N360 JTCG Concept Document To Support Annex SL
N360 JTCG Concept Document To Support Annex SL
N360 JTCG Concept Document To Support Annex SL
ISO/TMB/JTCG
Joint technical Coordination Group on MSS (TAG 13)
Email of secretary:
Convenorship:
Attached please find JTCG N 360 concept document developed by TF4 and approved by JTCG at
its Atlanta meeting. Many thank you to TF4 for the substantial work in its development
Kind regards
Anne-Marie
Please find attached Concept document developed by TF4 and approved by JTCG at its
meeting.
Please note the Annex SL text in here has not been updated in line with JTCG N362 proposal
for minor edits
Please note due to time constraints the format of the table has not been adjusted to
remove the breaks that should not be there. It is intended that the table shall be one
continues text table with no breaks between clauses.
1
Secretariat administered by: SIS, Swedish Standards Institute
email: [email protected] Phone +46 8 5555 2025
JTCG/TF4/ N27
3 December 2013
This guidance is provided in a table format that includes the Annex SL text provides where necessary information on the concept behind the
requirement in the Annex SL text, and guidance, examples or comments as appropriate.
2
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
The intent of the Introduction is to give specific Refer to ISO/IEC Directives Part 2: Rules for
Introduction information or commentary about the technical the structure and drafting of International
NOTE Specific to the discipline. content of the MSS, and about the reasons prompting Standards, for specific requirements,
its preparation. An Introduction is optional. It shall not guidance and examples.
contain requirements.
The intent of the Scope clause is to succinctly define Refer to ISO/IEC Directives Part 2: Rules for
1. Scope without ambiguity the subject of the MSS and the the structure and drafting of International
NOTE Specific to the discipline. aspects covered, thereby indicating the limits of Standards, for specific requirements,
applicability of the MSS or particular parts of it. It shall guidance and examples.
not contain requirements.
The intent of the Normative Reference clause is to Refer to ISO/IEC Directives Part 2: Rules for
2. Normative references give a list of the referenced documents which have the structure and drafting of International
NOTE Clause Title shall be used. Specific to the been cited in the MSS in such a way as to make them Standards, for specific requirements,
discipline. indispensable for the application of the MSS. guidance and examples.
Normative references are optional.
The intent of the Terms and Definitions clause is to This section should contain only the
3. Terms and definition provide the common set of harmonized definitions for definitions of words used by specialists in
NOTE Clause Title shall be used. Terms and definitions MSS terminology. Further, standards writers provide the particular subject field in which the
may either be within the standard or in a separate document. To additional definitions for the discipline-specific terms, document is written, i.e., these words are
reference Common terms and Core definitions + discipline specific i.e., words used in particular subject fields by called “terms” that are necessary for
3
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
ones. specialists that are necessary for understanding the understanding the MSS. Words used in
MSS. general language and ordinary
For the purposes of this document, the following terms and
definitions apply. communicative settings are not defined, as
As per ISO directives, Part 2, D.1.2, arrangement, the everyday use and meaning of these
NOTE 1 The following terms and definitions constitute an integral Terms and definitions should be preferably organized words can be found in a dictionary.
part of the “common text” for management systems standards. according to the hierarchy of the concepts.
Additional terms and definitions may be added as needed. Notes For instance, the word “dog” in general
Alphabetic order is the least preferred.
may be added or modified to serve the purpose of each standard. language is commonly understood to
mean a domestic canine. However, the
NOTE 2 Bold type in a definition indicates a cross-reference to
another term defined in this clause, and the number reference for word “dog” in mechanical engineering
the term is given in parentheses. has a very specific meaning restricted to
NOTE 3 Where the text “XXX” appears throughout this clause, the this field. The former is a “word”, and the
appropriate reference should be inserted depending on the context latter is a “term”.
in which these terms and definitions are being applied. For example:
“an XXX objective” could be substituted as “an information security Terms that are not used in a MSS do not
objective”.
have to be defined.
