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FEATURED BOOK

Featured Book


MASTERING SAFETY RISK MANAGEMENT FOR MEDICAL AND IN VITRO DEVICES

Jayet Moon; Arun Mathew, May 2024



When it comes to medical and in vitro devices, risk management starts with a
design assurance process that helps practitioners identify, understand, analyze,
and mitigate the risks of the healthcare product design for favorable
benefit-risk assessment. Risk management actively follows the product’s life
cycle into production and post-market phases. Mastering Safety Risk Management
for Medical and In Vitro Devices offers a blueprint for implementing an
effective risk management system. It provides risk management tools and a
compliance framework for methods in conformance to ISO 13485:2016, ISO
14971:2019, European Union MDR, IVDR, and U.S. FDA regulations (including the
new FDA QMSR).

Jayet Moon, CQE, CQIA, and CQSP, has a M.S. in biomedical engineering, a B.S. in
electrical engineering, an MBA degree, and is a PMI-RMP, CQI Chartered Quality
Professional, ERMCP, and RIMS-CRMP. Moon was awarded the Australian Organization
for Quality ‘Passion for Excellence’ Award and was recognized in 2021 as an ASQ
‘40 under 40’ Rising Star. He is a Fellow of International Institute for Safety
and Risk Management (FIIRSM) and an industry expert on safety and post-market
surveillance. He authored several articles and the Quality Press book,
Foundations of Quality Risk Management (2020).

Arun Mathew, CQA, CQE, is the Quality System Owner for Quality Risk Management
for AbbVie, Inc. Arun earned an Executive MBA from the Quantic School of
Business Technology and a master’s degree from Coventry University in addition
to a diploma in electronics. With over 20 years of experience in the medical
devices and pharmaceutical industries, Arun has pioneered risk-based approaches
in design control, verification and validation, process validation, CAPA, and
other quality management systems within organizations. He won the 2022 ASQ
Delaware J.M. Juran Award for achievements in quality risk management.




MEMBER PRICE: $49.00

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NEW TO THE STORE

Book


MASTERING SAFETY RISK MANAGEMENT FOR MEDICAL AND IN VITRO DEVICES (EBOOK)

When it comes to medical and in vitro devices, risk management starts with a
design assurance process that helps practitioners identify, understand, analyze,
and mitigate the risks of the healthcare product design for favorable
benefit-risk assessme...

Member Price: $49.00
List Price: $70.00

Full Details
Book


MASTERING SAFETY RISK MANAGEMENT FOR MEDICAL AND IN VITRO DEVICES

When it comes to medical and in vitro devices, risk management starts with a
design assurance process that helps practitioners identify, understand, analyze,
and mitigate the risks of the healthcare product design for favorable
benefit-risk assessme...

Member Price: $49.00
List Price: $70.00

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QUALITY RISK MANAGEMENT IN THE FDA-REGULATED INDUSTRY, THIRD EDITION (EBOOK)

For quality professionals and manufacturers in the food safety and medical
device industries, risk management is essential to ensuring organizations meet
FDA regulations and requirements. Without these recognized standards, the lives
of consumers ar...

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QUALITY RISK MANAGEMENT IN THE FDA-REGULATED INDUSTRY, THIRD EDITION

For quality professionals and manufacturers in the food safety and medical
device industries, risk management is essential to ensuring organizations meet
FDA regulations and requirements. Without these recognized standards, the lives
of consumers ...

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BEST SELLERS

Standard


ASQ/ANSI/ISO 9001:2015: QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS

The ISO 9001 standard specifies requirements for quality management systems. All
requirements of ASQ/ANSI/ISO 9001:2015, the American National Standard (ANS)
version of ISO 9001, are generic and are intended to be applicable to all
organizations.

Member Price: $156.00
List Price: $194.00

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ROOT CAUSE ANALYSIS, SECOND EDITION (EBOOK)

This best-seller can help anyone whose role is to try to find specific causes
for failures. It provides detailed steps for solving problems, focusing more
heavily on the analytical process involved in finding the actual causes of
problems. It does...

