Making the Case for Quality

Imaging Core Lab Takes Quality Beyond

Regulatory Requirements With ISO 9001
MedicalMetricsInc.(MMI),
hadanexistingquality
managementsystem
structuredtomeetFDA
regulations,butitwas
missingaframeworkto
helpdriveorganization-
wideimprovement.
MMIworkedwithan
externalconsultanttocreate
anintegratedmanagement
systemafusionof
regulatoryrequirements
withtheISO9001
frameworkandreceived
certificationtothestandard
inlessthansevenmonths.
MMIcontinuestomake
itsqualitymanagement
systemstrongerafter
passingtheaudit.
ThoughMMIscertification
isrecent,itisalready
seeingimprovementstothe
timelinessofdeliverablesto
clinicaltrialsponsors.MMI
alsoreportsanincreasein
qualityawarenessfromthe
ISO9001implementation
andhasreceivedpositive
feedbackfromsponsors.
At a Glance
As a 30-person imaging core lab, Medical Metrics Inc. (MMI) works hard to get the job done. But some-
times, getting the job done leaves room for little else. Although it had been operating under an existing
quality management system (QMS) structured to meet Food and Drug Administration (FDA) regulations,
increasing efficiency was considered outside the scope of regulatory agency requirements
1
. MMI found it
lacked an organization-wide framework in place to analyze and improve the business. Thats why MMI
decided to implement ISO 9001:2008 Quality management systems Requirementsto not only get the
job done, but to get the job done better.
About Medical Metrics Inc.
MMI is a provider of independent imaging core lab services for
clinical trials of medical devices, drugs, and biologics based in
Houston, TX. Since 2000, the company has partnered with
clinical trial sponsors on more than 300 investigations and
research studies across a wide range of therapeutic areas. Its
services include imaging protocol development, medical image
management, expert image review, and scientific interpretation.
MMIs areas of expertise include orthopedics, spine, neurology,
cardiology, and vascular medicine. MMI supports domestic and
multinational clinical trials ranging from early-phase clinical
testing to post-approval surveillance. Participation in regulated
studies has resulted in numerous product approvals, including
several first to market products.
Why ISO 9001?
In addition to regulatory requirements, MMI must meet the
quality system standards of large multinational organizations
that have stringent vendor evaluation programs.
Before taking on new studies, trial sponsors (MMIs customers)
require MMI to complete supplier questionnaires. MMI found
almost every questionnaire included a question as to whether
MMI was ISO 9001 certified. While MMIs interest in ISO
9001 certification was not imposed by a sponsor, compliance to
the standard would give the lab an edge in the industry.
by Megan Schmidt
June 2012
ASQ www.asq.org Page 1 of 5
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Skeleton Management System
MMI had an existing quality system infrastructure in place based
on 21 CFR Part 812, 21 CFR Part 820, and 21 CFR Part 11 regu-
lations because of MMIs clinical trial participation and because it
utilized proprietary technology for analyzing radiographic images.
The existing system underwent several FDA visits and numerous
sponsor audits that contributed to continual improvement, but this
improvement was primarily limited to software validation and
data management. What was missing was a company-wide frame-
work to identify real and potential deficiencies to improve upon.
Knowing that it lacked the internal expertise to implement ISO
9001 and not wanting to delay services to clients, MMI selected
external consultant Gretchen McAuliffe, principal consultant of
Labtopia, to lead the project. In McAuliffes initial discussions
with MMI, they contemplated two separate quality systemsone
based on FDA regulations and one based on ISO 9001. She pro-
posed a structure where ISO 9001 encompassed the entire
organization, forming an umbrella quality system that included
all FDA regulatory requirements.
Rapid Certification
MMI planned to achieve ISO certification in less than seven
months, an aggressive timeline guided by a clear project
schedule (Figure 1).
Senior management supported ISO 9001 certification from the
beginning and elevated the project to an organizational priority.
