What is the Difference Between ISO 9000 and ISO 9001? ISO 9000 is a family of standards that describe a Quality Management System. ISO 9001 is the document that contains the requirements. Companies register to ISO 9001. The other documents are very important and helpful in developing and improving quality management systems. In a nutshell, ISO 9000 standards describe a Quality Management System. ISO 9001 is a document that describes all of these requirements. Most companies will register to ISO 9001 and possess just one of the essential components in the family of documents. In this case, ISO 9001 describes only the requirements; whereas, ISO 9000 describes vocabulary, and ISO 9004 describes guidelines for improvements.
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 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
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, 2018organizations 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).
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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
The Seven Principles of ISO 9001:2015
Iso 9000 Ou 9001
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, 2018organizations 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
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
Read 'What’s the cost?' from Quality Progress for a checklist you can use to assess the costs of certifying to ISO 9001.
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.
ISO 9001 Resources
ISO 9001:2015
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:
- 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
Awareness and use of ISO 9000
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:
- IAF Transition Planning Guidance for ISO 9001:2015 (PDF)
- ISO 9001:2015 Frequently Asked Questions (FAQs) (DOC)
Transition planning guidance for ISO 9001:2015
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.
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.
ISO 9001:2015 Books
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ISO 9001:2015 Articles and Case Studies
- Keep Calm and Prepare for ISO 9001:2015 (Quality Progress) Eight experts outline key changes and how to handle them.
- ISO 9001 Made Easy(Quality Progress) Informative review of the eight sections that make up ISO 9001.
- The Process Approach to QMS in ISO 9001 and ISO 9004(Quality Progress) Revisions make the two standards more straightforward and applicable to all organizations.
- What's the Cost?(Quality Progress) Experts explain how to accurately estimate costs associated with obtaining ISO 9001 certification.
- What's Old is New Again: ISO 9001 revision planning is under way(Quality Progress) Details on the changes that took effect in the revision from ISO 9001:2008 to ISO 9001:2015.
- Open to Change(Quality Progress) How business sectors will handle revisions to their own guidance documents
- 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
- Brought Into Focus(Quality Progress) How the revision introduces the concept of risk
- Standard Wise(Quality Progress) View ISO 9001 as more than a QMS standard
- (E)Quality for All: You, Your Job, and ISO 9001 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.
- Get Your Ducks in a Row(Quality Progress) A step-by-step guide to implementing a quality management system
- Using the Whole ISO 9000 Family of Quality Management System Standards (PDF) There is a great deal of richness in the ISO 9000 family of documents and it is a shame for users to not know about and take advantage of the full range of possibilities.