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    Guidelines for the Designation and Operation of Certification Bodies f…

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    댓글 댓글 0건   조회Hit 622회   작성일Date 24-01-03 10:51

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    Article 1 (Purpose)

    The purpose of this Public Notice is to stipulate matters delegated to the Director General of the National Fishery Products Quality Management Service (hereinafter referred to as the “Director General”) pursuant to Article 26 of the Act on the Promotion of Environment-friendly Agriculture and Management and Support for Organic Foods, etc., Article 27 (2), Article 29 (4), and Article 31-2 (6) of the Enforcement Rules of the same Act, and to provide detailed matters necessary for its implementation.


    Article 2 (Definitions)
    For the purposes of this Public Notice, the terms used herein shall be defined as follows:

    1. The term “Director General” means the Director General of the National Fishery Products Quality Management Service.

    2. The term “Branch Director” means the head of a branch office of the National Fishery Products Quality Management Service having jurisdiction over the relevant area.

    3. The term “Certification Auditor” means a person who has been granted auditor qualifications by the Director General pursuant to Article 31-2 of the Enforcement Rules of the Act on the Promotion of Environment-friendly Agriculture and Management and Support for Organic Foods, etc. under the jurisdiction of the Ministry of Oceans and Fisheries, and who performs certification audit work.

    4. The term “Certification Work” means certification audits, re-audits, approval of changes, renewal of certification, extension of validity period, cancellation of certification, and other dispositions, as well as investigation of certified business operators pursuant to Articles 20, 21, 24, 31, and 34 of the Act.

    5. The term “Certified Products” means organic fishery products, organic processed foods, antibiotic-free fishery products, and non-use of active treatment agent fishery products certified under Articles 20, 21, or 34 of the Act.

    6. The term “Certified Business Operator” means a person who has obtained certification under Articles 20, 21, or 34 of the Act.

    7. The term “Certification Body” means an institution designated by the Director General pursuant to Articles 26 and 35 of the Act to carry out certification of organic foods and antibiotic-free fishery products.

    Article 3 (Scope of Application)
    Deleted.


    Article 4 (Application for Designation)
    A person who intends to be designated as a certification body shall submit to the Director General an application for designation in Form No. 11 of the Enforcement Rules, together with a business plan under Article 26 (2) of the Enforcement Rules and documentary evidence.


    Article 4-2 (Standards for Designation)
    The detailed standards for designation under Article 27 (2) of the Enforcement Rules shall be as set forth in Attached Table 1.


    Article 5 (Examination for Designation)

    1. Upon receiving an application for designation or renewal of designation of a certification body pursuant to Articles 26 and 30 of the Enforcement Rules, the Director General shall organize an examination team of two or more members to examine the following matters:

      1. Appropriateness of the documents submitted under Article 4;

      2. Compliance with the designation standards prescribed in Attached Table 9 of the Enforcement Rules and Article 4-2 of this Public Notice.

    2. Where the result of the examination under paragraph (1) is deemed non-compliant, the Director General shall determine the application as non-conforming.

    3. Where the documents attached under Article 4 are incomplete, the Director General may require the applicant to submit additional materials.

    Article 5-2 (Training of Certification Auditors)

    1. The Director General shall publish on the website the annual training plan for certification auditors, including the schedule, venue, application procedures, and contents.

    2. Detailed matters concerning the training of certification auditors shall be as set forth in Attached Table 2.

    Article 5-3 (Issuance of Certification Auditor’s Identification Card)

    1. When issuing an identification card for a certification auditor pursuant to Article 31-2 (4) of the Enforcement Rules, the Director General shall manage the information through the certification management information system or register.

    2. A person whose certification auditor’s identification card is lost, damaged, or requires reissuance due to changes in registered information shall submit an application for reissuance in Form No. 3 to the Director General within seven days from the date the relevant cause occurred.

    3. A certification auditor who loses his/her qualification or whose qualification is revoked shall promptly return the certification auditor’s identification card to the Director General.

