Training
OBJECTIVES
COURSES OFFERED
ON-SITE
TRAINING WORK SHOPS
Objectives
To
provide companies and businesses with the information that will enable them to
successfully implement into their organization a Management System under
guidance of the international Quality Management System Group of Standards. The
prime objective is to achieve an understanding of business and operational
effectiveness improvements using the guidelines of these international standards
and associated tools. Secondly would be to position your organization for the
assessment process to gain the recognition as a certified company to the
selected standard and maintenance of your existing business certification.
Base line of the training process starts with the coverage
of the ISO 9000 series group. With the ISO 9000 series group as a prerequisite
the student then is enable to participate in any of the follow:
Aerospace AS9100 International Standard Training, for Medical Devices ISO
13485-2003 International Standard Training (includes Canadian requirements), for
Automotive TS16949 International Standard Training.
Course Instructors have credentials in Business and
Engineering, and are certified by the organizations that govern and accredited
these standards. The certifications include:
Registrar Accreditation Board/QSA (RABQSA), International
Registry of Certificated Auditors (IRCA), International Aerospace Quality Group
(IAQG), International Harmonization Group for Medical Devices (MDD/CMDR),
Automotive Industry Action Group (AIAG). Trainers
in addition are or have been practicing certification auditors assessing
business in accordance with these international standards for attaining business
certifications.
(See
our Current
Events page for current public course
offerings)
All
Courses offered can be delivered on-site at your facility. Call or e-mail for
pricing
ONE DAY ISO 9001-2000
QUALITY MANAGEMENT SYSTEM TRAINING
Description: This course will provide a detailed review of the ANSI/ISO/ASQ
9001-2000 standard, released December 2000. Covered will be the process model
concept, specific requirements within each clause of the standard, and
interpretation. The scope of this course will include the Registrar’s point of
view, expectations of what should be in place, and specific audit points.
The course is designed to give an overview of the requirements, and/or as
a refresher course for companies that are currently certified or presently in
the development stages of their ISO 9000 Quality Management System.
The principal objective of this course is to provide insight as to the
potential use of the ISO 9001-2000 Management System to Improve the
effectiveness of your business operations, how to prepare your existing
operations for implementing these management system tools, and for those who are
in their initial pursuit towards ISO 9001-2000 Certification. Course format is
lecture and interactive group workshops.
Prerequisite:
None: However, reading the
standard prior to attendance would be beneficial. Bring a copy of the ISO9001-2000 standard with you for the
training.
Course Outline and Objectives
-
The quality system process model
-
The continual improvement focus
-
Examination & interpretation of the eight element
system
-
Specific audit points
-
Learning through workshop sessions
___________________________________________________
2 DAY ISO 9001-2000 INTERNAL AUDITOR TRAINING
Description: This program is designed to develop internal quality management systems
auditing skills for implementation to meet the requirements of the ANSI/ISO/ASQ
Q9001-2000 standard. Covered will be the
process model concept, specific requirements within each clause of the standard
and interpretations, development of auditing techniques, planning, and
management of the internal audit process. The course will provide for the
understanding of quality management system auditing in accordance with ISO
10011-1, Guidelines For Auditing Quality Systems. The scope of this seminar will
include a review of quality management systems (QMS) concepts and
interpretation, the Registrar’s point of view, the audit process and
mechanics, audit management, and audit reporting and corrective action
follow-up. The course is conducted by a practicing Registrar Lead Auditor,
providing first hand information on how best to conduct internal audits to
prepare for certification, certification upgrade, or to maintain certification
status. Course format is lecture and interactive group workshops.
Prerequisite: Read
the standard before coming to class. Bring a copy with you.
Course Outline
and Objectives
·
Develop an understanding of
the quality management system principles and the process model.
·
Detailed examination and
interpretation of the ISO9001:2000 elements.
·
Continual effectiveness
improvement focus and specific audit points.
·
Audit mechanics: Auditing the documentation - the documented
quality system audit.
·
Audit mechanics: Audit
sampling and development of the audit checklist.
·
Audit mechanics: Conducting
the audit, investigation, and psychology.
·
Audit mechanics: Audit
management - development of the activity/process based audit plan and schedule.
·
Audit mechanics: Writing
non-conformity statements and audit reports.
·
Corrective action
implementation, follow-up and closure process.
·
Effectiveness evaluation of
quality system performance based on audit results for management review.
