Vol. 24, No. 3, March 2015, pp. 369–382 DOI 10.1111/poms.

12252
ISSN 1059-1478|EISSN 1937-5956|15|2403|0369 © 2014 Production and Operations Management Society

The Influence of ISO 9000 Certification on Process

Compliance
John V. Gray
Fisher College of Business, The Ohio State University, 2100 Neil Avenue, Columbus, Ohio 43210, USA, gray.402@osu.edu

Gopesh Anand
Department of Business Administration, University of Illinois at Urbana-Champaign, 350 Wohlers Hall, 1206 S. Sixth Street, Champaign,
Illinois 61820, USA, gopesh@illinois.edu

Aleda V. Roth
Department of Management, College of Business and Behavioral Sciences, Clemson University, 132E Sirrine Hall, Clemson,
South Carolina 29634-1305, USA, aroth@clemson.edu

his article examines the influence of ISO 9000 certification on plant-level process compliance, which arguably is its
T first-order, targeted performance dimension. The empirical setting is the medical device manufacturing industry. Pro-
cess compliance is measured through Food and Drug Administration inspections of manufacturing plants. We control for
several observable factors that possibly affect process compliance by matching certified plants with non-certified plants.
Using longitudinal data, we find plants that obtained certification in the earlier diffusion period (early-certified plants)
tend to have significantly better process compliance than a matched, non-certified control group of plants. The compliance
difference between early-certified plants and their matched control group is greater than the compliance difference
between late-certified plants and their matched control group. We also find deterioration in process compliance over time
after certification. Because we capture longitudinally the first-order effects of ISO 9000 on process compliance, this study
provides a useful baseline for assessing causality in ISO 9000-performance linkages. Also, we explain, in part, the inconsis-
tencies observed in related ISO 9000 literature examining the performance effects of certification. Further, this research
offers managerial insights on the dynamics of certification and process compliance with time, and highlights the need for
continued vigilance post certification.
Key words: certifications; decay; diffusion; management standards; quality control
History: Received: July 2012; Accepted: March 2014 by Kalyan Singhal, after 3 revisions.

of ISO 9000 certification are mixed (Boiral and

1. Introduction
Using a longitudinal approach, this research aims to
empirically assess the direct, first-order influence of
ISO 9000 certification on process compliance at the
manufacturing plant level. ISO 9000 is a management
standard designed to ensure that procedures are cre-
ated and adhered to such that products consistently
meet customer and regulatory requirements (ISO 2009).
Thus, organizations meeting the standard’s intent
should be operating with high levels of compliance
with procedures and regulations. ISO 9000 is perhaps
the most prevalent management standard certifica-
tion, spanning a variety of industries (Schroeder et al.
2005, Uzumeri 1997). Because of its importance to
practice, a large body of academic literature on ISO
9000 has accumulated (Boiral 2012). However, the
results of studies focusing on the performance effects
369
Amara 2009, Yeung et al. 2011). Since certification
requires considerable commitment of organizational
resources, studies on the effectiveness of certification
continue to be of interest to practitioners and academ-
ics (Lo et al. 2013).
We propose that the lack of consistent evidence for
performance outcomes of ISO 9000 certification may
be attributed to several factors. First, few existing
studies are longitudinal, which limits their ability to
test causal linkages. Second, those studies that are
longitudinal examine a performance dimension that
is a second-order effect of certification (e.g., business
performance), rather than a first-order effect of certi-
fication (i.e., process compliance), thereby introduc-
ing confounding effects. Third, all longitudinal
studies and many cross-sectional studies assess per-
formance at the firm level vs. the plant level where
 Gray, Anand, and Roth: IS0 9000 and Process Compliance
370 Production and Operations Management 24(3), pp. 369–382, © 2014 Production and Operations Management Society

the production processes reside, which may intro-
duce attribution errors. In contrast, this study is the
first to longitudinally assess the first-order, direct
effect of ISO 9000 certification at the plant level.
Therefore, we can more precisely assess its effective-
ness regarding the intended process compliance out-
come over time. In so doing, we help to reconcile
some contradictions in the literature.
To gauge the certification-compliance dynamics,
this study uses a 13-year panel of data on manufactur-
ing plants in the medical device industry. The mea-
sure of process compliance is based on the results of
inspections conducted by the Food and Drug Admin-
istration (FDA). We consider two time-related aspects
of certification: the timing of ISO 9000 certification
and the passage of time after certification. Regarding
the timing of initial certification, we compare process
compliance of certified plants to control groups of
non-certified plants and contrast plants certified early
in the diffusion of the certification with those certified
later. Our results indicate that early certification
relates largely to superior process compliance. Next,
considering the post-certification period, our study
reveals deterioration in process compliance among all
plants over time after certification. Delving further
into this result, we find it is primarily driven by dete-
rioration among early-certified plants in the ISO 9000
diffusion process. Thus, our empirical analyses pro-
vide plausible explanations for why existing studies
of ISO 9000 have produced inconsistent results.
Because a cross-sectional study cannot account for
these two temporal factors individually, the date of
certification (earlier is better) and the time since certi-
fication (more recent is better) may counteract each
other in cross-sectional research.
2. Literature
We classify previous empirical studies of ISO 9000
certification into two categories based on the principal
phenomena they examine: (1) the diffusion of ISO
9000 and (2) performance effects. Studies in the first
category focus on the adoption process of ISO 9000
and its diffusion in industries and countries, address-
ing why and how organizations choose to obtain certi-
fication (e.g., Anderson et al. 1999, Boiral 2003,
Corbett 2006, Ivanova et al. 2014). These studies
inform our arguments relating the timing of adoption
to its performance effects.
In this study, the main focus of the ISO 9000 litera-
ture review is on studies that associate certification
with performance. We organize this literature in
Table 1 along two dimensions: (1) type of performance
assessed, which is divided between performance
related to ISO 9000’s effect on process compliance-
related outcomes and to other outcomes; and (2)
research design, which is bifurcated between cross-
sectional and longitudinal. Within each cell, we

Table 1 Classification of the Quantitative Empirical Literature Examining the Performance Consequences of ISO 9000 Certification: Type of
Performance Measure by Time Frame*

Performance measure

Time frame Other than process compliance/quality performance Process compliance/quality performance
Cross-sectional Perceptual measures: Bernardo et al. (2012), Prajogo (2011), Perceptual measures: Singh et al. (2011), Karapetrovic et al. (2010)†,
Mart
ınez-Costa et al. (2009), Boiral and Roy (2007), Nair and Prajogo (2009), Singh (2008), Casades
us and
Naveh et al. (2004), Chow-Chua et al. (2003), Karapetrovic (2005), Naveh and Marcus (2005)‡,
Terziovski et al. (2003), Jones et al. (1997), Naveh and Erez (2004)§, Naveh and Marcus (2004),
Terziovski et al. (1997) Dreyfus et al. (2004), Singels et al. (2001), Brown et al. (1998),
Archival measures: Simmons and White (1999) Curkovic and Handfield (1996)
Longitudinal Archival measures: Lo et al. (2013), Iyer et al. (2013),
Yeung et al. (2011), Levine and Toffel (2010), Benner (2009),
Lo et al. (2009), Benner and Veloso (2008), Dick et al. (2008),
Naveh and Marcus (2007), Terlaak and King (2006), The “gap” in the ISO 9000 literature addressed by this study
Corbett et al. (2005), Sharma (2005), Naveh and
Marcus (2005)‡, Benner and Tushman (2002),
Heras et al. (2002), Wayhan et al. (2002), H€aversj€o (2000),
Docking and Dowen (1999)

*Representative set of literature in each quadrant.

