People
The organization shall ensure that these people are aware of the quality policy, relevant quality objectives, their contribution to the effectiveness of the Quality Management System including the benefits of improved performance, and the implications of not conforming with the QMS requirements.
Who are " persons doing work under the organization's control"? (7.3)
The organization shall apply all the requirements of this document if they are applicable within the determined scope of the QMS.
What is "this International Standard"? (4.3)
This clause requires Top Management to ensure that the integrity of the QMS is maintained when changes to the QMS are planned and implemented.
What is "organizational roles, responsibilities , and authorities"? (5.3)
Top Management shall establish, implement, and maintain this item, which provides a framework for setting quality objectives.
What is "Quality Policy"? (5.2.1)
This is the organization to which the registration auditor belongs.
What is "Certification Body"? (CB)
Daily Double
Personnel performaing work affecting performance and effectiveness of the QMS shall be ______
on the basis of appropriate education, training, skills, and experience.
What is "competent"? (7.2)
To the extent necessary the organization shall maintain this type of document to support the operation of the processes.
What is "documented information"? (4.4.2)
This clause requires the organization to control and correct the cause of non conformities.
What is "Nonconformity and Corrective Action? (10.2)
This International Standard promotes the adoption of this when developing, implementing, and improving the effectiveness of the QMS.
What is "Process Approach"? (0.3.1)
The year the first ISO standard was published.
What was "1987"?
These people shal be informed promptly in the event that nonconforming product has been shipped.
Who are "customers"? (8.7.1)
These items provide the basis for calibration or verification.
What are "measurement standards"? (7.1.5.2)
This clause requires the organization to determine what will be done, what resources will be required, who will be responsible, when it will be completed, and how the results will be evaluated for acheiving quality objectives.
What is "Quality Objectives and Planning to Achieve Them"? (6.2.2)
This term is used to define the internal and external issues relevant to the organization's purpose and it's strategic direction.
What is "Context of the Organization"? (4.1)
Information marked as a "Note" in the standard is used for this.
What is "Guidance"?
These people shall take accountability for the effectiveness of the QMS.
Who are "top management"? (5.1.1)
Top management ensures that this includes a commitment to satisfy applicable requirements and continually improve the quality management system.
What is the "Quality Policy"? (5.2.1)
This clause requires the organization to determine, provide, and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.
What is "Infrastructure"? (7.1.3)
This term is described by the following: customer focus, leadership, engagement of people, process approach, improvement, evidence based decision making, and relationship management.
What are "Quality Management Principles? (0.2)
This "cycle" enables and organization to ensure that its processes are adequately resourced and managed and that opportunities for improvement are determined and acted on.
What is "PDCA cycle"?
These people are responsible for the ISO 9001:2015.
Who are the "Technical Committee ISO/TC 176"?
This is required when traceability is a requirement
What is "unique identification of the outputs"? (8.5.2)
This clause requires the organization to determine the risks and opportunities that need to be addressed.
What is "Actions to Address Risks and Opportunities"? (6.1.1)
This term describes the boundaries and applicability of the Quality Management System.
What is "scope"? (4.3)
Name one additional standard based on ISO 9001.
What is "ISO 14001, AS 9100, TS 16949, or ISO 13485"?