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Top 20 ISO 9001 Foundation Certification Interview Questions and Answers

ISO 9001 is defined as the international standard that outlines the specifications for a quality management system (QMS). Organizations use the standard to demonstrate that they can consistently deliver goods and services that adhere to legal and consumer standards. ISO 9001:2015 applies to any organization, regardless of size or industry. It has been implemented into the quality management systems of more than one million organizations from more than 160 nations. ISO 9001 Foundation Certification is an entry-level credential awarded to individuals pursuing a career in quality management.

Professionals obtaining ISO 9001 Foundation Certification are familiar with the fundamentals of the standard and its methodology. They also learn about various aspects of a QMS based on ISO 9001, including the top management position, risks, and opportunities, quality policy, specifications for performance evaluation, and the significance of ongoing improvement. Certified professionals can hunt for employment or further pursue other ISO 9001 Certifications. Additionally, the certification is globally acknowledged, enabling professionals to seek opportunities throughout the world.

Plan-Do-Check-Act (PDCA) is a four-stage iterative method for resolving issues and improving processes, products, or services. The "Plan, Do, Check, Act" cycle is continually used to advance the continuous improvement process. This method is used for all aspects of the business and allows for the improvement of the caliber of the organization’s products and services.

ISO 9001:2015 applies to any organization, regardless of size or industry. ISO 9001 standard aids organizations in process organization, process efficiency enhancement, and ongoing process improvement. It demonstrates the company's ability to consistently deliver products and services that satisfy clients and adhere to relevant legal and regulatory requirements. Additionally, it seeks to increase customer satisfaction by effectively implementing the system.

A Pareto chart is used for assessing of relative importance of various causes of the defect. It is created using the FMEA approach in order to construct an ISO 9001 QMS. It is used to determine the most prevalent sort of cause. Additionally, it is used to rank all the causes from most often to least frequent.

A quality management system must meet the requirements outlined in ISO 9001:2015. The ISO 9001 standard provides details on a variety of topics, including requirements for a QMS, such as recorded data, planning, and figuring out how processes interact, management of resources, such as human resources and the working environment within an organization, realization of a product, from creation to delivery and internal audits, corrective and preventative action, and measurement, analysis, and improvement of the QMS.

A flowchart is utilized throughout the process to identify the major issue areas and track unnecessary gaps that obstruct QMS improvement. When creating a flowchart, ISO 9001 Foundation professionals should take into account a few fundamental ideas:
  • Every process has a start and a finish.
  • Various complicated processes, problem areas, wasteful loops, and crucial decision points to address them are recognized throughout the process.
  • These are represented by many symbols.

ISO 9001 standard is revised to ensure that ISO 9001 continues to adapt to the changing environments in which organizations operate. The following are a few of the significant modifications in ISO 9001:2015:
  • Adoption of new terminology
  • Reorganizing a section of the information
  • Focus on risk-based thinking to improve how the process approach is used
  • Increased service applicability
  • Enhanced leadership requirements

An ISO 9001 process approach is utilized in a quality management system to help with understanding and consistency in fulfilling requirements, perceiving processes in terms of value addition, attaining effective process performance, and improving process performance based on analysis and assessment of the data and information.

The PDCA approach is very adaptable and can be used in a variety of situations. It increases productivity by enhancing organizational performance. It is a very effective procedure to test the action plan and the adjustments business intends to make on a small scale. Additionally, the PDCA method functions as a cycle, allowing them to engage in continual development.

This question is intended to gauge the candidate's understanding of the ISO 9001 standard. Therefore, ISO 9001 Foundation experts should be able to outline the ISO 9001 requirements throughout the answer. Their answer must include the eight ISO 9001 principles. Additionally, they have to demonstrate their familiarity with fundamental systems concepts like document control and corrective action.

The clause of ISO 9001: 2015 are
  • Clause 0-3 – Introduction and scope of the standard
  • Clause 4 – Context of the organization
  • Clause 5 – Leadership
  • Clause 6 – Planning
  • Clause 7 – Support
  • Clause 8 – Operation
  • Clause 9 – Performance evaluation
  • Clause 10 – Improvement

The leadership clause of ISO 9001 specifies the requirements for top management. The requirements are fostering a customer-centric culture across the whole business, creating and adhering to a quality policy that defines direction and alignment, and defining roles and authorities throughout the entire QMS to make it obvious who has decision-making authority and what is expected of each function operating within the system.

The Control Chart is a graph used to examine how a process evolves over time. It can alert the user when the process outputs begin to deviate from the predicted measurements and then provide an opportunity for adjustment. As there will be a consistent shift in the data after improvement work is done, ISO 9001 Foundation professionals will easily demonstrate if improvement actions have been successful.

Cause and effect analysis is a technique used by ISO 9001 experts to determine the root cause of an issue or prospective problem. It is an evaluation tool that combines mind mapping and brainstorming approaches to investigate potential problems' causes. Cause and effect analysis enables experts to identify the underlying causes of issues, locate process bottlenecks, and pinpoint the areas and reasons why a process is failing.

QMS system offers assurance in consistency, assisting the organization in retaining its existing clients while building a reputation for excellence that will attract more consumers. A QMS can help with compliance initiatives as well. The data produced by the system can assist ISO 9001 experts in analyzing the company and identifying any potential compliance concerns.

Quality assurance and quality control are components of quality management rather than concepts independent of it. Quality assurance (QA) refers to the plans and requirements ISO 9001 professionals create to provide quality products or services to their customers. Quality control (QC) is the steps professionals take after the fact to assure that they have met their quality objectives. The QMS encompasses both of these processes. The framework it creates will provide a structured approach for QA and standardized procedures for QC. It also improves functionality and enables the staff assigned to each process to work together to achieve the highest possible level of quality.

ISO 9000 is the whole family of QMS standards; ISO 9001 is one specific standard within that family, which provides the regulations for gap analysis and internal auditing that must be conducted while creating and maintaining a quality management system.

Clause 7 support and resource management contain a wide range of requirements for management, including the provision of human resources, infrastructure including tools, hardware, and software, building facilities, work environments including temperature control, humidity control, dust control, and sterilization control, the control of any equipment needed to monitor or measure the product or service, and the organizational expertise necessary to run the QMS. It is also emphasized how crucial communication, awareness, and competency are for human resources.

Control charts are used to monitor and manage ongoing processes by identifying and fixing issues as they arise. It is employed for forecasting the range of anticipated outcomes from a process and figuring out whether a process is stable. Additionally, it is utilized to decide if the quality improvement effort should focus on preventing certain issues or making significant process improvements.

The ISO 9001 certification stresses specific guidelines for the proper tool used to improve QMS. Before selecting any of the quality tools, certified ISO 9001 Foundation must concentrate on the following questions to assist them in achieving the goal of the selected approach:
  • What do they intend to quantify?
  • What do they want to accomplish?
  • What format have the data taken?
  • What do they want to accomplish with the result?

PDCA stands for plan, do, check, act, whereas PDSA stands for plan, do, study, act. They both are four-stage, iterative problem-solving frameworks that are used to enhance processes. The PDCA model, which was created before the PDSA model, has the "check" step, which is the fundamental distinction between the two.