†
Karapetrovic et al. (2010) analyzed perceptions using the same survey in the same region over three different time periods. Thus, the research has a
longitudinal component, using perceptual measures. However, there was little overlap in the companies sampled in each time period. So, by our
classification, we consider these three cross-sectional samples, as they do not track the evolution of performance. Similarly, Casades
us and Karapetrovic
(2005) is based on two surveys of independent samples conducted over two time periods.
‡
Naveh and Marcus (2005) used a cross-sectional survey to assess improvement in defect rates, scrap, etc., and also used COMPUSTAT data to assess
business performance.
§
Although Naveh and Erez (2004) studied the time sequence of different quality interventions, their research did not focus on the time period of ISO 9000
adoption or the effects of ISO 9000 over time, so we consider their sample cross-sectional with respect to ISO 9000 certification.
Gray, Anand, and Roth: IS0 9000 and Process Compliance
Production and Operations Management 24(3), pp. 369–382, © 2014 Production and Operations Management Society
identify whether the research is based on archival
measures (secondary data) or perceptual measures
(primary data). Table 1 is representative of a more
exhaustive literature review.
Table 1 illustrates two key aspects of the extant
literature. First, all the research that uses secondary-
source archival performance measures has empha-
sized outcomes other than process compliance
quality. Examples include productivity (Iyer et al.
2013), return on assets (Lo et al. 2013), Tobin’s q
(Benner and Veloso 2008), sales and profit margins
(Naveh and Marcus 2005), and stock prices (Docking
and Dowen 1999). Moreover, most of this research is
at level of analysis of the firm, as explained by Levine
and Toffel (2010, p. 980): “ISO 9000 is typically
adopted at the plant level, whereas outcome data are
typically available only at the firm level.” Certification
may certainly affect non-process compliance-related
performance outcomes. However, such outcomes
often are second-order effects that materialize from
improved operational outcomes. Furthermore, sec-
ond-order performance improvements also may be
attributed to other non-operational factors, such as
“signaling,” in which the certified company is treated
more favorably by its customers and by the stock mar-
ket, regardless of any realized, process-level benefits
of certification (Terlaak and King 2006). Perhaps
because of the varied causal chains from certification
to such non-process compliance performance dimen-
sions, these studies have had mixed results (Boiral
2012), most finding benefits (e.g., Corbett et al. 2005,
Levine and Toffel 2010, Lo et al. 2009, Naveh and
Marcus 2007) and others failing to do so (e.g., Heras
et al. 2002, Terziovski et al. 1997, Yeung et al. 2011).
Table 1 also shows that all the research on the first-
order effects of ISO 9000 certification on process com-
pliance/quality performance (as well as some
research examining other performance dimensions)
used perceptual outcome measures and was cross-
sectional. The self-administered surveys consisting of
psychometric scales used in these studies allowed
researchers to consider a rich set of explanatory fac-
tors related to ISO 9000 adoption. These factors
include adoption costs (Chow-Chua et al. 2003),
quality management experience (Naveh et al. 2004),
integration of quality management practices
(Mart
ınez-Costa et al. 2009, Naveh and Marcus 2005),
and motivation for adoption (e.g., Naveh et al. 2004,
Prajogo 2011). However, perceptual measures of per-
formance, especially when collected using the same
method as independent variables, can be prone to
common methods bias (Podsakoff et al. 2003, Siemsen
et al. 2010). More importantly, the absence of longitu-
dinal studies of the first-order effect of certification on
process compliance limits the extent to which causal-
ity of certification–performance relationships can be
371
examined (Boiral 2012, Boyer 1999). Furthermore,
cross-sectional research cannot disentangle two
dynamic aspects related to plant level certification:
namely, the timing of ISO 9000 certification in the
diffusion process and the passage of time after plant
certification. Perhaps due to these temporal factors,
some studies found ISO 9000 certification to be related
to improved process compliance performance (e.g.,
Naveh and Erez 2004, Singh et al. 2011); others did
not (e.g., Curkovic and Handfield 1996, Karapetrovic
et al. 2010).
This study targets the void in the ISO 9000 literature
on longitudinal studies of process compliance repre-
sented in the lower right quadrant of Table 1. Levine
and Toffel (2010, p. 979) noted that there is “no prior
[longitudinal] research that examines how the ISO
9000 quality standard affects product or process qual-
ity, or employees.” Levine and Toffel’s seminal work
aimed to fill the gap in employee-related outcomes
through a longitudinal study of ISO 9000 certification.
As the first to focus exclusively on the first-order pro-
cess compliance effects of ISO 9000 certification at the
manufacturing plant level longitudinally, this study
complements their work.
3. Theory and Hypotheses
3.1. Influence of the Date of Certification
We first address the issue of whether a manufacturing
plant obtains ISO 9000 “early” or “late,” referring to
the broader period of diffusion of this certification.
Institutional theory suggests that first-mover organi-
zations obtaining certification during the earlier diffu-
sion of a standard are more likely to be internally
motivated to adopt its underlying practices (Westphal
and Zajac 1994). Early adopters may be more likely to
deliberately scrutinize existing values, reframe strate-
gies, and take corrective actions to enable effective
adoption of the standard. In other words, early
adopters may be more likely to pursue double-loop
learning, which “involves modifications of an organi-
zation’s underlying norms, policies and objectives”
(Argyris and Sch€ on 1978, p. 3).
In contrast, organizations obtaining certification
relatively later in the diffusion of the certification
standard are more apt to do so in response to an exter-
nal motivation, such as copying competitors or
appeasing customers (Barratt and Choi 2007, Lee and
Klassen 2008). Such externally motivated seekers of
certifications are, on average, more likely to ignore
the certification’s stated intentions, and adopt rituals
superficially to achieve symbolic certification (Keto-
kivi and Schroeder 2004). Adopting any management
system can create a mismatch between intended out-
comes and organizational goals, and disrupt existing
systems (Abrahamson 1991, Westphal et al. 1997). In

