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How To Respond Excellently At ISO 13485 Lead Auditor Interview Questions?

Internal audits of an MDQMS at regular intervals keep a medical device-producing company free of worries. It often happens that with time even the most effective quality management processes retain the same vigor. This causes loopholes in the manufacturing operations that ultimately affect the end product’s quality. So, keeping track of every action through documentation and checking them with the actual performance at a given time, is necessary. This is where the role of an ISO 13485 Lead Auditor Certification comes to play. Medical device producers hire individuals possessing this certification. They demand performance-recording documents from MDQMS to analyze and detect flaws. For this purpose, they schedule individual sessions and inform the participants. Certified professionals are empowered to conduct audits because they have in-depth knowledge of ISO principles. The same knowledge must be exhibited while answering the questions of an interviewer. Here is an idea of the type of questions one might face while getting shortlisted for a lead implementer position. Practicing beforehand is essential for interviewees to avoid a lack of confidence and showcase their expertise brilliantly.

An audit schedule is essential for conducting audits at regular intervals. This requires an ISO 13485 Lead Auditor to prepare a master schedule, especially for planning the organization’s internal audits during a year.

To maintain audit efficiency and cover every area, 2 to 4 areas are included that differ from month to month. This ensures that all the organizational aspects especially those related to MDQMS undergo proper inspection for smooth sailing.

Yes. A ISO 13485 Lead Auditor takes the charge of an entire audit program and all its phases. He/she is responsible for selecting the audit team. The scope, duration of the audit, and the competencies required for it are the factors considered when choosing the members of an audit team.

To determine an audit program’s feasibility, it is essential to verify the following:
  • If any of the team members are engaged in completing a task deadline or on a vacation
  • Budget sufficiency and time suitability for conducting an audit
  • Availability of the required information
  • If the auditees will cooperate adequately

An ideal ISO 13485 audit plan must comprise the following:
  • 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

Yes, an ISO 13485 Lead Auditor is his/her team concerning the management and auditees. This individual is responsible for determining the team members’ qualifications and assigning them tasks accordingly.

One of the prime responsibilities of an ISO 13485 Lead Auditor is making the most of available resources. This makes resource management an integral part of an audit program for effective screening of the concerned areas.

ISO 13485 Lead Auditor Certification proves fruitful for an individual to acquire the knowledge needed for training others, as well. It helps a lead auditor to guide his/her teammates in the right direction for making every audit a success.

Listed below are the other prominent responsibilities of an ISO 13485 Lead Auditor:
  • Organization of audit members
  • Guidance to the team in concluding decisions
  • Prevent conflicts between members and resolve them
  • Completion of the audit report

An ISO 13485 Lead Auditor must devote 2 hours to preparing a detailed plan before starting the audit. There is a high chance of missing out on any of the most important areas that need to be included. Thus, that particular session renders useless without delivering the desired results.

A lead auditor must have easy access to the following documents:
  • Previous audit findings
  • Non-conformity reports
  • Reports on corrective actions
  • Audit evidence
  • Meeting attendance forms
  • Plans of audit sampling
  • Checklists

ISO 13485 audit preparation’s final stage includes updating an auditee with the respective audit’s details. It is the responsibility of a lead auditor to provide information on the date, venue, and time of the audit.

The primary objective of an ISO 13485 audit is to determine the following:
  • The level of MDQMS effectiveness
  • Documentation of MDQMS as per the audit criteria
  • Effective implementation and proper maintenance of MDQMS

An ISO 13485:2016 audit varies from the manufacturing of one medical device to another. The MDQMS scope and staff facilities also impact an audit session’s length. It typically depends on how many components the audit would be covering.

A polite approach to auditees works like magic in fetching from them the information needed. One mustn’t criticize the efforts of auditees. It is wise to avoid any sarcasm during conversations with them. A lead auditor needs to balance secrecy with revealing his/her opinions. Being punctual and remaining unbiased about organizational personalities or politics are also necessary.

ISO 13485 Lead Auditor Certification teaches individuals to overcome the weariness of an audit session. Lead auditors do not save observations recording for the next day but debrief them to auditees at the end of the session.

