The document compares ISO 9001:2008 and the draft ISO 9001:2015 standard. Some key changes in the draft standard include a new 10-section structure aligned with other ISO management standards, an increased emphasis on risk management over preventative action, and considering the organization's context. Other changes involve terminology like replacing "documents" with "documented information" and "purchased product" with "externally provided products and services". The draft also removes exclusions and adds requirements related to monitoring, measurement, and management review.

1. ASSIGNMENT
Comparison between ISO 9001:2008
and ISO 9001:2015
PRESENTED TO:
DR. USMAN AWAN
PRESENTED BY:
ZAHRA BADAR MUNIR PGD 01
KHUNSA IQBAL 42
AAMNA ZIA 60
SIDRAH JAVAID 70

2. ISO 9001 Quality Management Systems
Revision
ISO 9001, the world's leading quality management standard, is under revision, with an updated
version due by the end of 2015.
Why is ISO 9001 being revised?
All ISO standards are reviewed every five years to establish if a revision is required to keep it
current and relevant for the marketplace. The future ISO 9001:2015 will respond to the latest
trends and be compatible with other management systems such as ISO 14001.
The revision process
ISO 9001 is currently at the Draft International Stage (DIS), the fourth stage of a six stage
process, whereby any interested parties can submit feedback to the experts on the technical
committee that is revising the standard. All comments are submitted via national member bodies.
The next step:
Once all comments have been considered and the draft is approved, it will move into the Final
Draft International Standard (FDIS) stage before publication.
The new version is published:
ISO 9001:2015 is due to be published by the end of 2015.
(ISO 9001 Quality Management Systems)1
Changing in ISO 9001:2015:
While two years away from scheduled publication, initial drafts of the new ISO 9001:2015
standard the emphasis appears to be in these specific areas and concepts from the existing
standard:
 Changes in structure for ISO 9001-2015, expanding the number of sections to ten from
the current standard’s eight with additions for performance management and evaluation
which is said to help with future closer alignments among different standards through a
new so called “Annex SL’ model” which provides a framework for drafting standards
which can be applied concurrently integrated management systems or multiple
management systems.

3.  Movement away from classical corrective/preventative action approach to more of a
general risk management model, perhaps as embodied in ISO’s own standard ISO
31000:2009, Risk management-Principles and Guidelines, although it’s not clear how
much may be “borrowed” from that management standard.
 Requiring systems which take into account the “context of the organization” which
implies a broader measurement, planning and implementation view perhaps taking into
account areas such as “sustainability” (energy use, materials procurement, environmental
impact, etc.), “corporate social responsibility,” “organizational resilience,” and
“organizational health.”.
 Movement from “documents” (ISO 9001:2008 Clause 4.2.3) and “records” (Clause 4.2.4)
to “document information,” (Clause 9.2 of ISO 9001:2015 Committee draft) which seems
to be more accepting of electronic documents and document control approaches.
However, the new clause language which more generally “requires organizations to:
Retain documented information as evidence of the implementation of the audit program
and the audit results,” has opened up some discussion about it not mandating procedures
as in the past.
There are other changes being considered such as replacing the term “product” replaced with
“goods and services” and consolidating the previous ISO 9001:2008 standard into seven
principles for ISO 9001:2015. The main change is dropping “Principle 5: System approach to
management” because it is already a component of having a quality management system (QMS).
(Paris,2013)2
Section Changes in ISO 9001:2015
Section Number Current Standard Sections Proposed Standard Sections
Section 1: Scope Scope
Section 2: Normative Reference Normative References
Section 3: Terms and Definitions Terms and Definitions
Section 4: General Requirements Context of the Organization
Section 5: Management Responsibility Leadership
Section 6: Resource Management Planning
Section 7: Product Realization Support
Section 8: Measurement, Analysis and
Improvement
Operation
Section 9: Performance Evaluation
Section 10: Improvement
(Kunder, 2013)3

