What is ISO 9001:2015 – Quality management systems?
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.
Who Should Use the ISO 9001:2015 – Quality Management Systems Revision?
ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems.
Organizations of all types and sizes find that using the ISO 9001 standard helps them:
- Organize processes
- Improve the efficiency of processes
- Continually improve
All organizations that use ISO 9001 are encouraged to transition to ISO 9001:2015 as soon as possible. This includes not only organizations that are certified to ISO 9001:2008, but also any organizations involved in training or certifying others.
As of September 14, 2018 organizations that are currently registered to ISO 9001:2008 should have transitioned to the 2015 standard.
Guidance on transitioning from ISO 9001:2008 to ISO 9001:2015 can be downloaded from the International Accreditation Forum (IAF).
What Topics Does ISO 9001:2015 Cover?
ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization. Specific sections of the standard contain information on many topics, such as:
- Requirements for a quality management system, including documented information, planning and determining process interactions
- Responsibilities of management
- Management of resources, including human resources and an organization’s work environment
- Product realization, including the steps from design to delivery
- Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action
Changes introduced in the 2015 ISO 9001 revision are intended to ensure that ISO 9001 continues to adapt to the changing environments in which organizations operate. Some of the key updates in ISO 9001:2015 include:
- The introduction of new terminology
- Restructuring some of the information
- An emphasis on risk-based thinking to enhance the application of the process approach
- Improved applicability for services
- Increased leadership requirements
How do I get Started with ISO 9001:2015?
Whether you are beginning your ISO 9001 journey or transitioning to the 2015 revision, your first step is to purchase a copy of ISO 9001:2015.
Organizations and individuals that use ISO 9001 are encouraged to transition to the 2015 revision as soon as possible. However, the International Accreditation Forum (IAF) and the ISO Committee on Conformity Assessment (CASCO) agreed to a three-year transition period from the publication date of ISO 9001:2015. Therefore, organizations that are currently registered to ISO 9001: 2008 have until September 14, 2018 to transition to the new standard.
What are the Benefits of ISO 9001?
ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits, including satisfied customers, management, and employees.
Because ISO 9001 specifies the requirements for an effective quality management system, organizations find that using the standard helps them:
- Organize a quality management system (QMS)
- Create satisfied customers, management, and employees
- Continually improve their processes
- Save costs
In Nevada, the Clark County School District used ISO 9001 to save $174 million over 10 years in actual expenditures and cost avoidance. More than 3,000 employees were trained to the standard, enabling three critical components of the system’s success: training, communication and respect, and efficiency.
ISO 9001 Certification
ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify. Achieving ISO 9001:2015 certification means that an organization has demonstrated the following:
- Follows the guidelines of the ISO 9001 standard
- Fulfills its own requirements
- Meets customer requirements and statutory and regulatory requirements
- Maintains documentation
Certification to the ISO 9001 standard can enhance an organization’s credibility by showing customers that its products and services meet expectations. In some instances or in some industries, certification is required or legally mandated. The certification process includes implementing the requirements of ISO 9001:2015 and then completing a successful registrar’s audit confirming the organization meets those requirements.
Organizations should consider the following as they begin preparing for an ISO 9001 quality management system certification:
- Registrar’s costs for ISO 9001 registration, surveillance and recertification audits
- Current level of conformance with ISO 9001 requirements
- Amount of resources that the company will dedicate to this project for development and implementation
- Amount of support that will be required from a consultant and the associated costs
Note: ASQ does not issue ISO 9001 certification.
Training in the ISO 9001 Standard
Training can provide an opportunity to review the ISO 9001:2015 standard and apply quality management principles in a practice environment.
Professionals responsible for developing, implementing, auditing, and managing an ISO quality management system or quality professionals interested in updating their documented ISO 9001-based QMS can take ISO 9000 training courses, which include courses focused on ISO 9001 and quality management systems. Additionally, organizations looking to improve employee performance and employees looking to continually improve will also find ISO 9000 training relevant.
