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Circular 20/2013/ttlt-Byt-Bct-Bnnptnt: Regulated Conditions, Procedure Sequences Specify The Basis Of Testing Food Served In State Management

Original Language Title: Thông tư liên tịch 20/2013/TTLT-BYT-BCT-BNNPTNT: Quy định điều kiện, trình tự thủ tục chỉ định cơ sở kiểm nghiệm thực phẩm phục vụ quản lý nhà nước

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MINISTRY OF HEALTH-MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT
Number: 20 /2013/TTLT-BYT-BCT-BNPTNT
THE SOCIALIST REPUBLIC OF VIETNAM.
Independence-Freedom-Happiness
Hanoi, August 1, 2013

FEDERAL INFORMATION

Regulating the condition, the procedure itself specifies the basis of food testing serving the state management.

Food Safety Law Base June 17, 2010 and Decree No. 38/20. 1 2/ND-CP April 25, 20 1 2 of the Government on the Regulation details I i Some of them. All right of the Law of Safety Food. ()

Quality Law Base, product of h Fuck. 21st Ah! 11 in 2007 and the Digital Decree. 1 32 /2008/NĐ-CP December 31, 2008 by Ch I'm The government rules. details I i One. Stain. Go. Okay. The U's quality Oh, product of goods ()

Standard Law Base and Technical Regulation June 29, 2006 and Decree of the S Stain. 127 /2007/ND-CP August 1, 2007 of the Government Regulation details I i One. Stain. Go. Okay. The U's Standard and standard Engineering.

Base of Protocol 63 /2012/NĐ-CP 3 1 August 2012 of Ch I'm The government rules, functions, powers, and structures. organization of the Ministry of Health;

"95/20". 1 2/ND-CP on November 12, 2012 of the Government regulates the function, mandate, authority and structure. organization of the Ministry of Commerce;

Base of Protocol 01 /2008/NĐ-CP 03 January 2008 of the Government rules the functions, duties, powers, and structures. organization of the Ministry of Agriculture and Rural Development and Agenda Stain. 75 /2009/NĐ-CP modified Article 3 Protocol 01 /20. 0 8/ND-CP March 03 Ah! 01 of 2008 the Government regulates the functions, duties, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

At the suggestion of the Bureau of Food Safety, the Ministry of Health Oh, Case Here. Department of Science and Technology-Ministry of Commerce, Director of the Bureau Quality Management Farm l Music and Fisheries-Ministry of N cell Agriculture and Development,

Minister. Ministry of Health-Minister of Trade - Minister of Agriculture and Development Oh. n rural n Oh. Private Yes. condition of the condition, the procedure itself specifies the basis of a food testing facility serving state management. Oh,

Chapter I

GENERAL REGULATION

What? 1. The tuning range and subject apply

1. The adjustment range: This joint venture rules the conditions, the sequence, the procedure that specifies the basis of the food testing that serves the state management (the latter is called the test basis).

2. Subject applies: This federated information applies to the testing facilities, the governing bodies associated with evaluation activities, designation, and management of the testing facilities.

What? 2. Explain the word

In this link, the following words are understood as follows:

1. Testing facility is the organization that has a legal status that performs the quality of quality, food safety indicators.

2. Quality Management System including the management and technical system to ensure the quality, accuracy, transparency of the test results, the entire profile involved in the testing operation and ensuring the quality of the test results performed at the facility with the registration range such as: personnel. The equipment, the facilities, the facilities, the testing.

3. Link comparison is the assessment of the quality of test results between two or more testing facilities organized by the independent unit by comparing the test results on the uniform samples with the general value of the set of results acquired from the test facilities involved in the results. It's a good experiment.

4. Proficiency testing is the implementation of the trials on the same pattern by two or more testing facilities under the predetermined conditions in order to evaluate the experimental implementation of the test facility.

5. Test base assessment is the activity that considers the suitability of the quality management system and the ability to analyze the response requirements for specific indicators of quality, food safety.

6. Registration area specified : Includes application-to-use indicators applicable to food groups or food products under the management of the Department of Industry Management.

What? 3. Common Principles

Contact Department: Department of Food Safety-Ministry of Health; Department of Science and Technology-Ministry of Commerce; Department of Quality and Agriculture Quality Management-Ministry of Agriculture and Rural Development is the unit to help the Minister of Health, Minister of Trade and Minister of Commerce and Minister of Health Agriculture and rural development rural management of food testing (later called the state governing body with authority) perform the organization receiving registration records, evaluation, designation, inspection, monitoring of the respective testing facility. with the state management range of food safety is assigned.

Chapter II

THE CONDITION FOR THE TESTING FACILITY

What? 4. Request Legal.

Established by the rule of law; there is a function of food testing or the decision to hand over the duties of the competent authorities.