4. ISO 9001:2008vs. ISO 9001:2015Draft International
Standard(DIS)
ISO 9001:2015 Draft International Standard (DIS) has been issued for comments. Voting on DIS
is planned between 10July 2014 to 10Oct 2014.
Following are the key changes in this draft:
1. New Structure
The new standard has 10 clauses. ISO is in process of harmonizing all management system
standards. For this a harmonized structure (Annex SL) has been developed. Some standards such
as ISO 30301:2011 (Information and documentation – Management systems for records), ISO
22301:2012 (Societal security – Business continuity management systems), ISO 20121:2012
(Event sustainability management systems) have already been changed to this new structure and
some other are in process of being revised to this new structure.
2. Process Approach
ISO 9001:2015 promotes the process approach beyond the existing requirements of ISO
9001:2008.Clause 4.4 (Quality management system and its processes) of the DIS provides
specific requirements for adopting a process approach.
3. Preventive Action vs. Risk Management
one of the key purposes of implementing a quality management system is to act as a preventive
tool. As a result the formal requirement related to preventive action is no more existing in the
current draft. This is being replaced with risk based approach.
Although it is required by the organization to determine and address risks, there is no
requirement for implementing a formal risk management process.
4. Context of the Organization
two new clauses have been added to the draft standard.
 4.1 Understanding the organization and its context
 4.2 Understanding the needs and expectations of interested parties.
5. Quality Management Principles
so far the standard was based on eight quality management principles. In this standard the earlier
existing eight principles have been reduced to seven quality management principles.

5. 6. Products and Services:
In 2008 version of the standard the term "product" was used. This term also included services. In
the Committee Draft issued in June 2013, this term was proposed to be changed to "Goods and
Services. In this DIS the proposed term is "Products and Services".
7. Documented Information:
2008 version of the standard had two separate terms: "documents" and "records". In the
Committee Draft issued earlier it was combined together and called "documented information.
The same term is maintained in the recently issued Draft International Standard.
Annex A of the DIS clarifies that where ISO 9001:2008 would have referred to documented
procedures, it is now expressed as a requirement to maintain documented information.
Documented procedures in ISO 9001:2008 = Maintain documented information in ISO
9001:2015
And where ISO 9001:2008 would have referred to records this is now expressed as a requirement
to retain documented information.
Records in ISO 9001:2008 = Retain documented information in ISO 9001:2015
To see the list of mandatory documents and records required by clicking here.
8. No Exclusions:
ISO 9001:2008 version allows organizations to exclude the standard requirements under the
following conditions:
 Exclusions are allowed for the requirements which cannot be applied due to the nature of
the business.
 Exclusions are limited to clause 7 (Product Realization)of the standard.
 Such exclusions do not affect the organization's ability to provide products which meet
the customer requirements and also the applicable legal requirements.
The new standard does not make any reference to exclusions. However in Annex A, the standard
clarifies that the organization cannot decide a requirement to be not applicable if it falls under the
scope of its QMS. Also non-applicability is not allowed if that could lead to failure to achieve the
conformity or to enhance customer satisfaction.
9. Work Environment:
The term "work environment" used in ISO 9001:2008 has been replaced with "Environment for
the operation of processes".

6. 10. Purchased Product:
The term "purchased product" has been replaced with "externally provided products and
services".
11. Supplier
The term "supplier" has been replaced with "External provider".
This does not meet that organizations would need to change this term in their QMS as well.
Organizations can still maintain the term "supplier", "vendor", "contractor", "consultant" etc. as
per their own need. (Paul Palmes)4
Comparison between ISO 9001:2008 and ISO 9001:2015
Draft International Standard (DIS)
ISO 9001:2008 ISO 9001:2015 DIS
0. Introduction 0. Introduction
1.1 General 1. Scope
1.2 Application
4.3 Determining the scope of the quality management
system
2. Normative references 2. Normative references
3. Terms and definitions 3. Terms and definitions
4. Quality Management System 4. Context of the organization
4.1 General Requirements 4.4 Quality management system and its processes
4.2 Documentation Requirements 7.5 Documented information
4.2.1 General 7.5.1 General
4.2.2 Quality Manual -
4.2.3 Control of Documents 7.5 Documented Information
4.2.4 Control of Records 7.5 Documented Information
5. Management Responsibility 5. Leadership
5.1 Management Commitment
5.1.1 Leadership and commitment for the quality
management system
5.2 Customer Focus 5.1.2 Customer focus
5.3 Quality Policy 5.2 Quality policy
5.4 Planning 6. Planning for the quality management system
5.4.1 Quality Objectives 6.2 Quality objectives ans planning to achieve them
5.4.2 Quality Management System
Planning
6.3 Planning of change

