Overview
ISO 13485 Quality Management System for Medical Devices
ISO 13485 is the most accepted standard worldwide for manufacturers of medical. The standard is based on ISO 9001, but includes additional requirements specific to this business sector. In addition, important terms have been defined including: medical device, active medical device, active implanted medical device, sterile medical device, and many more.
ISO 13485 is the most accepted standard worldwide for manufacturers of medical. The standard is based on ISO 9001, but includes additional requirements specific to this business sector. In addition, important terms have been defined including: medical device, active medical device, active implanted medical device, sterile medical device, and many more.
BENEFITS
Eligibility for submitting tenders or proposals for projects.
Evidence of adherence to legal and regulatory or contractual requirements
Generates new business opportunities
Can boost your organisation’s brand reputation and be a useful promotional tool, especially when going up against competitors who aren’t certified
Guarantees high quality of provided services and products
Reduces production loss rate
Reduces operational costs
Increases effectiveness across the whole organisation
Increases your customers‘ trust in you as a safe supplier or producer
Minimize corporate risk