Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 certification in Italy requirements and structure.
The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.
Clause 4 – Quality Management System (“Intersection”)
Clause 5 – Management Responsibility (“Highway”)
Clause 6 – Resource Management (“Roadway”)
Clause 7 – Product Realization (“Overpass”)
Clause 8 – Measurement, Analysis and Improvement (“Bridge”)
What do you achieve by calibrating measuring and monitoring equipment?
- Restoring the accuracy of the instrument
- Adjusting or repairing an instrument which is out of calibration
- Minimizing uncertainty or error
- Ensuring the reliability and consistency of the instrument
- Keeping measurements within specification limits
- Building trust, confidence and reliability in measurements
- Establishing traceability of the measurement to a National / International Standard, which is a mandatory requirement for most standards.
To summarize, calibration quantifies and controls errors and uncertainties within measurement processes and brings them to an acceptable level.
Compliance to ISO 13485 requirements
A well-designed calibration program as described above helps you maintain the accuracy of your instruments. It also helps you achieve compliance with the calibration requirements set out in ISO 13485:2016; Clause 7.6 (Control of monitoring and measuring equipment).
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