ISO 9001:2015 and the 8 Quality Management Principles to take you to the head of the class (2024)

For more than half a century, the International Organization for Standardization (ISO) has been developing standards to protect society from potential errors. It’s been more than three decades since the introduction of the Quality Management System standards model, ISO 9001, specifically.

The most current version, ISO 9001:2015 was adopted to address fulfilling regulatory requirements and customer satisfaction through continuous improvement of the quality system. The standards apply worldwide and provide consumers with a base-level confidence in an organization’s ability to provide conforming products.

Ensuring a passing grade

According to ISO, the intention of introducing periodic revisions to the standard is to keep ISO 9001 relevant, to reflect changes in its environment, and to ensure it continues to deliver “confidence in the organization’s ability to consistently provide product that meets customer and applicable statutory and regulatory requirements.”

The current iteration is expected to guidequality management systemstandards for, at minimum, one decade or until 2025. We are halfway there now, and in a few short years, ISO’s Technical Committee will begin planning the standard’s next iteration.

A primer for quality

Despite the potential for revision, the core set of requirements within the ISO 9001 standard contains standardized language based on the eight major quality management principles. These principles were developed in the mid-1990s by a small group of experts who were familiar with the teachings and philosophies of the well-known quality gurus of the last century.

The eight principles are:

• Principle 1 – Customer focus: Organizations can establish this focus by trying to understand and meet their customers’ current and future requirements and expectations.
• Principle 2 – Leadership: Organizations succeed when leaders establish and maintain the internal environment in which employees can become fully involved in achieving the organization’s unified objectives.
• Principle 3 – Involvement of people: Organizations succeed by retaining competent employees, encouraging continuous enhancement of their knowledge and skills, and empowering them, encouraging engagement, and recognizing achievements.
• Principle 4 – Process approach: Organizations enhance their performance when leaders manage and control their processes, as well as the inputs and outputs that tie these processes together.
• Principle 5 – System approach to management: Organizations sustain success when processes are managed as one coherent quality management system.
• Principle 6 – Continuous improvement: Organizations will maintain current levels of performance, respond to changing conditions, and identify, create and exploit new opportunities when they establish and sustain an ongoing focus on improvement.
• Principle 7 – Factual approach to decision making: Organizations succeed when they have established an evidence-based decision making process that entails gathering input from multiple sources, identifying facts, objectively analyzing data, examining cause/effect, and considering potential consequences.
• Principle 8 – Mutually beneficial supplier relationships: Organizations that carefully manage their relationships with suppliers and partners can nurture positive and productive involvement, support, and feedback from those entities.

These principles form the conceptual foundation for the ISO portfolio of quality management standards and serve as the basis for the Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) required by most government regulatory bodies. But these principles are not just the backbone of quality systems; they’re also simply good business principles to put into practice across an enterprise. The standardization of management approach based on them will continue driving global improvement and process excellence worldwide.

Putting it all into practice

Like the eight quality principles, an automated enterprise quality management system built on the ISO standard has far-reaching impact on the total operation of an organization. IQVIA SmartSolve® QMSprovides the tools to automate quality processes but also makes it easier to deploy them across an organization’s entire value chain, impacting the opportunity for success from top to bottom.