372 Production and Operations Management 24(3), pp. 369–382, © 2014 Production and Operations Management Society
other words, later adopters may be more prone to
pursue single-loop learning (Argyris and Sch€
on 1978),
making reactionary adjustments to their processes to
fulfill the standard’s requirements. Based on the
above arguments, we posit two hypotheses:
HYPOTHESIS 1 (H1). Early ISO 9000-certified plants
exhibit greater post-certification quality-related process
compliance than non-certified matched plants, on average.
HYPOTHESIS 2 (H2). There is a greater difference in
post-certification quality-related process compliance
between early ISO 9000-certified plants and their
matched non-certified plants than there is between late-
certified plants and their matched non-certified plants.
3.2. Time Since Certification
Next, we examine the effects of the passage of time
following ISO 9000 certification on process compli-
ance quality. Based on theory, we identify the ways in
which ISO 9000 certification effectiveness may change
dynamically. To become ISO 9000 certified, a plant
must demonstrate awareness of the importance of
process compliance and implement systems to
achieve such compliance. Thus, the generation of
good quality control practices and routines can insti-
gate sustained improvements in quality (Jones et al.
1997, Terziovski et al. 2003). The emphasis on docu-
mentation and data collection inherent in ISO 9000
can also promote learning behaviors that may lead to
accumulated benefits over time (Adler and Clark
1991, Lapr
e et al. 2000). According to the evolutionary
theory of economic change, repeated, deliberate use
of organizational routines results in their improved
execution (Nelson and Winter 1982). Similarly, organi-
zational learning theory typically predicts improved
performance with experience (Lapr
e et al. 2000).
Furthermore, improvements in capabilities, such as
those enabled by certification, may increase organiza-
tional capacity to assimilate developments related to
those capabilities (Cohen and Levinthal 1990). Relat-
ing this to ISO 9000, assimilation of the standard can
heighten quality awareness and result in improved
process compliance by using quality management
practices beyond the stated requirements (Naveh and
Marcus 2004).
On the other hand, organizational forgetting (de
Holan and Phillips 2004) can diminish process com-
pliance-related advantages gained from certification
over time. Managers make decisions based on their
finite, information processing capacities, and in the
presence of multiple goals, can pay attention only to a
subset of information at a time (Simon 1957). Thus,
managerial attention at a plant may shift to other
competing priorities, eventually leading to process
Gray, Anand, and Roth: IS0 9000 and Process Compliance
compliance decay (Anand et al. 2012, Katz and Kahn
1978, Knott 2001). This deterioration is consistent with
the observed declines in implementing coherent oper-
ational strategies in manufacturing plants as priorities
evolve (Giffi et al. 1990, Hill and Duke-Woolley 1983).
In light of these two plausible opposing effects
drawn from organizational learning theories, the
directional relationship between the passage of time
after certification and process compliance is unclear.
Therefore, we propose two competing hypotheses:
HYPOTHESIS 3A[B] (H3A[B]). Quality-related process
compliance performance at the plant level increases
[decreases] as time passes after ISO 9000 certification, on
average.
4. Data
4.1. Data Sources for Variables Used in Matching
and Analysis
To access information on plant characteristics for this
research, three data sets were merged (1) the FDA
medical device establishment inspection database, (2)
the McGraw-Hill ISO 9000 certification database, and
(3) the National Establishment Time Series (NETS)
database.
4.1.1. FDA Inspection Database. The data used
for assessing quality-related process compliance (i.e.,
the study’s dependent variable) were obtained from
the FDA. The FDA’s responsibilities include the phys-
ical inspection of US plants classified as manufactur-
ers of medical devices (FDA 2012a). These inspections
are conducted to assess their compliance with good
manufacturing practices documented in the Code of
Federal Regulations: 21 CFR, mainly part 820 for med-
ical devices (FDA 2012b). We obtained the FDA’s
database of medical device facility inspections from
1994 to 2007. For each inspection, the database con-
tains the following: (1) a dichotomous (yes/no) cate-
gorical variable that indicates whether the inspector
issued a Form 483, which is used to document non-
compliance, and (2) a three-level categorical variable
documenting the FDA’s district decision for the
inspection. Considering the district decision, the out-
come implying the least process non-compliance is
“No Action,” which denotes that no follow-up action
is required by the plant after the FDA’s inspection.
The outcome indicating the most process non-compli-
ance is “Official Action,” whereby a publicly posted
warning letter is typically issued threatening the plant
with seizure, injunction or recall if deviations are not
corrected. “Voluntary Action” falls in between these
two. Following the measure developed in Gray et al.
(2011), each plant’s inspection result (NonComply) in
this study was scored from 0 to 3.5. NonComply equals
Gray, Anand, and Roth: IS0 9000 and Process Compliance
Production and Operations Management 24(3), pp. 369–382, © 2014 Production and Operations Management Society
0 when the plant was in the highest observed state of
compliance (i.e., a Form 483 was not issued and a
district decision of “No Action” was recorded); and
NonComply equals 3.5 when the plant was severely
non-compliant (i.e., a Form 483 was issued and a dis-
trict decision indicated “Official Action” was taken).
The Gray et al. (2011) scoring procedure of FDA
inspections was developed following an iterative Del-
phi process, employing a panel of industry experts.
As noted in Anand et al. (2012), in pharmaceuticals,
and observed in this study’s medical device data, the
FDA seems to be issuing fewer “Official Action” out-
comes over time. Anand et al. (2012, p. 1710) stated
“. . .the year dummies. . .seem to indicate that inspec-
tion outcomes have been tending to improve through
the years. . ..Because it is our understanding that there
were no substantial changes to the inspection protocol
during our study time frame, this result could also
imply that the FDA’s district managers in the 2000s
began to make it easier for plants to obtain better
inspection outcomes.” To address this apparent eas-
ing of FDA inspection scores over time, in the current
study, we normalized our inspection scores to reflect
the plant’s performance in relation to the entire indus-
try in the given year. Appendix A describes this
normalization process in detail. Note that higher
scores indicate lower levels of process compliance. We
employ the variable label “NonComply” for an individ-
ual inspection (used in the panel analysis for H3) and
“AvgNonComply” for a plant’s average compliance
over all inspections in a given period (H1–H2). For
the analysis of H1–H2, we average the NonComply
scores for the 0–24 month period after certification to
compute AvgNonComply.
4.1.2. ISO 9000 Certification Database. The
McGraw-Hill database of ISO 9000 certifications was
used to determine plant certifications up to the year
2000. The database, which contains the name,
address, and initial certification date for all establish-
ments included, has been used in multiple studies,
including Benner (2009), Lenox and King (2004), and
Naveh and Marcus (2004, 2007). It is widely believed
to be an accurate representation of ISO 9000 certifica-
tion. We intended to supplement this database,
which only includes certifications through 2000, with
other publicly available listings of ISO 9000 certifica-
tions. In our search, the most extensive data set
found was the Quality Digest Database. While sup-
plementing our database with the Quality Digest
data, we cross-checked the Quality Digest certifica-
tion information with the McGraw-Hill database and
other sources. This process raised concerns about the
reliability of the Quality Digest data (as of 2007) to
the point that these certifications could not be
viewed as having sufficient validity for the analysis.
373
We discussed these concerns with the database
owners at Quality Digest, who stated: “The data
provided by the registrars got progressively worse,
and the updates became very few and far between,
to the point where we felt it wasn’t really serving its
intended purpose, which is why we discontinued it
[sometime after 2007]” (D. Dusharme, Editor-in-
Chief, Quality Digest, pers. comm., April 21, 2010).
Additional communication with Mary Benner (Assis-
tant Professor, Wharton School of Management, pers.
comm., June 23, 2010), who has multiple publications
based on the McGraw-Hill data, indicated that the
certification data collected through 2000, and used in
this study, were indeed accurate. To reduce the
possibility of misclassifying a certified plant as non-
certified because it (1) became certified later than
2000, (2) was certified but inadvertently omitted
from the McGraw-Hill database, and/or (3) obtained
an industry-specific ISO quality-related certification,
we maintained the unreliable information about
certification from Quality Digest’s ISO certification
database collected in 2007 in our database. There
were 198 plants for which evidence existed of a
quality-related certification not included in the
McGraw-Hill data. As these plants apparently have
been certified at some point, they were deleted from
the database so they would not be erroneously
included as a non-certified plant.
4.1.3. National Establishment Time Series
Database. The NETS database captures annual,
establishment-level data from Dun and Bradstreet
(D&B). It contains longitudinal data on all US estab-
lishments covered by D&B since 1990. It was the
source of the following variables: industry (i.e., four-
digit SIC code), two proxies capturing distinct aspects
of plant size (i.e., number of employees [NumEmp]
and sales [PltSales]), Public (i.e., 1 = plant part of a
public company, 0 = otherwise), and Standalone (i.e.,
1 = the plant is the only establishment of its firm,
0 = otherwise).
4.1.4. Merged Data for Analysis. To merge the
three above mentioned databases to generate a sam-
ple, first, the NETS database was manually searched
to find corresponding plants in the FDA database
and, where found, the unique DUNS identification
number was added to the FDA database. This step
located 2459 plants that were in both the NETS and
FDA databases. Then, using a manual search direc-
ted by the nearest geocoded address, 479 of these
plants were located in the McGraw-Hill ISO 9000
certification database. These plants appeared in the
FDA and NETS databases and were certified per the
McGraw-Hill database. The candidate set of control
non-ISO 9000 facilities for matched comparisons with

374 Production and Operations Management 24(3), pp. 369–382, © 2014 Production and Operations Management Society
ISO 9000 facilities included all plants that appeared
in both the FDA and the NETS databases and had no
evidence of ISO 9000 certification based on the
McGraw-Hill data or any other source, as discussed
in section 4.1.2.
4.2. Matching Procedure
As previously stated, our aim is to identify the aver-
age effect of ISO 9000 certification on its first-order,
intended outcome—operational process compliance.
The only way to ensure any findings are directly
attributable to ISO 9000 certification would be to run
a randomized experiment, which is not feasible in this
case. To partially control for endogeneity concerns
(Kennedy 2008), a matched control group was created
similar to the treated (ISO 9000-certified) group in
observable characteristics (Barber and Lyon 1996,
Corbett et al. 2005). As noted in Corbett et al. (2005, p.
1051), “There is no unique best way to choose a con-
trol sample.” Our matching approach is similar to
coarsened exact matching (CEM; King et al. 2010).
This procedure involves matching exactly on categori-
cal dimensions, but for continuous dimensions
matching on categories of the continuous variables.
Similar matching approaches exist in the operations
management literature (Hendricks and Singhal 2001,
Zhang and Xia 2013).
Unlike most prior research, but similar to Levine
and Toffel (2010), this study matched at the plant level
(vs. the firm level). We matched ISO-certified plants
to non-ISO plants on a 1:1 basis, with replacement
(Abadie and Imbens 2006). Following the CEM
approach, the following factors had to be exactly the
same between the ISO plant and the non-ISO plant for
a match: (1) four-digit SIC codes, (2) Public, (3)
Standalone, and (4) plant employee count category (11
categories, based on those in the NETS database: 1–5,
6–10, 11–20, 21–50, 51–100, 101–250, 251–500,
501–1000, 1001–2500, and >2500). All matching was
conducted using data from the year in which the ISO-
certified plant’s certification occurred. In some cases,
the matching algorithm resulted in multiple non-ISO
plants being mapped to a single ISO-certified plant.
To resolve this, we selected the pairing that had the
smallest differential in annual plant-level sales. A
total of 312 ISO plants were successfully matched.
Alternative matching approaches, including propen-
sity score matching (Rosenbaum and Rubin 1983)
were considered; however, the CEM approach
employed here resulted in superior matches, which is
common (King et al. 2010).
4.3. Timing of Certification: Early vs. Late
Based on the inflection point of the diffusion of ISO
9000 (see Figure 1, taken from Naveh et al. 2004, p.
1845), plants certified through 1996 were deemed
Gray, Anand, and Roth: IS0 9000 and Process Compliance
Figure 1 Cumulative ISO 9000 Certifications through 2000 (Naveh
et al. 2004, p. 1845)
“early certified” and those certified later were deemed
“late certified.” This classification produced a sample
of 109 early-certified and 203 late-certified plants.
Robustness tests of this designation are presented in
section 5.4.
4.4. Descriptive Statistics
Table 2 shows descriptive statistics for variables
used to match ISO 9000 and non-ISO plants, and for
additional variables used in this study. Table 3 pre-
sents the correlation coefficients for the study vari-
ables. In addition to obtaining exact matches on
four-digit SIC codes, Table 2 reveals that the match-
ing algorithm selected non-certified plants with char-
acteristics similar to their certified counterparts.
Average values of the matching criteria are similar
between the certified and matched non-certified
plants (p > 0.30 for all tests; i.e., comparisons based
on the entire sample, as well as on early and late-
certified sub-samples).
Now, the average NonComply for certain periods
related to ISO 9000 certification timing is described
for non-certified plants, early-certified plants, and
late-certified plants. Figure 2 reveals that both early
and late-certified plants show some process compli-
ance improvement within 24 months of certification.
Both groups of plants eventually return to approxi-
mately their pre-certification level, although late-
certified plants do so sooner (after ~24 months) than
early-certified plants (after ~48 months).
5. Analysis
5.1. Relationship between Certification and
Process Compliance (H1)
To examine H1, we followed a post-certification
approach similar to that of Corbett et al. (2005), per-
forming a t-test for the difference between the certi-
fied group of plants and a matched control group,
considering only early-certified plants. Recall that the
Gray, Anand, and Roth: IS0 9000 and Process Compliance
Production and Operations Management 24(3), pp. 369–382, © 2014 Production and Operations Management Society 375