4
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
3.01
organization
person or group of people that has its own functions with
responsibilities, authorities and relationships to achieve
its objectives (3.08)
5
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
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
3.07
policy
6
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
intentions and direction of an organization (3.01) as
formally expressed by its top management (3.05)
7
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
3.08
objective
result to be achieved
9
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
3.11
documented information
information required to be controlled and maintained by
an organization (3.01) and the medium on which it is
contained
3.13
performance
measurable result
10
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
3.14 For purposes of Annex SL, an outsourced
outsource (verb) process is one which
make an arrangement where an external organization
the function or process is integral
(3.01) performs part of an organization’s function or
process (3.12) to the organization’s functioning
the function or process is needed
NOTE 1 to entry: An external organization is outside the for the MS to achieve its intended
scope of the management system (3.04), although the outcome
outsourced function or process is within the scope.
liability for the function or
process conforming to
requirements is retained by the
organization
the organization and the external
provider have an integral
relationship e.g. one where the
process is perceived by interested
parties as being carried out by
the organization
3.15
monitoring
determining the status of a system, a process (3.12) or
an activity
11
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
3.17 Annex SL 9.2 pertains to internal audits. Independence can be demonstrated by the
audit
systematic, independent and documented process freedom from responsibility for the activity
Annex SL requires that internal audits are conducted being audited or freedom from bias and
(3.12) for obtaining audit evidence and evaluating it
objectively to determine the extent to which the audit by the organization or by an external party on its conflict of interest.
criteria are fulfilled behalf.
“Audit evidence” consists of records,
statement of fact and other information
NOTE 1 to entry: An audit can be an internal audit (first party) relevant to the audit criteria and verifiable,
or an external audit (second party or third party), and it can be
a combined audit (combining two or more disciplines).
and “audit criteria” are the set of policies,
procedures or requirements (3.03) used as a
reference against which audit evidence is
Note 2 to entry: An internal audit is conducted by the compared as defined in ISO 19011
organization itself, or by an external party on its behalf.
NOTE 3 to entry: “Audit evidence” and “audit criteria” are Audit findings and the audit conclusion may
defined in ISO 19011. be described collectively as the audit result.
”Audit findings” consist of the results of the
evaluation of the collected audit evidence
against audit criteria and the “audit
conclusion” is the outcome of an audit after
consideration of the audit objectives and all
audit findings, as defined in ISO 19011.
12
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
3.18
conformity
fulfilment of a requirement (3.03)
3.19
Nonconformity relates to the requirements
nonconformity
non-fulfilment of a requirement (3.03) specified by the management system
standard and to the requirements adopted
by the organization
3.21
continual improvement
13
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
efforts to plan, implement and operate the legal, regulatory, financial,
management system. technological, economic, natural and
competitive context, whether
Standards writers may prescribe additional international, national, regional or
requirements related to understanding the local;
organization and its context in their discipline specific – characteristics or conditions of the
MSS. organization, such as
o organizational governance,
information flows and
decision-making processes
o organizational policies,
objectives, and the strategies
that are in place to achieve
them;
o the capabilities of the
organization, understood in
terms of resources (e.g.
capital, time, people,
knowledge, processes,
systems and technologies);
o the organization's culture;
o standards, guidelines and
models adopted by the
organization;
o the life cycle of the
organization’s products and
services.
4.2 Understanding the needs and expectations of The intent of the clause on Understanding the needs Examples of potential interested parties may
interested parties and expectations of interested parties is to specify include:
the requirements for a high-level (e.g. strategic) legal and regulatory authorities
The organization shall determine understanding of the needs and expectations of (local, regional, state/provincial,
the interested parties that are relevant to the relevant interested parties that are applicable to the
14
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
XXX management system, and MS and to the MSS national or international),
parent organizations,
The organization shall determine Not all interested party requirements are customers,
requirements of the organization. Some are not trade and professional associations,
the relevant requirements of these interested
parties
applicable to the organization or relevant to the community groups,
management system. Others are mandatory because non-governmental organizations,
they have been incorporated into laws, regulations, suppliers,
permits and licenses by governmental or court action. neighbours,
There may be others that an organization may decide employees and others working on
to voluntarily adopt or decide to enter into an behalf of the organization.
agreement or contract. Once adopted or agreed to, it Examples of interested party requirements
must comply. may include:
law;
If an interested party ‘perceives’ themselves to be
permits, licences or other forms of
affected by the management system, they must make
authorization;
it known.