Member Price: $42.00
List Price: $60.00

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Standard


ASQ/ANSI/ISO 19011:2018: GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS

Also available as a PDF e-standard. This document provides guidance on auditing
management systems, including the principles of auditing, managing an audit
programme and conducting management system audits, as well as guidance on the
evaluation...

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NEW RELEASES!

 Zero Acceptance Number Sampling Plans, Sixth Edition (H1607)
The ASQ Certified Quality Engineer Study Guide, Second Edition (H1601) 
The ASQ Certified Supplier Quality Professional Handbook, Second Edition (H1605)
The ASQ Certified Six Sigma Black Belt Study Guide, Second Edition (H1600) 
The Quality Toolbox, Third Edition (H1592)
NEW! Mastering Safety Risk Management by Jayet Moon and Arun Matthew (H1641)
Quality Risk Management in the FDA-Regulated Industry, Second Edition (H1636)

 


COMING SOON TO QUALITY PRESS  

2024 Releases:

Certification Products
The ASQ Certified Pharmaceutical GMP Handbook, Third Edition
The ASQ Certified Six Sigma Green Belt Study Guide, Second Edition (H1604)
The ASQ Certified Software Quality Engineer Handbook, Third Edition
The ASQ Certified Quality Technician Handbook, Fourth Edition

ASQ Products
NEW! Leading a Quality Organization: Supercharging From Your Core
Remote Auditing Fundamentals Pocket Guide (formerly "e-Auditing Fundamentals")
The Internal Auditing Pocket Guide, Third Edition



2025 Releases:

ASQ Products
NEW! Lean Six Sigma Pocket Guide for Young Professionals
NEW! Implementing Quality 4.0 from the Ground Up



Certification Products
The ASQ Certified Supplier Quality Professional Study Guide, Second Edition
The ASQ Certified Quality Inspector Handbook, Fourth Edition
The ASQ Certified Reliability Engineer Handbook, Fourth Edition
NEW! The ASQ Certified Construction Manager Handbook


2026 Releases:

ASQ Products
TQM: Introduction to and Overview of Total Quality Management, Second Edition

Certification Products


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Standard


ISO14017:2022 ENVIRONMENTAL MANAGEMENT - REQUIREMENTS WITH GUIDANCE FOR
VERIFICATION AND VALIDATION OF WATER STATEMENTS

This document specifies principles, requirements and guidelines for the
verification and validation of water statements. It is applicable to
organizational, product and project water statement verification and validation,
and can also be used to p...

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CREATING A CUSTOMER-CENTERED CULTURE

Customers demand and expect nothing less than great service, but try to get ten
employees to agree on what great service means and you’ll find the definition to
be elusive. Even though few of us personally make widgets, most change
management and qua...

Member Price: $15.00
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Book


COACHING GREEN BELT PROJECTS FOR SUSTAINABLE SUCCESS

Six Sigma Green Belts need support in applying new skills after training, yet
there is little research about how this works and even less advice about what
support looks like in the field. This book is that missing link in providing
coaching tips to ...

Member Price: $42.00
List Price: $60.00

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Standard


ISO 14030-3:2022 ENCIRONMENTAL PERFORMANCE EVALUATION - GREEN DEBT INSTRUMENTS -
PART 3: TAXONOMY

This document defines a taxonomy of eligible investment categories for
designation as green debt instruments, including bonds and loans. This document
categorizes economic sectors and establishes criteria for determining the
eligibility of projects,...

Member Price: $278.00
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Standard


ISO 14015:2022 ENVIRONMENTAL MANAGEMENT - GUIDELINES FOR ENVIRONMENTAL DUE
DILIGENCE ASSESSMENT

This document gives guidance on how to conduct an environmental due diligence
(EDD) assessment through a systematic process of identifying environmental
aspects, issues and conditions as well as determining, if appropriate, their
business consequence...

