The American Society for Quality defines a Quality Management System as a formalized system that documents processes, procedures, and responsibilities for achieving quality policy and objectives. And according to ISO 9001, it is a set of policies, processes, and procedures required for planning and execution in the core business area of an organization. In this article, we review the concept of a Quality Management System as it concerns the Medical Technologies (MedTech) industry, examining 7 key elements of the system and how, working together, these elements can help bolster the quality and consistency of medical devices.
Who needs a Quality Management System?
A Quality Management System is important for any organization concerned about the reputation of its brand. Customers demand excellent product quality and in a market brimming with several alternatives and substitutes, have little hesitation in switching to other manufacturers. And while the loss of a single (or even several) customers may have little effect on a company, the reverberating effect of their dissatisfaction – increasingly likely to be expressed on social media – can be seriously damaging. Quality management assumes even greater importance in industries where poor quality products can have direct, fatal, and traceable consequences to the lives of users.
One of which is the Medical Technology industry (MedTech).
In a May 2019 blog post, the New York Times called for ‘a reckoning on medical devices’ after more than 80000 deaths and 2 million injuries were linked to faulty medical devices in the preceding decade. For the MedTech industry, a Quality Management
System is not just another box to tick, but a necessary tool to forestall faulty devices and reduce the potential for fatalities and costly litigations.
Overall, a QMS provides a structured and systematic approach to managing the quality (and consistency) of a product or service. It removes the idea of quality as an arbitrary concept and instead specifies actionable mechanisms that organizations can follow thus placing the responsibility of quality firmly in the hands of top management and stakeholders.
ISO 13485 – Quality Management System for MedTech
First published in 1996, ISO 13485 is a third-party certification standard that requires organizations to demonstrate that their Quality Management System is effective and that it meets customer and regulatory requirements. It is specially designed for organizations in the medical device and diagnostics industry. Its latest update, ISO 13485: 2016, places a great emphasis on risk management and takes into consideration technological developments during the intervening period from the ISO 13485: 2003 update.
7 elements of an effective QMS
- Quality policy and strategic objectives
- Documentation and document control
- Leadership, roles, and responsibilities
- Training and quality-focused programs
- Process control and non-conformance management
- Quality hardware
- Performance measurement
Quality policy and strategic objectives
Without a coherent quality policy, a Quality Management System is vague and hopelessly aimless. This is because a written policy is required to spell out the intention and direction of the organization, and demonstrate the management commitment to quality. The presence of a policy will clarify where the organization stands to stakeholders, regulators, and their customers. It will promote accountability from within and buttress perceptions without. Some features of a quality policy include
- It should be written out
- It should be flexible and easy to update
- It should be signed by the top management
- It should be clear, specific to the organization, and easily understandable by all categories of stakeholders
- It should be easily accessible
Closely aligned with policies are strategic objectives – simple, usually short-term improvement goals that can span every aspect of the organization. These objectives are typically SMART (specific, measurable, attainable, relevant, and timely). An example of a SMART quality goal is a MedTech company proposing to enroll 30 of their workers in verification and validation software training within a 1-month period with all 30 scoring at least 90% in a post-program internal assessment.
Documentation and document control
A Quality Management System should have provisions for documentation and predetermined ways to manage all documents created, for example delegating a point person/ group for updates, disposal, and overall management.
Preeminent among the documents that are required in a QMS is the quality manual, a ‘handbook’ that covers the scope of the management system and expounds on the quality policy and objectives. The manual documents all the processes and enumerates the standards, standard operating procedures, and safe working procedures adhered to. It may also contain additional information like the maintenance regimes for instruments (according to manufacturer’s guidelines) and instructions for instrument calibration.
Leadership, roles, and responsibilities
The success of a QMS depends on the commitment of the leadership to quality. Leadership, in this case, comprises the top management and key internal stakeholders whose roles are enshrined in the Quality Management System. These stakeholders include managers, internal ‘customers’, and risk managers – all have job descriptions tailored towards maintaining the quality policy and achieving the step-by-step goals.
The top management, on their part, will communicate the roles and through effective change management, seamlessly bed-in stakeholders to these roles. They will also allocate the human resources, technology, and infrastructure necessary for stakeholders to fulfill their roles.
Training and quality-focused programs
Without training, workers may lack the knowledge or skills necessary to implement the core tenets of a Quality Management System. This is the case in MedTech where there exists a plethora of stringent regulations that are regularly updated, and for which there are serious consequences for non-compliance. Here, workers have to be abreast with the frequent changes and the best way to achieve this is through periodic training programs. Relevant training programs in the MedTech industry include:
- Raw materials risk management
- Device surveillance
- Toxic material handling training
- FDA medical device regulations etc.
Process control and non-conformance management
No Quality Management System is complete without process control and quality control. The former is a part of quality management focused on fulfilling quality requirements within the production sequence. Essentially, process control involves the monitoring of production to ensure consistency with established variables.
In the MedTech industry, there are several methods of performing quality control, including the statistical process control method where process inputs are analyzed to observe and correct variations with regulatory requirements. This allows organizations to detect product defects earlier and significantly reduce their cost of production.
The machines and equipment that are used to validate processes should be of the utmost quality. Anything less and they may render incorrect results that distorts the measured data and negatively affects decision-making. The equipment should also be calibrated according to industry standards and regularly maintained.
The final step of the Quality Management System is performance measurement – necessary to correct lapses and further continuous improvement. Through audits, KPIs, customer feedback, and reviews, an organization can quantitatively assess the effectiveness of its Quality Management System. Based on the results of this assessment, necessary adjustments can be made to continue the iterative growth process.
Qualitative measurement techniques could also be used and may involve asking questions like:
- Were complaints disproportionately high compared to previous periods?
- Were complaints adequately resolved?
- Did customers demonstrate an overall positive attitude towards the products?
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