Previous Versions of ISO 9001
Originally published in 1987, ISO 9001 underwent revisions in 1994, 2000 and again in 2008. The latest revision was published in September 2015.
- ISO 9001:1994 included changes to improve the control of design and development clause, as well as provide other clarifications. The 1994 series also slightly modified the role of ISO 9002 and 9003.
- The ISO 9001:2008 revision sought to clarify issues raised during the application of ISO 9001:2000.
ISO 9001 Resources
The 2015 revision to ISO 9001, the international standard specifying requirements for quality management systems, has been published and is now available for purchase in these formats:
- Published hard copy
- PDF e-standard for immediate download (please note that e-standards cannot be printed)
- Site license for posting an electronic version to your Local Area Network or Intranet
Created by US TAG to ISO TC/176, this presentation is intended for use by the public in providing training on the importance of ISO 9000:2015 when it comes to understanding and implementing ISO 9001:2015.
Download the presentation slides.
Communicating ISO 9001:2015
Presentation slide decks and other documents to help communicate the message of ISO 9001:2015 are available from the ISO sub-committee, which is responsible for the development of International Standards and documents in the ISO 9000 series. Among the documents you can download from the ISO website are:
- ISO 9001:2008 to ISO 9001:2015--Summary of Changes
- "Risk-based Thinking" paper and presentation
- Transition Planning Guidance for ISO 9001:2015
- Correlation matrices between ISO 9001:2008 and ISO 9001:2015
- ISO 9001:2015 Frequently Asked Questions (FAQs)
ISO-focused articles from Quality Progress
Looking for a longer introduction to the ISO 9001 standard and the process approach? Read these popular open-access articles from QP magazine:
- Keep Calm and Prepare for ISO 9001:2015
- ISO 9001 Made Easy
- The Process Approach to QMS in ISO 9001 and 9004
- What's the Cost
This document provides guidance for the transition from ISO 9001:2008 to ISO 9001:2015 and has been prepared by the International Accreditation Forum (IAF) in cooperation with ISO/TC 176/SC 2/WG 23, the working group that focuses on communications and product support for standards including ISO 9001.
Details on the changes that took effect in the revision from ISO 9001:2008 to ISO 9001:2015.
Need to write a quality manual that conforms to ISO 9001:2008? Download an example quality manual and read about how to create one.
ISO 9001:2015 Books
- ISO 9001:2015 Internal Audits Made Easy, Fourth Edition
- ISO 9001:2015 Explained, Fourth Edition
- Memory Jogger ISO 9001:2015
- ISO 9001:2015 Handbook for Small and Medium-Sized Businesses, Third Edition
- How to Audit ISO 9001:2015
- How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements
- Using ISO 9001 in Healthcare
ISO 9001:2015 Articles and Case Studies
- Open to Change: How business sectors will handle revisions to their own guidance documents
- ISO 9001:2015 Transition Starts With Top Management: Why leadership needs to be directly involved in the transition to ISO 9001:2015
- A New Look: 15 things you need to know now about the 2015 revision of ISO 9001
- Brought Into Focus: How the revision introduces the concept of risk
- Standard Wise: View ISO 9001 as more than a QMS standard
- (E)Quality for All: You, Your Job, and ISO 9001
- Imaging Core Lab Takes Quality Beyond Regulatory Requirements with ISO 9001
- Get Your Ducks in a Row: A step-by-step guide to implementing a quality management system
- Using the Whole ISO 9000 Family
- Additional articles and case studies
ISO 9001:2015 Videos
- ISO 9001:2015--What You Must Know Now
- Transforming a QMS Using ISO 9001
- Team Builds ISO 9001 QMS on Wiki
- Additional videos
ISO 9001:2015 Webcasts
- Quality Management Systems: Background, Evolution, and Future of ISO 9001
- Quality Snapshot - Corrective Action - A Practical and Effective Approach for ISO 9001:2008 Webcast
- Quality Snapshot--Preventive Action and Its Linkage to Risk Management
- Lean ISO 9001
- Additional webcasts