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ISO 9001:2015 Draft International Standard

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Posted June 8th, 2015 by admin (http://dqsindia.com/author/admin-2-2/) & filed under News
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ISO 9001:2015 Draft International Standard is published. The revised version of the quality
management system standard is due to release in September 2015, by the International
Organization for Standardization (ISO).

Back ground of ISO 9001

(http://dqsindia.com/wp-content/uploads/2015/06/Back-ground-of-ISO-9001.png)

WHY ISO 9001:2015?


As per the policy of ISO all standards needs to be reviewed and revised in every 5 Years and to
incorporate the new High Level Structure as defined in the Annex SL of ISO 17021. ISO new
version main objective is to provide confidence in the organizations ability to consistently provide
customers with conforming goods and services and to enhance customer satisfaction.
New ISO 9001:2015 standard characterize a technical revision compared to 2008 edition. It also
adopts revised clause sequence, quality management principles and addition of new concepts.
Some concepts introduced in new standard are:
Integration of Risk Management
Resource Management
Systematic problem solving and learning
Voice of the customer
Knowledge management
Measures (examples are performance, satisfaction and ROI.)

ISO 9001:2015 REVISION PROCESS

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(http://dqsindia.com/wp-content/uploads/2015/06/REVISION-PROCESS.png)

QUALITY MANAGEMENT PRINCIPLES used in ISO 9001:2015 DIS


Seven Management System Principles were used in ISO 9001:2015 DIS standard
Customer Focus
Leadership
Engagement of People
Process Approach
Improvement
Evidence based Decision Making
Relationship Management

Major Changes in ISO 9001:2015 DIS


High Level Structure is used in text writing (i.e. clause sequence, common text and
terminology)
New clause sequence is adopted in new version which is consistent with Annex SL, highlighted
in main body of the text (clause 1 to 10).
No specific reference and text for possible exclusions of requirements
No specific requirement and text fordocumentedprocedures and records. Both have been
replaced throughout by the text documented information.
Role ofManagement Representative Now the activities of Management Representative should
be performed by one of group of Senior Management.
No mention of a Quality Manual. Specific word Quality Manual is no-were mentioned in the
Draft Standard.
Quality policy / objectives compatible with strategic direction
Integration of QMS requirements into business processes
Change of tem product to product and services. New term include all output categories i.e.
hardware, services, software and processed materials
Organization needs to determine the knowledge necessary for the operation of the QMS and
its processes and to achieve conformity of process
Risk-based thinking introduced in all clauses
Organization needs to determine the risks to conformity of goods and services and to
customer satisfaction and opportunities in place of preventive action

RISK ADDRESSED IN FOLLOWING CLAUSES OF ISO 9001:2015 DIS

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Clause 4

Organization is required to determine risks that can affect its ability to meet objectives.

Clause 5

Top management are required to commit to ensuring Clause 4 is followed.

Clause 6

Organization is required to plan and take action to address risks and opportunities.

Clause 8

Organization is required to have processes which identify and address risk in its
operations.

Clause 9

Organization is required to consider risks and opportunities when determining what


needs to be monitored, measured, analyzed and evaluated.

Clause 10

Organization is required to improve by responding to changes in risk and opportunities.

PDCA CYCLE APPROACH IN RISK MANAGEMENT

(http://dqsindia.com/wp-content/uploads/2015/06/PDCA-CYCLE-APPROACH.png)

ISO 9001:2015 DIS CLAUSES


CLAUSE 4: Context of an organization
4.1

Understanding the organization and its context

4.2

Understanding the needs and expectations of interested parties

4.3

Determining the scope of the quality management system

4.4

Quality management system and its processes

CLAUSE 5: Leadership
5.1

Leadership and commitment

5.2

Quality policy

5.3

Organizational roles, responsibilities and authorities

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CLAUSE 6: Planning for quality management system

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6.1

Actions to address risks and opportunities

6.2

Quality objectives and planning to achieve them

6.3

Planning of changes

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CLAUSE 7: Support
7.1

Resources

7.2

Competence

7.3

Awareness

7.4

Communications

7.5

Documented information

CLAUSE 8: Operations
8.1

Operational planning and control

8.2

Determination of requirements for products and services

8.3

Design and development of products and services

8.4

Control of externally provided products and services

8.5

Production and service provision

8.6

Release of products and services

8.7

Control of nonconforming process outputs, products and services

CLAUSE 9: Performance Evaluation


9.1

Monitoring, measurement, analysis and evaluation

9.2

Internal audit

9.3

Management review

CLAUSE 10: Improvements


10.1

General

10.2

Nonconformity and corrective action

10.3

Continual improvement

ISO 9001:2008 Standard Mapping with ISO 9001: 2015 DIS


ISO 9001:2008

ISO 9001:2015 DIS

List of
Clauses

Description

List of
Clauses

Description

Scope

1.1

General

Scope

Remarks

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4.1

Understanding the organization and its


context

New Clause

4.2

Understanding the needs and expectations

New Clause

of interested parties
1.2

Application

4.3

Determining the scope of the quality


management system

Normative Reference

Normative Reference

Terms and Definitions

Terms and Definitions

4.0

Quality Management System

Context of the organization

4.1

General Requirements

4.4

Quality management system and its


processes

Documented
scope required

New
Determination of
risks and
opportunities

4.2

Documentation Requirements

7.5

Documented information

New term
introduced in place
of documents and
records. No
requirement of
documented
procedure.

