3. Criteria for Recognition of Certification Bodies

Transcription

1 SYSTEMS CERTIFICATIONSCHEME FOR PROCESS, SERVICES AND MANAGEMENT SYSTEMS THROUGH BIS RECOGNIZED CERTIFICATION BODIES 1. Introduction Bureau of Indian Standards (BIS) is authorized under Section 10 (1)(l) of Bureau of Indian Standards Act, 1986 and Section (11)(1) of Bureau of Indian Standards Rules, 1987 to appoint agents for carrying out inspections of manufacturer s premises in India or outside for allowing use of the Standard Mark. Accordingly, BIS is launching a Scheme for Systems Certification for Process, Services and Management Systems through BIS Recognized Certification Bodies to carry out conformity assessment on behalf of BIS. The Indian Standards covered under the Scheme is enclosed at Annexure I. BIS would be maintaining a global directory of its certified clients and the clients certified under the schemes would have the option of getting themselves listed in the BIS global directory giving them instant exposure to a wide market thereby enhancing business opportunities. 2. Scope 2.1 This document describes the criteria for Recognition of Certification Bodies (including the terms and conditions for their recognition, renewal, de-recognition, appeal, complaint handling mechanism) as well as the fee structure and the procedure for the recognition and renewal under the BIS Systems Certification Scheme on Process, Services and Management Systems through Recognized Certification Bodies. 2.2 Hereafter, BIS Systems Certification Scheme refers to the Systems Certification Scheme for Process, Service and Management Systems through BIS Recognized Certification Bodies 3. Criteria for Recognition of Certification Bodies 3.1 Certification Body means a third party conformity assessment body operating certification schemes (Ref. ISO/IEC 17065). Conformity assessment is a demonstration that specified requirements related to a product, process, system, person or body are fulfilled. (Ref. ISO/IEC 17000). 3.2 The following shall be the essential minimum criteria for the recognition of Certification Bodies by BIS: a) Certification Bodies (CBs) shall be registered as a legal entity in India. b) CB shall be accredited as per ISO/IEC and/or ISO/IEC by NABCB or any other Accreditation Body which is a member of International Accreditation Forum (IAF) and a signatory to the IAF multilateral recognition arrangement. c) CB or its parent body shall be in the business of systems certification preferably for the last 5 years and in good reputation. d) CB shall be preferably maintaining a minimum of 300 systems certifications and 100 re-certifications for the Management Systems/ similar Management Systems, process & services/evaluation services for which recognition is sought.

2 e) CB shall have in India as part of its own organization overall 10 auditors of which atleast one auditor should be of the discipline and the relevant NACE-02 Code as per the scheme for which recognition is sought. f) The audited financial health of the CB should be positive in the last three financial years. g) CB shall not be providing in-house training and consultancy of the clients on the process, service or management systems that it certifies. If there is any perceived conflict of interest due to any reason, recognition will not be granted. 3.3 CB shall be required to seek recognition separately for each BIS System Certification Scheme. 3.4 BIS to have all rights to recognize/deny recognition without assigning any reasons. 4. Grant of Recognition 4.1 A certification body applying for recognition will undergo evaluation by BIS to enable BIS assessors to determine the competence of the certification body and its conformity with the standard(s) against which recognition is sought. In the event that recognition is granted, a letter of recognition will be issued to the certification body. The scope of recognition is set out as an Annexure to the letter of recognition that BIS would give to each Recognized Certification body. 4.2 BIS will apply the criteria for recognition consistently and will provide suitably qualified personnel for assessment and surveillance of applicant and Recognized Certification Bodies. 4.3 The letter of recognition shall be granted for a defined period on condition that the Recognized Certification Body: (a) (b) (c) (d) (e) complies with the terms of the Agreement demonstrates continuing conformity to relevant Recognition criteria, standards and guideline documents issued by BIS from time to time demonstrates continuing competence within the scope of its recognition give such undertakings as BIS may reasonably require pays such fees as are due to BIS. 4.4 The detailed procedure for Grant of Recognition and Renewal of Recognition of CBs is enclosed at Annexure II. 5. Validity of Recognition The recognition of the CB for BIS Systems Certification Scheme shall be granted for a period of three years. The effective date of recognition shall be from the date of grant of recognition. 6. Fees for Recognition 6.1 The following fees shall be applicable for Certification Bodies seeking recognition by BIS: i) Application and Processing fees for recognition for a particular BIS Systems Certification Scheme. Rs. 30,000 Additional Processing Fees for each Additional BIS Systems Certification Scheme/Extension of Scope Rs. 10,000

