Mobirise

Informative Guide

1. INTRODUCTION
The sections of this Code of Practice have been formulated to provide a comprehensive guidance to the applicant and / or certified client to know ZQAPL-MSCD001 policies and deal in accordance with the policies.
These policies are in accordance with our accreditation body/s requirements, published to date.

2. SCOPE
ZQAPL-MSCD001 provides independent certification service for organizations operating various Management Systems complying with the requirements of the International Standards mentioned below:
" ISO 9001 Quality Management Systems
" ISO 13485 Medical Devices - Quality Management Systems

3. LEGAL STATUS
ZQAPL-MSCD001 is an internal business division of Zenith Quality Assessors Pvt. Ltd.
ZQAPL is legally responsible for all audit and certification services conducted by ZQAPL-MSCD001
ZQAPL is legally responsible by the main objects of the company to be pursued by the company on its incorporation and as described in "Memorandum of Association" dated 20th December 2005.
Zenith Quality Assessors Pvt. Ltd. which was incorporated on 14th October 2005 in Pune, Maharashtra, India under the Companies Act, 1956 (No. 1 of 1956).
" Certificate of Incorporation No. : CIN U 74 999 PN 2005 PTC 021411.
" PAN No. : AAACZ2426L
" Good and Service Tax No. : AAACZ2426LST001


4. CONFIDENTIALITY
ZQAPL-MSCD001 will maintain complete confidentiality regarding all information with which it becomes acquainted as a result of contact with the organization.

5. GENERAL CONDITIONS FOR CERTIFICATION
" The applicant shall make available to the Audit team all information required to establish the status of the management system.
" ZQAPL-MSCD001 approves the certification as per the applicant defined scope only if the applicant's documented management system conforms to applicable standard/s.
" The approval is also subject to, that there is no major discrepancy arising out of the audit and/or suitable corrective action has been applied and evidenced.
" Where the applicant cannot show that effective corrective action has occurred within the specified time limit, it may be necessary for ZQAPL-MSCD001 to conduct a further additional audit of the management system. The additional audit will be at extra cost to the applicant.
" In case of multi-site audits and subject to successful verification of compliance, a certificate clearly defining the activities and locations will be issued. The applicant shall not claim or otherwise imply that the certification applies to other locations or activities not covered by the issued certificate.
" Certification will be valid for a period of three years w.e.f the date of approval, on a condition that the surveillance Audits are conducted as per the planned interval and reveal no deterioration in the management system. And the client does not breach the terms and conditions mentioned in the Certification Agreement.

6. APPLICATION FOR REGISTRATION 
The applicant is required to submit a duly filled Application Form to ZQAPL-MSCD001.
ZQAPL-MSCD001 accepts the Application Form based on the positive application review output and ability to conduct audit and certification activity with compliance to review output.
The audit and certification service may be declined by ZQAPL-MSCD001 for one or more of the following reasons:
" Non-availability of accredited scope
" Non-availability of audit personnel with approval of specific technical area
" Non-availability of audit personnel to conduct audit in a specific geographical location
" Failure to establish legality of the business activity provided by the potential client
" Any other adverse market information which does not allow audit and certification activity to happen
" Any reason identified by ZQAPL-MSCD001 as an unavoidable threat to impartiality / bias
The applicant organization is formally informed with reasons through a mail about ZQAPL-MSCD001 decision to decline the application.


7. STAGE 1 AUDIT 
The purpose of the Stage 1 Audit is to verify information about the applicant company related to the size, complexity of operations and capabilities for which registration is sought. The auditor will establish whether further development of the management system is necessary before the Stage 2 Audit takes place.

8. STAGE 2 AUDIT
The stage 2 Audit is carried out to ascertain that whether the applicant company's Management System can be certified based on the objective evidences found during audit.
The gap between Stage 1 Audit and Stage 2 audit should be minimum 7 days. The gap between Stage 1 and Stage 2 audit should not exceed 90 days. On Lapse of 90 days Stage 1 audit is re-conducted.
The auditor will be looking for objective evidence (records, documents, etc) to verify that the activities of the organization are in accordance with the documentation and the requirements of the relevant management system standard.
All records resulting from the implementation and operation of the Management System must be made available to the Audit team for evaluation.

