ISO13485: 2016 (Medical)

ISO 13485: 2016 Quality Management System (Medical)

ISO 13485: 2016 defines the requirements for a Quality Management System applicable to the design and manufacture of medical devices. The organization must demonstrate continuous improvement, properly control work environment, address requirements for inspection and traceability, maintain pertinent documentation and records, validate processes for sterile medical devices, assess attributable risks, follow stringent design transfer rules, implement effective CAPA actions, etc.

For over 15 years we specialize in design and implementation of Quality Management Systems compliant with ISO 9001 / ISO 13485, regulatory (FDA, Health Canada) requirements. Our consultants provide comprehensive training, consulting and hands-on assistance, which includes:

– analysis of company needs, applicable regulatory and statutory requirements and, where
applicable, customer specifications and expectations
– pre-assessment and gap analysis of existing Quality Management System
– design and integration of ISO 13485-compliant Quality Management Systems
– Quality Management System development and implementation action plan
– preparation of Quality Manual, policies, procedures/protocols in line with ISO 13485
– GMP /cGMP – (current) Good Manufacturing Practices requirements
– Document Control, including applicable forms, templates, publications, etc.
– Control of Records, Data Management, R&D, manufacturing, shipping, traceability and QA
– research and assistance in preparation of the specifications, procedures and standards
– Design Qualification (DQ), Process Qualification (PQ) and Operational Qualification (OQ)
– Risk Assessment and Failure Mode and Effect Analysis
– selection and customization of suitable software
– step-by-step guidance and on-going advice throughout the program
– hands-on participation in Quality Management System implementation
– Internal Audits and Management Review activities
– preparation of the Quality Management System for the assessment
– assistance during Quality Management System assessment by the Registrar
– post-assessment follow-up support

– no hassles (and extra costs) associated with external training
– compliance with ISO 9001/13485 and other regulatory and statutory requirements
– trained and motivated personnel
– better documentation, repetitive processes, improved performance

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