What To Expect At An MDQMS Interview?

Medical device-making organizations dare not leave any room for manufacturing defective products or they will be blacklisted. Users of medical equipment and their consumers have to pay a large price for purchasing a faulty device. Such businesses cannot do away without effective quality management systems. ISO 13485 Foundation Certification imparts extensive knowledge to interpret and explain the ISO guidelines to organizations. Certified individuals help medical equipment companies realize the benefits of conforming to this benchmark. It provides them with better service and faster production without compromising consumer expectations.

Production efficiency and the maintenance of quality standards depend on every staff in an enterprise. To maintain consistency in these operations, an organization requires a quality management system with the best regulatory compliance. Relevant knowledge is needed for establishing such systems. Medical device manufacturers demand professionals well-versed in ISO 13485 principles to assist the former in planning an effective QMS. They ask questions in a manner such that the type of responses received helps them in cherry-picking candidates. One needs to be very insightful for answering effortlessly when a recruiter interviews.

The latest version of ISO 13485 became effective from March 2016 onwards. It was done to improve the practices of manufacturing, servicing, installing, and designing medical equipment. The 2016 edition more strongly focuses on catering to consumer expectations and its associated regulations.

ISO 13485 is a globally accepted benchmark with principles firmly based on the expertise and knowledge of medical equipment making. Therefore, manufacturers or sellers possessing a certification of this quality management standard attract customers more quickly than non-certified ones.

First, the processes need to be determined that would be executed by the QMS. This responsibility lies with hired employees who have pursue ISO 13485 Foundation Certification. Secondly, they decide on the roles and resources that would be needed for quality management. Then comes the task of establishing the interaction and sequence of the determined processes.

The quality management system in a medical equipment enterprise is expected to provide proof of its devotion. This means that it must be dedicated to its function of meeting the ISO 13485 Standard principles through necessary practices.

An organization must first make its staff aware of the significance of regulatory compliance. It must establish a policy for producing high-value quality instruments. The organization must ensure that its MDQMS has proper resources available to meet its quality-related goals.

ISO 13485 documentation states that an organization must be committed to the provision of necessary resources to its QMS. It cannot function properly in alignment with the ISO and other regulations in the absence of the right resources.

As per ISO 13485 regulatory body, resource management comprises five sections. They are:
  • Contamination control
  • Human resources
  • Workplace environment
  • Resource provision
  • Infrastructure

Section 7.1 of ISO 13485 ensures that an organization prioritizes product planning before moving on to its development. It states the establishment of a product’s quality requirements and defines its manufacturing processes accordingly. The MDQMS is required to get the supporting documentation ready required for process execution.

The MDQMS of a medical instrument manufacturer has to determine procedures for the following stages:
  • Measurement
  • Traceability
  • Distribution
  • Inspection
  • Handling
  • Storage
  • Validation
  • Verification

ISO 13485 conveys in its scope the outcomes expected of the QMS of organizations devising medical equipment. It states the desired approach towards executing the required processes alongside improving them.

Professionals having undergone ISO 13485 Foundation Training interpret the different terms present in ISO regulations. These fall into different categories like labeling, implantable/ sterile medical device, consumer complaint, advisory notice, etc.

SOPs, records, forms, documentation of control procedures, and a quality manual clearly stating the scope. A MDQMS has to furnish each of these items to acquire ISO 13485 documentation and become certified.

ISO 13485 calls for the top management to ensure consumer safety by maintaining transparency with the rest of the organization. This is done by establishing a quality policy that would clearly mentions the objectives of the company including its MDQMS. The highest level of authority in the enterprise must also review the management frequently.

Product realization pertaining to medical equipment production includes the following steps:
  • Traceability
  • Design
  • Planning
  • Purchasing
  • Manufacture
  • Feedback capturing and taking necessary actions

Some of the monitoring and measurement procedures in a medical equipment manufacturing MDQMS are:
  • Non-conformance control
  • Auditing
  • Maximize product safety
  • CAPAs

Focussing on upstream quality refers to emphasizing the planning stage of the concerned medical device. This goes a long way in preventing the emergence of quality issues during the upcoming phases of production of medical devices.

Unlike the paper-based system, an electronic MDQMS is equipped with the structure of ISO 13485. It is the best option for ensuring regulatory compliance, operational efficiency, and quality control of medical equipment manufacturing.

An ISO-certified MDQMS must document the activities related to product conformity, packaging, labeling, maintenance, and returns. Environment management, maintenance activity, shelf life, and quality data must also be documented. Other essential documentations are concerned with network activity, quality policy, product specifications, and non-conforming product release.

ISO 13485 makes it mandatory that the MDQMS must follow the rules regarding medical equipment installation and verification. Organizations must abide by these rules to obtain and keep their ISO certification intact.

ISO 13485 emphasizes MDQMS while ISO 9001 emphasizes on Quality Management System in general. Each of these standards emphasizes risk analysis and mitigation. PDCA and Deming Cycles are used by both of them. The use of consumer feedback to analyze product quality is common between them. Both are concerned with the infrastructure and competency needed to achieve the best quality. These standards ensure that QMS meets a product’s quality in general and that of medical device expectations before its release and delivery.