CQS_ISO 2015_ASQR (4-16-15)

4/16/15 Copyright ©2015 Compass Quality Solutions

ISO 9001: What to expect with the

2015 version

Lori Cohen

Compass Quality Solutions

585-737-8441

Copyright ©2015 Compass Quality Solutions

Agenda

Overview of main changes to ISO 9001 based on

ISO 9001:2015 DIS

• Timeline

• Key Changes

o Structure

o Terminology

o Requirements

• Transition Resources


Timelines – ISO 9001:2015

2014 2015 2016 2017 2018

Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q3

DIS

FDIS

9001:2015

Published

Transition to

9001:2015

July -FDIS Ballot

Sept/Oct 2015

ISO 9001:2008 expires 3 yrs. from issue of ISO 9001:2015


Key Changes

• Structure (Annex SL)

o New format – high level structure

• Terminology (Annex SL)

o Standard text – identical core text

o Common terms and core definitions

• Requirements

o More generic, less prescriptive

o New requirements


Key Changes: Structure

Structure - Annex SL

• New format – high level structure

• Describes framework for generic management

system

• 10 clauses

• ISO/IEC Directives, Part I, Directive 1 for ISO

Management Systems

o Appendix 2 - High level structure,

identical core text, common terms and

core definitions


Structure – Annex SL

Annex SL

4. Context of the organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

10. Improvement

1 Scope

2 Normative references

3 Terms and definitions

ISO 9001:2008

4. Quality Management System

5. Management Responsibility

6. Resource Management

7. Product Realization

8. Measurement, Analysis and

Improvement

http://www.iso.org/tc176/sc02/public


Structure – ISO 9001:2015

Plan Do Check Act

1 Scope



10

Improvement

Resources

Competence

Awareness

Communication

Documented

information

Actions to

address risks &

opportunity

Quality objectives

Planning of

changes

Nonconformity &

corrective action

Improvement

Monitoring,

measurement,

analysis &

evaluation

Internal audit

Management

review

Quality policy

Roles,

responsibility &

authority

Leadership &

commitment

Determination of

requirements for

products and

services

Design and

development of

products and

services

Control of

external provided

products and

services

Production and

services

provision

Operations of

planning and

control

Release of

products and

services

Nonconforming

process outputs,

products and

services

5

Leadership

4

Context of

organization

9

Performance &

evaluation

8

Operation

7

Support

6

Planning

Understanding

the organization

and its context

Expectations of

interested parties

Scope of QMS

QMS


Structure – ISO 9001:2015

Plan Do Check Act

1 Scope



10

Improvement

Resources

Competence

Awareness

Communication

Documented

information

Actions to

address risks &

opportunity

Quality objectives

Planning of

changes

Nonconformity &

corrective action

Improvement

Monitoring,

measurement,

analysis &

evaluation

Internal audit

Management

review

Quality policy

Roles,

responsibility &

authority

Leadership &

commitment

Determination of

requirements for

products and

services

Design and

development of

products and

services

Control of

external provided

products and

services

Production and

services

provision

Operations of

planning and

control

Release of

products and

services

Nonconforming

process outputs,

products and

services

5

Leadership

4

Context of

organization

9

Performance &

evaluation

8

Operation

7

Support

6

Planning

Understanding

the organization

and its context

Expectations of

interested parties

Scope of QMS

QMS


Key Changes: Terminology

Annex SL

• Identical core text

• Common terms and core definitions

ISO 2015 DIS - Annex A

• Informative

• Provides clarification on

o Structure

o Terminology and concepts


Terminology - Major Differences

ISO 9001:2015 DIS - Annex A

ISO 9001:2008 ISO 9001:2015

Products Products and services

Exclusions Not used Application

Documentation,

Records

Documented information

Work Environment Environment for operation of

processes

Purchased Product Externally provided products and

services

Supplier External provider


Terminology - Major Differences

Documented information

• Replaces “documented procedure” and

“record”

• Procedure - Maintain documented information

• Record - Retain documented information

• No significant change


Structure and Terminology

Per ISO 9001:2015 DIS - Annex A

• Your QMS documentation structure is not

required to mirror ISO 9001:2015

• Not required to change or replace your

terminology

Choose what’s best for your organization


Key Changes: Requirements

• More generic

o More flexible for service

• Less prescriptive

• Risk-based thinking

• New requirements

o Context of Organization

o Planning and Risk


Requirements - Less prescriptive

Will not require

• Documented procedures

• Quality Manual

• Management Representative


Requirements - Less prescriptive

ISO 2008 ISO 2015 DIS

Documented procedures Replaced with “Maintain documented

information”

Quality Manual

- Scope

- Justifications for exclusion

- Documented procedures

or reference to them

- Description of process

interactions

4.3 Scope of QMS

- Products and services covered by

QMS

- Justification for requirements that do

not apply

4.4 QMS and its processes

- Maintain information about processes

Required documented information

Management

Representative

5.3 Organizational roles, responsibilities

and authorities

- Responsibilities still exist, title removed


Key Changes: Risk-based thinking

Concept explained in ISO 2015 DIS – Introduction

• Risk defined as the effect of uncertainty on an

expected result

• Has been implicit in ISO 9001, explicit in ISO

2015

• Requirements incorporated into all aspects –

from establishing QMS through continual

improvement


Risk-based thinking

• Risk include opportunities

• “Risk and opportunities” throughout the

standard

• Replaces Preventive Action - Part of planning

(6.1)

• Formal Risk Management program not

required


Key Changes: New Requirement

Context of the Organization

4.1 Understanding the Organization and Its

Context

4.2 Understanding the needs and expectations of

interested parties


Context of Organization

4.1 Understanding the Organization and Its

Context

• Determine external and internal issues

o Relevant to purpose and strategic direction

o Affect ability to achieve intended results

• Monitor and review information about external

and internal issues



Context of the organization

• Business environment

• Factors and conditions that affect your

approach to business

External issues – technological, competitive,

market, cultural, social, economic, legal…

Internal issues – culture, values, knowledge,

performance….




interested parties

• Consider relevant interested parties - those

that have potential impact on organizations

ability to provide products and services that

meet requirements

Examples: Relevant interested parties -

customers, suppliers, owners/partners,

employees, bankers……….




interested parties

• Determine

o Relevant interested parties

o Requirements of relevant interested

parties

• Monitor and review information related to

interested parties and relevant requirements


Planning – Risk and Opportunity

6.1.1 Actions to address risk and opportunities

• Consider issues determined in 4.1 and

requirements for relevant interested parties

(4.2)

• Determine risks and opportunities to address

o QMS can achieve its intended results

o Prevent or reduce undesired effects

o Continual improvement

Key Changes: New Requirement


6.1.2 Actions to address risk and opportunities

• Plan actions to address risks and opportunities

• Plan how to

o Integrate and implement actions

o Evaluate effectiveness of actions

• Actions proportionate to potential impact

Planning – Risk and Opportunity


o 1. 1. INTRODUCTION

Main Changes per IAF


Transition Resources

ISO website

ISO TC/176/SC2 Home Page

http://isotc.iso.org/livelink/livelink/open/tc176SC2public




Transition Resources

ASQ website

http://asq.org/standards-iso-9001-2015.html









Questions and Answers

Thank you!

Any questions?

Lori Cohen

Compass Quality Solutions

585-737-8441

www.compassqs.com

[email protected]

http://www.compassqs.com/

mailto:[email protected]

Documents

CQS_ISO 2015_ASQR (4-16-15)