9. CORRECTIVE ACTION REQUEST
If a non-conformance is detected during the Audit, a Corrective Action Request (CAR) will be issued and a corrective action process will commence. The auditor will discuss with you the occurrence of the CAR. The client is responsible to submit formal corrective action plan to resolve the non-conformity within a stipulated time period. These Corrective action plans and related evidences are verified by the Lead auditor to decide on the closure of non-conformity.

10. REGISTRATION
After successful verification of the system and no major deficiencies (or has subsequently rectified the deficiencies) is observed, then a recommendation will be made to the ZQAPL-MSCD001 certification authority that your organization be certified. Upon approval and subsequent acceptance, client is awarded a "Management System Certificate" confirming registration.
The "Management System Certificate" will be valid, initially for a period of three years from the date of issue, and subjected to condition that the surveillance Audits have revealed no deterioration in the Management System.

11. SURVEILLANCE
Periodic surveillance Audits will be carried out to ensure that the management system is not only being maintained, but is being reviewed and developed further to improve the efficiency and effectiveness of the business processes. These Audits are conducted at mutually agreed intervals (not exceeding 12 months). Surveillance Audits will always cover certain key elements crucial to the success of your business. These would include internal Audits, management reviews, continuing operational control and corrective actions. Your Customer Complaints data would also be examined to see how quickly and effectively you deal and resolve customer complaints.
Other aspects of the Management System will be covered selectively, over the period of certification, depending on their importance of their scope of certification.
ZQAPL-MSCD001 shall be granted the right of access for surveillance purposes whenever deemed necessary and shall reserve the right to make short notice visits as required.
An audit report will provide the client with feedback regarding the results of the Audit.

12. RENEWAL
Every three years of certification, client will be subjected to another comprehensive audit similar to that of the Initial Audit. This will ensure that the entire management system is cohesive and continues to effectively comply with your selected certification standard.

13. CHANGE OF ADDRESS / EXTENSION OF REGISTRATION
In order to extend the scope of registration to cover additional products, processes or services, a fresh application needs to be submitted by the client. The application procedure previously outlined will be followed and an Audit will be carried out on those areas not previously covered. The cost of extending the scope of registration will be based on the nature and programme of work. Following a successful Audit, an amended certificate of registration will be issued covering the aspects. The validity of the certificate remains the same as granted during the initial certification.
The certificate is issued to cover the place(s) where the Audit was conducted. If client intends a change in address or addition of sites, the client informs ZQAPL-MSCD001 and a similar process as indicated above is carried out. Temporary site covered during the audit will not appear on the Certificate.
The client shall inform ZQAPL-MSCD001 of any intended modification to the product, process or Management System that may affect compliance with the relevant part of international standard. ZQAPL-MSCD001 will then determine whether the notified changes require additional Audit.
Failure to notify ZQAPL-MSCD001 may result in suspension of the Certificate.

14. PUBLICITY BY CERTIFICATE HOLDERS
A Certificate Holder has the right to publish that the management system has been successfully audited and registered. The relevant 'Certification Mark' may be applied to stationery and promotional material relating to the scope of registration, as detailed in the "Management System Certificate". ZQAPL-MSCD001 will provide specific guidelines on the use of Certification and Accreditation Marks valid at the time of issuing a Certificate.
In every case, the client must ensure that in its publications and advertising, there is no misleading information or confusion arising between registered and non-registered scope.
The client must ensure that the Certification Mark affixed does not indicate product certification or conformity.
ZQAPL-MSCD001Certification Mark
An organization whose management system has been certified by ZQAPL-MSCD001 may use the "Certification Mark"' along with Accreditation Mark, in promotional and corporate publications.

15. MISUSE OF A CERTIFICATE
ZQAPL-MSCD001 takes reasonable precautions to control the use of its Certificates. Incorrect references to registration, or misleading use of Certificates found in advertisements, catalogues, etc., will be dealt with by suitable actions which could include suspension or withdrawal of Certificate, legal action and / or public notice.

