LL-C (Certification) Rule 03 CERTIFICATION PROCEDURE 1) MANAGEMENT SYSTEMS 2) PRUDUCTS, PROCESSES AND SERVICES. Czech Republic s.r.o.

Transcription

1 Czech Republic s.r.o. Rule 03 CERTIFICATION PROCEDURE 1) MANAGEMENT SYSTEMS 2) PRUDUCTS, PROCESSES AND SERVICES Revision No. 20 from Owner and Publisher: Head of CB, MUDr. Michal Krutský

2 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. 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 VI. Suspension or termination of certification VII. Responsibility of Certification Body VIII. Responsibilities of Certified Client (holder of certification) A. Management Systems certification B. Product certification IX. Application of Certification Rules modifications X. Certification fees and other expenses XI. Complaint and Appeal Procedure RULE 03, Revision 20, Page 2 (total 22)

3 List revisions and motivations Rev. Date Motivation Insert Approved by First publication M.Krutský M.Krutský Page 8 M.Krutský M.Krutský Page 3-8, 10 M.Krutský M.Krutský Page 3-8, M.Krutský M.Krutský Page 8 M.Krutský M.Krutský Page 1 M.Krutský M.Krutský Page 3-12 M.Krutský M.Krutský Page 3-12 M.Krutský M.Krutský Page 3-12 M.Krutský M.Krutský Page 3-12 I.Angelovski M.Krutský Page 2-12 I.Angelovski M.Krutský Page 2, 4, 5, 7 I.Angelovski M.Krutský Revision of all document B.Kuchtová M.Krutský Page 2,20 L.Holub M.Krutský Page 19 B.Kuchtová M.Krutský Pages 12, 13 D.Tokar M.krutský Revision of all document B.Kuchtová M.Krutský Page 7 D.Tokar M.Krutský Page 22 L. Holub L. Holub Page 3, 7, 11, 12, 13, 21 M.K., I.A M.Krutský I. Supporting Statements The LL-C (Certification) Czech Republic s.r.o. (hereinafter LL-C) is a certification body offering a national and international wide range of certification services in the field of Management Systems, e.g. 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 and GMP+) RULE 03, Revision 20, Page 3 (total 22)

4 with the requirements of HACCP, IT Service Management Systems (as per ISO ), both in production and service companies. 1 LL-C offers certification of products according to EN ISO 3834, EN , EN , EN , EN , EN and ISO 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 The legal status of LL-C is a limited liability company with 100% foreign investments. 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 IN 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). 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; - 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; 1 All standards mentioned are in up to date version. RULE 03, Revision 20, Page 4 (total 22)

5 - 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; - 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 (up to date version), MPA , ČSN EN ISO (up to date version). B) Procedures used for Product Certification. Further, the Rule explains substances and procedures of certification process relevant for organizations with an interest for certification. Instruction are based on the requirements of ISO/IEC Scope This definition of scope applies to Management Systems Certification of organizations active in manufacturing, non-state or government sectors in areas for which LL-C is accredited for. This definition of scope applies to Product Certification of organizations active in manufacture of products for which LL-C is accredited for. Regulations or standards specific for a particular field, not designated here in detail, are adequately regarded and applied according to inherent requirements if needed. Any nonconformities or deviations will be presented to any Client case by case pursuant inherent requirements. III. Definitions and Abbreviations The present Rule contains definitions from: EN ISO (up to date version) - General requirements for certification bodies for Management System Certification (including MPA of Czech accreditation institute) EN ISO Guidelines for Auditing of Management Systems RULE 03, Revision 20, Page 5 (total 22)

6 EN ISO/IEC General Requirements for Bodies Operating Product Certification Systems Abbreviations used: CB CBP HCB Certification Body CB for Product Certification Head of CB DHCB Deputy Head of CB QM A LA DM TE Quality Manager Assessor which provides Conformity Assessment Lead Assessor Decision Maker on Certification Technical Expert Certified Client - Client Documents mentioned: F30 - F31 - F32 - F46 - Rule 01 - Rule 02 - Rule 03 - Rule 05 - Rule 12 - IV. Selection and Use A. Selection and use of Certification Standard Quality Management System (QMS) For Quality Management System certification ISO 9001 standards (up to date version) is used. Further, quality management system must meet expectations of the relevant field and customers. RULE 03, Revision 20, Page 6 (total 22)

