1. Home
  2. Interview Questions
  3. ISO 9001 Foundation Interview Questions

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.

The 1SO 9001 standard emphasizes the significance of continuous improvement. They must take steps to enhance services and goods for their growth. Organizations should understand the customer needs and improve their satisfaction. They should also identify situations where procedures are failing to meet their objectives and modify them accordingly.

The PDCA cycle allows organizations to respond to changing market conditions and customer demands by quickly adjusting their processes and procedures. Furthermore, using data and measurements during the check phase enables informed, evidence-based decision-making, which improves problem-solving..

Professionals carry out a gap analysis to compare the organization's current systems and procedures to those mandated by ISO 9001. This will assist them in determining any areas where the organization might not be currently adhering to the standard's requirements.

An effective Quality Management System (QMS) implementation and maintenance depend heavily on employee training. Training makes ensuring employees are aware of the QMS's requirements, including its guidelines, processes, and standards. This understanding is vital for aligning their work with the QMS objectives and compliance.

Quality Management principles guide organizations in establishing and maintaining a Quality Management System. It ensures the quality of the goods and services and fosters a culture of ongoing development, client satisfaction, and overall excellence. Organizations that accept and uphold these principles are therefore better equipped to provide high-quality outputs and maintain their competitiveness in their respective sectors.

Internal auditing contributes to ensuring that an organization's processes and procedures adhere to the requirements of the QMS standard, ISO 9001. It aids in determining whether the processes are accomplishing their intended goals and whether the QMS is operating as planned. Additionally, it aids in finding non-conformities and variances from the established QMS processes and standards.

PDCA is a general framework for continuous improvement applicable to a wide range of processes and systems. On the other hand, Six Sigma is a more specialized, data-driven methodology primarily focused on defect reduction and process improvement in manufacturing and other domains.

Quality Management System (QMS) documents are essential for establishing, implementing, maintaining, and continuously improving a QMS within an organization. The documents include Scope of the Quality Management System, a Quality Policy, Quality Objectives, and a Procedure for the control of outsourced processes.

Over the years, the ISO 9001 standard has undergone several revisions and updates to bring about improvements, adjustments, and changes to the standard. The first version of the ISO 9001 standard was ISO 9001:1987. Later modifications took place in 1994, 2000, and again in 2008. In September 2015, the most recent standard was released.

The following are seven principles of Quality Management:
  • Focus on customers
  • Leadership
  • People Engagement
  • Process Approach
  • Continuous Improvement
  • Evidence-Based Decision Making
  • Relationship Management

As part of ISO 9001 compliance, organizations should document their control chart data, analysis, and any actions taken in response to out-of-control situations. This documentation helps ensure transparency and accountability.

Organizations are interconnected with various stakeholders, including suppliers, customers, and regulatory bodies. Therefore, effective relationship management is essential for mutually beneficial outcomes, risk reduction, and improved quality performance.s

Organizations should understand and meet customer needs and expectations. This involves identifying both internal and external customers and consistently delivering products and services that satisfy their requirements. Customer feedback and satisfaction are crucial elements in this principle.

ISO 9001 itself is not a legal requirement. It is an international standard for Quality Management Systems (QMS). Implementing ISO 9001 enables organizations to improve their quality management and satisfy stakeholders' and consumers' expectations. ISO 9001 certification may, however, be required by some sectors, authorities, or specific contracts.

The different types of ISO 9001 audits are as follows:
  • Internal Audit
  • Certification Audit
  • Surveillance Audit
  • Re-certification audit
  • Supplier Audit

Organizations are subject to periodic surveillance audits by a third-party certification body after initial certification. The audit is normally completed in a single visit on site, and no certificates are issued at the end. They could bring up non-conformities that businesses must address in the allotted amount of time. Additionally, these audits make sure the company maintains its compliance with ISO 9001.

Aerospace, automotive, pharmaceutical, and healthcare industries frequently want ISO 9001 since it can guarantee the quality of their goods and services. Government procurement contracts in various nations might state that suppliers must be certified to ISO 9001 to conduct business.

Quality Manual is a document that provides an overview of the organization's QMS, including its scope, objectives, and the interaction of various processes. It often serves as a top-level document that introduces the QMS to stakeholders.

Professionals find a problem or an opportunity to make improvements during the plan stage of the PDCA cycle. They develop objectives, a precise strategy, and measurable goals. Additionally, they gather the resources and pertinent data required for the improvement attempt.

Businesses interested in implementing ISO 9001 should evaluate their present quality management procedures, identify areas that need improvement, and modify the standard's criteria to fit their specific requirements. In addition, achieving ISO 9001 certification involves a formal assessment by a certification body to ensure that the organization's QMS complies with the standard.