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Standard


ISO 16355-7:2023 APPLICATIONS OF STATISTICAL AND RELATED METHODS TO NEW
TECHNOLOGY AND PRODUCT DEVELOPMENT PROCESSES - PART 7: GUIDELINES FOR DEVELOPING
DIGITALIZED PRODUCTS AND SERVICES - GENERAL PRINCIPLES AND PERSPECTIVES FOR THE
QFD METHOD

The current ISO 16355 series is written intentionally independent of industry
because the principles of applying statistical methods for product and
technology development are similar for all types of products. However, when
applying the standard f...

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Standard


ISO TR 14055-2:2022 ENVIRONMENTAL MANAGEMENT — GUIDELINES FOR ESTABLISHING GOOD
PRACTICES FOR COMBATTING LAND DEGRADATION AND DESERTIFICATION — PART 2: REGIONAL
CASE STUDIES

This document provides regional case studies of good practices in land
management to prevent or minimize land degradation and desertification in
support of ISO 14055-1:2017. The case studies are presented to facilitate the
application of ISO 14055...

Member Price: $250.00
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Standard


ISO TS 14074:2022 ENVIRONMENTAL MANAGEMENT - LIFE CYCLE ASSESSMENT - PRINCIPLES,
REQUIREMENTS AND GUIDELINES FOR NORMALIZATION, WEIGHTING AND INTERPRETATION

This document specifies principles, requirements and guidelines for
normalization, weighting and life cycle interpretation, in addition to those
given in ISO 14040 and ISO 14044.   The document is applicable to any life cycle
assessment (LC...

Member Price: $124.00
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Standard


ISO TS 14029:2022 ENVIRONMENTAL STATEMENTS AND PROGRAMMES FOR PRODUCTS - MUTUAL
RECOGNITION OF ENVIRONMENTAL PRODUCT DECLARATIONS (EPDS) AND FOOTPRINT
COMMUNICATION PROGRAMMES

This document specifies requirements for mutual recognition arrangements (MRAs)
and gives guidance on how to initiate developments on MRAs between environmental
product declaration (EPD) and footprint communication programme operators. It
addresses a...

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Standard


ISO TS 23471:2022 EXPERIMENTAL DESIGNS FOR EVALUATION OF UNCERTAINTY - USE OF
FACTORIAL DESIGNS FOR DETERMINING UNCERTAINTY FUNCTIONS

This document specifies experimental procedures and statistical analysis for the
determination of measurement uncertainty in situations where the following
conditions are fulfilled: Condition 1: The level of the measurand is
non-negative, e.g. co...

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Standard


ISO 14020:2022 ENVIRONMENTAL STATEMENTS AND PROGRAMMES FOR PRODUCTS - PRINCIPLES
AND GENERAL REQUIREMENTS

This document establishes principles and specifies general requirements that are
applicable to all types of product-related environmental statements and
environmental statement programmes. Environmental statements result from
environmental statemen...

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Standard


ISO 14083:2023 GREENHOUSE GASES - QUANTIFICATION AND REPORTING OF GREENHOUSE GAS
EMISSIONS ARISING FROM TRANSPORT CHAIN OPERATIONS

The self-assessment approach described in this report provides a simple and
easy-to-use approach to determine the maturity of a QMS and to identify the main
areas for management to consider for improvement. It is not a substitute for
internal audit...

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Standard


ISO 14093:2022 MECHANISM FOR FINANCING LOCAL ADAPTATION FOR CLIMATE CHANGE -
PERFORMANCE-BASED CLIMATE RESILIENCE GRANTS - REQUIREMENTS AND GUIDELINES

This document establishes an approach and methodology for a country-based
mechanism to channel climate finance to subnational authorities to support
climate change adaptation and to increase local resilience thereby contributing
to the achievement of...

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Standard


ISO 7870-2:2023 CONTROL CHARTS - PART 2: SHEWHART CONTROL CHARTS

This document establishes a guide to the use and understanding of Shewhart
control chart approach to the methods for statistical control of a process. This
document is limited to the treatment of statistical process control methods
using only Shewhar...

