Improving your Quality

Management System

While certifying to ISO 9001:2015

About Milt Dentch • Consultant at MPD Consulting on ISO requirements for quality, environmental, and

safety management systems

• Conducted over 500 audits for large and small companies

• Diverse client background from a floating oil rig in the Gulf of Mexico to a 4,000

employee electronics manufacturer in the Ukraine

• Past roles include being an engineer for the paper industry, and a manager at both

the Polaroid Corporation and the Furon Corporation

• BS in mechanical engineering from Worcester Polytechnic Institute

• MS in Total Quality Systems from the National Graduate School of Quality

Management

• An Exemplar Global lead auditor (QMS and EMS)

• The author of The ISO 9001:2015 Implementation Handbook and The ISO

14001:2015 Implementation Handbook

Goals of Presentation

• Clarify a few ISO 9001:2015 interpretations issues;

• Provide guidelines for a few ISO 9001 requirements

with a history of misinterpretations;

• Provide recommendations to improve documentation;

• Provide examples of metrics for improvement

baseline;

• Illustrate use of flow chart for procedures

AGENDA

• The ISO 9001 Process

• Vision, Mission & the Quality Policy

• Defining the QMS processes & their interactions

• Documentation

• Risk Based Thinking

• Outsourcing defined

• Validation of processes

• Monitoring process metrics

• Example flow chart as Procedure

The ISO 9001 Process Management establishes the context, scope and boundaries of the QMS

The core processes of the QMS and their interactions are determined

Performance Indicators are established for the core processes

Controls are established to ensure customer requirements are met

Management establishes the Quality Policy of the QMS

Quality Objectives are selected with programs established to achieve the objectives

Vision, Mission & the Quality Policy

Vision: What the organization aspires to be.

How the future will look if the organization achieves its

mission.

Mission: What our organization is all about.

Who we are, who are our customers, what we do

and how do we do it.

Quality Policy: A guide as how the organization should

provide products and services to our customers.

Example Vision for Jones Plastics Company

Vision:

Jones Plastics Company will be the injection

molding manufacturer of choice

Example Mission for Jones Plastics Company

Mission Statement:

The Jones Plastics Company will:

- Innovatively manufacture injection molded

products to the highest quality standards;

- Provide superior service and application technology

to our customers

- Maintain a cooperative partnership with our

suppliers;

- Create a challenging, rewarding and safe working

environment for our employees

Quality Policy for Jones Plastic Company

Quality Policy:

“Jones Plastics Company will satisfy the needs and

expectations of our customers by understanding

their requirements and providing (high quality)

products that meet (or exceed) all performance

requirements, while promoting (full) employee

involvement and empowerment.”

Defining processes and their interactions

• How to define the sequence of processes in the

QMS? Description or chart?

• How to define (and control) interactions in the

QMS?

Clause 4.4: Quality management system and

its processes

ISO 9001:2015 Clause 4.4.1:

The organization shall determine the processes

needed for the quality management system and their

application throughout the organization, and shall:

a) Determine the inputs required and the outputs

expected from these processes;

b) Determine the sequence and interaction of these

processes;

Clause 4.4: Quality management system and its

processes

A properly designed flow chart will illustrate the

sequence of the *core processes and their

interactions.

*Core processes: selling, designing, producing,

servicing, releasing, and maintaining

infrastructure

Jones Plastics Process Flow Chart

Jones Plastic Sequence & Interactions

The flow chart indicates the sequence of the

core processes.

The flow chart indicates how the core processes

interact – but does not control the interactions.

To control the interactions of the processes,

Jones Plastic employs an ECN process

(engineering change notice).

Support Processes

Documentation Internal Audit

Training Communication

Quality Assurance Risk Assessment

Calibration Monitoring & Measurement

Maintenance Management responsibilities

Corrective Actions Management Review

Support Processes

- The support processes can be listed on the Flow

Chart.

- Illustrating the interactions of the support

processes with the core processes is usually not

helpful.

Documentation: Terminology

ISO 9001:2015 suggests (but does not require)

replacing current terminology of documents and

records with “documented information”.

Each certified organization should consider the

value the new terminology provides to their

business model before changing.

Documentation: Quality Manual

I suggest organizations continue to use a quality

manual as a high level consolidation of the key

elements- or roadmap, of their quality

documentation- BUT streamlined to eliminate

non-value verbiage and paraphrasing.

ISO 9001:2015 does not require a quality

manual.

Quality Manual: Contents

• A description of the context of the organization and

expectations of interested parties.

• The scope of the quality management system.

• The description of the ISO 9001:2015 requirements,

which are not applicable to the quality management

system.

• The documented procedures established for the quality

management system, or reference to them.

• A description of the processes and their interaction

between the processes of the quality management system.

• The Quality Policy.

• Responsibilities/ Authorities.

Documentation: Summary

The overarching principle in documentation

should be to formalize and control what is needed

to ensure users of the documentation have a source

for information and instructions that is accurate

and timely, providing consistency in managing the

business.

Risk Based Thinking (RBT)

• There is no requirement for formal methods for

risk management or a documented risk

management process in ISO 9001:2015.

I suggest organizations establish RBT or risk

analysis as appropriate to the context of their

business and as a replacement for preventive action

( PA not required in ISO 9001:2015).

A strong Change Control process can identify and

mitigate risks in the QMS!

Outsourcing Defined

ISO 9001:2015 does not define “outsourced”

processes. ISO 9001:2008, clause 4.1 General

requirements provided the following definition of

an outsourced process:

“A process that the organization needs for its quality

management system, and which the organization

chooses to have performed by an external party.”

Outsourcing Defined

Organizations purchase processes (or materials)

from external parties.

What’s the difference between purchasing and

outsourcing?

