CIRCULAR stipulated conditions, the sequence specified procedures test base food service management basing on food safety Laws 17 June 2010 and Decree No. 38/2012/ND-CP dated 25 April 2012 of the Government on the detailed implementation of some articles of the law on food safety;
Pursuant to the law, the quality of goods and products on November 21, 2007 and the Decree No. 132/2008/ND-CP on December 31, 2008 detailing the Government's implementation of some articles of the law, quality goods and products;
Pursuant to the law of standards and technical regulation on June 29, 2006 and Decree No. 127/2007/ND-CP on 1st August 2007 detailing the Government's implementation of some articles of the law on technical regulation and standards;
Pursuant to Decree No. 63/2012/ND-CP on August 31, 2012 of the Government functions, tasks, powers and organizational structure of the Ministry of health;
Pursuant to Decree No. 95/2012/ND-CP on November 12, 2012 of the Government functions, tasks, powers and organizational structure of the Ministry of industry and trade;
Pursuant to Decree No. 01/2008/ND-CP dated 9 January 2008 of the Government functions, tasks, powers and organizational structure of the Ministry of agriculture and rural development, and Decree No. 75/2009/ND-CP amending article 3 of Decree 1/2008/ND-CP of March 1, 2008 of the Government functions duties, powers and organizational structure of the Ministry of agriculture and rural development;
At the suggestion of the Director of the Bureau of food safety, Ministry of health, Director of the science and Technology-Ministry of industry and trade, Director of quality management of agriculture and forestry and fisheries, Ministry of agriculture and rural development, Minister of Health-Minister of industry and Trade-Minister of agriculture and rural development issued the circular stipulated the conditions procedure sequence, specify the base testing food served in State management, chapter I GENERAL PROVISIONS article 1. Scope and objects 1. Scope: this circular stipulates the conditions, sequence, procedure specifies the basis of testing food served in State management (hereinafter referred to as the test basis).
2. Objects: this circular applies to the testing facility, the agency manages activities related reviews, specify and manage the facilities tested.
Article 2. Explanation of terms In this circular the terms below are interpreted as follows: 1. the test facility is the organization with legal personality test implementation the norms of quality, safe food.
2. quality management systems including document management systems and techniques to guarantee the quality, accuracy, transparency, the full test results of records related to the operation tested and quality assurance testing results conducted at the base with the scope of registration as : personnel, equipment, infrastructure, testing methods.
3. Compare the Union is evaluating the quality of test results between two or more premises tested by independent units organized by comparing the test results on the samples are identical to the common values of the set of results obtained from test establishments involved testing proficiency.
4. proficiency test is the implementation of the test on the same sample by two or more of the test facility according to predetermined conditions to assess the ability to perform that test of the test facility.
5. Evaluate the test facility is active in considering the suitability of the system for quality management and analysis capacity to meet the requirements for testing the specific norms of quality, safe food.
6. the registration fields indicated: include targets, the test applicable to the groups of foods or food products under the scope of the assigned sector Manager management.
Article 3. General principles the Federation: food safety Bureau-Ministry of health; Science and Technology-Ministry of industry and trade; The quality management Department of agriculture forestry and fisheries, Ministry of agriculture and rural development is to help the Minister of health, Minister of industry and trade and the Minister of agriculture and rural development, governance of tested food (hereinafter referred to as the State administration authority) made the organization receiving the registration profile , evaluate, specify, verify, monitor test basis corresponding to the scope of the governance of food safety is assigned.
Chapter II CONDITIONS for TESTING BASE article 4. Legal requirements established under the provisions of the law; functional food testing or sewerage decision of the competent authority.
Article 5. Capacity the capacity requirements of the testing facility for the specified registration criteria must meet the following requirements: 1. the quality management system meets the ISO standard ISO/IEC 17025:2007 or international standard ISO/IEC 17025:2005;
2. Have enough equipment, the facilities match the requirements and testing specified registration fields;
3. Have at least two (2) membership test is qualified technical staff the University match the specified registration field are trained and have experience of testing in the same field from three (3) years;
4. The test method was updated and confirmed the value of use, capacity analysis/testing/test targets register specified to meet regulations or the corresponding technical regulation and other relevant requirements as specified by The management of the sector;
5. proficiency test results or compare Union reached required for at least one of the target/test registration.