7 Environmental Management System For Environmental Management System certification standard ISO is used. Further, management system must meet expectations of the relevant field and customers. Information Security Management System For Information Security Management System certification standard ISO is used. Further, quality management system must meet expectations of the relevant field and customers. Currently, IT Service Management System is currently often used in ICT sector; as per ISO This standard contains elements of IT services outsourcing management, quality management of ICT services and security management system information. Critical Control Points Management Food Industry is certified in accordance to HACCP regulation (FAO/WHO Codex Alimentarius). Further, quality management system must meet expectations of the relevant field and customers. This standard gives basis for a more comprehensive Food Safety Management System (ISO and FSSC 22000), which integrates feedback and process management, as well as quality compatibility. As well as GMP+ (B2, B4, B4.3) feed safety certification scheme Occupational Health & Safety Management System For Occupational Health & Safety Management System certification ISO OHSAS standard is used. Further, management system must meet expectations of the relevant field and customers. Other management systems When other standards are used, additional requirements according to relevant accreditation body or contractual entity might occur. These additional requirements will be provided to interested parties upon request. B. Selection and Use of Certification Scheme Products/Processes as per EN ISO /3/4, EN /3, EN , EN , EN , EN , EN and IS , The conformity assessment is based on system certification audit methodology in the scope of accreditation, in accordance with EN 45011, EA-6/02 and a valid accreditation entity prescription. The quality assurance of welding processes in manufacturing, execution of steel/aluminium construction, welding work on railway vehicle and ensuring GMP-cosmetics products are generally controlled during the certification procedure. Machinery Devices Machinery devices certification means conformity assessment and evaluation procedures are provided based on EC type-examination. In this regard, CB ascertains and certifies that a sample of machinery devices (product concerned) meets provisions and requirements of Directive 2006/42/EC. RULE 03, Revision 20, Page 7 (total 22)

8 Medical Devices (MDD) MDD certification means that conformity assessment and evaluation procedures are provided based on EC Declaration of Conformity assessment procedures of Full Quality Assurance System (Annex II of Directive 93/42/EEC), Production Quality Assurance (Annex V of Directive 93/42/EEC) and Production Quality Assurance (Annex VI of Directive 93/42/EEC), by which CB ascertains and certifies that a sample of MDD (product concerned) meets provisions and requirements of this Directive. Construction Products (CPR) The procedure provides an evaluation based on conformity assessment and durability verification in accordance with Regulation (EU) No 305/2011 of the European Parliament and of the Council, Annex V (System 2+). CB conducts Factory Production Control (FPC) certification based on factory s initial inspection, factory production control and continuous surveillance and factory production control (FPC) approval. Toys Evaluation of Toys means conformity assessment procedure is provided based on EC Declaration of Conformity by procedure EC type-examination. In this regard, CB ascertains and certifies that a toy sample (product concerned) meets provisions and requirements of Directive 2009/48/EC, Regulation of Government No. 86/2011. Software for MDD The conformity assessment is based on system certification audit methodology in accordance with ISO and efforts to fulfil individual chapters of Directive 93/42/EEC related to MDD and Directive 98/79/EC related to IVVD. The assessment model is based on other Annexes of Directives and Client requests. LL-C provides assessment of MDD class III based on Annex II of Directive 93/42/EEC; including examination of product design. RULE 03, Revision 20, Page 8 (total 22)

9 V. Certification processes A. Management Systems Certification Certification process diagram Process participants: CLIENT LL-C SUBCONTRACTOR CLIENT INQUIRY TELEPHONE INQUIRY DETAILS APPLICATION FORM (F30) APPLICATION REGISTRATION CERTIFICATION STANDARDS OFFER/AGREEMENT (F31) APPLICATION EVALUATION INTEGRATION OTHER NORMATIVE DOCS. BUSINESS CONDITIONS (F32) Evaluation failed due to incorrect audit/assessment procedure ASSESSMENT SCOPE DEFINITION STAGE 1 AUDIT - OFF SITE /ON SITE APPOINTMENT OF AUDITORS (F40) AUDIT PLAN (F41) STAGE I QUESTIONNAIRE (F42 I.) GMP+ temporary acceptance (max 4th months) STAGE 2 AUDIT - ON SITE NON-CONFORMITY REPORTS (F46) Unsuccessful evaluation EVALUA TION AUDIT OUTCOME EVALUATION AUDIT RECORD (F44) AUDIT REPORT (F43) Successful COMPILATION OF FINAL DOCUMENTS (Certificates) AUDIT REPORT (F 43) REJECTION NOTICE OF CERTIFICATE ISSUE (F 48 V) COMMENTS AND ACCEPTANCE BY CLIENT ACCEPTANCE BY CLIENT RULE 03, Revision 20, Page 9 (total 22)