Table 2 Descriptive Statistics, Plant-Level Variables, Overall Sample (n = 552)

All plants Early certified Late certified

Used to All plants Certified Matched Certified Matched Certified Matched

Variable match N = 552 (n = 312) (n = 240)* (n = 109) (n = 74)* (n = 203) (n = 166)*
Public (Public = 1, Yes 0.344 (0.476) 0.359 (0.480) 0.325 (0.469) 0.569 (0.498) 0.568 (0.499) 0.246 (0.432) 0.217 (0.413)
private = 0)†
Standalone Yes 0.457 (0.499) 0.439 (0.497) 0.479 (0.501) 0.183 (0.389) 0.203 (0.405) 0.576 (0.495) 0.602 (0.491)
(Standalone = 1, >1
establishment
in firm = 0)†
NumEmp (Plant-level Yes 142.8 (253.3) 151.05 (260.03) 132.15 (244.43) 266.31 (375.36) 239.55 (372.75) 89.16 (133.24) 84.28 (132.63)
number of
employees,
year certified)‡
PltSales (Plant sales, Yes 19.2 (42.0) 19.6 (38.8) 18.6 (45.9) 34.1 (58.2) 35.0 (74.8) 11.8 (18.2) 11.3 (19.9)
$MM, as of year
certified)‡
AvgNonComplyall No 1.10 (0.740) 1.10 (0.743) 1.11 (0.737) 0.949 (0.681) 1.03 (0.657) 1.18 (0.764) 1.14 (0.770)
(Average
NonComply score,
plant level)§

*The number of matched, non-certified plants is less than the number of ISO-certified plants because we matched “with replacement,” as described in
section 4.3. When matching with replacement, some matched non-certified plants were matched to more than one certified plant.
†
Although perfectly matched, Public and Standalone are slightly different here because we matched with replacement and only count a matched non-
certified plant once, even if it was the best match more than once.
‡
These variables may be time varying; we report them during the year in which the match was made (i.e., the same year that a plant became certified).
§
All years, all inspections are the plant-level average of the NonComply inspection scores. Individual inspection scores range from 0 (best process
compliance) to 3.5 (worst process compliance), as discussed in section 4.1.1.

Table 3 Pearson Bivariate Correlation Coefficients: Plant-Level Variables, Total Sample (n = 552)‡

AvgNonComplyall Public Standalone NumEmp PltSales ISO9K § Early¶

AvgNonComplyall 1
Public
0.06 1
Standalone 0.14**
0.43** 1
NumEmp
0.09* 0.28**
0.36** 1
PltSales
0.08† 0.26**
0.20** 0.93** 1
ISO9K §
0.01 0.04
0.04 0.04 0.01 1
Early¶
0.12** 0.33**
0.38** 0.31** 0.26** 0.04 1

**p < 0.01, *p < 0.05, †p < 0.10.

‡
For more detailed descriptions of all variables except ISO9K and Early, see Table 2.
§
ISO9K: ISO 9000 certified = 1, 0 otherwise.
¶
Early: plants certified early (≤1996) and their matched, non-certified plants = 1; plants certified in 1997 or later and their matches, Early = 0.

Figure 2 Average NonComply for Non-Certified, Early-Certified, and Late-Certified Plants, Relative to Time of ISO 9000 Adoption
1.4
1.2
1
0.8 Non-CerƟfied
0.6 Late CerƟfied
0.4 Early CerƟfied
0.2
0
Pre-CerƟficaƟon 0-24 Months Post- 24-48 Months Post- >48 Months Post-
Cert Cert Cert

376 Production and Operations Management 24(3), pp. 369–382, © 2014 Production and Operations Management Society
Table 4 Process Compliance (AvgNonComply): Early Certified [Early = 1996 or Earlier; H1]*,†
ISO-certified plants
AvgNonComply(StdDev)
[n = no. of plants]*,†
AvgNonComply(0–24 months) 0.74 (0.87) [n = 68]
*Not all plants had an inspection during the time period; if not, they were excluded from this analysis.
†
Plant-level non-compliance scores (AvgNonComply) are based on FDA inspection outcomes. Individual inspection scores range from 0 to 3.5, with
higher scores indicating lower process compliance. See section 4.1.1.
performance measure is AvgNonComply, which is the
average of all inspections performed in the 0–
24 month period post-certification. The statistically
significant difference (p < 0.01) provides support for
H1 (Table 4).
Though not presented, the same analysis with all
plants (both early and late-certified) is also statisti-
cally significant (p < 0.05). The analysis of only late-
certified plants with their matched non-certified
plants did not show a statistically significant differ-
ence in process compliance (p > 0.10), indicating that
the significant result including all plants is driven by
the early-certified plants. We further analyze this dif-
ference in our tests of H2.
5.2. Difference between Early and Late-Certified
Plants in Relation to Control Groups (H2)
To test H2, we performed a “difference-in-differ-
ences” test in Stata (Wooldridge 2009) to determine
whether a statistically significant difference exists
between (1) the difference in AvgNonComply between
early-certified plants and their matched counterparts
and (2) the difference in AvgNonComply between late-
certified plants and their matches. Specifically, we ran
the following regression:
AvgNonComply ¼ b0 þ d0 Early þ b1 ISO9K
ð1Þ
þ d1 Early  ISO9K þ u;
where ISO9K is defined as = 1 for all certified
plants, and 0 for all non-certified matched plants;
and, Early is defined as = 1 if the plant is either an
early-certified plant or a non-certified match to an
early-certified plant, and = 0 if the plant is either a
late-certified plant or a non-certified match to a late-
certified plant.
From Equation (1), a significant and negative d1
would indicate that the difference between the early-
certified plants (Early = 1 and ISO9K = 1) and their
matched controls (Early = 1 and ISO9K = 0) is greater
than the difference between late-certified plants
(Early = 0 and ISO9K = 1) and their matched controls
(Early = 0 and ISO9K = 0). Table 5 presents the
results of this regression, which shows moderate
significance (p = 0.09). No control variables are
included in the regression because the plants are
Gray, Anand, and Roth: IS0 9000 and Process Compliance
Matched non-ISO-certified Difference in
Plants AvgNonComply(StdDev) means
[n = no. of plants] (p = p-value, one-tail)
1.16 (1.12) [n = 66] 0.42 (p = 0.009)
Table 5 Difference-in-Differences, DV = AvgNonComply 0–24 Months
After Certification (n = 300 Plants, R2 = 2.2%, F(3,
296) = 2.18†) [H2]
Variable Coefficient (SE)
Constant 1.10 (0.11)**
ISO9K
0.08 (0.16)
Early 0.06 (0.17)
Early × ISO9K
0.34 (0.24)†
Control variables not included due to matching.
**p < 0.01, †p < 0.10.
matched. Nonetheless, we ran the regression with
control variables, and as expected, it did not affect the
result. This regression has a low R-squared, which is
common in difference-in-differences analyses
(Wooldridge 2009, p. 455). Figure 3 depicts the “dif-
ference in difference” graphically, comparing the
mean predicted levels of AvgNonComply of early and
late-certified plants and their matches.
5.3. Examination of Process Compliance after
Certification (H3)
To test H3a and H3b, we establish whether non-
compliance increases or decreases after certification.
As there are multiple post-certification inspections,
we tested these hypotheses with a panel analysis,
using Stata 12’s “xtreg” procedure. For the main
analysis, a random effects regression model was
employed with the normalized inspection score
(NonComply) as the dependent variable and the
natural log of the number of days since certification
(Ln_DaysSinceISO) as the key independent variable.
The change in NonComply, as posited by H3a and
H3b, is indicated by the sign of the coefficient of
Ln_DaysSinceISO. To employ robust standard errors
and simultaneously account for the fact that some
participating plants belong to the same firm, we
employed the cluster option in Stata (Rogers 1993).
Since this analysis only involved certified plants, and
therefore, was no longer a matched sample, we
included control variables. Table 6 presents results of
the analysis for all certified plants and the subset of
early-certified plants. The empirical results support
H3b, indicating that time since certification has a
significant detrimental effect on process compliance
Gray, Anand, and Roth: IS0 9000 and Process Compliance
Production and Operations Management 24(3), pp. 369–382, © 2014 Production and Operations Management Society 377

