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Annex SL - ISO 9001: 2015

The document provides guidance on developing consistent management system standards across ISO. It establishes a common high-level structure, identical core text, and common terms and definitions to be used. The aim is to align requirements standards and enhance compatibility. Appendices provide the specific high-level structure, core text, and common terms for use in developing new or revised management system standards.
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0% found this document useful (0 votes)
195 views15 pages

Annex SL - ISO 9001: 2015

The document provides guidance on developing consistent management system standards across ISO. It establishes a common high-level structure, identical core text, and common terms and definitions to be used. The aim is to align requirements standards and enhance compatibility. Appendices provide the specific high-level structure, core text, and common terms for use in developing new or revised management system standards.
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Annex SL

(normative)

Proposals for management system standards

Appendix 2
(normative)

High level structure, identical core text and common terms and core definitions for use
in Management Systems Standards
1. Introduction
The aim of this document is to enhance the consistency and alignment of ISO management
system standards by providing a unif ying and agreed high level structure, identical core text
and common terms and core definitions. The aim being that all ISO management system
“requirements” standards are aligned and the compatibility of these standards is enhanced. It
is envisaged that individual management systems standard will add additional “discipline -
specific” requirements as required.

The intended audience for this document is ISO Technical Committees (TC), Subcommittees
(SC) and Project Committees (PC) and others that are involved in the development of
management system standards.

This common approach to new management system standards and future revisions of existing
standards will increase the value of such standards to users. It will be particularly useful for
those organizations that choose to operate a single (sometimes called “integrated”)
management system that can meet the requirements of two or more management system
standards simultaneously.

Appendix 3 to this Annex SL sets out the high level structure, identical core te xt and common
terms and core definitions that form the nucleus of future and revised ISO Type A
management system standards.

Appendix 4 to this Annex SL sets out guidance to the use of Appendix 3 to this Annex SL .
2. Use
ISO management system standards include the high level structure and identical core text as found in
Appendix 3 to this Annex SL. The common terms and core definitions are either included or
normatively reference an international standard where they are included.
NOTE The high level structure includes the main clauses (1 to 10) and their titles, in a fixed sequence. The
identical core text includes numbered sub-clauses (and their titles) as well as text within the sub-clauses

3. Non applicability
If due to exceptional circumstances the high level structure or any of the identical core text, common
terms and core definitions cannot be applied in a discipline-specific management system standard
then the TC/PC/SC needs to notify ISO/TMB through the ISO/TMB Secretary at tmb@iso.org of the
rationale for this and make it available for review by ISO/TMB.
NOTE TC/PC/SC strive to avoid any non-applicability of the high level structure or any of the identical core text,
common terms and core definitions.
4. Discipline-specific management system standards – using this document
Discipline-specific text additions are managed as follows.
1. Discipline-specific additions are made by the individual ISO/TC, PC, SC or other group that is
developing the specific ISO management system standard.
2. Discipline-specific text does not affect harmonization or contradict or undermine the intent of the
high level structure, identical core text, common terms and core definitions.
3. Insert additional sub-clauses, or sub-sub-clauses (etc.) either ahead of an identical text sub-
clause (or sub-sub-clause etc.), or after such a sub-clause (etc.) and renumbered accordingly.
NOTE 1 Hanging paragraphs are not permitted – see ISO/IEC Directives, Part 2, clause 5.2.4.
NOTE 2 Attention is drawn to the need to check cross referencing
4. Add or insert discipline-specific text within Appendix 3 to this Annex SL. Examples of additions
include:
– new bullet points
– discipline-specific explanatory text (e.g. Notes or Examples), in order to clarify
requirements
– discipline-specific new paragraphs to sub-clauses (etc.) within the identical text
– adding text that enhances the existing requirements in Appendix 3 to this Annex SL
5. Avoid repeating requirements between identical core text and discipline-specific text by adding
text to the identical core text taking account of point 4.2 above.
6. Distinguish between discipline-specific text and identical core text from the start of the drafting
process. This aids identification of the different types of text during the development and balloting
stages.
NOTE 1 Distinguishing options include by colour, font, font size, italics, or by being boxed separately etc.
NOTE 2 Identification of distinguishing text is not necessarily carried into the published version.
7. Understanding of the concept of “risk” may be more specific than that given in the definition
under 3.09 of Appendix 3 to this Annex SL. In this case a discipline-specific definition may be
needed. The discipline-specific terms and definitions are differentiated from the core definition,
e.g. (XXX) risk .
NOTE The above can also apply to a number of other definitions.
8. Common terms and core definitions will be integrated into the listing of terms and definitions in
the discipline-specific management system standard consistent with the concept system of that
standard.
5. Implementation
Follow the sequence, high level structure, identical core text, common terms and core definitions for
any new management system standard and for any revisions to existing management system
standard.
6. Guidance
Find supporting guidance in Appendix 4 to this Annex SL .
Appendix 3
(normative)

