If you work in quality management, you've likely heard of the ISO 9001 and ISO 19011 standards. But do you know what they are and how they differ? In this post, we will describe the objective, scope, and requirements of these two quality audit standards, as well as how you may utilize them to improve your quality performance.
What is ISO 9001?
ISO 9001 is an international standard that sets the standards for a successful and efficient quality management system. It specifies the requirements for a standard quality management system. Customers expect quality products and services from organizations that use a quality management system. ISO 9001 is founded on seven quality management principles: customer focus, leadership, employee engagement, process approach, improvement, evidence-based decision-making, and relationship management.
What is ISO 19011?
The ISO 19011 standard guides the auditing management system. It is need for companies for their internal and external audit of the management system. It explains how to assess the skills and competencies of auditors and other audit participants. It provides a framework for planning, conducting, reporting, and following up on audits of any form of management system, whether internal or external, first-party or third-party, combined or joint. ISO 19011 addresses auditing concepts, auditor roles and responsibilities, the audit process, and the audit program. ISO 19011 further includes annexes that guide auditing certain management system disciplines such as quality, environmental, and information security.
How Do We Relate ISO 9001 and ISO 19011?
ISO 9001 and ISO 19011 are interrelated standards that can be used by both quality management systems. Internal audits are required by ISO 9001 at regular intervals to check that the QMS complies with the standard and the organization's own needs, as well as to identify possibilities for improvement. ISO 19011 specifies the best methods for performing these audits effectively and efficiently. Furthermore, ISO 19011 can be used by external auditors to assess an organization's QMS's adherence to ISO 9001 or other standards.
How are ISO 9001 and ISO 19011 Different from Each Other?
While ISO 9001 and ISO 19011 are connected, they serve different objectives, have different scopes, and have different standards. ISO 9001 is a normative standard that sets the standards for a QMS that an organization can implement and certify. ISO 19011 is an educational guideline that covers the suggestions for auditing any management system, not just QMS. ISO 9001 is required for organizations that seek to demonstrate compliance with the standard or gain certification. ISO 19011 is a voluntary standard for organizations that desire to adopt optimal auditing practices or improve their audit skills.
How can You Put ISO 9001 and ISO 19011 to Use?
There are numerous stages to follow to implement ISO 9001 and ISO 19011 in your organization. To begin, you must comprehend the requirements and principles of both standards, as well as how they relate to the context and objectives of your organization. Second, you should create, develop, implement, and maintain a quality management system (QMS) that fulfils ISO 9001 requirements and captures your organization's processes, resources, and outputs. Third, use the ISO 19011 framework and advice to design, conduct, report, and follow up on internal audits of your QMS; these audits should be objective, impartial, and competent. Fourth, assess the success and performance of your QMS and audits, and take remedial steps for any nonconformities or improvement opportunities that are found.
What are the Advantages of ISO 9001 and ISO 19011?
Integrating ISO 9001 with ISO 19011 can provide many advantages for organizations looking to improve their quality performance. These advantages include higher customer confidence and satisfaction, improved process efficiency and effectiveness, and improved organizational culture and reputation. Furthermore, it can lead to continual development and innovation, providing organizations with a competitive edge and market access by meeting regulatory and contractual criteria. Finally, this integration may result in international recognition and reputation.
ISO 9001:2015 is primarily concerned with Quality Management Systems, whereas ISO 19011:2011 is concerned with auditing management systems. As a result, both ISO standards are required for each organization to improve or avoid any type of risk in the organization.
I hope this post has helped you grasp the distinguish between ISO 9001:2015 and 19011:2011.
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