THE NEW ISO 9001:2015
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1987
19942000
2008
2015
Revisions
First published in 1987, ISO 9000 has consistently been ISO’s most popular
series of standards. The 1st edition of ISO 9001 was published, along with
ISO 9002, ISO 9003. Like all ISO standards ISO 9001 generally undergoes a
revision every five years.
ISO 9001
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ISO 9001 & 9004 series
PreviousAdd latest Versions
ISO9001:2000 is
Quality management
systems – Requirements
ISO9004:2005 is
Guidance for
implementation of– A
quality management
system
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Process
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Input Process
Output
ISO 9001 & 9004 series
CurrentAdd latest Versions
ISO9001:2008 is
Quality management
systems – Requirements
ISO9004:2009 is
Managing for the
sustained success of an
organization – A quality
management approach
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Process Approach
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ISO 9001:2015 development process
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There are several distinct stages when
developing an ISO standard; the key ones being:
1. Working Drafts (WDs);
2. Committee Draft (CD);
3. Draft International Standard (DIS);
4. Final Draft International Standard (FDIS);
5. International Standard (IS).
The standard is published after approval of the FDIS by
participating national standards bodies and is reviewed at regular
ISO/CD 9001
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
2013
CD ballot opens: June 2013
CD ballot closes: August 2013
It is standard practice for the CD to be distributed only to
member body mirror committees. However, some member
bodies may distribute the CD to the public (free or for sale)
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ISO/DIS 9001
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
2014
DIS ballot opens: April 2014
DIS ballot closes: August 2014
It is standard practice for the DIS to be distributed to members
of the public (free or for sale). Some member bodies provide
electronic tools for viewing and commenting on the DIS.
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ISO/FDIS 9001
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
2015
FDIS ballot opens: July 2015
FDIS ballot closes: August 2015ISO 9001 published:
September 2015
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���ر �Reasons for changesا"! ب ا�
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Revision of quality principles
�را-$( �! دىء ا�-ودة
4. Process
Approach
Quality Principles
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Risk and preventive action
� Preventive action has been removed from ISO/CD
9001:2015. To be replaced by the wider perspective
of planning, risk management as a core element of
planning, and the having of a management system in
the first place. Indeed, all references are made to risk,
identification of risks and opportunities and planning
actions to address risks and opportunities identified.
Risk based thinking goes throughout the entire
ISO/CD 9001:2015.
� Stays in line with Annex SL that contains no specific
requirements for ‘preventive action’
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Major Changes
� Adopts the high-level structure of Annex SL, a general structure
used for the development of all new ISO standards
� There are now 10 main clauses, 1-3 as before, with requirements
now set out in clauses 4-10. As a result, many requirements from
the existing version are now located differently
� Hoped to facilitate the development of integrated management
systems. Having a uniform structure as the basis of certification for
MS will more likely improve the comprehensibility of standards and
make combined certification more efficient.
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Changes in Structure
ISO 9001:2008
=
=
=
=
ISO 9001:2015
0. Introduction 0. Introduction
1. Scope 1. Scope
2. Normative references 2. Normative references
3. Terms and definitions 3. Terms and definitions
4. Quality Management
System Requirements
4. Context of the Organisation
4.1. General requirements 4.1. Understanding the organization and its
context
4.2. Documentation
requirements
Now Section 7.5.
