Overview of Quality Management Systems
and ISO 9001
Why is ISO 9001 so popular?
The scope of the Standard specifies requirements
intended to:
► demonstrate organization’s ability to consistently
provide product meeting customer & applicable
regulatory requirements
► enhance customer’s satisfaction through effective
application of the system including processes for its
continual improvement and assurance of conformity
to customer and applicable regulatory requirements
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2
New Structure & Focus
Why is ISO 9001 so popular?
►Significantly less emphasis on
procedures and records.
►Significantly more emphasis on
management involvement and a system
that works to achieve the goals of your
business.
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The ISO 9000 “Family”
► ISO 9000:2005 Quality management - Fundamentals and vocabulary
► ISO 9001:2000 Quality management systems - Requirements
► ISO 9004:2000 Quality management systems - Guidelines for
performance improvements
► ISO 10006:2003 Quality management - Guidelines for quality
management in projects
► ISO 10007:2003 Quality management systems - Guidelines for
configuration management
► ISO 10012:2003 Measurement management systems - Requirements
for measurement processes and measuring equipment
► ISO 19011:2002 Guidelines for quality and/or environmental
management systems auditing
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Relationship with ISO 9004
► ISO 9001 & ISO 9004 - consistent pair
► Designed to complement each other
► Different scope - same structure
► ISO 9001 can apply for certification or contractual
purposes and focuses on effectiveness
► ISO 9004 aims on improving performance and
efficiency
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The Use of ISO 9004 as a Management Tool
► ISO 9004 includes all of ISO 9001 plus additional
items to consider for improvement ideas.
► ISO 9004 should be regularly used throughout the
organization to lead beyond the basics of ISO 9001
and improve the QMS.
► There is a possibility that we may offer ISO 9004
“certification” for clients seeking to achieve results
beyond ISO 9001
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New Structure & Focus
►The ISO 9001 Standard is modelled for Quality
Management with 5 Major clauses:

Quality Management System (QMS)

Management Responsibility

Resource Management

Product Realization

Measurement, Analysis & Improvement
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System Approach of ISO 9k2k
C
U
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T
O
M
E
R
S
Continual Improvement of the
Quality Management System
R
e
q
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Management
responsibility
Resource
management
Input
Measurement, analysis,
improvement
Product
Product
S
a
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f
a
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Output
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The Deming Cycle
The Deming Cycle
for improvement is
the cornerstone of all
Management
Systems
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1. PLAN: Design or revise business process
components to improve results
2. DO: Implement the plan and measure its
performance
3. CHECK / STUDY: Assess the measurements
and report the results to decision makers
4. ACT: Decide on changes needed to improve
the process
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Every organization’s
management systems are
comprised of various
processes, each with
their own set of metrics,
goals, targets and
initiatives.
The key is to align each
process’ PDCA cycle with
the overall strategic effort
of the organization.
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As your Management Systems mature, effective use
of the Deming Cycle will ensure continual
improvement
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System Approach of ISO 9k2k
C
U
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O
M
E
R
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Continual Improvement of the
Quality Management System
R
e
q
u
I
r
e
m
e
n
t
s
Management
responsibility
Resource
management
Input
Measurement, analysis,
improvement
Product
Product
S
a
t
I
s
f
a
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t
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Output
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THE VALUE ADDED AUDITING APPROACH
PERFORMANCE
RISK
SELL IT!
PROCESS
AUDITS
WASTE
VARIATION
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8 Management Principles
New Structure & Focus
► The intent of ISO 9001 is based on the 8 Management
System Principles described in ISO 9004:

customer focus

leadership

involvement of people

process approach

system approach

continual improvement

factual approach to decision making

mutually beneficial supplier relationships
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Customer Focus
Customer Focus
Customer Focus
“Organizations depend on their
customers and therefore should
understand current and future
customer needs, should meet
customer requirements and strive
to exceed customer expectations.”
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System Approach of ISO 9k2k
C
U
S
T
O
M
E
R
S
Continual Improvement of the
Quality Management System
R
e
q
u
I
r
e
m
e
n
t
s
Management
responsibility
Resource
management
Input
Measurement, analysis,
improvement
Product
Product
S
a
t
I
s
f
a
c
t
I
o
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C
U
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Output
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Customer Focus
►Information on Customer perception as to
whether the organization has met their
requirements must be collected, reviewed
and appropriately acted upon (8.2.1).
►The methods of doing this are not
prescribed by the standard but should be
objective, representative of the customer
base, and ADD VALUE.
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Customer Focus
► The most common methods of collecting Customer
Satisfaction data are customer surveys and
customer report cards (when provided).
► Other methods include measuring repeat orders,
market share, industry benchmarking, capturing
info. from sales visits, focus groups, and hiring
consulting firms.
► A good system will use multiple methods and
compare data from multiple sources to
comprehensively understand customer perceptions
and balance out any potential biases.
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Customer Focus
Additionally, the organization must
demonstrate that effective
arrangements for communicating
with customers are in place in
relation to:
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Customer Focus
Product Information (7.2.3-a):




How well do you communicate your product
information to your customers?
Consider the experiences of using your favorite
store Catalogue, or browsing Amazon.com or
ebay...
Were you satisfied with these experiences?
How do you know what your customers think about
your ability to communicate information that they
are looking for?
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Customer Focus
Enquiries, contracts, and order handling,
including changes (7.2.3-b):


Now consider the “buying experience” with these
same companies and ask the same questions…
How do you think your customers feel about the
ordering experience with your company? What
about your quoting and order amendment
processes?
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Customer Focus
Customer feedback, including complaints
(7.2.3-c)


Consider that a customer can be more loyal when
you handle their problems to their satisfaction (or
delight) vs. them never having a problem at all.
Your want to know whether your customers are
satisfied with how you handle their feedback
(even positive) and complaints.
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Process and System Approach
The Process Approach
Process Approach
“A desired result is
achieved more efficiently
when activities and related
resources are managed as
a process.”
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The System Approach to Management
System Approach
“Identifying, understanding and
managing interrelated processes
as a system contributes to the
organization’s effectiveness and
efficiency in achieving its
objectives.”
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ISO 9000 – 2.4 The Process Approach
Any activity, or set of activities, that uses resources to
transform inputs to outputs can be considered as a
process.
For organizations to function effectively, they have to
identify and manage numerous interrelated and
interacting processes. Often, the output from one
process will directly form the input into the next
process. The systematic identification and management
of the processes employed within an organization and
particularly the interactions between such processes is
referred to as the “process approach”.
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ISO 9000 – 2.8.1 Evaluating processes within
the quality management system
When evaluating quality management systems, there are four basic
questions that should be asked in relation to every process being
evaluated.
a) Is the process identified and appropriately defined?
b) Are responsibilities assigned?
c) Are the procedures implemented and maintained?
d) Is the process effective in achieving the required results?
The collective answers to the above questions can determine the
result of the evaluation.
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Process Interactions
Inputs and Outputs
Controls
(procedures, inspections, training, etc.)
Inputs
Process
Activities
+
Resources
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Outputs
33
Management Systems – must define the sequence and
interactions of processes
Process
A
Process
C
Process
B
Process
D
Input
Output
Controls
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A Quality Management System is focussed on meeting customer
requirements.
Process
A
Process
C
Customer
requirements
Customer
Satisfaction
Process
B
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Process
D
35
Other Management Systems (Environmental, Safety, SOX, etc.) are
mainly focussed on meeting regulatory requirements.
Process
A
Process
C
Regulatory
requirements
Regulatory
Compliance
Process
B
Process
D
The Process Approach can be used for all Management Systems!
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Ultimately every Management System must be seen by Top
Management as an effective method for ensuring financial
performance (even though it’s not a requirement).
Process
A
Process
C
Investment
Profitability
Process
B
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Process
D
37
Compatibility with other management systems




