DBS Quality Management Int’l
ISO 9001/AS9100/ISO 13485/TS16949

Quality Systems Assessments, Training & Development
Access Database Development and Lean Six Sigma Implementation

Training

2 Day ISO 9001:2015 
Internal Auditor Training

2 Sessions 
September 12 & 13, 2018

October 18 & 19, 2018

December 6 & 7, 2018


Course Outline

Day 1
Understanding ISO 9001:2015

This day is designed to provide an understanding of ANSI/ISO/ASQ 9001:2015 quality management systems requirements for implementation. Training will examine the 10 specific clauses of the standard, Management's role, business operational processes tied to metrics (Key Performance Indicators, "KPI's"), the application of the "Risk Management Process" and review of examples.  Course format is lecture, discussion, and learning feedback workshops

Day 2
Audit Mechanics-Process Based Audit Methodology

This day is designed to develop internal quality management systems auditing skills using the process approach.  Attendees will use the understanding from Day 1 and apply that material to the auditing process.  Course format is lecture plus discussion, and audit skill development involves individual, team and interactive role play sessions.

Who should attend: Individuals who need to understand the requirements of ISO 9001:2015 Standard to meet certification requirements or to maintain existing certification. This course is configured for beginners as well as seasoned professionals. 

Day 1

Agenda

  • Higher Level Structure - QMS Principles, Scope
  • Context Requirements,
  • Documentation Methods
  • Leadership Requirements
  • Planning the QMS and Risk Requirements
  • Support and Operations Requirements
  • Performance and Improvement Requirements
  • Planning for Implementation
  • Understanding through feedback workshops

Day 2
Agenda

  • The Auditor, Auditee, Audit, and Audit Preparation
  • Auditing Documented Information 
  • Develop the Process Audit Plan 
  • Process Audit Preparation
  • Auditing Metrics, Goals and Performance 
  • Auditing for Compliance 
  • Writing the Process Audit Report
  • Root Cause Analysis & Corrective Action Plan 
  • Corrective Action Verification and Closure
  • Audit skill development through individual, team, role play sessions


   2nd Day Prerequisite: Understanding ISO 9001:2015 Requirements (Day 1)

Bring a copy of the Standard to the Training

Cost

$750 for the two day program or $450 for the first or second day only

 


AS9100D

Requirements for Aviation, Space and
Defense Organizations Standard

2 Sessions
September 25 & 26, 2018

November 15 & 16, 2018

Course Outline

Day 1
Understanding ISO 9001:2015

This day is designed to provide an understanding of ANSI/ISO/ASQ 9001:2015 quality management systems requirements for implementation. Training will examine the 10 specific clauses of the standard, Management's role, business operational processes tied to metrics (Key Performance Indicators, "KPI's"), the application of the "Risk Management Process" and review of examples.  Course format is lecture, discussion, and learning feedback workshops

Day 2
AS9100D-2016 Additional Requirements to ISO 9001:2015

This day concentrates on the AS9100 revision “D” aerospace supplements over and above the requirements of the ISO 9001-2015 Standard, the application of AS9101F Audit Criteria/Requirements, AS9104/1, OASIS database and implementation strategies for certification preparation. Understanding through study workshops

 

Who should attend: Individuals who need to understand the requirements of ISO AS9100:2016 Standard to meet certification requirements or to maintain existing certification.

 
Course Outline

Day 1
Understanding the ISO 9001:2015 Requirements

  • Higher Level Structure - QMS Principles, Scope
  • Context Requirements, Documentation Methods
  • Leadership Requirements
  • Planning the QMS and Risk Requirements
  • Support and Operations Requirements
  • Performance and Improvement Requirements and Planning for Implementation
  • Understanding Through Interactive Work Shops
 

Day 2
AS9100D (2016) 

The Aerospace and Defense additional requirements

to the ISO 9001:2015 Standard

1. Introduction, AS9104/1 & AS9101F

2. AS9100D Additional Requirements to ISO9001:2015

3. Most Common Gaps

4. AS9100D Internal Auditing Tools

2nd Day Prerequisite: Read the AS9100D 2016 Standard prior to attending. Bring a copy of the Standard to the Training 

Cost

$750 for the two day program or $450 for the first or second day only

 


1 Day ISO 9001:2015
Quality Management Systems Requirements

3 Sessions
September 12, 2018

October 18, 2018

December 6, 2018

 

Course Outline

 
Understanding the ISO 9001:2015 Requirements

This day is designed to provide an understanding of ANSI/ISO/ASQ 9001:2015 quality management systems requirements for implementation. Training will examine the 10 specific clauses of the standard, Management's role, business operational processes tied to metrics (Key Performance Indicators, "KPI's"), the application of the "Risk Management Process" and review of examples.  Course format is lecture, discussion, and learning feedback workshops

Who should attend: Individuals who need to understand the requirements of ISO 9001:2015 Standard to meet certification requirements or to maintain existing certification. This course is configured for beginners as well as seasoned professionals.

