Table of Contents
ISO Success Factors
Why has ISO failed, in the real world, to live up to its full potential?
PQA’s 8-Step ISO
Learn how PQA's ISO
Expertise can help you
PQA provides implementation assistance for a wide range of
ISO management systems:
QS-9000 Based on ISO 9001 for Ford,
Chrysler, GM, Navistar, etc. suppliers
ISO 9001:2000 Quality Management System
ISO/TS 16949 for Automotive
ISO 13485/88 for Medical Devices
ISO 14001 Environmental Management System
ISO 17025 for
Testing, Calibration, Measurement, & Certification laboratories
ISO 46001 for CE Mark
Good Manufacturing Practices (GMP)
Hazard Analysis Critical Control Point (HACCP)
The ISO 9000 series of standards (including ISO 9001:2000) has been the most widely adopted set of quality
management systems ever conceived. Implementing an ISO based system can be
a tremendous benefit to organizations. Some organizations have
achieved as high as a 1700% ROI by implementing ISO.
For the average organization however, ISO has become a mediocre initiative
for helping an organization remain effective &/or competitive. On
average, PQA estimates that ISO has helped companies achieve only a 16.25%
return on investment.
When management, stockholders, and accountants are demanding pay backs of
100% to 300% (ie. 1 year to as short as a 4 month payback), ISO can easily
become an “also-ran”, or a non-starter.
Go to PQA's White Paper on
“Return on Investment from Implementation of an ISO-based Quality
Buy a copy of PQA's Whitepaper on:
Why ISO has failed to live up to its full
Based on our research in why some companies had such great success with
their ISO implementations and others failed spectacularly, PQA has
identified 10 Critical Success Factors that make an ISO
implementation successful. They are, in order of importance:
Management's recognition of their crucial role in the ISO
system management process
Involvement of people at all levels in the organization
Developing a better understanding of the organizational
processes and the critical points in the process that must be controlled
to satisfy customer needs & expectations
People trained in how to do their job (including
A willingness to provide the effort and self-discipline
to change the system for the better
Focusing on organizational development & improvement,
not on just getting to the ISO certification finish line
Finding the right balance between too much ISO
paperwork, and not enough information to do the job consistently.
Dedication to following the agreed procedures at all
levels in the organization
Keeping the organization focused on meeting the ISO
Effective ISO Audits
Timely management response on feedback of how the system
is functioning, and how it can be improved
PQA’s 8-Step ISO
PQA has developed an 8-step ISO implementation program that can be applied
to all management system implementations. This 8-step program encompasses
all of the critical success factors:
Develop Implementation Strategy with Senior
Management PQA will work with the senior management
team to determine the strategy for implementing your quality or
environmental management system, so that it become an integrated part of
the business operations and is recognized as a crucial element to the
company’s success. PQA has developed several proprietary analysis tools
to assess an organization’s recognized strengths and significant sources
of problems/ frustrations. They include:
21 Success Factors
9 Competitive Factors
7 Deadly Sins of Customer Communication & Service
Perform a Gap Analysis PQA
will perform a gap analysis of your current quality or environmental
management system to determine the frequency, consistency &
effectiveness of compliance to the requirements, the root causes of any
shortcomings, and what will have to be developed to meet your business
needs and the needs of the management system requirements.
Project Schedule PQA will work with
the Project Coordinator to prepare a project schedule. The schedule will
list the actions identified from the Strategy session and Gap Analysis,
the “Process Owners” responsible to perform the action, and a timeline.
Establish Implementation Teams
PQA will help you identify the personnel at all levels in the
organization who will be on the “Process Teams”. This ensures input,
involvement & buy-in throughout the organization.
Develop Process Maps PQA will assist the
“ProcessTeams” to develop Process Maps. There will be 2 levels of
Define the high-level processes and their
interactions. These would include, for example, Quotation, Design,
Purchasing, Manufacturing, etc.
Each block in the high-level map becomes a Process Map
of its own.
Develop Documentation PQA will
help the Process Teams identify and prepare the level of documentation
required. This will include:
Procedures to cover the ISO requirements for
documented procedures. For some processes, this may be just the
Process Maps. In other processes, explanatory step-by-step
instructions may be needed.
The numerous forms which may be needed for recording
the results of the process measurements that will be performed (where
possible, we will use existing forms as is, or modify them to meet the
Employee Training PQA will
help you identify the training needs of your employees so they will be
able to fulfil their responsibilities in the ISO system. PQA offers a
wide range of
Training Workshops to address most training needs.
Pre-Registration Internal Audit
PQA will provide pre-registration internal audit services as follows:
PQA will act as Lead Auditor, using your internal
audit team, to conduct a Dress Rehearsal Audit of the entire quality
system. Performing a Dress Rehearsal Audit that involves the your
Internal Quality Auditors serves three purposes.
Provide your internal auditors with practice in
Determine those elements of your ISO system which
need to be fine-tuned prior to the Registrar’s audit.
You will have completed an internal audit of your
entire ISO system prior to your registration audit - this is a
requirement to obtain your registration.
PQA will conduct a Post Audit Meeting, presenting the
results of the Dress Rehearsal Audit to your Management Review team,
and assist in identifying corrective actions needed.
PQA has more than 18 years experience in ISO consulting, training, and
implementation. We know what works, and how to get an ISO system to
quickly work better.
Contact PQA. Ask about your ISO opportunities. Tell PQA
your ISO frustrations. Free initial consultation.
Send PQA an e-mail at firstname.lastname@example.org, call us, or call Don Whitred at