Recommended Certification Procedure For Medical Value Travel Facilitator

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0. Introduction

It is observed that although ISO 22525 for medical value travel facilitators (MVTFs) has been available, there is no formal certification against this standard. Therefore, until any specific certification scheme for MVTF based on ISO 22525 comes up, it was decided to provide a certification procedure for uniformity among certification bodies (CBs), should any MVTF decide to seek certification. Hence this recommended procedure for certification is provided to facilitate certification with immediate effect and CBs are encouraged to adopt it.

1. Scope

This document explains the recommended process of certification to be adopted by the Certification Bodies in the absence of a formal certification scheme for MVTFs based on ISO 22525 to be eligible for grant of Ayush Quality Mark under the Ayush Quality Mark Programme, hereinafter referred to as the Programme, operated by Ayushexcil.

2. Preparing for MVTF Certification

The MVTF management should first decide about getting certification for its services. It is important for MVTF to make a definite plan of action for obtaining certification and nominate a responsible person to co-ordinate all activities related to seeking certification. The person nominated should be familiar with MVTF's services, functions and existing quality system, if any.

A request can be made to the Programme Secretariat for relevant certification documents. The documents can also be downloaded from https://ayushexcil.in/mvtfs. A list of documents is given on the website under each programme and general documents. Clarifications on any document/ process may be obtained from the Programme Secretariat in person, by post, on telephone or through e-mail. The MVTF must get fully acquainted with relevant documents and understand the audit procedure & methodology of making an application.

Before an application is made, it is required that MVTF do the self-audit to ascertain whether MVTF is fulfilling certification requirements, if any gaps are identified, take necessary measures to fill those gaps.

Relevant requirements for certification should be discussed amongst concerned staff of the MVTFs. This will enable them to understand their weaknesses and strengths. The MVTF must ensure that policies, procedures and other documents for various sections/ departments and services being provided are available and implemented.

The MVTF interested in going for certification should understand the certification procedure and prepare accordingly.

1. All applicable certification criteria and regulatory/ statutory requirements as given in the following documents:

a) System for Grant of Ayush Quality Mark to Medical Value Travel Facilitators (MVTFs)

Additional requirements for Medical Value Travel Facilitators (MVTFs) as per ISO 22525

2. Must have completed at least one self-assessment against the certification criteria. Any observations identified in this process have to be addressed before the submission of application.

NOTE: This is a mechanism of ensuring compliance to the certification criteria by the MVTF themselves and therefore it would be easier for the audit teams to verify those compliances during on-site visits. It also gives confidence to MVTF about documentation and implementation of the requirements.

4. Description of Procedure

4.1 Application for Certification

The MVTF shall apply to a CB in the prescribed application form, along with supporting documents of the MVTF in accordance with relevant certification criteria. The application shall be accompanied with the prescribed application fee.

4.2 Registration and Acknowledgements of application

Within one week of receipt of the application from an MVTF, the following actions shall be taken:

• Review application to see for which certification programme application is made and accordingly allocate a Unique Registration Number
• Open a folder in the computer system and hard copy document file
• Update the database maintained
• Fee received as DD/ cheque is transferred to the account
• Performing completeness check of application including supporting documents and fee received on-line
• Issue acknowledgement mentioning unique Registration number. If deficiencies are identified, it shall be recorded and the MVTF be informed for corrective actions within one week
• This unique Registration number shall be allocated for recording system and also for correspondence with the MVTF. All MVTFs are advised to use this registration number while communicating with CB
• The CB shall maintain confidentiality of application submitted by MVTF
• After the application is accepted, the CB shall define the number of mandays required to undertake this certification process for the scope applied for.

4.3 Defining Man-days

4.3.1 Audit time (Man-days) requirement: The certification body shall conduct the audit in two stages, offsite (desk review) and onsite audit.

4.3.2 The number of man-days required are decided as follows:

1. offsite Document review and making report: max 2 mandays
2. Office audit: depending upon the scope: max 2 man-days per process/activity
3. Submission of Audit report by Lead auditor: within 10 working days and 1man-day

4.4 Appointment of Lead auditor and team

The CB shall identify a Lead auditor to be team leader and constitute an audit team for initial audit. The team shall include besides the Lead Auditor, auditor(s), technical expert(s) and observers or trainee auditors (if required) in order to cover the scope of certification. The MVTF is informed about the team members and consent is taken to avoid any conflict of interest.

The Team Leader shall have the overall responsibility of conducting the audit and shall be responsible for conducting the on-site audit of the concerned MVTFs. Towards the task of audit (on-site, remote, hybrid), he/she may be assisted by a team of auditors commensurate with the scope of certification.