3 i Recognition fee and renewal of recognition fee for each BIS System Certification Scheme (for three years) Grant of Licence per certificate (for witnessing/ensuring quality) Rs. 30,000 a) IS/ISO Standards Rs. 1,000 b) Indian Standards Rs. 5,000 v) Listing Fees for Global directory per certificate Rs vi) Special visit charges (optional /need based) per manday Rs Concession in fee The following concessions in fees are applicable: i) Listing in the global directory of more than 50% and upto 75% of the clients by the CB 10% discount in recognition fee during subsequent renewal of recognition Listing in the global directory of more than 75% of the clients by the CB 20% discount in recognition fee during subsequent renewal of recognition i Listing of client in the Global Directory 20% discount inper certificate fee for grant of licence/renewal 7. Agreement between BIS and Recognized CB The Recognized CB would enter into an agreement with BIS which would set out the relationship between BIS and the Recognized CB and the terms and conditions to be met by the CB in the operation of the Scheme. 8. Operating Procedure for BIS Systems Certification Scheme The procedure for Conformity Assessment of Clients by Recognized CBs and Grant of license by BIS is as given under Clause 16 of the Agreement between BIS and CB. 9. Mechanism for ensuring Quality of Services of Recognized Certification Body BIS shall ensure the quality of services rendered by Recognized CBs through the following mechanism: i) The first five, and thereafter one in every five certification audits of the clients (Stage 2 Audit), by the Recognized CB in each scheme would be witnessed by BIS. The frequency of witnessing the Certification Audit of clients by the Recognized CB may be increased or decreased at the discretion of BIS The first, and thereafter one in every five re-certification audits of the licensees (Stage 2 Audit), by the Recognized CB in each scheme would be witnessed by BIS. BIS may increase or decrease the frequency of witnessing of re-certification audits.

4 i BIS may carry out surprise audits of the clients without informing the CB. Such supervisory visits may be paid by BIS Audit Team specially nominated by the Competent Authority to ensure that the Scheme is strictly followed. No expenses for such visits would be charged from the Recognized CB. In addition, when a CB applies for extension of scope of recognition, BIS may carry out special audit for verification of additional competency of the auditing personnel of the CB. v) BIS may witness the surveillance audits of the licensee, if necessary. vi) vi) BIS may seek feedback about the performance of the Recognized CB and its activities from NABCB/ Accreditation Body, clients/customer of Recognized CB. Further, BIS may also take action based on feedback received from its Regional Offices (ROs)/Branch Offices (BOs). Any Complaint received against a Recognized CB would be examined/investigated and action as deemed fit by BIS will be taken. 10. General Any situation not covered under the scheme, will be considered by BIS and the decision of BIS would be final.

5 List of IS/ISO Standards ANNEXURE I List of Indian Standards for Systems Certification under Scheme SlNo. IS/ISO No. Title 1. IS/ISO 9001:2008 Quality Management System- Requirements 2. IS/ISO 14001:2004 Environmental Management Systems Requirements with Guidance for Use 3. IS/ISO/TS 16949:2009 Quality management systems Particular requirements for the application of ISO 9001 :2008 for automotive production and relevant service part organizations (Second Revision) 4. IS/ISO 22000:2005 Food Safety Management Systems- Requirement for any organization in the food chain 5. IS/ISO 50001:2011 Energy Management Systems Requirements with Guidance for Use List of Indian Standards Sl.No. IS No. Title 1. IS 15000:2013 Hazard Analysis and Critical Control Point (HACCP) Requirements for any organization in the food chain (First Revision) 2. IS 15700:2005 Quality Management Systems Requirements for Service Quality by Public Service Organization 3. IS : 2007 Managing environment, occupational health and safety legal compliance -Requirements of good practices 4. IS 15930(Part 1): 2010 Requirements for good agricultural practices - IndiaGAP - Part 1 Crop base 5. IS 16001:2012 Social Accountability at the Work Place - Requirements (First Revision) 6. IS 16019:2012 Food retail management - Basic requirements 7. IS 16020:2012 Food safety management - Requirements for good hygiene practices 8. IS 16021:2012 Good manufacturing practices (GMP) Requirements for organizations in the food processing sector 9. IS 16070:2013 Quality Management Systems Particular requirements for the application of ISO 9001 :2008 for power sector equipment manufacturing, service & utility organization 10. IS 18001:2007 Occupational Health and Safety Management Systems Requirements with Guidance for Use