orders issued by regulatory agencies;
judgments of courts or administrative
Apart from legal requirements, the needs and
tribunals;
expectations of an interested party become
treaties, conventions and protocols;
obligations when they are specified and the
organization decides that it will adopt them. Once the relevant industry codes and
organization subscribes, then they become standards; and
organizational requirements (see 4.3). contracts which have been entered
into;
The knowledge gained is then used to guide the agreements with community groups
efforts to plan, implement and operate the or non-governmental organizations;
management system. agreements with public authorities
and customers;
Standards writers can prescribe additional organizational requirements;
requirements related to understanding the needs and voluntary principles or codes of
expectations of interested parties in their discipline practice;
specific MSS. voluntary labelling or environmental
15
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
commitments;
obligations arising under contractual
arrangements with the organization.
4.3 Determining the scope of the XXX management The intent of the clause on Determining the scope of It should be noted that the term scope can
system the management system is to establish the physical be used in three different applications:
and organizational boundaries to which the - the Scope of the ISO MSS (clause 1)
The organization shall determine the boundaries and management system will apply. - the scope of the organization’s
applicability of the XXX management system to management system (as defined by
establish its scope. The organization has the freedom and flexibility to 4.3)
define its boundaries and may choose to implement - the “scope” of an organization’s
When determining this scope, the organization shall MSS within the entire organization, a specific unit, or certification.
consider particular function(s) within an organization.
the external and internal issues referred to in An understanding of the context (4.1) and the
4.1, and requirements of relevant interested parties (4.2) are
considerations when establishing the scope of the
the requirements referred to in 4.2.
management system and in determining which
requirements the organization will adopt.
The scope shall be available as documented
Documentation of the scope is created and controlled
information.
in accordance with the requirements of Documented
information (7.5).
The intent of the clause on Leadership and Visible support, involvement and
5. Leadership Commitment is to identify actions in which top commitment of the organization’s top
5.1 Leadership and commitment management is personally involved with and directs in management is important to the successful
the organization. implementation of the MSS. It sets the tone
Top management shall demonstrate leadership and and expectations, increases acceptance, and
commitment with respect to the XXX management Top management may not perform all of these motivates personnel to be engaged in the
system by actions themselves (e.g., they may delegate MS initiatives. It can provide reassurance to
responsibility to others), but they are accountable for external parties that an effective
ensuring that the XXX policy and XXX making sure they are performed. management system is likely in place.
objectives are established and are compatible
with the strategic direction of the organization
Standards writers can prescribe additional An example of a “business process” may be
ensuring the integration of the XXX requirements related to leadership and commitment an organization’s central human resource
management system requirements into the in their discipline specific MSS. function, which may be responsible for
organization’s business processes ensuring that the competency requirements
In the 2nd bullet the importance of “integration … into of an MSS are met.
17
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
NOTE Reference to “business” in this International Standard the organization’s business processes” is emphasized
should be interpreted broadly to mean those activities that are
and it is assigned as one of Top management’s roles.
core to the purposes of the organization’s existence.
ensuring that the resources needed for the XXX In the 7th bullet “to demonstrate their leadership as it
management system are available applies to their areas of responsibility” refers to the
“relevant management roles”, and not to Top
communicating the importance of effective XXX management.
management and of conforming to the XXX
management system requirements
The 7th bullet is intended to require Top management
ensuring that the XXX management system
to create a culture and environment that encourages
achieves its intended outcome(s) people with leadership roles (not necessarily formal
management positions, e.g. team leaders) to work
promoting continual improvement actively towards implementing the requirements of
the management system and seeking to achieve the
supporting other relevant management roles to XXX objectives.
demonstrate their leadership as it applies to their
areas of responsibility. Standards writers can prescribe additional
requirements for leadership and commitment in their
discipline specific MSS.
5.2 Policy The intent of the clause on Policy is to specify the high While the policy is expected to contain a
level organizational commitments required of the commitment to satisfy applicable
Top management shall establish a XXX policy that MSS, taking into account the organization’s purpose. requirements, in particular laws and
It is used to frame the objectives which the regulations, it is understood that even the
is appropriate to the purpose of the organization sets for itself. most effective MS will not guarantee full
organization compliance at any particular point in time.
