New High Level Structure for

ISO Management Systems

Standards
10
th
International Quality Forum
Cartagena de Indias, Colombia
28
th
August 2014
Contents
1. What is a management system (MS)
2. ISO MS Standards (MSS)
3. The problem: proliferation of different MSS
4. The solution: High Level Structure (HLS)
5. Update on ISO 9001, ISO 14001 & ISO 45001
(former OHSAS 18001)
What is a management system?
ISO/IEC Directives Part 1
Management System (MS)
Set of interrelated or interacting elements
of an organization to establish policies
and objectives and processes
to achieve those objectives


Management Systems Standards
ISO/IEC Directives Part 1
Management Systems Standards (MSS)
Standard that provides requirements or
guidelines for organizations to develop and
systematically manage their policies,
processes and procedures in order to
achieve specific objectives.
Some well known MSS
ISO 9001:2008 Quality management systems -- Requirements
ISO 14001:2004 Environmental management systems -- Requirements with
guidance for use
ISO 50001:2011 Energy management systems -- Requirements with
guidance for use
ISO 22000:2005 Food safety management systems -- Requirements for any
organization in the food chain
ISO/IEC 27001:2013 Information technology -- Security techniques
Information security management systems -- Requirements
ISO 20121:2012 Event sustainability management systems -- Requirements
with guidance for use
ISO 39001:2012 Road traffic safety (RTS) management systems -
Requirements with guidance for use
ISO 13485:2003 Medical devices -- Quality management systems --
Requirements for regulatory purposes


Issues related to proliferation of MSS
Growing number of MSS => concern among users
slightly different structures
different definitions for same terms
often contradicting requirements
=> ISO TMB found a solution
a high level structure for all MSS!

Annex SL particularly useful for organizations that
choose to operate a single MS (sometimes called
integrated) that can meet the requirements of two or
more MSS simultaneously (without causing confusion
or conflict)
The MSS vision
All ISO management system requirements standards to be aligned
ISO to enhance the compatibility of these standards, through the
promotion of identical:
Clause titles
Sequence of clause titles
Text
Terms and definitions
Permission to diverge only where necessitated by specific
differences in managing their individual fields of application
High Level Structure (HLS) for MSS
In 2012 Annex SL added to the Supplement to the ISO/IEC
Directives, Part 1, Procedures Specific to ISO. It defines:
a) the proposal process for a new MSS
b) the rules for drafting a MSS using a common
approach
Three appendices are included in Annex SL:
Appendix 1: Justification criteria questions
Appendix 2: HLS, identical text, and common
terms and core definitions
Appendix 3: Guidance on HLS, identical text, and
common terms and core definitions
Annex SL High Level Structure
Introduction
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement

Find all the detail and text
on Annex SL structure in
ISO Directives free from ISO

Sub-clause structure (I)
4. Context of the organization
4.1.Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the XXX management system
4.4 XXX management system
5. Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
6. Planning
6.1 Actions to address risks and opportunities
6.2 Objectives and plans to achieve them
Sub-clause structure (II)
7. Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8. Operation
Operational planning and control

Sub-clause structure (III)
9. Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10. Improvement
10.1 Non conformity and corrective action
improvement

Status of implementation of
Annex SL for MSS Type A
7 standards have been published following Annex SL
ISO 30301; ISO 22301; ISO 20121; ISO 39001
ISO 14298; ISO 22313; ISO 27001
9 standards under revision or new standards using Annex SL
ISO 9001; ISO 14001; ISO 55001; ISO 18420; ISO 19228
ISO 19600; ISO 21101, ISO 34001; ISO 37101
5 standards published before Annex SL was introduced
ISO 22000:2005; ISO 28000:2007; ISO 30000:2009
ISO 50001:2011; ISO /IEC 20000-1:2011

New: introducing concept of Risk
The topic of risk will be addressed by TC/SC/PCs
based on:
the scope of their MSS
their discipline related risks
the risk that the management system itself is
not effective
Each discipline should clarify its need for a formal
risk management approach
Update on high profile MSS
ISO 9001Quality management systems -
Requirements

ISO 14001 Environmental management
systems- Requirements with guidance for
use

ISO 45001 Occupational health and safety
management systems Requirements (former
OHSAS 18001)
ISO 9001
Current status: public consultation (DIS)
Ballot dates: 10 July to 10 October 2014
Target publication date: October 2015

What is the scope of the revision?
The main changes relate to its format and the increased
importance on risk:
the same high-level structure used by other MSS which will
help companies implementing more than one standard
the identification of risk and risk control as requirements in
the standard
the requirement of top management to take a more active
role in aligning quality policies with business needs
a number of changes in terminology (also in ISO/DIS 9000)
ISO 14001
Current status: public consultation (DIS)
Target publication date: October 2015

What is the scope of the revision?
1. based on the ISO/TMB approved requirements and
application guidance related to the JTCG work on the High
Level Structure (HLS) for Management System Standards
(MSS) and its identical text, common terms and core
definitions (referred to as Annex SL Structure)
2. consider the final report of the ISO/TC 207/SC 1 "Future
Challenges for EMS" Study Group
3. ensure the maintenance and improvement of the basic
principles of ISO 14001: 2004, and also the retention and
improvement of its existing requirements
ISO 45001

Current status: working draft (CD expected July 2014)
Target publication date: October 2016
Scope:
This International Standard specifies requirements for an occupational health and safety (OH&S)
management system, with guidance for its use, to enable an organization to control its OH&S risks and
improve its OH&S performance. It does not state specific OH&S performance criteria, nor does it give
detailed specifications for the design of a management system.

This International Standard is applicable to any organization that wishes to:

a) establish an OH&S management system to eliminate or minimize risks to personnel and other
interested parties who could be exposed to OH&S hazards associated with its activities;

b) implement, maintain and continually improve an OH&S management system;

c) assure itself of its conformity with its stated OH&S policy;

d) demonstrate conformity with the requirements of this International Standard.
ISO 45001

Former OSHAS 18001 migrated to ISO using new HLS
1
st
Working Draft (Dec 2013) generated nearly 1300
comments (230 pages)
Most comments related to definition of Risk and how it
is treated in clause 6.1
Committee Draft expected July 2014
Ongoing issue of title: Occupational Health and Safety
(OH&S) or Occupational Safety and Health (OSH)
Recommendations for an OH&S MS auditing
competency requirements ( new Part to ISO/IEC 17021)


Highlights of changes in the revision
Includes requirements for visible involvement, support and
commitment from top management
Incorporates requirements for a strategic understanding of
environmental issues that are important to an organization
Expands environmental policy commitments from
prevention of pollution to a more proactive and positive
commitment to protect the environment from harm and
degradation
Emphasizes a focus on improving environmental
performance
Takes a life cycle perspective of environmental issues
related to the organizations products and services
Benefits to an organization
Implementation will reinforce the importance of
environmental management to the organizations
business strategy
By using a risk-based approach, an organization can
prioritize its environmental challenges and focus on
opportunities that provide a competitive advantage
The standardized format will enable organizations
implementing multiple management systems to
streamline their internal processes and reduce
conflicts and variation
Most importantly, it will help an organization fulfill the
environmental pillar of sustainable development
Questions
Thank you / Muchas gracias!!