10 The certification process mainly consists of: - Inquiry completion of Application F30 (Questionnaire for Proposal Management System certification); - Verification of required documentation; - Identification of aspects, risks and processes of manufacture or services provided (Stage 1 Audit - On-site/Off-site); - On-site audit of implementation and application at both, the contractors Head Office and active operational site (branches), to demonstrate capabilities (Stage 2 Audit); - Audit evaluation results. Certification cycle: - Certification audit - Initial audit and evaluation; - Surveillance audits as per IAF requirement; the first surveillance shall be carried out within 12 months from the last day of Stage II Audit; - Recertification audit (audit re-assessment) with the frequency of 3 years after initial certification and before the expiry of valid certificate; to maintain a valid certification. The following articles describe details of individual steps of Certification cycle. Inquiry/ Offer /Offer Submission and Application Registration Inquiry of any new Client for Management System certification may be personally discussed with a responsible LL-C persona, send via at info@ll-c.cz or by mail to company address, as well as send via electronic form available at LL-C website Based on written inquiry or a face-to-face meeting, the LL-C coordinator conducts a review of obtained information and verifies whether the CB has a competence and abilities to perform the certification demanded (based on the scope of accreditation). Further, reviews whether specific processes (e.g. welding, sterilization) should be considered is conducted; in cooperation with the Head of CB. Based on Inquiry, Questionnaire data and a current tariff, LL-C issues F31 form (Proposal on a management system certification according to the standard(s) ) in written form, which is send to the address of the Applicant. Further, every Offer must be accompanied by Business Conditions (F32 form) as this document is its integral and mandatory annex. Client who accepts an Offer for certification has to confirm the F31 form and Business Conditions (F32 form). Only an Offer that is signed by an authorised persona and submitted with signed Business Conditions is taken as a valid contract/agreement for Management System certification. By the Application confirmation, following process is initiated: - Offer is registered to the internal system of LL-C, including information about the Applicant; - Lead Auditor is appointed; Lead Auditor starts to plan the audit (contact person authorised by the Applicant, additional conditions, creation of audit team, fix an audit date); - The Applicant is requested to submit the management manual or other document(s) describing the management system at least 14 days before the audit starts (first date of audit). Auditors The Lead Auditor, Auditors, members of Audit team, Technical Expert and DM (Decision Maker) are appointed by Head of CB LL-C. The appointment process must comply with general qualification of Auditors, including their competence and experience, reflecting RULE 03, Revision 20, Page 10 (total 22)

11 applicant activity and any specific processes (e.g. welding) if any occur, impartiality and independence. The Applicant must be notified in advance about the Lead Auditor appointment. Client s documentation submitted Documentation submitted must reasonably depict the organizational structure of Applicant company as well as it shall include a precise description of company s activities. Above the system management manual, the documentation may include procedures and work instructions. Documentation must take into account both, direct and indirect, requirements based on standard(s) applied and Client business scope. Documentation assessment LL-C considers all information and documentation of the Applicant/Client to be confidential. Lead Auditor shall examine documentation presented in adherence to completeness and conformity to the requirements of selected standard. In case of major nonconformities, the applicant receives a Protocol of nonconformities (F46 form). The applicant shall accept corrective actions to nonconformities which occurred and specify the date for their compliance. Major nonconformities must be corrected before Stage II Audit. Insignificant nonconformities and other anomalies may be clarified during the Stage II audit. Stage I Audit - Initial certification Stage I Audit is an obligatory part and is carried out as a part of the initial certification audit (Stage I Audit). Stage I Audit is performed to determine the preparedness of Client location, status and the main conditions for Stage II Audit. Results are documented in I. stage Questionnaire, Protocol of nonconformities (F46 form) and other forms. In certain cases, and under specific circumstance (particularly standard ISO 9001) Stage I Audit may be carried out as an offsite audit of the Applicant location via questionnaires and telecommunication technology (RAP remote auditing procedures). In case of GMP+ certification temporary acceptance for max 4 month can be issued. Audit planning and preparation Lead Auditor in cooperation with the Applicant draw up an Audit plan and inform the Applicant about its final version in an appropriate way. The Audit plan shall contain all information needed for the Applicant to prepare for audit. If necessary, Lead Auditor may visit the Applicant to plan details. In case of an integrated audit only one Audit plan is created. Lead Auditor prepares the Audit plan in order to avoid repeated verification of the common requirements of individual standards. AUDIT ON SITE Opening meeting The Opening meeting stands for an interview of Auditors with an Applicant and person responsible for management system in the Applicant company. The goal of Opening meeting is to: - Reach a consensus of both parties (Applicant and CB) on the content and procedures of certification; - Discuss results of Stage I Audit; - Determine a manner of communication between both parties; RULE 03, Revision 20, Page 11 (total 22)