4.2. Understaning the needs and expectations of
interested parties
4.3. Determining the scope of the quality
management system
4.4. Quality Management System
5. Management responsibility 5. Leadership
5.1. Management commitment 5.1. Leadership and commitment
5.2. Customer focus 5.2. Quality policy
5.3. Quality policy 5.3. Organizational roles,
Responsibilities and authorities
The new clauses require theorganisation to determine the issues,requirements and expectations ofstakeholders that may impact theQMS- a key input to its development
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Changes in Structure
5.1. Management commitment 5.1. Leadership and commitment
5.2. Customer focus 5.2. Quality policy
5.3. Quality policy 5.3. Organizational roles,
Responsibilities and authorities
5.4. Planning 6. Planning
6.1. Actions to address risks and
opportunities
6.2. Quality objectives and trying to
achieve them
6.3. Planning of changes
5.5. Responsibility, authority
and communication
Section 5.3. for responsibilities; section 7.4. for
communication
Now Section 9.3.5.6. Management review
6. Resource management 7. Support
6.1. Provision of resources 7.1. Resources
6.2. Human resources 7.2. Competence
7.3. Awareness
7.4. Communication
7.5. Documented information
6.3. Infrastructure
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7. Product realization 8. Operation
7.1. Planning of product
realization
8.1. Operational planning and control
7.2. Customer-related
processes
8.2. Determination of market needs and
interactions with customers
7.3. Design and development 8.3. Operational planning process
7.4. Purchasing 8.4. Control of external provision of goods and
services
7.5. Production and service
provision
8.5. Development of goods and services
7.6. Control of monitoring
and measuring
equipment
8.6. Production of goods and services
8.7. Release of goods and services
8.8. Nonconforming goods and services
8. Measurement, analysis
and improvement
9. Performance evaluation
8.1. General 9.1. Monitoring, measurement,
Analysis and evaluation
8.2. Monitoring and
measurement
Changes in Structure
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8.2.1. Customer satisfaction
8.2.2. Internal audit 9.2. Internal audit
8.2.3. Monitoring and measurement
of processes
Now Section 9.1.
8.2.4. Monitoring and measurement
of product
Now Section 9.1
9.3. Management review
8.3. Control of non-conforming
product Now Section 8.8.
Now Section 9.1.8.4. Analysis of data
8.5. Improvement 10. Improvement
8.5.1. Continual improvement 10.1
.
Non-conformity and corrective
action
8.5.2. Corrective action 10.2
.
Improvement
8.5.3. Preventive action Rem
ovedNote: Red: after Annex S. Black: after Committee Draft of ISO 9001- Document: ISO/TC 176/SC 2/N 1147.
Changes in structure
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‘Products’ replaced by ‘goods and services’
� Further to the ISO/IEC Directives using the term"goods and services", ISO/CD 9001:2015 hasreplaced “product” with “goods andservices”.
� This is to make it more generic and applicable toorganisations of any kind, i.e. in the servicefields, and remove the existing bias towardscompanies that deal with physical products
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„Control of external provision of
goods and services“� “Purchasing” and “outsourcing” are now replaced
by “external provision of goods and services”.
Clause 8.6 Control of External Provision of Goods and
Services addresses all forms of external provision,
whether it is by purchasing from a supplier, through an
arrangement with an associate company, through the
outsourcing of processes and functions of the
organization, or by any other means. The organization
is required to take a risk-based approach to
determine the type and extent of controls
appropriate to each external provider and all external
provision of goods and services.
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Replacing „Design and development“ by „Development“
� “Design and development undergo a substantial change. Thus, it
is implicit in ISO 9001:2008 that there is a design and development
model that goes from requirements, through design input, design
review, design output, etc.
� The new version replaces “design and development” with
“development” only. Thus, the organisation is no longer bound
by the prescribed development model, and it is now up to it to
define what this model is and what its own development processes
are.
� Having defined what development processes are, the organisation
would have to describe the controls, verification, validation, the
transfer from one particular stage to the next.
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Documentation requirements change-nill mandatory procedures
� In line with Annex SL Appendix 2 , ISO/CD 9001:2015 contains
general requirements for documentation only, with no reference to
documented quality manual, documented procedures or to quality
records. 'Documented information' now replaces both
procedures and records which seems to be more accepting of
electronic documents and document control approaches.
Consequently the terms “document” and “record” have both been
replaced throughout the requirements text by “documented
information.”
� Document control (ISO 9001:2008 Clause 4.2.3) and record
control (Clause 4.2.4) procedures do not exist anymore. Nill
mandatory procedures are required by the new version.
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Management representative not explicitly required
� Senior management is now required to take a more
active involvement in the quality management
system. Stronger emphasis on the overall
accountability of top management for the effectiveness
of the quality management system.
� The figure of management representative no longer
explicitly mentioned. In the absence of specific
requirement for a management representative, the
organisation may choose a structure of assigning
responsibilities as appropriate to ensure relevant
responsibilities and authorities are assigned.
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This change will benefit those clients whohave implemented or planned to implementmultiple ISO management systems e.g. ISO9001 and ISO 14001. As the trend for thesetwo standards will be using Annex SL as thebasic structure, it will be easier to integratemultiple management systems.
