ISO 9001 Flashcards
Learn all about 9001
What is the main purpose of Clause 1 in ISO 9001:2015?
To define the scope and applicability of the standard to organizations.
What does ISO 9001:2015 aim to achieve?
Consistent product and service quality and enhanced customer satisfaction.
Is ISO 9001:2015 applicable to all types and sizes of organizations?
Yes, it is designed to be generic and applicable to any organization.
What must an organization demonstrate to conform to ISO 9001:2015?
Its ability to meet customer and regulatory requirements.
What is the normative reference for ISO 9001:2015?
ISO 9000:2015 – Fundamentals and vocabulary.
Why is ISO 9000:2015 important in the context of ISO 9001:2015?
It provides definitions and terminology needed to understand the standard.
Where are the terms and definitions for ISO 9001:2015 specified?
In ISO 9000:2015.
Why is using standard terminology important in ISO 9001:2015?
For consistent understanding and implementation of requirements.
What must an organization determine about its context?
Internal and external issues affecting its QMS.
Why should interested parties be identified?
Their needs can affect the QMS’s ability to deliver quality.
What must organizations determine about interested parties?
Their relevant needs and expectations.
What inputs are required to determine QMS scope?
Context, interested parties, products, and services.
What should the documented scope of the QMS include?
Types of products/services and justification for non-applicable requirements.
What does Clause 4.4 require regarding QMS processes?
They must be established, implemented, maintained, and improved.
What is required from top management under Clause 5?
Leadership and commitment to the QMS.
What must the quality policy align with?
The organization’s context and strategic direction.
What should top management promote?
Process approach and risk-based thinking.
What is the role of leadership in customer focus?
Ensuring customer needs are understood and met.
What must top management assign?
Roles, responsibilities, and authorities within the organization.
What must an organization address during planning?
Risks and opportunities that affect the QMS.
What should quality objectives be?
Measurable, consistent with policy, and regularly updated.
What does Clause 6.3 cover?
Planning of changes in a controlled manner.
What resources must be provided for the QMS?
People, infrastructure, environment, and organizational knowledge.
What does Clause 7.2 focus on?
Competence of personnel.
What should employees be aware of regarding the QMS?
Policy, objectives, and their contribution to effectiveness.
What is the purpose of internal communication?
To ensure people are aware of their role in the QMS.
What is required for documented information?
It must be controlled, maintained, and available when needed.
What does Clause 8 cover?
Operational planning and control to meet product/service requirements.
What is required before accepting a customer order?
A review of customer and statutory requirements.
What is included in design and development controls?
Planning, inputs, outputs, verification, and changes.
What does Clause 8.4 cover?
Control of externally provided processes, products, and services.
What is the purpose of post-delivery activities?
To meet customer and legal obligations after product delivery.
When can products/services be released to the customer?
After verification of conformity to requirements.
What must be done with nonconforming outputs?
Identify, control, and correct them.
What does Clause 9 require about performance?
Monitoring, measurement, analysis, and evaluation.
What must be done with customer feedback?
It must be collected and analyzed to gauge satisfaction.
What is the purpose of internal audits?
To check QMS conformance and effectiveness.
What should management reviews evaluate?
Performance, risks, customer feedback, and improvement needs.
What is the focus of Clause 10?
Continual improvement of the QMS.
What triggers corrective actions?
Nonconformities and complaints.
What should the organization aim to improve?
Products, services, and the QMS itself.
What evidence must be retained for corrective actions?
Description of nonconformities and actions taken.
