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
Management context, scope and
establishes boundaries of the QMS
the Quality Policy of
the QMS The core processes of the
QMS and their
interactions are
determined
Quality Objectives
are selected
with programs
established
to achieve the
Performance Indicators
objectives
are established for
the core processes

Controls are established to

ensure customer
requirements
are met
 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

ISO 9001:2015 does not require a 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.
 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

An organization engages an external source

(supplier) to chrome plate parts produced by the
organization.

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.
 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/