High level structure, identical core text, common terms and core definitions

NOTE In the Identical text proposals, XXX = an MSS discipline specific qualifier (e.g. energy,
road traffic safety, IT security, food safety, societal security, environment, q uality) that needs to
be inserted. Blue italicized text is given as advisory notes to standards drafters.

Introduction
NOTE Specific to the discipline.

1. Scope
NOTE Specific to the discipline.

2. Normative references
NOTE Clause Title shall be used. Specific to the discipline.

3. Terms and definition


NOTE Clause Title shall be used. Terms and definitions may either be within the standard or in a
separate document. To reference Common terms and Core definitions + discipline specific ones.

For the purposes of this document, the following terms and definitions apply.

NOTE 1 The following terms and definitions constitute an integral part of the “common text” for
management systems standards. Additional terms and definitions may be added as needed. No tes may be
added or modified to serve the purpose of each standard.
NOTE 2 Bold type in a definition indicates a cross-reference to another term defined in this clause, and the
number reference for the term is given in parentheses.
NOTE 3 Where the text “XXX” appears throughout this clause, the appropriate reference should be inserted
depending on the context in which these terms and definitions are being applied. For example: “an XXX
objective” could be substituted as “an information security objective”.
3.01
organization
person or group of people that has its own functions with responsibilities, authorities and relationships to
achieve its objectives (3.08)

Note 1 to entry: The concept of organization includes, but is not limited to sole-trader, company, corporation, firm,
enterprise, authority, partnership, charity or institution, or part or combination thereof, whether incorporated or not,
public or private.
3.02
interested party (preferred term)
stakeholder (admitted term)
person or organization (3.01) that can affect, be affected by, or perceive themselves to be affected by a
decision or activity

3.03
requirement
need or expectation that is stated, generally implied or obligatory

NOTE 1 to entry: “Generally implied” means that it is custom or common practice for the organization and interested
parties that the need or expectation under consideration is implied.
NOTE 2 to entry: A specified requirement is one that is stated, for example in documented information.

3.04
management system
set of interrelated or interacting elements of an organization (3.01) to establish policies (3.07) and
objectives (3.08) and processes (3.12) to achieve those objectives

NOTE 1 to entry: A management system can address a single discipline or several disciplines.
NOTE 2 to entry: The system elements include the organization’s structure, roles and responsibilities, planning,
operation, etc.
NOTE 3 to entry: The scope of a management system may include the whole of the organization, specific and
identified functions of the organization, specific and identified sections of the organization, or one or more functions
across a group of organizations.
3.05
top management
person or group of people who directs and controls an organization (3.01) at the highest level

NOTE 1 to entry: Top management has the power to delegate authority and provide resources within the
organization.
NOTE 2 to entry: If the scope of the management system (3.04) covers only part of an organization then top
management refers to those who direct and control that part of the organization.
3.06
effectiveness
extent to which planned activities are realized and planned results achieved

3.07
policy
intentions and direction of an organization (3.01) as formally expressed by its top management (3.05)

3.08
objective
result to be achieved

NOTE 1 to entry: An objective can be strategic, tactical, or operational.


NOTE 2 to entry: Objectives can relate to different disciplines (such as financial, health and safety, and environmental
goals) and can apply at different levels (such as strategic, organization-wide, project, product and process (3.12)).
NOTE 3 to entry: An objective can be expressed in other ways, e.g. as an intended outcome, a purpose, an
operational criterion, as an XXX objective or by the use of other words with similar meaning (e.g. aim, goal, or target).
NOTE 4 to entry: In the context of XXX management systems XXX objectives are set by the organization, consistent
with the XXX policy, to achieve specific results.
3.09
risk
effect of uncertainty

NOTE 1 to entry: An effect is a deviation from the expected — positive or negative.