16. SUSPENSION OF A CERTIFICATE
A Certificate may be suspended for a limited period (Not exceeding three months) in cases, such as the following;
a) If Corrective Action Requests have not been closed out within the designated time limit;
b) If a case of improper use of the Certificate or misleading prints or advertising, is not solved by suitable interactions or other appropriate remedial measures by the registrant;
c) Surveillance Audits are not conducted as planned after sending three written notifications at a gap of 15 days.
d) Client fails to comply with due settlement of financial obligation of ZQAPL-MSCD001.
e) Client applies for voluntary suspension
The client shall not identify as certified, under a suspended Certificate.
An official suspension of a Certificate will be confirmed in writing by ZQAPL-MSCD001 to the client. The conditions under which the suspension will be removed will also be included.
At the end of the suspension period, an investigation will be carried out to determine whether the conditions for reinstating the Certificate have been fulfilled. On fulfilment of these conditions, the suspension shall be lifted and the client shall be notified of the Certificate reinstatement. If the conditions are not fulfilled, the Certificate will be withdrawn.
All costs incurred by ZQAPL-MSCD001 in suspending and reinstating the certificate will be charged to the client.

17. WITHDRAWAL OF A CERTIFICATE
A Certificate may be withdrawn in the following cases:
a) If inadequate measures are taken by the company in the case of suspension;
b) If the company fails to comply with the due settlement of its financial obligation.
c) Client does not wish to continue / renew the certificate and provides a voluntary request for Certificate withdrawal.
If either of the above applies, ZQAPL-MSCD001 has the right to withdraw the Certificate and will inform the client accordingly. The client may give notice of appeal (refer section on Appeals).
No reimbursement of Audit fees will be given. Withdrawal of a Certificate may be published by ZQAPL-MSCD001

18. FEES
Fees will be detailed in the quotation submitted to applicants. As costs are based on the rate applicable at the time of submitting a proposal. ZQAPL-MSCD001 reserves the right to increase charges during the certification period. Clients will be notified of any increase in fees.
Additional fees shall be charged for all additional work that is not included in the agreed proposal and for extra, unscheduled surveillance Audits required due to non-compliances being identified in the Management System.
This will include, but is not restricted to, the costs resulting from:
a) Repeats of all, or any part, of the Audit program due to the initial registration requirements not being met;
b) Additional work due to suspension, withdrawal and / or reinstatement of a Certificate;
c) Additional audit / special audit due to any changes in the Management System.
Special Condition: In case the accreditation of ZQAPL is cancelled or ZQAPL decides to discontinue certification activity, then only certificate fee shall be refundable on the remaining period of certification validity i.e. on pro rata basis.

19. APPEALS
A ZQAPL-MSCD001 Applicant and/or Certified Client can appeal against any ZQAPL-MSCD001 in the following aspects
a. Audit or Certification Decision
b. Notification against suspension or withdrawal
c. Any other matters subject to procedures of ZQAPL-MSCD001.
A statement shall be in writing with identification of the sender for consideration as appeal.
The e-mail goes to ZQAPL-MSCD001 Director Operations who in turn deals with the appeal. The receipt of the appeal is acknowledged to the client in writing, and appellant is regularly provided with progress reports and outcome.
It is ensured that the person/s engaged in the appeals-handling process are different from those who carried out the audits and made the certification decisions or been involved in the subject of appeal. And as such if Director Operations was involved as an auditor or certification decision maker in the case against which the appeal has been made, then the appeal is forwarded to CFSI chairperson and appellant is informed about this.
Submission, investigation and decision on appeals do not result in any discriminatory actions against the appellant.
Effectiveness of these actions is reviewed by Director Operations or the CFSI Chairperson, as responsible to deal with specific appeal. The decisions taken by Director Operations or CFSI Chairperson is binding on ZQAPL-MSCD001 to take suitable actions.
ZQAPL-MSCD001 gives a formal notice to the appellant at the end of the appeals-handling process and the relevant records are maintained. The feedback is taken from the appellant / concerned client.
Once the appeal has been resolved by ZQAPL-MSCD001 Director Operations and/or ZQAPL-MSCD001 Committee for Safeguarding Impartiality Chairperson, CFSI, then no counter claim by either party in dispute can be made to amend or change the decision.
In instances where the appeal has been successful and the Certificate reinstated, then no claim can be made against ZQAPL-MSCD001 for reimbursement of costs or any losses incurred as a result of the initial withdrawal notification.
Contact e-mail id of ZQAPL-MSCD001 Director Operations - certification@zenith-worldwide.com
Contact e-mail id of ZQAPL-MSCD001 Chairperson for Committee for safeguarding impartiality - cfsi@zenith-worldwide.com

