Certification process

 

 Certification Process

The Certification process consists of the following key stages, enquiries and quotations, application, Stage-I, Stage-II and surveillance visits. Re-Audits are also features of the certification process. The certification process can be summarized as follow: 

Certification Agreement 

TCI receive the requests / enquiries about certification services via email, TCI website, telephone calls, Facebook, WhatsApp or any mean can communicate that there is an inquiry message received about certification.

TCI administration or certification manager shall send to the applicant organization an application /request for quotation to be filled with all needed information. 

After TCI receive the application form from the applicant, the certification manager shall carry out the application review and decide if TCI will accept or reject the application and record the justification on that decision and send the Quotation if the application is accepted. 

On acceptance of the Quotation, this certification agreement is signed between TCI and the client for providing certification of the client’s management system by TCI to the applicable international standard.

Stage –1 Audit 

TCI shall conduct a stage –1 audit at client site to verify the adequacy of documentation with respect to the requirements of the applicable standard and also to understand and gather further information on the client activities and processes including applicable statues, to plan for the stage –2 audit .The client shall satisfactorily resolve all the observations raised in document review along with other concerns / issues highlighted during the audit and the same confirmed to TCI before planning the  stage –2 audit .TCI shall submit a formal report to the client 

The objectives of stage – 1 audit are to:

  1. a) Review the client’s management system documented information; 
  2. b) Evaluate the client’s site-specific conditions and to undertake discussions with the client’s personnel to determine the preparedness for stage 2; 
  3. c) Review the client’s status and understanding regarding requirements of the standard, in particular with respect to the identification of key performance or significant aspects, processes, objectives and operation of the management system; 
  4. d) Obtain necessary information regarding the scope of the management system, including: 

— the client’s site(s); 

— processes and equipment used; 

— levels of controls established (particularly in case of multisite clients); 

— applicable statutory and regulatory requirements; 

  1. e) Review the allocation of resources for stage 2 and agree the details of stage 2 with the client; 
  2. f) Provide a focus for planning stage 2 by gaining a sufficient understanding of the client’s management system and site operations in the context of the management system standard or other normative document; 
  3. g) Evaluate if the internal audits and management reviews are being planned and performed, and that the level of implementation of the management system substantiates that the client is ready for stage 2.

In determining the interval between stage 1 and stage 2, consideration shall be given to the needs of the client to resolve areas of concern identified during stage 1. TCI may also need to revise its arrangements for stage 2. If any significant changes which would impact the management system occur, TCI shall consider the need to repeat all or part of stage 1. The client shall be informed that the results of stage 1 may lead to postponement or cancellation of stage 2.

Stage –2 Audit 

TCI’s audit team shall visit the client’s premises, as per an agreed plan, to verify effectiveness of the client’s management system in meeting the requirements of the applicable ISO standard. Sites involved in design, development, and manufacturing of medical devices cannot be sampled. 

The purpose of stage 2 is to evaluate the implementation, including effectiveness, of the client’s management system. The stage 2 shall take place at the site(s) of the client. It shall include the auditing of at least the following: 

  1. a) Information and evidence about conformity to all requirements of the applicable management system standard or other normative documents; 
  2. b) Performance monitoring, measuring, reporting and reviewing against key performance objectives and targets (consistent with the expectations in the applicable management system standard or other normative document); 
  3. c) The client’s management system ability and its performance regarding meeting of applicable statutory, regulatory and contractual requirements; 
  4. d) Operational control of the client’s processes; 
  5. e) Internal auditing and management review; 
  6. f) Management responsibility for the client’s policies. 

Audit Report and Non-Conformity Report

TCI shall provide a written report for each audit to the client. 

TCI shall require the client to analyze the cause and describe the specific correction and corrective actions taken, or planned to be taken, to eliminate detected nonconformities, within a defined time.

If a nonconformance is detected during audit, a Nonconformity Report shall be issued to the client. For the non-conformities raised during the audit,  client shall submit the correction and the corrective action (based on root cause) to TCI office within 28 days from the last day of the audit..  TCI shall verify the submitted correction and the corrective action and confirm the acceptance of the same to the client. Client shall take the correction and corrective action within the stipulated date and submit the documentary evidence to TCI to verify the effectiveness of action taken and accordingly to close the non-conformances.  

