How to implement a risk-based approach to quality management with ISO 13485

Published: Sun, 03/05/23

Getting your ISO 13485 certification can be a real game changer for maintaining and repairing quality.

Your maintenance of equipment will be held to the highest standards, ensuring that only top quality service and products are delivered.

You'll need to make sure that all requirements, procedures, activities and special arrangements are properly documented if you want to stay in compliance with ISO 13485.

This documentation and adherence to the standard will help ensure that your quality management system is effective and reliable.

Moreover, it will give customers peace of mind knowing that you meet the highest standards and that you're striving to maintain quality from start to finish.

Although ISO 13485 and ISO 9001 share many of the same criteria, ISO 13485 takes the additional step of addressing medical devices specifically, helping to ensure customer safety within this industry.

With ISO 13485, you'll have the assurance that comes with being certified and the support needed to ensure your products remain top quality!

Unlock maximum performance: Unleash the power of ISO 13485 KPIs and watch your business reach its full potential:

1) Percentage of ISO 13485 process compliant orders

2) Percentage of Regulatory Certification attainment

3) Quality Control checks completed

4) Corrective and preventive actions validated

5) Annual Training Maturity of ISO 13985 Lead Auditors

6) On-time completion of Safety Assessments

7) Audit defects identified

8) Response time to customer complaints

9) Number of deviations from the standard procedure

10) Number of successful process validations

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