- Module 1: Introduction to ISO 9001
- What is a Quality Management System (QMS)
- Purpose, Scope & Application of ISO 9001 2015
- Benefits of ISO 9001 2015
- Structure & Key Terms in ISO 9001 2015
- Module 2: Key Concepts of ISO 9001
- Risk Based Thinking (RBT)
- Process Based Approach
- Plan Do Check Act (PDCA) Cycle
- Module 3: Principles of Quality Management
- Quality Management Principles
- QMP 1: Customer Focus
- QMP 2: Leadership
- QMP 3: Engagement of People
- QMP 4: Process Approach
- QMP 5: Improvement
- QMP 6: Evidence-based Decision Making
- QMP 7: Relationship Management
- Module 4: Context of the Organization
- Clause 4.1 Context of the Organization
- Idea of Currency
- Clause 4.2 Needs and Expectations of Interested Parties
- Clause 4.3 Scope of the QMS
- Clause 4.4 QMS and its Processes
- Module 5: Leadership & Planning
- Clause 5.1 Leadership and Commitment
- Clause 5.1.2 Customer Focus
- Clause 5.2 Establishing the Quality Policy Requirements
- Clause 5.2.2 Communicating the Quality Policy Requirements
- Clause 5.3 Organizational Roles, Responsibilities and Authorities
- Overview of Clause 6 Planning including Clauses 6.1, 6.2 & 6.3
- Module 6: Support
- Clause 7.1 Resources
- Clause 7.2 Competence
- Clause 7.3 Awareness
- Clause 7.4 Communications
- Clause 7.5 Documented Information Requirements
- Module 7: Operation
- Clause 8.1 Operational Planning and Control
- Clause 8.2 Requirements for Products and Services
- Clause 8.3 Design and Development of Products and Services
- Clause 8.4 External Providers
- Clause 8.5 Production and Service Provision
- Clause 8.6 Release of Products and Services
- Clause 8.7 Control of Non-Conforming Outputs
- Module 8: Performance & Improvement
- Clause 9.1 Monitoring, Measurement, Analysis and Evaluation
- Clause 9.2 Internal Audit Requirements
- Clause 9.3 Management Review
- Clause 10.1 Improvement
- Clause 10.2 Non-conformity and Corrective Actions
- Clause 10.3 Continual Improvement
- Module 9 - Introduction to QMS Auditing
- Internal Audit Requirements
- Introduction to ISO 19011 2018
- Onsite & Remote Audits
- Principles of Auditing
- Audit Lifecycle
- Auditor Roles & Responsibilities
- Desired Auditor Behaviour
- Module 10 - Audit Initiation and Preparation
- Audit Planning
- Audit Scope, Objectives and Criteria
- Initiating the Audit
- Selection of Audit Team
- Document Review
- Preparing Audit Activities
- Internal Audit Plan
- Audit Checklist
- Module 11 - Conducting Audit Activities
- Audit Activities Workflow
- Conducting the Audit
- Opening Meeting
- Communication during an Audit
- Collecting & Verifying Information
- Generating Audit Findings
- Non-Conformity Grading
- Module 12 - Audit Report, Close and Following Up the Audit
- Non-Conformity Reporting
- Closing Meeting
- Audit Report & Distribution
- Completing the Audit
- Audit Follow Up Activities
Blended Course Format
This course is split into a blend of 6hrs of eLearning that is completed first before attending a 1-day of skills-based Live Instructor Workshop.
On completion, successful Learners will have the knowledge needed to:
- Explain the purpose of a quality management system, of quality management systems standards, and the business benefits of improved performance of the quality management system
- Outline the structure and content of ISO 9001 and its relationship with ISO 9000
- Explain the specific quality management-related requirements of ISO 9001
- With reference to the PDCA cycle, explain the process based QMS Model for ISO 9001 2015 and the role of an internal auditor in the maintenance and improvement of Quality Management Systems
- Explain the role and responsibilities of an auditor to plan, conduct, report, and follow-up an internal audit in accordance with ISO 19011:2018
In order to successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for
- Fully attend the Live Instructor Workshop as 100% attendance is required
- Obtain 70% or higher in the graded assessments during the Live Instructor Workshop
Recommended Prior Learning
Before completing this course, each Learner should have the following prior knowledge:
- It is recommended that anyone wishing to attend this course has some work-based experience in Quality Management (based on ISO 9001)
- The Plan, Do Check, Act (PDCA) Cycle
- The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.
ISO 9001 Requirements
- Knowledge of the requirements of ISO 9001 and the commonly used quality management terms and definitions
Fluency in spoken and written English
- For participants whose first language is not English, we recommend a minimum English language competency of IELTS 5.5 (or equivalent) for successful completion of the program. This is not assessed by Comply Guru in advance & each participant must self-assess their competency.
ISO 9001 2015
Each participant requires a copy of the standard in completing this course. This is not provided by Comply Guru & without it, this course will be extremely challenging to complete.
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well.
Click here to read the full technology requirements.
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