Standard is intended to be compatible with other
systems
It is aligned with ISO 14001 and 18001 to enhance
compatibility
Standard does not include requirements for other
management systems such as EMS, OHSM, or
financial management
Integration of management systems is possible
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The ultimate goal of any organization is to
fully integrate all
customer
shareholder
regulatory
and any other requirements? (discuss)
into ONE Business Management System.
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Ideal scenario:
Our clients’ Quality, Health & Safety and Environmental
Management Systems operate within their Business Management
System
BMS
Their BMS =
QMS
•QMS+
•FMS+
OHSMS
•OHSM+
•EMS+
EMS
•ERP+
•HR
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All too common scenario that we need to help change:
Their QMS, OHSMS and EMS are seen as the “ISO
systems” and operate mostly outside of their BMS.
Management does not see the value of these. “It’s
something that we have to do for ISO”
EMS
BMS
QMS
OHSMS
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Sequence versus Interactions
 This example clearly defines the sequence of
processes but does it clearly define their interactions?
How should process interactions be defined?
Process
A
Process
C
Process
B
Process
D
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Interaction of Processes
► Interaction should be defined using inputs and outputs
► Graphical representations such as process maps /
flowcharts are perhaps the most easily understandable
methods of describing interaction between processes,
however not a specific requirement.
► Interaction can be described with words if desired
► At a minimum, the processes of the organization need
to be identified as per 4.1a and their interaction needs
to be clearly defined in the manual as per 4.2.2c.
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Common methods used to define process interactions:
1. Flowcharting
2. SIPOC diagrams (Six Sigma method)
3. Process Turtles (ISO 9001 method)
4. Value Stream Mapping (Lean Manufacturing
method)
NOTE: How many times have your processes been
defined in how many ways? Are all process definitions
linked and do they complement each other (no
redundancy)?
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Personnel/Competency:
Inputs:
Tools/Equipment:
Outputs:
Process:
Measurements:
How/Methods/Controls
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With What?





CAD/CAM systems
Test equipment
Warranty database
Call center



Customer
Consumer
Marketing



PROCESS
INPUTS
SUPPLIERS






Lessons learned
Service/Warranty
Customer needs
Marketing data
Charter




OUTPUTS
Process Interactions
Status of projects – >90%
First time capability >96%
Eng. Warranty claims < 5%
of total
Budget – within 10%




CUSTOMERS
Robust design, durability,
reliability, maintainability
BOM/purchasing data
Specifications
Product standards
Engineering
How Effective?
With Who?
Eng. Manager
CAD Technicians
Mech/Elec Engineers
Administrative assistance
Service Technicians





Purchasing
Marketing/Sales
Service
Insp /Test department
Internal /
External
 Mfg.
 Consumer
How?
CAD systems and Database
Engineering procedures
5-stage design process
Test and build standards
Warranty/claim data
PROCESS FLOW

Charter review and
approval


5 Stage design plan
Kick-off meeting multifunctional




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CAD drawings, approval
Simulation, life cycle
Prototype
Supplier evaluation/capability




Pre-production run
Capability Ppk/Cpk
Mfg. Feedback meeting
Lessons learned
46
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Most importantly, does Top
Management use their
process definitions to
effectively manage their
business (not just for audits)?
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Every process has an
owner.
The process outputs
are their job
description!
The process measures
are their performance
review!
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Evidence to find and communicate:
 Organization charts are process based and show
clear process ownership
 Business metrics are process based and ensure
transparent accountability for process performance
 Facility floor plans can be linked to processes
 Business plans and budgets align with their process
definitions.
 Management reviews of “process performance”
include ALL processes at some frequency
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Quality Manual
ISO 9001, clause 4.2.2 requires:
► The organization shall establish and maintain a
quality manual that includes



