ISO 9001:2015AN ORIENTATION INTO THE UPCOMING REVISION

1

Presented on January 14, 2015 by Dan Brown

President, DB Performance Solutions, LLC

Chicago Section, 1201, American Society for Quality

Key Objectives for ISO

9001:2015Extracts from ISO 9001:2015 "Design Specification":

Provide stable core set of requirements for

next 10 years or so

Maintain current focus on effective process

management to produce desired outcomes

Take account of changes in QMS practices

and technology since the last major revision

(in 2000)

Implement Annex SL

2

Key Changes

Reformatted to align with "Annex SL"

“Products and services" instead of

"product"

More emphasis on addressing "risks &

opportunities"

“Documented information” in place of

documents and records

3

Continued

Elimination of the term "preventive

action"

the concept still remains, and is actually

reinforced throughout the standard (by

addressing "risk")

"External provision of goods and

services" instead of "purchasing" —

includes outsourced processes

4

Harmonization Via “Annex SL”

New “Common Core” for all ISO

Management System Standards

10 Elements with identical sub-clause

titles

Common Vocabulary

Ease in managing multiple certifications

9001, 14001, AS9100, 18001, 26000, etc

5

Elements of Annex SL & 9001 6

Section 1 Scope

Section 2 Normative References

Section 3 Terms & Definitions

Section 4 Context of the Organization

Section 5 Leadership

Section 6 Planning for the QMS

Section 7 Support

Section 8 Operation

Section 9 Performance Evaluation

Section 10 Improvement

Annex A Clarification of Structure

Annex B Quality Management Principles

Annex C Portfolio of QM Standards (ISO 10000)

Quality Principles: 7

2008 2015Customer Focus Customer Focus

Leadership Leadership

Involvement of People Engagement & Competence

Process Approach Process Approach

Systems Approach Improvement

Continual Improvement Informed Decision Making

Factual Decision Making Relationship Management

Mutual Supplier Relations

Core Concepts Identify Key Processes

Those processes needed to achieve planned results

How do they relate to each other?

Continually Monitor those Processes

Cause & Effect

What is key metric for process?

Risks Associated, including from sub-standard

performance

Manage those Processes

Plan – Do – Check – Act

Show actions taken when targets not met

8

2000/2008 ISO MODEL

CU

ST

OM

ER

Re

qu

irem

en

ts

CU

ST

OM

ER

Sa

tisfa

ctio

n

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

Management Responsibility

Resource Management

Measurement, Analysis,

Improvement

Product

Inputs

Outputs

ProductRealization

Plan

Do

Check

Act

9

THE 2015 PROCESS MODEL

CU

ST

OM

ER

S &

OT

HE

RR

ELE

VA

NT

INT

ER

ES

TE

D P

AR

TIE

S

Requirements

CU

ST

OM

ER

S

AT

ISFA

CT

ION

CONTINUAL IMPROVEMENT

General Process Approach

PlanningPerformance Evaluation

Products & Services

Inputs

Outputs

Operations

Plan

Do

Check

Act

10

Leadership

EST SCOPE

OF QMS

Process Turtle Diagram

11

With What? (Materials & Equipment)

Inputs

Measurements How? (Procedures & Techniques)

Competencies,

Skills, Training

OutputsPROCESS

NOW

WITH

ADDED

RISK!

Process Interaction Sample 12

Process 7

Process 4

Process 8

Process 5

Process 2Process 1

Process 3

Process 6

Defined Management

System

No Mgmt Rep Requirement, but defined roles

& responsibilities

No quality manual, but a defined quality

system:

identification of interested parties

Scope of system

Identification and justification of non-application

Processes, interactions, metrics, risks

13

No Required Procedures

Records Required:

Operation of Processes (4.4)

Quality Objectives (6.2.1)

Monitoring & Measuring

Resources (7.1.6)

Competency Evaluation (7.2)

Ops Planning & Control (8.1)

Requirements Review (8.2.3)

Design & Development (8.3.5)

