Learning Outcomes

History of ISO 9001 Revisions

Process Approach And PDCA Cycle

Context Of Organization And Risk Based Thinking

Lesson Summary

Reading ISO 9001:2015 is often difficult to understand without having the basic knowledge of concepts discussed in the standard. Some of the basic concepts are Process Approach, PDCA Cycle and Risk based thinking. This module helps you to grasp those concepts which act as a foundation for Quality Management System.

Clauses on Planning of the Quality Management System

Clauses on the Operation of the Quality Management System

Clauses on the Check & Act of the Quality Management System

This module explains the existing auditable clauses of the standard along with all their requirements and guidelines. The clauses are explained in simple terms and with simple meaningful sentences. Auditable clauses are from Clause 4 to Clause 10, and it includes Context of Organization, Leadership, Planning, Support, Operation, Evaluation and Improvement.

Organization Knowledge

Internal Auditing

Management Review

Quality Management System is based on some essential elements. Some of these elements were present in ISO 9001:2008, but ISO 9001:2015 has added one more essential element (management of organizational knowledge), while the other two elements (internal audits and management reviews) are already part of the previous version. However, there are some changes in the latest version to these two elements as well.

ISO 9001:2015 - Quality Management System (QMS) - Course Assessment

In this free online ISO 9001 course learn how ISO 9001:2015 offers a framework for organizations to maintain QMS.

ISO 9001:2015 - Quality Management System (QMS)

This free online Quality Management Systems(QMS) course shows organizations how to maintain QMS according to the ISO 9001 standard. The standard was revised in September 2015 to incorporate some vital changes. This course explains all the clauses and changes to the standard and outlines the basic concepts of the standard to new learners. By taking this course, you will gain expertise, which will make you a valuable asset to companies worldwide.

Quality Management System of Medical Devices' Suppliers and Manufacturers

ISO 13485:2016 Important Terminologies

Publication of ISO 13485:2016 and Context of Publication

This module explains the existing relevant standards and regulation for medical devices' industry and enlightens the revision of ISO 13485. It also presents some important terminologies with related definitions as defined by ISO 13485; which are arranged in separate groups. It also covers the comparison of ISO 13485 to FDA 21 CFR Part 820. All mandatory documents required by different clauses of the ISO 13485:2016 standard are also enumerated in this module along with its given clause reference.

Quality Management System Requirements

Management Responsibility and Resource Management

Product Realization – Planning to Design and Development

Product Realization – Purchasing and Production

In this module you will learn the operations of the QMS for a medical devices company. It covers top management requirements and offers ideas to manage resource requirements in the organization. It enlightens the concept of medical devices' product realization. It covers all elements of product realization such as quality planning, customer related processes, design and development, purchasing and production etc.

Monitoring and Measurement

Control of Non-Conforming Product

Analysis and Improvement

In this module, Clause - 8 of the ISO 13485:2016 standard is taught. Clause - 8 specifies the general requirements, management of monitoring and measurement issues, nonconforming product management, data analysis etc. Within this clause - 8, Clause - 8.5 is on improvement which paves out ways for the organization to improve its system, products, and processes through the framework of corrective and preventive actions.

ISO 13485:2016 - Quality Management Systems for Medical Devices - Assessment

In this free online course learn about the requirements of Quality Management Systems for Medical Device organizations and its regulatory aspects.

ISO 13485:2016 - Quality Management Systems for Medical Devices

This free online ISO 13485 certification training course will teach you about quality management systems for medical devices. You will study the ISO 13485:2016 standard, learn how it was developed, and look into the practical steps to company certification on ISO 13485. You will cover the types of available personal certifications and look closely at standard terminologies related to stakeholders, product, QMS, Risk and Sterilization, and more!

Fundamentals of GMP and Safety

GMP: Requirements and Practices

Comprehending Pollution

Contamination Management

Contamination Prevention and Control

Sanitation and Hygiene GMP Essentials

This module delves into the core of GMP, emphasising the pivotal role of hygiene and preventing contamination. From personal hygiene standards to premises maintenance, pest control, and equipment safeguards, you will grasp the essence of maintaining a clean, compliant, and efficient manufacturing environment.

