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Informações chaves para elaboração da Norma ISO 9001:2015 Palestrante Alka Jarvis | Representante do USA no ISO 176/SC2
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1
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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