ISO 9001:2015 Review 122

"ISO 9000 Overview" provides an introduction to the key components and requirements of ISO 9001:2015. This class discusses the standard's ten sections, along with describing the role of a quality management system (QMS) and ISO 9001:2015'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 improvement.

ISO 9001:2015 is an internationally recognized standard that outlines the requirements of an effective, organized quality system. Many organizations are becoming ISO 9001:2015 registered to prove their commitment to product quality and customer service. Although streamlining documentation and implementing change can be a challenge, ISO 9001:2015 can create a more goal-oriented, connected, and efficient organization. This class helps new practitioners familiarize themselves with ISO 9001:2015's structure, content, and purpose in quality management.

Class Details

Class Name:
ISO 9001:2015 Review 122
Description:
"ISO 9000 Overview" provides an introduction to the key components and requirements of ISO 9001:2015. This class discusses the standard's ten sections, along with describing the role of a quality management system (QMS) and ISO 9001:2015'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 improvement.

ISO 9001:2015 is an internationally recognized standard that outlines the requirements of an effective, organized quality system. Many organizations are becoming ISO 9001:2015 registered to prove their commitment to product quality and customer service. Although streamlining documentation and implementing change can be a challenge, ISO 9001:2015 can create a more goal-oriented, connected, and efficient organization. This class helps new practitioners familiarize themselves with ISO 9001:2015's structure, content, and purpose in quality management.
Version:
2.0
Difficulty:
Beginner
Number of Lessons:
23

Class Outline

  • ISO 9000 Series
  • ISO 9000 Background
  • ISO 9000 Contents
  • Quality Management Principles
  • The Importance of Process
  • ISO 9000 and Quality Management Principles Review
  • ISO 9001:2015 Components
  • Context of the Organization
  • Leadership
  • Planning
  • ISO 9001:2015 Sections 1-6 Review
  • Support
  • Documented Information
  • Operation
  • Performance Evaluation
  • Internal Audits and Management Reviews
  • Improvement
  • ISO 9001:2015 Sections 7-10 Review
  • Types of ISO 9001 Companies
  • Advantages of ISO Registration
  • ISO Registration Steps
  • The Audit Process
  • ISO 9001:2015 Registration Review

Objectives

  • Describe the ISO 9000 series.
  • Describe the role of ISO.
  • Identify the documents comprising the ISO 9000 series.
  • Describe the seven quality management principles.
  • Describe process design.
  • Describe the key components of ISO 9001:2015.
  • Explain how an organization determines the scope of its QMS.
  • Describe the role of management in a quality management system.
  • Describe the purpose of quality objectives.
  • Describe resource management in a quality management system.
  • Describe the importance of documented information in a QMS.
  • Explain the methods for achieving conforming products and services in a QMS.
  • Describe how performance is evaluated for a QMS.
  • Describe internal audit and management review methods outlined in ISO 9001:2015.
  • Describe how improvement is achieved.
  • Describe ISO 9001 registered organizations
  • Identify the advantages of ISO 9001 registration.
  • Describe the steps required to obtain ISO 9001:2015 registration.
  • Describe the auditing process.