    Article 6 (Notification of Examination Results)

    (1) Where the Head has determined, as a result of the examination under Article 5, that the applicant meets the designation criteria, the Head shall issue a Certificate of Designation of Certification Body in the form prescribed in Annex Form 12 of the Enforcement Rules.
    (2) The Head shall notify the applicant in writing of the examination results under Article 5 as follows:

    1. Where the applicant does not meet the designation criteria under Article 27 of the Enforcement Rules, the specific reasons for such non-compliance shall be indicated.

    2. In the case of minor matters other than designation criteria which can be corrected within a short period, such matters and the correction period shall be specified.
      (3) The designation number of the Certificate of Designation of Certification Body shall be assigned in serial order (starting with No. 101 at the first issuance), and in cases of cancellation or renunciation of designation, such numbers shall remain permanently vacant.
      (4) Where the Head has issued a Certificate of Designation of Certification Body, or has reissued it due to changes in designation details, such issuance or reissuance shall be recorded in the Certification Body Register in the form prescribed in Annex Form 1.

    Article 6-2 (Compliance Requirements for Certification Bodies)

    (1) A certification body shall, pursuant to Articles 19, 36, and 40(2) of the Enforcement Rules, take administrative dispositions within 60 days from the date of confirming the violation committed by a certified operator.
    (2) Where a certified operator falls under Article 62(2)8, Article 62(3)1 or 4, or Article 62(4)3 of the Act, the certification body shall request the Head of the competent regional office to impose an administrative fine.


    Article 7 (Post-Management of Certification Bodies, etc.)

    (1) In accordance with Article 32 of the Act, the Head of the Regional Office shall implement the following to verify the actual certification activities of certification bodies:

    1. At least one on-site investigation per year of each certification body to confirm compliance with designation criteria, adequacy of certification audits, and post-management work;

    2. At least two attendance-based inspections per year of the certification audit process of each certification body to verify adequacy of audit procedures and methods: Provided, that the number of inspections may be adjusted for certification bodies conducting five or fewer audits per year;

    3. Any other investigations or reports deemed necessary by the Head.
      (2) The Head of the Regional Office may conduct inspection or investigation of production and distribution processes of certified products certified by a certification body.
      (3) Where violations of certification criteria are identified during investigations under Paragraphs (1) and (2), the Head of the Regional Office shall obtain a written confirmation in the form prescribed in Annex Form 2 and evidence documents, and report them to the Head: Provided, that if the violator refuses or avoids signing such confirmation, the fact may be confirmed with signatures or seals of at least two investigators.
      (4) Where investigations of certification bodies outside the jurisdiction are required, the Head of the Regional Office may request such investigations from the competent regional office or directly conduct them.

    Article 8 (Administrative Dispositions Against Certification Bodies, etc.)

    (1) Where the Head recognizes that a certification body has committed violations under Article 29 or Article 32(2) of the Act, the Head shall take dispositions pursuant to Article 34 and Annex 10 of the Enforcement Rules.
    (2) The Head shall publish the details of administrative dispositions against certification bodies under Paragraph (1) on the website of the National Fishery Products Quality Management Service (NFQS).
    (3) Certification bodies subject to dispositions under Paragraph (1) shall notify certified operators within seven days from the date of disposition, by SMS, email, fax, phone, or written notice, that certification services may not be provided, as follows:

    1. In case of cancellation of designation: the cancellation date;

    2. In case of suspension of certification activities: the suspended activities and suspension period.
      (4) Where the case falls under Article 62 of the Act, the Head of the Regional Office shall impose and collect fines pursuant to Article 9 and Annex 2 of the Enforcement Decree of the Act on the Promotion of Environment-friendly Agriculture and Fisheries and the Management and Support for Organic Foods, etc.

    Article 9 (Re-Examination Period)

    The Head shall review the validity of this Notice every three years, as of July 1, 2023 (by June 30 of every third year), pursuant to the Regulation on the Issuance and Management of Directives and Guidelines, and take necessary measures such as improvement.

