A Review ISO 9001:2015

What’s Important to Know Now

 What’s New?
• Risk management is being added with focus on risk-based
thinking. Identification of risk and risk control now a
requirement.

• Standardized core text, structure, definitions enable

organizations with multiple management systems to achieve
improved integration & implementation.

• Major focus on achieving value for organization and its

customers.

• Revisions allow ISO 9001 to be more applicable by “service-

based” organizations.

• Primary focus remains on Customers!

 What Prompted Revisions?

• Business and industry has changed.

• Greater diversity of ISO 9001 users and
broader interests of users.
• Knowledge and technology developments.
 ISO 9001 – 2015
• Review based on ISO Working Draft 9001 – 6/13.
• Firms may wish to consider these changes and plan
accordingly .
• New revisions slated for release Sept 2015 with full
implementation Sept 2018.
• Draft revisions now 21 pages of requirements
compared to 9 pages in the 2008 revised standard
 Objective of Revisions
• Enhance an organization’s ability to satisfy
customers.
• Maintain relevance, provide integrated
approach to organizational management, and
integrate with other management systems.
• Reflect needs of all user groups and
increasingly complex operating environments.
• Set a consistent foundation for next 10 years.
 ISO 9000 Series
 ISO 9000 - Quality management systems — Fundamentals and vocabulary
 ISO 9000 provides an essential background for the proper
understanding and implementation of the ISO 9001 International
Standard.
 ISO 9001 – Quality Management Systems - Requirement
 ISO 9001 specifies requirements aimed primarily at giving confidence
in the products and services provided by an organization and thereby
improving customer satisfaction.
 ISO 9004 - Managing for the sustained success of an organization - A quality
management approach
 ISO 9004, Provides guidance for organizations that choose to progress
beyond the requirements of the ISO 9001 International Standard to
address a broader range of topics that can lead to continual
improvement of the organization's overall performance.
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New “Terms” in the first 6 Clauses of ISO
9001:2015
1. Scope of standard
2. Normative references
3. Terms and definitions
4. “Context of the 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 - b) the
requirements of relevant “interested parties”
4.4 Quality management system and its processes - f) address the “risks “
5. “Leadership”
6. “Planning”
6.4 Actions to address “risks and opportunities”.
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ISO 9000 Table of Contents
Foreword & Introduction
1 Scope
2 Fundamental concepts and quality
management principles
2.1 General
2.2 Fundamental concepts
2.2.1 Quality

2.2.2 Quality management system

2.2.3 Context of an organization
Descriptive
2.2.4 Interested parties language with no
requirements
2.2.5 Support

Compliments of US TAG to ISO TC 176 8/26/2015

ISO 9000 Table of Contents Continued
2.3 Quality management principles
2.3.1 Customer focus
2.3.2 Leadership
No requirements;
2.3.3 Engagement of people ideas useful in
guiding
2.3.4 Process approach organizations’
actions. Used as a
2.3.5 Improvement basis for
developing ISO
2.3.6 Evidence-based decision making 9001.

2.3.7 Relationship management

Compliments of US TAG to ISO TC 176 8/26/2015

 ISO 9000 Table of Contents Continued

2.4 Developing the QMS using fundamental

concepts and principles
2.4.1 QMS model
2.4.2 Development of a QMS
2.4.3 QMS standards, other management systems
and excellence models

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ISO 9000 Table of Contents Continued
3 Terms and definitions - Terms related to …

3.1 person or people 3.8 data, information and

document
3.2 organization
3.9 customer
3.3 activity
3.10 characteristic
3.4 process
3.11 determination
3.5 system 3.12 action
3.6 requirement 3.13 audit
3.7 result
Required definitions of terms used in
requirements standards such as ISO 9001
Compliments of US TAG to ISO TC 176 8/26/2015 11
3/25/14
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Understanding the definitions and fundamental
concepts in ISO 9001:2015
The Following are examples of some of the
New, Revised or Removed Terms of ISO 9001
 Interested party New  Competence Revised
 Risk New  Output Revised
 Risk-based thinking  Information Revised
New
 Provider  Information system Revised
 Documented New  Verification Revised
information
 Validation
Revised
 Effectiveness New
 Corrective action Revised
Revised  Preventive action Removed

