Laboratory and Test House Accreditation

Guide and Outline Strategy for Test and Calibration or Clinical Research Centre Authorization

SDAB certification includes an independent review of documented plans to ensure that laboratory management operates in accordance with defined training and competence standards.

The SDAB approach is designed to ensure that its licensing activities are conducted in an open, transparent, fair, and technically competent manner. The system is intended to be dependable, repeatable, responsive, and authoritative for ease of use by stakeholders.

To ensure that the needs and prerequisites of laboratory partners are met, SDAB operates within a documented quality management framework. The organization supports the establishment of quality objectives and the implementation of effective quality practices. This ensures that all competent personnel are fully aware of quality arrangements, customer confidence is maintained, and that staff welfare, safety, and regulatory support are prioritized. Visitors to facilities are treated with due respect, and appropriate consideration is given to their wellbeing while on site.

SDAB promotes the maintenance of technical competence and emphasizes best professional practices. It also supports environmental responsibility by encouraging the use of recyclable and renewable materials and by minimizing waste generation and energy consumption.

SDAB recognizes the importance of relevant guidelines for all stakeholders within its scope of operations and therefore aligns its activities with ISO/IEC 17011:2017.

The SDAB fee structure is based on reasonable moderation for research facilities. Fees are calculated to recover the costs of accreditation activities, taking into account factors such as the turnover of the research facility or, in the case of non-commercial or government laboratories, the number of tests performed.

Charges depend on the initial accreditation and ongoing surveillance activities. Guide 52 provides a detailed explanation of the fee structure.

Accreditation Process

• Applicants shall submit a formal application for accreditation. Test laboratories or clinical research facilities are required to use the prescribed application format.
• Upon review of the application and preliminary correspondence, and if suitability is confirmed, an invoice for the application fee will be issued as specified.
• The applicant test, calibration, or clinical research centre is required to comply with ISO/IEC 17025 or ISO 15189, as applicable, and to maintain a Quality Management System aligned with ISO 9001:2015.
• SDAB will review the application, may request additional information, and, if the application and preliminary assessment confirm suitability, an invoice for the assessment fee will be issued.
• Complete documentation, including manuals, systems, and organizational structures, shall be submitted as required by SDAB.
• SDAB will issue key documents to the applicant for agreement upon successful evaluation. These include:
  • Agreement
  • Memorandum of Understanding
  • Licence imprints and logos
  • Agreements
  • Set of principles
  • Worldwide affiliations
  • Authority
  • Rules for use of imprints
• Accreditation and Surveillance Process (Continued)
  1. The candidate shall submit to SDAB all documentation related to the activities of the test and calibration or clinical research center.
  2. SDAB will review and assess the submitted documentation. If necessary, SDAB may require the candidate to make revisions and submit responses before proceeding to the next stage.
  3. Upon a positive licensing decision, SDAB will issue an agreement. Test agreements may also be issued prior to application upon request.
  4. SDAB will grant a temporary license once the documented management system is found to be satisfactory. The candidate will be listed on the SDAB website as a “Temporary Body.”
  5. The candidate shall conduct test or calibration activities. Copies of verified or electronic records related to these activities shall be submitted to SDAB as required, consistent with previously reviewed reports.
  6. Where necessary, SDAB will conduct on-site observations of the candidate’s testing or calibration activities. The candidate shall bear the cost of assessor day rates, in addition to travel and related expenses.
  7. Following a successful on-site assessment, the candidate’s license will be upgraded to Full Accreditation. The candidate will be listed on the SDAB website, including any applicable conditions.
  8. The candidate may continue testing and calibration or clinical research activities without the need to submit further desk-based documentation unless specifically requested.
  9. SDAB will monitor the scope and level of testing, calibration, or clinical laboratory activities and conduct certification audits as appropriate.
  10. SDAB will arrange for the listing of the accredited test and calibration or clinical laboratory in the Global Register.
  
  NOTE
  It is essential that the candidate’s clients clearly understand the relationship between SDAB and public regulatory authorities. Candidates must not imply or suggest that SDAB activities are carried out on behalf of, or with the endorsement of, public authorities. For this reason, the Terms and Conditions are critically important. SDAB guidance documents are publicly available, and candidates are encouraged to provide these to their clients prior to commencing work.
  
  SDAB assessment activities are proportionate to the level of risk involved. Increased laboratory activity or higher operational complexity may require greater levels of assessment and surveillance. Research centers are therefore required to inform SDAB of changes in workload, income, or testing activity to ensure that appropriate certification and surveillance arrangements are maintained.
  
  Where SDAB appoints an Assessor for a specific geographical region or country, the term “SDAB” used in this guide shall be understood to refer to the appointed Assessor.

Branches

SDAB Accreditation

SDAB Head Office

SDAB Sanatan Dharma Accreditation Board
SDAB House
C/O Mr.Garry 54, Glengarnock Avenue,
E-14 3BP Isle Of Dogs, London UK
Tel .: +44-8369083940
email: info@sanatanboards.com
Website: www.sanatanboards.com

MUMBAI Head Office

Sanatan Dharma Accreditation Board (SDAB)
SDAB House
B-401, New Om Kaveri Chs. Ltd., Nagindas pada,
Next To Shiv Sena Office, Nallasopara (E)
Tel .: +91-7499991895
email: info@sanatanboards.com
Website: www.sanatanboards.com

DELHI-NCR Regd. Office

Sanatan Dharma Accreditation Board (SDAB)
SDAB House
Asaoti, Dist Palwal
Faridabad Delhi NCR, Haryana
Tel .: +91-7979801035
Fax: +91-250 2341170
Website: www.sanatanboards.com