This document discusses the changes between ISO 9001:2008 and ISO 9001:2015 quality management system standards. Some key changes include reorganizing clauses into a 10 clause structure for better alignment, adding requirements for determining organizational context and risks/opportunities, expanding the process approach, and changing terminology like replacing "preventative actions" with "risks and opportunities". Each clause is also analyzed in detail highlighting revisions and additional requirements in the 2015 version.

1. QMS 9001:2008 vs 9001:2015
Major Changes
1
OBS PSQA
Impact Study

2. Content
OBS PSQA 2
1. ISO – Introduction
2. QMS – Introduction
3. History of Changes in QMS
4. ISO 9001:2008 – Introduction ( Structure & Philosophy )
5. Need for Change/ Revision
6. ISO 2008 Vs 2015 – Clause wise changes

3. ISO- Introduction
• The International Organization for Standardization (ISO ) is an international standard-setting body.
• The organization today known as ISO began in 1928 as the International Federation of the National Standardizing
Associations (ISA). Suspended in 1942 due to World War –II .
• In October 1946, ISA and UNSCC (United Nations Standards Coordinating Committee ) delegates from 25 countries met
in London and agreed to join forces to create the new International Organization for Standardization; the new
organization officially began operations in February 1947.
• Working through Technical Committees, it has developed and published over 22572 different ISO standards that are
used internationally for subjects ranging from film speeds to wine glasses to quality management systems.
• The official purpose for the issuance of ISO Standards is to facilitate world trade through standardization.
• It is headquartered in Geneva, Switzerland, and works in 164 countries.
OBS PSQA 3

4. OBS PSQA 4
QMS- An Introduction
A quality management system (QMS) is a collection of business processes focused on consistently
meeting customer requirements and enhancing their satisfaction.
It is aligned with an organization's purpose and strategic direction (ISO 9001:2015).
Benefits of QMS
1. Meeting the customer’s requirements, which helps to instill confidence in the organization,
in turn leading to more customers, more sales, and more repeat business
2. Meeting the organization's requirements, which ensures compliance with regulations and
provision of products and services in the most cost- and resource-efficient manner, creating
room for expansion, growth, and profit
These benefits offer additional advantages, such as helping to communicate a readiness to
produce consistent results, preventing mistakes, reducing costs, ensuring that processes are
defined and controlled, and continually improving the organization's offerings.

5. OBS PSQA 5
QMS- Change History

6. OBS PSQA 6
QMS- 9001:2015- Summarized Structure
4,5,6,7

7. Need For Change
• Changes introduced in the 2015 ISO 9001 revision are intended to ensure that ISO 9001 continues to adapt to
the changing environments in which organizations operate.
• Reflect the increasingly complex environments in which organizations operate.
• Ensure alignment with other management system standards.
• 10-clause structure and core text for all Management System Standards (MSS)
• Clearer understanding of the organization’s context is required “one size doesn’t fit all”
• Concept of preventive action now addressed throughout the standard by risk identification and mitigation
• Control of externally provided products and services replaces purchasing/outsourcing
• Increased emphasis on seeking opportunities for improvement
• Enhanced leadership involvement in the management system
OBS PSQA 7

8. OBS PSQA 8
QMS- ISO 9001:2015 Section/Clause Changes
ISO 9001:2008 ISO 9001:2015 - Changes
Structure Eight clauses
Ten clauses; reorganization of clause order and content to better
align with other standards. HLS
Context of the organization No requirement
An organization must determine, monitor and review internal
and external issues as well as relevant interested parties and
their requirements.
Documented information Six required procedures
Document the QMS scope, objectives, quality policy and any
process the organization determines needs to be documented.
Risk Based Thinking Preventative Actions
Organizations must take actions to address risks and
opportunities.
Exclusions & requirements
Excluding a standard requirement was specific to Product
Realization
Any requirement that cannot be applied may be excluded as
long as it is justified.
Objects, outputs, products
and services
Process Based Only
The process model is expanded to include anything that affects
quality.
Terminology
“Product” “Products and services”
“Supplier” “External provider”
“Preventative actions” “Risks and opportunities”
“Documents and records” “Documented information”

9. OBS PSQA 9
QMS- ISO 9001:2015 Section/Clause Changes
ISO 9001: 2015 ISO 9001:2008 Discussion
4 Context of the organization 1.0 Scope
4.1 Understanding the organization and its context New clause
Organizations must determine the external and internal issues that affect its purpose and strategic direction as
well as relevant interested parties and their requirements. PESTEL for issues arising from external context.
4.2 Understanding the needs and expectations of
interested parties
New clause
Relevant interested parties and their requirements must be determined and this information is to be monitored
and reviewed.
4.3 Determining the scope of the quality
management system
1.2 Application The Quality Manual is no longer mandatory. The requirement remains for determining and documenting
the QMS scope.4.2.2 Quality manual
4.4 Quality management system and its processes
4 Quality management system
This requirements remains, but now includes risks, opportunities, and assigning authority for processes. SIPOC
4.1 General requirements
5 Leadership 5 Management responsibility
5.1 Leadership and commitment 5.1 Management commitment
5.1.1 Leadership and commitment for the quality
management system
5.1 Management commitment
The 2015 version requires top management to become accountable for the QMS’ effectiveness and integration
with the organization’s business processes as well as ensuring the quality policy and objectives are compatible
with the organization’s context and strategic direction.
5.1.2 Customer focus 5.2 Customer focus
The 2015 version includes services (along with products) and also addresses statutory and regulatory
requirements.
5.2 Quality policy 5.3 Quality policy The quality policy must now be appropriate to the purpose, strategic direction and context of the organization.
5.3 Organizational roles, responsibilities and
authorities
5.5.1 Responsibility and authority The 2015 version requires top management to assign responsibility and authority for ensuring processare
delivering their intended outputs.5.5.2 Management representative

