-
Americas
-
Asia & Oceania
-
A-I
J-Z
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Regions
-
Americas
-
Asia & Oceania
-
Europe
-
Middle East & Africa
-
Americas
-
Asia & Oceania
-
Europe
Europe
- Adriatic
- Belgium
- Bulgaria
- Czech Republic
- Deutschland
- España
- France
- Greece
- Hungary
- Ireland
- Israel
- Italia
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
WHO WE HELP
-
Pharmaceutical Manufacturers
-
Emerging Biopharma
-
MedTech
-
Financial Institutions
-
Government and Public Health
-
Health Plans
-
Hospital and Health Systems
-
Insurers and Risk
-
Medical Specialty and Patient Advocacy
Pharmaceutical Manufacturers
Harness unparalleled healthcare data, advanced analytics, and cutting-edge technologies with our expertise to accelerate the development and commercialization of innovative medicines, enhancing patient lives.
Discover MorePharmaceutical Manufacturers
Emerging Biopharma (Global page)
Boost your innovation with IQVIA's expert team. Our comprehensive solutions integrate top-tier insights, technology, and expertise to maximize your asset's success in a competitive landscape.
Discover InnovationsMedTech
Navigating MedTech's unique landscape: U.S. decision-making now rests with GPOs, IDNs, and payers, who demand solid value proof through rigorous outcomes analyses and pricing scrutiny.
Explore MedTechMedTech
Financial Institutions
Invest in healthcare with confidence. Stay ahead of pharma and medical device trends using real-time, high-quality data. Access market insights, historical sales, prescription trends, and emerging product information for informed, risk-reduced decisions.
Access InsightsGovernment and Public Health
Unlock deeper health insights with unmatched data and innovative technology to enhance decision-making for your essential government programs.
Unlock InnovationsGovernment and Public Health
Health Plans
Accelerate digital innovation with our data-driven expertise in data science and healthcare, optimizing business processes for smarter decisions.
Navigate Health PlansHospital and Health Systems
Leverage digital innovation to cut costs, boost efficiency, and elevate patient engagement, all while enhancing quality and health outcomes.
Streamline DecisionsHospital and Health Systems
Insurers and Risk
Enhance your ability to evaluate and forecast population risk swiftly and accurately by integrating unmatched data, expertise, and technology.
Uncover More
Medical Specialty and Patient Advocacy
Transform into a data-driven organization that enhances your specialty and showcases value to your members through digital transformation.
Explore NowU.S. PROGRESS POINT
A curation of IQVIA's best thinking on topics and trends driving change, disruption, and progress in the United States healthcare market.
LEARN MOREBLOGS, WHITE PAPERS & CASE STUDIES
Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.
DISCOVER INSIGHTS
PODCASTS
"Discover the future through our enlightening podcasts available in the United States.
EXPLORE PODCASTS
Blog
ISO 9001:2015 and the 8 Quality Management Principles to take you to the head of the class
Nov 06, 2019
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 guide quality management system standards 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® QMS provides 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.
Fact Sheet: IQVIA SmartSolve Platform of Compliance
Build and execute a more successful market access strategy in today’s pressure-filled landscape.