A young Entrepreneur with an Engineering background and a rich experience of 34 years, in Quality Management, Training, Marketing and Administration. Has an in-depth knowledge on Quality, Regulatory affairs and a Lead Auditor in
QMS – ISO 9001:2015
EMS – ISO 14001:2015
OHSMS – ISO 45001:2018
FSMS – ISO 22000:2018
MDQMS – ISO 27001:2016
ISMS – ISO 27001:2022
PIMS – ISO 27701:2019
ITSMS - ISO 20000-1:2018
Started the firm THE CRAFTERSS (www.thecrafterss.in) in 2011. The firm mainly concentrates on creating and implementing documentation for the Client Organizations to ensure that the Organization follows the Standards as required by the International Organization for Standardization (ISO) in accordance with their respective industry. The firm is having an active clientele of more than 500 in India and a few in the United States.
THE CRAFTERSS, as the name suggests, crafts the Dreams of Companies (Established as well as Start-ups) and Individuals in to REALITY by driving them into Systematic Approaches.
We are delighted to mention that we have completed a DECADE of service, having started our venture in April’11.
At Crafterss, we are specialized in Creating and Implementing Systems / Documentations as per the SOP’s (Standard Operating Procedures) in the following areas:
At Crafterss, we strive hard to bring in excellence in all we do to ensure Systematic Approaches are Imbibed and followed in all our Operations as well as our Client’s Operations.
We at Crafterss, work with an objective of being the extended arm of Quality Control process of our Clients, ensure that all the necessary Compliances are adhered to right from maintaining their Documentation or handling Supplier / Regulatory Audits.
Company Restructuring by following the requirement of Sustainability Standards as specified in Integrated Management System (IMS)
Implementing / Training on Medical Devices Regulations Act – Indian MDR 2017
Implementing Documentation as required by 510k standards of USFDA
Implementation / Training on Information Security Management System (ISMS)
Guidance on Compliance in Medical Devices as per CDSCO (Central Drugs Standard Control Organization) with regard to Manufacturing / Import / Wholesale Distribution / Loan Licensing.
Guidance on other Compliances as per the requirement of each of the industry’s like
o Food
o Schools / Colleges
o Manufacturing industries
o BPOs
o IT Firms
o Hospitals
o Diagnostic Labs
We also provide Training on
o Personality Development Programs
o Soft Skills
o Marketing
o 5S Implementation
o TQM
o ISO Awareness and
o ISO Internal Auditor Training for QMS, MDQMS, FSMS, ISMS, EMS, OHSMS & EnMS
The firm is currently having 4 staffs handling the back-end operations
1. ISO Documentation: Complete Documentation like Quality Manual Standard Operating Procedures, Work Instructions Process Interaction Charts… for all the above referred standards can be supported.
2. Training: Awareness Training for all the above referred standards,
• Internal Auditor Training on all the above referred Standards
• Training on 5S,
• Six – Sigma,
• Personality Development Programs,
• Sales Training &
• Soft Skill Training.
3. Medical Device Documentation: Documentation Support as per Indian MDR 2017 (CDSCO), EU MDR and 510K along with Risk Assessment as per ISO 14971:2019 will be provided.
4. NABL / NABH: The complete END – to – END solution for Start-Up / Established Labs / Hospitals for NABL / NABH Standard will be provided.
5. Compliance Counselling: Compliance Guidance for all the Regulatory Requirements for all the Industries will be provided.
6. Company Restructuring: Specialized in Restructuring of Companies in varied Industries using sustainability approaches.
7. Third Party Auditing: Involved in Third Party Supplier audits for On-Shore and Off-Shore Projects.
8. NAAC (The National Assesment And Accreditation Council): Complete Guidance on the implementation and the documentation as per the NAAC criteria.
9. Sustainability Audits: Complete Guidance and Support will be provided for Sustainability Audits based on Integrated Management System Procedures.
10. ISO Certification: All Quality Certifications including their compliance Certifications will be processed / obtained.
11. CDSCO (Central Drugs Standard Control Organization) Licensing/Registration: Support & Guidance will be provided for,
• Manufacturing License for all categories of Devices.
• Import License for all categories of Devices.
• Wholesale Distribution License and,
• Loan Licensing.
12. Outsourcing Of Documentation Activities: We provide Outsourcing support on Documentation & QA Profile wherever the Client Organization feels the need for the same due to Lack of Manpower, Work Overload, etc…
We are one of the Preferred Training Provider for few of the Corporate Houses and MNC’s apart from providing Guest Lectures on the above-mentioned Topics to few Engineering Colleges & Polytechnics.
1. Implementation of NABH Standard for 3 Hospitals
2. Implementation of MDQMS / CDSCO Licensing for 18 Organizations
3. Implementation of QMS for 4 Organizations
4. Implementation of IMS for 2 Organizations
5. Implementation of NABL for one Diagnostic Lab
6. Outsource contractor for documentation for 6 Clients
