ISO 9001:2015 - What Is New?
Summary of Changes
- New Structure
- New Wording
- New Clauses
- Changed Clauses
How Am I Affected?
The ISO 9001 family of standards is reviewed and revised by its publisher (the International Organization for Standardization "ISO") approximately every 7 - 8 years. The latest revision was published on September 23, 2015; it is called ISO 9001:2015 (the ":2015" indicates the year of revision).
Each revision of the ISO 9001 standard may introduce new or changed requirements and/or a different structure of the standard; in some cases, only the wording is changed for the sake of clarity.
Previous versions of the ISO 9001 standard are: ISO 9001:1994 (along with ISO 9002 and ISO 9003), ISO 9001:2000, and ISO 9001:2008. The 1994, 2000 and 2008 versions are obsolete and certifications are no longer valid (all ISO 9001:2008 certifications expired in September 2018).
ISO 9001:2015 is the newest revision of the ISO 9001 standard. ISO 9001:2008, the previous revision, remained valid and applicable along with ISO 9001:2015 during a 3-year transition period.
With the publication of ISO 9001:2015 on September 23, 2015, the 3-year transition period started. During those three years, both revisions of ISO 9001 remained valid in order to give companies sufficient time to upgrade their certification. By September 2018, all ISO 9001:2008 certifications should have transitioned to ISO 9001:2015. Companies that missed the transition deadline lost their ISO 9001 certification.
Summary of Changes
Here is a summary of the changes in the ISO 9001:2015 standard compared to ISO 9001:2008:
ISO 9001:2015 is based on a new high-level framework that will be common to all ISO management systems standards. The purpose is to simplify the integration of ISO 9001 with other management standards (for example, ISO 14001). The new framework leads to a change in the structure of the ISO 9001 standard.
The new structure of ISO 9001:2015 requirements:
Section 4: Context of the organization
Section 5: Leadership
Section 6: Planning
Section 7: Support
Section 8: Operation
Section 9: Performance evaluation
Section 10: Improvement
Note: sections 1-3 remain introductory and explanatory sections (scope, normative references, terms and definitions).
It is important to note that the structure of the ISO 9001:2015 standard is intended to provide a coherent presentation of the ISO 9001 requirements. It is NOT intended to be a model for your company's ISO 9001 documentation. In other words, you may or may not use the new structure and numbering system for your procedures and related documentation.
In order to facilitate better integration with other ISO standards, the new high-level framework also incorporates a change of wording.
The new wording includes:
The term "products" has been replaced by "products and services" to make it clearer and easier for service providers
The terms "documentation", "documented procedures", "records", and "quality manual" have all been replaced by the term "documented information"
The term "work environment" has been replaced by the term "environment for the operation of processes"
The term "monitoring and measuring equipment" is now referred to as "monitoring and measuring resources"
The term "purchased product" has been replaced by the term "externally provided products and services" partially in order to make it clearer that services need to be considered as well
The term "supplier" is now called "external provider"
While people may argue if the new wording improves understanding or not, the good news is that you don't have to use the same wording. As with the structure, the change in wording was done in order to create a common framework for all ISO management standards.
ISO 9001:2015 introduces a number of completely new requirements that have not been part of any previous version of ISO 9001. These new requirements can be found in the following sections:
Section 4.1 "Understanding the Organization and its Context"
Section 4.2 "Understanding the Needs and Expectations of Interested Parties"
Section 4.4 "Quality Management System and its Processes"
Section 5.1 "Leadership and Commitment"
Section 6.1 "Actions to address Risks and Opportunities"
Section 6.3 "Planning of Changes"
Section 7.1.6 "Organizational Knowledge"
The most important of the new requirements in ISO 9001:2015 is the focus on risk management in section 6.1. While previous versions had a section on preventive action, the new 2015 version expands upon preventive action to create a complete section on risk management. This new requirement will be of great value for many small businesses that had previously not properly managed the internal and external risks to their very existence.
Changes to Existing Requirements
Besides introducing several completely new requirements, the 2015 revision also introduces some changes to existing requirements (i.e., requirements of the 2008 revision). You will need to make changes to your existing procedures, forms and flowcharts that cover the following topics:
Scope of the quality management system (as shown on your ISO 9001 certificate)
Control of Documents (section 4.2.3 in ISO 9001:2008)
Management Commitment (section 5.1 in ISO 9001:2008)
Customer Focus (section 5.2 in ISO 9001:2008)
Management Review (section 5.6 in ISO 9001:2008)
Human Resources (section 6.2 in ISO 9001:2008)
Customer Property (section 7.5.4 in ISO 9001:2008)
Corrective Action (section 8.5.2 in ISO 9001:2008)
Preventive Action (section 8.5.3 in ISO 9001:2008)
With the 2015 revision, top management gets more involved in ISO 9001. To prevent misunderstandings right away, this DOES NOT mean that top management has to engage in any bureaucratic paperwork or operational issues; it DOES mean that top management uses ISO 9001 as a useful tool to manage the business. Areas that some top management may have paid insufficient attention to in the past must now be addressed by top management in order to be an ISO 9001 certified business; these areas include top management's understanding of its overall market and business environment, as well as its internal strengths and weaknesses.