Chapter III records, ORDER and REGISTRATION PROCEDURES, SPECIFY the TEST BASE article 6. The specified registration 1. Testing facility meet the requirements stipulated in article 4 and article 5 of this circular filed a (01) the specified registration profile (filed directly or by post) to the governing body of the competent State as defined in article 3 of this circular.
2. The management authority of the State having the jurisdiction referred to in article 3 of this circular has the responsibility of receiving registration documents, the Organization reviews the facilities tested food in the corresponding management of each organization or coordination Ministry reviews the facilities tested food most areas along the procedure specified in this circular and consider designating suitable according to the field was assigned to the management of each of The sectors.
3. Registration documents specified include: a) the specified application test base according to the form prescribed in annex 1 attached to this circular;
b) decided to set up or business registration certificate (certified copy);
c) documents, technical records and processes related to indicators/registration test.
d) capacity: profile-profile, list of equipment, infrastructure (content suitable active capacity reports testing facility according to the form prescribed in Appendix 2 attached to this circular);
-List of tested member profile, corresponding with the registration field specifies the authenticated copies attached to the Specialist certification;
-The documentation on the quality assurance testing: plan, proficiency testing results or compare Union; Report test results of vocational proficiency test rounds for target/test the specified registration;
Report-test facility capacity according to the form prescribed in Appendix 2 attached to this circular;
-Test results Form as prescribed in Appendix 3 attached to this circular;
-Results of operations for the field testing of registration specified in the twelve (12) months according to the form prescribed in annex 4, issued as circular.
DD) for testing facility was held to recognize Vietnam's legal or recognized organization abroad as members joined the mutual acknowledgment agreement signing of the Agreement, the international laboratory accreditation (ILAC-International Laboratory Accreditation Cooperation), laboratory accreditation Association Asia-Pacific (APLAC-Asian Pacific Laboratory Accreditation Cooperation) reviews and accreditation certificate according to national standard ISO ISO/IEC 17025:2007 or international standard ISO/IEC 17025:2005, Subscribe to specify the target, the test in the range have been recognized: the filing of the documents referred to in Points a, b, c and d of Paragraph 3 of this article; copy (with proof) recognized certificate, category, range.
Article 7. Renewal registration records indicated before the specified decision expire ninety (90) days, send a test facility (7) record the extension specified for the State administration authorities. The records include: 1. the renewal application specifies test facility according to the form prescribed in annex 1 attached to this circular;
2. inter comparison results, proficiency testing for target/test by State administration authorities or from the proficiency testing provider, related to the scope of the registered charity;
3. Report the results of the test in the specified time according to the form prescribed in Appendix 3 attached to this circular.
Article 8. Registration of changes and supplements the scope specified testing base has been specified when there is change, additional specified scope must perform the registration of changes and supplements submit State administration authority. Registration of changes and supplements the range specified is made according to the provisions of article 6 of this circular. The base case testing has indicated a change in legal personality or base address must have text stating the contents change.
Article 9. The specified procedure 1. During the ten (10) working days from the date of receipt, the State Agency has the authority to conduct review of records. If that requires additional amendments must have the message text for the unit to complete the filing of records as prescribed. The case does not require additional amendments, the State Agency has the authority to conduct reviews under the provisions of article 10 of this circular.
2. test establishments not subject to the provisions of article 6 paragraph 3 DD-point circular: a) during the period of fifteen (15) working days from the date of receipt of a valid, full, State regulators have the authority to sign the decision formed the basis of the evaluation group tested.
b) testing facility assessment Group includes members with expert knowledge and experience in the field of evaluation, specify.
c) decided to establish the Corps reviews must specify the scope, content, reviews, list and assigned the responsibility of each Member to conduct reviews in testing facility. In the period of five (5) working days, since the end of the reviews in the basis of 3 reviewers must send conclusions about the State administration authority (form a basis of assessment test specified in annex 5 attached to this circular).
d) during the period of fifteen (15) working days from the receipt of the conclusions of the Evaluation Division, State Agency of competent jurisdiction have the responsibility to consider and specify the unit testing if satisfactory (model specified decision provisions of annex 6 attached to this circular). If not satisfactory, the governing body of the competent State must be informed in writing about the reason not specified for testing facility.