A lead auditor is empowered to and must dictate to his/her auditees for furnishing exactly the documents. Otherwise, auditees might cherry-pick documents to avoid exhibiting any of their flaws in the document.

The prime goal of an ISO 13485 Lead Auditor is to ensure that auditees are keeping track of MDQMS activities. The latter is expected to possess the relevant information for reporting to their lead auditor.

The supply chain network plays an integral part in the medical device production MDQMS. To conduct a supplier audit, a lead auditor reviews the desirable operation of the relevant processes. Then he/she observes the prevailing processes, reviews their records, and conducts interviews to gather evidence. The collected information is used for identifying disparities between the stated requirements and the current execution of processes.

An ISO supplier audit also looks into whether MDQMS is exercising proper purchase controls on its resource suppliers. This ensures that an organization is paying the right amount for quality materials instead of suffering losses.

The following are the clauses of ISO 13485:
  • Scope
  • Normative references
  • Terms and definitions
  • Quality management system
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis and improvement

Organizations are required by ISO 13485 to assess and manage the risks related to their processes and products, including the risk of non-compliance with legal and regulatory requirements. This improves product safety and quality while assisting businesses in avoiding adverse legal and financial consequences.

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

Resource management refers to the effective allocation and management of resources within an organization's quality management system to comply with the standard's requirements. It includes allocating resources for personnel, infrastructure, work environment, and monitoring of resource performance.

Organizations in the medical device sector must adhere to the laws and regulations of the nations and markets in which they conduct business, according to ISO 13485. This covers compliance to legal requirements and guidelines for the development, advancement, manufacturing, distribution, and maintenance of medical equipment.

ISO 13485 auditing is conducted by
  • Internal Auditors
  • Certification Bodies

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

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

The documentation that is required by ISO 13485 helps an organization build a comprehensive knowledge base. They can also 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.

The organization conducts an internal audit to confirm that the QMS complies with ISO 13485. This entails examining the procedures, documents, and paperwork to make sure they adhere to the standards. In addition, they show the effectiveness of the QMS and resolve any nonconformities or areas of concern found during the audit.

Organizations may use best practices in quality management, risk reduction, and regulatory compliance with the help of the framework offered by ISO 13485. Ensuring that medical equipment are safe, of the highest quality, and fulfill consumer expectations enables enterprises to improve customer satisfaction.

The following are the three ways audits are conducted:
  • Internal audits
  • External audits
  • Unannounced audits

Both ISO 13485 and ISO 9001 standard helps organizations achieve a quality management system. They both emphasize risk assessment and reduction. Additionally, they both make use of the Deming cycle, sometimes referred to as Plan Do Check Act.

Auditors physically visiting the place or facility are referred to as "on-site audits. It is performed in full days. The duration of this audit is determined by a variety of variables, such as an organization's size, complexity, risk level, and type.

Remote audits are conducted in the absence of the auditee. Remote audits can be carried out using electronic process verification, online conferences, or teleconferences. Compared to on-site audits, remote audits are less frequent and usually less effective.

The following are methods of collecting information for the ISO 13485 audit
  • Visual observation
  • Examination of records
  • Employee interviews

Quality management system documentation, such as the quality manual, procedures, and work instructions.; Records related to product design and development, including design inputs, risk assessments, and design change documentation; Production and process control records and Records of corrective and preventive actions (CAPA).

Through employee interviews, Auditors have the chance to learn personally how members of the business understand and implement ISO 13485 requirements. They conduct interviews with employees to learn about how well they know about their roles and responsibilities in the quality management system, how to handle events and nonconformities, and how to report quality problems.

ISO 13485 Lead Auditor should have knowledge of ISO 13485, hands-on experience in auditing, communication skills, interviewing skills, analytical skills, time management skills, and problem-solving skills.

Time management skills enable ISO 13485 Lead Auditors to efficiently manage their time so they can complete all the audit tasks within the specified time frame. These abilities considerably aid in planning, execution, and timely reporting of the audit's findings.