Tom Martin, president and CEO, felt ISO 9001 certification
would communicate the companys customer focus and a com-
mitment to continual improvement. Without a comprehensive
QMS, we cannot be sure that we are meeting our customers
needs. We also cannot be sure that we are working on the right
things without understanding the overall organization and how
it is performing in our customers eyes. The quality system
helps us focus on what is important, Martin said.
ISO 9001:2008 is an international management standard based
on eight quality principles:
Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships
Certification to ISO 9001 means that an independent authority
has assessed and approved an organizations management sys-
tem against the standard.
ASQ www.asq.org Page 2 of 5
Milestone Deadline Tasks
BusinessProcesses May31,2011 Defineandmapbusinessprocesses.
Training May31,2011 ConductISO9001:2008overviewtrainingwithstaff.
Metrics June15,2011 Definebusiness/departmentmetricsforkeybusinessprocesses.
Metrics June30,2011 Haveinplacemechanismtotrackinformationforkeybusinessmetrics.
Documentation July31,2011 Revise/draftSOPs.
August31,2011 Revise/draftworkinstructions.
August31,2011 Draftqualitymanual(s).
SOPTraining August31,2011 Trainallpersonnelonjob-relatedprocedures/processes.
InternalAudit September10,2011 Completeinternalaudit.
QualitySystemsOverviewTraining September15,2011 Trainpersonnelonanoverviewofthequalitymanagementsystem.
RegistrarAudit September30,2011 Stage1registraraudit.
CorrectiveActions October31,2011 Closeallcorrectiveactionsfromaudit.
ManagementReview(MR)* October31,2011 Conductfirstquarterlymanagementreviewwithinputsofpreviousquarterquality
objectives/metrics.
* Quarterly MRs were conducted prior to starting the ISO 9001 project; however, they did
not include all the inputs required by the standard. They also did not review any metrics.
RegistrarAudit November30,2011 Stage2registraraudit.
CertificateinHand! January2012
Figure 1: MMIs project schedule for achieving ISO certification
ASQ www.asq.org Page 3 of 5
MMI attributes its rapid certification to weekly QMS meetings
for the core implementation teamwhich consisted of senior
management, department managers, and the consultantto
discuss the status of tasks and to identify areas where addi-
tional resources were required to meet goals. MMI created
time to focus on the quality system, discussed issues and
delays, and allocated resources when necessary so bumps
wouldnt become roadblocks.
Since ISO 9001 was a new way to do business, MMI also
involved more staff to actively participate in implementing the
quality management system than it would have historically.
This helped send the message across the organization that qual-
ity is no longer solely the responsibility of the quality
management representative.
McAuliffe explained that preparing MMI for ISO 9001 was a
change management issue. The organization readily embraced
the QMS, but lacked the discipline or understanding on how
and when to use the system (i.e., documenting a complaint,
entering a nonconformance, etc). Throughout the implementa-
tion, McAuliffe trained staff on how a QMS functions and what
its requirements are, and made sure they were kept informed of
developments to procedures and processes.
Implementation Milestones
McAuliffe said since a quality system infrastructure was in
place, implementing ISO 9001 and integrating it with the FDA
requirements was essentially taking what was there and mak-
ing it better and more automated. MMIs integrated
management system is shown in Figure 2.
21 CFR Part 820 QSR
Management commitment
and customer focus
Quality planning
Quality management system
Management review*
Quality policy and objectives
Control of documents* and records*
Management responsibility
processes
D&D planning
Inputs/Outputs
Design review
Verication and validation
Change control
Design and development
related processes
Project requirements
Contract review
Customer related
processes
Purchasing
Product project life cycle
Consulting project life cycle
Monitoring and measuring
equipment
Data management
Product realization processes
Customer satisfaction (inc. complaints*)
Internal audits*
Control of nonconforming material
Improvement (CA/PA)*
Statistical techniques
Measurement, analysis, and
improvement processes
Human resources
Training*
Infrastructure
Work environment
Resource management processes
*Indicates QSR requirement
relevant to 510(k) software
Software
Requirements
Requirements Customer
Deliverables
Feedback
Figure 2: MMI quality management system overview
ASQ www.asq.org Page 4 of 5
Highlights from MMIs ISO 9001 implementation include:
Gap analysis
One of MMIs first steps toward ISO 9001 compliance was to
conduct a gap analysis to reveal areas for improvement in the
existing system. In many cases, processes and requirements had
already been defined, but documentation was either outdated or
the processes did not always reflect current operations. Because
of this, much of the existing documentation had to be rewritten.
