Auditor Listing
Leigh Andrew Brand
- Name: Leigh Andrew Brand
- Email: lbrand@bcgiso.com
- Phone Number: 561-408-1698
- Location: New York
- Standards: ISO 9001
Twenty-two years of experience promoting operational excellence within small and large private sector businesses and US government departments and agencies. Consulted, trained, and audited organizations in a diverse group of industries including basic steel making, plastics, respirator manufacturing, chemical processing, healthcare compliance and healthcare providers, hospitals, real estate management, food and drug manufacturing, food safety and grading, information technology, medical devices, clinical studies, software developers, automotive, service providers including contract management, banking, cashiering, disbursements, payroll, and payment processing, shipping and customs, logistics management, IT customer service, help desk support and call centers, telephone operations, facility maintenance, human resources, architecture and design, munitions, and environmental management. Expert in trouble shooting, root cause analysis, and problem solving under difficult and stressful circumstances. Expert in curriculum development.
Developed and provided training to more than 7,000 people, as well as, auditing, and consulting services to clients on six continents and twenty-six countries including: North America-United States, Canada, and Mexico, South America-Colombia, Ecuador, Chile, and Brazil, Africa-Senegal and South Africa, Europe-France, England, Denmark, Germany, Italy, Sweden, Poland, and Czechoslovakia, Asia-Ukraine, China, Japan, India, and South Korea, Australia-Australia and New Zealand.
Specialties: Quality Assurance, Operational Excellence, ISO 9001, AS 9100/9110, Lean Six Sigma, ISO 14001, ISO 22001, ISO 15378, ISO 27001, US FDA cGMP’s, CE Marking, SA 8000, TL 9000, Capability Maturity Model
Integration (CMMI), TS 16949, 42 CFR 84, 21 CFR 210 and 211, Malcolm Baldrige Award, OHSAS 18001, and ITIL, training, auditing, and consulting, private equity operational due diligence and operational excellence implementation, government contracting.
EXPERIENCE
President
Third party certification body for international standards including: ISO 9001, AS 9100/9110, ISO 14001, ISO 22001,
ISO 27001, ISO 15378, SA 8000, TL 9000, TS 16949, and OHSAS 18001. Clients include US Department of Veterans
Affairs, Energy, Defense, and Walter Reed Medical Center. Client focus is on military and government departments and
agencies along with the private sector contractors servicing these groups. Geographic coverage is worldwide.
GMCS is accredited by the International Accreditation Service (IAS). IAS is a nonprofit, public-benefit corporation that
has been providing accreditation services since 1975. It is a member of Asia-Pacific Laboratory Accreditation
Cooperation (APLAC), International Laboratory Accreditation Cooperation (ILAC), International Accreditation Forum
(IAF), and the Pacific Accreditation Cooperation (PAC).
Chairman and Founder
Chairman and Founder of an operational excellence management consulting firm specializing in the implementation of
industry and global standards and best practices in both private sector and government and military organizations
utilizing training, auditing, and consulting techniques. One of the only consulting firms that is ISO 9001 registered
itself.
Clients include US Departments of Defense, Transportation, Treasury, Homeland Security, Veterans Affairs, Energy,
Interior, State, Health and Human Services and Agriculture, Postal Service, NYC Metropolitan Transit Authority,
Federal Reserve Bank, United Nations, National Transportation Safety Board, Particle Technology Labs, KS Bearings,
Island Peer Review Organization, Cellomics, Cerilliant, Agribuys, Von Roll America/WTI, Metamorphic Surgical
Devices, Simplot, Con Edison, POMS Corporation, Intellisys Technology Corporation, Steris Corporation, FirstMiss Steel,
NEW YORK UNIVERSITY 1991 – 1993
BOSTON UNIVERSITY 1987 – 1991
FOX CHAPEL HIGH SCHOOL 1983 – 1987
CERTIFIED QUALITY MANAGEMENT SYSTEM LEAD AUDITOR 03 / 1995
ASQ SENIOR MEMBER 01 / 1995
LEAN SIX SIGMA MASTER BLACK BELT (PENDING)
PRIVATE PILOT 08 / 1999
KRAV MAGA ORANGE BELT 09 / 2011
Automated Liquid Packaging, International Filler Corporation, The Valspar Corporation, Tissue International, Georgia
Tissue Bank, Insituform East, Unique Pharmaceuticals, Rozinn Electronics, Allegheny Performance Plastics, WMMC,
New Brunswick Scientific, ManTech, The Solar Group, IBM, and GM.