DD) in the case of need, the State Agency has the authority might formed Advisory Council before signing the decision.
3. for testing facility at VND Account specified in point 3 of this circular article 6: a) during the thirty (30) days from the date of receipt of a valid, full, State regulators have the authority to verify the record. If profiles meet according to the provisions of article 4, article 5 of this circular and the requirements of the management of the industry, State regulators have authority to sign the decision specifies the test facility attached to the directory of the target/test.
Case records are not satisfactory, the governing body of the competent State must be informed in writing about the reason not specified for testing facility.
b) in the case of need (profile evaluation results not sufficient basis to conclude the analysis capacity of the facility to meet according to the provisions of article 5), the State Agency has the authority to review group will be established to conduct reviews at the testing facility.
4. The time limit for the validity of the decision indicated: decided in effect three (3) years from the date of signing.
Article 10. Reviews test base Crew reviews by State administration authorities established to conduct reviews at the test facility (does not apply to the testing facility specified in point paragraph 3 article 6 and DD art. 3 article 9 of this circular). The steps to conducting reviews of the following: 1. evaluation compliance, suitability of the test base for the requirements specified in article 5 of this circular;
2. the report reviews the basis of testing according to the form prescribed in annex 6 attached to this circular;
3. The conclusions of the reviews according to the form prescribed in annex 5 attached to this circular. On the basis of the report of the test base remediation, if necessary, State regulators have authority to conduct the review of reviews in the testing facility.
Article 11. Code-level test facility 1. The State Agency has the authority and responsibility to manage the code for the specified test facility.
2. test base codes are designated as follows: (number)/(level)/BYT-KNTP (BCT-KNTP/BNN-KNTP).
For example: 001/2011/BYT-KNTP 3. How to write test base codes: a) test base codes are presented by capital letters, font Times New Roman font size 16, bold, vertical font. In it, the order number of the test base codes include three (3) digits.
b) testing facility code is printed in the upper left corner the vote results tested. On the vote results testing should specify the norms has been indicative of test facility.
Article 12. Verify the test facility based on demand management, the criteria specified in article 4, article 5 of this circular and the other relevant regulations as prescribed by industry managers, industry managers specify verify test facility under the provisions of the law.
Chapter IV inspection and MONITORING AFTER the SPECIFIED article 13. The method of checking, monitoring 1. Check, periodic monitoring: One (1) times one (01) year.
2. Check the sudden scrutiny, as requested by the governing body.
Article 14. Compare Union 1. Organizational unit compare Union to meet the requirements of international standards ISO/IEC 17043:2010 or have equivalent capacity.
2. On the basis of the capacity of the units held to compare Union eligibility, State regulators have the authority to designate units conduct joint comparative institutions.
Article 15. Active monitoring tests, apply for the test basis is indicated with a (1) times one (01) year. Check, monitoring activities include the following forms: 1. preliminary assessment through activity reports sent by the testing facility as prescribed (six (6) months and annually).
2. Check the monitoring activity at the base was testing facility test will be announced prior to the implementation of monitoring of fifteen (15) days. The delegation examined by competent State agencies established under decision is responsible for performing the following tasks: a) reviews the maintenance of compliance and conformity of management system and the capacity of the test facility according to article 5 of this circular;
b) test procedure the test specified by the method. Methods must meet the requirements of the corresponding technical standards or regulations;
c) compliance test systems documentary, process, specified in the test;
d) checking records of the testing process;
DD) monitoring results report form in annex 8 attached to this circular;
e) evaluation results monitoring Group remedy, reported the State administration authorities. Results based reporting remedy, the State Agency has the authority will conduct the actual test at the test facility if necessary.
Article 16. Free of supervision 1. Surveillance inspection exemption for testing facility specified in point paragraph 3 article 6 DD satisfies the provisions of article 4, article 5 of this circular and the other relevant regulations as prescribed by industry Manager.
