision of the values has to be from the approved method must conform to the requirements of customers when evaluating intended use (i.e.: not sure of the results, detection limit, selectivity of the method, the linear speed, the stability with respect to the external influences speed limit, repeat/duplicate re-mode) 6. Reviews degrees do not guarantee measure a. laboratory performs internal calibration must have and must apply the procedures reviews not sure measure for all the standard accessories.
b. the laboratory must have and must apply the procedure to evaluate the degrees do not guarantee measure. In some cases, the nature of the method can otherwise limit th the calculated n ng promised aviation disaster on the means of measurement and statistics degrees do not guarantee measure. In the case ờng cases, the laboratory must at least identify the component degrees do not guarantee measure, make a reasonable assessment and must ensure that the form of the announcement of results is not the wrong impression about the degrees do not guarantee measure. Reasonable evaluation must be based on knowledge of the features of the method and field measurements and is used, for example, previous experience and valuable data.
c. When reviews do not guarantee the device measured, Ridin all the component level is not guaranteed to be considered important in the specific circumstances need to be accounted for by using the analysis methods like defined.
7. Control data a. the calculation and transfer of data must be examined in the appropriate manner.
b. when using computers or automation equipment to collect, process, report, archive, or check the test data must ensure: (i) computer software by the mermaid life used to be established the full text, details and approved as appropriate to use;
(ii) To establish and apply procedures to protect data, procedures that should include (but not limit) the ability to protect the integrity and confidentiality when entering or collect data, data retention, transfer and processing of data;
(iii) computer and automation equipment must be maintained to ensure the good operation of the environmental conditions and operational conditions necessary to maintain the integrity of the test data.
Article 18. The device 1. Laboratory must be equipped with all devices for measuring, sampling and testing needed to make accurate hand testing (including sampling, preparation of test samples, handling and analysis of experimental data).
2. equipment and software of the device used for testing and sampling must be able to achieve the accuracy required and must conform to the technical regulations relating to the corresponding test. The program should be set for the quantity or value of the device when these properties have a significant influence on the results. Before putting into use, equipment (including equipment used to sample) must be calibrated or tested to confirm that the equipment meets the technical requirements specified by the room tested and comply with the technical regulations of the respective standards.
3. Only those who are authorized to use the new equipment. Laboratory must always available instructions for use and maintenance of the equipment has been updated (includes documentation of equipment provided by the manufacturer) for employees like defined by laboratory use.
4. All items of equipment and software equipment used to test have important implications for the results must be clearly recognizable.
5. Laboratory must maintain records for each category of equipment and software has important implications for the test execution. The profile must include at a minimum the following information: a. The identification of items of equipment and software of the device;
b. the manufacturer's name, serial number, or other responsibilities;
c. checking the device match the technical regulations;
d. the current location of the equipment;
e. the instructions of the manufacturer (if available) or lead to institution where can find the documentation of the manufacturer;
f. day, results and a copy of the minutes or the certificates of all times and calibrate calibration, on accepting standards calibration next month;
g. appropriate maintenance plan and maintenance was done according to plan;
h. All damaged, problems, repair, the changes to the device.
6. the laboratory should have the procedure on preserving, transporting, storing, safe use and maintenance according to the plans of the measurement equipment to ensure good operation and to prevent the contamination or avoid degradation.
7. The device is overload, poor management or for the results suspect, or have disabled or out of bounds rules allow is not used. The device must be to own or clearly labeled or marked as not used to avoid using it until the device is repairing and testing and calibration points out is done correctly. Laboratory to check, consider the effects of the disability or skewed compared to the limit specified by the previous trial and to apply control procedures inconsistent work.
8. When the examination between KY calibration is necessary to maintain the level of trust about the status of device calibration, testing between States must be done according to a specified procedure 9. The case of the indicated calibration factors to adjust, the laboratory must have the procedures ensure the version (for example in computer software) are updated correctly.
10. test equipment, including both hardware and software must be protected to avoid the adjustment can cause a loss of the correctness of the test results.
Article 19. The standard measurement of link 1. All equipment used for experimental work, including extra equipment (for example to determine the condition of the environment) have a significant influence on the accuracy or correctness of the test results or samples must be calibrated before use. Laboratory to build plans and procedures for the calibration of equipment.
2. When the test room enable calibration services from outside, the standard link of the measurement must be ensured by the use of calibration services from the calibration room has the capacity, the ability to measure and ensure the standard links. The calibration certificate due to the standard accessories room level must record the results of measure including degrees do not guarantee measure.
3. Laboratory to build plans and procedures to calibrate standards. The main calibration must be hidden by an organization can provide the standard links. The main standard room ki ểm retention test was used only to calibrate the ANC to come along without the use for other purposes. The main manufacture must be calibrated before and after any correction for the old b.
4. When possible, standard model must derive to the SI units or to the standard model are certified. The model internal standard must be tested to the fullest extent when economic and technical conditions allow.