TCI shall review the corrections, identified causes and corrective actions submitted by the client to determine if these are acceptable. TCI shall verify the effectiveness of any correction and corrective actions taken. The evidence obtained to support the resolution of nonconformities shall be recorded. The client shall be informed of the result of the review and verification. The client shall be informed if an additional full audit, an additional limited audit, or documented evidence (to be confirmed during future audits) will be needed to verify effective correction and corrective actions.

In case of a major non-conformance, Correction and corrective actions are to be closed within 90 days from the last day of the audit and verified either by desktop review or where appropriate during an additional follow up visit, agreed with the client.

In case of certification audit (fresh client) the TCI shall cancel the audit under the following conditions:

  1. Client does not submit Corrective Action Plan for the Non Conformity raised within 28 days as stipulated above
  2. In case of major Non-Conformity the Correction and corrective actions are not completed within 90 days as stipulated above 

In case of certified clients TCI shall suspend the certificate under the following conditions

  1. Client does not submit Corrective Action Plan for the Non Conformity raised within 28 days as stipulated above 
  2. In case of major Non-Conformity, the Correction and corrective actions are not completed within 90 days as stipulated above 

 

Recommendation for Certification

TCI shall recommend certification of the client’s management system, based on the following : 

  1. TCI has reviewed the audit reports and has accepted the recommendations of the audit team 
  2. The client has submitted the correction and corrective action for the non-conformities raised within the stipulated time and TCI has accepted the same 
  3. In case of a major non-conformance, the effectiveness of correction and corrective action is verified by TCI’s auditors as agreed and the non-conformity either closed or downgraded to minor.

If the client is not recommended for certification, TCI shall accordingly inform the client 

Issue of certificate 

TCI shall issue the certificate against the applicable standard to the client only after the closure of all the non-conformances.

The Certificate is the property of TCI and shall be produced to TCI as and when requested. 

The certification will be valid for a period of three years from the date of approval of certification, subject to the satisfactory maintenance of the Management System as confirmed through agreed surveillance audits 

Surveillance Audit

Surveillance audits are on-site audits, but are not necessarily full system audits, and shall be planned together with the other surveillance activities so that the TCI can maintain confidence that the client’s certified management system continues to fulfil requirements between recertification audits. Each surveillance for the relevant management system standard shall include: 

  1. a) Internal audits and management review; 
  2. b) A review of actions taken on nonconformities identified during the previous audit; 
  3. c) Complaints handling. 
  4. d) Effectiveness of the management system with regard to achieving the certified client’s objectives and the intended results of the respective management system (s); 
  5. e) Progress of planned activities aimed at continual improvement;                                                             f) Continuing  operational control; 
  6. g) Review of any changes; 
  7. h) Use of marks and/or any other reference to certification. 

Surveillance audits shall be conducted regularly at the client site at least once in a year to confirm that the Client’s Management System continues to conform to the requirements of the standard to which it is certified. 

The first surveillance audit shall take place within twelve months from the last day of the stage –2 audit and failure to comply with this requirement will lead to suspension and subsequently withdrawal of certification.

For the non-conformity raised during the surveillance audit the conditions stipulated in section 3.5 of this agreement shall be applicable 

In the case that a surveillance audit cannot be carried out because the client’s operations are affected owing to factors outside its control, e.g.: employee union strike, natural calamity, etc. the case shall be presented to TCI for a decision. 

TCI shall submit a formal report to the client

Re-certification Audit

The purpose of the recertification audit is to confirm the continued conformity and effectiveness of the management system as a whole, and its continued relevance and applicability for the scope of certification. A recertification audit shall be planned and conducted to evaluate the continued fulfilment of all of the requirements of the relevant management system standard or other normative document. This shall be planned and conducted in due time to enable for timely renewal before the certificate expiry date.

The recertification activity shall include the review of previous surveillance audit reports and consider the performance of the management system over the most recent certification cycle. 

Recertification audit activities may need to have a stage 1 in situations where there have been significant changes to the management system, the organization, or the context in which the management system is operating (e.g. changes to legislation). 

The recertification audit shall include an on-site audit that addresses the following: 

  1. a) The effectiveness of the management system in its entirety in the light of internal and external changes and its continued relevance and applicability to the scope of certification; 
  2. b) Demonstrated commitment to maintain the effectiveness and improvement of the management system in order to enhance overall performance; 
  3. c) The effectiveness of the management system with regard to achieving the certified client’s objectives and the intended results of the respective management system (s).

