This is a guest post by Lorri Hunt, a U.S. technical expert and task group monitor for the next revision to ISO 9001. She is an ASQ Senior member, an Exemplar Global lead auditor, a frequent contributor to quality publications and journals, and a speaker all over the world. She is the president of Lorri Hunt and Associates Inc.
Author’s Note: ISO 9001:2015 is still in the revision process and subject to change. Information in this blog should be used with caution when making changes to a quality management system or for legal agreements.
ISO 9001:2015 is currently at the Draft International Stage (DIS) with a scheduled publication date of September 2015. As organizations have gotten their first glance at the proposed changes, many have focused on specific words rather than what the requirements actually say. While a new structure demonstrates the biggest visual change, the standard also uses different words, in some cases, to explain requirements that have existed in ISO 9001 since its infancy.
Some of these changes are based on the fact that the text related to certain concepts is part of the standard structure and common text and definitions that have been established for every management system standard to follow. This includes documented information instead of documents and records, and the removal of terms such as the “quality manual” and “management representative.” Other terms have been changed by the technical experts who are drafting ISO 9001:2015. These include “external provider” instead of “supplier” and “applicability” instead of “exclusion.”
In all of these cases, the requirements that relate to them have not changed, just the term.
Requirements for assigning responsibilities and authorities are included in Clause 5.3 Organization Roles, Responsibilities and Authorities. All of the requirements for the role of management representative from ISO 9001:2008 are included with some minor enhancements. The ISO 9001:2015 DIS just doesn’t define the term.
The requirements that would have been included in the quality manual from ISO 9001:2008 are included in Clause 4.3 Determining the Scope of the Quality Management System and 4.4 Quality Management System and Its Processes. The information that was included in the quality manual must be maintained as documented information. It just doesn’t call the documented information a quality manual.
The requirements that were included under control of documents and control of records in ISO 9001:2008 are included in 7.5 Documented Information. Because there have been substantial changes in how documented information is controlled, the difference between a document and a record has become more difficult. To help users, the phrase “maintain documented information” is used when referring to the legacy term “document” and the phrase “retain documented information” is used when referring to the legacy term “record.” Organizations that have a quality management system that is compliant to ISO 9001:2008 requirements should be compliant to ISO 9001:2015 requirements.
In ISO 9001:2008, organizations could exclude requirements as long as they did not affect an organization’s ability to provide product that conformed to requirements. In the DIS, an organization can determine that a requirement does not apply if it does not affect the organization’s ability to ensure that a product or service conforms to requirements. This application must also be maintained as documented information according to the requirements in 4.3 Determining the Scope of the Quality Management System.
In each of these cases of change of terminology, many users see this as a reduction or change in requirements. However, there has not been a reduction in requirements. The change in terminology is simply providing a less prescriptive standard. As users begin the transition to ISO 9001:2015 and initiate a gap analysis to the requirements, it is important to not just consider the words that have been written, but the requirements that they represent.
Users of the standard can also continue to use whatever terminology they wish when implementing a quality management system. This concept is reinforced in Annex A.1 in the DIS for ISO 9001:2015.
Simply put, there is not a need to throw everything you have in your quality management system out, but ensure that your quality management system meets the new requirements in ISO 9001:2015 regardless of the terminology used.