Organizations audited against industry standards on behalf of clients include: 3M, Draeger AG, Air Ace Oy, Avon
Technical Products, Camlock (UK) , Interspiro, Respirex, Scott Health and Safety, Sundstrom Safety, MSA, Japan
Vilene, San M Packaging, Alpha Pro Tech,Safety Equipment Australia, RPB Safety, Maco Pharma, Supplied Air
Monitoring Systems, Inc., Sata-Farbspritz, Shigematsu, Koken, Masprot, Nitta, Aearo Safety, Avox, Honeywell, Louis M.
Gerson Co. Inc., and Venus Safety.
Leigh Brand has personally conducted more than 150 accredited ISO 9001 Lead Auditor Courses, and conducted more
than 150 third party audits on behalf of the National Institute of Occupational Safety and Health against 42 CFR 84 on
6 continents and 30 countries around the world.
EDUCATION
Master of Arts (M.A.) , Communications
Bachelor of Arts (B.A.) , Political Science
President, Alpha Epsilon Pi Vice President Student Affairs Rugby Football Club President Interfraternity Sorority Council
Scarlet Key Award Recipient Dean’s List
INTERESTS
Cycling, Skiing, Scuba Diving, Pilot, Hiking, Wine, Cooking, History, Travel, Music, Theater, Politics, Education
ASSOCIATIONS
American Society of Quality, International Registry of Certificated Auditors
CERTIFICATIONS
International Registry of Certificated Auditors (IRCA) · License: A008984
American Society of Quality (ASQ)
Federal Aviation Administration
Krav Maga Association of America and Krav Maga Alliance
ADVANCED DIVER 03 / 1991
HARMONIZING THE MEDICAL DEVICE DIRECTIVE, CURRENT GOOD MANUFACTURING PRACTICES, AND ISO
9001
03 / 2000
MUTUAL RECOGNITION AGREEMENTS 11 / 2001
ISO 9001 EXECUTIVE OVERVIEW COURSE 01 / 1995
ISO 9001 IMPLEMENTATION COURSE 01 / 1995
ISO 9001 INTERNAL AUDITOR COURSE 01 / 1995
ISO 9001 IN HEALTHCARE EXECUTIVE OVERVIEW 10 / 2007
ISO 9001 V AS 9110 EXECUTIVE OVERVIEW COURSE 05 / 2008
PROCESS MAPPING AND MANAGEMENT 06 / 2006
Professional Association of Diving Instructors (PADI)
LANGUAGES
English ( Native or bilingual proficiency )
French ( Elementary proficiency )
PUBLICATIONS
Journal of cGMP Compliance · Authors: Leigh Andrew Brand, Allen Bailey · http://www.ivtnetwork.com/
Article describing method of developing a single Quality Management System meeting the requirements of ISO 9001,
the European Union Medical Device Directive, and US FDA Current Good Manufacturing Standards.
Journal of cGMP Compliance · Authors: Leigh Andrew Brand, Allen Bailey · http://www.ivtnetwork.com/
Article describing the forthcoming Agreements between the US and EU with respect to medical devices and other
regulated products.
Brand Consulting Group, Inc. · Authors: Leigh Andrew Brand, Arthur E. Fitch, Carl V. Scheuplein
Executive Level Course designed to introduce participants to the ISO 9001 standard. Participants are C-Level and
executive management who desire a quick (2-4 hour) overview of the requirements of the ISO 9001 standard and how
the implementation of the standard will benefit their organization.
Brand Consulting Group, Inc. · Authors: Leigh Andrew Brand, Arthuer E. Fitch, Carl V. Scheuplein
Two (2) Day Seminar on how to implement the ISO 9001 standard within one’s own organization.
Brand Consulting Group, Inc. · Authors: Leigh Andrew Brand
Three (3) Day course designed to train individuals on how to conduct Internal Audits in accordance with ISO 19011
Guidelines for Auditing Environmental and Quality Management Systems.
Brand Consulting Group, Inc. · Authors: Leigh Andrew Brand
Introductory course on the applicability of ISO 9001 in a healthcare environment.
Brand Consulting Group, Inc. · Authors: Leigh Andrew Brand, Carl V. Scheuplein
Executive Overview on the differences between ISO 9001 and AS 9110.
Brand Consulting Group, Inc. · Authors: Leigh Andrew Brand
CORRECTIVE ACTION AND ROOT CAUSE ANALYSIS 06 / 2009
Two (2) day interactive seminar on mapping processes and the critical control points associated with process
management.
Brand Consulting Group, Inc. · Authors: Leigh Andrew Brand
Seminar on problem-solving using the 5 WHY technique and how to develop good corrective action plans designed to
prevent recurrence of nonconformances and customer complaints.
ISO Terms Explained
To the novice quality manager, ISO jargon can be extremely overwhelming. What is an NCR? What do you mean by OFI? Are we certified or accredited? But before you go and pull out your hair, let’s take a moment to go over some of the most frequently used terms and their definitions with regards to ISO and Management System Certification.