ETQ - QMS Selection - Your Decision Criteria Checklist - v2

GAME PLAN
QMS Decision Criteria

Checklist
The ETQ Decision Criteria Checklist
is designed to help you identify key
considerations and QMS software
capabilities that you and your team should
keep in mind as you evaluate potential QMS
partners. The checklist should be compared
against your goals and be modified to
precisely fit your unique objectives and
environment. The suggested checklist items
below were developed based on hundreds
of hours of collaboration with ETQ’s QMS
customers as well with industry
analysts who are often called upon to
guide prospective QMS buyers.
Generally, we find that a comprehensive QMS offers customers a range of benefits that
can be grouped in four areas. It is helpful when working through your Decision Criteria
Checklist to keep these global strategies in mind. A world class QMS should always:
• Reduce risk of non-compliance

• Streamline operations
• Reduce costs
• Grow and protect revenue
While the decision process often centers on features and functionality of the QMS, we
urge you to consider the overall strength of your QMS partner and their ability to help
you achieve long term success.
www.etq.com
2 | QMS Product Checklist www.etq.com
QMS PRODUCT CHECKLIST

As you review potential QMS solutions, use this checklist to ensure the QMS can deliver your “must-haves” to get the
maximum business value from your new deployment. In general, you’ll want a QMS solution that is flexible enough
to not just meet your needs today but can grow with you as your needs and business requirements evolve. Your
prospective partner’s QMS solution portfolio should also be a comprehensive solution with the ability to handle all
your critical QMS processes such as supplier quality management, risk management, audit management and training
management, among others. In addition, today’s QMS must incorporate flexible reporting and, better yet, offer
advanced analytics.
Specific checklist must-haves include:
Data migration: You’ll have some quality data on hand already and, likely, a lot of it. Make
sure the vendor can provide a method for cleanly moving all of your relevant data into the
new software with a minimum of disruption to your organization.
Document control: The heart of the QMS solution is typically document control, so vet
this capability fully. You’ll need a solution that manages the creation, distribution and
archival of all critical documents in a centralized and controlled framework. Make sure
workflows can be easily modified.
Corrective and Preventative Action (CAPA) management: CAPA workflows help

define, address and manage the root cause of nonconformances to help prevent future
recurrences.
Training management: This is a vital baseline requirement to ensure that all staff, in all
locations, are fully trained and up to date on certifications and other requirements.
Change management: To be in business is to be comfortable with change. A solid change

management solution helps automate and closely manage your environment in times of
change or disruption.
Supplier quality: Supply chain quality means end-product quality. So, supplier quality
management and collaboration are critical. The most efficient way to manage supplier
quality is in your QMS, even allowing suppliers access to your QMS to participate in
workflows, such as managing Supplier Corrective Actions (SCARs). Further, regulated
businesses should track supplier audits and findings in the QMS as a means of maximizing
supplier quality visibility.
New Product Introduction (NPI): Building great products means integrating quality as
far upstream in the development process as possible, and including quality in every step,
from design to delivery. A robust NPI capability makes this possible.
3 | QMS Product Checklist www.etq.com
Nonconformance handling: You can reduce the cost of poor quality in many ways but a
robust nonconformance handling system is one of the most comprehensive and effective
tools in your QMS kit. Look for a solution that covers nonconformance reporting and
customer feedback as well as planned deviations and return material authorization (RMA)
capabilities.
Risk management: ISO 9001:2015 dictates that organizations adopt a risk-based

approach to quality management. So, make sure your potential partner has a solution for
assessing, managing and mitigating risk. Determine if your possible partner has a simple
checklist to help you make sure you are compliant with ISO 9001:2015, too.
Data analytics and reporting: Look for a solution with advanced analytics and integrated
dashboards that deliver the ability to
extract information from your QMS
and drill directly from the dashboard
into quality data so you can make
well-informed decisions about your
quality processes on the spot.
Integration with existing

enterprise systems: Quality doesn’t
live in a vacuum, so look for a vendor
whose product easily integrates with
other critical B2B applications like
ERP, PLM, MES, SPC and LMS, as well
as your corporate BI strategy. The
ability to interoperate and share data
across these systems is an essential
capability for a comprehensive QMS. A
certified integration partner status or a
rich toolkit of APIs indicate a vendor is
enterprise integration ready.
Flexibility and adaptability: No two

quality environments are the same, so
it’s important that your QMS partner’s
software is flexible enough to meet
you where you are on you Quality
Journey today, and adaptable to grow
and scale as your needs evolve.
4 | Company Checklist www.etq.com
COMPANY CHECKLIST
You’ll want to know as much as you can about your prospective QMS partner. From financial stability
to post-sales onboarding, training, support and guidance, your partner must be more than “just a
software company.” Some corporate background checklist items to consider include:
Company history and heritage in the QMS Customer support, online training programs
industry and on-going customer success managers
to guide you as you expand your usage and
Company financial stability
take on new processes after your initial
Track record of projects similar in scope to deployment
yours
Easy access to other customers who use
Experience in your specific industry the same QMS, ideally via online networking
Global reach and capabilities if your or a community-type portal as well as
organization is widely dispersed virtual and in-person conferences
A compelling and realistic product roadmap High customer retention rates and positive
customer references with long-term
Ability to virtually implement and support customer accounts
your deployment
Partnerships with adjacent technology

firms for both infrastructure and end-user
software
This Decision Criteria Checklist is a strong set of guidelines but don’t let it be a generic
substitute for a careful and detailed analysis of your organization’s cross functional
requirements and quality culture fit. You should modify this list to best match your
environment (just as your QMS should!) and fully scrutinize your potential partners to
determine the optimal long-term partner for your organization.
About ETQ
ETQ is the leading provider of quality, EHS and compliance management software, trusted by the world’s strongest brands, like
Kimberly-Clark, Jazz Pharmaceuticals, Herman Miller and Chobani. More than 570 global companies, spanning industries including
automotive, biotech, food and beverage, manufacturing and medical devices, use ETQ to secure positive brand reputations, deliver
higher levels of customer loyalty and enhance profitability. ETQ Reliance offers built-in best practices and powerful flexibility to drive
business excellence through quality. Only ETQ lets customers configure industry-proven quality processes to their unique needs
and business vision. ETQ was founded in 1992 and has main offices located in the U.S. and Europe. To learn more about ETQ and its
product offerings, visit www.ETQ.com.

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GAME PLAN

QMS Decision Criteria

• Reduce risk of non-compliance

QMS PRODUCT CHECKLIST

Specific checklist must-haves include:

Corrective and Preventative Action (CAPA) management: CAPA workflows help

Change management: To be in business is to be comfortable with change. A solid change

Risk management: ISO 9001:2015 dictates that organizations adopt a risk-based

Integration with existing

Flexibility and adaptability: No two

Partnerships with adjacent technology

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