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ISO 9001:2015 Internal Auditing Workshop

Course Description
This interactive course employs a metrics-driven, process-based approach to the theory and practice of conducting value-added audits to the ISO 9001:2015 Standard. It prepares internal auditors to perform effective process audits and helps managers and supervisors take full advantage of the internal audit process. Training includes a detailed review of all elements of ISO 9001:2015, effective implementation, and the benefits of quality management systems. This course meets the training portion of the requirements for certification of individual internal auditors. Training also addresses the requirements of the ISO 19011 Auditing Standard.

Who Should Attend
This course is designed for individuals responsible for managing an audit program for ISO 9001:2015, internal auditors, Quality Managers, and Quality Assurance engineers. It is appropriate for anyone seeking to learn the process-based, metrics-driven audit process.

Learning Objectives
Through training, participants will:

  • Gain a working knowledge of a quality management system based on the requirements of ISO 9001:2015
  • Enhance their understanding of process-based, metric-driven auditing techniques
  • Learn the requirements of ISO 9001:2015 and understand its inter-relationship with other elements of the ISO family of standards. Role-play exercises give students practical experience with auditing

Course Outline
The ISO 9001:2015 Standard and Internal Auditing
This session is a comprehensive review of the theory and practice of the ISO 9001:2015 Standard and Internal Auditing. Training topics include:

  • The Challenge for Top Management
  • Quality Management Principles
  • The ISO 9001 Standard Explained
  • The ISO 9001 Family of Standards

This session includes a detailed review of all elements of the ISO 9001:2015 Standard. Participants will also gain an understanding of Customer Oriented Processes (COPs), as well as the customer-specific requirements defined by ISO 9001:2015.

Process-Based, Metric-Driven Auditing
During this session, students will explore effective auditing techniques, interviewing skills, communication skills, and teamwork concepts through a series of interactive workshops, simulated audits, tutorials, and case studies. Training includes a discussion about internal auditing metrics. Specific topics include:

  • Introduction to ISO 9001 Audit Trails
  • Documentation for ISO 9001
  • The audit cycle and ISO 19011
  • Introduction to Quality Audits
  • Management of Audit Programs
  • Audit Planning and Preparation
  • Scope and Objectives
  • Audit Plan
  • Performing the Audit
  • Opening Meeting
  • Quality Audits
  • Conducting the Audit
  • Writing Nonconformity Statements
  • Writing Nonconformities (using CARs)
  • Closing Meeting
  • Summary Statement and Closing Meeting
  • Completing the Audit Report
  • Corrective Action and Close Out (using CARs)
  • Verification and Close Out

Course Format
16 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities and on-site at your organization

Course Evaluations Set 1
Course Evaluations Set 2
Course Evaluations Set 3
Course Evaluations Set 4

Location:
March: Salem, MA


Payment Type
Date Attending
Name of Attendee(s)



AS9100:2016 REVISION

AS9100:2016 (D) – NEW QUALITY MANAGEMENT STANDARD for the International Aviation, Space and Defense IndustrySpecial Bulletin

The AS9100:2016 Standard introduced in September 2016 has undergone a major revision in keeping with the changes being made to the ISO 9001 standard. AS9100:2009 is an internationally-recognized quality management system for the Aviation, Space and Defense industry that specifies the quality system requirements for the design/development, production, and where relevant, installation and servicing of a variety of products and services. AS9100:2009 provides organizations with a basic quality management system for continual improvement and customer satisfaction.

AS9100 Rev. D is built on the structure of ISO 9001:2015 and includes all the requirements of ISO 9001:2015 along with approximately 105 additional requirements specific to the Aviation, Space and Defense industry. The drivers of AS9100 Rev. D are the changes found in ISO 9001:2015, along with aerospace additions and other IAQG standards.