What? 5. Request for Power

The competence of the testing facility on the designated registration indicators must meet the following requirements:

1. Quality management system meets the National Standard TCVN ISO/IEC 17025: 2007 or ISO/IEC International Standard 17025:2005;

2. There are sufficient equipment, facilities that are in accordance with the requirements for testing and registration requirements;

3. There are at least two (02) audits as technical cadres that have a university level consistent with the field of registration designated for training and have practical experience of testing in the same field from three (03) years or more;

4. The test methods are updated and validated the value of use, the analytical force/test of the instructions/registration tests that specify the regulation response or the corresponding technical regulation and other requirements as defined by the Department of the Department of the Industry;

5. The test results are proficiency or the required interroom comparison with at least one designation/registration test specified.

Chapter III

PROFILE, REGISTRATION PROCEDURE, TEST BASE

What? 6. Subscription Only -

1. The basis of testing meets the regulation requirements at Article 4 and Article 5 of this (1) (1) registration of the specified register (file directly or via the postal route) to the state governing body has jurisdiction under the regulation at Article 3 of the relevant information. All right.

2. State management agencies with the authority to state at Article 3 of this Federal Registered Citizenship is responsible for receiving registered records, organizing the evaluation of food testing facilities in the respective management areas of each Ministry or coordination of the assessment of the organization. The multi-field food testing facility in accordance with the procedures specified in this Affiliated Information and considers the appropriate designation in accordance with the management division of each of the industry departments.

3. The specified registration profile includes:

a) The registration application specifies the basis of a regulatory basis by the specified template at Appendix 1 attached to this Conventional Information;

b) The decision to establish or the certificate of business registration (a copy of evidence);

c) Document, technical records, and processes associated with the specified registration/designation.

d) Power profile:

-List, primary equipment site records, infrastructure (in accordance with the capacity reporting facility operating facility in Annex 2 issued by this Federal Information);

-List, audit records corresponding to the field of registration indicated with a copy of the certificate of specialized certificates;

-The proof materials guarantee quality assurance: plan, proficiency test results or interroom comparison; Report the test results proficiency of the test hands on the designation/registration test designation;

-A regulatory facility capacity report prescribed by the Appendix 2 issued by this Information (s);

-The prescribed test results in Annex 3 issued by this Relevant Information;

-The results of testing activity on the field of registration specified in twelve (12) last month under the prescribed pattern at Annex 4 issued by this Registered Notification.

For the testing facility that has been held legally recognized by Vietnam or the organization of foreign recognition as a member of the agreement to sign mutual consent of the Association, the International Laboratory of Testing (ILAC-International Laboratory) Accreditation Cooperation), the Asia-Pacific Laboratory Recognition Association (APLAC-Asian Pacific Laboratory Accreditation Cooperation) evaluation and certification level certification under the National Standard TCVN ISO/IEC 17025: 2007 or Standard Standard. international ISO/IEC 17025:2005, registration specifies only the instructions/trials in the recognized range: file the documents stating at the point. a, b, c and d Clap 3 This; copy (certificate) certificate recognition, category, recognition range.

What? 7. G Registry Profile i A specified term

Prior to the decision to specify only the ninety (90) days, the testing facility sent one (01) of the specified extension case for the state governing body to have jurisdiction. The profile consists of:

1. The extension application specifies the basis of the prescribed testing facility at the Appendix 1 issued with this Relevant Information;

2. Result of the interroom comparison, the test of proficiency in the direction/trial of testing by the state governing body of authority or from proficiency testing providers, in relation to the scope of the organization registration;

3. Report the results of the test work in the time specified by the prescribed form at Annex 4 issued by this Article.

What? 8. Lake s Uh ... Register for change, plugin scope Ch. All right -

The basis of testing has been specified when there is a change, with the addition of the specified scope to make the registration change, the addition of the required state management agency. Registration profile changes, the specified scope plugin is made as specified in Article 6 of this federation. The test base case has been specified whether a legal personality change or address must have a text stating that the content is changed.

What? 9. The procedure specified

1. During the ten (10) days of work, since the date of the filing, the state governing body has the authority to conduct the filing of the filing. If there is a modified request, the plugin must have a text message for the filing unit to complete the case in accordance with the specified rules. In the absence of a revised request, the state governing body has the authority to conduct an evaluation under the regulation at Article 10 of this Article.

