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What does the acronym "QMS" stand for in ISO 9001:2015?
Quality Management System
What is the importance of objective evidence in an internal audit?
Objective evidence helps to verify the effectiveness of the QMS/EMS and provides a basis for making informed decisions and recommendations for improvement.
What is the purpose of the "Documented Information" clause in ISO 9001:2015 & ISO 14001:2015?
To ensure that the QMS/ EMS has the necessary documentation to ensure the effective operation and control of its processes.
What is the difference between an internal audit and an external audit?
An internal audit is conducted by employees of the organization, while an external audit is conducted by an independent third-party organization.
What is the difference between a corrective action and a preventive action?
A corrective action is taken to address a NC that has already occurred, while a preventive action is taken to prevent a potential NC from occurring in the future.
What is the meaning of "interested parties" in ISO 9001:2015?
Interested parties are individuals or organizations that can affect or be affected by the organization's QMS.
What is the purpose of a quality policy?
The purpose of a quality policy is to communicate the organization's commitment to quality and to provide a framework for establishing quality objectives.
What is the purpose of the "Leadership" clause in ISO 9001:2015?
To ensure that top management provides leadership and commitment to the QMS/ EMS and creates a culture of continual improvement.
What is the purpose of conducting an opening meeting during an internal audit?
The purpose of an opening meeting is to introduce the audit team to the auditee, to explain the audit process, and to establish clear communication between the audit team and the auditee.
What is the purpose of a closing meeting during an internal audit?
The purpose of a closing meeting is to summarize the findings of the audit, to discuss any NC's or opportunities for improvement.
What is the role of the "Customer Focus" clause in ISO 9001:2015?
To ensure that the organization understands and meets customer requirements and enhances customer satisfaction.
What are the primary objectives of ISO 9001:2015 & ISO 14001:2015?
To provide a framework for a QMS & EMS that can be used by organizations to improve customer satisfaction and meet regulatory requirements
What is the purpose of the "Management Review" clause in ISO 9001:2015 & ISO 14001:2015?
To evaluate the effectiveness of the QMS/EMS, identify opportunities for improvement, and ensure its continuing suitability, adequacy, and effectiveness.
What is the difference between a nonconformity and an observation?
A NC is a failure to meet a specific requirement of the QMS/EMS, while an observation is a potential area for improvement that is not necessarily a NC.
What is the importance of risk-based thinking in auditing?
Risk-based thinking helps auditors to identify areas of the QMS/EMS that are most critical to the organization's success and to focus their audit activities accordingly.
What is the role of the "top management" in ISO 9001:2015?
To provide leadership and commitment to the QMS, ensure that it is implemented and maintained, and continually improve its effectiveness.
What is the difference between a "document" and a "record" in ISO 9001:2015?
A document is information that is created, maintained, and controlled by the organization, while a record is evidence of the implementation of the QMS
What is the purpose of the "Control of External Providers" clause in ISO 9001:2015?
To ensure that external providers are selected and evaluated based on their ability to meet the organization's quality requirements, and to monitor their performance.
What is the meaning of "continual improvement" in ISO?
It is the ongoing process of enhancing the effectiveness of the QMS/ EMS and the organization's performance.
What are the key principles of auditing?
The key principles of auditing include integrity, objectivity, confidentiality, competency, and due care
What is the purpose of the "Context of the Organization" clause in ISO 9001:2015?
To ensure that the organization considers all internal and external factors that can affect its ability to achieve the intended results of its QMS
What is the meaning of "documented information" in ISO 9001:2015?
It refers to information that is created, captured, and maintained as evidence of the implementation of the QMS
What is the purpose of the "Internal Audit" clause in ISO 9001:2015 & ISO 14001:2015?
To evaluate the effectiveness of the QMS/ EMS and identify opportunities for improvement.
What is the purpose of the "Risk-based thinking" approach in ISO?
To identify and address potential risks and opportunities that can affect the performance of the QMS/ EMS and the organization's ability to achieve its objectives
What is the difference between "nonconformity" and "corrective action" in ISO?
Nonconformity (NC) is the non-fulfillment of a requirement of the QMS/EMS, while corrective action is the action taken to eliminate the cause of a NC and prevent its recurrence