AYUSH Certification for Trusted Brands

Certified units under the AYUSH scheme must adhere to defined responsibilities to retain their certification. These obligations ensure consistent compliance with certification standards, uphold public trust, and maintain product quality and safety. Organizations are expected to follow guidelines related to certification usage, internal processes, product integrity, and communication protocols. Regular updates, cooperation during assessments, and transparent reporting are essential.

Below is a structured overview of the key responsibilities that certified AYUSH organizations must follow to ensure continued compliance and certification validity:

1. Compliance with Certification Requirements The client shall always comply with all certification requirements, including product standards and any changes communicated by IRQS.
2. Responsibility for Certified Products The client is fully responsible for ensuring that certified products consistently meet all AYUSH certification requirements.
3. Access and Cooperation During Evaluation The client shall make all necessary arrangements for evaluation, including access to documentation, records, facilities, relevant areas, personnel, and any information needed for complaint investigations.
4. Claims Within Approved Scope The client shall make claims regarding certification only within the scope for which certification has been granted by IRQS.
5. Proper Use of Certification The client shall not use its certification in any way that could mislead others or bring IRQS into disrepute.
6. Suspension or Withdrawal of Certification Upon suspension or withdrawal, the client shall: Stop using all promotional material referencing certification. Return all certification documents as required. Recall any non-conforming certified AYUSH products that caused the suspension. Submit recall status updates to IRQS every 15 days. IRQS will inform QCI of the recall status or affected product details as necessary.
7. Suspension and Corrective Action Upon receiving suspension instructions, the certified unit shall immediately stop using the AYUSH Certification Mark and perform a root cause analysis to identify and implement corrective actions.
8. Accurate Use of Certification Documents The client shall ensure that no certificate, report, or part thereof is used in a misleading manner.
9. Reproduction of Certification Documents If copies of certification documents are shared, they must be reproduced in full and without alteration.
10. Implementation of IQAP The client shall maintain and implement the agreed Internal Quality Assurance Protocol (IQAP) to ensure continuous compliance of products and processes with certification requirements.
11. Renewal of Certification Renewals shall take effect from the expiry date of the previous certificate. The period between expiry and renewal will be treated as a suspension period during which certification marks cannot be used.
12. Changes to Certification Requirements When new or revised requirements are introduced, IRQS will communicate these to all applicants and certified units. The client must implement the required changes within the specified time frame.
13. Notification of Significant Changes The client shall inform IRQS (A Division of IRCLASS Systems & Solutions Pvt. Ltd.) within three working days of any significant change affecting compliance, including: Legal, commercial, or ownership changes Organizational or management changes Changes in name, address, or site details Scope of operations, dosage forms, or product range Any update that affects the certificate's accuracy The organization shall seek IRQS's guidance when unsure about the significance of a change.
14. Reporting of Serious Events The client shall immediately inform IRQS of any incident that could affect product safety or certification integrity, including: Legal proceedings or prosecutions related to product legality or safety Public product safety events such as recalls or alerts IRQS will assess the situation and may conduct verification or additional audits, which may impact certification status.
15. Use of Certification in Communications The client shall comply with IRQS requirements when referencing certification in marketing materials, brochures, or advertising.
16. Use of Certification Mark The certification mark shall be used only on products verified to meet all certification requirements and within the approved scope.
17. Placement of Certification Mark The mark may appear on certified products, packaging, or accompanying documentation, but never on uncertified products or prior to certification approval.
18. Design and Format of Certification Mark The size, color, and usage of the certification mark must comply with guidelines from the Ministry of AYUSH and QCI. Accreditation marks are not to be used on products. For details, refer to Annexure A: Approval for Use of Certification Mark to Certified Units available on the IRQS website (www.irqs.co.in).
19. Complaint Management The client shall maintain records of all complaints related to certification compliance and document actions taken. These records must be available to IRQS upon request.
20. Information Sharing and Transparency The AYUSH-certified organization agrees to: Share relevant information with QCI, NABCB, and government authorities when required. Allow IRQS and QCI to display certification details, including organization name, scope, and location, on their official websites.
21. Confidentiality of External Information Any information about the client obtained from sources other than the client (such as complaints or regulators) will be treated as confidential.
22. Providing Access and Information to IRQS The client shall provide IRQS with all documents, information, facility access, and updates necessary to deliver certification services.
23. Access for Accreditation Bodies The client shall provide IRQS's accreditation bodies with all necessary documents, information, and site access to verify audits conducted by IRQS.
24. Staying Updated on Certification Scheme Clients must regularly visit the IRCLASS website (www.irclass.org) to stay informed about any updates or changes to the AYUSH Certification Scheme.
25. Validation Visits by NABCB Based on assessments, feedback, or complaints, NABCB may conduct validation visits to certified organizations. IRQS will include provisions for such visits in client contracts. NABCB will share visit details with IRQS, including purpose, duration, and data to be collected. IRQS may accompany NABCB assessors if required. The cost of these visits will currently be borne by NABCB.
26. Validation Visits by IRQS IRQS may conduct its own validation visits instead of standard witnessing activities. NABCB will inform IRQS in advance about the number of visits, duration, charges, and sample selection.
27. Witness Assessments If the accreditation body or IRQS selects the organization for a witness assessment, the client must participate. Refusal to participate will result in immediate withdrawal of certification.
28. Multi-Site Audits The client organization shall ensure that audits cover all certified sites within the approved certification scope to maintain compliance and validity.