ISO 9001-2015 General Awareness PDF

Overview ISO 9001:2015
Prepared by
Jamil M Vora
(Qualice Solutions, Ahmedabad)
(9824049613)
Prepared By : Jamil Vora, Qualice Solutions(9824049613)

Agenda
Background Changes
Interest Changes
High Level Structure
Standards Development Process
ISO 9001: 2015 Timeline
coverage Changes

Background Changes
ISO standards should be reviewed every five years to ensure
that standards are kept up-to-date and relevant to the times.
Thorough formal review done by all members of the

organization ISO (National Member Bodies / NMBS) to
standard ISO 9001 in 2012 concluded that the 9001 standard
should be revised.
last few various standard management system has been used

extensively throughout the world. So that organizations using
the system requires a multi format and language that is
relatively similar between those standards.

Background Changes
Input from users of the system (system

user) conducted through surveys around
the world, generating "user key input" as
follows:
ISO 9001 should be amended in order to remain

relevant .
Must be integrated with other management
systems standards such as EMS
Should be more collaboration with ISO and IAF
to ensure the efficiency and effectiveness of the
audit and resolve problems in the audit
certification.
Must include "tools" and "risk management "

Interest Changes
Maintaining standards of relevance to the changing

demands and environmental development organizations
that are increasingly complex and dynamic
To improve the effectiveness of the system

implementation and
conformity assessment
Increase confidence associated with the organization's

ability to supply products and services that meet the
requirements and the ability to satisfy customers.

Provide a consistent framework for the long term (10-25
years)
Interest Changes
ISO 9001 standard makes more "generic" and

more easily applied to the service industry.
Ensuring ISO 9001 standards meet the needs of the entire

group of potential users.
Increased emphasis on Management

Risks in achieving the objectives
To improve the Compatibility" with other management

system requirements (ie, ISO 14001, OHSAS 18001 / ISO
45001 through the application of uniform structure (High
Level structure)
High-level structure
In the future all will adopt a management system standard
high-level structure.
What and why high-level structure? (Annex SL)
Mandated by ISO's Technical Management Board (TMB)
High-level structure, identical core text and common terms and core definitions
for use in all Management System Standards
Purpose - Enhance the consistency and alignment of different

management system standards
Organizations who implement a single system addressing multiple standards

(e.g. QMS, EMS, ISMS etc) will see the most potential benefit

High-level structure
1. Scope
2. Normative references
3. Terms and definitions 4,5,6,7,
4. Context of the organization
5. Leadership 10 8
6. Planning 9
7. Support
8. Operation
9. Performance evaluation
10. Improvement
ISO 9000 standards development process
International
Standard
ISO
FDIS 9001
Final Draft
International
DIS Standard
Draft
CD International
standard
Committee
WDs Draft
Working
Draft Conditions determination FDIS so
International Standard must be
approved by a minimum of 75%
of ISO

ISO 9001:2015 Timeline
2013 2014 2015
May 2013 CD
(Committee Draft)
+ Transition period
February 2014 DIS for certification
(Draft International Standard)
July 2015 FDIS

(Final Draft International Standard)
September 2015 Published IS

(International Standard)
ISO 9001:2015 Timeline
2015 2016 2017 2018
September 2015
Publisged International
Standard
September 2015 start of 3 years transition

period to September 2018

coverage Changes
Changes to the standard ISO 9001: 2015 covers

changes in terminology and content requirements

Major differences in terminology between ISO 9001:2008 and
ISO 9001:20015
ISO 9001:2008 ISO 9001:2015
Products Products and service
Exclusions Not used
Documentation, records Documented information
Work environment Environment for the operation of process
Purchased product Externally provided products and services
Suplier External provider
Management Leadership
responsibility
Continual improvement Improvement

Significant changes in ISO 9001: 2015
1. Adopting the high-level structure and terminology of

Annex SL (Integrated Guidelines for the development of
all the new ISO standard). So the number of clauses
from the previous turned 10 earlier 8.
2. Risk-based thinking more explicit and become part of the

requirements
Risk-based thinking consider qualitative risk (and,
depending on the organizational context, quantitatively)
when assessing the level of formality needed to plan and
control the quality management system, as well as
activities and Supporting process.
Risk The effect of uncertainty on the expected result (effect
of uncertainty on an expected result)

3. The term document (document) and recording (record) is

replaced with documented information (documented
information).
4. Quality management principles (QMP) turned into seven of
the previous eight.
5. No more specific requirements for Management
representative (MR) or Quality Management Representative
6. No more specific requirement for preventive action
(preventive action), but accommodated in the clause on
understanding the organization and its context (4.1) and action
to deal with the risks and opportunities (6.1)
7. There are no specific requirements for quality guidelines
(quality manual).
Jamil Vora , Qualice Solutions (9824049613)