4.2.1

General

7.5.1

General

4.2.2

Quality Manual

4.2.3

Control of Documents

7.5

Documented Information

4.2.4

Control of Records

7.5

Documented Information

5.0

Management Responsibility

Leadership

5.1

Management Commitment

5.1.1

Leadership and commitment for the quality


management system

5.2

Customer Focus

5.1.2

Customer focus

5.3

Quality Policy

5.2

Quality policy

5.4

Planning

6.

Planning for the quality management


system

5.4.1

Quality Objectives

6.2

Quality objectives and planning to achieve


them

5.4.2

Quality Management System


Planning

6.3

Planning of change

5.5

Responsibility, Authority and


Communication

5.3

Organizational roles, responsibilities and


authorities

5.5.1

Responsibility and Authority

5.3

Organizational roles, responsibilities and


authorities

5.5.2

Management Representative

5.5.3

Internal Communication

7.4

Communication

5.6

Management Review

9.3

Management Review

Responsibilities
are re-defined

New requirements
added and only 7
quality
management
principles
introduced

More specific
requirements
introduced

New requirements
introduced

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5.6.1

General

9.3.1

Management Review

5.6.2

Review Input

9.3.1

Management Review

5.6.3

Review Output

9.3.1

Management Review

6.0

Resource Management

7.1

Resources

6.1

Provision of Resources

7.1

Resources

6.2

Human Resources

7.1.2

People

6.2.1

General

7.2

Competence

6.2.2

Competence, Awareness and

7.2

Competence

7.3

Awareness

New Clause

7.1.6

Monitoring and measuring resources

New Clause

New Clause

Training

6.3

Infrastructure

7.1.4

Infrastructure

6.4

Work environment

7.1.5

Environment for the operation of


processes

7.0

Product realization

Operation

7.1

Planning of product realization

8.1

Operational planning and control

7.2

Customer-related processes

8.2

Determination of requirements for products


and services

7.2.1

Determination of
Requirements Related to the
Product

8.2.2

Determination of requirements related to


products and services

7.2.2

Review of Requirements
Related to the Product

8.2.3

Review of requirements related to products


and services

7.2.3

Customer Communication

8.2.1

Customer communication

7.3

Design and Development

8.3

Design and development of products and


services

7.3.1

Design and Development


Planning

8.3.2

Design and development planning

7.3.2

Design and Development


Inputs

8.3.3

Design and development inputs

7.3.3

Design and Development


Outputs

8.3.5

Design and development outputs

7.3.4

Design and Development


Review

8.3.4

Design and development controls

7.3.5

Design and Development


Verification

8.3.4

Design and development controls

7.3.6

Design and Development


Validation

8.3.4

Design and development controls

7.3.7

Control of Design and


Development Changes

8.3.6

Design and development changes

7.4

Purchasing

8.4

Control of externally provided products and


services

7.4.1

Purchasing Process

8.4.1

General

7.4.2

Purchasing information

8.4.3

Information for external providers

New Clause

products and
services new term

products and
services new term

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7.4.3

Verification of purchased
product

8.4.2

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Type and extent of control of external


provision and 8.6 Release of products and
services

8.6

Release of products and services

7.5

Production and service


provision

8.5

Production and service provision

7.5.1

Control of production and

8.5.1

Control of production and service provision

8.5.1

Control of production and service provision

New requirements
introduced

service provision
7.5.2

Validation of processes for


production and service
provision

7.5.3

Identification and traceability

8.5.2

Identification and traceability

7.5.4

Customer property

8.5.3

Property belonging to customers or


external providers

7.5.5

Preservation of product

8.5.4

Preservation

7.6

Control of monitoring and

7.1.6

Monitoring and measuring resources

measuring Equipment
8.0

Measurement, analysis and


improvement

9.1

Monitoring, measurement, analysis and


evaluation

8.1

General

9.1.1

General

8.2

Monitoring and measurement

9.1.1

General

8.2.1

Customer satisfaction

9.1.2

Customer satisfaction

8.2.2

Internal audit

9.2

Internal Audit

New Clause

New requirements
introduced

8.2.3

Monitoring and measurement


of processes

9.1.3

Analysis and evaluation

8.2.4

Monitoring and measurement


of product

8.6

Release of products and services

8.3

Control of nonconforming
product

8.7

Control of nonconforming process outputs,


products and services

8.4

Analysis of data

9.1.3

Analysis and evaluation

8.5

Improvement

10

Improvement

10.1

General

8.5.1

Continual improvement

10.3

Continual Improvement

8.5.2

Corrective action

10.2

Nonconformity and corrective action

8.5.3

Preventive action

6.1

Actions to address risks and opportunities

New requirements
introduced

New Clause

You have questions about ISO 9001:2015?


Please contact us for questions about the new standard and your next assessment.
Contact Details
Mr. Rajendra Khare, + 91 9810268573, rkhare@dqsindia.com (mailto:rkhare@dqsindia.com)
Source: Information collected from ISO Website

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