Major areas of focus include:

  • Configuration Management – Risk Management
  • Special Requirements
  • Critical Items
  • On Time Delivery
  • Project Management
  • Supplier Scope of Approval

Other areas of focus include:

  • Product Safety – Added in carefully selected areas and consistent with 9110
  • Human Factors – Added as a consideration in Nonconformity/ Corrective Action
  • Risk – Merged current 9100 requirements with the new ISO requirements
  • Preventive Action – Current clause requirements absorbed into Risk, Opportunities and Nonconformance
  • Counterfeit Parts – Enhanced in carefully select areas and limited new requirements
  • Configuration Management Clause – clarified and improved considerably to address stakeholder needs
  • Product Realization & Planning
  • Post Delivery Support – Merged current 9100 requirements with the new ISO requirements
  • Project Management – Combined with Operation Planning clause to address user interpretation issues
  • Design Development and Supplier Management
  • Gap analysis – ISO text has been added back in a few places to meet the IAQG needs
  • Quality Manual – Note added pointing to the requirements that make up a Quality Manual or the equivalent
  • Management Representative Requirement – added back in for Management Representative QMS oversight

This document provides correlation matrices from AS9100:2016 to AS9100:2009 and AS9100:2009 to AS9100:2016.

This document can be used to highlight where the new, revised and deleted clauses are located, as well as the location of clauses that are unchanged.

When implemented and managed well, the AS9100:2016 requirements can:

  • Produce and continually improve safe and reliable products
  • Meet or exceed customer and regulatory requirements to ensure satisfaction
  • Processes necessary to conduct day-to-day business are defined and managed
  • Documentation accurately reflects the work to be performed and actions to be taken
  • Focus on the complete supply chain and stakeholders
  • Fewer customer unique documents
  • Recognized by Regulatory Authorities

Transition Process and Timing
All organizations currently certified to AS9100/9110/9120 will need to transition to the new version of the standard by September 14, 2018. You can start preparing for the transition immediately, educating the relevant people in your business and revising your QMS in line with the new High Level Structure

Quality Support Group will offer (starting on November 1, 2017) several training courses to get your and your staff up to speed on the new AS9100:2016 requirements. Plan to attend one of the below training courses to ensure you have all of the information on the latest requirements.

Membership


Over the last 20 years Quality Support Group has grown its membership to 175 companies. We continue to expand through our networking and best practice meetings, training workshops, by word of mouth from loyal customers, and due to the financial support of our Members.

Your membership helps support Quality Support Group’s diverse training and educational programs. The financial support of our Members also allows QSG to engage industry experts for our Quarterly Meetings and various other initiatives.

Please consider supporting QSG with a paid membership!

Benefits of Membership
QSG Members have access to the industry’s best consulting and training solutions, delivered by top-notch professionals who understand your industry and business requirements. QSG Members also receive the following benefits:

  •  Free access to Quarterly Meetings
  • Continuing Education Unit (CEU) credits for ASQ Certifications
  • Discounts to ALL QSG Public Training Workshops
  • Free ½ Day, On-Site GAP Analysis Assessment to the ISO 9001:2015 Standard
  • Free ½ Day, On-Site Lean Manufacturing GAP Assessment
  • Free Consulting and Assistance for Workforce Training Fund Program applications and training (General and Express Programs)
  • Access to a pool of Qualified Second Party Auditors
  • Access to Master Black Belts for best practices and benchmarking
  • One Membership includes ALL company employees

Membership Options
Option 1 : $100, companies with 50 people or fewer
Option 2 : $250, companies with 51 – 200 people
Option 3 : $500, companies with over 200 people

MEMBERS ONLY PAGE


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Lean Six Sigma

Operations Management deals with the design and management of products, processes, services and supply chains. It considers the acquisition, development, and utilization of resources that businesses need to deliver goods and services to their clients.