6 ANNEXURE II Procedure for Grant of Recognition and Renewal of Recognition of Certification Body 1 Grant of Recognition of CB 1.1 Application for Recognition i) The CB seeking recognition from BIS for Systems Certification and fulfilling the criteria as laid down at clause 3 of the Scheme shall apply to BIS in the Application form as prescribed (Appendix A) along with the application fee and the following documents: i a) Document establishing the legal entity of the CB b) A copy of the accreditation certificate and the description of the related scope of accreditation c) Quality Manual of the CB d) Details of auditors with CB with NACE -02 Codes including their competence and evaluation e) Duly filled in checklist (Appendix B) f) An undertaking as prescribed (Appendix C) g) Details of two cases of earlier grant of license and two cases of renewals done in the past one year by the CB. The application is to be signed by the Director(s) or the Chief Executive Officer (CEO) or any other person so authorized for the purpose by the management. The name and designation of the person signing the application shall be recorded legibly in the space for the purpose in the application form. In case of authorized signatory, a certificate from the top management of the CB on its official letter head bearing seal of the CB clearly attesting the signature of the authorized signatory. The application shall be addressed to Head, Management Systems Certification Department, Bureau of Indian Standards, 9, Bahadur Shah Zafar Marg, New Delhi Processing of application for recognition i) All applications shall be scrutinized with respect to the enclosures/application fees, etc. BIS would return an application which is incomplete and found deficient. i Recording All applications found to be complete with listed documents and other prerequisites shall be recorded. Every application shall be assigned a serial number to be known as 'Application Number' In all future correspondence, reference must be made to the 'Application Number'. Once the application is recorded, application fee is not refundable. Adequacy audit Adequacy audit of the application, associated documents and Quality manual will be done by BIS. Deficiencies observed (with respect to the criteria laid down at para 3.2 of the Scheme), if any, will be conveyed to the applicant CB for clarification/compliance within 21 days. CB may be asked to supply supplementary information as required within 30 days failing which the application shall be rejected without any further reference.

7 v) Assessment audit After satisfactory adequacy audit, in case it is felt necessary, BIS team may visit the CB for office assessment of the CB s compliance to the recognition criteria, procedures and activities enumerated in the documented management system and ISO/IEC and/or ISO/IEC as the case maybe. The audit may also cover witness audit of the existing client of CB. 1.3 Process for Recognition i) Before considering grant of recognition to the Certification Body, corrective actions taken by the Certification Body on the Non-conformities (NCs), if any, observed during the Audit shall be physically verified by BIS (through a special audit), if needed, for its closure. Any nonconformity /inadequacy observed in scrutiny of assessment report shall also be brought to the notice of Certification Body for necessary corrective actions/ clarifications within specified time which shall also be verified. i If required, BIS may seek feedback about the applicant CB and its activities from NABCB/Accreditation Body, clients/customer of applicant s CB before granting recognition to the CB. Based on the findings of the audit team and recommendations made after due scrutiny, the Competent Authority shall take a decision on the grant of recognition to the Certification Body or otherwise. On the basis of scope of recognition sought by the applicant CB and also the scope of its accreditation, BIS would decide upon the recognition of the applicant. BIS reserves the right to accord recognition of activities with a restricted scope than for which the CB has been accredited by NABCB/ Accreditation Body. The decision of BIS according recognition of the applicant CB or otherwise shall be communicated to the applicant s CB within 30 days of the audit carried out by BIS (with reasons in case it is rejected).the Recognition shall be granted for an initial period of three years on payment of necessary recognition fee. The name of the CB so recognized will be hosted on BIS website. 1.4 Rejection of application i) Application shall be liable for rejection, if a) CB does not take corrective action (s) on deficiencies observed during adequacy/office/witness audit within 45 days. b) CB does not confirm readiness for audit within 45 days of intimation from BIS. c) Non-payment of any prescribed fees. d) CB gives false declaration in the application with respect to infrastructure, competence of auditors, etc. f) Any Conflict of Interest as per Clause 3.4 of the Scheme g) Any other (past antecedents, feedback from accreditation body regarding credentials of CB)

