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Introduction to ISO 13485:2016 Support

The capabilities of modern healthcare are remarkable and the general public is more informed about healthcare than in past decades. The healthcare industry is growing with new procedures, medications and treatments, introduced with amazing frequency. With this growth in the industry, more organizations are becoming involved in the manufacture or supply of medical devices. These organizations must provide the highest quality products due to their importance in providing top notch healthcare and the dire consequences that can result from a product failure or non-conformance. But how can organizations monitor their performance, identify possible risks of non-conformance and take action to prevent any costly incidents?  One effective tool is the ISO 13485:2016 Standard for Medical Device Quality Management Systems. Through effective planning, implementation and monitoring of a compliant Quality Management System, the organization can reduce the risk of product failures or non-compliance to any customer or regulatory requirements. In today’s highly competitive world marketplace, most organizations are looking for ways to reduce cost. Often that is accomplished by either reducing the available workforce or not back-filling open positions. Therefore, these organizations may simply not have adequate resources or experienced subject matter experts available to properly develop, implement and maintain an effective QMS.

At Quality-One, we have the ability to provide the resources and support your organization’s needs. Our team of highly skilled and experienced professionals can assess your current system and devise an effective plan for the development and implementation of your Quality Management System.  Our support services have a proven track record of accomplishment and are noted as providing value through reduced time for system development and implementation. At Quality-One, we recognize that each organization has unique challenges and requirements. For that reason, our subject matter experts utilize best practices from multiple industries to provide a custom solution for your organization.

About ISO 13485:2016 Auditing

At Quality-One, we provide professional 2nd Party Auditing services. A 2nd Party Audit is an audit performed at your facility by a qualified representative from an outside firm such as Quality-One. These audits are of significant value to organizations that may lack the proper resources and time to conduct their own internal QMS audits. Quality-One auditors will review your processes objectively and offer a fresh perspective. Quality-One will provide your organization with qualified 2nd party audit resources. Our audit services are useful in:

  • Ensuring fulfillment of  ISO 13485:2016 requirements for Internal audits
  • Pre-certification audits to identify possible non-conformances to aid in first time certification
  • Familiarizing your personnel responsible for system audits to a structured audit process

Benefits of ISO 13485:2016 Auditing

Management Systems 2nd Party Auditing services enable your organization to establish a robust auditing process while conserving valuable internal resources. In addition, 2nd party auditors provide a different perspective and an extra set of eyes that may bring issues to light that may have been overlooked by internal auditors who observe the same processes on a regular basis. The professional auditors at Quality-One can support your organization by:

  • Providing direct support for your auditing process with experienced, highly trained professionals
  • Reducing the time required by internal staff to complete required audits
  • Permitting internal personnel to complete their necessary regular duties
  • Coaching of  internal personnel responsible for conducting internal audits
  • Ensuring your QMS audit process meets the ISO requirements

About ISO 13485:2016 Facilitation

Qualified professional facilitators are experts at planning, developing and implementing ISO 13485:2016 compliant Quality Management Systems. Organizations that involve professional facilitators quite often realize a quantifiable reduction in the time required to achieve certification. Professional facilitation methods can enable your organization to build an efficient and robust QMS while avoiding many of the common pitfalls experienced during implementation of a new management system. Development and implementation of a Management System without facilitation often leads to waste in the forms of:

  • Unsuccessful non-conformance  identification
  • Inadequate risk analysis and mitigation
  • Lack of engagement of workers in the process
  • Objectives that are not well defined
  • Missed opportunities for improvement
  • Impact on business due to every day responsibilities not completed
  • Ineffective communication regarding the QMS requirements
  • Failure to achieve 3rd party certification within project timeline


Regrettably, organizations sometimes underestimate the extra time and costs incurred due to inadequate Quality Management System implementation, planning and execution. The costs quickly exceed the cost of involving a professional facilitator. They fail to see the value. It is crucial that you weigh the benefits of involving a professional facilitator to lead your team to success.

Benefits of ISO 13485:2016 Facilitation

The benefits of utilizing a professional facilitator result in more than a measurable reduction in the time, resources and cost required to design, develop and implement an ISO 13485:2016 Quality Management System.  Quality-One professional facilitation services enable your organization to avoid certain obstacles and risks to the project’s success, while gaining the advantages of a robust Quality Management System. Some of the many advantages include:


  • Improved non-conformance identification
  • Clear and achievable objectives for the QMS
  • QMS objectives aligned to the organization’s strategic goals
  • Proficient use of risk analysis tools and development of effective countermeasures
  • QMS management system structure based on the process approach
  • Increased knowledge and awareness of the QMS within all areas of the organization
  • Reduced number of non-conformance findings and required corrective actions
  • Frequent first time 3rd party audit certification

About ISO 13485:2016 Contract Services

When development and implementation of your ISO 13485:2016 compliant Quality Management System is a priority, and you find yourself short on resources and time, other daily responsibilities sometimes go unattended. In today’s very competitive marketplace, many companies are looking for ways to cut cost. Unfortunately, management often looks at reducing the headcount thereby forcing departments to accomplish more with less. This can delay your QMS implementation or cause vital steps to be overlooked.  That is only one example of when utilization of Management Systems Contract Services is an effective and practical solution.  Our experienced contracted professionals at Quality-One can step in and relieve the pressure of a time crunch and put your development and implementation plan back on track. Our seasoned professionals bring with them experience gained through work in many industries with multiple organizations. Successful implementation of your ISO 13485:2016 compliant Quality Management System can be achieved without the time and expense required to hire additional personnel. Quality-One contract personnel produce positive results through the application of best practices and knowledge gained from years of experience. Our contract services may be used in:

  • Facilitating the development and implementation of your Quality Management System
  • Development of required documentation to achieve your third party registration objective
  • Implementing computer-based systems and documentation tools relative to identifying non-conformances, risk analysis and mitigation.  Development of effective corrective actions, measuring management system performance, and promoting continual Improvement.
  • Professional training and mentoring of key personnel responsible for the support and maintenance of your Quality Management System.

Benefits of ISO 13485:2016 Contract Services

Organizations generally invest a sizeable amount of time and resources in the development and Implementation of an ISO 13485:2016 compliant Quality Management System.  In order to have a successful implementation, the organization must train or hire individuals who are experienced subject matter experts. If a project that is understaffed and under supported, or the team does not possess the required body of knowledge for success, it will result in a less than optimum outcome.  This is particularly true for ISO 13485:2016 development and implementation projects. In addition, these inadequately supported projects also often fail to meet deadlines or achieve third party certification.  Quality-One Quality Management System contract services can help your organization avoid such pitfalls and potential failure of your certification initiative.  Our experienced professionals at Quality-One can enable your organization by:

  • Reducing the amount of time required for development and implementation of your Quality Management System.
  • Providing experienced personnel with expert knowledge of Quality Management Systems
  • Taking on some of the project load, enabling your personnel to devote more of their time to vital daily responsibilities
  • Providing your employees with direct assistance with their non-conformance identification, risk analysis and corrective action skills development
  • Establishing a robust internal auditing system to gauge system performance
  • Performing 2nd party audits to measure and document the continual improvement of your Quality Management System.

Learn More About ISO 13485:2016 Support

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.

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