12 - Verify whether the extent of audit shall provide sufficient results for further assessment carried out by the Auditors; - A declaration of confidentiality and impartiality of audit team. Stage 2 Audit - Audit performance Auditors with an assistance from company management or its representatives shall examine whether the organization unit system is in accordance with the plan; including amendments adopted during the Opening meeting. During the assessment Auditors can use questionnaires (for specific standards) and verify whether the management system is introduced and applied in conformity with requirements of the selected standard as well as with Client s documentation. Lead Auditor shall communicate a preliminary report on results after the audit is done. Audit team is not authorized to release the final result of certification. A written Audit report containing results of an audit and other important information shall be received by an Applicant within 14 days. The Applicant may raise objections and comments within following 14 days. If any nonconformities (major or minor) are found in the system, the Applicant must propose appropriate corrective actions and the date of their implementation; the date depends on specific findings. In case of GMP+ the period between Stage I and II. must not be longer than 4 months. Evaluation of Audit results Lead Auditor shall forward all necessary documentation from audit performed to a responsible persona for an impartial evaluation and decision on certification. Criteria for evaluation of audit results are as follows: - Verification of compliance with the relevant standard; - Verification of compliance with the LL-C Rules; - Submission and completeness of audit results in the documentation of audit (f.e. report, questionnaire, reports of nonconformities). If any uncertainties occur, they shall be clarified by a responsible Evaluator and Lead Auditor. If any nonconformities occur an additional audit is needed to verify that corrective actions were taken successfully before the certificate will be granted. Information for Applicant If an Evaluator decides that an outcome of an audit assessment authorizes the CB to grant a new certificate or maintain a current certificate, the Applicant will receive a certificate (in case of an initial audit) as well as the Audit report. If an Evaluator decides that an outcome of an audit assessment does not allow the CB to grant a new certificate or maintain current certificate, the final decision is notified to the Applicant including reasons for the decision. The Applicant has the right to appeal to the Head of CB with a request to challenge the decision. Certification contract The certification contract on management systems dealing with rights and obligations of any Applicants and CB is concluded by a confirmation of Offer of Management System Conditions (F31 form) and Business Conditions (F32 form). The Applicant must confirm both documents (sign), before the Stage I Audit starts. Signed contract is mandatory for the certification and follow up/ surveillance period. Certification RULE 03, Revision 20, Page 12 (total 22)

13 Ones all criteria are met; LL-C grants a certification in the form of a certificate. The Applicant receives official certificates, two original sets in Applicant national language as well as two original sets in English. Additional fee might be charged if additional copies or the foreign language version(s) of certificate are required. All issued certificates are valid for a period of three years under certain conditions; follow up / surveillance audits are performed as well as compliance with conditions of the relative standard are confirmed. Use of LL-C logo and other marks The use of LL-C logo and marks is regulated in compliance with Business Conditions (F32 form). Any certified entity must comply with the terms in F32 form. Certification maintenance In order to maintain the valid certificate LL-C provides an annual surveillance audit to determine the effectiveness of the system. Surveillance audits are carried out in compliance with the certification cycle; surveillance audit shall not be later than 1 year from the last day of Stage II Audit or no later than last day of first surveillance audit. If surveillance audit findings show nonconformities in Client s management system according to the standards, the Client is allowed to take corrections and corrective actions and implement them by the established deadline. LL-C verifies and decides if the relative corrective action(s) is/are sufficient enough to maintain the current certification. The recertification audit shall be done prior to the expiry date of the certification if Client wishes to continue certification with LL-C. Therefore, recertification audits shall be planned ahead of time and Client shall be informed. Recertification audits evaluate and confirm the continued conformity and effectiveness of the management system, further its commitment to maintain the effectiveness and improvement, and its continued relevance and applicability for the scope of certification. The recertification audit shall be planned and conducted in due time to enable for timely renewal before the certificate expiry date. Procedures and guidelines for recertification audits are consistent with procedures and guidelines for an initial audit. If any important changes, e.g. object of activity or documentation, in Client s organization occur they shall be submitted to LL-C at least 14 days before the audit starts. Additional audits (in GMP+ schemes are carried out in accordance with GMP+C12 document. RULE 03, Revision 20, Page 13 (total 22)