Adoption of Annex SL
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Adoption of Annex SL
This change will be beneficial to auditorswho audit integrated management systemswhich will be based on the same structure.More efficient auditing is expected.
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Embedding Process Approach
This change sends a very clear message toclients that “Process Approach” is a must, notan option. All the clients shall ensure that theirQMS is based on process approach i.e.determining inputs and outputs from eachprocess, the sequence and interaction of theprocess, etc. Training on process approachwould become a priority for those clients whodo not have a well-developed process-basedQMS.
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Embedding Process Approach
In relation to that, section 5.1.1 c) of theISO/CD 9001:2015 requires top managementto make sure that QMS are integrated intobusiness processes. That is to say that QMSshould reside within, or be built into, the veryprocesses that really output product. It isbelieved that this focus would “result in aholistic system with the primary objective ofmeeting customer requirements andenhancing customer satisfaction”.
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This change could make it easier to auditclients’ QMS using process approach as theclients have been explicitly required by thestandard to implement their QMS based onprocess approach. Less challenge from theclients could be expected when auditors writingnonconformity on “process approach”.
Auditors’ knowledge and competence onprocess approach auditing shall be ensured.
Embedding Process Approach
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This change requires the clients to adopt risk-based thinking and risk-driven approach in theirQMS. Risks and opportunities shall bedetermined to assure QMS achieving itsintended results, good and service conformityand customer satisfaction; preventing orreducing undesired effects and achievingimprovement. Actions to address risks andopportunities identified shall be planned andtheir effectiveness of the actions shall beevaluated.
Risk and Preventive Action
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Risk and Preventive Action
Auditors will not need to use the term
“Preventive Action” anymore as it no
longer exists in the ISO 9001:2015
Standard. Risk-based thinking and risk-
driven approach shall be required from
the clients by auditors when auditing
clients’ QMS.
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Documented Information
The clients do not need to have 6 minimumdocumented procedures (as required by ISO9001:2008 Standard) anymore. The clientsshall be familiar with the term of“documented information” which replaces theterms of “document” and “record”.
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Documented Information
Auditors do no longer require the clients
to have six minimum documented
procedures in their QMS. Auditors shall
be familiar with the term of documented
information which replaces “document’
and “record”.
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Control of External Provision of Goods and Services
The client shall determine what forms ofexternal provision of goods and services theyare using now – through suppliers, associatecompanies or outsourcing of certain processesand functions to sub-contractors.
Then evaluate the risk level and determinewhat type and extent of control shall beapplied to external providers and externally-
provided processes, goods and services.
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Seven Quality Management Principles
The clients should be aware of the change
from eight quality management principles
to seven quality principles.
Per Clause 5.2 “Note” in ISO 9001:2015
Standard, the quality management
principles can be used as the basis for the
quality policy.
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Seven Quality Management Principles
Auditors shall be aware of the change
from the eight quality management
principles to seven quality management,
the four quality management principle title
change, what are their meanings and
rationales.
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Continual Improvement becomes Improvement
The client should be aware of the term
change from “Continual Improvement” to
just “Improvement”, which can be
reflected in their QMS documentation.
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Continual Improvement becomes Improvement
Auditors should be aware of the term
change from “Continual Improvement”
to just “Improvement” in their auditing.
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Impacts
Risk based thinking becomes the very basics of the improvement
agenda, the QMS is now more risk sensitive, more outward
oriented, more flexible to innovation and improvement
opportunties. This is the change that organisations need to
understand by all means possible and further reenforce. The
transition, in this sense, is more than a change of
documents, but implies intelligently and proactively
revisiting current approaches to addressing risks and
opportunities.
The agenda is a long term one, a conditio sine qua non in the
process is the extended involvement of top management in the
QMS development and implementation.
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Impacts
• Without appropriate leadership and
commitment, any changes undetaken may
bring desired outcomes only accidentally
with limited, if any chances for sustained
improvement!!!
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Transition Period
The transition period for users of ISO
9001:2008 to transfer to ISO
9001:2015 is planned for 3 years from
the release date (September 2015).
*Please note that the above
arrangement is subject to agreement
by ISO/CASACO and the IAF.
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Thank You
Any Questions?
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