ISO 9001:2015

It is here - now what

David W. Wu
1/19/2016

ISO 9001:2015
ISO 9001 offers more than quality benefits.
The standard should be thought of as a business
management tool an organization can use to
drive value,
improve its operations,
and reduce its risks.
Oscar Combs
President of the ISO 9001 Group

Objectives
ISO9001:2015

What is new
What has changed
Let us compare
Transition strategies

What is new
ISO9001:2015

Begins with leadership

Introduces risk/opportunity concept
New structure which is more general/flexible
New terminologies and changes
Business, performance, and customer focuses

What is new
BEGINS WITH LEADERSHIP

Top Management shall demonstrate leadership and

commitment
Leadership
Top management more accountable for system
Policy and objectives compatible with strategy

Management Representative - Not Required

Replaces the Management responsibility with
Leadership and Commitment

What is new
INTRODUCES RISK/OPPORTUNITY CONCEPT

What risks and opportunities have the potential to impact

(negatively or positively) the operation and performance of
an organizations QMS?
Risk only mentioned in ISO 9001:2008 clause 0.1
Risk mentioned 16 times in ISO 9001:2015
requirements section

What is new
CLAUSES ADDRESSING RISK IN ISO 9001:2015
CLAUSE 4

CLAUSE 5

CLAUSE 6

THE ORGANIZATION IS
REQUIRED TO DETERMINE
RISKS THAT CAN AFFECT ITS
ABILITY TO MEET
OBJECTIVES

TOP MANAGEMENT ARE

REQUIRED TO COMMIT TO
ENSURING CLAUSE 4 IS
FOLLOWED

THE ORGANIZATION IS
REQUIRED TO PLAN AND
TAKE ACTION TO ADDRESS
RISKS AND OPPORTUNITIES

CLAUSE 8

CLAUSE 9

CLAUSE 10

THE ORGANIZATION IS
REQUIRED TO HAVE
PROCESSES WHICH
IDENTIFY AND ADDRESS
RISK IN ITS OPERATIONS

THE ORGANIZATION IS
REQUIRED TO CONSIDER
RISKS AND OPPORTUNITIES
WHEN DETERMINING WHAT
NEEDS TO BE MONITORED,
MEASURED, ANALYZED AND
EVALUATED

THE ORGANIZATION IS
REQUIRED TO IMPROVE BY
RESPONDING TO CHANGES
IN RISK AND
OPPORTUNITIES

What is new
NEW STRUCTURE WHICH IS MORE GENERAL/FLEXIBLE
ISO 9001:2008

ISO 9001:2015
1. Scope

1. Scope
2. Normative Reference

Introduction

2. Normative Reference

3. Terms and Definitions

3. Terms and Definitions

4. Quality Management System

4. Context of the Organization

5. Management Responsibility

Plan

6. Planning

6. Resource Management
7. Product Realization
8. Measurement, Analysis,
and Improvement

5. Leadership

Do
Check,
Act

Plan

7. Support
8. Operation
9. Performance Evaluation
10. Improvement

Introduction

Do
Check
Act

What is new
NEW TERMINOLOGIES AND CHANGES
ISO 9001:2008

ISO 9001:2015

Products

Products and services

Exclusions

Not used

Management representative

Not used

Documentation, quality manual,

documented procedures, records

Documented information

Work environment

Environment for operation of processes

Monitoring & measuring equipment

Monitoring & measuring resources

Purchased product

Externally provided products & services

Supplier, outsourced process

External provider

What is new
BUSINESS, PERFORMANCE, AND CUSTOMER FOCUSES

Understand the business environment using SWOT

Determine and monitor internal and external issues
Determine needs and expectations of interested parties
Integrate quality into business processes
Should be compatible with strategic direction of the
business
Focus on performance and add value, not just conformity
Ensure customers consistently receive high quality
products and services
Service output realized at interface with customer

10

What has changed

ISO9001:2015
ADDED

AMENDED

NEW HIGH-LEVEL STRUCTURE

RISK MANAGEMENT
HARMONIZATION WITH OTHER
MANAGEMENT SYSTEMS

QM MANUAL
DOCUMENTATION REQUIREMENTS
REPRESENTATIVE APPOINTED BY
TOP MANAGEMENT

IMPACT
ISO 9001:2015 PROVIDES A STABLE FRAMEWORK OF REQUIREMENTS FOR THE
NEXT TEN YEARS
THE GENERIC APPROACH PROVIDES THE NECESSARY RELEVANCE FOR ALL
ENTERPRISES REGARDLESS OF THEIR
SIZE
ORGANIZATIONAL STRUCTURE
INDUSTRY OR SECTOR

11

Other Changes
ISO9001:2015
5.1.1 LEADERSHIP AND COMMITMENT
FOR THE QUALITY MANAGEMENT
SYSTEM

Top management shall demonstrate

leadership and commitment with respect to
the quality management system by:
d) ensuring the integration of the quality
management system requirements into the
organizations business processes
k) supporting other relevant management
roles to demonstrate their leadership as it
applies to their areas of responsibility.

6.3 PLANNING OF CHANGES

Where the organization determines the
need for change to the quality
management system the change shall
be carried out in a planned and systematic
manner.
The organization shall consider:
a) the purpose of the change and any of its
potential consequences;
b) the integrity of the quality management
system;
c) the availability of resources;
d) the allocation or reallocation of
responsibilities and authorities.

The organization shall obtain information

relating to customer views and opinions
of the organization and its products and
services.

12

Other Changes
ISO9001:2015
7.4 COMMUNICATION
The organization shall determine the internal
and external communications relevant to the
quality management system including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate.

8.4.3 INFORMATION FOR EXTERNAL

PROVIDERS
The organization shall communicate to external
providers applicable requirements for the
following:
d) their interactions with the organization's
quality management system;
e) the control and monitoring of the external
providers performance to be applied by the
organization.

8.5.5 POST-DELIVERY ACTIVITIES

As applicable, the organization shall meet requirements for post-delivery activities
associated with the products and services.
In determining the extent of post-delivery activities that are required, the
organization shall consider:
a) the risks associated with the products and services;
b) the nature, use and intended lifetime of the products and services;
c) customer feedback;
d) statutory and regulatory requirements.

13

Let us compare
ISO9001:2015
Count

2008 Edition

2015 Edition

Requirement Pages

13

18

Definitions (ISO 9000)

84

146

Shall

136

132

Procedure

10

Documented Procedure

Process

35

57

Record

29

Documented Information

41

14

Let us compare
ISO9001:2015
Count

2008 Edition

2015 Edition

Strategic Direction

Risk

16

Knowledge

12

Performance

16

Results

27

28

Change

13

27

Improvement

14

15

Resources

15

15

Transition strategies
ISO9001:2015

Dont rush to change the current system

Remember the transition period is 3 years
Fully understand ISO 9001:2015 requirements
Apply the proper interpretation of the standard in actual
audit situations
Transition to Risk-based Thinking
Plan actions/options for risks and opportunities
Determine relevant interested parties

16

Transition guidance
ISO9001:2015

17

Perform gap analysis against new requirements

Develop ISO 9001:2015 transition plan
Help leadership understand their roles
Align quality policy and objectives with strategy
Use transition to improve quality and business
Review plan with registrar for integration
Contact ASQ Greater Memphis for ISO 9001:2015
transition training