1. COMPARISON BETWEEN ISO
9001:2008 & ISO 9001:2015
SUBMITTED TO: Sir.Usman
Awan
SUBMITTED BY:
Wajeeha Farooq 08
Narmeen Haroon 74
Samreen Fatima Naila
Ghani 22 MS TQM
Session 2013 to 2015
2. Introduction:
The ISO 9000 series of quality standards is by far the best selling and most
extensively used management system worldwide. Like all ISO standards ISO 9001
generally undergoes a revision every five years.
The International Organization for Standardization (ISO) is currently undertaking a
process for updating the ISO 9001:2008 Quality Management System standard.
The process is well underway and a Committee Draft has been published (ISO/CD
9001:2015).
The process involves a number of draft releases and interested parties are invited
to comment at various stages of the standard production. Once the draft has been
finalized and accepted it is expected to be published and will become ISO
9001:2015.
Reason for changes:
The main reasons for the change is to keep ISO 9001 relevant, reflect changes in its
environment and ensure it continues to deliver “confidence in the organization’s
ability to consistently provide product that meets customer and applicable
statutory and regulatory requirements”.
The current focus on effective process management is to be maintained but
greater emphasis will be placed on producing desired outputs and providing
confidence in product.
Structure of the proposed revision ISO/CD 9001:2005
The structure of the new standard will be significantly changed in accordance with
Annex SL which was issued by ISO in 2012 to define the framework for a generic
Management System Standard.
All new ISO management system standards will adhere to this framework and all
current ISO management system standards (MSSs) will migrate at their next
revision.
3. In future, all ISO MSSs should be consistent with this format and will all have the
same look and feel.
The 2015 version of ISO 9001 will therefore be based on this Annex SL framework.
Other standards which will change include:
ISO/IEC 27001:2013 Information security management systems, will be the next
ISO standard to be based on Annex SL
ISO 14001:2015 Environmental Management, will be the next published shortly
before ISO 9001:2015 Quality management
ISO 23001: 2012 Business Continuity Management, based on an early version of
Annex SL (Guide 83)
The following clause structure and proposed changes are included in the ISO/CD
9001:2015
1. Scope
2. Normative References
3. Terms and Definitions
4. Context of the Organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance Evaluation
10.Improvement
Summary of Main Changes
The term “product” will be replaced by “goods & services” and the word
“continual” will be dropped from “continual improvement.”
“Purchasing” and “outsourcing” will be replaced by “external provision of
goods and services”
4. CD/9001:2015 puts a greater emphasis on the definition of scope, which has
always been the most important and critical aspect of a quality management
system.
It is proposed to replace preventive action in the current edition of the
standard. References are made to risk, identification of risks and
opportunities and planning actions to address risks and opportunities
identified.
CD/9001 will 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. The proposed standard addresses risks which can affect
conformity of goods and services as well as customer satisfaction.
Senior management will be required to take a more active involvement in
the quality management system.
There will be general requirements for documentation, with no reference to
documented quality manual, documented procedures or to quality records.
The Committee Draft refers to “Documented Information.”
The need for exclusions may not be considered to be necessary in the new
version of the standard but feedback on this is being sought as part of the
revision process.
Publication Programmed:
June 2013 – Committee Draft Issued – ISO/CD 9001
September 2013 – Cut-off Date for Comments & Votes – ISO/CD 9001
April 2014 – Draft International Standard (DIS) – Ballot opens
August 2014 – Draft International Standard (DIS) – Ballot closes
July 2015 – Final Draft International Standard (FDIS) – Ballot opens
August 2015 – Final Draft International Standard (FDIS) – Ballot opens
September 2015 – Target date for publication of International Standard (ISO
9001:2015)
Impact of the changes:
The impact of this revision will be similar to, if not greater than the 2000 edition,
which was a major change for accreditation bodies, certification bodies, and
training organizations, implementing organizations, procurement organizations,
consultants and customers.
5. Organizations may have to align their management systems with the structure of
the revised standard, for example:
1. As an example the organization’s quality manual may need to be amended.
2. A risk management processes may need to be developed to determine the
level and extent of control for “external provision of goods and services”, if
not already in place. This will have implications for the organizations
procurement and outsourcing activities and therefore has implications for
suppliers.
3. Auditors will need to become familiar with the revised ISO 9001:2015
standard and so training may need to be considered.
4. Organizations seeking ISO 9000 family certification, will still need to be
registered under the existing standard, which will have the normal 3 year
period. However, those who are going to recertify after that date are going
to be impacted. At this time, the major changes to the standard seem to
emanate from the Annex SL (ISO 22301:2012) integrated/multiple standards
requirements, so becoming familiar with those will be important,
particularly if a business is going for integrated standards certification. The
timing of recertification may also be a factor for some organizations, since
there could be more effort required to update existing ISO 9001:2008
materials and processes. Organizations whose three year term is nearly up
when the new standard is adopted may wish to accelerate their
recertification.
These are just some of the possible effects on the organization but until the
final version is published it will not be possible to definitively know the
implications of revised requirements, put in place detailed plans for revising
internal processes or procedures, or plan the arrangements for transition or
certification to ISO 9001:2015.