10. OBS PSQA 10
QMS- ISO 9001:2015 Section/Clause Changes
ISO 9001: 2015 ISO 9001:2008 Discussion
6 Planning for the quality management system 5.4.2 Quality management system planning
6.1 Actions to address risks and opportunities
5.4.2 Quality management system planning 8.5.3
Preventive action
Preventative action has been replaced by risks and opportunities.
6.2 Quality objectives and planning to achieve them 5.4.1 Quality objectives
Quality objectives must now be monitored. There are also additional requirements for planning how the
organization will achieve it’s objectives. SMART- Specific, Measurable, Achievable, Realistic, Time Bound
6.3 Planning of changes 5.4.2 Quality management system planning Impact of change to be considered before a change is made
7 Support 6 Resource management
7.1 Resources 6 Resource management
7.1.1 General 6.1 Provision of resources
7.1.2 People 6.1 Provision of resources appropriate team to implement QMS and control its processes.
7.1.3 Infrastructure 6.3 Infrastructure
7.1.4 Environment for the operation of processes 6.4 Work environment Site Condition
7.1.5 Monitoring and measuring resources
7.6 Control of monitoring and measuring
equipment
tools to measure business performance
7.1.6 Organizational knowledge 6.2.2 Competence, training and awareness
The 2015 version makes a distinction between knowledge specific to the organization and general training or
competence.
7.2 Competence 6.2.2 Competence, training and awareness Competence clause separated for clarity and focus .Focus on skill gap and skill matrix updation
7.3 Awareness 6.2.2 Competence, training and awareness Awareness clause separated for clarity and focus .Awareness about qms and its goal.
7.4 Communication 5.5.3 Internal communication Communication expanded in the 2015 revision to eternal communication.
7.5 Documented information 4.2 Documentation requirements
Documents and records are now referred to as “documented information“. Where “retain” is used this refers to
records and where “maintain” is used this refers to documents. For evidence purpose
7.5.1 General 4.2.1 General
7.5.2 Creating and updating
4.2.3 Control of documents
Clear document control with versions
4.2.4 Control of records
7.5.3 Control of documented Information
4.2.3 Control of documents
New requirement to protect records from unintended alterations.
4.2.4 Control of records

11. OBS PSQA 11
QMS- ISO 9001:2015 Section/Clause Changes
ISO 9001: 2015 ISO 9001:2008 Discussion
8 Operation 7 Product realization
8.1 Operational planning and control 7.1 Planning of product realization
New requirement to review the consequences of unintended changes and take actions to
mitigate any adverse effects.
8.2 Determination of requirements for products and services 7.2 Customer-related processes
8.2.1 Customer communication 7.2.3 Customer communication
8.2.2 Determination of requirements related to products and services 7.2.1 Determination of requirements related to the product
8.2.3 Review of requirements related to the products and services 7.2.2 Review of requirements related to the product
8.3 Design and development of products and services 7.3 Design and development
8.3.1 General New clause
Establish, implement and maintain a design and development process that is appropriate for
your organization.
8.3.2 Design and development planning 7.3.1 Design and development planning
Organization’s must now consider the need for involvement of customers and users in the
design and development process.
8.3.3 Design and development Inputs 7.3.2 Design and development inputs
8.3.4 Design and development controls
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
8.3.5 Design and development outputs 7.3.3 Design and development outputs
8.3.6 Design and development changes 7.3.7 Control of design and development changes
8.4 Control of externally provided products and services 7.4.1 Purchasing process
8.4.1 General 7.4.1 Purchasing process
8.4.2 Type and extent of control of external provision
7.4.1 Purchasing process
7.4.3 Verification of purchased product
8.4.3 Information for external providers 7.4.2 Purchasing information
8.5 Production and service provision 7.5 Production and service provision
8.5.1 Control of production and service provision 7.5.1 Control of production and service provision
8.5.2 Identification and traceability 7.5.3 Identification and traceability
8.5.3 Property belonging to customers or external providers 7.5.4 Customer property Extends requirements for property belonging to external providers (as well as customers).Achroma Std
8.5.4 Preservation 7.5.5 Preservation of product
8.5.5 Post-delivery activities 7.5.1 Control of production and service provision Companies need to think about things that could go wrong and their impacts
8.5.6 Control of changes 7.3.7 Control of design and development changes
8.6 Release of products and services
8.2.4 Monitoring and measurement of processes 7.4.3 Verification
of purchased product
8.7 Control of nonconforming process outputs, products and services 8.3 Control of nonconforming product

12. OBS PSQA 12
QMS- ISO 9001:2015 Section/Clause Changes
ISO 9001: 2015 ISO 9001:2008 Discussion
9 Performance evaluation
8 Measurement, analysis and
improvement
9.1 Monitoring, measurement, analysis
and evaluation
8.2 Monitoring and measurement
9.1.1 General 8.1 General
9.1.2 Customer satisfaction 8.2.1 Customer satisfaction
9.1.3 Analysis and evaluation 8.4 Analysis of data
9.2 Internal audit 8.2.2 Internal audit
The new standard does not require a documented procedure for internal audit, but an internal
audit program must be established.
9.3 Management review 5.6 Management review
Management reviews now include review the QMS for alignment with the organization’s
strategic direction. QMS will help in achieving company goals.
10 Improvement 8.5 Improvement
10.1 General 8.5.1 Continual improvement Focus on customer need and satisfaction.
10.2 Nonconformity and corrective action
8.3 Control of nonconforming product
8.5.2 Corrective action
Update risks and opportunities data base.
10.3 Continual Improvement 8.5.1 Continual improvement Use data from monitoring & measuring for performance review and improvement.