ISO 9001 CHAPTER 4 Flashcards
What is the primary focus of Chapter 4 of ISO 9001?
Support, which includes ensuring the necessary resources, competence, awareness, and communication to effectively implement and maintain the QMS.
What are “resources” in the context of ISO 9001?
Resources refer to personnel, infrastructure, work environment, and other organizational assets required to implement and maintain the QMS.
Why is competence important in ISO 9001?
Ensuring that all personnel are competent and qualified for their roles ensures the effective functioning of the QMS and the achievement of quality objectives.
What does ISO 9001 require organizations to do regarding employee competence?
Determine the necessary competence, provide appropriate training, and ensure that employees can demonstrate their ability to perform their roles.
How should organizations ensure the continual competence of employees?
By providing ongoing training, evaluating performance, and maintaining records of qualifications and certifications.
What is the purpose of “awareness” in ISO 9001?
Employees must be aware of the quality policy, their role in the QMS, and how their actions contribute to achieving the organization’s quality objectives.
How should awareness be communicated within an organization according to ISO 9001?
Through regular communication, training, and updates, ensuring that employees understand the relevance and importance of their tasks.
What does the term “communication” refer to in ISO 9001?
The internal and external exchange of relevant information to ensure that the QMS operates effectively.
What are the key elements of communication in the QMS?
What needs to be communicated, who will receive the communication, how it will be communicated, and when communication will take place.
Why is external communication important in ISO 9001?
To ensure that stakeholders, such as customers and suppliers, are kept informed about relevant aspects of the QMS and quality performance.
What is “documented information” in ISO 9001?
Documents and records that provide evidence of QMS compliance and support the operation of the organization.
What is the difference between “document” and “record” in ISO 9001?
A document provides information and instructions, while a record provides evidence of completed activities and achievements.
What are the requirements for “control of documented information” in ISO 9001?
Organizations must ensure that documented information is available, adequately protected, and properly controlled.
How should organizations control access to documented information?
By defining roles and responsibilities for creating, updating, accessing, and deleting documents to ensure proper use and security.
What is the importance of infrastructure in ISO 9001?
Infrastructure (e.g., buildings, equipment, IT systems) must support the QMS and be maintained to ensure process reliability.
How should organizations manage infrastructure in the QMS?
Through regular maintenance, calibration of equipment, and ensuring that infrastructure meets operational needs.
What does the “work environment” refer to in ISO 9001?
The physical, psychological, and environmental conditions under which work is performed, which can affect the quality of outputs.
How should organizations ensure a suitable work environment?
By managing factors such as safety, temperature, cleanliness, and ergonomics to maintain quality and employee well-being.
What role does “monitoring and measuring resources” play in ISO 9001?
It ensures that equipment used to monitor and measure processes and products is calibrated and maintained for accuracy and reliability.
What are the requirements for managing monitoring and measuring equipment?
Equipment must be calibrated, traceable to recognized standards, and controlled to prevent incorrect measurements.
What is the importance of “organizational knowledge” in ISO 9001?
It refers to the collective expertise and experience within the organization that supports QMS performance and continual improvement.
How should organizations manage their organizational knowledge?
By identifying, capturing, sharing, and protecting knowledge that is critical to maintaining the QMS and meeting quality objectives.
What does ISO 9001 say about retaining documented information?
Organizations must retain documented information as evidence of conformity and to ensure it is available when needed.
Why is it necessary to control the creation and updating of documented information?
To ensure that only authorized personnel can make changes, and that documents remain relevant and accurate.
What should organizations do when obsoleting or archiving documents?
Ensure that outdated documents are removed from circulation or marked as obsolete to prevent accidental use.
How does ISO 9001 handle external providers (suppliers) in terms of resources?
The organization must ensure that externally provided resources conform to requirements and contribute to the effectiveness of the QMS.
