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Customized ISO 13485 Consulting

Expert Support for ISO 13485

ISO 13485:2016 is an internationally recognized standard for Quality Management for the Medical Device Industry designed to help manufacturers comply with regulatory systems and understand what they need to do to place compliant devices on markets throughout the world.

Kelmac Group specialize in Quality Management Systems [including ISO 13485:2016 Certification] for the Medical Devices Industry.

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

  • Case Study: Nestlé USA Achieves Multiple ISO Certifications & More

    Kelmac Group helped Nestlé USA achieve ISO 22000, ISO 14001 and OHSAS 18001 Certification, but also much more.

  • Case Study: LuLu achieve ISO 9001:2015 Certification & Positive Business Change

    LuLu International Exchange achieved ISO 9001:2015 Certification & a positive business change as the organization transitioned from a business funded organization to a sustainable and profitable organization.   

  • Case Study: Zevas Communications achieve ISO 27001 Certification

    The most significant benefit was the adoption of a consistent and best practice approach via their information security controls and practices within a relatively young organization.

  • Case Study: Nestlé USA achieves multiple ISO Certifications

    Learn about how ISO can improve a firm’s competitiveness, operational controls and operational efficiency through process excellence.

  • Case Study: LuLu International Exchange achieves ISO 9001:2015 Certification

    Learn about how LuLu achieved ISO 9001:2015 Certification & a positive business change.

  • Case Study: Zevas Communications achieves ISO 27001 Certification

    Learn how Zevas achieved ISO 27001 Certification with zero nonconformities.

  • Case Study: Nestlé USA achieves multiple ISO Certifications

    Learn about how ISO can improve a firm’s competitiveness, operational controls and operational efficiency through process excellence.

  • Case Study: LuLu International Exchange achieves ISO 9001:2015 Certification

    Learn about how LuLu achieved ISO 9001:2015 Certification & a positive business change.

  • Case Study: Zevas Communications achieves ISO 27001 Certification

    Learn how Zevas achieved ISO 27001 Certification with zero nonconformities.

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