The transition period is expected to be around three years as there are over
one million registered ISO 9001 organizations worldwide. The revised ISO
9001:2015 standard should provide a stable set of requirements at its core
for the next 10 years or more.
6. Changes in ISO 9001 Revision 2015 Committee Draft (CD):
1. The term "product" has been replaced by "goods and services".
2. Two new clauses related to the context of the organization:
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties.
3. The requirement to use the process approach has been more explicit by adding
a new clause.
4.4.2 Process approach
4. The standard does not include a specific clause for "Preventive Actions".
5. The terms "document" and "records" have been replaced with the term
"documented information".
6. Control of external provision of goods and services address all forms of external
provisions.
7. The term "continual improvement" has been replaced with "improvement".
What is Changing in ISO 9001:2015 So Far?
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
7. management and evaluation (see chart below for comparison) 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) such as such as ISO 9001, ISO
14001, ISO 27001, or ISO 22301.
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.” (This
latter element seems to incorporate areas relating to business continuity,
perhaps from ISO 22301:2012 Societal security -- Business continuity
management systems --- Requirements standard.
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).
8. 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
Tabulated comparison:
9. ISO 9001:2008 ISO 9001:2015 CD Remarks
0. Introduction 0. Introduction
1. Scope 1. Scope
2. Normative references 2. Normative references
3. Term and definitions 3. Terms and definitions
4. Quality Management System 4. Context of the
organization
4.1 General Requirements 4.1 Understanding the
organization and its context
4.2.2 Quality Manual - Quality Manual not required
4.2.3 Control of Documents 7.5 Documented
Information
Records and Documents are
now "Documented
Information"
4.2.4 Control of Records 7.5 Documented
Information
Records and Documents are
now "Documented
Information"
5. Management Responsibility 5. Leadership
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning 6. Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System
Planning
5.5 Responsibility, Authority, and
Communication
5.5.1 Responsibility and Authority
10. 5.5.2 Management Representative MR not required
5.5.3 Internal Communications
5.6 Management Review 9.3 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6. Resource Management 7. Support
6.1 Provision of Resources 7.1 Resources
6.2 Human Resources 7.2 Competence
6.2.1 General
6.2.2 Competence, Training, and
Awareness
6.3 Infrastructure
6.4 Work Environment
7. Product Realization 8. Operation
7.1 Planning of Product
Realization
7.2 Customer-Related Processes
7.2.1 Determination of
Requirements Related to the
Product
7.2.2 Review of Requirements
Related to the Product
11. 7.2.3 Customer Communication
7.3 Design and Development
7.3.1 Design and Development
Planning
7.3.2 Design and Development
Inputs
7.3.3 Design and Development
Outputs
7.3.4 Design and Development
Review
7.3.5 Design and Development
Verification
7.3.6 Design and Development
Validation
7.3.7 Control of Design and
Development Changes
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased
Product
7.5 Production and Service
Provision
7.5.1 Control of Production and
Service Provision
7.5.2 Validation of Processes for
12. Production and Service Provision
7.5.3 Identification and
Traceability
8.6.2 Identification and
traceability
7.5.4 Customer Property
7.5.5 Preservation of Product 8.6.4 Preservation of goods
and services
7.6 Control of Monitoring and
Measuring Equipment
8. Measurement, Analysis, and
Improvement
9. Performance evaluation
8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit 9.2 Internal Audit
8.2.3 Monitoring and
Measurement of Processes
8.2.4 Monitoring and
Measurement of Product
8.3 Control of Nonconforming
Product
8.4 Analysis of Data
8.5 Improvement 10. Improvement
8.5.1 Continual Improvement 10.2 Improvement Continual deleted
8.5.2 Corrective Action 10.1 Nonconformity and
corrective action
13. Comparison between ISO 9001:2008 and ISO 9001:2015 Committee Draft (CD)
The latest update to ISO 9001 is underway, the first since ISO 9001:2008. But it
is really the first major revision since ISO 9001:2000, which essentially
consolidated three previous standards including ISO 9001, ISO 9002 and ISO
9003.
While still in the drafting stage (see enclosed time line for publication), this
latest revision takes into account the vast changes in technology, business
diversity and global commerce (which the ISO 9000 family and its spin-offs
were created to support), including:
The growth of service businesses and their needs for quality management
Recognition of the need to harmonize, integrate quality management into
overall business management systems, perhaps to serve as the basis of
business management itself
Making it easier for companies to adopt multiple ISO series general business
management standards such as ISO 14001 (environmental) and/or vertical
standards such as AS9100
Helping to simplify the understanding of the standard, and make it easier
(and more mandatory) to apply it more uniformly
The update/revision process is also supposed to keep the current focus on
managing processes (as opposed to managing more specific program
elements) as an effective method to gain a more repeatable pattern of
success, and to remain more applicable to a wider array of enterprises. It is
doing this to help make this standard revision more durable by "providing a
stable core set of requirements for the next 10 years or more" even amid the
increasingly changing business situations in which it must operate.
8.5.3 Preventive Action - No requirement related to PA