14 B) Process of Product Certification Certification process diagram certification of product, process or service* PROCESS PARTICIPANT CLIENT LL-C SUBCONTRACTOR CLIENT INQUIRY APPLICATION TELEPHON INQUIRY DETAILS APPLICATION FORM F30 V TECNICAL EXPERT APPLICATION REGISTRATION EVALUATION FAILED DUE TO INCORRECT EVALUATION PLAN APPLLICATION EVALUATION EVALUATION SCOPE DEFINITION REGULATIONS OF GOVERN. HARMONISED STANDARDS PLAN OF EVALUATION F41 V OWN EQUIPMENT NO OWN EQUIPMENT YES EXECUTION OF TESTS IN LABORATORY, CALCOLATIONS EXECUTION OF TESTS IN LABORATORY, CALCOLATIONS EVALUATION QUESTIONNAIRE Unsuccessful evaluation DM EVALUATION OF THE RESULTS OF TESTS (F 42 V) RECORDS FROM ASSESSMENT( F44) Successful evaluation COMPILATION OF FINAL DOCUMENTS EVALUATION REPORT (F 43 V) DECISION ON CERTIFICATIO (F 47 V) CERTIFICATION OF CONFORMITY (F 49 V) CERTIFICATE ISSUE REJECTION NOTICE (F 48 V) COMMENTS AND ACCEPTANCE BY CLIENT ACCEPTANCE BY CLIENT * The Certification process diagram (above) does not apply to Medical Devices Certification process; Medical Devices Certification process described separately in Technical Guide for Product certification - Medical Devices MDD (Rule 15.11). RULE 03, Revision 20, Page 14 (total 22)

15 The Certification process mainly consists of: - Inquiry and completion of application Questionnaire for Proposal Product certification (F30V form); - Verification of required documentation; - Documentation assessment and creation of Certification Offer Product certification (F31V) - Evaluation process; - Certification review and; - Decision on certification. Certification cycle: - Initial audit, review and decision on certification by DM (decision maker); - Surveillance assessment as per IAF requirement; if requested by certification scheme; - Recertification (repetitive evaluation and conformity assessment) before the expiry of valid certificate; to maintain a valid certification. Inquiry / Offer / Offer Submission and Application Registration Inquiry of any new Client for Product certification may be personally discussed with a responsible LL-C persona, send via at info@ll-c.cz or by mail to company s address, as well as send via electronic form available at LL-C website Based on written inquiry or a face-to-face meeting, the LL-C coordinator conducts a review of obtained information and verifies whether the CB has a competence and abilities to perform the certification demanded (the scope of accreditation). Documentation received at the stage of Application for certification must adequately define the organizational structure of the Applicant. Further, it has to describe Applicant s activities essential for certification for which Application was made. Documentation may include, in addition to the manual, procedures and work instructions. Documentation must take into account both, direct and indirect, requirements based on standards used and the business scope. Coordinator reviews documentation received to assure that a product certified is covered by the LL-C accreditation, and whether the CB has competences and capabilities to perform certification itself. If evaluated positively, based on Inquiry, data from Questionnaire and a current tariff, LL-C issues Certification Offer Product certification (F31V) in written form, which is send to the address of the Applicant. Further, every offer must be accompanied by Business Conditions Product certification (F32V) as this document is its integral and mandatory annex. Client who accepts an offer for certification has to confirm the Certification Offer Product certification (F31 form) and Business Conditions (F32). Only an Offer that is signed by an authorised persona and submitted with signed Business Conditions is taken as a valid contract/agreement for Product Certification. The contract is generally governed by the provisions of the Civil Code Nr. 89/2012 Sb in Czech Republic and accreditation criteria. By the Application confirmation, following process is initiated: - Offer is registered to the internal system of LL-C, including information about the Applicant; - Lead Assessor is appointed; Lead Assessor starts to plan the assessment (contact person authorised by the Applicant, additional conditions, creation of Assessor team, fix a date of assessment); - The Applicant is requested to submit Product technical documentation (product documents, design drawings, validation test reports, instruction manual, risk analysis, RULE 03, Revision 20, Page 15 (total 22)

