ISO 9001:2015
Quality management systems — Requirements
What is ISO 9001?
ISO 9001 is a globally recognized standard for quality management. It helps organizations of all sizes and sectors to improve their performance, meet customer expectations and demonstrate their commitment to quality. Its requirements define how to establish, implement, maintain, and continually improve a quality management system (QMS).
Implementing ISO 9001 means your organization has put in place effective processes and trained staff to deliver flawless products or services time after time.
Why is ISO 9001 important?
With more than one million certificates issued to organizations in 189 countries, ISO 9001 is the most widely used quality management standard in the world. Within the ISO 9000 family, which defines seven quality management principles including a strong customer focus and continual improvement, ISO 9001 is the only standard that can be certified to (though certification is not mandatory).
Business benefits include:
Customer confidence: The standard ensures that organizations have robust quality control processes in place, leading to increased customer trust and satisfaction.
Effective complaint resolution: ISO 9001 offers guidelines for resolving customer complaints efficiently, contributing to timely and satisfactory problem-solving.
Process improvement: The standard helps identify and eliminate inefficiencies, reduce waste, streamline operations, and promote informed decision-making, resulting in cost savings and better outcomes.
Ongoing optimization: Regular audits and reviews encouraged by ISO 9001 enable organizations to continually refine their quality management systems, stay competitive, and achieve long-term success.
Benefits of ISO 9001
Increased customer trust and satisfaction
Sound quality control processes
Cost savings and productivity gains
Culture of continuous improvement
What is the difference between ISO 9001 and ISO 13485?
The International Standards ISO 9001 and ISO 13485 both define requirements for quality management systems, but one has a much broader user group than the other. ISO 9001 provides a quality management framework that can apply to organizations of any size or sector. ISO 13485, on the other hand, has been developed specifically for the medical device industry with a focus on regulatory compliance. The standard helps ensure the safety and effectiveness of medical devices, including risk management, traceability and process validation. Compared to ISO 9001, it contains additional requirements specific to organizations involved in the life cycle of medical devices, whereas elements of ISO 9001 that are not relevant as regulatory requirements are not part of ISO 13485.