8. Outsourcing activities more explicitly regulated in a

separate clause (clause 8.4)
9. The terms and definitions described fully in clause 3, not
only mentions the ISO 9000 as in previous versions.
10. Giving emphasis on achieving Objectives for the
organization and its customers and give more attention to
the process of fulfilling the requirements of products and
services and customer satisfaction
11. Program to achieve quality objectives more explicit set in
separate clause (Clause 6.2.2)
12. Introduces two new clauses that clause 4.1 of the
Understanding the organization and its context and clause
4.2 of the Understanding the needs and expectations of
interested parties.
ISO 9001:2008 vs ISO 9001:2015
2008 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 4. Context of the organization

4.1 General requirements 4.1 Understanding the organization
4.2 Documentation requirement and its context
See Caluse 7.5
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the
quality manageent systems
4.4 Quality management systems and
its processes

ISO 9001:2008 vs ISO 9001:2015
5. Management responsibility 5. Leadership
5.1 Management commitmen 5.1 Leadership and commitment
5.2 Customer fpcus 5.2 Quality policy
5.3 Quality policy 5.3 Organizational roles,
responsibilities and authorities
5.4 Planning 6. Planning for the quality
management system
6.1 Actions to address risks and
opportunities
6.2 Quality objectives and planning to
achieve them.
6.3 Planning of changes
5.5 Responsibility, authority and

communication See clause 5.3 and 7.4
5.6 Management review
See clause 9.3
ISO 9001:2008 vs ISO 9001:2015
6. Resources 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 See Clause 7.1 for Infrastructure

6.4 Working environment See Clause 7.1 For Workplace
criteria

ISO 9001:2008 vs ISO 9001:2015
7. Prodoct realization 8. Operation
7.1 Planning of product realization 8.1 Operation planning and control
7.2 Customer-related processes 8.2 Determination of requirements for
7.3 Design and development products and services
7.4 Purchasing 8.3 Design and development of
products and services
7.5 Production and service provision
8.4 Control of externally provided
7.6 Control of monitoring and products and services
measuring equipment
8.5 Production and service provision
8.6 Release of products and srvices
8.7 Control of nonconforming process
outputs, products and services

ISO 9001:2008 vs ISO 9001:2015
8. Measurment, analysis and 9. Perfoermance evaluation
improvement 9.1 Monitoring, measurement, analysis
8.1 General and evaluation
8.2 Monitoring and measurement 9.2 Internal audit
9.3 Management review
8.3 Control of nonconforming product See Clause 8.7

8.4 Analysis data
See Clause 9.1
8.5 Improvement
10. Improvement
10.1 General
10.2 Nonconformity and corrective
action
10.3 Continual improvement
Jamil Vora , Qualice Solutions (9824049613)

Quality Management Principles
ISO 9001:2008 ISO 9001:2015
1. Customer focus 1. Customer Focus
2. Leadership 2. Leadership
3. Involvement of people 3. Engagement of People
4. Process approach 4. Process Approach
5. System approach to management
6. Continual improvement 5. Improvement
7. Factual approach to decision 6. Evidence-based Decision Making
making
8. Mutually benefial suplier relationship 7. Relationship Management

Process Approach
4.1, 4.2, 4.3
Establish context, 10. Continual improvement
define relevant
interested parties
& scope of QMS
*
5. Leadership
Customers & 4.4 QMS-general &

other Process Approach
relevant
interested Customers
9. Performance
parties 6. Planning * evaluation
Satisfaction
Products &
Requirements Inputs 8. Operation Outputs
Service
7. Supprot processes

Process Approach
Act incorporate Plan the process

Interaction with other processes
Interaction with other processes

improvements as (Extent of planning
necessary depends on RISK
INPUTS Do Carry out the OUTPUTS

process
Check monitor/measure
process performance
Schematic representation of a single process within the system

Deming (PDCA Cycle)
Act Plan
How to improve What to do?
Next time? How to do?
Check Do
Did things happen Do what was
According to plan? planned

Deming (PDCA Cycle)
Establish the objectives of the system and its

Plan component processes, and the resources needed
to deliver results in accordance with customers
requirements and the organizationspolicies.
Do Implement what was planned
Monitor and (where applicable) measure processes

Check and the resulting products and services against
policies, objectives and requirements, and report
the results
Take actions to improve process performance, as

Act necessary

Clause 4: Context of the organization
1. Understanding the organization and its context

2. Understanding the needs and expectations of interested
parties
3. Determining the scope of the quality management
system
4. Quality management system and its processes
Core Changes
Clauses 4.1 and 4.2 is a new clause

Clause 4.1 gives emphasis on the organization to establish, monitor
and review the issues of internal and external that affect the
organization's ability to achieve results desired