16 investigations, technical test, etc.) at least 14 days before the assessment starts (first date of assessment). Assessors The Lead Assessor, Assessment team members, Technical Experts and person responsible for the review and Certification decision are appointed by Head of CB LL-C. The appointment process must comply with general qualification of Assessors, including their competence and experience, reflecting specificities of the product its assessment/evaluation, impartiality and independence. An Applicant must be notified in advance about the Lead Assessor appointment. Evaluation activities/processes Conformity assessment of requirements covered by the scope of certification and other requirements of certification scheme. Conformity assessment shall be governed by different procedures depending on the type of product and consists mainly of: - Verification of supporting documents, requirements and provisions of the manufacturer for his quality system, documented in a systematic and orderly manner in the form of written policy statements, procedures, further a uniform interpretation of quality policy and procedures such as quality programmes, plans, manuals and records is granted; - Conformity assessment of Quality Assurance system to determine whether requirements set by documentation structure are met; - Inspection on the manufacturer premises, where technical documentation is verified, to ensure health and safety requirements are met; - Verification of Technical documentation submitted by the Applicant, further conformity assessment of product type (demonstrated) with technical documentation; - Appropriate inspection, measurements and tests verifying the compliance with basic technical requirements for health and safety; - Appropriate inspection whether harmonised standards were applied. If any nonconformities occur, the Applicant receives a Report of Nonconformities (F46 form) to which corrective actions must be accepted and a date for their compliance must be specified. These nonconformities shall be removed before the assessment is done. Irrelevant nonconformities and anomalies shall be clarified during the assessment period, if any. During the evaluation DMs use Questionnaire and verify whether there is a conformity of documents; relevant standards, Applicant documentation, government regulation and directives. Lead Assessor shall communicate a preliminary report on the results of evaluation. The team of Assessors is not authorized to release the final result. A written Evaluation report containing results of evaluation and other important information shall be received by the Applicant within 14 days. The Applicant may rise objections and comments within following 14 days. If any nonconformities (major or minor) are found, the Applicant must propose appropriate corrective actions and the date of their implementation; the date depends on specific findings. Review of certification decision Lead Assessor shall forward all necessary documentation related to evaluation to DM (e.g., Head of CB or his deputy) for an impartial assessment and decision on certification. Criteria for an assessment and a review of evaluation results are as follows: RULE 03, Revision 20, Page 16 (total 22)

17 - Test records/questionnaires; - Theoretical calculation records and reports (if requested); - Evaluation Report (F43V); - Verification of compliance with the LL-C Rules; - Submission and completeness of evaluation results in the documentation (report, questionnaire, reports of nonconformities) - Corrective actions list including response actions and a date of implementation. If any uncertainties occur, they shall be clarified by a responsible DM and Lead Assessor. If any nonconformities occur additional tests may be needed to verify that corrective actions were taken successfully before the certificate will be granted. Based on findings review the Applicant is informed if additional tests will be needed to verify the effectiveness of the corrective action(s) taken before granting the Certificate. The DM reviews the results of additional evaluation. In relation, DM reviews the final results of evaluation and assessment. Information for Applicant If DM decides that outcome of a conformity assessment authorizes the CB to grant a new Certificate or maintain a current Certificate, the Applicant will receive a Certificate (in case of an initial evaluation) as well as the Evaluation report, further a report with additional conditions to be fulfilled before issuing a Certificate (maintaining in case of surveillance audits). If a Decision Maker decides that an outcome of conformity assessment does not allow the CB to grant a new Certificate or maintain a current Certificate, the final decision is notified to the Applicant including reasons for the decision. The Applicant has the right to appeal to the Head of CB with a request to challenge the decision. Certificate Issuance Ones all criteria are met; the LL-C grants a certification in the form of a Certificate. The Applicant receives official Certificates, two original sets in Applicant s office national language as well as two original sets in English. Additional fee might be charged if additional copies or foreign language version(s) of Certificate are required. All issued certificates are valid for a period of three years under certain conditions; surveillance audits are performed as well as compliance with conditions of the relative standard are confirmed. Use of LL-C logos ad marks The use of LL-C logo and marks is regulated in compliance with Business Conditions (F32 form). Any certified entity must comply with the terms in F32 form. Certification maintenance If required by the certification scheme, to maintain the valid certificate LL-C provides an annual surveillance assessment to determine that product requirements are fulfilled. Surveillance assessments are carried out in compliance with the certification cycle; surveillance assessment shall not be later than 1 year from the last day of Stage II Audit or no later than the last day of first surveillance assessment. If surveillance assessment findings show nonconformities, product requirements do not comply with the standard, the Client is allowed to take corrections and corrective actions and implement them by the established deadline. LL-C verifies and decides if the relative corrective action(s) is/are sufficient enough to maintain the current certification. RULE 03, Revision 20, Page 17 (total 22)