Documentation of the policy is created and controlled Under such circumstances, it should not be
provides a framework for setting XXX
in accordance with the requirements of Documented considered out of conformance so long as
objectives
information (7.5). the MS results in the prompt detection and
includes a commitment to satisfy applicable corrective action of the system deficiencies
requirements, and The policy is communicated internally in accordance that contributed to the instance(s) of
with the requirements of the Communication clause noncompliance.
18
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
includes a commitment to continual (7.4). It also shall be made available to other
improvement of the XXX management system. interested parties.
5.3 Organization roles, responsibilities and authorities The intent of the clause on Organization roles, The role of ensuring that the management
responsibilities and authorities is to assign system conforms with the requirements of
Top management shall ensure that the responsibilities responsibility and authority for the implementation of the MSS can be assigned to an individual,
and authorities for relevant roles are assigned and the MS requirements to relevant roles within the shared by several individuals, or assigned to
communicated within the organization. organization. a team. Such individuals should have
sufficient access to top management in
Top management shall assign the responsibility and Top management is accountable for these order to keep management informed of the
authority for: responsibilities and authorities being assigned and status and performance of the MS.
communicated to the respective persons performing
a) ensuring that the XXX management system those roles.
conforms to the requirements of this International
Standard: and
The responsibilities and authorities are communicated
in accordance with the requirements of the
b) reporting on the performance of the XXX
Communication clause (7.4).
management system to top management.
Demonstration of conformance to the requirements
of the MSS is conducted in accordance with the
requirements of the Internal audit clause(9.2)
be updated as appropriate.
Objectives are communicated in accordance with the
requirements of the Communication clause (7.4).
The organization shall retain documented information
on the XXX objectives. Documentation of the objectives is created and
controlled in accordance with the requirements of
When planning how to achieve its XXX objectives, the Documented information (7.5).
organization shall determine
what will be done The actions required to achieve the objectives (i.e.,
‘what’) and the associated timeframe (i.e., ‘when’) are
what resources will be required determined. In addition, assignment of responsibility
for doing it (i.e., ‘who’) is established in accordance
who will be responsible with the requirements of Organization roles,
responsibilities and authorities (5.3). Any need for
when it will be completed budgets, specialized skills, technology or
infrastructure, for example, are determined and
how the results will be evaluated
provided in accordance with the requirements of
Resources. (7.1). Lastly, a mechanism for evaluating
the overall results of what was accomplished is
determined in accordance with the requirements of
Monitoring, measurement, analysis and evaluation
(9.1) and reported in accordance with Management
Review (9.3).
22
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
The intent of the clause on Resources is to anticipate, Resources may include
7. Support determine and allocate the resources needed for human resources
7.1 Resources creating and implementing the MS (including its specialized skills or knowledge
operations and controls), as well as those needed for organizational infrastructure (i.e.,
The organization shall determine and provide the its ongoing maintenance and improvement. buildings, communication lines, etc)
resources needed for the establishment, technology
implementation, maintenance and continual Standards writers can prescribe additional financial resources
improvement of the XXX management system. requirements related to resources in their discipline
specific MSS.
7.2 Competence The text is self-explanatory when read in conjunction Intentionally left blank
with the definition of competence (3.10).
The organization shall
determine the necessary competence of Documentation providing objective evidence of
person(s) doing work under its control that competence is created and controlled in accordance
affects its XXX performance, and with the requirements of Documented information
(7.5).
ensure that these persons are competent on
the basis of appropriate education, training, or
experience; Standards writers can prescribe additional
requirements related to competence in their
where applicable, take actions to acquire the discipline specific MSS.
necessary competence, and evaluate the
effectiveness of the actions taken, and
7.3 Awareness The intent of the clause is self-explanatory. Awareness of the policy should not be taken
to mean that it needs to be memorized;
23
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
Persons doing work under the organization’s control Standards writers can prescribe additional rather, persons should be aware of the key
shall be aware of requirements related to awareness in their discipline policy commitments, and their role in
specific MSS. achieving them.
the XXX policy
7.4 Communication The intent of the clause is self-explanatory. Communications should adhere to the
principles of transparency, appropriateness,
The organization shall determine the internal and
Annex SL requires communication on the following: credibility, responsiveness and clarity.
external communications relevant to the XXX
-importance of effective XXX management and of
management system including
conforming to the MS requirements Communication can be verbal or written,
on what it will communicate -policy one-way or two-way, internal or external.
