CERTIFICATION

Leveraging ISO Certification

Standards to Drive Performance

How Management System Certifications can

help you achieve world-class performance

Andrew Porter

February 23, 2017

Agenda

• What are Management Systems and how do they

drive improvement

• Some popular Management System standards:

ISO 9001 Quality Management Systems

AS9100 Aerospace Quality Management Systems

ISO 14001 Environmental Management Systems

Food Safety Systems

• Talk with the experts

2

Ask Yourself Some Questions…

• How did your business do last year compared to 2015?

3

• Which measures do you rely on to know how it’s going?

Profit, ROI? Sales?

Productivity?

Quality, Lead time, On-time delivery?

Customer Satisfaction?

• If your business improved, was it by luck or deliberate action?

Did you implement significant improvements to the business?

Did you have data to help you make sound decisions?

Did you identify potential risks and take action to reduce them?

Did you identify problems and eliminate root causes?

Did you improve your supplier base?

So let’s agree that we’re not going to rely on luck….

So How Do We Manage toward Success?

• We create a vision and a strategy to achieve the

vision

• We create policies to convey the vision to the

organization

• We document what we people need to do

• We assign resources and responsibilities

• We measure our progress toward the vision

• We identify gaps between what we’re doing and what

we should be doing

• We take action to close these gaps

4

What we’ve described here is the

foundation of a management system

What Are Management Systems Standards?

• Documented practices for running a business well,

typically including:

Understanding the context of the organization

Demonstrating leadership in the organization

Planning on how to achieve desired results

Providing support for the organization

Performing the work to realize a product or service

Measuring performance against targets

Making Improvements

5

If you’re thinking this is common sense, you’re starting to get it!

So How Does a Management System Standard

Drive Continual Improvement?

• Management System Standards employ Plan-Do-

Check-Adjust (PDCA) to drive continual

improvement:

1. Decide what to do and make a plan

2. Execute the plan

3. Measure results and identify gaps

4. Make improvements and repeat

6

Two important characteristics of PDCA:

• It doesn’t matter where you start, you are always

moving toward becoming excellent

• How quickly you improve is determined by how fast

you cycle through these steps

What Else Is Included in a Management System?

Requirements for:

• Describing your processes and how they interrelate

• Setting overall objectives and targets for how well

you meet your policies

• Planning changes to your management system

• Performing processes to achieve high-quality results

• Controlling and correcting problems

• Determining customer satisfaction

• Evaluating how well the organization is functioning

• Making improvements

7

Management System Standards are not all the same

• Some are intended to be very general and broadly

applicable, such as ISO 9001.

• Others are more specific, like

Food Safety

Environmental

Aerospace

Automotive

Medical Device

Worker Safety

8

How many of you have

one of these standards?

For example lets look at ISO 9001

• Probably the most widely adopted management

system standard worldwide, spanning more than 25

years

• It describes a Quality Management System, but truly

it is a Business Management System

However…

• Despite all of the great business wisdom embedded

in this standard we see organizations with systems

that aren’t driving improved performance

• Despite the improvements made to the standard

over more than 25 years, these organizations’

management systems have hardly changed

9

Why Did We Implement Our ISO System?

• Sales thought it would increase customer orders

• Marketing thought the logo would look great on the

website

• Quality saw it as a big power play

• Operations knew it would never work

• The President thought everyone else was doing it

10

And of course we all wanted to improve…

But why didn’t we improve?!!

Why Didn’t ISO 9001 Help Us Improve?

• We delegated ISO 9001 to the Quality department

because it seemed logical.

• We added more paperwork to make sure we did

things the ISO way.

• Our ISO 9001 system was constraining us so we

ignored some of the rules

• We created a big heavy quality manual but nobody

read it.

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Finally, Why Didn’t We Improve?

For most of us, we just didn’t get it!

This is about running our business, and we can’t

delegate that.

This is about doing something we do every day:

• Plan what you do,

• Do it,

• Check your progress, and

• Adjust your course.

It’s just not that hard.

12

Is your Management System running like a

Clunker or a Race Car?

Clunker:

• Bureaucratic

• Meaningless measures

• Same problems

returning over and over

• Long arduous

management reviews

that yield nothing

• Business performance

has stalled

Race Car:

• Simplified processes

• Meaningful measures

• Corrected problems

that don’t return

• Engaging reviews and

actions that achieve

measurable results

• Consistent

improvement over time

13

What Are Some Management System Standards?

• Quality Management Systems: ISO 9001

• Aviation, Space, and Defense Quality Mgmt. Systems: AS9100

• Environmental Management Systems: ISO 14001

• Food Safety Systems: GFSI, FSSC 22000, SQF, BRC

• Automotive Quality Mgmt. Systems: ISO/TS 16949 or IATF 16949

• Medical Device Quality Management Systems: ISO 13485

• Occupational Health and Safety Management Systems:

OHSAS 18001 (ISO 45001 expected Dec. 2017)

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ISO 9001 Quality Management System Standard

• Applies to any business and all industries

Most general of all management system standards

• Revised in 2015:

Greater emphasis on demonstrating improvement over time

Fewer required documents

Better aligned with Plan-Do-Check-Adjust

More focus off the shop floor than in prior versions

Added needs and expectations of relevant interested parties

Added internal and external issues

Added actions to address risks and opportunities

Removed requirement for Management Representative

• All ISO 9001 businesses must be recertified to 2015 version by

September 2018.

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First Let’s Clear The Air….