GMP Guidelines for Pharmaceuticals

GMP Management and Compliance

Overview of Food Industry GMP

Good Manufacturing Practices for the Food Trade

Industry-Specific GMP for Cosmetics

Manufacturing Processes and Guidelines for Cosmetics

GMP-Related IT Applications

This module uncovers the impact of IT systems on ensuring consistent product quality and safety for the pharmaceutical, food, and cosmetic industries. You'll navigate the intricacies of cGMP and GMP, grasping their value in a rapidly evolving landscape. You'll also gain insights into data integrity and how to maintain compliance proactively.

Good Manufacturing Practices (GMP) for Safeguarding Product Quality - Course Assessment

Take a step towards excellence by mastering Good Manufacturing Practices with our free online course.

Good Manufacturing Practices (GMP) for Safeguarding Product Quality

How can you integrate your existing talents into management and strategic controls? This all-inclusive course will teach you the GMP principles that control industrial production. Gaining this knowledge will facilitate your comprehension of sanitation protocols, the potential for contamination, the criticality of establishing customer confidence, and the adherence to ISO standards to guarantee consistent product quality.

Quality Engineers and Supplier Surveys

Conducting Formal Surveys in Supplier's Premises

Supplier Evaluation and Rating

In this module, you will learn to evaluate your role as a quality engineering supplier management. In this regard, you will learn about performing a formal survey at the supplier's premises and performing a thorough evaluation. The module also teaches you about rating your supplier and the contents to be added to your survey report.

Quality Engineer - Supplier Quality Evaluation & Management - Course Assessment

Learn how quality engineers conduct vendor surveys to ensure effective supplier management in this free online course.

Quality Engineer - Supplier Quality Evaluation & Management

This course for quality engineers provides the insights and tools required to perform effective supplier management. We outline the strategies, techniques and best practices used to ensure that materials and components meet quality standards and organizational specifications. We cover each aspect of this job, from supplier evaluation and selection to risk management and performance metrics. Sign up to enhance your quality management skills.

Costs of Quality and TQM Tools - Part 1

Costs of Quality and TQM Tools - Part 2

Costs of Quality and TQM Tools - Part 3

Costs of Quality and TQM Tools - Part 4

Costs of Quality and TQM Tools - Part 5

Costs of Quality and TQM Tools - Part 6

In this module you will learn about cost of quality means and how it is measured. It describes in detail how the ISO 9000 and QS 9000 standards function, and how quality measurement in service industries is carried out.

Module 2: Understanding Cost of Quality and TQM Tools Assessment

Learn about Quality Management standards and practices with this free TQM certification course on the Cost of Quality.

Understanding Cost of Quality and TQM Tools

This free online Total Quality Management(TQM) Certification Training course will show you how to implement a quality management system. Here you will learn that Cost of Quality is not about the cost of creating a quality product or service but rather the cost of not creating a quality product or service. It is essential that quality managers are familiar with Cost of Quality and important tools for improving Total Quality Management.

Quality Management and TQM

TQM and Risk Adjustment

Quality Control and Its Approach

In this module, you’ll be introduced to the fundamentals of quality management with real-world examples. You’ll be taught the principles and benefits of quality management and total quality management, including its history, benefits, drawbacks and more. We’ll teach you risk adjustments, data-based adjustments, quality control types and techniques.

Customers’ Expectations and Needs

Lean and Six Sigma

Supply Chain and Audit

This module introduces you to customers’ needs and expectations and how to determine them. You’ll then learn about Six Sigma, Lean and the application of Six Sigma. We’ll cover supply chain management, its components and management, including the importance of audits, the role of auditors and the audit cycle.

Achieving Excellence in Quality Assurance - Course Assessment

Learn how to use QA and QC to ensure high levels of customer satisfaction in this free online quality management course.

Achieving Excellence in Quality Assurance

Are you looking to enhance your methods and processes to achieve exceptional outcomes for your business? Do you aim to provide your customers with top-quality products and services? This quality management course provides cutting-edge techniques and strategies you can employ to boost business productivity and efficiency. We explain how to receive positive customer feedback for your products and services through quality assurance and excellence.

