Successful establishment of an ISO 13485:2016 compliant QMS is dependent upon many factors. To be successful, requires a commitment by organizational leadership to provide adequate resources to develop, implement, monitor, maintain, and evaluate the system. Organizations must come to the realization that their most valuable resources are their team members. To best utilize this resource training is required. Proper training by experienced professionals is vital to the success of your QMS. Professional baseball teams have spring training. Do you think they would allow a brand new player to hit the field with no training and no coaching? They have invested time, effort and money to recruit some of the best players in the league. It would be wasted if the player never received coaching or training and was never given any direction. It is the same for the players on your team. Your organization invested much effort and many hours, not to mention the financial costs involved in locating and recruiting top notch talent. Therefore, why would you undertake the sizable task of pursuing ISO 13485:2016 certification? Your team members or associates and organizational leadership need proper training for your QMS to be a success. Successful implementation of an ISO 13485:2016 compliant Quality Management System will allow your organization to identify risk relating to possible non-conformances, reduce or prevent costly incidents. Just one non-conformance could result in expenses much greater than the cost of professional training. Our highly skilled professionals at Quality-One are ready to provide your teams with a training package designed to fit your organizational requirements. At Quality-One we offer three different training options:
- Onsite Training at your facility
- Offsite Training at one of our many conveniently located training centers
- Online Training
For additional information, contact one of the professionals at Quality-One and we can help you select the option that best fits your needs. Discover the Value.
The body of information covered within the ISO 13485: 2016 Training Course consists of the following main sections:
- Executive Overview
- Implementing ISO 13485:2016
- Documentation Requirements
- Internal Auditing
- Continual Improvement
Implementing ISO 13485:2016
This course includes an overview of the ISO 13485:2016 requirements and the application of the requirements with the objective of developing an effective Quality Management system and achieving certification. The ISO standard requires involvement in the QMS throughout all levels and divisions of the organization. The standard requires organizations to establish and maintain a proactive approach towards product quality.
The Role of Management
Top management must commit to providing adequate resources for implementation, maintenance, evaluation, and continual improvement of the QMS. The training course includes planning and allocation of resources, gaining commitment from all parties, and communicating throughout the organization the importance of the QMS along with the ISO standard and adherence to its requirements.
The ISO 13485:2016 standard requires that the QMS and all information required by the standard be documented and controlled. This includes the QMS policy and any supporting documents. The ISO 13485:2016training includes information regarding:
- Documentation of the Management System
- Establishing and communication a QMS Policy
- Document Control Requirements
- Medical device files
- Records Retention Requirements
Quality Policy and the Quality Manual
The ISO 13485:2016 standard requires the establishment of a Quality Policy and a Quality Manual. The Quality policy is a statement consisting of the company stance regarding product quality along with their basic goals or objectives and the plan to realize them. The objectives are the more definitive goals related to the QMS and quality plans. The quality manual shall contain the Quality Policy along with references to the supporting documents of the QMS.
This course provides methods to document and implement the Quality Management System in accordance with the ISO 13485:2016 standard. This section of the course is intended for participants that are new to internal auditing, or currently performing internal audits. This section of the training is vital for the audit process owners and personnel responsible for managing the QMS audit process. The training materials include information on:
- Internal Auditing methodology
- Proper audit documentation
- Developing a standard review interval
- Audit Records Retention
The standard requires that organizations identify opportunities to continually improve their quality systems, and achievement of the established goals and objectives. The training materials will include information describing and explaining the continual improvement process, its advantages, and how to incorporate it throughout the organization. The standard requires organizations to establish processes for reporting and investigating product nonconformities, and developing effective corrective actions. Organizations should ensure that the Root Cause Analysis (RCA) of any nonconformity is identified and addressed. If the root cause is not determined, the issues may re-occur within the same process or elsewhere in the organization. Multiple tools are discussed along with their practical application. Some of the tools covered in the training include:
- Is/Is Not analysis
- The Ishikawa or Fishbone diagram
- 5 Why & 5 How
- Failure Modes and Effects Analysis (FMEA)
The training will also determine appropriate Corrective Action Preventative Actions (CAPA) and developing a plan for implementation of the corrective actions, the importance of ownership, and properly documenting the results.
At Quality-One, our objective is to deliver effective, professional training designed around your organization’s products and / or processes. Our ISO 13485:2016 Training is dynamic and interactive, incorporating team activities and relevant exercises in a workshop format. The 13485:2016 training materials provide a clear understanding of the basic requirements of the standard. In addition, our training contains information that should enable your organization to establish the processes and documentation to build an effective Quality Management System. At Quality-One, we offer three different training options:
- Onsite Training at your facility
- Offsite Training at one of our technical training centers
- Online Overview Training
During an onsite training event, a Quality-One subject matter expert will bring the knowledge to your location; this may provide immediate benefits for your team and your ISO 13485:2016 implementation plan. The onsite training is conducted in a dynamic instructor-led format. By delivering the training at your location, participants are given the perfect opportunity to ask questions and discuss examples relating to your particular product and processes. The Quality-One reference materials and examples also provide an invaluable resource for review long after the training workshop is completed. Upon successful completion of the Quality-One training course, each participant will receive a “Certificate of Completion.” On-site training is convenient for scheduling and is generally more beneficial for organizations seeking training for several individuals or groups.
Quality – One has Technical Training Centers in several convenient locations available for offsite training in a workshop format. The Off-Site option allows the participants to learn in an environment free from every day distractions and interruptions. The relatively distraction free environment frequently results in the sharing of different experiences by participants from diverse backgrounds and various industries. This professional interaction tends to maintain interest and promote a higher level of knowledge transfer. Upon successful completion of a Quality-One training course, each participant will receive a “Certificate of Completion.” The Off-Site training option is generally more cost effective for organizations with five or less associates that require training.
The Quality-One online training materials cover the basic requirements of the ISO 13485:2016 standard. The online training is perfect for those individuals requiring a basic introduction to the standard. On-line participants will have 30 days to complete the course and may access it as often as desired. The training materials are available 24 hours a day 7 days a week. The online training includes audio, video, illustrations, and reference materials relating to the new ISO standard. Upon completion of the training the participant should be able to identify potential or existing product non-conformances, understand root cause analysis methods and develop effective countermeasure. The On-Line option allows the participants to advance through the training material at their own pace as time permits.
Quality-One offers Medical Device QMS Development through Consulting, Training and Project Support. Quality-One provides Knowledge, Guidance and Direction in QMS development activities, tailored to your unique wants, needs and desires. Let us help you Discover the Value of ISO 13485 Consulting, ISO 13485 Training or ISO 13485 Project Support.