8 Procedure for rejection of application a) A notice for rejection stating the reason(s) thereof, with the provision of personal hearing shall be served to the CB giving 15 days time to reply, b) If no reply is received within the stipulated time or if the reply is unsatisfactory or if the plea(s) extended at the time of personal hearing are not acceptable to the Competent Authority, the application shall be liable for rejection. 1.5 Extension of Scope of Recognition - The CB may apply for extension of scope of recognition along with requisite fees and send the list of auditing personnel with the relevant competency requirement. In case changes are to be made to the Quality Manual, the revised copy of the Manual should also be submitted. Audit for verification of additional competency of the auditing personnel, if needed, will be arranged by BIS. 2 Renewal of Recognition, Expiry and De-recognition of Certification Bodies 2.1 Renewal of Recognition i) For renewal of recognition, the CB shall apply to BIS on application form as prescribed (Appendix-A) at least three months before validity date of the recognition along with requisite fees (which is non-refundable) as prescribed and related documents. A renewal notice, four months in advance will be sent to the CB by BIS. However, non-receipt of such notice from BIS cannot be considered as ground for not applying for renewal in time as the onus of applying for renewal lies solely with the CB. i Quality Manual is required to be submitted with renewal application only if there is any significant change in the manual. If no change, the CB will submit a declaration to this effect. If the renewal process is delayed beyond the validity period of recognition due to any reason on the part of the Certification Body, recognition if renewed by BIS will be valid from a fresh date. During the interim period between the validity date and fresh date of recognition, the recognition shall stand expired. Applications pending with the Certification Body at the time of expiry of recognition shall not be processed without prior approval of BIS. Certification Body shall furnish to BIS the details of applications pending. The BIS will take a decision on processing of these cases. v) Renewal application received after 30 days of validity shall be treated as application for fresh recognition. 2.2 Expiry of Recognition: The recognition shall stand expired at the end of validity period: i) If renewal is not sought by the CB along with requisite fees i 2.3 De-recognition If recognition is not renewed by the Competent Authority If recognition is renewed from a fresh date. i) The CB may be de-recognized any time during the recognition period by the Competent Authority for any of the following reasons: (a) If the CB surrenders recognition

9 i (b) (c) (d) (d) (e) (f) (g) (h) (i) If continuation of the recognition of the CB would not be of any assistance to certification activities of BIS; If the CB is able to certify less than 10 clients in a year If the CB does not carry out the conformity assessment activities of its clients under the Scheme properly and does not take corrective steps to improve as advised; If the CB is engaged in providing in-house training and consultancy on the process, service or management systems that it certifies or if there is any perceived conflict of interest due to any reason. If the CB does not maintain adequate secrecy pertaining to the clients information (applicant or licensee); If the CB or its personnel are found to be not free from any commercial, financial or other pressures which might influence their technical judgment; If the CB acts/works directly or indirectly against the interest of BIS in any form or in any manner; If the CB is found indulging in unethical practices or unhealthy competitive practices; If the CB is found violating any of the terms & conditions of recognition & does not comply with the undertaking given along with the application. A notice for de-recognition shall be given to the CB with provision of personal hearing to explain as to why such proposed action may not be taken against the CB. If no reply is received within stipulated time or if the reply is found unsatisfactory or if the plea(s) extended at the time of personal hearing are not acceptable to the Competent Authority, the CB shall be de-recognized. The cooling period for any de-recognized CB shall be minimum 6 months. 2.4 Appeal - Any CB aggrieved by a decision of BIS regarding recognition/derecognition/expiry of recognition or any other order of BIS may file an appeal to the DG, BIS within a period of 60 days from the date of such decision. 2.5 Complaint/Feedback Any Complaint received against a CB will be examined/investigated, and action as deemed fit by BIS will be taken. Further, the BIS may also take action based on feedback received from Regional Offices (ROs)/Branch Offices (BOs).