ISO 13485 is an internationally recognised 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.
With over 20 years ISO consulting experience working with many organizations & industries, we have developed The Ananya Consultents 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.
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.
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.
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.
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.
This module focuses on the design and development of the organization document management system. The aim is to the document management system is effective.
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.
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.
This module involves coaching/mentoring during the initial certification audit process. The aim is to ensure the initial certification outcome is successful.
This module involves coaching/mentoring to sustain the gain and/or performance improvement. The aim is to ensure the organization's management system is effectively maintained and improved on further.
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.
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.
This is the average project duration in the experience of Ananya Consultents. 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.
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.
*each client project varies, the above are project averages to serve as a guideline only
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.
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.
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 Ananya Consultents 9-Step Roadmap.