Purchasing vs Outsourcing

Purchasing: “Materials, products or services provided for

the organization by external providers and delivered directly

from the external provider’s site to the organization.”

Outsourcing: “Materials, products or services provided

for the organization’s customers by external providers

and shipped directly from the external provider’s site to

the customer of the organization.”

Outsourcing and Controls

- Outsourced materials create a risk that the

external provider may not satisfy the

organization’s requirements;

- Controls commensurate to the risks are required.

Example: Chrome Plating

An organization engages an external source

(supplier) to chrome plate parts produced by the

organization.

If the supplier returns the chrome plated parts to

the organization- that is purchasing, as the

organization can ensure the quality requirements

are met.

Example: Chrome Plating Outsourcing

If the supplier delivers the chrome plated parts directly

to the organization’s customer- that is outsourcing, as

the organization will have to establish controls for the

chrome plater to ensure quality requirements are met

before parts reach its customer.

An organization engages an external source

(supplier) to chrome plate parts produced by the

organization.

Other “Outsourced” Activities

• Human Resources

• Information Technology

• Accounting

• Design

Controls should be established for these

activities commensurate with the risks.

ISO 37500:2014 – “Guidance on Outsourcing” provides

organizations with the necessary foundation to establish and

maintain outsourcing arrangements between countries.

Validation of Processes

ISO 9001:2015 removed a main clause from ISO

9001:2008, “Validation of Processes” clause 7.5.2 and

moved the requirement into 8.5.1 Control of

production and service provision as sub clause 8.5.1 f.

This is unfortunate, in my opinion, as validation of

processes can be an important facet of and

organization’s quality performance and has often

been overlooked by both auditors and

organizations.

Validation of Processes

If an organization can measure their products,

either by dimensional, functional or visual

standards, then the organization would not have

process validation requirements for products

delivered to customers.

Validation of Processes Examples

• Soldering (integrity of soldered joint)

• Welding

• Machine assembly

• Cleaning

• Lamination

• Coating or painting

• Heat treating or plating

Monitoring & Measuring Processes:

ISO 9001:2015

4.4.1 c): “Determine and apply the criteria and

methods (including monitoring, measurements and

related performance indicators) needed to ensure the

effective operation and control of these processes;”

4.4.1 g): “Evaluate these processes and implement

any changes needed to ensure that these processes

achieve their intended results;”

Replaces ISO 9001:2008 “Monitoring and

Measurement of Processes”

ISO 9001:2008 Clause 8.2.3:

The organization shall apply suitable methods for

monitoring and, where applicable, measurement

of the quality management system processes

4.4 Quality management system and its

processes: ISO 9001:2015

- Organizations are required to establish metrics

(and goals) for their core processes. Corrections

should be initiated when goals not met.

- Support processes should be monitored as part of

the organization’s Internal Audit process.

Possible Metrics: Sales

Selling

• $ Revenue

• $ Revenue per employee

• Sales Performance as % of plan

• Bid Success Rate

Order Entry/ Contract Review

• Order entry errors

• On Time Delivery

• Actual Cost vs Estimate

Possible Metrics: Design

• New Sale $ for design projects as % of

annual sales

• % of design projects that create sales $

• Cycle time to complete projects

• % of design projects completed on time and

budget

Possible Metrics: Purchasing

• Delivery and quality performance of

suppliers

• PPV (purchased price variance)

PPV connects the purchasing performance to

the organization’s business performance by

establishing spending reductions in material

costs to improve profits

Possible Metrics: Production

Production:

• On time delivery (OTD)

• % defective at customers

• Material yield

• Productivity (employee labor hours)

• Internal waste.

Possible Metrics: Service

Service:

• Distributers/ Sales: OTD; sales revenue

• Software: project cycle time; 1st release

acceptance rate;

• Engineering: Performance to cost and

completion time.

Possible Metrics: Infrastructure

Maintenance:

• % lost production time

• Maintenance $

Information Technology:

• Data upsets

Transportation:

• $ product damage

• Insurance costs

Procedure: Customer Complaints

Complaint Process 1) Customer service (CS)receives

complaint from customer. 2) Form is submitted to CS by initiator. 3) CS forwards form to QC. 4) QC enters in NCR Log 5) QC determines if CA required per

*Criteria. 6) If CA is not required, CS communicates

disposition to customer. 7) If CA required, QC completes CA form. 8) When CA complete, QC forwards CA

form to CS. 9) CS communicates to Customer (if

applicable). 10) NCR Log is updated by QC.

*Corrective Action Criteria Customer request RMA >$500. Repeat item QC request

Using Flow Charts as a Procedure

• Flow Chart can’t be just a “picture”

• Responsibilities need to be defined

• When decision box, criteria needs to be defined

• If chart becomes too busy, terminate and make new page

• Records and forms should be defined

Benefits of Flow Chart as a Procedure

• More efficient: fewer pages

• Useful in training

• Easy for internal auditors to follow

• External auditors like them!

Summary

• Responding to ISO 9001: 2015 requirements

should be beneficial to the organization’s business;

• Documentation should be a useful tool for

communication and consistency;

• “If it is not documented, it didn’t happen”;

• “If you can’t measure it, you can’t improve it”;

ISO 9001 supports the business- ISO 9001 doesn’t

run the business!

To learn more…

About Milt Dentch:

• Email: miltdentch@gmail.com

• Look out for his books, “The ISO 9001:2015

Implementation Handbook” and “The ISO

14001:2015 Implementation Handbook”

www.asq.org/quality-press/

About the topic:

• Go to ASQ’s Learn About Quality area

www.asq.org/learn-about-quality/

• Search ASQ’s Knowledge Center @

www.asq.org/knowledge-center/search/