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What To Expect At An MDQMS - ISO 13485 Foundation 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.

  • Scope
  • Normative references
  • Terms and definitions
  • Quality management system
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis and improvement

The general documentation requirements of ISO 13485 include:
  • Quality manual with scope of the QMS
  • Required procedures
  • Required forms and records
  • Control of documents
  • Control of forms

Gap analysis is the process of evaluating the company's existing quality management system to the requirements of ISO 9001. It aids in figuring out what adjustments and enhancements are required to put the company's quality management system into conformity with ISO 13485.

Process Mapping in ISO 9001 involves documenting and understanding all the key processes within the organization. It is used to document, analyze, and improve these processes to ensure compliance with ISO 13485 requirements. Additionally, it helps to identify areas for improvement, streamline operations, and enhance customer satisfaction.

The product realization clause maps out requirements for the end-to-end medical device product realization process. It including production and manufacture, capturing and actioning feedback, design and development, purchasing, and production and service provision.

ISO 13485 standard is applicable to manufacturers of medical devices, suppliers of medical device components, manufacturers of reagents or substances for use in IVD or MD, and medical device traders.

  • Quality management system
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis, and improvement

Documentation required for the ISO 13485 certification are the quality manual, procedures, work instructions, records, and policies relevant to the organization's Quality Management System (QMS).

Verification in ISO 13485 is the process of assessing and confirming that a system, product, or component satisfies established requirements. Validation, on the other hand, emphasizes making sure the system or product satisfies the needs and intended purpose of the usage.

Ensuring that every employee has knowledge of their responsibilities and functions within the QMS is essential. Conducting comprehensive training sessions helps to familiarize the team with the requirements of ISO 13485, as well as any updated procedures and processes.

The implementation of ISO 13485 helps to find and get rid of inefficiency and waste in business processes. It also motivates businesses to create and maintain effective procedures. This assists businesses in lowering operational expenses linked to ineffective procedures.

The two stages of the ISO 13485 certification audit are
  • Documentation review
  • On-site audit

Organizations should regularly review their processes, assess their compliance with legal and regulatory requirements, and make necessary adjustments. This ensures that the organization remains up-to-date with evolving regulations and maintains a high level of quality.

User and consumer feedback about specific medical equipment is taken into consideration in evidence-based decision-making. This improves the caliber of that equipment as well as future products of a similar nature.

  • Scope and objectives of the audit
  • Documents of audit criteria and their references
  • Duration, venue, and date of the audit
  • The method to be applied to the audit, including sampling
  • Responsibilities of observers, guides, and team members of the audit
  • Appropriate resource allocation
  • Communications and logistics arrangements

The last step in ISO 13485 audit preparation is providing the auditee with the relevant audit details. ISO 13485 certified professionals are accountable for communicating the audit's date, location, and time.

The documentation that is required by ISO 13485 might help a company build a comprehensive knowledge base. They may use this to identify problems and make improvements to their operations and products. Additionally, documentation enables them to ensure that team members always have access to updated information.

Measurement, Analysis, and Improvement Clause gives requirements on monitoring and improving processes such as customer satisfaction, internal audits, control of non-conforming product and corrective and preventive action.

Organizations must set up procedures for managing changes to their quality management system, which includes documents, procedures, and medical devices. This ensures that changes are appropriately examined, approved, and applied.

ISO 13485 emphasizes the need for corrective and preventive actions to address nonconformities and prevent their recurrence. This entails looking into the underlying causes of issues, implementing remedial measures, and being proactive in preventing problems of a similar nature from occurring in the future.