Punyam.com Started the ISO 13485 Consultancy with Documents and Training Resources

2024-12-18 12:10:03 Education

Punyam.com is pleased to start the ISO 13485 certification consultancy for Medical Devices - Quality Management Systems. ISO 13485:2016 Medical Devices - Quality Management System Requirements is a regulatory document that supersedes ISO 9001, EN 46001, EN 46002, and ISO 13488. It emphasizes meeting regulatory and customer requirements, risk management, and maintaining effective processes, replacing ISO 9001's emphasis on continuous improvement and customer satisfaction. The standard aims to facilitate compliance with global regulators.

Punyam.com is a top Indian ISO 13485 consultant with extensive experience in implementing ISO systems for various medical device manufacturing industries, including surgical instruments and orthopaedic implants. ISO 13485 certification aligns an organization's management system with the FDA's Quality System Regulation (QSR) requirements and other global regulatory requirements. It serves as a framework for compliance with regulatory and customer requirements. The industry can implement this standard to establish, maintain, and improve quality management systems, ensure conformity with customer and regulatory requirements, demonstrate conformity with ISO 13485:2016 through enhancements, risk management, process validation, compliance with statutory and regulatory requirements, and effective product traceability and recall systems. Punyam.com provides consultancy services for ISO 13485 Certification, issued by an accredited body. The certificate is valid for 3 years after completing pre-assessment and registration assessments.

Punyam.com also offers ISO 13485 documents and training resources like ISO 13485 Documents kit, ISO 13485 Auditor Training ppt, ISO 13485 Lead Auditor training, ISO 13485 auditor training, ISO 13485 Lead Implementer Training, and ISO 13485 Foundation Training. The ISO 13485 auditor training courses include audio-video lectures, Handouts, and session exams. The ISO 13485 Auditor Training courses are designed for professionals, management students, and individuals to enhance their careers, renew their licenses, and update their knowledge and skills. It is suitable for those seeking certification or starting a new profession. The course is open to any working professional, graduate, undergraduate, management student, entrepreneur, quality manager, or technical manager. There are lots of benefits of these online courses’ user login anywhere and anytime, cost effective, time efficient, auto-generating with quick control, and 24/7 accessible online course. The consultants, with over 25 years of experience in ISO and management consultancy in 35 countries, have developed an online auditor training course for ISO 13485, specializing in designing and conducting cost-effective e-learning courses and training programs.

The ISO 13485 documents are a set of editable MS Word files that cover all aspects of the medical device quality management system. The documents kit includes a Manual, Procedures, Exhibits, Sample formats, SOPs, and filled forms for quick record keeping. The ISO 13485 audit checklist covers over 900 audit questions based on clause-wise and department-wise requirements, allowing users to customize their internal audit checklist. The medical device file includes sample technical documents for medical devices by ISO 134852016 certification requirements. The documents are written in an easy-to-understand language, with hand-outs in.docx format accessible with MS Word 2007 and later versions. The ISO 13485 documentation model is natural, simple, and free from excessive paperwork, developed under the guidance of experienced quality experts.

About Punyam.com
Punyam.com is one of India's top suppliers of ISO certification consultancy services and management systems. They impact major international and national management systems standards such as FSSC 22000, RC 14001, ISO/IEC 17025, ISO 50001, BRC food, ISO 14001, ISO 45001, ISO 22000, ISO 27001, IFS, API, SEDEX Certification, and 5S. The food, pharmaceutical, building, IT, healthcare, hotel and tourism, education, automotive, oil and petrochemical, electrical, and textile industries are just a few of the sectors that profit from these services.