What is Reliability Engineering?

Reliability and Its Role in Improving Equipment Quality

Reliability and Redundancy

This module explains reliability engineering and its importance in ensuring the quality of the products. It also explains the main principles of reliability, along with the methods that ensure a product's reliability. It also looks at the concepts of reliability and redundancy in production management and different types of maintenance as well.

Stress-Strength Analysis and Distribution Curves

Design for Reliability (DfR) and Common Mechanical Failures

HALT/HASS Testing

In this module, you will learn about different graphs, analyses, and testing incorporated in reliability engineering techniques. It also explains the importance of Design for Reliability and common mechanical failures in mechanical products. The module also discusses HALT/HASS testing briefly.

Reliability Engineering (RE) Fundamentals - Enhanced Performance Level - Course Assessment

Learn about reliability engineering, and how it can help build and sustain quality products for manufacturers.

Reliability Engineering Fundamentals - Enhanced Performance Levels

Manufacturers find it very difficult to ensure that only the products with top notch quality make their way to the market. However, one of the various ways they can ensure their products' quality is reliability engineering. Reliability engineering is a set of principles and practices that help them ensure their products' sustainability longer than their anticipated life. This course will help you understand this concept more deeply and robustly.

Quality Assurance and Quality Control - Introduction

Why is Quality Assurance Important?

Quality Assurance in Software Engineering

Quality Assurance in Industrial Practices

This module introduces you to the fundamentals of Quality Assurance and Quality Control. It mentions the essential principles of QA and its industrial aspects and importance. The module also discusses the importance of QA and QC in software engineering and development and some of the most important QA certifications.

Quality Assurance (QA) - Techniques and Methodologies - Assessment

Learn how to ensure quality assurance (QA) and quality control (QC) in this free online quality management course.

Quality Assurance (QA) - Techniques and Methodologies

Quality assurance (QA) and quality control (QC) are integral concepts for any industry. This quality management course demonstrates the importance of these practices and explains how organizations implement them to ensure that only high-quality products reach consumers. We focus on the role of QA and QC practices within the software engineering and development industry. Sign up to launch your career as a trained quality management professional.

Introduction to Operations Management

Manufacturing versus Service Operations

The Systems View of Operations Management

This module introduces you to the concept of operations management, it explains the importance of operations management, historical development and the role of an operations manager.

Going further, you will learn the difference between manufacturing and service operations and the various planning processes in both operations.

Progressing, you will learn what 'operations as a system' means as well as understand how the transformation model works.

Finally, we will present the module summary.

Role of Strategy in Operations Management

Generating Ideas

Product Screening

Process Selection

Having learned what operations management is about, the module is designed to help the learner understand the role of strategy in operations management. It begins by outlining the strategies that could be employed in operations management. After that, the learner is exposed to the strategy hierarchy. Moving on, the module explains the concepts of idea generation, product screening, product development process, process selection and finally, computer-aided manufacturing/design.

Supply Chain Procurement

Supply Chain Distribution

Lean Manufacturing

Eliminating Waste

Just-in-time Systems

In this module, you will learn about the principles of Supply Chain Management, Lean Manufacturing and how to eliminate waste. You'll also learn about the Just-In-Time principles and how these principles can help reduce waste.

Capacity Planning

Facilities Layout

Location Planning and Analysis

In this topic, you will learn how manufacturing and service organizations can plan capacity to match customers' demands. Also, this topic will help you understand the concept of facility layout in organizations and help you understand the factors that should be taken into consideration when choosing a location for your business.

Job Design

Motion Study

Work Measurement

In this module, we will explore how operations managers use strategies like skill variety, task significance, or work organization to enhance job performance. We will also consider models for analyzing work to eliminate unnecessary tasks and regulate the duration of each stage in a production line.

Inventory - Learning Outcome

Inventory Management

Inventory Costs

Benefits and Dangers of Inventory Management

Inventory Control

In this module, you will learn the important practices of inventory management. You will be exposed to the concept of inventory control which will help you ensure that the right amount of inventory needed for production at a time is available.