4.4 Audit

4.5.1 Offsite Document Review

A Review of the Self-Audit checklist, Scope/Manuals, procedures /documents to verify if all the requirements of standard have been adequately addressed is carried out by TL (LA) and appointed team members, if any.

4.5.2 Onsite audit

1. If the document review is satisfactory, the onsite audit shall be planned. ii. The CB shall fix up dates for audit of the MVTF in consultation with the MVTF and the audit team.
2. The MVTF is informed about the audit team and date(s). A copy of this communication is marked to the members of audit team, along with the requisite documents. The auditors are required to reach the place of audit, preferably a day before the start of audit.
3. An Audit plan is prepared by Team Leader and shared with MVTF and his team. It would detail the scope, methodology and the audit criteria.
4. The audit team assess the MVTF's services and functions and verifies its compliance with the certification criteria, for the purpose audit team carries out various audit activities (document/records review, functional interview and special interviews, witness critical activities by way of sampling etc.). The team will assess the extent of implementation of certification criteria, the non-compliances, if identified are reported in the audit report.
5. The findings shall be categorised as Major/minor/concerns depending upon the severity of the findings and their impact on the output of the process. This shall be discussed with MVTF and their agreement on the findings is taken in the closing meeting.
6. A copy of the report containing final summary, details of the non-compliances (NC/PC) observed during the audit is provided to the MVTF within 10 days of the audit shall be sent by Lead Auditor, with action plan as detailed below (for any observations/ non-conformities.) If no comments are received, the report is submitted to the CB.
7. The audit report shall contain evidence of compliance to each requirement of the certification criteria and non-compliances, if any found during audit.

4.6 Resolving non conformities

4.6.1 The MVTF shall prepare an action plan to address all non-confirmitiess or any concerns raised during audit. MVTF shall prepare an action plan which will include proposed corrections and corrective actions with root cause analysis and timeline to complete them and submit to Audit team within 30 days

4.6.2 The audit team shall respond within 15 days. Once proposed correction/corrective actions are accepted by the audit team, the MVTF shall implement these within 30 days and provide evidence to the audit team.

4.6.3 If the audit team accepts the implemented actions, it shall verify them onsite in case of major NCs and through documented evidence in case of minor NCs/concerns and then close the NCs.

4.6.4 if at any stage the audits team does not accept submission by the MVTF, it may be given an additional chance to submit fresh response.

4.7 Recommendation and Grant of Certification

4.7.1 Recommendation for Certification:

a) After satisfactory corrective action by the MVTF as accepted by the audit team, the CB prepares a brief summary of all relevant information gathered during the processing of the application, the audit report, additional information received from the MVTF.

b) The summary report is placed for review and decision by competent individual(s)

c) In case the review finds deficiencies in the audit report or otherwise, , the CB shall obtain clarification(s) from the Team Leader/ auditor/ MVTF concerned as needed.

d) Once the competent individual(s) are satisfied with the recommendation, the CB shall take a decision for certification. The review and decision shall be duly recorded.

4.7.2 Grant of Certification:

4.7.2.1 The CB shall grant certification after ensuring the following:

I .Complete compliance to the Certification Criteria based on evaluation reports resulting in favourable certification decision,

II. Certification Scheme requirements and

III .Nonconformities raised have been addressed

4.7.2.2 The effective date of certification shall not be before the date the decision to grant the certification to the organization is made.

4.7.2.3 Validity of the Certificate: The certificate shall be valid for 3 years from the decision to grant it.

4.7.2.4 The CB shall make the certification decision within a maximum of 15 calendar days after closing any outstanding non-conformances and receipt of all due payments. If no nonconformances are detected during the audit, the CB shall make the decision no later than 15 calendar days after the end of the audit.

4.7.2.5 On grant of certification, the CB shall inform the organization and issue a Certificate, uniquely identified, either a paper certificate or e-format, to the organization indicating as a minimum:

a) the name and address of the organization & the site(s) covered under

>b) certification

c) Scope of certification

d) the certification criteria against which the certification has been awarded,

e) date of initial certification

f) date of recertification, if applicable,

g) date of expiry

h) Name and address of the certification body

4.7.3 Use of certificate/certification mark

4.7.3.1 The certificate is nontransferable except in case ownership of the site certified changes; the certificate may be transferred to the new owner on production of the ownership documents.

4.7.3.2 On grant of certification the MVTF can use the certification mark, if any, on its letterheads, brochures and any other material issued to its customers. The guidelines for using certification/certification mark are given by the scheme owners or the CB.

