ISO 9001:2015 DIS Version – What is Annex SL Platform?

ISO 9001 Quality Management System Review

A quarter of a century ago, in December 1987, ‘ISO 9001 Quality systems – Model for quality assurance in design/development, production, installation and servicing’ was published. This was the start of a global phenomenon which saw the range of ISO management system standards (MSS) expand through environment (1996) through to asset management (2014) and accredited certifications approach 1.5 million. So what is this event that will have such a significant impact on organizations, trainers, consultants, certification bodies, accreditation bodies, auditors and MSS writers? It is the publication of Annex SL (previously ISO Guide 83) which defines the framework for a generic management system. All new ISO MSS will adhere to this framework and all current MSS will migrate to the framework at their next revision.

The ISO 9001 Quality Management Systems standard is under review and an updated version is expected by the end of 2015. All ISO standards are reviewed every five years to make sure they remain helpful and relevant. First published in 1987, ISO 9000 “family series” has consistently been ISO’S most popular series of standards. The impending fifth revision provides further opportunity for organizations to take stock of their current practices and use this standard as the basis for the development of a Business Management System, to unlock the untapped value within their operations. ISO Technical Committee ISO/TC 176 Quality Management and Quality Assurance, sub-committee SC2, Quality Systems is busy laying the groundwork for the next generation of quality management standards. Of significance in this process is the use of the new “Annex SL” platform.

What is Annex SL Platform?

ISO has recently completed work on a common platform to provide identical structure, text and common terms and definitions for management systems standards of the future. This platform, known as Annex SL, will ensure consistency among future and revised management systems standards, make the standards easier to read and be understood by users, and greatly aid with the integration of multiple standards within one organization.

Annex SL is a new management system format that helps streamline creation of new standards, and implementation of multiple standards within one organization easier. It replaces ISO’s Guide 83, which provided a base structure and standardized text for management system standards (MSS). Guide 83 started to address complaints that many have when integrating current MSS like ISO 9001, ISO 14001, ISO 22000, and ISO 27001 which also help to relive much criticism from organizations integrating multiple management systems. While these standards have common elements, they are described and organized differently, making it difficult for organizations to implement multiple standards.

"Annex SL" further addresses these issues by creating a “template” upon which ISO MSS are to be built in the future. Written primarily as a guide to those who draft the standards, the core of Annex SL consists of 8 clauses and 4 appendices that encompass a “high level structure” (essentially shared high level concepts among standards), shared terms/ definitions and actual shared clause titles and text.  While these standards have common elements, they are described and organized differently, making effective integration difficult. The use of the same structure, as well as commonly used terms and definitions, will make it far easier, less time-consuming, and consequently cheaper to implement, integrate, and maintain standards. Annex SL is intended to enable organizations to enhance alignment among ISO’s management system standards, and to facilitate their implementation for organizations that may need to simultaneously meet the requirement of two or more such standards. To this end approximately 30% or so of each new and revised standard will contain identical text.

The intent is that in future where all new management system standards will have the same overall look and feel. Current standards will progressively migrate during their next phase.  In addition, Annex SL describes the framework for a generic management system. However, it will require the addition of discipline-specific requirements to make fully functional standards for systems such as quality, environmental, service management, food safety, business continuity, information security and energy management. Annex SL addresses the requirements for proposals for ISO MSS. As stated above it consists of eight clauses and four appendices. Appendix three is in three parts: high-level structure, identical core text and common terms and core definitions.

For MSSs writers, Annex SL will provide the template for their work. They can concentrate their development efforts on the discipline-specific requirements of their MSS, which will be focused on clause 8 – Operation. For management system implementers this will provide an overall management system framework within which they can pick and choose what discipline-specific standards they need to include. Gone will be the conflicts and duplication, confusion and misunderstanding from different MSSs. In future, all ISO MSSs should be consistent and compatible. For management system auditors, it will mean that for all audits there will be a core set of generic requirements that need to be addressed, no matter which discipline. And for IRCA auditor training, it could drive the development of training, addressing the common core set of requirements with additional training for discipline-specific requirements.