Figure 3 Comparison of Early and Late-Certified Plants (AvgNonCom-
ply, 0–24 months after certification) vs. Their Non-Certified,
Paired Matches (Match), Based on Difference-in-Differences
Regression in Table 5
1.4
1.2
1
0.8
0.6
0.4
0.2
0
Early CerƟfied Plants Late CerƟfied Plants
for early-certified plants (p = 0.03) and a moderate
effect for all certified plants (p = 0.06). Though not
presented, there is no significant effect (p > 0.10)
when only considering the late-certified plants.
5.4. Supplemental Analyses
First, we tested the robustness of the results to the dis-
tinction between “early” and “late.” The classification
for all the main analyses in the study is that the early-
certified plants were certified before January 1, 1997,
and late-certified plants were certified on or after that
date. Our FDA inspection data began in 1994 and our
ISO 9000 certification data ended in 2000. Figure 1
indicates this range of dates should cover any reason-
able early/late cutoff for ISO 9000 diffusion. We
performed five supplementary analyses for each
hypothesis, testing the early/late cutoff dates before
January 1, 1995, 1996, 1998, 1999, and 2000. H1, H2,
and the analysis of H3 for only early-certified plants
are all robust (p < 0.10) to the later cutoff dates (Janu-
ary 1, 1998, 1999, and 2000). H1 and H3 are also robust
(p < 0.10) to a cutoff of January 1, 1996, but H2 is not.
None are robust to the January 1, 1995 cutoff, but by
this classification there were only 23 early-certified
plants. Taken together, our results are mostly robust
to different early/late classifications, except for the
earliest cutoff dates. Table 7 shows the results of this
supplemental analysis.
We also performed a supplemental analysis related
to the post-certification period. For the main analysis
presented in sections 3.1–3.2, we used AvgNonComply
as our dependent variable in the 0–24 month post-
certification period. Here, to understand the dynamic
ISO9K
differences between certified plants and matched
Match
plants, the results are reported in different, discrete
time buckets. Specifically, we examined AvgNonCom-
plyt for the following post-certification time buckets:
0–12 months, 0–18 months, 0–36 months, and all
inspections post certification (see Table 8). Consider-
ing H1, for both the 0–18 (p < 0.05) month and 0–36
(p = 0.051) month periods, the early adopters signifi-
cantly outperformed their matched plants. There was
no such difference for 0–12 months or when all
inspections post certification are included. Consider-
ing H2, moderate significance (p < 0.10) was main-
tained in two of the four supplemental analyses. The
0–12 month time period was not significant, nor was
the 0–36 month time period (p = 0.13). Taken
together, H1 and H2 tend not to be supported when
the post-certification period in which AvgNonComplyt
is calculated is too short, both hindering sample size
and possibly implying a period of adjustment to the
new system (Pil and MacDuffie 1996, Sterman et al.
1997). In the longer post-certification periods, results
become less consistent as the effects of decay begin to
be realized.
The next supplemental analyses consider pre-cer-
tification performance in analyzing H1. Our sparsely
populated process compliance measure, combined
with a lack of process compliance data prior to
1994, prevented matching based on pre-certification
process compliance. Nonetheless, there is no sig-
nificant difference (p > 0.50) in pre-certification
AvgNonComply between certified plants and their
matches. We incorporate pre-certification by
employing a “difference-in-differences” methodol-
ogy (Wooldridge 2009), similar to our analyses of

Table 6 Random-Effects Analysis, DV = NonComply (Post-Certification) [H3]

All plants Early-certified plants only

(n = 1075 insp., 300 plants; Wald v = 10.54*)

2
(n = 522 insp., 109 plants; Wald v2 = 14.28**)

Variable Coefficient (SE) Variable Coefficient (SE)

Ln_DaysSinceISO 0.065 (0.035)† Ln_DaysSinceISO 0.113 (0.051)*
Standalone 0.080 (0.102) Standalone
0.078 (0.210)
Public
0.018 (0.094) Public
0.030 (0.141)
PltSales
0.0015 (0.0006)* PltSales
0.0015 (0.0005)**
Constant 0.619 (0.256)** Constant 0.238 (0.382)

Note: NumEmp was removed due to high correlation with PltSales; H3 result is unaffected if included.
**p < 0.01 *p < 0.05, †p < 0.10.
 Gray, Anand, and Roth: IS0 9000 and Process Compliance
378 Production and Operations Management 24(3), pp. 369–382, © 2014 Production and Operations Management Society

Table 7 Results of Supplemental Analysis Related to Early/Late Cutoff post certification (indicating that, overall, certification
#Early #Late
helps, when controlling for time) and (2) decay is
Early adopter cert cert #Non-cert H1 H2 H3‡ more substantial after than before certification.
†
Before January 1, 2000 139 14 147 * *
Before January 1, 1999 124 29 147 * ** * 6. Discussion
† †
Before January 1, 1998 92 61 147 **
Before January 1, 1997 68 85 147 ** †
*
Supporting H1, our empirical results indicate that
†
early-certified plants had consistently better process
Before January 1, 1996 47 106 147 n.s. * compliance than their matched non-certified plants
Before January 1, 1995 23 130 147 n.s. n.s. n.s.
(p < 0.01). Furthermore, in support of H2, moderate
Grey-shaded cells are used in main analysis. evidence suggests that early-certified plants outper-
**p < 0.01, *p < 0.05, †p < 0.10 H1 and H2 one-tailed tests; H3 two- formed their matches more than late-certified plants
tailed. did (p < 0.10). Combined with insights from the ISO
‡
H3 test is for early-certified plants only; analogous to right-side column
of Table 6. Of course, test of all plants (left-side column of Table 6) is
9000 adoption literature (Anderson et al. 1999,
unchanged by early/late designation. Corbett 2006), our results suggest any industry-wide
learning advantages related to process compliance for
late-certified plants (Ansari et al. 2010, Delmas and
H2, but examining a different “difference.” Here, Montiel 2008) were outweighed by the fact that early-
the objective was to determine if there is a statisti- certified plants are more likely to have been internally
cally significant difference between (1) the difference motivated to obtain certification.
in AvgNonComply before and after certification for Further, using longitudinal panel data, we found
certified plants and (2) the difference in AvgNon- decay in process compliance after certification (H3b),
Comply before and after their match’s certification especially among early-certified plants. This finding
for non-certified plants. This analysis casts certifica- is contrary to any expectations that changes made to
tion as a treatment and assesses the effect of this practices at the time of certification would prompt
treatment relative to an untreated matched plant. continual improvement of certification-related perfor-
We operationalized before-certification as the aver- mance over time (Ansari et al. 2010, Sun 1999). In
age of all inspections before certification and after aggregate, deterioration in process compliance
certification as in H1 and H2. Results of this analysis appears to dominate any experiential and deliberate
indicate moderate significance (p < 0.10). learning effects in these plants over time. Our empiri-
H3, which found support for deterioration in com- cal results demonstrate that the managerial difficulty
pliance over time, was tested considering only time and challenges of sustaining the operationally ori-
after certification. This approach does not assess ented gains of ISO 9000 certification over time are
whether certification affects the rate of decay. To widespread.
study this, we performed a supplemental analysis We now consider the placement of our research in
with the new independent variables of Days (days the context of existing literature that has examined
since December 31, 1993), Pre-Cert (whether the the effects of ISO 9000 on performance dimensions
inspection occurred before or after certification), and related to process compliance. As previously dis-
the interaction Days*Pre-Cert. As the start date is arbi- cussed, our study design (longitudinal, plant level,
trary from the standpoint of decay, it did not make matched sample, and focused on plant-level process
sense to take the log of Days. As expected, the coeffi- compliance) is unique to this literature (Boiral 2012).
cient for Pre-Cert is positive and significant, and the Our results indicate that previous cross-sectional
interaction of the two is negative and significant. studies, even when they consider time since certifica-
Taken together, these results indicate that (1) Non- tion, may face conflicting time-related effects leading
Comply, on average, is higher pre-certification than to inconsistent results. Specifically, cross-sectional

