ISO 9001:2015 Quality Management System Standard
Deciding to implement a quality management system is a strategic decision for an organization as it helps improve overall performance and provides a solid foundation for sustainable development initiatives. Implementing a quality management system based on the ISO 9001:2015 Quality Management System standard provides the following potential benefits to an organization:
The ability to consistently provide products and services that meet customer requirements and applicable primary and secondary regulatory requirements,
Opportunities to enhance customer satisfaction,
Identifying risks and opportunities related to the organization’s context and objectives,
The ability to demonstrate conformity to specified quality management system requirements.
The ISO 9001 Certificate, specifically the ISO 9001:2015 Quality Management System standard, can be utilized by relevant internal and external parties.
The ISO 9001:2015 Quality Management System standard applies a process approach that includes the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. The process approach enables the organization to plan its processes and their interactions. The PDCA cycle ensures that the organization has appropriately allocated resources, properly manages its processes, identifies opportunities for improvement, and takes necessary actions. Risk-based thinking helps the organization determine factors that may lead to deviations from planned results, apply preventive controls to minimize negative impacts, and maximize benefits from opportunities as they arise.
Regularly meeting requirements and determining future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve the purpose of the ISO 9001 Certificate, an organization may need to adapt improvements in various forms, such as major changes, innovation, and organizational transformation, in addition to verification and continuous improvement.
The ISO 9001:2015 Quality Management System standard is based on the quality management system principles explained in ISO 9000. These explanations include a statement related to each principle, the rationale for why the principle is important for an organization, examples of benefits related to the principle, and typical activities that organizations can undertake to enhance their performance while applying the principle.
The quality management principles of the ISO 9001 Certificate include:
Customer focus,
Leadership,
Engagement of people,
Process approach,
Improvement,
Evidence-based decision making,
Relationship management.
The ISO 9001:2015 Quality Management System standard promotes the adoption of a process approach to establish, implement, and improve the effectiveness of the quality management system to enhance customer satisfaction by meeting customer requirements. Specific requirements deemed essential for the application of the process approach are included in Clause 4.4 of the ISO 9001:2015 standard.
Understanding and managing interrelated processes as a system contributes to an organization’s effectiveness and efficiency in achieving intended results. The process approach, as defined in the ISO 9001:2015 Quality Management System framework, allows an organization to control the relationships and interdependencies between processes, thereby improving overall performance.
The process approach involves systematically defining, managing, and interacting with processes to achieve desired outcomes based on the organization’s quality policy and strategic direction. Managing processes and the system as a whole can be achieved by using the PDCA cycle, which has an integrated focus on risk-based thinking aimed at capitalizing on opportunities while preventing undesired results.
Implementing the process approach within the ISO 9001:2015 Quality Management System ensures:
Understanding and maintaining compliance with requirements,
Considering processes in terms of value addition,
Achieving effective process performance,
Improving processes based on evaluation of data and information.
The PDCA cycle is briefly explained as follows:
Plan: Establish the system’s purpose, processes, and required resources based on customer requirements and organizational policies. Identify and assess risks and opportunities.
Do: Implement the planned processes.
Check: Monitor and measure processes and final products against policies, objectives, requirements, and planned activities. Report results accordingly.
Act: Take necessary actions to improve performance when required.
Risk-based thinking is essential for achieving an effective quality management system. The concept of risk-based thinking was partially included in previous editions of the ISO 9001:2015 Quality Management System standard in the form of preventive actions, analysis of nonconformities, and actions taken to prevent recurrence based on the impact of nonconformities.
To comply with the ISO 9001 standard, an organization must plan and implement activities to identify risks and opportunities. Identifying risks and opportunities provides a basis for improving the effectiveness of the quality management system, achieving enhanced results, and preventing negative effects. Opportunities arise as a positive deviation from an expected outcome and may help organizations influence customers, develop new products and services, reduce waste, or improve efficiency. Identifying opportunities may also involve evaluating associated risks.
Risk is the effect of uncertainty and may have both positive and negative implications. A positive deviation from a risk may create an opportunity, but not all positive effects of a risk result in opportunities.
The ISO 9001 Certificate includes requirements related to understanding an organization’s context (see ISO 9001:2015 Clause 4.1) and determining risks as a basis for planning (see ISO 9001:2015 Clause 6.1). This demonstrates the application of risk-based thinking in planning and implementing quality management system processes (see ISO 9001:2015 Clause 4.4) and helps determine the extent of documented information required.
One of the fundamental objectives of a quality management system is to act as a preventive tool. Therefore, ISO 9001:2015 Quality Management System Standard does not include a separate clause or sub-clause on preventive actions. The concept of preventive action is embedded within the structured framework of risk-based thinking. The application of risk-based thinking in the ISO 9001:2015 Quality Management System Standard has led to a reduction in prescriptive requirements and an increase in performance-based requirements.
The ISO 9001:2015 Quality Management System standard does not refer to "exclusions" regarding the applicability of quality management system requirements. However, an organization may review the applicability of requirements based on its size, complexity, management model, range of activities, and the nature of risks and opportunities it faces. Applicability conditions are outlined in ISO 9001:2015 Clause 4.3, where an organization may determine that a requirement is not applicable to its management system only if noncompliance does not lead to failure in ensuring the conformity of products and services.
The full set of requirements in the ISO 9001:2015 Quality Management System standard is intended to be applicable to all organizations, regardless of their type, size, or the nature of products and services they provide.