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Standard


ISO TR 11462-4:2022 GUIDELINES FOR IMPLEMENTATION OF STATISTICAL PROCESS CONTROL
- PART 4: REFERENCE DATA SETS FOR MEASUREMENT PROCESS ANALYSIS SOFTWARE
VALIDATION

This document describes examples for software validation for software
implementing the standards of ISO 22514‑7 on the capability of measurement
processes. In detail, the following standards are covered: —    ISO 22514‑7. It
pro...

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Standard


ASQ/ANSI/ISO 14004:2016 ENVIRONMENTAL MANAGEMENT SYSTEMS — GENERAL GUIDELINES ON
IMPLEMENTATION

ISO 14004:2016 provides guidance for an organization on the establishment,
implementation, maintenance and improvement of a robust, credible and reliable
environmental management system. The guidance provided is intended for an
organization seeking t...

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Standard


ASQ Z1 TR1:2022 GUIDELINES FOR PERFORMING A SELF-ASSESSMENT OF A QUALITY
MANAGEMENT SYSTEM

Publication of this Technical Report registered with the American National
Standards Institute (ANSI) has been approved by an accredited standards
developer—the American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Milwaukee, WI 53203, US...

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STRUCTURING YOUR ORGANIZATION FOR INNOVATION

Organizations face many ongoing challenges, which can lead to restructuring— an
expensive, disruptive solution that doesn’t always offer successful outcomes or
better results. As a business leader in a competitive environment, you must
fi...

Member Price: $21.00
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ISO 56000 BUILDING AN INNOVATION MANAGEMENT SYSTEM

Innovation management can provide a competitive edge in the business world, and
research shows a major correlation between profitability and innovation. The
challenge, however, is how to integrate innovation management with quality
management. Enter ...

Member Price: $42.00
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STRUCTURING YOUR ORGANIZATION FOR INNOVATION (EBOOK)

Organizations face many ongoing challenges, which can lead to restructuring— an
expensive, disruptive solution that doesn’t always offer successful outcomes or
better results. As a business leader in a competitive environment, you must
fi...

Member Price: $21.00
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MAKING CHANGE WORK (EBOOK)

As organizations strive to remain ahead of the competition, there will
inevitably and often come the need for change. All successful organizations
regularly use change to improve processes and increase performance. While these
times of change can be ...

Member Price: $24.50
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COACHING GREEN BELT PROJECTS FOR SUSTAINABLE SUCCESS (EBOOK)

Six Sigma Green Belts need support in applying new skills after training, yet
there is little research about how this works and even less advice about what
support looks like in the field. This book is that missing link in providing
coaching tips to ...

Member Price: $42.00
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Book


F-NOTES (EBOOK)

There are many occasions when a project leader will preside over a team meeting
that ends up falling short of the desired outcomes. Entering a room full of
people who are expecting you to guide them to results can be a source of
tremendous pressure, ...

Member Price: $28.00
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TRANSFORMATIONAL LEADERSHIP (EBOOK)

Transformational Leadership is an e-book to guide organizational transformation,
while delivering breakthrough results. Shop ASQ's bookstore for discounts!

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THE ASQ SUPPLY CHAIN MANAGEMENT PRIMER (EBOOK)

Written to promote the application of basic and sound supply chain management
principles, the author and contributors wrote this book for a global audience of
practitioners and their managers. In this book, accepted methods used in
national and inter...

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MAKING CHANGE WORK

Making Change Work is designed to help organizations prepare for and
successfully implement change. This resource provides tools to measure your
organization's readiness to change while effectively increasing performance.

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PROCESS QUALITY CONTROL (EBOOK)

Ellis Ott taught generations of quality practitioners to be explorers of the
truth through the collection and graphical portrayal of data. From a simple plea
to "plot the data" to devising a graphical analytical tool called the analysis
of means (AN...

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THE AS9100C, AS9110, AND AS9120 HANDBOOK

The AS9100C, AS9110 & AS9120 Handbook discusses of each of the 3 standards’
clauses, & suggests best practices to comply with them. Shop ASQ for discounts!

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