A somewhat smaller change is the increased focus on good communication within the company and with external parties, as well as the requirement for awareness (members of the company have to be aware of the consequences of their work or the failure of doing their work properly). Two new sections, 7.3 "Awareness" and 7.4 "Communication" are addressing those requirements.
Even more so than the 2008 version of ISO 9001, the new 2015 version better clarifies existing requirements as well as the intent of existing requirements. For example, the requirements for quality objectives, measurement and change are more detailed.
It is important to realize that those are not changes in requirements but merely clarifications of existing requirements that may have been wrongly applied or interpreted in the past. If, after careful review of the ISO 9001:2015 standard, you think that there are new and changed requirements beyond the ones we listed above, then you should consider this to be an indicator that your understanding of the 2008 version may not have been complete. If you have been using the 9001Simplified materials in the past, you don't need to be concerned as we always have been properly interpreting ISO 9001 requirements and their intent, and our materials have been reflecting this.
How Will ISO 9001:2015 Affect Me?
In general, ISO 9001 will have a positive impact as it is clearer and better than the previous standard. Those unfortunate companies that have had a bureaucratic ISO 9001 system in place will benefit the most as the 2015 revision will further help them get rid of bureaucracy and busywork. 9001Simplified customers, on the other hand, who have always had the benefit of an efficient and lean ISO 9001 quality management system, will see fewer changes in operations and documentation.
If You Are Completely New to ISO 9001
If you are planning on getting ISO 9001 certified for the first time, you will benefit from the improvements in the 2015 version right away. Our recommendation is that you start your ISO 9001 implementation as soon as possible. Don't delay enjoying the numerous benefits of ISO 9001. We offer excellent ISO 9001:2015 materials. Please take a look at the ISO 9001:2015 Certification Package; it's a comprehensive ISO 9001 implementation kit (free e-Consulting included so you won't get stuck).
If Your Company Missed the Transition Deadline
Many companies have missed the transition deadline of September 2018 and lost their ISO 9001:2008 certification. It's not the end of the world. Your company will need to contact your registrar to make an appointment for a new certification audit.
Preparing your company for the ISO 9001:2015 standard and certification audit is not difficult if your current ISO 9001:2008 system is working well. You only need to make modifications to your existing QMS to accommodate for the new and changed requirements.
The update will be rather pain-free with our ISO 9001:2015 Upgrade Package.
Summary of What You Need to Know
ISO 9001:2015 was published on September 23, 2015 and superseded ISO 9001:2008 (which was published in November 2008).
Existing ISO 9001:2008 certifications lost their validity in September 2018.
Companies that had been certified to ISO 9001:2008 can upgrade their QMS rather easily and then apply for a new ISO 9001 certification.
ISO 9001 will not be revised again until the year 2022 or later.
The 2015 revision brought some welcome changes in content and structure of the standard. The changes will affect companies with an inflexible and bureaucratic ISO 9001 system more; our own customers, on the other hand, have already benefited from an efficient and business-friendly ISO 9001 system and can expect further improvements.
Companies that are planning on ISO 9001 certification should implement ISO 9001:2015 as soon as possible.
Companies whose ISO 9001:2008 certification expired should upgrade their QMS and apply for new ISO 9001 certification.
We have ISO 9001:2015 upgrade kits available to make the transition to ISO 9001:2015 pain-free.
Stay Current With 9001Simplified
We are monitoring planned changes to ISO 9001 requirements as well as the latest interpretations of the ISO 9001 standard, and we are reviewing and revising our ISO 9001 templates, forms and guides to ensure that they are always current and fully compliant with all ISO 9001 requirements as well as with all accepted interpretations of ISO 9001 worldwide.
Our customers are always a step ahead as our materials not only meet the written word of ISO 9001 but also its spirit. Many of the apparent changes in ISO 9001:2015 are only clarifications of the intent of the 2008 version. Our materials have already included the intent and spirit of the 2008 version.
All our ISO 9001 materials are applicable to all countries worldwide, including your country.