2. test facility to meet the requirements specified in paragraph 1 of this article, filed a (01) record suggest long supervision of State administration authorities. The records include: a) The suggested test exemption;
b) minutes of the Agency's monitoring recognize national standards ISO standards ISO/IEC 17025:2007 or international standard ISO/IEC 17025:2005 (within twelve (12) months from the filing date);
c) reported results of operations within twelve (12) months from the date of filing, which stated capacity self assessment results the analysis of the test basis compared with the relevant provisions of the Ministry of industry management.
3. Within a period of no more than five (5) working days from the date of receiving the complete and valid dossier, the competent State management evaluation profile and answer results in writing to the testing facility.
4. Every year, the testing facility are exempt from the test prescribed in paragraph 1 of this article must still be subject to the checks, the sudden scrutiny of regulators.
Article 17. Announcing the test results, monitoring based on the test results, monitoring; Depending on the level of violation the rules according to the circular, the delegation examined the proposed monitoring, with State administration authorities form processing: 1. Request the fix and fix the report about State administration authority.
2. Suspension of the implementation of the decision. After completing the testing facility and report the fix at the request of the delegation check, monitoring, State regulators have authority to conduct the review of recovery decisions.
3. Withdrawal, cancellation of the decision and management industry report as a basis in one of the following cases: dissolved; no longer active in the scope have been assigned; exceeding the time limit to remedy; the offense didn't fix.
Chapter V RESPONSIBILITIES of REGULATORS and TESTING FACILITY Article 18. The responsibility of the governing body of the competent State 1. Made receiving registration documents, renewal of registration, registration of additional changes; the Organization reviews, specify testing facility.
2. Examine, monitor after specified.
3. Insure objectivity and fairness in performance reviews, specify, verify, monitor.
4. Security of the information, the data related to the testing facility.
5. Granted, suspend, remove, restore, revoke the decision.
6. Publish a list of specified testing facility, suspended, cancelled, reinstated, revoked the decision.
7. test organization, resolve the complaint accusations related to the testing facility in accordance with the law.
8. Save the test facility records.
9. Currency, using fees assessed, specify active monitoring, testing facility conducted pursuant to the law on fees and charges.
Article 19. The responsibility of test facility 1. Perform a periodic report, irregular about the State Agency has the authority to: a) periodic report: report on activities of six (6) months prior to July 10, and the report of the previous year on December 30 of each year (according to the model in Appendix 3 attached to this circular).
b) irregular reporting: as requested by the governing body of the competent State.
2. The report when there are changes to the testing range is specified, within a period not exceeding thirty (30) days from the date of the change. The content of the change must be reported include: a) legal personality;
b) organizational structure and leadership;
c) policies and procedures;
d) address, telephone, Fax, E-mail;
DD) personnel, key staff, equipment, facility, work environment or if there are other resources that impact the management system;
e) corrective measures when requested according to the form prescribed in Appendix 3 attached to this circular.
3. In addition to the implementation of the provisions of paragraph 1, item 2, this test facility, also must perform the following: a) guarantee the reliability, accuracy of the test results for the test is specified;
b) subjected to testing, monitoring on testing activities of domestic and foreign inspection division when there is a requirement of the State administration;
c) Created favorable conditions for the reviews in process reviews at the facility tested;
d) pay fees for reviews, specify active monitoring, testing facility conducted pursuant to the provisions of the law on fees and charges.
4. Perform other obligations provided for in article 20 of law the quality goods and products.
Chapter VI PROVISIONS Enacted 20. Effective circular to take effect from October 10, 2013.
Food testing facilities have been assigned according to the regulations of the Ministry of industry management was continuing to maintain in force until expiry of the decision.
Article 21. Implementation of food safety Bureau-Ministry of health, science and Technology-Industry, quality management Bureau of agriculture and forestry and fisheries, Ministry of agriculture and rural development is responsible for the Organization, monitoring, inspection and guidance made this circular.
In the process, if there are concerns, organizations, individuals in need of timely reflection on the Ministry of health (food safety Bureau), Industry (science and technology), the Ministry of agriculture and rural development (quality management Bureau of agriculture and forestry and fisheries) to research, resolve./.