Processes and documentation
A document control structure was established early in the jour-
ney using an alpha-numeric numbering system. McAuliffe and
the management team created common document templates
that were used to collaborate with process owners in defining
and documenting processes. The companys business develop-
ment and technical services groups experienced the most
process development.
Quality policy and objectives
MMI had an existing quality policy that was broadened to include
ISO 9001 requirements, such as continual improvement. This
spring boarded improvements to MMIs quality objectives.
Quality objectives were largely driven by customer satisfaction,
and MMI felt this focus was the best way to continue. However,
MMI needed to establish parameters around where
and how objectives would be tracked, the fre-
quency of measurement, goals, and when metrics
would be reviewed. For most of the objectives,
MMI added new fields to the existing customer
relationship management (CRM) system so perfor-
mance was more visible.
Defining customer requirements
Customer requirements were already clearly
defined under the existing system. MMI operates
under a schedule of work for each project. The
schedules are akin to project plans and typically
entail 15 to 20 pages of documents outlining the
scope of work, which is defined by the sponsors
clinical protocol, which receives FDA approval.
Using and improving the QMS
With design and development of the QMS com-
pleted, the next step was to continually improve it
based on internal and external feedback. Senior
management began holding weekly quality meet-
ings to review complaints and nonconformances.
An internal audit also provided a more formal and comprehen-
sive assessment of opportunities to improve.
To seek external feedback, MMI shared its QMS with sponsors.
The quality manual proved to be an especially useful tool to
show sponsors how MMI does businessits conformance to
ISO 9001 and regulatory requirements.
MMI also implemented a customer satisfaction survey. Initially,
a beta survey was sent to 20 contacts that MMI identified as
friends of MMI. MMI used feedback from the pilot to adjust the
survey accordingly before sending it to all existing customers.
Results
MMI reached its goal of attaining ISO 9001:2008 certification
in less than seven monthsthe final, stage 2 audit from ABS
Quality Evaluations occurred in November 2011 and MMIs
ISO 9001 certificate was in hand by early January 2012.
Because its certification is recent and the QMS is still in its
infancy, MMI said the bottom-line impact has yet to be fully
evaluated. However, MMI saw improvements to two of its key
metrics during third and fourth quarters of 2011more than
90percent of its deliverables to sponsors were on time and
more than 90 percent of its business proposal submissions were
on time. McAuliffe anticipates that MMI will further refine its
objectives and see improvements as the company continues to
Validity of this certificate is based on the periodic audits of the management systemdefined by the above scope and is contingent upon prompt, written
notification to ABS Quality Evaluations, Inc. of significant changes to the management systemor components thereof.
ABS Quality Evaluations, Inc. 16855 Northchase Drive, Houston, TX 77060, U.S.A.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Copyright 2003 ABS Quality Evaluations, Inc.. All rights reserved.
ABS QuaIity EvaIuations
Certificate Of Conformance
has been assessed by ABS Quality Evaluations, nc. and found to be in conformance with the requirements set forth by:
This is to certify that the Quality Management System of:
MedicaI Metrics, Inc.
2121 Sage Road
Suite 300
Houston, TX 77056
U.S.A.