For any major nonconformity, TCI shall define time limits for correction and corrective actions. These actions shall be implemented and verified prior to the expiration of certification. 

TCI shall conduct the recertification audit at least 60 days in advance to the expiration of certification so that the client has time to implement corrective actions before the expiry of the certification 

For non-conformities raised during the audit, the conditions specified in section 3.5 of this agreement become applicable.  TCI shall submit a formal report to the client. 

When recertification activities are successfully completed prior to the expiry date of the existing certification, the expiry date of the new certification can be based on the expiry date of the existing certification. The issue date on a new certificate shall be on or after the recertification decision.

If TCI has not completed the recertification audit or the TCI is unable to verify the implementation of corrections and corrective actions for any major nonconformity prior to the expiry date of the certification, then recertification shall not be recommended, and the validity of the certification shall not be extended. The client shall be informed, and the consequences shall be explained. 

Following expiration of certification, TCI can restore certification within 6 months provided that the outstanding recertification activities are completed, otherwise at least a stage 2 shall be conducted. The effective date on the certificate shall be on or after the recertification decision and the expiry date shall be based on prior certification cycle. 

Special Audits

TCI shall conduct special audits under the following conditions:

  1.  Extension to the scope of certification already granted, in response to an application introduced by the client. TCI undertake a review of the application and determine any audit activities necessary to decide whether or not the extension may be granted This may be conducted in conjunction with a surveillance audit.
  2.  It may be necessary for TCI to conduct audits of certified clients at short notice or unannounced

       –   To investigate complaints received by TCI about the client

        –    In response to changes, 

       –   Follow up on suspended clients. .

  1. Changes to TCI’s certification requirements.

For non-conformities raised during the audit, the conditions identified in section 3.5 of this agreement shall become applicable.

TCI shall submit a formal report to the client.

Notice of Changes by TCI 

TCI shall inform the client any changes to its requirements for certification by mail within one month and shall subsequently verify that each client complies with this new requirement, and this may include a special audit in certain cases.

Notice of Changes by the client 

The client shall inform TCI, without delay, of matters that may affect the capability of management system to continue to fulfill the requirements of the standard used for certification. These may include changes related to,

  1.  The legal, commercial, organizational status or ownership,
  2.  Organization and management (e.g. changes in key managerial, decision making or technical staff)
  3.  Contact address and sites 
  4.  Scope of operations under the certified management system 
  5.  Major changes to the management system and processes. 

TCI shall review the changes and accordingly discuss with client for an early verification to ensure that the capability of the management system continues to fulfill the requirements of the applicable standard.

Maintaining Certifications 

The Certification is maintained for a period of 3 years under the following conditions. 

  1.  The Surveillance Audits are conducted as planned and the client has demonstrated that it continues to satisfy the requirements of the management system standard as confirmed by TCI. 
  2.  All the non-conformities raised during  previous surveillance are closed within the time frame agreed and correction and corrective actions for the non-conformities raised during the current audit are identified and accepted by TCI as per conditions specified in section 3.5 of this agreement.
  3.  The Internal Audit and the management reviews are conducted as scheduled and there are no issues pending. 
  4.  The client shall maintain suitable records of customer complaints and keep the records of investigation and remedial actions taken with respect to such complaints for verification by the TCI auditors. 
  5.  All outstanding dues to TCI are paid

Suspending, Withdrawing, or reducing the scope of certification 

(a) Suspension 

TCI shall suspend certification in cases wherein 

  • The client’s certified management system has persistently or seriously failed to meet certification requirements, including requirements for the effectiveness of the management system. 
  • The certified client does not allow surveillance and recertification audits to be conducted at the required frequencies. 
  • The certified client has voluntarily requested a suspension.
  • The certified client wishful misuse of logo & reference to certification.
  • Noncompliance to submission of Corrective action as stated in section 3.5 of the agreement.

Under suspension, the client’s management system certification is temporarily invalid. 

The suspension shall be for a period of maximum six months and the suspended status of the client shall be publicly made available in the register of certified clients being maintained by TCI at its registered office. During this period the client shall discontinue the use of logo or any reference of certification in advertising matter, as directed by TCI, at the time of giving notice of suspension.

Suspension is lifted and certification is restored if the issue that has resulted in the suspension has been resolved.

(b) Withdrawal

TCI shall withdraw the certificate under the following circumstances:

  • Failure of the client to resolve the issues of suspension within six months shall result in withdrawal of certification. 
  • Other reason like major legal complaint, company involved in malpractices, TCI loses accreditation etc.
  • Client voluntarily requested for a withdrawal.