Table 8 Results of Supplemental Analyses Related to Post-Certification Time Period

Post-certification time period #Early cert #Early matches H1 #Late cert #Late matches n‡ H2
0–12 months 41 37 n.s. 56 53 187 n.s.
†
0–18 months 57 49 * 71 69 246
†
0–24 months 68 66 ** 85 81 300
†
0–36 months 79 80 114 102 375 n.s.
†
All post-certification inspections 107 109 n.s. 191 176 583
‡
n = sample size for difference-in-difference regression to test H2. It is the sum of all plants with data during the time period studied.
Gray, Anand, and Roth: IS0 9000 and Process Compliance
Production and Operations Management 24(3), pp. 369–382, © 2014 Production and Operations Management Society
studies are unable to disentangle the countervailing
positive performance effects of early certification with
the increased time to deteriorate since the earlier certi-
fication. For example, while two previous studies
included the year of certification as an independent
variable, they did not find it significantly related to
performance (Nair and Prajogo 2009, Prajogo 2011).
Their results may be attributed to any performance
benefits related to early certification decaying over
time post-certification. Two other studies explicitly
examined temporal issues and found significant
results. In a cross-sectional study, Naveh and Marcus
(2005) found that time since certification related to
better performance, which is opposite to our finding
related to H3b, but consistent with H1 and H2. As
their performance measurement was designed to
capture improvement in no more than five years after
certification, we infer that the decay effects in that
time frame (0–5 years since certification) were likely
dominated by the benefits of early certification. In
contrast, Karapetrovic et al. (2010) examined three
different samples at four-year intervals and found
declining benefits in each subsequent sample. As
Karapetrovic et al. (2010) examined independent
samples, and did not specifically include time since
certification, their observed decline in performance
is consistent with our two findings about late
certification and time since certification. Specifically,
each later sample would contain more late certifica-
tions as well as, presumably, greater average time
since certification.
7. Limitations, Future Research, and
Conclusion
As with all empirical research, this study has limita-
tions, some of which present opportunities for future
research. For example, the matching algorithm only
ensures that the pairs of plants are similar or identical
in publicly observable characteristics (and not
less-observable factors such as internal motivation,
top-management leadership, and competence of
employees). It is possible that plants seeking certifica-
tion and those not seeking certification differ in some
unobservable characteristics that affect process com-
pliance. There are two reasons to believe this is not
the case in our study. First, the certified and non-certi-
fied plants performed similarly in process compliance
before certification. Second, two phenomena were
observed, especially among early adopters: an
improvement in process compliance performance
(relative to matched plants) and then a decay in such
performance post certification. It is difficult to con-
struct an unobserved managerial characteristic that
explains both improvement and decay unrelated to
certification.
379
Another limitation is the coarse and noisy depen-
dent variable assessed infrequently for each plant. We
assert that our measure of process compliance is the
best widely available measure of the performance
dimension with which ISO 9000 is concerned. How-
ever, the FDA may sometimes examine more than just
compliance with procedures or focus only on part of a
facility. However, this “noise” should not bias our
results. A practical limitation discussed earlier is that
we were only able to obtain reliable data on the ISO
9000:1994 certifications because conversations with
registrars and database owners indicated that the
databases became unreliable soon after the 2000 stan-
dard was created. Further, our capacity to categorize
our plants as being component manufacturers and
final assemblers in the medical devices industry was
also limited by the data. This information could have
allowed us to study whether the certified and non-
certified plants differed based on the positions they
occupied in the supply chain.
This research has led to several salient opportuni-
ties for future research. If reliable data on certifica-
tions of plants from later ISO 9000 standards (2000
and 2008) could be found, it would be worthwhile to
determine whether these updated standards have
succeeded in enabling long-term improvements in
compliance. It would also be interesting to examine
longitudinally the long-term implications of other
management standard certifications on their primary
intended outcomes. Another potentially fruitful ave-
nue would be to combine more detailed plant-level
characteristics, such as factors related to the imple-
mentation process and/or managerial efforts post cer-
tification, and tie these to process compliance and its
sustainability.
In the context of medical device manufacturing,
our analysis of longitudinal data provides an assess-
ment of the effectiveness of ISO 9000 on quality-
related process compliance. While the results are not
encouraging for practitioners, they do provide
insights about the reliance on ISO 9000 certification.
Our research shows plants that obtained ISO 9000
certification, on average, outperformed similar plants
that did not under two conditions. First, the plants
were early seekers of certification. Second, the plants
were recently certified, as their heightened level of
process compliance appears to be rather short-lived,
on average. This research provides insights that have
implications for buyers’ sourcing strategies. Buyers
must be aware of the conditions under which certifi-
cation serves as a reliable “signal” of compliance
performance in their potential suppliers. Moreover,
to ensure compliance, buyers may need to incur
monitoring costs. Executives considering plant certi-
fication must be aware any improvement tends to
decay without renewal interventions. Thus, it is
 Gray, Anand, and Roth: IS0 9000 and Process Compliance
380 Production and Operations Management 24(3), pp. 369–382, © 2014 Production and Operations Management Society