18 Certification renewal The recertification assessment shall be done prior to the expiry date of the certification if the Client wishes to continue product certification with LL-C. Therefore, recertification assessment shall be planned ahead of time and the Client shall be informed. Recertification assessment evaluates and confirms the continued conformity and effectiveness of the product requirements. The recertification assessment shall be planned and conducted while taking into consideration time necessary for the renewal before the certificate expiry date; new Certificate shall be issued before the expiry of the old one. If any important changes, e.g. object of activity or documentation, in Client s organization occur they shall be submitted to LL-C at least 14 days before the reassessment starts. VI. Suspension or termination of certification Certificate Suspension In case a breach of certification contract or an infringement by Client occurs and is followed by a subsequent re-examination of severity violation, the Certificate may be suspended for a period specified by LL-C. Certificate suspension may arise for example in following cases: - Surveillance findings show that the manufacturer does not fulfil obligations imposed by Management System, further agreed corrective actions were not properly implemented in time specified and in a way agreed; - Surveillance audit could not be conducted on time (e.g. entity certified refuses to perform surveillance); - Entity certified is in an insolvency or in an anticipation of bankruptcy. - Entity certified has been using the certificate in an unauthorised way. The Certificate suspension shall be communicated to the Client by a registered letter and published on the website of the CB. The holder may appeal to Head of CB within 30 days. The suspension is withdrawn immediately if the Certified Client demonstrates that corrective action(s) was/were taken and sufficiently implemented; a breach of certification contract was removed. Withdrawal/Termination of certification If the Certified Client, despite the instructions from LL-C fails to fulfil contract obligations, e.g. does not take corrective actions or fails to comply with the above mentioned shortcomings, LL-C immediately terminates the validity of the certificate. Following, the Client is notified and asked to return all original certificates by registered mail and to publish information about certificate withdrawal. Other reasons for Termination of certification may be, for example: - Surveillance audit shows that essentials Management System requirements are not met; - The Certified Client requested a withdrawal; - Certified products are no longer offered by Client (technical parameters of the product have changed, therefore the product does not conform with current requirements anymore); - The Client fails to meet financial obligations to LL-C RULE 03, Revision 20, Page 18 (total 22)

19 - Any other violations of Business Conditions (F32 form) by the Client. VII. Responsibility of Certification Body Confidentiality LL-C considers all information and documentation of the Applicant/Client to be confidential. Appointment of Auditors and their qualification (Management System certification) Auditors with an appropriate qualification and relevant professional experiences are appointed for Management System certification. Required skills and knowledge of Auditors are continuously updated by internal and external trainings. Auditors or appointed Evaluators involved in certification of a certain Client must not participate in any consultancy, introduction of management system or to be in any other way connected to the Applicant/Certified client; impartiality needs to be guaranteed. Appointed Auditors are presented to the Applicant; Applicant has the right to refuse individual Auditors. However, the Client/Applicant must explain his motivation for the refusal of an individual Auditor. On those bases Head of LL-C considers and adopts final decision. If a complaint from a Client arises, Head of LL-C acts in accordance with the internal Quality Manual (Rule 01) mentioned bellow. Further, external Experts and Auditors are also bound by confidentiality pursuant to the contract with LL-C. Appointment of Evaluators and their qualification (Product certification) Assessors with an appropriate qualification and relevant professional experience are appointed by Head of CB for Product certification. Required skills and knowledge of Assessors are continuously updated by internal and external trainings. Assessors or appointed Decision Makers for certification assessment and review shall be only CB employees, who have not participated in any consultancy, further have no work relationship to the Applicant/Certified client at least for 2 years and have not participated on the development of a product certified; impartiality needs to be guaranteed. Unless appointed Assessor/Decision Maker and/or Technical Expert is a permanent full-time employee of CB, the assessment is provided under conditions written in the Act and Behaviour of CB personnel (Rule 05); confidentiality and conflict of interest avoidance are ensured. Applicant/Certified client has the right to refuse individual Assessors. However, the Applicant/Certified client must explain his motivation for the refusal of an individual Assessor. On those bases the Head of LL-C considers and adopts final decision. If a complaint from a Client arises, the Head of LL-C acts in accordance with the internal Quality Manual (Rule 01) mentioned bellow. Further, external Experts and Assessors are also bound by confidentiality pursuant to the contract with LL-C. Records (documents stored) For the purpose of Market Surveillance Authority (CAI in CZ) and Medical Devices Surveillance Authority (SÚKL State Institute for Drug control in CZ), complete documentation, a part of MDD conformity assessment shall be kept by the manufacturer or authorised representative for minimum of 5 years from the manufacture of the last product (in case of implantable MDD for 15 years). In case of critical nonconformity (annex 1 GMP+ C12 document) certification body is obligate to inform the GMP+ International. RULE 03, Revision 20, Page 19 (total 22)

