QMS 9001:2008 vs 9001:2015

Major Changes
Impact Study

OBS PSQA
1
 Content

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

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 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.

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 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.

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QMS- Change History

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QMS- 9001:2015- Summarized Structure

4,5,6,7

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 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

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Structure
Context of the organization
Documented information
Risk Based Thinking
Exclusions & requirements
Objects, outputs, products
and services
Terminology
QMS- ISO 9001:2015 Section/Clause Changes
ISO 9001:2008 ISO 9001:2015 - Changes
Ten clauses; reorganization of clause order and content to better
Eight clauses
align with other standards. HLS
An organization must determine, monitor and review internal
No requirement and external issues as well as relevant interested parties and
their requirements.
Document the QMS scope, objectives, quality policy and any
Six required procedures
process the organization determines needs to be documented.
Organizations must take actions to address risks and
Preventative Actions
opportunities.
Excluding a standard requirement was specific to Product Any requirement that cannot be applied may be excluded as
Realization long as it is justified.
The process model is expanded to include anything that affects
Process Based Only
quality.
“Product” “Products and services”
“Supplier” “External provider”
“Preventative actions” “Risks and opportunities”
“Documents and records” “Documented information”
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 QMS- ISO 9001:2015 Section/Clause Changes
ISO 9001: 2015 ISO 9001:2008 Discussion
4 Context of the organization 1.0 Scope

Organizations must determine the external and internal issues that affect its purpose and strategic direction as
4.1 Understanding the organization and its context New clause
well as relevant interested parties and their requirements. PESTEL for issues arising from external context.

4.2 Understanding the needs and expectations of Relevant interested parties and their requirements must be determined and this information is to be monitored
New clause
interested parties and reviewed.

4.3 Determining the scope of the quality 1.2 Application The Quality Manual is no longer mandatory. The requirement remains for determining and documenting
management system 4.2.2 Quality manual the QMS scope.

4 Quality management system

4.4 Quality management system and its processes 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

The 2015 version requires top management to become accountable for the QMS’ effectiveness and integration
5.1.1 Leadership and commitment for the quality
5.1 Management commitment with the organization’s business processes as well as ensuring the quality policy and objectives are compatible
management system
with the organization’s context and strategic direction.

The 2015 version includes services (along with products) and also addresses statutory and regulatory
5.1.2 Customer focus 5.2 Customer focus
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 5.5.1 Responsibility and authority The 2015 version requires top management to assign responsibility and authority for ensuring processare
authorities 5.5.2 Management representative delivering their intended outputs.

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 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
5.4.2 Quality management system planning 8.5.3
6.1 Actions to address risks and opportunities Preventative action has been replaced by risks and opportunities.
Preventive action
Quality objectives must now be monitored. There are also additional requirements for planning how the
6.2 Quality objectives and planning to achieve them 5.4.1 Quality objectives
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
7.6 Control of monitoring and measuring
7.1.5 Monitoring and measuring resources tools to measure business performance
equipment
The 2015 version makes a distinction between knowledge specific to the organization and general training or
7.1.6 Organizational knowledge 6.2.2 Competence, training and awareness
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.
Documents and records are now referred to as “documented information“. Where “retain” is used this refers to
7.5 Documented information 4.2 Documentation requirements
records and where “maintain” is used this refers to documents. For evidence purpose
7.5.1 General 4.2.1 General
4.2.3 Control of documents
7.5.2 Creating and updating Clear document control with versions
4.2.4 Control of records
4.2.3 Control of documents
7.5.3 Control of documented Information New requirement to protect records from unintended alterations.
4.2.4 Control of records
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 QMS- ISO 9001:2015 Section/Clause Changes
ISO 9001: 2015 ISO 9001:2008 Discussion
8 Operation 7 Product realization
New requirement to review the consequences of unintended changes and take actions to
8.1 Operational planning and control 7.1 Planning of product realization
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
8.3 Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development Inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4 Control of externally provided products and services
8.4.1 General
8.4.2 Type and extent of control of external provision
8.4.3 Information for external providers
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services
7.2.2 Review of requirements related to the product
7.3 Design and development
Establish, implement and maintain a design and development process that is appropriate for
New clause
your organization.
Organization’s must now consider the need for involvement of customers and users in the
7.3.1 Design and development planning
design and development process.
7.3.2 Design and development inputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.3 Design and development outputs
7.3.7 Control of design and development changes
7.4.1 Purchasing process
7.4.1 Purchasing process
7.4.1 Purchasing process
7.4.3 Verification of purchased product
7.4.2 Purchasing information
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.3 Identification and traceability
7.5.4 Customer property Extends requirements for property belonging to external providers (as well as customers).Achroma Std
7.5.5 Preservation of product
7.5.1 Control of production and service provision Companies need to think about things that could go wrong and their impacts
7.3.7 Control of design and development changes
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 OBS PSQA
8.3 Control of nonconforming product 11
 QMS- ISO 9001:2015 Section/Clause Changes
ISO 9001: 2015 ISO 9001:2008 Discussion
8 Measurement, analysis and
9 Performance evaluation
improvement
9.1 Monitoring, measurement, analysis
8.2 Monitoring and measurement
and evaluation
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

The new standard does not require a documented procedure for internal audit, but an internal
9.2 Internal audit 8.2.2 Internal audit
audit program must be established.

Management reviews now include review the QMS for alignment with the organization’s
9.3 Management review 5.6 Management review
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.

8.3 Control of nonconforming product

10.2 Nonconformity and corrective action Update risks and opportunities data base.
8.5.2 Corrective action

10.3 Continual Improvement 8.5.1 Continual improvement Use data from monitoring & measuring for performance review and improvement.
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