    Supplementary Provisions

    Article 1 (Enforcement Date)
    This Notice shall enter into force on the date of its promulgation.

    Article 2 (Application of Scope and Fields of Accreditation Certificate)
    The amended provisions of Subparagraph (b) of Paragraph 1 of Annex 1 shall apply to applicants who apply for designation or renewal of certification bodies under Article 26(2) and (3) of the Act after the enforcement of this Notice.

    Article 3 (Transitional Measures Regarding Designation Criteria for Certification Bodies)
    Any institution or organization already designated as a certification body under previous regulations as of the enforcement date of this Notice shall be deemed to have been designated in accordance with the amended provisions of Subparagraph 3 of Annex 1.

    [Annex 1]

    Detailed Criteria for Designation of Certification Bodies (Related to Article 4-2)

    1. General Requirements
      (a) Certification bodies shall be accredited as product certification bodies by the Korea Laboratory Accreditation Scheme (KOLAS) in conformity with ISO/IEC 17065 “Conformity assessment – Requirements for bodies certifying products, processes and services”: Provided, that accreditation by a member body under the International Accreditation Forum Multilateral Recognition Arrangement (IAF MLA) for the same scope shall be deemed equivalent.
      (b) The field and scope of accreditation shall be limited to “fishing industry” or “fishery food manufacturing industry” as prescribed in Annex 1, Subparagraph 8 of the KOLAS Operation Guidelines.
      (c) Certification bodies shall maintain documentation on their founding purpose, objectives, organizational status, major activities, organizational chart, financial resources, utilization plans, and settlement data.

    2. Organization
      (a) Certification bodies shall maintain documents proving legal incorporation.
      (b) Certification bodies shall provide evidence that the head of the certification body and certification auditors independently carry out certification activities.
      (c) Certification bodies shall demonstrate financial resources sufficient for at least three months of operation through corporate account balances or equivalent evidence.
      (d) Certification bodies shall maintain insurance coverage to compensate for potential damages to certified operators caused by cancellation, bankruptcy, or dissolution.

    3. Personnel
      (a) Certification bodies shall secure at least two full-time certification auditors, considering workload.
      (b) Certification bodies shall secure at least one full-time certification auditor qualified under Article 31-2(1) of the Enforcement Rules, corresponding to the certification scope:

      1. For organic aquaculture products, antibiotic-free aquaculture products, and aquaculture products without chemical treatment: aquaculture qualification;

      2. For organic processed foods: food qualification.

    4. Facilities
      Where a certification body entrusts tasks such as measurement or analysis of certified products to external laboratories (entrusted institutions), the following requirements shall be met:
      (a) Written agreements specifying period, scope, methods, fees, confidentiality, termination, and responsibilities;
      (b) Retention of test samples for at least 15 days and raw data for at least two years;
      (c) Provision of such data upon request by the NFQS or certification body;
      (d) Cooperation with NFQS inspections or evaluations;
      (e) Immediate notification to certification body in case of suspension or cancellation of designation of the testing institution.

    [Annex 2]

    Detailed Rules on Qualification Training for Certification Auditors (Related to Article 5-2)

    1. Training Institutions
      NFQS or institutions/organizations designated by the Head.

    2. Application and Registration
      Applicants seeking qualification as certification auditors shall apply for training to the head of the designated training institution.

    3. Training Contents and Evaluation
      (a) Training shall consist of theoretical and practical components:

      1. Theoretical: roles and duties of auditors, relevant laws, certification criteria, audit procedures and methods.

      2. Practical: verification of application contents, sampling for analysis, evaluation methods, and other field practices.
        (b) The training institution shall conduct evaluations upon completion of the course.

    4. Certificate of Completion and Notification of Results
      (a) A certificate of completion shall be issued to trainees who attend at least 90% of the course and score 60 points or higher in the evaluation.
      (b) The head of the training institution shall notify the Head of the NFQS of the results within three days, in writing or electronically.


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