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Key inputs into the Design

Specification for ISO 9001:2015

Alka Jarvis

Alka Jarvis © January 2012

ISO 9001 history, At A Glance

Global Presence: Over

1,000,000 Cert.

If Implemented Right:

helps organizations to

Improve & remain

sustainable

Over 10 years since

any significant

changes

Increase relevance to

drive growth

Technology/Innovation

Alka Jarvis © January 2012

Details

9001/9004 first published in 1987, undergone

three revisions: 1994, 2000 and minor changes in 2008

―

YEAR HISTORY

1987 Standard was based on traditional quality assurance

standard used in Manufacturing sector

1994 Minor revision, without significant change

2000 Concept of eight quality management principles: Customer

focus, leadership, involvement of people, process

approach, system approach, fact-based decision making,

continual improvement, mutually beneficial supplier

relationships

2008 Minor revision, without significant change

Alka Jarvis © January 2012 4

Design Specification

The Design Specification provides:

Principles and general expectations for the revision of ISO

9001

Does not have a fixed list of specific items or requirements to

be considered in the standard

This will allow ISO/TC 176/SC 2 to communicate:

Purpose and direction regarding the strategic intent of the

revision

Clear specifics of the purpose of the revised standard and the

scope of the revision process

Alka Jarvis © January 2012

• It is a golden age of technology and

innovation. These two are

transforming:

• The way we do business

• The way we work

• The way we communicate

• The way we live

• The way we learn

Mobile Access

Online Banking

Global Positioning

System: GPS

Technological Changes: Over 10 years

Alka Jarvis © January 2012 6

Purpose of the Revision

Provide updates to the QMS Standards to meet

today’s complex and technological changes

Ensure the requirements are stated to facilitate

effective implementation by organizations and

effective audits by 1st, 2nd and 3rd parties

Ensure that the standard is adequate to provide

confidence to the organization in meeting the

standard’s requirements

Alka Jarvis © January 2012 7

Requirements for the New Contents

Generic to all sizes/types and types

Capable of being applied by the widest possible range of

organizations

Current purpose, the title and the field of application be unchanged

from ISO 9001:2008

Simplified language and writing styles used for understanding and

consistency

Consistent phrasing and terms maintained to facilitate both

translation into other languages

Maintain focus on effective process management to produce the

desired outcomes

Others!

Alka Jarvis © January 2012 8

Key Sources for Design Inputs

User needs have been determined from the

following:

The results of the "systematic review" that was

completed on ISO 9001:2008 during 2011-2012

Analysis of the results of the extensive worldwide

ISO 9001 User Survey

Alka Jarvis © January 2012

Importance of New Concepts in ISO 9001 How important is it to incorporate the following concepts into ISO 9001?

Alka Jarvis © January 2012

Key User Inputs from the World-wide

Survey

• ISO, as it is, must change to be relevant

• Integrate with other MSS (EMS etc.)

• Provide one integral approach to the management of the organization for Leadership commitment & understanding, strategic planning, management buy-in

• Ensure efficiency/effectiveness of audits and address problems in certification audits

• Include tools and risk management

(

ISO Input

For Future

Alka Jarvis © January 2012 11

Other Design Input Sources: 19

ISO/TC176/SC2 Vision and Mission

ISO/TC 176/SC2 Strategic

Objective

Work of the Ad Hoc Group:

examination whether the req. of ISO

9001 support clause 1.1

Outputs from the

SC1/SC2 Task Group on

the revision of QM

principles

Annex SL*

ISO/TC 176/SC 2/WG

18/TG1.19 Project

Review Report

User needs from 2000/2008

Design Specs

Comments from

systematic

review/proposed actions

ISO 9001:2015

Alka Jarvis © January 2012 12

Other considerations

ISO responded to user requests for greater alignment by

developing Annex SL for use in all of its management system

standards.

A number of standards have been developed based upon ISO

9001. Where practicable, consideration of the content of those

standards may be used as input into the revision of ISO 9001

Consistency with other standards in the ISO 9000 family should

be maintained, particularly with respect to the definitions given in

ISO 9000

WG24 is expected to work in close liaison with ISO/TC176/SC1 to

ensure consistency of approach, using an iterative process to

ensure compatibility between the Fundamentals of ISO 9000

Alka Jarvis © January 2012 13

Liasons: 13+

Auditing Practices Group

Communications and Product Support.

Interpretations

Concepts and Terminology

Environment Management Systems

Outsourcing

Others

ISO/TC 176/SC 1

ISO/TC 176/SC 2/WG 22

ISO/TC 176/SC

2/WG 23

ISO/TC 176/IAF/ISO

ISO/TC

207/SC 1

ISO/PC 259

Alka Jarvis © January 2012 14

The Ultimate Results

The Standard:

Will address user concerns

Increase confidence in an

organization’s ability to

provide conforming products

Enhance an organization’s

ability to satisfy its

customers

Enhance customer

confidence in QMS based on

ISO 9001

Alka Jarvis © January 2012 15

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