Punyam.com is excited to announce the launch of a new service for ISO 13485 certification consultancy. Punyam.com is the finest ISO 13485 consultant in India with years of experience in consulting clients on ISO certification and establishing effective quality management systems into place for businesses that produce various types of medical devices, including orthopedic implants, surgical tools, and other products.
Punyam.com works with all the certifying bodies, which are authorized to provide provides ISO 13485:2016 certification and help organization to achieve quick certification. After the pre-assessment and registration (final) assessments are completed, the certificate is granted for a period of three years. The certificate has validity for three years from the date of issue. Depending on the type and size of the organization, surveillance audits are carried out by the certifying authority every 3 years at intervals of 9 or 12 months. A renewal audit is conducted for a new cycle of three years after the first three have passed. Punyam.com will assist you throughout the certification procedure.
To create an ISO 13485:2016 Medical Devices – Quality Management System for its clients, Punyam.com follows the steps listed below.
1. Beginning with the creation of a thorough gap analysis report and a micro-level survey for every operation of the organization
2. preparation of the relevant documentation required by ISO 13485:2016 standard, based on a thorough analysis of all the organizationsâ€™ activities
3. Providing ISO 13485 training to all organizational levels of staff
4. Until ISO 13485:2016 certification, assist in the efficient implementation of the ISO 13485 system with recurring visits
5. To ensure organizations are prepared for the certification, perform an internal audit
6. Organise management review meetings in front of the top management to direct the company in the efficient implementation of all QMS-related concerns
7. Practise product recalls and product traceability by running a simulation exercise
An organization that adopts the ISO 13485 certification receives numerous advantages, including increased customer satisfaction, lower operational costs, better stakeholder relations, legal compliance, greater risk management, established business credentials, and the capacity to secure additional business. To know more about the ISO 13485 consultancy service, visit here: https://www.punyam.com/iso-13485-standard-certification.htm
About Punyam.com â€“ India
Punyam.com, a leading ISO consultancy company in India, provides ISO implementation, documentation, auditor training as well as management training. Punyam has implemented ISO 9001, ISO14001, OHSAS 18001, ISO 22000, ISO 37001, ISO 15189, ISO 17020, ISO 17024, ISO 13485, SA8000, FSSC 22000, ISO 44001, BRC, GMP, CE mark, and many more associated quality standards in all industries since 1991. Punyam has small and big-size manufacturers and services provider organizations as a list of satisfied clients in India. For more details visit our web portal at www.punyam.com