• Post category:StudyBullet-4
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Enhance your understanding of ISO 9001 clauses, risk-based thinking, and the principles of quality management

What you will learn

Clause-by-clause ISO 9001 explanation

Context of the Organization, Leadership, Planning, Support, Operations, Evaluation, Improvement

Seven Principles of Quality Management as per ISO 9000

Principles of Risk Management

Risk-Based Thinking

Description

Welcome to ISO 9001 Quality Management Knowledge and Understanding. This course is suitable for all levels.

I’ll teach you this course using a presentation and voiceover with background music.

I’ll be covering the following areas:

1. ISO 9001 Clause-by-clause overview and explanation

2. ISO 9000 Seven Principles of Quality Management

3. Risk-Based thinking


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Whenever I create a new ISO 9001 course covering an additional topic. I’m going to add it to this main course as well as a “compilation course”.

ISO 9001 is the focus of this course. There’s nothing more important in today’s market than the ability to effectively deliver value to your customers. It is only possible through efficient resources management, leadership, and identifying customer needs and requirements.

Any organization-type of any size and in any industry can implement ISO 9001. An organization can use it as a generic management system and tailor it to their needs.

ISO 9001 requires organizations to determine the needs and expectations of their interested parties. They then develop a system that enables them to fulfill the requirements. These requirements must be regularly evaluated and updated based on changing circumstances and trends.

ISO 9001 is a risk-based system. A core purpose of the entire management system is to prevent adverse events from occurring. Therefore, it’s vital to understand the risks associated with each activity, interested party, and internal or external factors. Furthermore, such assessments lead to the discovery of new opportunities. While analyzing different systems and communicating with interested parties, you will become aware of new opportunities. These can be opportunities for innovation, improved terms, and conditions, investments in new infrastructure, or new training opportunities.

A foundational concept of quality management is continual improvement. It means that leadership or top management must reassess the management system at regular intervals. There have to be procedures in place for them to evaluate and assess the effect of their actions. These reports can help them make better decisions in the future and restart the cycle of plan-do-check-act.

English
language

Content

Introduction

Clause 1-3

Clause 4 Context of Organization

4 Context of the Organization
4.1 Understanding the Organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management  system
4.4 Quality management system and its processes

Clause 5 Leadership

5 Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational Roles, Responsibilities, and Authorities

Clause 6 Planning

6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality Objectives and Planning to Achieve Them
6.3 Planning of Changes

Clause 7 Support

7 Support
7.1 Resource
7.1.5 Monitoring and Measuring Resources
7.2-4 Competence, Awareness, Communication

Clause 8 Operation

8. Operation
8.1 Operational Planning and Control
8.2 Determination of Requirements for Products  and Services
8.3 Design and Development of Products and Services
8.4 Control of Externally Provided Products and Services
8.5 Production and Service Provision
8.6 Release of Products and Services
8.7 Control of Nonconforming Process Outputs, Products, and Service

Clause 9 Performance Evaluation

9. Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal Audit
9.3 Management Review

Clause 10 Improvement

10. Improvement
10.1-3 Nonconformity and Improvement

Seven Principles of Quality Management

Customer Focus
Leadership
Engagement of People
Process Approach
Improvement
Evidence-based decision making
Relationship Management

Principles of Quality Risk Management

Introduction
Principles of Quality Risk Management
Risk Assessment
Risk Identification and Analyses
Risk Evaluation
Risk Control
Risk Communication
Risk Review

Risk-Based Thinking

Risk-Based Thinking
Plans to address risks
Definition
Risk in ISO 9001:2015
QMS and its processes
Leadership
Customer Focus
Planning
Evaluation
Management Review
Use of risk-based thinking
Use of risk-register