What is ISO 9001:2015 – Quality management systems?

Quality Glossary Definition: ISO 9001

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 9001:2015 revision?
• What are the benefits of ISO 9001?
• ISO 9001 certification
• ISO 9001 resources

Who Should Use the ISO 9001:2015 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 QMS, 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

The Seven Principles of ISO 9001:2015

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.

As of September 14, 2018 organizations that are currently registered to ISO 9001:2008 should have transitioned to the 2015 standard. 

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 Timeline

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 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

Read "What’s the cost?" for a checklist you can use to assess the costs of certifying to ISO 9001.

Note: ASQ does not issue ISO 9001 certification.

Courses 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. 

• 16 Hour ISO 9001: 2015 Lead Auditor Training Exemplar Global Certified
• Documentation in ISO 9001: 2015
• Implementing and Auditing an ISO 9001: 2015 Quality Management System
• ISO 9001: 2015 Certified Internal Auditor (Quality Management System Training)
• ISO 9001: 2015 Certified Lead Auditor (Quality Management System Training)
• ISO 9001: 2015 Foundations
• ISO 9001: 2015 Requirements from A to Z
• ISO Lesson Guide: 9001 2015 Made Easy
• More ISO 9001 courses

ISO 9001 Resources

You can also search articles, case studies, and publications for ISO 9001 resources.

ISO 9001:2015 Standard

The 2015 revision to ISO 9001, the international standard specifying requirements for quality management systems, is 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
• Request for Interpretation (RFI) for ISO 9001:2015 

Example Quality Manual

Need to write a quality manual that conforms to ISO 9001:2015? Download an example quality manual and read about how to create one. 

Books

• Cracking the Case of ISO 9001: 2015 for Manufacturing
• Cracking the Case of ISO 9001: 2015 for Service
• 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
• ISO 9001:2015 Explained
• The ISO 9001: 2105 Implementation Handbook
• ISO 9001:2015 Handbook for Small and Medium-Sized Businesses
• ISO 9001:2015 Internal Audits Made Easy
• The Magic of ISO 9001
• A Practical Field Guide For ISO 9001: 2015

Articles

• Auditing Strategy for ISO 9001:2015 (Journal for Quality and Participation) When standards and other frameworks are used as models for an organization’s processes, having a suitable audit strategy can ensure appropriate compliance and corrective action.
• The Influence Of Human Factors On ISO 9001:2015 Compliance (Journal for Quality and Participation) Understanding the importance of people is crucial to the success of any management system. The ISO 9001 model is no different.
• ISO 9001:2015 Transition Starts With Top Management (PDF) Why leadership needs to be directly involved in the transition to ISO 9001:2015.
• A New Look (Quality Progress) 15 things you need to know now about the 2015 revision of ISO 9001.

Case Studies

• (E)Quality for All: You, Your Job, and ISO 9001 (PDF) ISO 9001 certification affects everything from how your customers perceive you, to how effective your processes are, to your organization's ability/qualification to bid on major projects.
• Imaging Core Lab Takes Quality Beyond Regulatory Requirements with ISO 9001 (PDF) Though MMI’s ISO 9001 certification is recent, it is already seeing improvements to the timeliness of deliverables to clinical trial sponsors, an increase in quality awareness from the implementation, and positive feedback from sponsors.

Videos

• ISO 9001:2015 Overview As you get ready to implement or transition to ISO 9001:2015, it's helpful to get a high-level overview of the standard before jumping in. 
• ISO 9001:2015 - 15 Things You Must Know Now In this video interview, Paul Palmes discusses the ISO 9001 revision and key points organizations must consider as the draft international standard progresses through the development process.
• Team Builds ISO 9001 QMS on Wiki Learn how Geometrica, a dome manufacturer based in Texas and Mexico, involved its entire organization in documenting its quality management system for ISO 9001 certification using a Wiki.
• More ISO 9001 videos

Webcasts

• Improving Your QMS While Certifying to ISO 9001 Author Milt Dentch shares how organizations can go beyond ISO 9001:2015 compliance to substantially improve their quality management systems and the bottom line.
• Guidance on Conforming to ISO 9001:2015 Author Milton Dentch provides guidance on conforming to ISO 9001:2015.
• Lean ISO 9001 ISO 9001 expert Mike Micklewright walks through how and why documentation systems get out of control, what’s wrong with an overly lengthy documentation system, and how to get it back in control and make it more user friendly with the 5S lean tool.
• More ISO 9001 webcasts