How to build and implement an eQMS: efficiency, compliance and data integrity – Replay

News / The 7 Principles of Quality Management

News

Upholding Excellence: GxpManager's Adherence to ISO 9001:2015 Principles

The 7 principles of Quality Management are defined in ISO 9001:2015, so organizations can improve performance, enhance customer satisfaction, increase employee commitment, optimize processes, foster innovation, make informed decisions, and develop strong relationships with stakeholders.

images of cubes with "certification ISO 9001" written on them

Today, GxpManager is ISO 9001:2015 certified and follows its principles on a daily basis to ensure customer satisfaction, continuous improvement, and operational excellence.

According to ISO 9001:2015, here are the seven principles of Quality Management:

PrinciplesDefinitionGxpManager
Customer focusCustomer orientation means understanding and responding to customers' current and future needs. Organizations must strive to exceed customer expectations by offering quality products and services, building strong relationships, and continually improving customer satisfaction.GxpManager prioritizes understanding its customers' needs at the start of each project and continuously improving its products and services.
LeadershipLeadership involves setting a clear vision, ambitious goals, and strategic direction for the organization. Leaders must set an example in quality management, fostering employee commitment, encouraging innovation, and creating an environment conducive to excellence.GxpManager is an innovative start-up with values shared by. The technical and professional development environment encourages employees to play an active role in the company's success.
Employee involvementInvolving staff at all levels is essential to achieving quality objectives. Employees must be competent, motivated, and involved in continuous process improvement. A culture of trust, cooperation, and responsibility fosters employee commitment.All staff are involved in guaranteeing quality and continuous improvement. Thanks to a Quality department in touch with all employees and a quality management system that encourages cooperation and responsibility.
Process approachA process approach involves understanding, managing, and improving the interconnected processes that contribute to achieving quality objectives. Identifying the interactions between processes, defining relevant performance indicators, and implementing continuous improvement actions is crucial.The Quality department at GxpManager is proactive in helping all employees to understand and improve processes. Continuous improvement is achieved by optimizing performance through effective process management, efficient use of resources, and reduction of cross-functional barriers.
Continuous improvementContinuous improvement aims to increase the effectiveness and efficiency of processes constantly. This means regularly assessing performance, seeking opportunities for improvement, innovating, and implementing corrective and preventive actions to resolve identified problems.The review and improvement of processes are supported by our Quality department with the managers and employees of each process, with the aim of resolving problems quickly and efficiently and identifying areas for improvement.
Evidence-based decision-makingDecisions must be taken objectively, based on factual data and information. This requires the collection, analysis and interpretation of relevant data to assess performance, identify trends and make informed decisions.Decisions must be taken objectively, based on factual data and information. This requires the collection, analysis and interpretation of relevant data to assess performance, identify trends and make informed decisions.
Stakeholder relations managementOrganizations must identify and manage relationships with stakeholders (customers, suppliers, employees, partners, etc.) that impact their ability to deliver quality-compliant products and services. This involves understanding their needs, establishing mutually beneficial partnerships, and managing expectations.GxpManager has identified the stakeholders involved in each of these processes, and ensures that we understand their needs and expectations.

These seven Quality Management principles, defined by ISO 9001:2015, provide a solid framework for establishing and maintaining an effective quality management system focused on continuous improvement. By applying these principles, all organizations can strengthen their overall performance, increase customer satisfaction and achieve operational excellence.

An interesting approach to understanding these principles is to take them in their opposite meaning.

  • lack of interest in the customer,
  • lack of leadership,
  • staff disengagement,
  • a fragmented approach to processes,
  • stagnation,
  • decision-making based on assumptions,
  • ignorance of stakeholders.

This allows us to realize its negative impact on the organization if its principles are not respected and followed.

Since April 2023, GxpManager has been ISO 9001:2015 certified, which is proof and guarantees that all employees within the company are committed to a quality approach to daily customer satisfaction by following these 7 principles of the quality approach.

Discover our QMS

Other news

News
2025 upcoming events

GxpManager will participate at many exhibitions and webinars in 2025.

Learn more
News
Laboratory equipment: facilitating inventory and maintenance

Manage your laboratory equipment stress-free with digitalization.

Learn more
News
GxpManager Achieves an Outstanding Score of 944 in the CyberVadis Evaluation

GxpManager achieves excellence in cybersecurity with a "Mature" rating in the CyberVadis evaluation. This recognition highlights our dedication to ISO 27001 compliance certification (in progress) and protecting critical data for clients in regulated industries.

Learn more
News
Paper on Glass”: An Initial Digitization with Surpassable Limits for High-Performance Solutions

Paper on Glass" represents an initial approach to digitization. This method quickly reveals its limitations in terms of efficiency and innovation. To go further, solutions like GxpManager provide comprehensive, optimized digitization that complies with the requirements of regulated industries.

Learn more
News
GxpManager: the system compliance solution

GxpManager simplifies compliance for regulated sectors by reducing administrative complexity, automating validation, and ensuring secure data management. Achieve faster ROI while meeting ISO, GMP, and FDA standards with this tailored platform.

Learn more
News
Medical Device show, 12th edition

Discover our innovative solutions for compliance management, risk analysis, and process digitalization. Visit us at stand 12 to learn how we can optimize your quality management system and streamline your medical device compliance.

Learn more
News
7 compelling reasons to digitalize your artwork management

Digitalizing artwork management streamlines workflows, reduces errors, and ensures compliance. It centralizes files, improves collaboration, and accelerates product launches, making operations more efficient and secure.

Learn more
News
GxpManager at Digital Transformation Week

Visit us at Booth 262 on October 1-2 at the RAI Amsterdam Convention Centre. Explore our innovative No-Code/Low-Code solutions for compliance and digital transformation. Connect with our experts and discover how we can optimize your business processes!

Learn more
News
The 6 benefits of digitalizing audit management

In an environment where regulatory compliance is essential, digitalization improves the efficiency and security of audits and enhances transparency and data traceability.

Learn more