 

Agenda

  • Higher Level Structure - QMS Principles, Scope
  • Context Requirements,
  • Documentation Methods
  • Leadership Requirements
  • Planning the QMS and Risk Requirements
  • Support and Operations Requirements
  • Performance and Improvement Requirements
  • Planning for Implementation
  • Understanding through feedback workshops
Cost

$450 per person


½ Day ISO 9001:2015 Quality Management System
Management Training

Key Applications:

  • ISO 9001:2015, AS9100D:2016, ISO/TS 16949:2016

Offered On-Site

 

Course Outline
  • Introduction and QMS Principles
  • Context of the Organization Requirements
  • Management Leadership Requirements
  • Planning and Risk Management Requirements
  • Performance Metrics/KPI Requirements
  • Summarized Planning for Implementation

Prerequisite: None

Call for on-site training pricing


1 Day ISO 13485:2016
Medical Device Training

 Offered On-site Call For Pricing


Course Outline

Understanding the ISO 13485:2016 Standard.  This course concentrates on the ISO 13485-2016 Medical Device Regulation and the requirements of the ISO9001-2008 Standard, which forms the base line for ISO 13485;2016. Discussions will include: essential regulatory requirements associated with European Medical Device Directive (MDD), CE Mark, Canadian Medical Device Regulations (CMDR), G210 links to the ISO13485, & FDA’s 21CFR 820, and implementation strategies for certification preparation and certification maintenance.

Course Agenda
  • Introduction
  • Structure, Scope, Normative References,Terms and Definitions
  • Requirements Based on ISO 9001:2008
  • Risk Management Clauses
  • Process Clauses
  • Medical Device Clauses
  • Documented Procedure Requirements

 

Prerequisite: Read the standard. Bring a copy to the training


1 Day
Risk Management Training

Offered On-Site - Public Training TBD

 

Course Outline

This course provides for an overview of the various Risk Management methodologies. Risk Management aspects associated with ISO 9001, AS9100, TS16949, ISO 13485, as well as many others: NADCAP, FAA, FDA, URAC, EHNAC, etc. For on-site non-public training we can customize the agenda to fit your organization’s needs.

Typical Agenda

  • Understanding Risk Management, “Risk Based Thinking”
  • Risk Consequence
  • Risk Mitigation
  • Risk Management Methods
  • Risk Assessment Examples: Cause and Effects, Risk Tolerance,
        SWOT, Business Continuity/Capability Matrix, FTA, FMEA’s
  • Selective Workshops

Prerequisite: None

Offered On-site Call For Pricing


2 Day TS 16949:2016
Quality Management Systems Training
Includes: Quality Core Tools Overview

Offered On-Site - Public Training TBD

 

 

Prerequisite: Review of the Standard

Cost

Call for on-site training pricing - Public Training $750/person TBD

INSTRUCTOR

Principal Instructor: Michael J. Dougherty

Exemplar Global QMSLA, IAQG AEA, CMDCAS LA Certified
22 Years ISO 9001, AS-9100, ISO 13485, QS9000 Registrar Lead Auditor/AEA. For more about the instructor go to LinkedIn.

PUBLIC COURSE LOCATION

Public Training Courses Include: Training material and continental breakfast.

Lunch is on your own.

Courses run from 8:30AM to 4:30PM.

Location:

Holiday Inn, 1750 Sumneytown Pike, Kulpsville, PA 19443  Ph. 215-368-3800

Exit 31 (Lansdale) Northeast Extension of the PA Turnpike. Exit "A" Right off exit ramp "Easy Pass". Exit "B" ramp for cash Toll Booths and Left at light. Hotel on the right.

Please be sure to reserve your overnight room early if needed.

Contact Deidra to register.
Phone: 215-368-6266, Fax: 215-393-4873
e-mail: deidradoc@aol.com or mikedocrt@aol.com

PO, Check, or Money Order Payable to: DBS Quality Management Int’l.

Click here for Registration Forms

 

  • 894 Carriage Way, Lansdale, PA, 19446      
  • 215.368.6266       
  • Fax215.393.4873       
  • info@dbsqualitymgmt.com
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