ISO 13485-2016 Certification
Medical Devices – Quality Management Certification
ISO 134852016 identifies requirements for a quality operation system where an association conditions to demonstrate its capability to offer medical bias and affiliated services that constantly meet customer and applicable nonsupervisory requirements. Similar associations can be involved in one or further stages of the life- cycle, including design and development, product, storehouse and distribution, installation, or servicing of a medical device and design and enhancement or provision of associated conditioning (e.g. specialized support). ISO 134852016 can also be used by dealers or external parties that deliver product, including quality operation system- related services to similar associations.
The standard offers manufacturers, contrivers, and suppliers to the medical device assiduity with the frame needed to demonstrate compliance to nonsupervisory conditions, alleviate pitfalls, and confirm stylish practices are taken for quality, safety, and sustainability.
Some of the biggest changes between the 2003 and 2016 interpretation include
- Objectification of threat- grounded approaches beyond product consummation.
- Threat is considered in the environment of the safe tand performance of themedical
- device and in meeting nonsupervisory requirements;
- Advanced relation with nonsupervisory requirements, particularly for nonsupervisory attestation;
- . Operation to associations throughout the lifecycle and force chain for medical bias;
- Adjustment of the requirements for software confirmation for different software operations
- (QMS software, procedurecontrol software, software for monitoring and dimension) in different clauses of the standard;
- . Emphasis on complaint running and reporting to regulatoryauthorities in agreement with nonsupervisory
- Requirements, and consideration ofpost-market surveillance; and
- . Emphasis on correct structure, particularly for product of sterile medical bias,
- . Fresh requirements in design and development on consideration of usability, use of norms,
- . verification and confirmation planning, design transfer and design records;
- .and addition of requirements for confirmation of sterile hedge parcels;
- Planning and establishing corrective action and preventative action, and applying corrective action
- . without overdue holdback.