The major clause numbers and titles of all ISO management system standards will be identical, such as the introduction, terms and definitions and operation. The introduction, scope and normative references will have content which is specific to each discipline and each standard can have its own bibliography.

Overall, there is a reorganizing of management system requirements into this structure that may be unfamiliar. However, some management system standards have already successfully migrated to this new structure.

Identical Core Text

Annex SL has 45 ‘shall’ statements (generating 84 requirements). Obviously, each discipline will have their own requirements, so the total for any new standard will have more – this is the minimum.

Common Terms and Core Definitions

Annex SL Appendix 3 Clause 3 lists 22 terms and definitions. These can be in a separate standard, but they must be addressed; they cannot be deleted or changed.  Each standard can add their own additional terms and definitions if required. However, they can add or modify the notes.

Migration

The migration of most of the current management system standards should not prove arduous; ISO 22301:2012 was developed using a draft version of Annex SL and ISO 27001 is in the final stage of development (developed using the published version of Annex SL). The ISO 9001 requirements document has also started its revision cycle and if it is to be revised then it too will be developed using the published version of Annex SL.

New Structure

The new standard has 10 clauses.

ISO is in process of harmonizing all management system standards. For this a harmonized structure (Annex SL) has been developed. Some standards such as ISO 30301:2011 (Information and documentation – Management systems for records), ISO 22301:2012 (Societal security – Business continuity management systems), ISO 20121:2012 (Event sustainability management systems) have already been changed to this new structure and some other are in process of being revised to this new structure.

Process Approach

ISO 9001:2015 promotes the process approach beyond the existing requirements of ISO 9001:2008. Clause 4.4 (Quality management system and its processes) of the DIS provides specific requirements for adopting a process approach.

Preventive Action Vs Risk Management

One of the key purposes of implementing a quality management system is to act as a preventive tool. As a result the formal requirement related to preventive action is no more existing in the current draft. This is being replaced with risk based approach.

Although it is required by the organization to determine and address risks, there is no requirement for implementing a formal risk management process.

Context of the Organization

Two new clauses have been added to the draft standard.

4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties.

Quality Management Principles

So far the standard was based on eight quality management principles. In this standard the earlier existing eight principles have been reduced to seven quality management principles.

Products and Services

In 2008 version of the standard; the term "product" was used. This term also included services. In the Committee Draft issued in June 2013, this term was proposed to be changed to "Goods and Services". In this DIS the proposed term is "Products and Services".

Documented Information

2008 version of the standard had two separate terms: "documents" and "records". In the Committee Draft issued earlier it was combined together and called "documented information". The same term is maintained in the recently issued Draft International Standard.

Annex A of the DIS clarifies that where ISO 9001:2008 would have referred to documented procedures, it is now expressed as a requirement to maintain documented information.

Documented procedures in ISO 9001:2008 = Maintain documented information in ISO 9001:2015

And where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain documented information.

Records in ISO 9001:2008 = Retain documented information in ISO 9001:2015

No Exclusions

ISO 9001:2008 version allows organizations to exclude the standard requirements under the following conditions:

Exclusions are allowed for the requirements which cannot be applied due to the nature of the business.

Exclusions are limited to clause 7 (Product Realization) of the standard.

Such exclusions do not affect the organization's ability to provide products which meet the customer requirements and also the applicable legal requirements.

The new standard does not make any reference to exclusions. However in Annex A, the standard clarifies that the organization cannot decide a requirement to be not applicable if it falls under the scope of its QMS. Also non-applicability is not allowed if that could lead to failure to achieve the conformity or to enhance customer satisfaction.

Work Environment

The term "work environment" used in ISO 9001:2008 has been replaced with "Environment for the operation of processes".

Purchased Product

The term "purchased product" has been replaced with "externally provided products and services".

Supplier
The term "supplier" has been replaced with "External provider".

This does not meet that organizations would need to change this term in their QMS as well. Organizations can still maintain the term "supplier", "vendor", "contractor", "consultant" etc. as per their own need.