-responsibilities and authorities
when to communicate -performance of the MS
-objectives
with whom to communicate. [-contribution to the effectiveness of the MS,
including the benefits of improved performance
how to communicate
-implications of not conforming with the MS
requirements]
-results of audits
24
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
7.5 Documented information The intent of the clause General, Documented The minimum documented information
Information is to provide a description of the types of required to be created, controlled and/or
7.5.1 General information that must be created, controlled, and maintained in a MSS includes:
maintained in a management system. This includes - Scope of the management system
The organization’s XXX management system shall that which is - Policy
include - required for all MSS (as presented in clause
- Objectives
7.5.1 and in the respective clauses of Annex
SL), - Evidence of competence
documented information required by this
- required by a particular MSS, and - Documented information of external
International Standard
- any additional information the organization origin necessary for the planning and
determines necessary to be documented. operation of the management system
documented information determined by the
organization as being necessary for the - Documented information necessary to
effectiveness of the XXX management system. The phrase “documented information as evidence of have confidence that the processes
...” implies the former term “record”. have been carried out as planned
NOTE The extent of documented information for a XXX - Monitoring, measurement, analysis
management system can differ from one organization to
another due to and evaluation results
— the size of organization and its type of activities, It is the responsibility of the organization to - Evidence of internal audit programme
processes, products and services, determine what documented information it needs implementation
— the complexity of processes and their interactions, beyond that which is required by the MSS. The - Internal audit results
and
— the competence of persons. factors it should take into account are listed in the - Management review results
note. - Nature of nonconformities and actions
taken
The term “documented information” refers to - Corrective action results
information that a MSS determines is necessary to
control and maintain in any format or media (see Documented information, originally created
7.5.3) for purposes other than the MSS, may be
used.
Documented information is created and controlled in
accordance with the requirements of 7.5.2 and 7.5.3.
25
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
7.5.2 Creating and updating The intent of the clause Creating and Updating The identification, format and media used
Documented Information is to specify the for documented information are the choice
When creating and updating documented information requirements for uniquely identifying the information, of the organization implementing the MSS; it
the organization shall ensure appropriate defining the format and media it will be maintained need not be in the form of a textual format
in, and for its approval. or a paper manual.
identification and description (e.g. a title, date,
author, or reference number) Standards writers can prescribe additional
requirements related to creating and updating
format (e.g. language, software version,
documented information in their discipline specific
graphics) and media (e.g. paper, electronic)
MSS.
review and approval for suitability and
adequacy.
7.5.3 Control of documented information The intent of the clause on Control of documented The information required to be documented
information is to specify the internal controls that by the MSS may be integrated with other
Documented information required by the XXX need to be considered and implemented for information management or documentation
management system and by this International Standard information that is required to be documented. Not systems established by an organization.
shall be controlled to ensure all internal controls are applicable to all types of
documented information.
it is available and suitable for use, where and
when it is needed In addition to internal information that is required to
be documented, information created by external
it is adequately protected (e.g. from loss of
parties may be required for the MSS. The
confidentiality, improper use, or loss of
integrity). identification and control of such information is also
required.
distribution, access, retrieval and use,
Standards writers can prescribe additional
NOTE Access implies a decision regarding the requirements related to control of documented
permission to view the documented information only, or
the permission and authority to view and change the
information in their discipline specific MSS.
documented information, etc.
The organization shall control planned changes and Operational control is required for situations related
review the consequences of unintended changes, to business processes where absence of controls
taking action to mitigate any adverse effects, as could lead to deviations from the policy and
necessary. objectives or poses unacceptable risk. These
situations can be related to business operations,
27
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
The organization shall ensure that outsourced activities or processes; production, installation or
processes are controlled. servicing; maintenance; or contractors, suppliers or
vendors. The degree of control exercised will vary
depending on many factors, including the functions
performed; their importance or complexity; the
potential consequences of deviation or variability; or,
the technical competency involved versus what is
available.