Operations Management involves strategic, tactical and operational oversight. It focuses on carefully managing processes to produce and distribute products and services. Major operations management activities often include product development, supply chain, production and distribution. Related activities include managing purchasing, inventory control, quality control, storage, logistics and evaluations of processes. A great deal of focus is on efficiency and effectiveness of processes. Therefore, operations management often includes substantial measurement and analysis of internal processes. Ultimately, the nature of how operations management is carried out in an organization depends very much on the nature of the products or services and on the processes required for effective execution. Core processes to be managed effectively can include:

  • Purchasing
  • Product and Service Production
  • Quality Management
  • Inventory Management
  • Supply Chain Management
  • Logistics and Transportation Management
  • Facilities Management
  • Configuration Management
  • Distribution Channels
  • Enterprise Resource Planning

QSG’s Lean Operations consulting and training programs are designed for managers and other individuals involved with an organization’s operations. It is truly a learning experience that will transition into optimizing your organization’s costs, quality, speed and customer service – all of which will make a significant impact on your bottom line. Developing a structure for diagnosing, improving and designing effective processing systems is supported by real-world case studies, group workshops and simulation models.

Under the guidance of the QSG Lean Operations Team, you will you master and implement the practice of Lean Six Sigma operations at your organization.

Quality Support Group (QSG) offers a full range of consulting and training services, including:

QSG can help your organization use Lean Six Sigma methods and tools to boost performance and results. Sustainable performance is central to QSG’s approach to helping our customers achieve sustainable success across the full value chain of the organization.


 

 

Training Grants

Government funding is available to help businesses train incumbent and newly hired workers. At the state level, economic development agencies often offer assistance in the form of grants. State training grant programs vary in size and scope, but in most cases they are designed to upgrade the skills of workers in order to improve business productivity and competitiveness in the global marketplace.

Our clients have received millions of dollars in grant funding for employee training.Regardless of region and industry, QSG will help your business identify grant programs that meet your training needs and work with you to provide the information and resources necessary to apply for a training grant.

Massachusetts
Massachusetts provides businesses with funding to train incumbent and newly hired employees through the Workforce Training Fund Programs (WTFP). Grant opportunities include a General Program for customized training in job-related skills, as well as Express Program grants for small companies to address their employee training needs through a list of pre-approved courses.

Recent Workforce Training Fund awards for QSG clients in Massachusetts include:

$242,000 to Communications &Power Industries, Inc. for Lean Sigma and Quality Tools Training
$234,000 to Columbia Tech for APICS/Supply Chain, Problem Solving and Lean
$234,000 to Cabot Corporation for Lean Processes, Project Management, SPC, & Kaizen Events
$189,940 to Autolive for IATF 16949:2016, CQM/OE Prep Training, CQA
$159, 244 to Innovative Mold Solution Lean/Six Sigma Leadership, GD&T, SPC & DOE
$156,690 to Sid Wainer for Lean, HACCP, SQF and Supervisory Skills
$119,400 to Ultra Herley for Lean, DOE and Project Management
$110,240 to GTR Manufacturing for Supervisory Skills, Solderablitly, Lean/Six Sigma Leadership
$100,000 to ABnote USA for Lean Manufacturing training
$86,400 to FLEXcon for ISO 14644 training (Clean Room)
$82,800 to Majalite Corporation Lean/Six Sigma Leadership, FMEA & Kaizen Events
$82,200 to Crystal Engineer for ISO 13485, AS9100 and Sales Training
$67,000 to Uno Foods, Inc. for Safe Quality Food (SQF) training
$48,000 to Hub Folding Box for Food Safety/HAACP and SQF Level II
$32,640 to Stellar Industries Corp. for AS9100 training
$17,680 to T & T Anodizing for ISO9001:2008

Michigan
The Michigan Economic Development Job Training (EDJT) program is designed to provide job training assistance to the State’s employers. Priority is given to projects that demonstrate a need for high-skill training and create or retain high-wage, high-skill jobs, in industries such as advanced manufacturing, life sciences, technology, and Homeland Security and defense.

New Hampshire
The New Hampshire Job Training Fund is available to businesses located in the New Hampshire, as well as businesses intending to locate in the State, that pay quarterly taxes into the NH Unemployment Trust Fund. Training programs may include: structured, on-site laboratory or classroom training; basic skills; technical skills; quality improvement; safety; management and supervision; and English as a second language.