NOTE 2 to entry: Uncertainty is the state, even partial, of deficiency of information related to, understanding or
knowledge of, an event, its consequence, or likelihood.
NOTE 3 to entry: Risk is often characterized by reference to potential events (ISO Guide 73, 3.5.1.3) and
consequences (ISO Guide 73, 3.6.1.3), or a combination of these.
NOTE 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including
changes in circumstances) and the associated likelihood (ISO Guide 73, 3.6.1.1) of occurrence.
3.10
competence
ability to apply knowledge and skills to achieve intended results

3.11
documented information
information required to be controlled and maintained by an organization (3.01) and the medium on which
it is contained

NOTE 1 to entry: Documented information can be in any format and media and from any source.
NOTE 2 to entry: Documented information can refer to
– the management system (3.04), including related processes (3.12);
– information created in order for the organization to operate (documentation);
– evidence of results achieved (records).
3.12
process
set of interrelated or interacting activities which transforms inputs into outputs

3.13
performance
measurable result

NOTE 1 to entry: Performance can relate either to quantitative or qualitative findings.


NOTE 2 to entry: Performance can relate to the management of activities, processes (3.12), products (including
services), systems or organizations (3.01).
3.14
outsource (verb)
make an arrangement where an external organization (3.01) performs part of an organization’s function
or process (3.12)

NOTE 1 to entry: An external organization is outside the scope of the management system (3.04), although the
outsourced function or process is within the scope.
3.15
monitoring
determining the status of a system, a process (3.12) or an activity

NOTE 1 to entry: To determine the status there may be a need to check, supervise or critically observe.
3.16
measurement
process (3.12) to determine a value

3.17
audit
systematic, independent and documented process (3.12) for obtaining audit evidence and evaluating it
objectively to determine the extent to which the audit criteria are fulfilled

NOTE 1 to entry: An audit can be an internal audit (first party) or an external audit (second party or third party), and it
can be a combined audit (combining two or more disciplines).
NOTE 2 to entry: “Audit evidence” and “audit criteria” are defined in ISO 19011.
3.18
conformity
fulfilment of a requirement (3.03)
3.19
nonconformity
non-fulfilment of a requirement (3.03)

3.20
correction
action to eliminate a detected nonconformity (3.19)

3.21
corrective action
action to eliminate the cause of a nonconformity (3.19) and to prevent recurrence

3.22
continual improvement
recurring activity to enhance performance (3.13)

4. Context of the organization


4.1 Understanding the organization and its context
The organization shall determine external and inter nal issues that are relevant to its purpose and
that affect its ability to achieve the intended outcome(s) of its XXX management system.

4.2 Understanding the needs and expectations of interested parties

The organization shall determine


¾ the interested parties that are relevant to the XXX management system, and

¾ the requirements of these interested parties.

4.3 Determining the scope of the XXX management system

The organization shall determine the boundaries and applicability of the XXX management
system to establish its scope.

When determining this scope, the organization shall consider

¾ the external and internal issues referred to in 4.1, and

¾ the requirements referred to in 4.2.

The scope shall be available as documented information .

4.4 XXX management system


The organization shall establish, implement, maintain and continually improve an XXX
management system, including the processes needed and their interactions, in accordance with
the requirements of this International Standard.

5. Leadership
5.1 Leadership and commitment

Top management shall demonstrate leadership and commitment with respect to the XXX
management system by
¾ ensuring that the XXX policy and XXX objectives are established and are compatible with the
strategic direction of the organization

¾ ensuring the integration of the XXX management system requirements into the organization’s
business processes

¾ ensuring that the resources needed for the XXX management system are available

¾ communicating the importance of effective XXX management and of conforming to the XXX
management system requirements

¾ ensuring that the XXX management system achieves its intended outcome(s)

¾ directing and supporting persons to contribute to the effectivene ss of the XXX management
system

¾ promoting continual improvement

¾ supporting other relevant management roles to demonstrate their leadership as it applies to


their areas of responsibility.

NOTE Reference to “business” in this International Standard should be interpreted broadly to mean those activities
that are core to the purposes of the organization’s existence.

5.2 Policy

Top management shall establish a XXX policy that

¾ is appropriate to the purpose of the organization

¾ provides a framework for setting XXX objectives

¾ includes a commitment to satisfy applicable requirements, and

¾ includes a commitment to continual improvement of the XXX management system.

The XXX policy shall

¾ be available as documented information

¾ be communicated within the organization

¾ be available to interested parties, as appropriate.

5.3 Organization roles, responsibilities and authorities

Top management shall ensure that the responsibilities and authorities for relevant roles are
assigned and communicated within the organization.

Top management shall assign the responsibility and authority for:

1. a) ensuring that the XXX management system conforms to the requirements of this
International Standard: and
2. b) reporting on the performance of the XXX management system to top management.

