LL-C (Certification)

1 LL-C (Certification) Czech Republic Rule 03 CERTIFICATION PROCEDURE 1) MANAGEMENT SYSTEMS 2) PRUDUCTS, PROCESSES AND SERVICES Revision No. 20 from 06. 10. 2016 Owner and Publisher: Head of CB, MUDr. Michal Krutsk LL-C (Certification) RULE 03, Revision 20, Page 2 (total 22) LL-C (Certification) Czech Republic , Pob e n 620/3, Praha 8 - Karl n 186 00 , section C, inset 97630, IC 27118339 Content List revisions and motivations .. 3 I. Supporting Statements .. 3 II. Scope and Objectives .. 5 III. Definitions and Abbreviations .. 5 Abbreviations used: .. 6 Documents mentioned: .. 6 IV.

2 Selection and Use .. 6 A. Selection and use of Certification Standard .. 6 B. Selection and Use of Certification Scheme .. 7 V. Certification processes .. 9 A. Management Systems Certification .. 9 B) Process of Product Certification .. 14 VI. Suspension or termination of certification .. 18 VII. Responsibility of Certification Body .. 19 VIII. Responsibilities of Certified Client .. 20 (holder of certification) .. 20 A. Management Systems certification .. 20 B. Product certification .. 20 IX. Application of Certification Rules modifications .. 22 X. Certification fees and other expenses .. 22 XI. Complaint and Appeal Procedure.

3 22 LL-C (Certification) RULE 03, Revision 20, Page 3 (total 22) LL-C (Certification) Czech Republic , Pob e n 620/3, Praha 8 - Karl n 186 00 , section C, inset 97630, IC 27118339 List revisions and motivations Rev. Date Motivation Insert Approved by 1 First publication 2 Page 8 3 Page 3-8, 10 4 Page 3-8, 12-13 5 Page 8 6 Page 1 7 Page 3-12 8 Page 3-12 9 Page 3-12 10 Page 3-12 11 Page 2- 12 12 Page 2, 4, 5, 7 13 Revision of all document 14 Page 2,20 15 Page 19 16 Pages 12, 13 17 Revision of all document 18 Page 7 19 Page 22 L.

4 Holub L. Holub 20 Page 3, 7, 11, 12, 13, 21 , I. Supporting Statements The LL-C (Certification) Czech Republic (hereinafter LL-C) is a certification body offering a national and international wide range of certification services in the field of Management Systems, Quality Management Systems (as per ISO 9001), Environmental Management Systems (as per ISO 14001), Occupational Health & Safety Management Systems (as per ISO 18001) and Information Security Management Systems (as per ISO/IEC 27001). Further, certification services are offered in Management of Critical Control Points in the Food Industry with requirements of Food/Feed Safety Management Systems (as per ISO 22000, FSSC 22000 and GMP+) LL-C (Certification) RULE 03, Revision 20, Page 4 (total 22) LL-C (Certification) Czech Republic , Pob e n 620/3, Praha 8 - Karl n 186 00 , section C, inset 97630, IC 27118339 with the requirements of HACCP, IT Service Management Systems (as per ISO 20000-1)

5 , both in production and service LL-C offers certification of products according to EN ISO 3834, EN 15085-2, EN 17660-1, EN 17660-2, EN 14554-1, EN 14554-2 and ISO 22716 in the scope of its accreditation and in a conformity with ISO/IEC 17065, EA-6/02 as well as valid Guidelines for accreditation. Further, LL-C offers certification of products (Construction Products REG EU 305/2011, Medical Devices and Machinery Devices) in the scope of its accreditation and in conformity with ISO/IEC 17065. The legal status of LL-C is a limited liability company with 100% foreign investments.

6 LL-C company was established as a subsidiary in the Czech Republic. The company is registered with the Municipal Court in Prague, section C inset 97630 IN 271 18 339. The company operates in the EU and beyond. Certification services offered by LL-C are available to all candidates who adopt rules laid down in this Directive (Rule 03) and officially demand any certification from LL-C. The policy of LL-C and its management is to offer certification of Management Systems and Products only within its own certification system while ensuring impartiality, confidentiality and independence for the Certified Client (hereinafter Client).

7 All policies applied to LL-C employees, such as knowledge, skills or relevant experiences are equally applicable to LL-C s external Auditors, Assessors, Decision Makers, Evaluators and Technical Experts. Auditors, Assessors, Evaluators, Decision Makers or Technical Experts involved in certification process shall carry out their obligations without any unfair advantage; no influence by any third party. Further, all of them are bound by strict rules of impartiality and independence of the certification body. Performed activities are an act carried out based on following principles: - Access maintenance to all certified entities, ensure non-discrimination of any organization or an individual; - Exclusion from participation in an audit and a decision-making granting a certificate for a specific Client where personally involved in consulting of management systems activities (above mentioned standards); impartiality and independence of the assessment for a particular Client is ensured.

8 - Exclusion from participation in an evaluation process/conformity assessment, and on decision on certification granting, where activities of personnel might be considered as violating obligation of impartiality; - Strict separation of Audit/Expert advice and decision on certification granting; - Strict separation of Evaluation/Conformity assessment and decision on certification granting; - Respect for confidentiality of all personnel involved in any certification process. LL-C services are based on following policies and principles: - Philosophy to promote confidence in certification as an effective instrument to improve the quality of products and services and as a more careful approach to the environment and other risk prevention; - Information system security improvement; - Ensuring the highest possible level of integration during assessment of management systems according to various established standards and regulations; - Ensuring territorial and term availability of Auditors and Assessors.

9 1 All standards mentioned are in up to date version. LL-C (Certification) RULE 03, Revision 20, Page 5 (total 22) LL-C (Certification) Czech Republic , Pob e n 620/3, Praha 8 - Karl n 186 00 , section C, inset 97630, IC 27118339 - Ensuring personnel with relevant experiences and competence Auditors and Assessors regarding expertise required, Auditor experience, conformity assessment experiences and of equal existence of ethical behaviour and empathy; - Strict respect for confidentiality; - Effective preference of precautions prior to formality of meeting the requirements of standards.

10 - Use of the most modern techniques for testing, as well as an adoption of organizational measures preventing conflicts of interest and challenging the legality of tests. II. Scope and Objectives Objectives The present Rule defines: A) Procedures used for Management Systems Certification. Further, the Rule explains substances and procedures of certification process relevant for organizations with an interest for certification. Instructions are based on the requirements of ISO 17021-1 (up to date version), MPA 50-01-07, SN EN ISO 19011 (up to date version). B) Procedures used for Product Certification.