A) the scope of the quality management system, including
any details of and justification for any exclusions
B) the documented procedures established for the QMS, or
reference to them
C) a description of the interaction between the processes
of the QMS
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Quality Manual
► A QM that simply regurgitates the ISO
clauses is not acceptable!
► A QM that includes a process map
showing sequence only is not
acceptable!
► The QM must define the process
interactions (outputs & inputs)!
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Quality Manual – potential uses
► To manage the business as a key input to
organizational planning, resource allocation,
goal setting, problem solving, etc.
► The training material for employee
orientation, especially managers!
► A communication tool for external parties
(customers, corporate management, board
of directors, regulatory bodies, etc.)
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Process Measurement
and Objective Deployment
Factual Approach to Decision Making
Factual Approach to
Decision Making
“Effective decisions are
based on the analysis of
data and information.”
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Analysis of Data & Measurement
Food for Thought:
► Consider all the records and data that you
collect and store in your company...
► How are each of these used for analysis,
training, and improvement purposes?
► If you can’t answer this question for nearly
every record you spend time and money
collecting then why do you do it?
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Analysis of Data & Measurement
8.4 - The organization shall determine, collect and analyze
appropriate data to demonstrate the suitability and effectiveness
of the quality management system and to evaluate where
continual improvement of the effectiveness of the quality
management system can be made. This shall include data
generated as a result of monitoring and measurement and from
other relevant sources.
The analysis of data shall provide information relating to
► customer satisfaction (see 8.2.1),
► conformity to product requirements (see 7.2.1),
► characteristics and trends of processes and products including
opportunities for preventive action, and
► suppliers.
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Continual Improvement
Continual Improvement
“Continual improvement of
the organization’s overall
performance should be a
permanent objective of the
organization.”
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Continual Improvement
► The organization shall implement actions
necessary to achieve planned results and
continual improvement of the QMS processes
(4.1-f).
► Top management shall provide evidence of its
commitment to the development and
implementation of the QMS and continually
improve its effectiveness (5.1).
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ISO 9000 – 2.11 Quality management systems
and other management system focuses
The quality management system is that part of
the organization's management system that
focuses on the achievement of results, in
relation to the quality objectives, to satisfy the
needs, expectations and requirements of
interested parties, as appropriate.
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ISO 9000 - 2.8.2 Auditing the quality
management system
Audit findings are used to assess the
effectiveness of the quality management
system
and to identify opportunities for
improvement.
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THE VALUE ADDED AUDITING APPROACH
PERFORMANCE
RISK
SELL IT!
PROCESS
AUDIT
WASTE
VARIATION
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Process Monitoring and Measurement
PROCEDURE*
(“Specified way to carry out an activity or a
process” - may be documented or not)
Input
PROCESS
(Includes
Resources)
(“Set of interrelated
or interacting activities”)
Output
MONITORING AND
MEASUREMENT OPPORTUNITIES
(Before, during and after the process)
* Note – This is the definition of “procedure” given in ISO 9000:2000.
This does not necessarily mean one of the 6
“documented procedures” required by ISO 9001:2000
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EFFECTIVENESS
EFFECTIVENESS
OF
OFPROCESS
PROCESS==
Ability
Abilitytotoachieve
achieve
desired
desiredresults
results
(Focus
(FocusofofISO
ISO
9001:2000)
9001:2000)
PRODUCT
(“Result of a
process”)
EFFICIENCY
EFFICIENCYOF
OF
PROCESS
PROCESS==
Results
Resultsachieved
achieved
vs
vsresources
resourcesused
used
(Focus
(FocusofofISO
ISO
9004:2000)
9004:2000)
63
Processes must be monitored and measured Measurement categories that need to be considered are:
 Quality: Does the process consistently produce desired
outputs?
 Delivery: Does the process consistently deliver the outputs on
time?
 Efficiency: Does the process produce and deliver the outputs
using the least amount of resources necessary
 Others such as Cost, Safety, Regulatory Compliance, etc.
Too often only one of these categories is applied and that misleads
management into thinking that everything is alright.
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How does a company implement
their BUSINESS PLAN?
The process approach is one of the
best methods to implement a
business plan
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Top Management
Effective policy
deployment
through
measurement is
required by all
ISO 9001 based
standards.
Policy
Top Management
Management
System (Business)
Objectives
Process Owners
Process Objectives
Operators
•Project / Product / Sub-process objectives
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We try to focus our audits on:
Order
Review
Process
Production
Planning &
Scheduling
Process
The linkage of the measures and
objectives to customer satisfaction
and business results
Warehouse
Process/
Inventory
Management
OTD
Purchasing
Process
Maintenance
Process
The planning and resource
allocation activities that are
necessary to achieve any
improvement objective
The leadership and
communications activities that
engage the entire organization in
this process
The effective use of the PDCA cycle
in every process that is focused on
company objectives
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Policy – Defect free product, on time to the customer at a reasonable
price and continually improving all processes in accordance with
the requirements.
► Organizational objective – 98% on time to customer promise date
► Process objectives established to meet organizational goal