6. Planning
6.1 Actions to address risks and opportunities

When planning for the XXX management system, the organization shall consider the issues
referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and
opportunities that need to be addressed to

¾ assure the XXX management system can achieve its intended outcome(s)

¾ prevent, or reduce, undesired effects

¾ achieve continual improvement.

The organization shall plan:

3. a) actions to address these risks and opportunities, and

4. b) how to

¾ integrate and implement the actions into its XXX management system processes

¾ evaluate the effectiveness of these actions.

6.2 XXX objectives and planning to achieve them

The organization shall establish XXX objectives at relevant functions and levels.
The XXX objectives shall

¾ be consistent with the XXX policy

¾ be measurable (if practicable)

¾ take into account applicable requirements

¾ be monitored

¾ be communicated, and

¾ be updated as appropriate.

The organization shall retain documented information o n the XXX objectives.


When planning how to achieve its XXX objectives, the organization shall determine
¾ what will be done

¾ what resources will be required

¾ who will be responsible

¾ when it will be completed


¾ how the results will be evaluated.

7. Support
7.1 Resources

The organization shall determine and provide the resources needed for the establishment,
implementation, maintenance and continual improvement of the XXX management system.

7.2 Competence
The organization shall
¾ determine the necessary competence of person(s) doing work under its control that affects its
XXX performance, and

¾ ensure that these persons are competent on the basis of appropriate education, training, or
experience;

¾ where applicable, take actions to acquire the necessary competence, and evaluate the
effectiveness of the actions taken, and

¾ retain appropriate documented information as evidence of competence.

NOTE Applicable actions may include, for example: the provision of training to, the mentoring of, or the re-
assignment of currently employed persons; or the hiring or contracting of competent persons.

7.3 Awareness

Persons doing work under the organization’s control shall be aware of

¾ the XXX policy

¾ their contribution to the effectiveness of the XXX management system, including the b enefits
of improved XXX performance

¾ the implications of not conforming with the XXX management system requirements.

7.4 Communication
The organization shall determine the need for internal and external communications relevant to
the XXX management system including
¾ on what it will communicate

¾ when to communicate

¾ with whom to communicate.

7.5 Documented information

7.5.1 General

The organization’s XXX management system shall include


¾ documented information required by this International Standard

¾ documented information determined by the organization as being necessary for the


effectiveness of the XXX management system.

NOTE The extent of documented information for a XXX management system can differ from one organization to
another due to
— the size of organization and its type of activities, processes, products and services,
— the complexity of processes and their interactions, and
— the competence of persons.

7.5.2 Creating and updating

When creating and updating documented information the organization shall ensure appropriate

¾ identification and description (e.g. a title, date, author, or reference number)

¾ format (e.g. language, software version, graphics) and media (e.g. paper, electronic)

¾ review and approval for suitability and adequacy.

7.5.3 Control of documented information

Documented information required by the XXX management system and by this International
Standard shall be controlled to ensure
¾ it is available and suitable for use, where and when it is needed

¾ it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

For the control of documented information, the organization shall address the following activities,
as applicable
¾ distribution, access, retrieval and use,

¾ storage and preservation, including preservation of legibility

¾ control of changes (e.g. version control)

¾ retention and disposition

Documented information of external origin determined by the organization to be necessary for the
planning and operation of the XXX management system shall be identified as appropriate, and
controlled.
NOTE Access implies a decision regarding the permission to view the documented information only, or the
permission and authority to view and change the documented information, etc.

8. Operation
8.1 Operational planning and control

The organization shall plan, implement and control the processes needed to meet requirements,
and to implement the actions determined in 6.1, by

¾ establishing criteria for the processes


¾ implementing control of the processes in accordance with the criteria

¾ keeping documented information to the extent necessary to have confidence that the
processes have been carried out as planned .

The organization shall control planned changes and review the consequenc es of unintended
changes, taking action to mitigate any adverse effects, as necessary .

The organization shall ensure that outsourced processes are controlled.

9. Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
The organization shall determine
¾ what needs to be monitored and measured

¾ the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure
valid results

¾ when the monitoring and measuring shall be performed

¾ when the results from monitoring and measurement shall be analysed and evaluated.

The organization shall retain appropriate documented information as evidence of the results.
The organization shall evaluate the XXX performance and the effectiveness of the XXX
management system.
9.2 Internal audit
The organization shall conduct internal audits at planned intervals to provide information on
whether the XXX management system;
5. a) conforms to
¾ the organization’s own requirements for its XXX management system

¾ the requirements of this International Standard;

6. b) is effectively implemented and maintained.