Design & Devel Changes (8.3.6)

Externally Provided Products &

Services (8.4.1)

Traceability (8.5.2)

Control of Changes (8.5.6)

Release of Products /Services (8.6)

Control of NC Products, Services,

or Process Outputs (8.7)

Monitoring, Measurement,

Analysis, and Evaluation (9.1.1)

Internal Audits (9.2)

Management Review (9.3)

NC and Corrective Action (10.2)

14

Primary External

• Customers

• Suppliers

• Debt Holders inc:ShareholdersBanksFinancial Institutions

• Regulators

Secondary External

• Public inc:Local Community

• Interest Groups inc: Employee Families

• Media

• Marketplace inc:CompetitorsPotential Customers

Internal

• Board of Directors

• Management Team (Top & Middle)

• Employees

• Unions (inc: Union Management)

Interested Parties – Examples

Additional Considerations

“Post Delivery” continues through to what

happens to the product after useable life

Don’t Rush to determine design as non-

applicable

SWOT can be an effective Risk Management

Tool

Six Sigma, Lean, Etc can dovetail more readily

into your QMS

Analysis is not enough, evaluation also

required

16

17

Learn More

1- Day Workshop by the Training Institute:

Title: ISO 9001-2015 Revisions and Changes

Location: Triton College

Date: February, 7, 2015

18

ISO 9001:2015

SOME KEY CHANGES BY CLAUSE

19

4.1 Organizational Context

The organization shall determine

external and internal issues that

are relevant to its purpose and

that affect its ability to achieve

the intended results of its quality

management system.

20

4.2 Needs of Interested

Parties

The organization shall determine

the interested parties that are

relevant to the quality

management system and their

related requirements.

21

5.1 Leadership - General

Persons in top management and other relevant management roles throughout the organization shall demonstrate leadership with respect to the quality management system.

NOTE This can be shown, for example, bymotivating and empowering persons to contribute to the effectiveness of the quality management system."

22

5.2 Management

Commitment…

providing the resources to establish, implement, maintain and continually improve the quality management system

communicating the importance of effective quality management and conforming to the quality management system requirements;

ensuring that the quality management system achieves its intended outcomes

directing and supporting continual improvement"

23

6.1 Actions to Address Risks &

Opportunities

"The organization shall consider the issues referred

to in 4.1 and the requirements referred to in 4.2

and determine the risks and opportunities that

need to be addressed to

• assure the management system can achieve its

intended outcome(s)

• prevent undesired effects

24

7.1 Resources

Outsourcing as a resource

Change management for new or

additional resources

Infrastructure includes supporting services

Knowledge resources

25

8.1 Operational Planning &

Control….

The organization shall control planned changes

and review the consequences of unintended

changes, taking action to mitigate any adverse

effects, as necessary The organization shall

ensure that outsourced processes are controlled."

26

9.1 Monitoring, Measurement

Analysis and Evaluation….

The organization shall evaluate the performance and the effectiveness of the quality management system.

Additionally, the organization shall:

take action when necessary to address adverse trends or results before a nonconformity occurs.

retain relevant documented information as evidence of the results."

27

10.1 Improvement

10.1 Nonconformity and corrective action

"When a nonconformity occurs, the organization shall:

a) react to the nonconformity, and as applicable

take action to control and correct it, and deal with the consequences;

b) evaluate the need for action to eliminate the causes of the nonconformity, in order that it does not recur or occur elsewhere, by

28

Credits/References

International Organization for Standardization (ISO), Geneva, Switzerland

ISO/DIS 9001:2014(E) 2014-07-10

Technical Advisory Group (TAG) 176 to ISO

American Society For Quality (ASQ)

American National Accreditation Board (ANAB)

Exemplar Global, Transition Course

DNV, Nigel Croft

Presentation, October 31, 2013

29

Contact Information

Daniel J. Brown

President, DB Performance Solutions, LLC

(312) 615-3530

danbrown@dbpsllc.us

www.dbpsllc.us

30