7. ISO 9001:2008 ISO 9001:2015 DIS
5.5 Responsibility, Authority, and
Communication
5.3 Organizational roles, responsibilities and
authorities
5.5.1 Responsibility and Authority
5.3 Organizational roles, responsibilities and
authorities
5.5.2 Management Representative -
5.5.3 Internal Communications 7.4 Communication
5.6 Management Review 9.3 Management Review
5.6.1 General 9.3.1 Management Review
5.6.2 Review Input 9.3.1 Management Review
5.6.3 Review Output 9.3.2 Management Review
6. Resource Management 7.1 Resources
6.1 Provision of Resources 7.1 Resources
6.2 Human Resources 7.1.2 People
6.2.1 General 7.2 Competence
6.2.2 Competence, Training, and
Awareness
7.2 Competence and 7.3 Awareness
6.3 Infrastructure 7.1.4 Infrastructure
6.4 Work Environment 7.1.5 Environment for the operation of processes
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 requirements for products and
services
7.2.1 Determination of Requirements
Related to the Product
8.2.2 Determination of requirements related to
products and services
7.2.2 Review of Requirements Related to
the Product
8.2.3 Review of requirements related to products and
services
7.2.3 Customer Communication 8.2.1 Customer communication
7.3 Design and Development 8.3 Design and development of products and services
7.3.1 Design and Development Planning 8.3.2 Design and development planning
7.3.2 Design and Development Inputs 8.3.3 Design and development inputs
7.3.3 Design and Development Outputs 8.3.5 Design and development outputs
7.3.4 Design and Development Review 8.3.4 Design and development controls
7.3.5 Design and Development
Verification
8.3.4 Design and development controls
7.3.6 Design and Development
Validation
8.3.4 Design and development controls
7.3.7 Control of Design and
Development Changes
8.3.6 Design and development changes
7.4 Purchasing 8.4 Control of externally provided products and

8. ISO 9001:2008 ISO 9001:2015 DIS
services
7.4.1 Purchasing Process 8.4.1 General
7.4.2 Purchasing Information 8.4.3 Information for external providers
7.4.3 Verification of Purchased Product
8.4.2 Type and extent of control of external provision
and 8.6 Release of products and services
7.5 Production and Service Provision 8.5 Production and service provision
7.5.1 Control of Production and Service
Provision
8.5.1 Control of production and service provision
7.5.2 Validation of Processes for
Production and Service Provision
8.5.1 Control of production and service provision
7.5.3 Identification and Traceability 8.5.2 Identification and traceability
7.5.4 Customer Property
8.5.3 Property belonging to customers or external
providers
7.5.5 Preservation of Product 8.5.4 Preservation
7.6 Control of Monitoring and Measuring
Equipment
7.1.6 Monitoring and measuring resources
8. Measurement, Analysis, and
Improvement
9.1 Monitoring, measurement, analysis and evaluation
8.1 General 9.1.1 General
8.2 Monitoring and Measurement 9.1.1 General
8.2.1 Customer Satisfaction 9.1.2 Customer satisfaction
8.2.2 Internal Audit 9.2 Internal Audit
8.2.3 Monitoring and Measurement of
Processes
9.1.3 Analysis and evaluation
8.2.4 Monitoring and Measurement of
Product
8.6 Release of products and services
8.3 Control of Nonconforming Product
8.7 Control of nonconforming process outputs,
products and services
8.4 Analysis of Data 9.1.3 Analysis and evaluation
8.5 Improvement 10. Improvement
8.5.1 Continual Improvement 10.3 Continual Improvement
8.5.2 Corrective Action 10.2 Nonconformity and corrective action
8.5.3 Preventive Action 6.1 Actions to address risks and opportunities
(Kumar, 2014)5

9. References:
ISO9001 Quality ManagementSystems.(n.d.).Retrievedfromwww.iso.org:
http://www.iso.org/iso/iso9001_revision
Kumar,S. (2014, jan 26). Comparison between ISO9001:2008 and ISO9001:2015 Draft International
Standard (DIS). RetrievedfromQualityGurus.net:http://www.qualitygurus.net/tiki-
index.php?page=ISO+9001%3A2015+Draft+International+Standard+%28DIS%29
Kunder,P.J.(2013). ISO 9001: 2015 overview andexpectations. FormerUSRepresentativeto ISO,59.
Paris,C. (2013, mar 30). Quick Review of ISO9001:2015 Working Draft. RetrievedfromOxebridge
QualityResourcesInternational:http://www.oxebridge.com
Paul Palmes.(n.d.).ISO9000:2015. BusinessStandardsArchitects,,3.