ISO 9000 Review 121

"ISO 9000 Overview" provides an introduction to the key components and requirements of ISO 9001:2008. This class discusses the standard's eight sections, along with describing the role of a Quality Management System (QMS) and ISO 9001:2008's connection to other standards in the ISO 9000 series. "ISO 9000 Overview" also outlines the steps to registration, the auditing process, and the importance of continuous improvement.

ISO 9001:2008 is an internationally recognized standard that outlines the requirements of an effective, organized quality system. Many organizations are becoming ISO 9001:2008 certified to prove their commitment to product quality and customer service. Although streamlining documentation and implementing change can be a challenge, ISO 9001:2008 can create a more goal-oriented, connected, and efficient organization. This class helps new practitioners familiarize themselves with ISO 9001:2008's structure, content, and purpose in quality management.

Class Details

Class Name:
ISO 9000 Review 121
Version:
2.0
Difficulty:
Beginner
Number of Lessons:
25
Related 1.0 Class:
ISO 9000 Overview 110

Class Outline

  • What is ISO 9000?
  • Understanding ISO 9000
  • ISO 9000 Background
  • ISO 9000 Contents
  • Versions of ISO Documents
  • ISO 9000 Review
  • Quality Management Principles
  • ISO 9001:2008 Components
  • ISO 9001:2008 Components: In Detail
  • Quality Management System
  • The Importance of Documentation
  • Required Documentation
  • ISO 9001:2008 Components Review
  • Management Responsibility
  • Resource Management
  • Product Realization
  • The Importance of Process
  • Measurement, Analysis, and Improvement
  • QMS Requirements Review
  • Types of ISO 9000 Companies
  • Advantages of ISO Registration
  • ISO Registration Steps
  • The Audit Process
  • ISO 9001:2008 Registration Review
  • Continual Improvement

Objectives

  • Define ISO 9000.
  • Describe ISO 9000.
  • Describe the role of the International Organization for Standardization.
  • Identify the documents comprising the ISO 9000 series.
  • Distinguish between the different versions of ISO 9000.
  • Describe the eight Quality Management Principles.
  • Describe the key components of ISO 9001:2008.
  • Define the Quality Management System.
  • Describe the importance of documentation in a QMS.
  • Identify key documents of a QMS.
  • Describe the role of management in a Quality Management System.
  • Define resource management in a Quality Management System.
  • Define product realization for a Quality Management System.
  • Describe process design.
  • Describe process analysis and improvement for a Quality Management System.
  • Identify industries suitable for ISO 9000 certification.
  • Identify the advantages of ISO 9000 certification and registration.
  • Describe the steps required to obtain ISO 9001:2008 certification and registration.
  • Describe the auditing process.
  • Define continual improvement.

Job Roles

Certifications

Glossary

Vocabulary Term Definition
crucial activities Procedures that must be defined and outlined so an organization is prepared for continual improvement. The six crucial activities of ISO 9000 include Control of Documents, Control of Records, Internal Auditing, Control of Nonconforming Product, Corrective Action, and Preventive Action.
external auditor An individual outside of the organization who objectively assesses the effectiveness of the organization's quality system. External auditors are required to register with ISO 9000.
input A step or change that enters and contributes to a process. Understanding input is critical to designing effective processes.
International Organization for Standardization ISO. A non-governmental organization based in Switzerland that develops and establishes standards, rules, and guidelines designed to ensure that products, processes, and services are fit for their purposes. ISO took its short-form name from the Greek word "isos," which means "equal."
ISO International Organization for Standardization. A non-governmental organization based in Switzerland that develops and establishes standards, rules, and guidelines designed to ensure that products, processes, and services are fit for their purposes. ISO took its short-form name from the Greek word "isos," which means "equal."
ISO 9000 A series of standards intended to guide an organization on the implementation and continual improvement of a QMS. Certification and registration to ISO 9000 indicates an organization is striving to meet the quality requirements of its customers.
ISO 9000:2005 One of the three main publications of the ISO 9000 series that describes the basics, defines vocabulary, and introduces the ISO quality standard. ISO 9000:2005 is titled "Quality Management Systems Fundamentals and Vocabulary."
ISO 9001:2008 The core standard of ISO 9000 that contains the requirements an auditor uses to verify conformity of a QMS. ISO 9001:2008 is titled "Quality Management Systems Requirements" and presents the actual material to which a company is certified.
ISO 9004:2009 One of the three main publications of the ISO 9000 series that describes additional recommendations a company can apply to improve their QMS. ISO 9004:2009 is titled "Quality Management Systems Guidelines for Performance Improvement."
output The result of a process, such as a finished part. Outputs are the results of inputs.
processes A set of activities that uses resources to transform inputs into outputs. Essentially, a process describes the way tasks are accomplished
Quality Management System QMS. The objectives and processes of a company designed to focus the company toward quality and customer satisfaction. The QMS consists of written documents that address the ISO 9001:2008 standard.
Quality Manual A key document of a QMS that outlines all existing practices and describes the interaction between processes, all of which affect the QMS. The Quality Manual is described in Section Four of ISO 9001:2008.
Quality Objectives A key document of a QMS that outlines measurable outcomes toward which all employees work in order to fulfill the quality policy. Quality Objectives are a requirement outlined in Section Four of ISO 9001:2008.
Quality Policy A key document of a QMS that reflects an organization's commitment to quality and continual improvement. The quality policy is disseminated to all employees, clearly posted in all facilities, and periodically reviewed.
shall statements A requirement, stated in plain language, designed to guide conformance to an ISO standard. The 136 shall statements within ISO 9000 include required records, required procedures, the quality manual, and other process requirements that must be established.
standard An established policy regarding a particular practice or method. The ISO 9000 family of standards is concerned with establishing and managing quality systems.
suppliers An organization that provides a product to another organization. Products are often passed in a chain, from the supplier to the organization to the customer.
surveillance audits A periodic audit performed by an external auditor to ensure that an organization still meets ISO 9000 requirements. Surveillance audits are required by ISO 9000.