How long does it take to implement ISO 13485?

4-6 months
How long does it take to achieve ISO 13485 certification if we have no system in place? Implementation usually takes 4-6 months for companies with fewer than 50 employees.

How is ISO standard implemented?

How To Implement ISO 9001 (In 8 Steps)

1. Familiarize Yourself with ISO 9001.
2. Plan Everything out for Implementation.
3. Identify Responsibilities, Policies, and Objectives.
4. Develop Your Documentation.
5. Launch Your Quality Management System.
6. Review Your Performance.
7. Assess and Register for Certification.
8. Continual Improvement.

What are the regulatory requirements for ISO 13485?

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

How do I become an ISO 13485 consultant?

GET CERTIFIED IN 5 STEPS

1. CALL/EMAIL US AND SHARE YOUR REQUIREMENTS. We will do a FREE GAP analysis of your organization with respect to CE MARK Standard and give you a quote.
2. TRAINING AND DOCUMENTATION.
3. IMPLEMENTATION AND REVIEW.
4. FINAL AUDIT BY CERTIFICATION BODY.
5. RECEIVE CERTIFICATE.

Why do you need ISO 13485?

ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose.

How do you implement a quality system?

The steps required for the conceptualization and implementation of a QMS include the following:

1. Define and Map Your Processes.
2. Define Your Quality Policy.
3. Define Your Quality Objectives.
4. Develop Metrics to Track and Monitor CSF Data.
5. Define Defects for Every Process.
6. Develop Documents and Records.
7. Define Quality Process.

What is an ISO 13485 audit?

An ISO 13485 audit helps determine the actual status and health of your current QMS and processes. The purpose of quality audits is to ensure that manufacturing, development, and related control facilities meet current good manufacturing processes (GMP), as well as conform to the commitments of ISO 13485.