Free ISO 13485 Consultant Finder
We offer a FREE ISO 13485 consultant finder service to help save you time. We are connected to a network of ISO 13485 consultants across North America, and our team does all the legwork for you to find the best fit for your organization. Just fill in the form below, and we will do the rest! We will contact you within 72 hours with a quote and options. If you need a remote or virtual service, just make note in the comments section of the form.
We can help with these services & more:
Remote and Virtual Options are available.
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Purchase: Copy of the ISO 13485:2016 Standard
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GAP Assessment
GAP Assessments will focus on where your company is on its current path to meeting requirements for conformity and identify gaps by working with your key people and process owners. Once the Gap is completed, you will have a complete prioritized analysis of your management system. This analysis provides the input into a Project Plan with a road-map, driving directions, assignments and due dates to meet the requirements for conformity to the ISO standard.
Internal Audits
The ISO 13485 standard requires an organization to perform internal audits. Many organizations choose to train their own auditor(s), but not every organization is large enough (auditors need to be outside the department they are auditing), or may not have enough time or personnel. We can help you find a consultant to perform your internal audits and keep you in conformance with the ISO 13485 standard.
Implementation Projects
Implementation Projects will focus on your organization’s unique needs and targets. Each implementation is customized, but a standard implementation is recommended to include:
- GAP Assessment (to target and prioritize activities and tasks in each phase of the Project Plan) – which focuses on where your company is on its current path and what gaps you have in your Business Management System that will need to be addressed and identified in your completed Project Plan)
- Project Plan Assistance- working with your team, our consultants will help to complete tasks identified in the GAP Assessment
- Internal Audits can be outsourced and completed by our team based on your resources and Organizations’ preferences
Suggested training phases identified within the Project Plan (these training event suggestions can be combined or customized as needed):
- Executive Overview for understanding of the standard and their roles and responsibilities
- Implementation Team Training for the process owners to understand the standard and implement the project plan (depending on the organization size- this may be accomplished with project support from one of our consultants)
- Auditor Training for your team that was chosen to complete internal audits and/or supplier audits- recommended with a 1 or 2 Day Facilitated Internal Audit (this Facilitated Audit is where the trainer stays additional days to help solidify the skills the auditors have acquired in the auditor training class by completing a portion of an internal audit for your organization)
- Employee Overview training to help your team to understand the standard and the importance, value and group effort it takes to solidify your management system
Overview Training:
Our overview courses are designed to meet your goals and objectives to help your team understand the standard and customize the training to meet targets for the specific audience. Whether you need to train management on its responsibilities and involvement to ensure success and improve the bottom line or to train your team to understand the standard and the importance, value and group effort it takes to solidify your Management Systems’ success.
Internal Auditor Training:
This Instructor led course includes lectures and activities that will help develop skills and techniques needed to complete successful internal audits.
The Learning Objectives for an Internal Auditor course:
- Understand interpret and audit to the requirements
- Learn roles and responsibilities of an auditor, the risks and the benefits associated with being an internal auditor
- Apply ISO 19011 concepts guidelines and terminology
- Prepare effective internal audit reports
- Team activities to practice their new skills and understanding of the standard
Lead Auditor Training:
This Instructor led course includes lectures and activities that will help develop skills and techniques needed to complete successful internal/external audits.
The Learning Objectives for a Lead Auditor course:
- Understand interpret and audit to the requirements
- Learn roles and responsibilities of an auditor, the risks and the benefits associated with being an internal auditor
- Apply ISO 19011 concepts guidelines and terminology
- Prepare effective internal audit reports
- Plan, Manage and schedule an audit program
- Conducting opening and closing meetings
- Lead Audits and conduct External Audits