IQA Training Review Game

Under Clause 4.1 Understanding the organization and its context, the organization shall determine external and internal issues that are relevant to its purpose and its strategic direction ad that affect its ability to achieve the objectives in quality management system.

• True
• False

All QMS requirements are GENERIC and intended to be APPLICABLE to all organization, regardless type, size and product provided.

• True
• False

____________ shall demonstrate leadership and commitment with respect to the quality

• Auditors
• Top Management
• Quality Team
• Auditee

____________ is established for the quality management system and are compatible with the context and strategic direction of the organization.

• Individual Development Plan
• Risk Registry
• Quality Policy
• Audit Plan

When the organization determines the need for changes to the quality management system, the changes shall be carried out in a ________________.

• planned manner
• unexpected manner
• risky manner
• surprising manner

The organization shall maintain documented information on the quality objectives.

• True
• False

Infrastructure can include:

• Buildings and associated utilities
• Equipment (including hardware and software), information and communication technology
• Transportation resources
• All of the above

What is an example of organizational knowledge that can be based on internal resources?

• Standards
• Conferences
• Intellectual Property
• Knowledge from customers

The organization’s quality management system shall not include documented information required by International Standard.

• True
• False

ISO 9001:2015 clause that states, “The organization shall ensure that persons doing work under the organization’s control are aware of the quality policy; quality objectives; their contribution to the effectives of QMS; and implications of not conforming with the QMS requirements.”

• 7.1 Resources
• 7.2 Competence
• 7.3 Awareness
• 7.4 Communication