5. Laboratory to conduct the mid-term test according to the procedures and plans to maintain credibility on the status of the calibration standards, standard model.
6. Laboratory must have safety management procedures, transport, store and use the main standard and standard model to prevent contamination or damage and to protect its integrity.
Article 20. Sample 1. Laboratory must have plans and procedures for sampling when making sampling of substances, materials or products for testing. Sampling plans and procedures are available in the sample implementation. Sampling plan must be reasonable and must be based on appropriate statistical methods. The process of sampling should record the factors are controlled to ensure the validity of the test results.

2. When the customer asks to modify, supplement or omitted the procedure for sampling the chemistry text was required to be recorded in detail along with the appropriate sampling data and to keep the entire documentation regarding the test results as well as to inform the persons concerned.
3. Laboratory procedure logs must have appropriate data and activities related to the sampling form a part of test activities that test conducted. The records shall include the sampling procedure used, awareness of the sampling, environmental conditions and the chart or similar ways to locate sampling when necessary and, if appropriate, the statistical sampling procedure to be applied.
Article 21. Sample management and calibration test 1. Laboratory must have procedures for transport, receive, manage, preserve, protect, archive or liquidate the prototype includes all provisions necessary to protect the integrity of the prototype and to protect the interests of customers.
2. the laboratory must have the encryption system prototype. The coding model must be maintained in the laboratory during the form existed in the laboratory. Sample encryption system to ensure samples are not mistaken in fact or when the Institute lead to the record or other document.
3. Laboratory must receive the profile template to see any differences or discrepancies compared with the conditions specified. When there is any doubt about the suitability of the templates, or when there is a template does not match the description provided, as well as the required tests are not specified, the laboratory must exchange ideas with customers about additional instructions before proceeding as well as to record the exchange of ideas.
4. the laboratory must have the appropriate means and procedures to avoid damage to, loss or damage to the prototype when kept for storage and preparation. When the template is stored in the specified environmental conditions, the conditions that must be maintained, controlled and documented l.
Article 22. Quality assurance test results 1. Laboratory must have quality control procedures to check the validity of the testing was done. The resulting data must be recorded so that you can get to know the parents of ớng damage results. This check must be planned and include but not limit to: a. use standard samples often are certified or internal control by using the standard model Wednesday;
b. join the program to process compare Union and th store experience proficient;
c. perform the tests using the same method or methods;
d. test patterns again;
e. take the correlation of the results from these different properties take a sample.
2. The quality control data must be analyzed and when other data outside of the specified standards must take action to remedy and prevent false results are announced.
Article 23. Reporting of results 1. The results of testing by the laboratory implementation must be reported accurately, clear, specific, objective as well as to match the specific instructions in the method or otherwise experience th.
2. The information outlined in the report th store experience including but not limited to the content outlined in paragraph 3 of this article. Results can be reported in a way more simple in case the test is done for the customer content. The case of the information listed in paragraph 3 of this article not notified to the customer must be available in the room ki ểm.
3. Test report includes at least the following information, Yes when laboratory has a reason dd can not comply with: a. the title, e.g. "test report";
b. the name and address of the laboratory and treatment where test if different from the address of the laboratory;
c. the number code of the test report and on each page must be to ensure that the code page that the ANC admitted to come along as part of the test report and define clearly the end of the test report;
d. name and address of the customer;
e. Stated/e method used cars;
f. Outlined the situation and clearly define the sample tested;
g. sample as well as the date of the day may do the experiment;
h. the Institute lead to sampling procedures and plans that organization or other laboratory has used if any related online effect or application of the results;
i. The test results together with the unit of measurement;
j. name, title, signature of the person authorized to grant test report;
k. when appropriate, announced about the validity of results only related template has been tested;
l. when appropriate, published speed ensure measure had been estimated, the information about the degrees do not guarantee measure is needed in the statement th otherwise experience when there are related online effect or application of the test results, when a customer asks, or when speed ensure measure influenced the match a specified limit.
4. When making the comment and interpretation laboratory must document the basis for laboratory launched a review and interpretation.
5. When the test report contains the results of testing performed by subcontractors, the results must be specified explicitly. Home th extra customer must notify the test results in writing.
6. In the case of the test results are transferred by telex, fax or other electronic means, then the requirements of this regulation must be met.
7. The amendment supplements the content of reports issued after testing is only done in the form of a supplementary document and should enclose declares "for additional test report, the serial number, or equivalent forms of identification. Modification of incompatible as such must meet all the requirements of this regulation. When the need to enact a new test report, the report must be to identify a unique way and is cited to the original report that it replaced.
Article 24. Improve laboratory must improve regularly the effect of system management through policy, such quality criteria, the results of the reviews, analysis of data, corrective actions, preventive and consideration of leadership.
Article 25. Review of leadership leadership laboratory should periodically perform a review of the management system of laboratory, the testing and calibration activities to ensure this system fit, performance and other improvements given inclusion or changes needed. To record all findings from the review of leadership and activities arising from the review.