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
See What The Kelmac Group® Can Do For You Get in touch with us today!
Would you like us to call you back to discuss it?
Virtual Instructor-Led Training for all ISO Courses Beginning 4/1
We are pleased to announce today, Wednesday 01st April 2020, CQI-IRCA approved the Kelmac Group® to start delivery of Virtual Instructor-Led Training [VILT] classes. The Kelmac Group® will immediately commence offering VILT classes for all ISO courses. We will shortly publish our VILT training schedule on our websites, plus we will also publish additional general information … Continue reading Virtual Instructor-Led Training for all ISO Courses Beginning 4/1Read More
Some Ways Your Business Can Benefit From ISO 9001:2015 Certification
The International Organization for Standardization (ISO) is the world’s largest developer of voluntary International Standards. ISO 9001 standards address various aspects of quality management. These standards provide guidance and tools for companies and organizations who want to ensure their products and services consistently meet their customers’ requirements. Why organizations pursue ISO 9001:2015 CertificationISO 9001:2015 is … Continue reading Some Ways Your Business Can Benefit From ISO 9001:2015 CertificationRead More
Evaluation of Process Performance in ISO 9001:2015
Every organization is made up of core, support and management processes which work together to ensure that the organization meets its business goals and objectives. If any process is not working effectively and efficiently, there can be a knock-on effect resulting in a negative impact on business performance.Consider an organization that has the following processes: … Continue reading Evaluation of Process Performance in ISO 9001:2015Read More