Order review processes – all orders processed within 2 days of
receipt
Warehouse process – 100% compliance with FIFO, 18 inventory
turns
Maintenance Process – 97% uptime, no past due scheduled items
Purchasing process – 95% of tier 1 suppliers on time and within
window
Production Scheduling – all shop routers completed within 1 day of
receipt and all orders scheduled to be completed 2 days prior to
required ship date
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Management Communication
and Employee Awareness
Leadership & Involvement of People
Leadership and Involvement of People
“Leaders establish unity of purpose and
direction of the organization. They should
create and maintain the internal environment in
which people can become fully involved in
achieving the organization’s objectives.”
“People at all levels are the essence of an
organization and their full involvement enables
their abilities to be used for the organization’s
benefit.”
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Leadership & Involvement of People
► Top Management shall ensure that appropriate
communication processes are established
within the organization… (5.5.3)
► Specific requirements for communicating
information regarding the effectiveness of the
QMS and the importance of meeting customer
and regulatory requirements (5.5.3 & 5.1-a).
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Leadership & Involvement of People
►The organization shall ensure that all
personnel are aware of the relevance and
importance of their activities and how
they contribute to the achievement of the
quality objectives (6.2.2-d).
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Imagine the power of
an organization that
has truly achieved
Unity of Purpose?
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Is this enough information to ensure that everyone
clearly understands what must be done to achieve the
improvement goal?
On Time Delivery
100
80
Actual
Goal
60
40
20
0
1st Qtr
2nd Qtr
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3rd Qtr
4th Qtr
74
Too often management only communicates
partial information. To understand the
complete path to improvement everyone
needs to know the following:
 Where are we now (measure) and where do we
want to be (goal)?
 Why are we here (causes of failure)?
 What are we doing to improve (plan)?
 How am I personally involved?
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Causes of Late Deliveries
On Time Delivery
100
100
80
80
Actual
Goal
60
60
machine down
part shortage
labor shortage
40
40
20
20
0
0
1st Qtr
2nd Qtr
3rd Qtr
1st
Qtr
4th Qtr
2nd
Qtr
3rd
Qtr
4th
Qtr
Plan for Improvement
Tasks
Resp.
Due
% Contribution
Status
Increase PM frequencies on key
machines
Joe K.
2/23/08
50
75% complete, Need more resources
4/1/08
30
50% complete, no issues
Increase buffer inventories of critical Janice Q.
parts
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EFFECTIVE Communication

Too often management only communicates in one way (think quarterly all employee meeting)

Does this communication effectively reach everyone (think - kids
in the back of the room)?

To truly achieve unity of purpose shouldn’t there be multiple
communication methods happening all the time?

Will management have to adjust their communication methods
and frequencies or do they normally achieve perfection on the
first try?

Can management communication be considered a process with
clear outputs (employee understanding, satisfaction, unity of
purpose, etc.) and measures?
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Summary
What is the role of
an auditor?
Especially
rd
3
party “pros”
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► To make sure that an organization is doing the
right things, the right ways, all the time.
► To find evidence that what the organization
does is conforming, effective and efficient.
► To add value by:

Identifying potential problems before they happen

Helping to solve existing problems, and

Identifying opportunities for improvement.
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Hierarchy of Quality
Advanced Auditing covers QA
and QM more effectively
Quality
Management
Quality Assurance
Quality Control
Basic “conformance”
auditing covers QC level
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Course Summary
It’s not about the paperwork…
It’s all about if it works!
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Course Summary
The majority of the efforts
needed to demonstrate
conformance to ISO 9001
lie with Top Management.
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Course Summary
Run properly, by
management, your QMS
will help you achieve your
business goals.
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