What is our ISO 13485 Consulting Process?
With over 14 years ISO consulting experience working with many organizations & industries, we have developed The Kelmac Group® 9-Step Roadmap to Going Beyond Certification and invite you to select the below icons to learn more about each step and learn about how we can add enormous business value to your processes and how you operate as a business.
Step 1 Foundation
This module focuses on the organization’s top leadership team and planning. The aim is to ensure the Top Leadership team can actively lead, participate and manage the management system from the outset.
Step 2 Process/Risk Management
This module focuses on the the organization’s business and management system processes and product/process risk assessments. The aim is to build and/or enhance the organization’s process and to identify the related product and process risks, risk mitigation and controls.
Step 3 Objective/Process Alignment
This module focuses on the design of the organization’s internal controls including alignment between goals and process controls. The aim is to ensure the business internal controls meets the needs of the organization.
Step 4 Human Resource System
This module focuses on the design of the organization’s structure, people, culture/behavior, and competency framework. The aim is to ensure the organization structure, culture, behaviors and HR system supports the organization management system.
Step 5 Compliance
This module focuses on compliance, i..e regulatory, e.g. 21 CFR Part 820, CMDCAS and other legal obligations
Step 6 Document Management System
This module focuses on the design and development of the organization document management system. The aim is to the document management system is effective.
Step 7 Implement The Management System
This module focuses on implementation of the organization management system. The aim is to ensure the management system is flawlessly implemented and expected benefits are fully realized.
Step 8 Check The Management System
This module focuses on verification of the organization management system. The aim is to ensure the organization’s verification system provides stakeholders with the assurance and insight to improve performance, if required.
Step 9 Certification Audit
This module involves coaching/mentoring during the initial certification audit process. The aim is to ensure the initial certification outcome is successful
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