2. For the non-object-specified testing facility at the Clause 3 Article 6 This links this link:

a) During the fifteen (15) days of work, since the full, valid date of receiving, the state governing body has the authority to sign the decision to establish an experimental basis assessment.

b) The test base assessment consists of members with specialized knowledge and experience in the field of evaluation, designation.

c) The decision to establish a review party must specify the scope, assessment, list, and assignment of each member to conduct evaluation at the testing facility. During the time of the year (05) the day of work, since the end of evaluation at the basis of the three assessment unions must submit conclusions about the competent state governing body (Form of the Prescribed Testing Basis at Annex 5 issued by the Federal Information) Hey!

d) During the fifteen (15) days of work, since the conclusion of the assessment party, the state governing body has the authority to take responsibility to review and specify the test unit if the request is reached (the decision template specifies regulations at Annex 6). It is accompanied by this Relevant Information. If the requirement is not reached, the state governing body has the authority to have a written notice on the reasons not specified for the testing basis.

In case of necessity, the state governing body has jurisdiction to be able to form a consultable council before signing the designation decision.

3. For the regulatory testing facility at the Section 3 Article 6 This links this link:

a) During the thirty (30) days of work, since the full, valid date of receiving, the state governing body has the authority to set the case. If the capacity profile responds by regulation at Article 4, Article 5 of this Federal Communications and the requirements of the Department Manager, the state governing body has the authority to sign the decision to specify an audit facility that is accompanied by the category of test/trial indicators.

The case case is not required, the state governing body has the authority to have a written notice on the reasons not specified for the testing basis.

b) In the case of necessity (the case of the case appraisal is not sufficient for the analysis of the analytical capacity of the specified response facility at Article 5), the state governing body has the authority to establish a review party to conduct evaluation at the testing facility.

4. The validity date of the designation of the Decision: The decision to specify a force of three (03) years from the date of the issue.

Fuck! i Ten. Test base assessment

The assessment crew was established by the state governing body to conduct an assessment at the testing facility (not applicable to the regulatory testing facility at Section 3 Article 6 and Point A 3 Article 9). The steps that conduct the assessment are as follows:

1. Evaluation of compliance, the appropriate compliance of the testing facility on the regulatory requirement at Article 5 of this Federal Information;

2. Set up a database evaluation report according to the prescribed form at Annex 7 issued by this Relevant Information;

3. The conclusion of the prescribed evaluation party at Annex 5 issued by this Federal Information. On the basis of the recoverable basis of the testing facility, if necessary, the state governing body has the authority to conduct review review at the testing facility.

Come on. U 11. Code Number Testing facility.

1. The state governing body has the authority to have the responsibility to grant and manage the code for the designated test facilities.

2. The number of testing base codes is signed as follows:

(serial number)/(junior year) /BYT-KNTP (BCT-KNTP/BNN-KNTP).

Example:

001 /2011/BYT-KNTP

3. Testing the number of testing facilities:

a) The number of testing base codes presented with the uppercase letter, the New Roman font size 16, the type, bold. In it, the order number of the test base number is three (03) digits.

b) The number of testing base codes is printed in the upper corner side of the test results results. On the results of the test results required to specify the specified index of the testing facility.

What? 12. Base Check it out. Come on -

Based on management needs, the criteria stipulated at Article 4, Article 5 of this and other provisions are associated with the provisions of the Department of Industry Management, the Department of Industry regulator which specifies the basis of examination testing under the rule of law.

Chapter IV

TEST, POST-DESIGNATED MONITORING

What? 13 The test, surveillance.

1. Check, monitor periodically: One (01) time/one (01) year.

2. Check out, monitor the sudden when there is a management agency ' s request.

What? 14. Federal Comparison

1. The interroom comparison organization unit must meet the requirements of the ISO/IEC 17043:2010 International Standards or to have equivalent capacity.

2. On the basis of the capacity of the eligible interroom comparison unit, the state governing body has the authority to specify the unit to conduct the association comparison organization.

What? 15. Check, monitor operations

Applies to test facilities designated with frequency one (01) time/one (01) years. Inspection, operational monitoring includes the following forms:

1. Preliminary review through the activity report provided by the basis of the deposit in accordance with the regulation (six (06) months and annually).

2. Audit monitoring operations at the facility

The test facility is inspected to be notified prior to the execution of the fifteen (15) days monitoring. The inspection corps was established by the state agency under the decision to take responsibility for the following duties:

a) Evaluation of the retention of compliance and suitability of the management and capacity system of the testing facility under Article 5 of this Federal Information System;

b) Process testing execution of the trials specified under the registered method. The method must meet the requirements of the respective Technical Standards or the current regulation;

c) Check out the compliance of the document system, process, regulation in testing;

d) Check the profile of the testing process;

The results of the sample monitoring results in Annex 8 issued by this same article;

e) The monitoring team results in the remediation, reports the state governing body with jurisdiction. The base reports the remediation, the state governing body whose jurisdiction will conduct an actual examination at the test facility if necessary.

Come on. U 16. t

1. As long as the monitoring of the monitoring of the prescribed testing facility at the Clause 3 Article 6 meets the full set of regulations at Article 4, Article 5 of this and other regulations are related as defined by the Department of Industry Management.