important that operations managers maintain vigi- scoring system from Gray et al. (2011). Table A1 also
lance in their focus, resources, and systems to sustain provides subsequent adjustments made to normalize
(and possibly grow) process compliance in their the scores. Note that the grand mean of the entire
plants. To the literature, our research design pro- medical devices industry is 1.1014. The normalization
vides insights and empirical evidence that help factor, depicted in the last column of Table A1, is
explain the inconsistent results from cross-sectional computed as the grand mean [1.1014] divided by the
studies of ISO 9000 and provides a springboard for average inspection outcome of a given year. Thus,
future studies on management standard certification multiplying each observed inspection outcome in our
in other industries and contexts. sample by the given year’s normalization factor stan-
dardizes year-over-year inspections to the average
level of stringency in the FDA inspections of the given
Acknowledgments year. These normalized scores are the only scores
The authors would like to acknowledge the Fisher College used in all analyses and are labeled NonComply for a
of Business at The Ohio State University for providing fund- single inspection and AvgNonComply for the average
ing to enable part of the data collection effort. We are very of a set of inspections for a given time period.
grateful to Brett Massimino for his extensive work as a We now discuss robustness of our main results to
research assistant on this manuscript; and Sriram Venkatar- the use of non-normalized scores. The results for H1
aman at Clemson University for his research assistance. We
and H2 are substantively the same, whether we use
are also in debt to Mary Benner and Dirk Dusharme for
their assistance as discussed in section 4.1.2. We thank Mike
normalized or non-normalized FDA inspection out-
Toffel for providing a careful friendly read of an earlier come scores, as would be expected since both analyses
draft of this study. Finally, we thank several student work- compare approximately contemporaneous inspection
ers at Ohio State (Amber Hurley, Eric Nash, Xiao Yao, and outcomes of plants and their matched control plants.
Erika Randolph) for manual data entry and auditing. H3b was not robust (p = 0.12) using the AvgNonCom-
ply_nonadj dependent variable. It is not surprising that
Appendix: Normalization of NonComply evidence of decay was difficult to detect in the face of
the observed industry-wide downward trend in
Scores adverse inspection outcomes shown in Table A1,
Careful observation of the FDA inspection results especially when we consider the hypothesized rela-
indicate they became “better” (i.e., lower levels of tionship in H3b tracks decay from the date of certifica-
detected process non-compliance) over time, a finding tion to early 2007, possibly over 10 or more years.
also observed by Anand et al. (2012) in a pharmaceu-
tical industry study. In Table A1 we show the average
NonComply_nonadj, which is the average of all
non-normalized inspections in that year based on the References
Abadie, A., G. W. Imbens. 2006. Large sample properties of
matching estimators for average treatment effects. Econometrica
Table A1 Average Inspection Compliance and Normalization Factors 74(1): 235–267.
by Year Abrahamson, E. 1991. Managerial fads and fashions: The diffusion
and rejection of innovations. Acad. Manag. Rev. 16(3): 586–612.
Average of Normalization
* Adler, P. S., K. B. Clark. 1991. Behind the learning curve: A sketch
Year NonComply_nonadj factor† of the learning process. Manage. Sci. 37(3): 267–281.
1994 1.338 0.823 Anand, G., J. Gray, E. Siemsen. 2012. Decay, shock, and renewal:
1995 1.196 0.921 Operational routines and process entropy in the pharmaceuti-
1996 1.026 1.073 cal industry. Organ. Sci. 23(6): 1700–1716.
1997 1.117 0.986 Anderson, S. W., J. D. Daly, M. F. Johnson. 1999. Why firms seek
1998 1.191 0.925 ISO 9000 certification: Regulatory compliance or competitive
1999 1.174 0.938 advantage? Prod. Oper. Manag. 8(1): 28–43.
2000 1.197 0.920
Ansari, S. M., P. C. Fiss, E. J. Zajac. 2010. Made to fit: How prac-
2001 1.112 0.990 tices vary as they diffuse. Acad. Manag. Rev. 35(1): 67–92.
2002 1.068 1.032
Argyris, C., D. Sch€on. 1978. Organizational Learning. A Theory of
2003 0.968 1.138
Action Perspective. Addison Wesley, Reading, MA.
2004 1.023 1.076
2005 1.020 1.080 Barber, B. M., J. D. Lyon. 1996. Detecting abnormal operating per-
2006 0.999 1.103 formance: The empirical power and specification of test statis-
2007 1.010 1.090 tics. J. Financ. Econ. 41(3): 359–399.
Barratt, M., T. Choi. 2007. Mandated RFID and institutional
*NonComply_nonadj in a given year is based on the complete medical responses: Cases of decentralized business units. Prod. Oper.
device inspection data set (n = 25,373 inspections), not just plants used Manag. 16(5): 569–585.
in this study’s analysis. Benner, M. J. 2009. Dynamic or static capabilities? Process man-
†
Each inspection score in the given year is multiplied by this number to agement practices and response to technological change. J.
create the AvgNonComply used in all analyses. Prod. Innov. Manage 26(5): 473–486.
Gray, Anand, and Roth: IS0 9000 and Process Compliance
Production and Operations Management 24(3), pp. 369–382, © 2014 Production and Operations Management Society
Benner, M. J., M. Tushman. 2002. Process management and techno-
logical innovation: A longitudinal study of the photography
and paint industries. Adm. Sci. Q. 47(4): 676–707.
Benner, M. J., F. M. Veloso. 2008. ISO 9000 practices and financial
performance: A technology coherence perspective. J. Oper.
Manag. 26(5): 611–629.
Bernardo, M., M. Casadesus, S. Karapetrovic, I. Heras. 2012. Inte-
gration of standardized management systems: Does the
implementation order matter? Int. J. Oper. Prod. Manag. 32(3):
291–307.
Boiral, O. 2003. ISO 9000: Outside the iron cage. Organ. Sci. 14(6):
720–737.
Boiral, O. 2012. ISO 9000 and organizational effectiveness: A sys-
tematic review. Qual. Manage. J. 19(3): 16–37.
Boiral, O., N. Amara. 2009. Paradoxes of ISO 9000 performance –
A configurational approach. Qual. Manage. J. 16(3): 36–60.
Boiral, O., M.-J. Roy. 2007. ISO 9000: Integration rationales and
organizational impacts. Int. J. Oper. Prod. Manag. 27(2): 226–247.
Boyer, K. K. 1999. Evolutionary patterns of flexible automation and
performance: A longitudinal study. Manage. Sci. 45(6): 824–842.
Brown, A., T. van der Wiele, K. Loughton. 1998. Smaller enter-
prises’ experience with ISO 9000. Int. J. Qual. Reliab. Manag.
15(3): 273–285.
Casades
us, M., S. Karapetrovic. 2005. Has ISO 9000 lost some of
its lustre? A longitudinal impact study. Int. J. Oper. Prod.
Manag. 25(6): 580–596.
Chow-Chua, C., M. Goh, T. B. Wan. 2003. Does ISO 9000 certifica-
tion improve business performance? Int. J. Qual. Reliab.
Manag. 20(8): 936–953.
Cohen, W. M., D. A. Levinthal. 1990. Absorptive capacity: A new
perspective on learning and innovation. Adm. Sci. Q. 35(1):
128–152.
Corbett, C. J. 2006. Global diffusion of ISO 9000 certification
through supply chains. Manuf. Serv. Oper. Manag. 8(4): 330–350.
Corbett, C. J., M. J. Montes-Sancho, D. A. Kirsch. 2005. The finan-
cial impact of ISO 9000 certification in the United States: An
empirical analysis. Manage. Sci. 51(7): 1046–1059.
Curkovic, S., R. Handfield. 1996. Use of ISO 9000 and Baldrige
award criteria in supplier quality evaluation. J. Supply Chain
Manag. 32(2): 2–11.
Delmas, M. A., I. Montiel. 2008. The diffusion of voluntary inter-
national management standards: Responsible care, ISO 9000,
and ISO 14001 in the chemical industry. Policy Stud. J. 36(1):
65–93.
Dick, G. P. M., I. Heras, M. Casades
us. 2008. Shedding light on
causation between ISO 9001 and improved business perfor-
mance. Int. J. Oper. Prod. Manag. 28(7): 687–708.
Docking, D. S., R. J. Dowen. 1999. Market interpretation of ISO
9000 registration. J. Financ. Res. 22(2): 147–60.
Dreyfus, L. P., S. L. Ahire, M. Ebrahimpour. 2004. The impact of
just-in-time implementation and ISO 9000 certification on total
quality management. IEEE Trans. Eng. Manage. 51(2): 125–141.
FDA. 2012a. Available at http://www.fda.gov/RegulatoryInfor-
mation/Legislation/FederalFoodDrugandCosmeticActFDC-
Act/FDCActChaptersIandIIShortTitleandDefinitions/ucm086297.
htm (accessed date February 9, 2012).
FDA. 2012b. Available at http://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1
(accessed date February 9, 2012).
Giffi, C., A. Roth, G. Seal. 1990. Competing in World Class Manufac-
turing, Business One Irwin, Homewood, IL.
Gray, J. V., A. V. Roth, M. J. Leiblein. 2011. Quality risk in off-
shore manufacturing: Evidence from the pharmaceutical
industry. J. Oper. Manag. 29(7–8): 737–752.
381
H€aversj€
o, T. 2000. The financial effects of ISO 9000 registration for
Danish companies. Manag. Auditing J. 15(1/2): 47–52.
Hendricks, K. B., V. R. Singhal. 2001. The long-run stock price
performance of firms with effective TQM programs. Manage.
Sci. 47(3): 359–368.
Heras, I., G. P. M. Dick, M. Casades
us. 2002. ISO 9000 registra-
tion’s impact on sales and profitability: A longitudinal analy-
sis of performance before and after accreditation. Int. J. Qual.
Reliab. Manag. 19(6): 774–791.
Hill, T. J., R. M. G. Duke-Woolley. 1983. Progression or regression
in facilities focus. Strateg. Manag. J. 4(2): 109–121.
de Holan, P. M., N. Phillips. 2004. Remembrance of things past?
The dynamics of organizational forgetting. Manage. Sci. 50(11):
1603–1613.
ISO. 2009. Selection and Use of the ISO 9000 Family of Standards.
ISO, Geneva.
Ivanova, A., J.V. Gray, K.K. Sinha. 2014. Towards a unifying the-
ory of management standard implementation: The case of ISO
9001/ISO 14001. Int. J. Oper. Prod. Manag 34(10): 1269–1306.
Iyer, A., H. Saranga, S. Seshadri. 2013. Effect of quality manage-
ment systems and total quality management on productivity
before and after: Empirical evidence from the Indian auto
component industry. Prod. Oper. Manag. 22(2): 283–301.
Jones, R., G. Arndt, R. Kustin. 1997. ISO 9000 among Australian
companies, Impact of time and reasons for seeking certifica-
tion on perceptions of benefits received. Int. J. Qual. Reliab.
Manag. 14(7): 650–660.
Karapetrovic, S., M. C. Fa, I. H. Saizarbitoria. 2010. What hap-
pened to the ISO 9000 lustre? An eight-year study. Total Qual.
Manag. Bus. Excellence 21(3): 245–267.
Katz, D., R. L. Kahn. 1978. The Social Psychology of Organizations,
2nd edn. John Wiley & Sons, New York, NY.
Kennedy, P. 2008. A Guide to Econometrics, 6th edn. Blackwell Pub-
lishing, Malden, MA.
Ketokivi, M. A., R. G. Schroeder. 2004. Strategic, structural contin-
gency and institutional explanations in the adoption of inno-
vative manufacturing practices. J. Oper. Manag. 22(1): 63–89.
King, G., R. Nielson, C. Coberley, J. E. Pope, A. Wells. 2010. Com-
parative effectiveness of matching methods for causal infer-
ence. Working Paper, Harvard University.
Knott, A. M. 2001. The dynamic value of hierarchy. Manage. Sci.
47(3): 430–448.
Lapr
e, M. A., A. S. Mukherjee, L. N. Van Wassenhove. 2000.
Behind the learning curve: Linking learning activities to waste
reduction. Manage. Sci. 46(5): 597–611.
Lee, S.-Y., R. D. Klassen. 2008. Drivers and enablers that foster
environmental management capabilities in small and med-
ium-sized suppliers in supply chains. Prod. Oper. Manag.
17(6): 573–586.
Lenox, M., A. King. 2004. Prospects for developing absorptive
capacity through internal information provision. Strateg.
Manag. J. 25(4): 331–345.
Levine, D. I., M. W. Toffel. 2010. Quality management and job
quality: How the ISO 9001 standard for quality management
systems affects employees and employers. Manage. Sci. 56(6):
978–996.
Lo, C. K. Y., A. C. L. Yeung, T. C. E. Cheng. 2009. ISO 9000 and
supply chain efficiency: Empirical evidence on inventory and
account receivable days. Int. J. Prod. Econ. 118(2): 367–374.
Lo, C. K. Y., F. Wiengarten, P. Humphreys, A. C. L. Yeung, T. C.
E. Cheng. 2013. The impact of contextual factors on the effi-
cacy of ISO 9000 adoption. J. Oper. Manag. 31(5): 229–235.
Mart
ınez-Costa, M., T. Y. Choi, J. A. Mart
ınez, A. R. Mart
ınez-
Lorente. 2009. ISO 9000/1994, ISO 9001/2000 and TQM:

