Medical Devices & ISO 13485 Certification Consulting

What is ISO 13485:2016? What are Quality Management Systems for the Medical Device Industry?

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.

 

Two Types of Management Systems - Functional vs. Performance

There are predominantly two types of Quality Management Systems that can be implemented: Functional-based and Performance-based. There are significant differences between the two types. Functional systems are those that are designed & implemented purely to gain ISO 13485:2016 Certification (and are what we refer to as minimalist systems). Performance systems are those that are fully aligned with the business model of the organization geared towards enhancing the existing competitiveness of the organization.

Kelmac Group specialize in performance-based Quality Management Systems including ISO 13485:2016 Certification.

What is our ISO 13485 Consulting Process?

With over 20 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

How Long Does It Take?

One of the most common questions with this type of project that needs to be answered is ‘how long does it take’. There are various considerations but the main ones include: is there a hard client/contract deadline? Are there available resources to support the project internally? Plus, the exact scope of work required and any potential complexity are key considerations. Many organizations will want to aim for an efficient turnaround but it is common that the amount of work required can be underestimated. The below gives an example of average timelines from start to certification based on the size of the organization – these are guidelines only. Each project varies & in all cases, is based on the client needs.

  • 3 to 6 months

    The average for a small business would be between 6 – 9 months. In general, the shorter the timeline, the higher the intensity of the project. A key consideration is whether there are available resources who can commit to the agreed workload required for the preferred project duration.

    Small Business*

  • 9 Months

    This is the average project duration in the experience of Kelmac Group®. A 9 month project has moderate intensity but generally doesn’t overload a client, particularly where resources who will be involved on the project internally will already have other priorities and responsibilities.

    Medium Business*

  • 12 Months

    This is a conservative project duration for small to medium enterprises but one that is common on larger, more complex projects. Certain projects may even extend up to 18 months.

    Large Business*

*each client project varies, the above are project averages to serve as a guideline only


What Resources Do We Need?


Small Business

Each and every business is different and it depends on the availability of resources and whether or not they have the ‘bandwidth’ to meet the internal demands of the project. An average project would involve 2-3 internal resources sharing responsibilities as part of the project.

Medium Enterprise

There are similarities between what challenges resources face whether you are a small, medium or large enterprise. An average project would involve 3-5 internal resources sharing responsibilities as part of the project.

Large Enterprise

This would vary for each enterprise based on the scope of the project and its complexity – including the enterprise’s structure. As an average, we have seen specific steering committees formed including implementation teams of 20+ assigned. The size of the organization, number of locations and complexity would more accurately determine the level of resources involved and would be a key outcome from Step 1 in the Kelmac Group® 9-Step Roadmap.

How can Kelmac Group & ISO 13485 Certification help your business succeed?

  • THE ONE SYSTEM MODEL APPROACH

    The unique Kelmac Group® One System Model enhances organizational compliance, effectiveness and efficiency based on including all the business processes to enhance a client’s ISO 13485 Certification and not just the processes outlined by ISO 13485.

    What most consultants may offer you is a minimalist Management System, which is one that will meet the minimum requirements to achieve certification. However, if you are looking for a management system that is enterprise-wide and fully integrated with your business, Kelmac Group would be the right partner for your organization.

  • IMPORTANCE OF BUSINESS PROCESSES

    We build or re-model the enterprise business processes and align the design of the stand-alone or integrated Quality Management System [Medical Devices] with the strategic direction and goals of the enterprise.

    What Business Process Management (BPM) offers a business?

    A Business Process Management System (BPMS) is a model and philosophy that facilitates the enterprise realize its full potential, aligning the delivery of enterprise-wide goals, processes, technologies and people, with the sole aim of making lasting improvements to their performance and realize their important goals

  • Fortune 500 Food and Beverage Company

    We worked in partnership with the Food and Beverage company [FBO] team and employed a number of initiatives to improve the firm’s competitiveness, operational controls and operational efficiency.

  • LuLu International Exchange

    Kelmac Group helped LuLu International Exchange achieve a positive business change as the organization transitioned from a business funded organization to a sustainable and profitable organization. The project also included the successful achievement of ISO 9001:2015 Certification.       

  • Zevas Communications

    Kelmac Group assisted Zevas with the adoption of a consistent and best practice approach via their information security controls and practices within a relatively young organization. This will help Zevas Communications provide a competitive, innovative and cost effective level of customer contact and communication service to their clients.

  • Fortune 500 Food and Beverage Company Case Study

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

  • LuLu International Exchange Case Study

    Learn about how this organization transitioned from a business funded organization to a sustainable and profitable organization including the successful achievement of ISO 9001:2015 Certification.

  • Zevas Communications Case Study

    Learn about how ISO 27001 Certification will help Zevas Communications provide a competitive, innovative and cost effective level of customer contact and communication service to their clients.

  • Fortune 500 Food and Beverage Company Case Study

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

  • LuLu International Exchange Case Study

    Learn about how this organization transitioned from a business funded organization to a sustainable and profitable organization including the successful achievement of ISO 9001:2015 Certification.

  • Zevas Communications Case Study

    Learn about how ISO 27001 Certification will help Zevas Communications provide a competitive, innovative and cost effective level of customer contact and communication service to their clients.

Request a Call Back

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call us on 1.312.496.6607

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