ISO 9001:2008
The Quality Management System is applicable to:
Certificate No: 46605
Effective Date: 06 January 2012
Expiration Date: 05 January 2015
Issue Date: 06 January 2012
Alex Weisselberg, President
DESIGN AND DELIVERY OF IMAGE MANAGEMENT, RADIOLOGIC REVIEW, AND CONSULTING SERVICES TO THE CLINICAL TRIAL INDUSTRY
ABSQualityEvaluationsInc.auditedMedicalMetricsqualitymanagementsystemand
foundthatitisinconformancetotherequirementsinISO9001:2008.MedicalMetrics
receivedacertificateofconformancefromtheregistrar.Thecertificatedemonstratesthat
athirdpartyhasverifiedtheorganizationscompliancetothestandard.
ASQ www.asq.org Page 5 of 5
set the bar higher.Its about learning to
crawl before we can walk, McAuliffe said.
Management review meetings are an inte-
gral part of monitoring, evaluating, and
improving a QMS. McAuliffe said the
results of the companys first management
review meetings were a bit shocking to
senior management. Having the results
for performance on key criteria was an
eye-opening experience. Often, I find com-
panies cannot see the forest through the
trees, and having the actual hard data,
which is a clear indicator of performance,
is critical to quality improvement, she
said. Once senior management saw where
the actual issues were, they were able to
implement corrective actions and saw
remarkable improvement over the next quarter.
Information from key, identified objectives and metrics are
reported to the board of directors during quarterly meetings.
Our first report to the board was in January 2012 and it has
been about educating the board members about the metrics, how
and why we chose them, and how and why we are improving
these processes, Martin explained. Going forward, we expect
that the board may have further input on what types of quality
metrics the organization will require.
Personnel are kept informed of monthly and quarterly objectives
through a quality bulletin. It includes results of recent audits,
upcoming audits, performance metrics, and minor procedural
notifications.
Continuing Commitment to Quality
In 2012, MMI will further define and refine its processes and
develop metrics to make them more granularespecially those
that involve multiple, interacting departments. There are still
some key business processes that the lab plans to further docu-
ment and develop into standard operating procedures. The
company plans to involve customers as it further develops its
QMS. MMI is currently working with a key customer to further
develop a process for delivering data. This program will eventu-
ally be evaluated by a second tier of customers before becoming
a standard practice at MMI.
Another goal of MMI is to use its Web-based CRM to manage
multiple aspects of the business, including the QMS. The pri-
mary reason for this move is that the CRM has the capability to
integrate workflow, email notifications to personnel, and it will
allow for a substantial improvement in reporting. Likewise, the
CRM will help MMI meet the 21 CFR Part 11 requirement and
will be able to be validated, which is a regulatory requirement
for the customer complaint and corrective
and preventive action (CAPA) system.
Plans are under way to integrate some
processes, such as quality and production,
into its CRM. The CRM serves as the
daily project dashboard. Fully linking the
QMS with the CRM will allow personnel
to review quality action items, CAPAs,
and complaints as a matter of their daily
business. This will allow issues to be visi-
ble to everyone in the organization and
will reinforce that the QMS is not a sepa-
rate entity.
While MMI has come a long way in a
short amount of time, ISO 9001 certifica-
tion is just the beginning to a new way of
doing business.
Registration was just the start, now we have to manage,
improve, and develop the system, Martin said.
For More Information
To learn more about MMI and the services it provides,
contact Michelle Council, director of business development
at 713-850-7500 x211 or mcouncil@medicalmetrics.com or
visit www.medicalmetrics.com.
For more information about MMIs ISO 9001 implementation,
contact Gretchen McAuliffe of Labtopia at 281-619-2600 or
gmcauliffe@labtopiainc.com.
Read more articles about quality applications in the healthcare
sector at asq.org/healthcare-use/library/overview.html.
Learn about ISO 9001 at asq.org/learn-about-quality/iso-
9000/overview/overview.html.
Reference
1. http://www.fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/PostmarketRequirements/
QualitySystemsRegulations/UCM134625.pdf
About the Author
Megan Schmidt is an ASQ staff writer.
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