·
Audit skill development
through individual and team workshops sessions.
Each attendee will receive procedures, work instructions
and forms templates in accordance with ISO 9001-2000, for internal audits,
corrective and preventive action, and management review, Audit Checklist
Templates, Audit Planning/Schedule Templates on CD in Microsoft Word.
___________________________________
1 DAY AS-9100B AEROSPACE TRAINING
Description: This course
concentrates on the AS-9100 revision “B”, aerospace supplements over and
above the requirements of the ISO 9001-2000 Standard, and implementation
strategies for certification preparation. This course also includes review of
the requirements of SAE AS 9104 and use of the AS9101 Aerospace Checklist.
Prerequisite: Understanding of ISO
9001-1994, ISO 9001- 2000 or AS-9000.
Review of the AS-9100 Standard prior to attendance would be beneficial.
Bring a copy to the training class.
Course Outline
-
The Aerospace Standards
-
The International Aerospace Quality Group
-
SAE AS9104
-
Risk Management, Configuration Management,
-
Program and Project Management
-
AS-9100 Elements 1 - 4 -Quality Management System
-
AS-9100 Element 5 - Management Responsibility
-
AS-9100 Elements 6 & 7 - Product Realization
-
AS-9100 Element 8 - Measurement, Analysis and Improvement
-
AS9101 Checklist
________________________________________
1 DAY ISO 13485-2003
INTERNATIONAL MEDICAL DEVICE REGULATION
Description: This course concentrates on the ISO 13485-2003
Medical Device Regulation supplements over and above the requirements of the
ISO9001-2000 Standard. Overview of the essential regulatory requirements associated with European Medical Device Directive
(MDD), for CE Mark, Canadian Medical Device Regulations (CMDR) Focus links to
the ISO13485 Standard, & FDA’s 21CFR 820, and implementation strategies for certification preparation and
certification maintenance.
Prerequisite:
Understanding of ISO 9001- 2000
Standard
Review of the ISO 13485-2003 Standard prior to
attendance would be beneficial. Bring a copy to the training class.
Course Outline and Objectives
European
Medical Device Directive (MDD),
Canadian
Medical Device Regulations (CMDR), with linkage to the ISO 13485
requirements
FDA’s
21CFR 820
Each
attendee will received a procedure template for application of the MDR and CMDR
requirements
__________________________________________
1 DAY TS-16949 SECOND EDITION
INTERNATIONAL AUTOMOTIVE STANDARD TRAINING
Description: This course
concentrates on the TS-16949-Second Edition automotive supplements over and
above the requirements of the ISO9001-2000 Standard, with comparison to the
QS9000 standard, and implementation strategies for certification preparation and
certification maintenance.
Prerequisite:
Understanding of ISO 9001-1994, ISO 9001- 2000 or QS-9000.
Review of the TS-16949 Standard prior to attendance would be beneficial.
Bring a copy to the training class.
Course Outline and Objectives
-
Requirements for Certification
and the IATF - International Automotive Task Force
-
Understanding of the specific
TS 16949 Automotive adders to the ISO 9001-2000 Standard
-
Process mapping
& requirements for reduction of waste and variation in the supply
chain
-
The impact of Manufacturing
Engineering
-
The impact of Manufacturing
Engineering
-
The impact of Manufacturing
Engineering
-
The requirements for
QMS,
Process, and Product Audits
________________________________
½
DAY ISO 9001-2000
MANAGEMENT
TRAINING
Description: This program is designed to provide an
understanding of Management’s role for implementation of the ISO 9001-2000
management systems requirements. The
scope of the training will include a review of quality management systems
concepts with specific focus on Management responsibilities, how the ISO
9001-2000 provides value added processes for bottom line results for business
operation’s effectiveness and productivity. Additional discussions include the
Registrar’s point of view and implementation of Management strategies. The
course is conducted by a practicing Registrar Lead Auditor and business manager,
providing first hand information on how best to prepare for certification,
certification upgrade, and/or to maintain certification status. Course format is
lecture and feedback workshops.
Prerequisite:
None
Course Agenda
Ø
Introduction
- The ISO9001-2000 Concept and "The Process Model"
Ø General
Quality Management System Requirements
Ø Management’s
Role and Responsibility
Ø Open
Discussion
___________________________________
ON-SITE TRAINING WORK SHOPS AVAILABLE.
CALL FOR PRICING
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