In some companies there are employees who embrace a true quality mindset that was not supported by executive management. It should be the Executive management sets the tone with respect to your company’s vision and importance of quality. For a QMS to be effective, executive management within a medical device company has to believe in its importance. That is why Deming and Juran emphasized this. “Management’s job is to know which systems are stable and which are not.” – Deming. “It is most important that top management be quality-minded. In the absence of sincere manifestation of interest at the top, little will happen below.” – Juran . The practice of quality should begin with the executive management. It should start at the head, and cascade to the root level. It cannot work reversely.


The quality policy is the keystone to ensuring effectiveness of your QMS. Many companies create a quality policy with fluffy words. A quality policy statement always is overused, but not observed.


QMS planning should incorporate identification of key quality objectives for the company. Quality objectives are like goals; these should be objective and measurable. And quality objectives should flow from your quality policy.


Management ensure that roles and responsibilities of the QMS are well defined. It should provide the necessary authority to applicable personnel regarding QMS initiatives. Executive management needs to appoint a management representative. The management representative must have the authority to oversee and manage your company’s QMS efforts.


It is expected and required that a medical device company establish processes for conducting planned management reviews. In my experience, most companies do this annually, and unfortunately, it often seems like a checkbox type of activity to say it was done. Management review is a continuation of this theme. It is to ensure QMS initiatives are on track and in alignment with the company’s quality policy.
In addition to reviewing the quality policy, quality objectives, and QMS planning, management review should also evaluate:

  •  Customer feedback and complaints
  •  Adverse events and regulatory reporting
  •  Internal, external, and supplier audits
  •  KPIs for processes, including any non-conformances
  •  KPIs for products
  •  Status of corrective actions
  •  Status of preventive actions
  •  Follow-ups from previous management reviews
  •  Issues that could impact the QMS, including updates to regulatory requirements
  •  Opportunities for improvement.

The ultimate objective of management review is to evaluate the adequacy and effectiveness of your QMS. Management reviews should be done at least once a year. Preparing for management review is very time-consuming as well.


All your resources are critical for effectively running your business. It includes people, infrastructure, processes, and overall work environment. With respect to the QMS, having the appropriate resources is just as important. Regardless of how you deploy and implement your QMS, having the right people with the relevant training and experience is essential to helping ensure QMS effectiveness. Resource management includes buildings, workspaces, process equipment, software etc. Your infrastructure must be appropriate for the types of activities and operations.


Product realization describes how your business designs, develops, manufactures, and delivers medical devices. It includes resources and processes required for defining customer needs, design and development, purchasing, production, and field support. From a high-level, product realization includes:

  •  Planning of Product Realization
  •  Customer-Related Processes
  •  Design and Development
  •  Purchasing
  •  Production and Service Provision
  •  Control of Monitoring and Measuring Equipment


Before you design and develop products, it is critical to identify the needs of your customers. Customer here stands for regulatory agencies, distributors, purchasing organizations, shipping & logistics resource, and the patient and end-user. If you do not know the requirements of your customer, your products may not be satisfying your customer.