What have you heard about ISO 9001?

• It’s a paperwork nightmare…

• It keeps us from getting real work done…

• Why do we do it this way? Because ISO SAYS SO!

16

Don’t be difficult

People make it difficult.

ISO 9001 is simple.

The new standard aligns better with Plan-Do-Check-Act

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Outline Of The New Standard

Quality Management

System

4. Context of the Organization

External and Internal Issues

Needs and expectations of

interested parties

Scope of the QMS

QMS Map

Process Maps

5. Leadership

Leadership Commitment

Customer Focus

Quality Policy

Organization Chart

6. Planning

Risks and Opportunities

Quality Objectives

Plan how to achieve Quality

Objectives

Plan Changes to the QMS

7. Support

People

Infrastructure

Suitable work environment

Calibration

Organizational knowledge

Competence, Awareness,

Communication

Documented Information

8. Operation

Planning

Determine and Review Product Requirements

Design & Development

Suppliers and Vendors

(Purchasing)

Control of Production

-ID/Traceability; -Customer property; -Preservation; -Post-delivery activities;-Change control

Product Release

Non-conforming outputs

9. Performance evaluation

Monitor & Measure

Customer

Satisfaction

Analysis & Evaluation

Internal Audit

Management Review

10. Improvement

Corrective Action

Continual Improvement

New Requirement

Requirement Largely

Unchanged

The philosophy has shifted from “Do this”

to “Did you improve?”

• Although some requirements have been eliminated,

more focus is placed on performance improvement

The first question is “did you improve?” If not, then did you:

• Create meaningful measures?

• Set appropriate targets?

• Take actions when you missed targets?

• Determine if the actions were effective?

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10.3 Continual improvement

The organization shall continually improve the suitability,

adequacy and effectiveness of the quality management system.

AS9100 Aerospace Quality Management System Standard

• Applies to suppliers to aviation, space, and defense industries

• Based on ISO 9001:2015 with added requirements for:

Specific terms: e.g. counterfeit part, critical items, key characteristics, …

Adds requirement for the Management Representative (dropped by ISO 9001)

Positive recall for calibrated instruments

Awareness of the importance of ethical behavior

Operational Risk Management

Configuration Management

Product Safety

Prevention of Counterfeit Parts

Quality and On-time Delivery must be measured and acted upon

Incorporates a stage-gate design and development process

Tighter control of suppliers and outsourced processes

Tighter control of production, equipment, tools, and software programs

• Companies should consider a joint certification with ISO 9001.

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ISO 14001 Environmental Management System Standard

• Applies to any business and all industries

System for managing actual and potential environmental risk and compliance

obligations

• Revised in 2015:

Organizational strategy and EMS are integrated

Increased accountability of leadership through integrated decision making and

increased environmental manager interaction with top management

Consideration of life cycle issues for risks and opportunities

Rethink impact as both organization effect on the environment and how

organization is affected by the environment

Environmental risks and opportunities in the supply chain

Proactively consider external reporting on environmental issues

Specify exactly how compliance is evaluated and recorded

stronger emphasis on the requirement for continual improvement

• All ISO 14001 certified businesses must be recertified to 2015

version by September 2018.

21

Example Certifications & Standards for Sustainable

Practice

• Unique Standards for Specific Needs/Expectations

Several frameworks exist to build additional unique customer and market

credentials

• Alliance for Water Stewardship – International Water Stewardship Standard –

Water risk, performance management and certification

• OHSAS 18001 or ISO 45001 (coming in December)

Occupational Health and Safety

• Environmental, Social and Governance (ESG) and Corporate Social

Responsibility (CSR)

Social Accountability 8000 (SA 8000)

Supplier Ethical Data Exchange (SEDEX) – SEDEX Member Ethical Trade Audit

(SMETA), The Sustainability Consortium (TSC)

• Aspect Specific

Carbon – Carbon Disclosure Project (CDP) & GHG Protocol

Water – Carbon Disclosure Project Water (CDP Water) & CEO Water Mandate

Waste – Zero Waste to Landfill

• Other Financial, Sector, Facility and Practice Standards and Certifications

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Food Safety System Standards

• Global Food Safety Initiative (GFSI)

FSSC/ISO 22000

SQF

BRC

• Food Safety Modernization Act (FSMA)

• HACCP - Hazard Analysis and Critical Control Points

• Third Party Audits

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Why become certified?

Because your competition is certified

Because your customers ask for it

Because you want to create consistent and sustained

improvement in your organization

Because capital markets respect it

Because certification systems now leverage your

strategic and operational management systems

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What the Roadmap to Improve?

1. Form an implementation team

Cross functional, 3-7 persons

2. Review the standard

Identify gaps in your current system and actions to close gaps

3. Simplify your current system

Create simple process documents

Reduce the number of procedures

Make your Quality Manual less than 20 pages

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“Complexity is your enemy. Any fool can make something

complicated. It is hard to make something simple.”

–Richard Branson

What the Roadmap to Improve?

4. Add what’s needed to meet requirements

Gaps identified when reviewing the standard

5. Rationalize measures and targets

Develop meaningful measures and reasonable targets

6. Perform an internal audit to the new standard

Bring in an outsider with fresh eyes to review your system

7. Recertify with your Registrar

26

Want to learn more?

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• There are people stationed

around the room to answer

questions on specific

standards.

• Consider asking them:

How much do I need to document?

How do I ….

What is the hardest part of

certification?

What if the auditor is

unreasonable?