Certifications

Glossary

Vocabulary Term Definition
conform To meet all specified quality requirements. Only conforming outputs should be delivered to customers.
conformance The act of meeting all specified quality requirements. Only conforming outputs should be delivered to customers.
continual improvement The practice of constantly measuring the effectiveness of an organization's processes. Continual improvement must be implemented into a quality management system for it to be registered for ISO 9001.
continual improvement The practice of constantly measuring the effectiveness of an organization’s processes. Continual improvement must be implemented into a quality management system for it to be ISO 9000 certified.
controlled To monitor and make necessary changes as needed. Controlling documented information ensures that information is up to date, accurate, and undamaged.
corrective action A plan created to address nonconformance. Corrective actions lead to quality improvement.
corrective action A plan to address the causes of nonconformances. Corrective actions lead to quality improvement.
customer surveys A marketing tool that polls customers to discover their satisfaction with a given product or company. Customer surveys provide a way to find whether or not customer needs have been fulfilled.
documented information Data or evidence required to be retained and controlled by an organization in order for its QMS to be effective. Documented information should be preserved in whatever format best serves the needs of each individual organization.
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 9001.
external providers An organization that provides a product or service to another organization. External providers pass products and services in a chain to the organization and then to the customer.
external providers An organization that provides a product or service to another organization. Products and services are often passed in a chain from the external provider to the organization and then to the customer.
feedback A response, either positive or negative, to a product. Customer feedback is one method for analyzing customer satisfaction.
input A step or change that enters and contributes to a process. Understanding input is critical to designing effective processes.
inspection The examination of a part during or after its creation to confirm that it adheres to specifications. Inspection allows manufacturers to identify and correct product defects.
interested parties Any individual or organization that will be affected either positively or negatively by a decision or situation. Relationships with interested parties should be maintained for a successful quality management system to function.
internal audits An examination of a company's processes, products, and services conducted by the company's own staff. Internal audits are required by ISO 9001.
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. The International Organization for Standardization took its abbreviation ISO 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. The ISO abbreviation comes from the Greek word "isos," which means "equal."
ISO 9000 series A series of standards intended to guide an organization on the implementation and continual improvement of a QMS. ISO 9000 certification and registration indicates an organization is striving to meet the quality requirements of its customers.
ISO 9000:2015 One of the three main publications of the ISO 9000 series that describes the basics of the ISO series, defines vocabulary, and introduces the ISO quality standard. ISO 9000:2015 is titled "Quality Management Systems-- Fundamentals and Vocabulary."
ISO 9001:2015 The core standard of ISO 9000 that contains the requirements an auditor uses to verify conformity of a QMS. ISO 9001:2015 is titled "Quality Management Systems-- Requirements" and presents the actual material to which a company is certified.
ISO 9001:2015 The core standard of ISO 9000 that contains the requirements an auditor uses to verify conformity of a QMS. ISO 9001:2015 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 "Managing for the Sustained Success of an Organization-- A Quality Management Approach."
management reviews An examination of a company's processes, products, services, and overall functioning conducted by the company’s top management. Management reviews should identify areas for improvement and areas where the QMS could benefit from changes.
market share analysis A marketing tool that discovers how a company compares to its competitors in a given market. Market share analysis is one method for analyzing customer satisfaction.
measuring resources Any method used to inspect a product or service for adherence to specified requirements. Measuring resources can be measuring devices used to inspect parts or a measuring process that uses some other means to test quality, such as visual inspection.
nonconforming Failing to meet one or more specified quality requirements. Nonconforming products and services must be monitored and controlled for successful ISO 9000 implementation.
nonconformities The act of failing to meet one or more specified quality requirements. Nonconformities must be monitored and controlled for successful ISO 9001 implementation.
output The result of a process, such as a finished part. Outputs are the results of inputs.
primary standards A measurement standard with the highest quality used in a given nation. Primary standards are usually either national standards or international standards, depending on the nation and the context in which the standard is used.
processes A set of activities that uses resources to transform inputs into outputs. A process describes the way tasks are accomplished.
QMS Quality management system. The objectives and processes of a company that work together as a system to focus the company toward quality and customer satisfaction. A quality management system consists of written documents that address the ISO 9001:2015 standard.
quality Conformance to a set of standards or specifications that results in customer satisfaction in a product or service. Quality products are free of defects and meet the requirements of their anticipated use.
quality management system QMS. The objectives and processes of a company that work together as a system to focus the company toward quality and customer satisfaction. A quality management system consists of written documents that address the ISO 9001:2015 standard.
quality objectives Documented information in a QMS that outlines measurable outcomes toward which the entire organization works in order to fulfill the quality policy. Quality objectives are a requirement outlined in the sixth section of ISO 9001:2015.
quality policy Documented information in a QMS that reflects an organization's commitment to quality and continual improvement. The quality policy is established by the organization's top management.
registered Validation that a person or company has achieved a certain standard. Registration may be awarded by a school, a professional organization, or other governing body.
requirements A specific mandate that is contained in a standard. Requirements must be followed for an organization to achieve certification.
standard An established policy regarding a particular practice or method. Standards within the ISO 9000 family are concerned with establishing and managing quality systems.
surveillance audits A periodic audit performed by an external auditor to ensure that an organization still meets ISO 9001 requirements. Surveillance audits are required by ISO 9001.
traceable Verifying the history, application, or location of an item using documentation. Measuring resources must be traceable to primary standards.
warranty A statement guaranteeing a product's ability to function for a specific time period. A warranty guarantees that a manufacturer will replace or repair a defective product within a certain time frame.