ANM Consultantse

Welcomes YOU
to
ISO 9001:2015
AWARENESS TRAINING
PROGRAM
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Awareness Training Program

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 Objective

To understand the
Clauses & Key
changes
in the
ISO 9001: 2015
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 Journey of 9001 standards
Refer ISO 9000:2005 for
definitions of Quality
Assurance (cl. 3.2.11)
1987
and
Quality Management 1994
(cl. 3.2.8)

2000

20XX 2015 2008

Risk Based

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 Terminology difference
ISO 9001:2008 Vs ISO 9001:2015

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 KEY CHANGES:

 There is no need of Quality Manual

 It emphasizes on Organization Context
and Risk Based Thinking
 There is no PREVENTIVE ACTION
 For Continual Improvement, another term
Improvement is introduced

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 Annex-SL-High level structure
 Introduction
 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.

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 Risk Based Thinking
ISO9001:2008 Requirements..
 Risk based thinking was implicit in the previous
edition……
 Preventive action to prevent occurrence of the
potential nonconformities.
 Taking action to prevent recurrence of the
nonconformities.

ISO 9001:2015 Requirements….

 Plan and implement actions to address risks &
opportunities.
 So as to improve the effectiveness of the QMS.
 Improved results and preventing negative effects.

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PDCA Cycle

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 Clause 1 – General
Plan DO Check Act
Establish Implement the
Objectives & Analyse the Take actions to
processes plan / processes,
outcomes / continually
necessary to observe,
deliver results, results of improve
in accordance measure, collect
processes and process
with the data.
Customer’s product against performance.
requirements policies , Choose best
and the policies
of the objectives and strategy,
Organization. requirements for adjust
Identify
parameters, the product. process,
resources, set Develop repeat the
standards and
procedures. recommendations cycle.

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Seven Management Principles

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QMS Structure

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 ISO 9001:2015 will bring to your QMS:

 Better integration with other business activities

 Enhancement of the process approach and PDCA cycle
 Decentralization of the system and spread of
responsibilities for the QMS throughout the
organization
 Greater involvement of the top management in the
QMS
 Introduction of risk-based thinking in the QMS
 Higher emphasis on performance monitoring

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 2008 Standards Vs 2015 Standards:

2008 2015

8 Principles 7 Principles

8 Clauses 10 Clauses

6 Mandatory Procedures 6 Mandatory documents

Mandatory records Mandatory DI

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 Requirements from ISO 9001:2008 that are gone

 Quality Manual

 Management Representative

 Preventive Action

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 MODERATE CHANGES IN ISO 9001:2015:

 Control of externally provided products, processes

and services.
 Quality Objectives and Plans for achieving them
 Design and Development
 Performance evaluation
 Document Management
 Production and Service Provision
 QMS Scope

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 MAJOR CHANGES IN ISO 9001:2015

 Risks and Opportunities

 Context of the Organisation

 Interested Parties

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 SMALL CHANGES IN ISO 9001:2015;

 Quality Policy
 Leadership
 Competence, Training and Awareness
 Management Review
 Internal Audit
 Corrective Action

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 Context of the Organisation:
 An organisation must consider both the internal and
external issues that can impact its strategic objectives and
the planning of QMS.
 While identifying these issues, you should focus only on
issues that can affect the customer satisfaction and
delivery of quality product and/or service.
 An organization’s internal context is the environment in
which it aims to achieve its objectives. Internal context can
include its approach to governance, its contractual
relationships with customers, and its interested parties.
Things that need to be considered are related to the
culture, beliefs, values, or principles inside the
organization, as well as complexity of processes and
organizational structure.

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 Context of the Organisation:

 To determine external context, you should consider issues

arising from its social, technological, environmental,
ethical, political, legal, and economic environment.
Examples of external context may include:
 Government regulations and changes in the law
 Economic shifts in the organization’s market
 The organization’s competition
 Events that may affect corporate image
 Changes in technology

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 Interested Parties:

 Interested parties will have an impact on the organization’s

ability to provide products and services that consistently
meet customer needs and legal requirements.

 Eg:
 Customers,
 Government , Non Government Organisations
 Suppliers
 Employees
 Shareholders

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 RISKS AND OPPURTUNITIES:

 ISO 9001:2015 defines risk as the effect of uncertainty on

an expected result.

 Or

 The concept of risk in the context of ISO 9001 relates to

uncertainty in achieving the company’s objectives.

 The target of a management system is achieve conformity

and customer satisfaction.

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Thank You

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