2. The test facility meets the regulation requirement at Clause 1 This Article 1 Article 1 (01) the case file recommended for a monitoring of the monitoring of the state governing body with jurisdiction. The profile consists of:

a) The work is recommended for immunity;

b) The monitoring of the oversight body of the national standard recognition agency TCVN ISO/IEC 17025: 2007 or ISO/IEC International Standard 17025:2005 (within twelve (12) months from filing date);

c) The results report works within twelve (12) months from the filing date, which specifies the result of self-evaluating the analysis of the testing facility compared to the relevant regulation of the Department of Industry Management.

3. During the period of no more than five (05) of working days, since the date of receiving full and valid records, the state governing body has the authority to question the case and answer the results by writing to the testing facility.

4. Every year, the test-exempt facilities are regulated at Clause 1 This is still subject to examination, the management of the governing body.

What? 17. the results Ki Okay. Check, monitor.

Based on test results, monitoring; depending on the extent of the violation of regulations according to this system, the inspection team, the monitoring proposal with the state governing body has the authority to form the following treatment:

1. Request to rectify and submit a remediation report on the state governing body with jurisdiction.

2. Suspend the implementation of the Decision Decision. After the completion of the testing facility and the inspection of the inspection at the request of the inspection team, the monitoring agency, the state governing body has the authority to conduct a review review of the specified decision.

3. recall, cancel the Decision to specify and report the Department of Industry as the base belongs to one of the following cases: dissolved; no longer activity within the range has been specified; the deadline is too limited; the violations are not recoverable.

Ch Move! V.

THE RESPONSIBILITY OF THE GOVERNING BODY AND THE TESTING FACILITY

What? 18 The responsibility of the state governing body has jurisdiction.

1. The execution of the specified subscription record, the specified subscription extension, the additional change registration; the assessment organization, the test base designation.

2. Check out the following designation.

3. Make sure objectively and fair in performance assessment, designation, inspection, supervision.

4. Secure the information, the metrics associated with the testing facility.

5. Level, suspension, cancellation, recovery, decision recall.

6. The list of designated test facilities, suspended, canceled, restored, revoked the specified decision.

7. The organization checks, addressing the alleged complaint regarding the basis of testing under the rule of law.

8. Save the database file.

9. Thu, use fees, rate of evaluation, designation, oversight of the operating facility operating under the rule of law on fees and fees.

What? 19. facility testing

1. Make the periodic reporting, the breakthrough on the state governing body with the authority:

a) A periodic report: The report operates six (06) months before July 10 and reported the year before December 30 each year (according to the template at Annex 4 issued by this Federal Information).

b) Breakthrough Report: At the request of the competent state governing body.

2. The report when there is a change in relation to the scope of the test activity specified, in the period of no more than thirty (30) days from the date of the change. The changing content must report to include:

a) the legal way;

b) organizational structure and leadership;

c) Policy and procedure;

d) Address, phone, Fax, E-mail;

Personnel, key cadres, equipment, facilities, work environments, or other resources if there is an impact on the management system;

e) The remedied measures are required by the prescribed pattern at Annex 9 issued with this Methodology.

3. In addition to the implementation of the regulations at Clause 1, Clause 2, This, the testing facility must also perform the following content:

a) Ensure the reliability, exact results of the test results for the specified trials;

b) subject to examination, monitoring of the testing operation of the inspectors in and out of the country at the request of the state governing body;

c) Create a favorable condition for the assessment team during evaluation at the testing facility;

d) The cost, the fee for evaluation, designation, oversight of the operating facility operating under the law of fees and fees.

4. Implemfication of other obligations stipulated at Article 20 of the Quality of Commodity Products.

Chapter VI

EXECUTION CLAUSE

What? 20.

This joint venture came into effect on 10 October 2013.

Food testing facilities that have been designated by the regulation of the Department of Industry are continued to remain in effect until the expiration of the specified decision.

What? 21. Do

Food Safety Department-Ministry of Health, Department of Science and Technology-Ministry of Commerce, Department of Quality and Agriculture Quality Management-Ministry of Agriculture and Rural Development is responsible for organizing, testing, monitoring, and guidelines for the implementation of this.

In the course of execution, if there is an entangrium, the organization, the individual needs to promptly reflect on the Ministry of Health (Food Safety Bureau), the Ministry of Commerce (Department of Science and Technology), the Ministry of Agriculture and Rural Development (Department of Agriculture and Fisheries Management) to Research, solve.

KT. Minister of Health.
Chief.

KT. MINISTER OF COMMERCE
Chief.

KT. Minister of Agriculture and Rural Development
Chief.

(signed)

(signed)

(signed)

Nguyen Thanh Long

Xiao Tú

Nguyen Thi Xuân