Clause 4: Context of the organization
Core Changes
Clause 4.2 emphasizes that organizations define "interested
parties" that are relevant to the organization following the
requirements of "interested parties" such
Clauses 4.3 and 4.4 are relatively similar to clauses 4.2 and 4.1 of
ISO 9001: 2008
Definition
context of the organization (business environment) : combination
of internal and external factors and conditions that can have an
effect on an organization's approach to its products, services and
investments and interested parties.
interested party: person or organization that can affect, be affected
by, or perceive themselves to be affected by a decision or activity

Clause 5: Leadership
1. Leadership and commitment

1. Leadership and commitment for the quality
management system
2. Customer focus
1. Quality policy
2. Organizational roles, responsibilities and authorities
Core Changes
Contents Clause 5 is basically the same relative to clause 5.1,
5.2, 5.3, and 5.5 on the ISO 9001: 2008. But in this latest
version of the standard, "top management" is expected to
further demonstrate leadership and commitment associated
with quality management system.
Clause 6: Planning for the quality management system
1. Action to address risks and oppurtunities

2. Quality objectives and planning to achieve them
3. Planning of changes
Core Changes
Clause 6.1 is a new clause that gives emphasis on the

organizational planning process should consider the issues
related to "the context of the organization" and the terms
"interested parties" to then define the risks and opportunities
that must be faced
Fill in Clauses 6.2 and 6.3 are relatively similar to the clause
5.4 of ISO 9001: 2008. The change is the insistence that every
quality objectives (quality objective) must be equipped with a
program to achieve it.

Clause 7: Supprot
1. Resources
1. General
2. People
3. Infrastructure
4. Environment for the operation of processes
5. Monitoring and meauring resources
6. Organizational knowledge
2. Competence
3. Awareness
4. Communication
5. Documented information
1. General
2. Creating and updating
3. Control of documented information
Clause 7: Supprot
Core Changes
Contents Clause 7.1, except clause 7.1.6 is relatively similar to
clause 6.1, 6.2, 6.3, 6.4, and 7.6 on the ISO 9001: 2008. Contain
requirements concerning the provision of resources, human
resources, infra structures are at, work environment, and
resource monitoring and measurement.
Clause 7.1.6 is a new clause that requires that organizations
establish "knowledge" required for running processes and
achieve conformity of products and services.
Clauses 7.2 and 7.3 are relatively similar to clauses 6.2.1 and
6.2.2 of ISO 9001: 2008. While relatively similar clause 7.3 to
clause 5.5.3 of ISO 9001: 2008
Clause 7.5 is relatively similar to clause 4.2.1, 4.2.3 and 4.2.4
ISO 9001: 2008
Clause 7: Supprot
Definition
Knowledge: available collection of information being a justified
belief and having a high certainty to be true.
Information: meaningful data (facts about an object)
Documented information : information required to be controlled

and maintained by an organization and the medium on which it is
contained
Documented procedures (ISO 9001:2008) to maintain

documented information (ISO 9001:2015)
Record (ISO 9001:2008) to retain doumented information

(ISO 9001:2015)

Clause 8: Operation
1. Operation planning and control
2. Determination of requirements for products and service
1. Customer communication
2. Determination of requirements related to products and
services
3. Review of requirements related to products and
services.
3. Design and development of products and services
1. General
2. Design and development planning
3. Design and development inputs
4. Design and development controls
5. Design and development outputs
6. Design and development changes
Clause 8: Operation
4. Control of externally provided products and services
1. General
2. Type and extent of control of external provision
3. Informatioan for external providers
5. Production and services provision
1. Control of production and service provision
2. Identification and traceability
3. Property belonging to customers or external providers
4. Preservation
5. Post-delivery activities
6. Control of changes
6. Release of products and services
7. Control of nonconforming process outputs, products and
services

Clause 8: Operation
Core Changes
Contents Clause 8.1 is relatively similar to clause 7.1 while
relatively similar clause 8.2 to clause 7.2 of ISO 9001: 2008.
Clause 8.3 is relatively similar to clause 7.3 of ISO 9001: 2008.
Clause 8.4 is relatively similar to the clause 7.4 of ISO 9001:

2008 with the addition that control not only for suppliers but
also including partner / subcon for outsourcing
Clause 8.5, 8.5.5 and 8.5.6 except relatively similar to clause
7.5 ISO 9001: 2008. No additions to clause 8.5.3 that
organizations should also be concerned with the "property"
external provider instead of "property" customers.

Clause 8: Operation
Core Changes
Clauses 8.5.5 and 8.5.6 is a new clause. Clause 8.5.5.
emphasizing the organization to meet the requirements of the
"post-delivery" related products and services. While clause
8.5.6 requires the organization to review and control essential
unplanned changes associated with the production and service
provision.

