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Chapter 1 General
Article 1
These regulations are set forth in accordance with the 2nd paragraph of Article 27 of the Act Governing Food Sanitation (hereinafter referred to as ‘the Act’)
Chapter 2 The Certifying Body
Article 2
The inspection and examination of food sanitation (hereinafter referred to as ‘inspection activities’) referred to in the 2nd paragraph of Article 27of the Act means the relevant inspection and examination of food safety, sanitation and quality; the certifying body referred to means the professional agencies(institutions) that are capable of providing certification.
The preceding certification bodys shall be accredited by the central competent authority or its commissioned agencies (institutions) (hereinafter referred to as ‘ commissioned institutions ’ ).
Article 3
Food businesses shall apply for certification to the certifying body that has been accredited.
Chapter 3 Application for Accreditation
Article 4
The institution which is qualified for the following terms may apply for accreditation to be a certifying body:
1. The institution ’ s organizational structure and operation, staffing and inspection capability comply with ISO standards, or the institution is capable of carrying out food sanitation inspection as prescribed in Article 24 of the Act after submitting for enforcement subject to approval of the central competent authority.
2. The institution is provided with inspection equipment, places, personnel and management systems for the inspection of food sanitation, having sufficient information and knowledge regarding food sanitation inspection skills and regulations relating to the items which have applied for accreditation.
3. The institution is organized with staffing which are graduated from the relevant divisions, departments and institutes of food, medicine or chemistry in both domestic and foreign colleges/universities and above accepted by the Ministry of Education and meet the following qualifications:
(1) The relevant professional training of food sanitation inspection as well as three years plus practice working experience at the post of inspection department superior;
(2) The relevant professional training of quality control as well as three years plus practice working experience at the post of QC department superior;
(3) The personnel who has been trained for inspection activities in possession of qualified certificate, document.
Article 5
The following documents must be submitted to the central competent authority or its commissioned institution for the preceding application:
1. The relevant instructions and documents for the preceding personnel and facilities;
2. A brief introduction of the organization, person in charge and business profile;
3. Quality management documents and operational procedure explanations of the institutions.
Article 6
Quality management documents and operational procedure explanations prescribed in the third subparagraph of Article 5 are as following contents:
1. Quality instruction manual;
2. Certification standards;
3. Procedures of certification, inspection tracking, additional certification and re-certification.
4. Selection, training, evaluation and assignment of inspection personnel and experts.
Contents of each procedure prescribed in Subparagraph 3 of the preceding paragraph are as follows:
1. Certification procedure: Application methods, application reviewing, organization of assessment team, assesses documents and drafts assessment plan, head office ’ s assessment and witness assessment as well as certification decision.
2. Inspection tracking procedure: Organizes inspection tracking team, inspection tracking frequency, inspection tracking timing, drafts inspection tracking plan, head office ’ s inspection tracking, witness assessment and inspection tracking decision.
3. Additional certification procedure: Application procedure, document checking, organizes assessment team, drafts assessment plan, head office ’ s assessment, witness assessment and additional assessment decision.
4. Re-certification procedure: Organizes re-assessment team, drafts assessment plan, head office ’ s re-assessment, witness assessment and re-assessment decision
Article 7
The application for being the certifying body should be accredited its certification capability for such certification items in accordance with the announcement of the central competent authority.
The central competent authority shall announce the procedures, methods and relevant work flow for the application of the certifying body.
Article 8
The central competent authority or its commissioned institution may conduct on-site review after reviewing written documents for the application of certifying body if necessary; once passed the review, the central competent authority should issue accreditation certificate specified the following items:
1. Title and address of certifying body;
2. Name of the person in charge of certifying body;
3. Accreditation items;
4. Accreditation standards;
5. Title and address of accreditation agency (institution);
6. Year, month, date, and certificate no. issued for accreditation certificate.
The validity period of the preceding accreditation certificate is three years; applications for ulterior extensions for a period of three years are available in the six months prior to expiry.
Chapter 4 Management of the Certifying Body
Article 9
The central competent authority or its commissioned institution shall regularly examine the certifying body ’ s equipments, staffing, operational procedures, quality management, inspection capability and relevant items etc.
Article 10
The certifying body shall charge for handling certification; charged items and amount must be submitted to the central competent authority for approval.
Article 11
The certifying body should display the accreditation certificate in a conspicuous place inside.
Article 12
The certifying body must report any change of personnel or place to the central competent authority or its commissioned institution in within14 days.
If there is any modification of accreditation items, quality management documents or operation procedure, the certifying body shall submit the relevant documents prescribed in Article 5 to the central competent authority or its commissioned institution for registration of modification.
Article 13
The certifying body shall handle only certification items being accredited.
Article 14
The central competent authority or its commissioned institution shall require the certifying body to report its business and accept inspection.
Without any reasonable ground, the certifying body shall not evade, obstruct or refuse the preceding inspection.
Article 15
In the event that the certifying body having one of the following conditions fails to improve within a time limit upon receipt of notice from the central competent authority or its commissioned institution, the central competent authority should abolish its accreditation certificate:
1. Any change of personnel or place causes inconformity with qualification prescribed in Article 4;
2. Any breach of provisions set forth in Article 12 is found after examination;
3. Any major violation is found in accordance with the inspection prescribed in the preceding article.
In case of abolishment of the aforesaid certificate, such certifying body shall not apply for accreditation to the central competent authority or its commissioned institution within one year.
Chapter 5 Supplementary Provisions
Article 16
These regulations are effective from the date of promulgation.
Web site:Laws & Regulations Database of The Republic of China