20 Publication of Certification LL-C publishes Certificate holders (Certified clients) at regular intervals on the LL-C website on the basis of Validity Code. In case of a suspension or a withdrawal of Certificate, information is published immediately. In private certification schemes (FSSC 22000, GMP+) the information about clients and certification dates etc. are uploaded to specific IS held by scheme owner within 14 days after every event. VIII. Responsibilities of Certified Client (holder of certification) A. Management Systems certification Management System supervision The System Management certification shall be regularly reviewed by documented internal audits to prove the effectiveness of the system. By acquiring a management certification Client s obligation is to uphold to the regular reviews. In case any non-compliance with the specific standard occur, the Client shall uphold to the commitment to take his own corrective actions. This commitment shall remain despite the regular monitoring by LL-C. Assistance for LL-C Auditors The Certified client is obliged to allow LL-C to perform audit on time, further to provide any assistance needed to LL-C Auditors performing the audit. The Certified client shall ensure an access to all premises, inducing scope of certification for Auditors as well as an access to inspect all relevant documents. Management System Modifications of Certified Client The Certified client is obliged to immediately inform LL-C if any changes or modifications to management system occur and might affect its validity, e.g.: - Organisational changes occur (change of name/place of cooperation, sale or undertaking of business or its part, bankruptcy, scope of certification, etc.); - Substantial changes of product, business activity or services occur; - In case of product recall (FSSC scheme, GMP+ FSA) - Substantial changes in documentation occur. LL-C shall examine occurred changes. In relation to their character and extent and extraordinary audit may be scheduled. B. Product certification The Certified client (manufacturer) shall affix the EC Declaration of Conformity in accordance with the Directive. RULE 03, Revision 20, Page 20 (total 22)

21 The Certified Client, holder of Machinery Device Certificate must constantly ensure that the machinery meets the current technical state of art. The Certified client, holder of construction product certificate must ensure that the construction product correspond with the manufacturing technical parameters indicated in the report and on the valid Certificate. If any changes to the manufacturing process or to product construction technical parameters occur, the Client is obliged not to include the existing Certificate with the changed product. Further, the Client is obliged to communicate any changes with CB, LL-C. The Certified Client undertakes to ensure fulfilment of obligations arising from the approved Quality System Management, further to ensure its appropriateness and effectiveness. Assistance for the LL-C Evaluators The Certified Client is obliged to allow LL-C to perform an assessment on time, further to provide any assistance needed to LL-C Assessors performing the assessment. The Certified Client shall ensure an access to all premises, inducing scope of certification for Assessors as well as an access for the inspection of all relevant documents. Product Modifications of Certified Client The Certified Client is obliged to inform LL-C if any intended changes in quality assurance occur. LL-C access changes and decides, whether changes caused a need for a new conformity assessment to be held. The Certified Client shall inform LL-C (CB) about all modifications to the approved proposal. Additional assessment of above mentioned modifications is required. The additional approval is in a form of a supplement to the EC Design-examination Certificate. The Certified Client is obliged to immediately inform LL-C if any changes or modifications, which might affect the certificate validity occur, e.g.: - Organisational changes occur (change of name/place of cooperation, sale or undertaking of business or its part, bankruptcy, scope of certification, etc.); - Substantial changes of product, business activity or services occur; - Substantial changes in documentation. LL-C shall examine occurred changes. In relation to their character and extent and extraordinary audit may be scheduled. RULE 03, Revision 20, Page 21 (total 22)

22 IX. Application of Certification Rules modifications The certification system of LL-C is based on the requirements of applicable standards and accreditation requirements. All Certified Clients shall be informed if changes/modifications requiring certification system modification occur. This situation may occur in the following cases: - Revision and/or modification of certification standards; - Modification of accreditation rules (e.g. changes in surveillance period, expenses related to accreditation and audits, etc.). If the Certified Client does not agree with occurred changes, the certification contract will terminate by the entry of modifications/changes into force. X. Certification fees and other expenses Certification fees are set by the Common Customs Tariff of LL-C, which is in accordance with methodical guidelines of ISO/EN LL-C must follow these requirements, especially requirements considering audit timeframe. Certification fees or any other additional costs are a subject of the certification Offer. A pro forma invoice shall be paid by the Applicant prior to the beginning of the audit/assessment; payment shall not be bound by the decision on certification, see F32 form. XI. Complaint and Appeal Procedure Appeal Clients may appeal to the LL-C Head of CB within following 30 days. In relation, CB shall establish an Appeals Committee consisting of 3 Auditors/Assessors or Experts who were not involved in certification activities related to a Complaint or an Appeal. This Committee reviews and verifies all necessary information and decides by simple majority vote. Complaints Any third party has the right to complain about certification decision to LL-C. If such a situation occurs, similar procedure as with Appeal (above mentioned) is applied; depending on the type of a Complaint. If an extraordinary audit is ordered, the Appeals Committee is convened after the outcomes are disputed. The precise procedure for receiving Complaints and Appeals, their evaluation and implementation is documented in Rules of Appeals Committee (Rule 12). RULE 03, Revision 20, Page 22 (total 22)