Upon withdrawal of certification, the client ceases to enjoy the certification status and shall accordingly return the certificate as directed by TCI at the time of withdrawal notice.

(c) Reduction in scope of certification 

TCI shall decide to reduce the client’s scope of certification by excluding the parts not meeting the requirements when the client has persistently and seriously failed to meet the certification requirements for those parts of the scope of certification. Such exclusions shall be consistent with the certification standard.

For Medical Device Quality Management Systems (ISO 13485), TCI shall precisely document the scope of certification and shall not exclude part of processes, products, or services (unless allowed by regulatory authorities) from the scope of certification when those processes, products or services have an influence on the safety and quality of products.

Upon request from any party, TCI shall provide information related to the validity of a given certificate. 

Certification and Use of Logo

The certificates issued by TCI remain the property of TCI and must be returned when requested. The client is authorized to use the certificate mark or its logo in advertising matter as per instruction given by TCI at the time of issuing the certificate.

The client, while using the its certification, shall ensure that it,

  1. Conforms to requirements of TCI when making reference to its certification status in communication media such as Internet, brochures or advertising or other documents.
  2. Does not make or permit any misleading statement regarding its certification,
  3. Does not use or permit the use of the certification document or any part thereof in a misleading manner,
  4. Upon suspension or withdrawal of its certification, discontinues its use of all advertising matter that contains a reference to certification, as directed by TCI
  5. Amends all advertising matter when the scope of certification has been reduced,
  6. Shall not use the certification information in a manner to imply that the product or service is certified. The certification mark or logo shall not be used on a laboratory test reports, calibration and inspection certificates and not applied to the product or product packaging as this could be interpreted as denoting product conformity.
  7. Does not imply that certification applies to activities that are outside the scope of its certification, 
  8. Shall not use the certification in such a manner that would bring TCI and /or the certification system into disrepute and lose public trust 
  9. Logos shall also not to be applied on visiting cards
  10. Use of Accreditation Body (AB) logo will be in compliance with AB and IAF Logo regulations 

publicly Accessible Information 

TCI shall make the following information publicly accessible through its web site and through documents 

  • TCI Quality Policy
  • TCI Impartiality Policy 
  • The current activities of TCI and status of accreditation 
  • The requirements for certification including information on the audit processes and certification process for granting, maintaining, extending, renewing, reducing suspending and withdrawing certification. 
  • Certification status of clients through the register of certified clients maintained at TCI office
  • Rules and regulation for using TCI Logo 
  • Appeal and complaint handling process. 

All other information shall be treated as confidential.

Obligations of the applicant / certified organization  

The applicant / certified organization shall commit to fulfill continually the requirements of certification set by TCI for the scope for which certification has been granted including adapting changes in requirements for certification as and when communicated.

  1. When requested the applicant / certified organization shall cooperate with TCI in the fulfillment of the requirements for certification. This shall apply to all locations included in the certification 
  2. The applicant / certified organization shall provide access to information, documents, and records as necessary for granting certification and maintaining certification 
  3. Certified organization shall allow the personnel from the accreditation body (e.g., EGAC) access to their sites and shall provide access to information, documents and records when requested by TCI
  4. The certified client shall claim certification only with respect to the scope for which certification has been granted 
  5. The certified organization shall not use its certification in such a manner as to bring TCI into disrepute 
  6. The applicant / certified organization shall pay fees as determined by TCI
  7. The applicant / certified organization shall inform without delay any significant changes relevant to the certification in respect of its status or its operation related to
    1. Its legal, commercial or ownership status 
    2. The organization, top management & key personnel  
    3. Resources and premises
    4. Scope of certification 
    5. Other such matters that might affect the ability of the certified organization to fulfill requirements of certification 

Obligations of TCI

  1. TCI shall make publicly available information about the status of certification that it has granted the certified organization. The information shall be updated regularly. The information shall include the following 
  2. Name and address of the certified client 
  3. Dates of granting certification and expiry date as applicable. 
  4. Scope of certification 

TCI shall give due notice of any changes to its requirements for certification. It shall take into account the views expressed by interested parties before deciding on the precise form and the effective date of the changes. Following a decision on, and publication of, the changed requirements it shall verify that each certified client carries out necessary adjustments.

CEO

The Certification International – TCI

20/5/2024