Clause 8: Operation
Core Changes
Contents Clause 8.6 is similar to clause 8.2.4 of ISO 9001: 2008.
Fill in clause 8.7 is similar to the clause 8.3 of ISO 9001: 2008
Definition
outsource (verb) : make an arrangement where an external
organization performs part of an organizations function or process.
design and development : set of processes that transforms
requirements for an object into more detailed requirements
Product : output that is a result of activities where none of them
necessarily is performed at the interface between the provider and
the customer .
Service : intangible output that is the result of at least one activity
necessarily performed at the interface between the provider and the
customer

Clause 9: Performance Evaluation
1. Monitoring, measurement, analysis and evaluation.
1. General
2. Customer satisfaction
3. Analysis and evaluation.
2. Internal audit
3. Management review
Core Changes
There is no significant change. Clause 9.1 is relatively the same
with clauses 8.1, 8.2.1 and 8.4 of ISO 9001: 2008.
Clause 9.2 is relatively similar to clause 8.2.2 of ISO 9001: 2008
clause 9.3 and clause 5.6 is relatively similar to ISO 9001: 2008.

Clause 10: Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Core Changes
There is no significant change. Clause 10.2 is relatively
similar to clause 8.5.2 of ISO 9001: 2008 and clause 10.3
relative together with clause 8.5.1 of ISO 9001: 2008.
There is an emphasis regarding the "improvement" in

which the organization should establish and selecting
opportunities for improvement and implement the
activities necessary to meet the requirements of customers
and strengthen customer satisfaction.

The ISO 10000 portfolio of quality management standards
Standard Content
ISO 9000 Quality Management System - Fundamental and
Vocabulary
ISO 9004 Managing for the sustained success of an organization
A quality management approach.
ISO 10001 Customer satisfaction Guidelines for codes of conduct
ISO 10002 Customer satisfaction Guidellines for handling
complaints
ISO 10003 Customer satisfaction Guidelines for external dispute
resolution
ISO 10004 Guidelines for monitoring and measuring customer
satisfaction
ISO 10005 Guidelines for quality plans
ISO 10006 Guidlines for quality management in projects
ISO 10007 Guidelines for configuration management

The ISO 10000 portfolio of quality management standards
Standard Content
ISO 10008 Customer satisfaction Guidelines for business-to-
consumer electronic commerce
ISO 10008 Customer satisfaction Guidelines for business-to-
consumer electronic commerce
ISO 10012 Guidance for management of measurement processes
ISO/TR 10013 Guidelines for quality management system
documentation
ISO 10014 Guidelines for realizing financial and economic benefits
ISO 10015 Guidance for training
ISO /TR 10017 Guidance on statistical techniques
ISO 10018 Guidelines on people involvement and competence
ISO 10019 Guidelines for the selection of quality management
system consultants
ISO 19011 Guidelines for auditing management systems

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Overview ISO 9001:2015

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

Thorough formal review done by all members of the

last few various standard management system has been used

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

Input from users of the system (system

ISO 9001 should be amended in order to remain

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

Maintaining standards of relevance to the changing

To improve the effectiveness of the system

Increase confidence associated with the organization's

ISO 9001 standard makes more "generic" and

Ensuring ISO 9001 standards meet the needs of the entire

Increased emphasis on Management

To improve the Compatibility" with other management

What and why high-level structure? (Annex SL)

Mandated by ISO's Technical Management Board (TMB)

Purpose - Enhance the consistency and alignment of different

Organizations who implement a single system addressing multiple standards

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

2013 2014 2015

July 2015 FDIS

September 2015 Published IS

2015 2016 2017 2018

September 2015 start of 3 years transition

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

Changes to the standard ISO 9001: 2015 covers

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

1. Adopting the high-level structure and terminology of

2. Risk-based thinking more explicit and become part of the

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

3. The term document (document) and recording (record) is

Jamil Vora , Qualice Solutions (9824049613)

8. Outsourcing activities more explicitly regulated in a

4. Quality Management System 4. Context of the organization

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

5.5 Responsibility, authority and

6.3 Infrastructure See Clause 7.1 for Infrastructure

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

8.3 Control of nonconforming product See Clause 8.7

Jamil Vora , Qualice Solutions (9824049613)

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

Customers & 4.4 QMS-general &

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

Act incorporate Plan the process

Interaction with other processes

INPUTS Do Carry out the OUTPUTS

Schematic representation of a single process within the system

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

Establish the objectives of the system and its

Do Implement what was planned

Monitor and (where applicable) measure processes

Take actions to improve process performance, as

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

1. Understanding the organization and its context

Clauses 4.1 and 4.2 is a new clause

Prepared By : Jamil Vora, Qualice Solutions(9824049613)

Prepared By : Jamil Vora, Qualice Solutions(9824049613)