ISO 13485 Consultancy

ISO 17020:2012 conformity assessment – requirements for the operation of various types of bodies performing inspection. It is accreditation provided by NABCB (National Accreditation Board for Certification Bodies)/ QCI (Quality Council Of India), new delhi. It is applicable to those industries who are doing various inspection activities. Ours is a celebrated name, actively involved in providing expert solutions related to ISO 17020 requirements. At ST, we are a pool of qualified and skilled professionals, having in-depth knowledge and providing solutions in accordance with the stated industry norms. We are operating from Pune (Maharashtra, India) and providing ISO 17020 Accreditation consultancy services since 2015. ISO 17020 entails a framework in which an authoritative body gives a formal recognition of technical competence for specific inspection. For any discussion and query, dial the given numbers.    Key Features : Lead auditor and internal auditor training programs Customized training programs as per clients requirements   Number of Clients : 01

ISO 13485 Standard includes the requirements for the implementation of a Quality Management System for medical devices. The structure of the Standard and the requirements are similar to those of international Quality Standard ISO 9001. Their main differences are the requirements for monitoring records for each product, the risk management in all process stages, the monitoring of infrastructure maintenance, the documented procedures for the work environment, the service provision, the customer feedback as well as keeping interested parties informed.   ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.   ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.