New Jersey
The Skills4jersey Training Grant Program provides funding for employers to upgrade the skills of incumbent and newly hired employees, for the purposes of retaining highly skilled and high wage jobs in New Jersey. Eligible projects include classroom, on-the-job, and computer-based training for a variety of industries.

Rhode Island
The Governor’s Workforce Board of Rhode Island Express Grant Program solicits applications for workforce improvement programs designed to increase the skills of the incumbent workforce and support the competitiveness and growth of Rhode Island businesses.

Virginia
Workforce training assistance in Virginia is provided through the Virginia Jobs Investment Program (VJIP), an economic development incentive providing customized recruiting and training services to companies that are creating new jobs or experiencing technological change.

Training Courses

Events Calendar

Quality Support Group designs and delivers industry-leading workforce training solutions for our clients. QSG’s training portfolio includes topical and systemic approaches to improving organizational cultures, and we provide both public and customized in-house training courses. Since 1993, QSG has trained over 10,000 people in all areas of quality/regulatory systems and continuous improvement.

Training Events Calendar

QSG offers training courses in the following areas:

Quality Management 

AS9100:2009 Implementation Course
AS9100:2009 Internal Auditing
Certified Quality Auditor (CQA) Exam Preparation Workshop
ISO 9001:2015 Update Revision: What you need to know now!
ISO 9001:2015 Leadership Workshop
ISO 9001:2015 Lead Auditor Training
ISO 9001:2015 Internal Auditing
ISO 9001:2015 Internal Auditor Transition Workshop
ISO 9001:2015 Transition and Implementation
ISO 9001: 2015 Risk Based Thinking
ISO 13485:2016 Internal Auditing
ISO 13485:2016 Lead Auditor Training
ISO 13485:2016 Overview
ISO/IEC 17025
Software Development for Medical Device Manufacturers
TS 16949:2009 Internal Auditing
TL 9000 Implementation

Process Improvement Tools / Techniques

Advanced Problem Solving: A Systematic Approach to Root Cause Analysis
Advanced Product Quality Planning
Basic Problem Solving
Basic Statistical Concepts
Blueprint Reading
Design of Experiments (DOE)
Advanced Design of Experiments
FMEA (Failure Mode and Effects Analysis)
Advanced FMEA (Failure Mode and Effect Analysis)
Geometric Dimensioning and Tolerancing (GD&T)
GR&R – Gauge Repeatability Reproducibility
Kaizen Events
Project Management
SPC (Statistical Process Control)
Supply Chain Management

Operations Management (Lean Six Sigma)

Basic Lean Manufacturing Concepts
Lean Business Simulation© Course
Basic Quality Tools for Process Improvement
DMAIC Process (Define, Measure, Analyze, Improve and Control)
Black Belt
Green Belt
Yellow Belt
Minitab Essentials Workshop
Creating Manufacturing Cells
Implementing a KanBan Pull System
Value Stream Mapping (VSM)
5S
Standard Work Documentation
SMED – Single Minute Exchange of Dies
Introduction to SolidWorks
Leadership Awareness
Leading Change

Business Management

Leading A Team
Supervisory Skills
Transformational Leadership

Food Safety / Certification

Control of Listeria in the Ready-to-Eat (RTE) Environment
FDA-Food Safety Preventive Controls
Food Safety Systems Internal Auditing
HACCP Fundamentals and Implementation
Implementing Safe Quality Food (SQF) Systems

Environmental Management Systems

ISO 14001:2015 Internal Auditing
ISO 14001:2015 Overview

FDA Quality System (QS) Regulation/Medical Device Good Manufacturing  Practices / ISO 13485

ISO 13485:2016 Internal Auditing
ISO 13485:2016 Lead Auditor Training
ISO 13485:2016 Overview
Process Validation: Principles and Protocols 

All of the above courses are available at QSG’s training facilities or on-site at your organization.

Training Grants

Membership