Organisations who design, develop, produce, or install medical device products or services often make a strategic decision to certify to ISO 13485:2016. ISO 13485 harmonises medical device regulatory requirements and provides a best practice framework for a medical device quality management system.
As well as providing internal efficiencies and structure for a medical device qms, ISO 13485:2016 gives customers confidence, promotes better communication, improves performance, and increases speed to market.
Kate Armitage, Head of Quality at Qualsys works closely with medical device Quality Managers. She said:
One of the main mistakes organisations make when implementing ISO 13485:2016 is viewing each of the requirements as separate. The best way to approach ISO 13485 is to consider quality as a whole. It's not just the quality management system, it's the business management system, and it's central to all processes, policies and practices. It's all integrated.
Although each of Qualsys's software modules helps with various parts of compliance with ISO 13485:2016, below we've shared some examples of exactly how the modules can be applied.
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ISO 13485:2016 clause number
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Examples of how our software helps
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Clause 4: Quality Management system
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- Formally document a quality management system with Document Manager
- Establish, control and retain records and medical device file with Document Manager
- Apply risk based thinking with all modules
- Document validation and re-validation activities for any requirement, procedure, or arrangement with Document Manager
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Clause 5: Management responsibility
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Clause 6: Resource management
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- Determine competence, provide training and evaluate the effectiveness of training, retain records on maintenance activities using Training Records Manager
- Document work environment health and safety requirements with Document Manager
- Plan and document control of contaminated or potentially contaminated products with CAPA Manager
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Clause 7: Product realization
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- Plan processes for product realization, document product requirements, and retain records of the results of the review and actions taken with Document Manager
- Identify, review, verify and validate any changes to the product with Change Manager
- Document procedures to ensure product conforms to specified purchasing information with Policy Manager
- Establish and implement inspection activities with Audit Manager
- Plan, carry out, monitor and control medical device production and service provision with Supplier Manager
- Ensure valid results with measuring equipment is identified. Manage calibration activities with Equipment Manager
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Clause 8: Measurement, analysis and improvement
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- Plan and implement the quality management system with all modules
- Gather and monitor information relating to whether the organisation has met customer requirements with GRC Dashboard
- Monitor and measure medical device characteristics at applicable stages of the product realization process with Change Manager
- Document procedures to determine, collect and analyse appropriate data with GRC Dashboard and Document Manager
- Take action to eliminate the causes of nonconformities with CAPA Manager
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