29
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
The organization shall conduct internal audits at maintaining an internal audit programme for integrity, fair presentation, due professional
planned intervals to provide information on whether purposes of checking that the organization’s MS care, confidentiality, independence and an
the XXX management system; conforms to both the MSS requirements and any evidence-based approach.
additional MS related requirements the organization
a) conforms to
self imposes, and that the MS is being effectively Guidance on establishing an internal audit
the organization’s own requirements for its XXX implemented and maintained as planned. programme, performing management
management system
system audits and evaluating the
the requirements of this International Standard;
An internal audit programme requires that competence of audit personnel is given in
-internal audits be planned and scheduled based on ISO 19011.
b) is effectively implemented and maintained. the importance of the processes audited and the
results of previous audits
The organization shall: -a methodology for planning and conducting internal
audits be established
a) plan, establish, implement and maintain an -roles and responsibilities within the audit programme
audit programme(s), including the frequency, be assigned taking into account the integrity and
methods, responsibilities, planning requirements
independence of the internal audit process
and reporting. The audit programme(s) shall take
into consideration the importance of the processes -the audit criteria (i.e., policies, procedures or
concerned and the results of previous audits; requirements used as a reference against which
relevant and verifiable records, statements of fact or
b) define the audit criteria and scope for each other information will be compared) and audit scope
audit; (i.e., description of the physical locations,
organizational units, activities and
c) select auditors and conduct audits to ensure
objectivity and the impartiality of the audit process;
processes, as well as the time period covered) for
each audit planned.
d) ensure that the results of audits are reported to
relevant management, and The internal audit programme is planned and
implemented and maintained by internal personnel,
e) retain documented information as evidence of or can be managed by external persons acting on the
the implementation of the audit programme and the organization’s behalf. In either case the selection of
audit results. internal audit programme personnel needs to meet
Competence (7.2) requirements.
30
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
The results of internal audits are reported to the
management responsible for the functions/unit
audited, and any other individuals deemed
appropriate in accordance with the requirements of
the Communication clause (7.4).
32
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
The intent of the clause on Nonconformity and Intentionally left blank
10. Improvement
corrective action is to specify the requirements for
10.1 Nonconformity and corrective action responding when the MSS and MS (including
operational) requirements are not satisfied. It
When a nonconformity occurs, the organization shall: includes taking action to correct the situation,
examine the cause and determine if other
a) react to the nonconformity, and as applicable
occurrences exist or potentially exist elsewhere so
take action to control and correct it, and that action can be taken to prevent reoccurrence.
Further, it requires evaluation of the action taken to
deal with the consequences; confirm that the intended result was achieved, and
evaluation of the MS to determine if changes are
b) evaluate the need for action to eliminate the warranted to avoid future occurrences of similar
causes of the nonconformity, in order that it does nonconformities.
not recur or occur elsewhere, by
33
Annex SL (text) as taken from ISO Directives 2013
editions – not updated in line with JTCG proposal in Concept of the requirement Guidance, examples, or commentary
JTCG N362
The organization shall retain documented information
as evidence of:
The intent of the clause on Continual improvement is Continual implies occurrence over a period
10.2 Continual improvement
to specify the requirements to improve the of time, but with intervals of interruption
The organization shall continually improve the Management System (MS). Improvement is focused in (unlike ‘continuous’ which indicates
suitability, adequacy and effectiveness of the XXX three main areas: occurrence without interruption). In the
management system. Suitability – the extent to which the MS ‘fits’ and is context of continual improvement, the
right for the organization’s purpose, its operations, expectation is that improvements occur
culture, and business systems periodically, over time. The rate, extent and
Adequacy – the extent to which the MS is sufficient in timescale of actions that support continual
meeting the applicable requirements; and improvement are determined by the
Effectiveness – the extent to which planned activities organization, in light of its context, economic
are realized and planned results achieved. factors, and other circumstances.
35