382 Production and Operations Management 24(3), pp. 369–382, © 2014 Production and Operations Management Society
The performance debate revisited. J. Oper. Manag. 27(6):
495–511.
Nair, A., D. Prajogo. 2009. Internalisation of ISO 9000 standards:
The antecedent role of functionalist and institutionalist driv-
ers and performance implications. Int. J. Prod. Res. 47(16):
4545–4568.
Naveh, E., M. Erez. 2004. Innovation and attention to detail in
the quality improvement paradigm. Manage. Sci. 50(11):
1576–1586.
Naveh, E., A. A. Marcus. 2004. When does the ISO 9000 quality assur-
ance standard lead to performance improvement? Assimilation
and going beyond. IEEE Trans. Eng. Manage. 51(3): 352–363.
Naveh, E., A. Marcus. 2005. Achieving competitive advantage
through implementing a replicable management standard:
Installing and using ISO 9000. J. Oper. Manag. 24(1): 1–26.
Naveh, E., A. Marcus. 2007. Financial performance, ISO 9000 stan-
dard and safe driving practices effects on accident rate in the
U.S. motor carrier industry. Accid. Anal. Prev. 39(4): 731–742.
Naveh, E., A. Marcus, H. K. Moon. 2004. Implementing ISO 9000:
Performance improvement by first or second movers. Int. J.
Prod. Res. 42(9): 1843–1863.
Nelson, R. R., S. G. Winter. 1982. An Evolutionary Theory of Eco-
nomic Change. Harvard University Press, Cambridge, MA.
Pil, F. K., J. P. MacDuffie. 1996. The adoption of high-involvement
work practices. Industrial Relations 35(3): 423–455.
Podsakoff, P. M., S. B. MacKenzie, J. Y. Lee, N. P. Podsakoff.
2003. Common method biases in behavioral research: A criti-
cal review of the literature and recommended remedies. J.
Appl. Psychol. 88(5): 879–903.
Prajogo, D. I. 2011. The roles of firms’ motives in affecting the
outcomes of ISO 9000 adoption. Int. J Oper. Prod. Manag.
31(1): 78–100.
Rogers, W. H. 1993. Regression standard errors in clustered sam-
ples. Stata Tech. Bull. 13: 19–23.
Rosenbaum, P. R., D. B. Rubin. 1983. The central role of the
propensity score in observational studies for causal effects.
Biometrika 70(1): 41–55.
Schroeder, R. G., K. Linderman, D. Zhang. 2005. Evolution of
quality: First fifty issues of Production and Operations Man-
agement. Prod. Oper. Manag. 14(4): 468–481.
Sharma, D. S. 2005. The association between ISO 9000 certification
and financial performance. Int. J. Account. 40(2): 151–172.
Siemsen, E., A. Roth, P. Oliveira. 2010. Common method bias in
regression models with curvilinear, quadratic and interaction
effects. Organ. Res. Methods 13(3): 456–476.
Simmons, B. L., M. A. White. 1999. The relationship between ISO
9000 and business performance: Does registration really
matter? J. Manag. Issues 11(3): 330–343.
Gray, Anand, and Roth: IS0 9000 and Process Compliance
Simon, H. 1957. A behavioral model of rational choice. H.A.
Simon, ed. Models of Man, Social and Rational Mathematical
Essays on Rational Human Behavior in a Social Setting. Wiley,
New York, NY, 241–260.
Singels, J., G. Ruel, H. van de Water. 2001. ISO 9000 series – Certifi-
cation and performance. Int. J. Qual. Reliab. Manag. 18(1): 62–75.
Singh, P. J. 2008. Empirical assessment of ISO 9000 related man-
agement practices and performance relationships. Int. J. Prod.
Econ. 113(1): 40–59.
Singh, P. J., D. Power, S. C. Chuong. 2011. A resource dependence
theory perspective of ISO 9000 in managing organizational
environment. J. Oper. Manag. 29(1): 49–64.
Sterman, J. D., N. P. Repenning, F. Kofman. 1997. Unanticipated
side effects of successful quality programs: Exploring a
paradox of organizational improvement. Manage. Sci. 43(4):
503–521.
Sun, H. 1999. Diffusion and contribution of total quality manage-
ment: An empirical study in Norway. Total Qual. Manag. 10(6):
901–914.
Terlaak, A., A. A. King. 2006. The effect of certification with the
ISO 9000 quality management standard: A signaling
approach. J. Econ. Behav. Organ. 60(4): 579–602.
Terziovski, M., D. Samson, D. Dow. 1997. The business value of
quality management systems certification. Evidence from
Australia and New Zealand. J. Oper. Manag. 15(1): 1–18.
Terziovski, M., D. Power, A. S. Sohal. 2003. The longitudinal
effects of the ISO 9000 certification process on business per-
formance. Eur. J. Oper. Res. 146(3): 580–595.
Uzumeri, M. V. 1997. ISO 9000 and other metastandards: Princi-
ples for management practice? Acad. Manage. Executive 11(1):
21–36.
Wayhan, V. B., E. T. Kirche, B. M. Khumawala. 2002. ISO 9000
certification: The financial performance implications. Total
Qual. Manag. 13(2): 217–231.
Westphal, J. D., E. J. Zajac. 1994. Substance and symbolism in
CEOs’ long-term incentive plans. Adm. Sci. Q. 39(3): 367–390.
Westphal, J. D., R. Gulati, S. M. Shortell. 1997. Customization of
conformity? An institutional and network perspective on the
content and consequences of TQM adoption. Adm. Sci. Q.
42(2): 366–394.
Wooldridge, J. M. 2009. Introductory Econometrics: A Modern
Approach, 4th edn. South-Western, Mason, OH.
Yeung, A. C. L., C. K. Y. Lo, T. C. E. Cheng. 2011. Behind the iron
cage: An institutional perspective on ISO 9000 adoption and
CEO compensation. Organ. Sci. 22(6): 1600–1612.
Zhang, G. P., Y. Xia. 2013. Does quality still pay? A reexamination
of the relationship between effective quality management and
firm performance. Prod. Oper. Manag. 22(1): 120–136.