The organization shall:

7. a) plan, establish, implement and maintain an audit programme(s), including the


frequency, methods, responsibilities, planning requirements and reporting . The audit
programme(s) shall take into consideration the importance of the processes concerned and the
results of previous audits;

8. b) define the audit criteria and scope for each audit;

9. c) select auditors and conduct audits to ensure objectivity and the impartiality of the
audit process;

10. d) ensure that the results of the audits are reported to relevant management, and
11. e) retain documented information as evidence of the implementation of the audit programme
and the audit results.

9.3 Management review


Top management shall review the organization's XXX management system, at planned intervals,
to ensure its continuing suitability, adequacy and effectiveness.

The management review shall include consideration of:


12. a) the status of actions from previous management reviews;

13. b) changes in external and internal issues that are relevant to the XXX management
system;

14. c) information on the XXX performance, including trends in:

¾ nonconformities and corrective actions

¾ monitoring and measurement results, and

¾ audit results;

15. d) opportunities for continual improvement.

The outputs of the management review shall include decisions related to continual improvement
opportunities and any need for changes to the XXX management system.
The organization shall retain documented information as evidence of the results of management
reviews.

10. Improvement
10.1 Nonconformity and corrective action
When a nonconformity occurs, the organization shall:

a) react to the nonconformity, and as applicable

¾ take action to control and correct it, and

¾ deal with the consequences;

16. b) evaluate the need for action to eliminate the causes of the nonconformity, in order
that it does not recur or occur elsewhere, by

¾ reviewing the nonconformity

¾ determining the causes of the nonconformity, and

¾ determining if similar nonconformities exist, or could potentially occur;

17. c) implement any action needed;

18. d) review the effectiveness of any corrective action taken; and


19. e) make changes to the XXX management system, if necessary.

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

The organization shall retain documented information as evidence of

¾ the nature of the nonconformities and any subsequent actions taken, and

¾ the results of any corrective action.

10.2 Continual improvement


The organization shall continually improve the suitability, adequacy and effectiveness of the XXX
management system.
Appendix 4
(informative)

Guidance on high level structure, identical core text, common terms and core
definitions

General comment
Clarifications or descriptions should be given for phrases such as “as applicable” or “as appropriate”,
perhaps in the Introduction

General comment

When referring to objectives, always use a “qualifier” (e.g. XXX objectives; XXX management system
objectives; process objectives etc.)

General comment

For those standards that address risk, there should be agreement on the positioning of risk assess ment and
risk treatment text (i.e. should it go in clause 6 or clause 8)

General comment

This High Level Structure and Identical text does not include a clause giving specific requirements for
“preventive action”. This is because one of the key purposes of a formal management system is to act as a
preventive tool. Consequently, the High Level Structure and Identical text require an assessment of the
organization’s “external and internal issues that are relevant to its purpose and that affect its ability t o
achieve the intended outcome(s)” in clause 4.1, and to “determine the risks and opportunities that need to
be addressed to: assure the XXX management system can achieve its intended outcome(s); prevent, or
reduce, undesired effects; achieve continual improvement.” in clause 6.1. These two sets of requirements
are considered to cover the concept of “preventive action”, and also to take a wider view that looks at risks
and opportunities.

Introduction
This content of this clause will be unique to the discipline

1. Scope

a) This will be specific to the discipline with possibly some identical text

b) The Scope should define the "intended outcomes" of the relevant MSS

Use “intended outcome” and not “expected outcome”

- Expected outcome is that “expected” by interested parties

- “Intended Outcome” is that which is “intended” as a result of the application of the standard, or process
etc.
2. Normative references
The Normative clause title shall be used, even when no references are given, for clause alignment
purposes; however the content will be unique to the discipline

3. Terms and definitions


The “Terms and definitions” clause title shall be used.
Terms and definitions may either be within the standard or in a separate standard/document.
The clause should reference the common terms and core definitions + discipline-specific ones

5.3 Organizational roles, responsibilities and authorities

Some MSS disciplines may wish to add a note that: <<Note the role of reporting on the performance of the
XXX management system is often assigned to a “Management Representative” >>

6.1 Actions to address risks and opportunities

Discipline specific standards can define “risk” in terms that are specific to their discipline. ISO 31000
provides a definition of ”risk” that some discipline-specific standards can use (see also definition 3.09).
Additionally, each discipline should clarify its need for a formal “risk management “ approach.

7.1 Resources
Each discipline may need to add a specific Note giving examples of resources

8. Operation
The concept behind this clause is that it applies to an organization’s general operations, as well as to the
operation of its management system

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