20. COMPLAINTS
A statement shall be in writing with identification of the sender for consideration as complaint.
The complaints can be made by the client expressing dissatisfaction over ZQAPL-MSCD001 decision related to certification i.e. granting, maintaining, renewing, extending, reducing, suspending and withdrawing of certification or any other unacceptable situation arising out of ZQAPL-MSCD001 activities with the client and a response is expected.
The e-mail goes to Director Operations who in turn deals with the complaint.
This process is subjected to requirements for confidentiality, as it relates to the complainant and to the subject of the complaint.
ZQAPL-MSCD001 gathers and verifies all necessary information to validate the complaint and acknowledge receipt of the complaint, and provides the complainant with progress reports and the outcome.
It is ensured that the person/s engaged in the complaint handling process are different from those who carried out the audits and made the certification decisions or been involved in the subject of complaint. If Director Operations was involved as an auditor or certification decision maker in the case against which the complaint has been made, then the complaint is forwarded to CFSI chairperson and complainant is informed about this.
Submission, investigation and decision on complaints do not result in any discriminatory actions against the Complainant.
Effectiveness of these actions is reviewed by Director Operations or the CFSI Chairperson, as responsible to deal with specific complaint. The decisions taken by Director Operations or CFSI Chairperson is binding on ZQAPL-MSCD001 to take suitable actions.
ZQAPL-MSCD001 gives a formal notice to the complainant at the end of the complaint handling process and the relevant records are maintained. And the feedback is taken from the complainant / concerned client.
In another case, a complaint can be made by an Interested Party against ZQAPL-MSCD001 certified client/s. An interested party is generally the one who has business interest with ZQAPL-MSCD001 certified client/s.
A statement shall be in writing with identification of the sender for consideration as complaint.
This process is subjected to requirements for confidentiality, as it relates to the complainant and to the subject of the complaint.
Upon receipt of a complaint from such an interested party, ZQAPL-MSCD001 confirms whether the complaint relates to certification activities that it is responsible for, and if so, takes necessary correction and corrective actions. If the complaint relates to a certified client, then examination of the complaint is done by a short notice audit at client's end and base on the audit outcome, necessary correction and corrective actions are taken.
Submission, investigation and decision on complaints do not result in any discriminatory actions against the complainant.
The complaint from an interested party is dealt by Director Operations. And in case, the interested party (complainant) does not accept the outcome reported by Director Operations then the interested party (complainant) has the right to raise the matter with CFSI chairperson.
ZQAPL-MSCD001 gives a formal notice to the complainant at the end of the complaint handling process and the relevant records are maintained. And the feedback is taken from the complainant / concerned client.
ZQAPL-MSCD001 determines together with the client and the complainant that to what an extent, the subject of the complaint and its resolution is to be made public.
Once the complaint has been resolved by ZQAPL-MSCD001 Director Operations and/or ZQAPL-MSCD001 Committee for Safeguarding Impartiality Chairperson FSI, then no counter claim by either party in dispute can be made to amend or change the decision.
In instances where the complaint has been resolved in favour of the complainant, then no claim can be made against ZQAPL-MSCD001 for reimbursement of costs or any losses incurred as a result of the initial problems faced by the complainant.
Contact e-mail id of ZQAPL-MSCD001 Director Operations - certification@zenith-worldwide.com
Contact e-mail id of ZQAPL-MSCD001 Chairperson for Committee for safeguarding impartiality - cfsi@zenith-worldwide.com