5.0 Maintaining Certification

5.1 Validity

5.1.1 The certificate shall be valid for a period of three years.

5.1.2 In order to maintain certification, MVTF shall undergo 2 annual surveillances during the validity period and a renewal audit before the end of validity of certification.

5.1.3 During the validity of certification, the MVTF shall continuously comply with the requirements of the certification criteria/standards and 'Terms and conditions for maintaining certification'.

5.1.4 At least one of the surveillances shall be a surprise/unannounced audit.

5.2 Surprise / Unannounced visit

5.2.1 Besides the regular surveillances, CB may also organise surprise/ unannounced visits at any time because of any reason felt necessary including the following reasons:

a) Misuse of CERTIFICATION mark

Whenever any information regarding misuse of CERTIFICATION Mark is received in CB Secretariat, it shall be investigated and objective evidence of such misuse is collected and reported to the CB. Verification/ unannounced Verification visit shall be organised based on the severity of the outcome of the investigation.

b) Complaint against an MVTF

In case, a complaint has been received and the facts need to be verified. Complaint will be dealt with as per the CB's complaint procedure.

5.3 Extraordinary visits

5.3.1 The CB may undertake extraordinary visits, if needed in situations such as:

a) Changes in the certification standards and requirements If there is a change in the general CERTIFICATION criteria, CB shall inform the MVTF of this in writing indicating the transition period, which shall be at least 6 months. On receipt of the aforesaid information, the MVTF must confirm to CB, its willingness to modify its quality system in accordance with the changes. On confirmation from the MVTF, CB may conduct a verification visit to assess the implementation of the same.

b) Changes affecting the MVTF operations In the event of the MVTF informing CB about any changes in the information affecting the MVTFs activities and operations, scope of certification or changes in key managerial/ technical personnel, a verification visit may be conducted.

6.0 Surveillance

6.1 Each certified MVTF shall undergo surveillance audit annually - one announced and one unannounced - the same as the initial onsite audit. Surveillance audit may be desktop review/ on-site/ virtual/ hybrid, based on situations

6.2 The duration of unannounced audit shall be the same as surveillance audits.

6.3 In conducting Surveillance audits of the certified sites, the CB shall ensure that the gap between two surveillance evaluations does not exceed one year. The CB may allow a grace period of one month based on valid grounds, beyond which delays shall lead to suspension of the certificate.

6.4 If multiple sites are covered under the certification, all sites shall be audited during the certificate's validity period.

6.5 in case of multi-site certification, sites equal to a minimum of the square root (or the following whole number rounded upwards if there are any decimals) of the total number of the sites shall be audited.

6.6 If necessary, based on the risk perceived, the CB may increase the total number of sites to be audited. The organization can oppose the CB's decision on the number of sites to be audited.

6.6 If necessary, based on the risk perceived, the CB may increase the total number of sites to be audited. The organization can oppose the CB's decision on the number of sites to be audited.

6.8 The CB may carry out any extraordinary audits based on any feedback or complaints or any other reason which may be announced / unannounced

7.0 Renewal of Certification

7.1 The CB Secretariat shall remind the MVTF, 6 months before the expiry of certification for making application for renewal of certification to ensure that MVTF applies for renewal.

7.2 The MVTF shall apply for renewal of certification by submitting an application in the prescribed form. The application shall be accompanied with the prescribed renewal fee, as detailed in the information brochure.

7.3 The request for renewal must be submitted at least 4 months before the expiry of the validity of certification. If the MVTF does not apply for renewal in time before the expiry the certification status of the MVTF shall expire on the validity date mentioned in the certificate. In such a case the MVTF shall have to apply afresh and the continuity of the certificate shall be disturbed.

7.4 Once applied within the time frame, the MVTF must be prepared for audit. CB shall conduct the renewal audit (on-site/ virtual/ hybrid), based on situations anytime during this period to ensure that the decision on the renewal audit can be arrived at before the expiry of the certification certificate. In circumstances, where the decision for renewal could not be arrived at before the expiry of the certification, CB may take a decision to extend the certificate validity up to a period not exceeding three months.

7.5 The procedure for processing of renewal application is similar to that of first application. The procedure for the on-site reaudit visit is similar to that of first audit visit.

7.6 If the results of re-audit visit are positive and all non-compliances are addressed through an action plan and recommended by the certification team, before the expiry of the certificate, then the validity of the certificate is extended by another three years without any discontinuity.

7.7 A new certificate is issued on renewal; however, the certificate number remains the same.

7.8 As this certificate pertains to the already certified facility (renewal cases), "Date of first certification" shall also be mentioned above this certification date.

7.9 If the MVTF missed making an application in time, but wishes to continue the certification, a grace period of three months would be considered for the renewal audit.

8.1 Suspension of Certification

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