Total Quality Management

Quality Inspections and Standards

Statistical Process Control

Producing for Quality

In this module, you will learn about the basics and practices of quality management. Since quality is one thing customers watch out for in a product or service, this module will help you understand the important things you need to know about quality management such as Total Quality Management (TQM) and Quality Inspections and Standards.

Course assessment

See how operations management can help you design products that meet your customers' needs with this free online course.

Diploma in Operations and Supply Management

This free online management course in operations and supply management presents you with all you need to optimize your manufacturing or service operations to satisfy your customers’ demands. This course provides a mix of ingredients needed to run a successful business. Operations management is a wide field of study but this course breaks it down into digestible steps to help you deliver services and products profitably.

Quality Assurance and Quality Control: Definitions and Importance

Business and Historical Aspects of Quality Assurance

Guidelines for Quality Control

P.D.C.A. Cycle and Quality Assurance Tools

Methods of Root Cause Analysis

This module covers critical quality and control concepts,  including the history, best practices, and trends in the field. You'll also learn about strategies and tools such as quality management systems, RCA, FMEA, SPC, and PDCA. These are vital for pinpointing and solving issues, enhancing operations, and assuring continuous improvement in Q.A.

The Role of Quality Control in the Software Business

Manufacturing and Service Industry Quality Control

L.E.A.N. Standards and Quality Assurance

Certifications in Quality Assurance

Quality Assurance as a Profession

This module covers software development, manufacturing, and service delivery quality control. You'll learn about techniques like statistical process control, Six Sigma, and lean manufacturing and how to use them effectively. You'll also learn about the certifications and competencies needed to become a successful Q.A. professional.

Fundamentals of Quality Assurance - Course Assessment

Learn how to maintain product excellence and client satisfaction in this free online quality management course.

Fundamentals of Quality Assurance

This quality management course is an ideal starting point if you want to work as a quality auditor or quality control engineer. We outline strategies you can use to ensure the high quality of your products and services in order to maintain high levels of customer satisfaction. We explain how to analyse key performance indicators (KPIs), manage risks and solve difficulties. These skills enable you to confront any challenge with confidence.

A free online course on inventory and quality management best practices that can help you reach your business goals.

Inventory and Quality Management

This free online certificate course will give you insights into the standard practices of proper inventory and quality management. The modules have been specifically developed around one of the most important aspects of an organization – operations. The course covers vital topics such as inventory control and quality inspections and standards, which can help you boost operational efficiency in your own business or department.

Development of Quality as a Competitive Advantage

Relevance of Quality Programs to Project Quality

Project Quality and Statistics

Planning and Controlling Project Quality

Assuring Quality

Learn about quality control in project management using statistics to interpret data, development of quality as a competitive advantage, relevance of quality programs to project quality, planning and controlling project quality, and assuring quality.

Defining Risk

Risk Management Process

Project Risk by Phases

Project Risk and the Project Complexity Profile

Evaluating risks for likelihood and impact is a key aspect of project management. In this module you’ll learn about defining, evaluating and managing risk, analyzing project risk by phases, and explore the relationship between project risk and the project complexity profile.

Identifying the Need for Resources Outside the Organization

The Procurement Plan

Selecting the Type of Contract

Procurement Process

Learn more about the procurement process in modern project management in this module from identifying the need for resources outside the organization, planning process for procurement, selecting the contract type, and the procurement process.

Project Closure

Learn more about the closure phase in modern project management in this module, from procedures for closing out contracts, to post-project review processes, documents to be archived, and project closeout celebrations.

Quality Control, Risk, Procurement and Project Closeout Assessment

Learn to take control of your project and ensure that goals are strategically aligned with this free online course.

Modern Project Management - Quality, Risk, Procurement and Project Closeout

This free online Project Quality Management course focuses on Quality, Risk, Procurement, and Project Closeout. A good project manager is the glue that holds a project together, ensuring quality and objectives are met on time and on budget. With this course, you will learn how to guide quality control procedures throughout the project life-cycle, assess risk, set up and run a project procurement system, and closeout projects successfully.

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