Compliments of US TAG to ISO TC 176 8/26/2015 20 20

Understanding “interested
parties”
When determining the scope of the organization, we shall
consider the expectations of “relevant interested parties.”
All of the following can be "interested parties”:
Person having an Organization that
interest in the Person that can perceives itself to
success of an affect an activity be affected by a
organization decision

Person having an
interest in the Providers’
Stakeholder regulators
performance of an
organization

Opposing pressure
Competitors group
There are more!
Understanding “Risk”
The term “Risk” has been added to ISO 9001:2015 and is
noted in many places throughout the standard.

“Risk” - effect of uncertainty positive or negative.

consequence, or likelihood reference to potential events
the consequences of an event

This may apply, for example, to; a product, service,

process, provider, customer, consumer, environment,
employee, & the competition.
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 Considering Risk
• Risk is very detailed in this revision to the standard as
compared to ISO 13485, Food Safety, or Aerospace.
• Think about adding/using words that are typical in
the risk process such as risk determination, risk
control, risk mitigation, acceptable level of risk.
• Next slide outlines the four phases of managing risk,
and maybe helpful as an organization addresses risk
to their business.
 Four Phases of Risk

Risk Analysis Risk Evaluation

• INTENDED USE Identification • RISK acceptability decisions
• HAZARD identification
• RISK estimation RISK ASSESSMENT

Risk Control Post Production

• OPTION analysis Information
• Implementation of measures • Post-production experience
• RESIDUAL RISK evaluation • Review of RISK MANAGEMENT
experience- customer use
• Overall RISK acceptance • Take appropriate actions
 Where Risk is Addressed in 2015

• 3.09 Risk - effect of uncertainty (definition)

• 4.1 Organization shall take account of these issues for

determining risk.

• 4.4 QMS - determine risk if unintended output produced.

• 5.1 Leadership - ensuring risks that could affect meeting

product requirements … managed.

• 6.1 Actions to address risk and opportunities.

 Risk Continued
• 6.3 Planning and Controlling Changes
a) identification of risk and control measures associated with
product

• 8.4 Control of External Processes or Products- evaluation

based on risks and risk control

• 8.5.1 Design and Development, define c) risk

• 8.5.3 Implement c) risk control measures

• 8.6 Execution/Implementation 8.6.1h) implementation of

risk controls

• 9.3 Management Review b) determined risks

 Timeline to Revision Release and
Client Transition

2013 2014 2015

June 2013 CD
(Committee Draft)

April 2014 DIS

(Draft International Standard)

July 2015 FDIS

(Final Draft International Standard)

September 2015
(Published International Standard)
Timeline to Revision Release and
Client Transition
2015 2016 2017 2018

September 2015
Published International Standard

September 2015 start of 3 years

transition period to September 2018
Reference links for additional
Information
 “ISO 9000:2015—What’s Normative, Anyway?” by Paul
Palmes
www.insidestandards.com/iso-90002015-whats-normative-
anyway/
 Standards Connection newsletter
asq.org/standardsconnection/
 Learn About Standards
asq.org/learn-about-quality/learn-about-standards/
 ASQ Standards Channel
videos.asq.org/asq-standards-channel
 ISO 9000 Series overview
asq.org/learn-about-quality/iso-9000/overview/overview.html
 ISO/FDIS 9000:2015 “NOTE Guidance on some additional
frequently used words in the QMS standards developed by
ISO/TC 176, and which have an identified dictionary
meaning, is provided in a glossary available at:
www.iso.org/iso/03_terminology_used_in_iso_9000_family.p
df” © 2015, US TAG to ISO/TC 176