Prerequisite: Review of the ISO Standard prior to attendance is strongly suggested. Bring a copy to the training class.

Transcription

1 2 DAY ISO *INCLUDES SPECIFIC ASPECTS OF ISO * INTERNAL AUDITOR TRAINING 2015 Course Offering Description: This program is designed to develop internal quality management systems auditing skills for implementation to meet the requirements of ANSI/ISO/ASQ standard. Covered will be the process model concept, specific requirements within each clause of the standard and interpretations, development of auditing techniques, process based auditing, planning, and management of the internal audit process. Overview of the ISO Key changes, 10 elements criteria, with focus on the requirements for Risk and Metrics. The course will provide for the understanding of quality management system auditing in accordance with ISO 19011, Guidelines For Auditing Quality Management 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. Each attendee will receive procedures, work instructions and forms templates in accordance with ISO , for internal audits, corrective and preventive action, management review, Audit Checklist and Audit Planning Templates on CD. Prerequisite: Review of the ISO Standard prior to attendance is strongly suggested. Bring a copy to the training class. IAQG AEA Aerospace, CMDCAS LA Medical Devices Certifications 20 Years ISO 9000, AS-9100, ISO Practicing Registrar Lead Auditor, 10 years QS9000 LA Member: RABQSA Technical Advisory Group (TAG), Examiner Aerospace personnel training certification schemes Cost: 750 per person two day program; 450 for the first day only. 10% Discount for 3 or more attendees. Includes training materials and continental breakfast. Lunch is on your own. Cancellations received less than 10 days prior to course date will be assessed 300/person. Location: Courtyard by Marriott, 1737 Sumneytown Pike, Lansdale, PA 19446, Ph At Exit 31 (Lansdale) Northeast Extension of the PA Turnpike; Left at light off exit ramp. Hotel is on the left. Please register the following for the one day AS-9100 Rev. C/AS-9101D/E Standard Training. Check which dates you/they will attend: August 26 & 27 September 24 & 25 November 19 & 20 4) 5) 6)

2 2 DAY ISO INTERNAL AUDITOR TRAINING Course Outline, Objectives and Agenda Course Outline and Objectives Develop an understanding of the quality management system principles and the process model. Detailed examination and interpretation of the ISO9001:2008 elements, and business processes. Overview of ISO 9001: Elements, Risk, Metrics. Continual effectiveness improvement focus and specific audit points. Audit mechanics: Auditing the documentation - the documented quality system audit. Audit sampling and development of the process based audit checklist. Conducting the audit, investigation, and psychology. Audit management - development of the process based audit plan and schedule. 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, team & role play workshop sessions. AGENDA Day 1 ISO Training & ISO Overview 8:30 AM - 9:00 AM 1:00 PM - 2:00 PM Introduction and Business Processes Element 8 Work Shop 4 9:00 AM 10:00 AM Elements 0 4 Work Shop 1 10:00AM to 11:00AM Elements 5 and 6 Work Shop 2 11:00 AM - 12:00 PM Element 7 Work Shop 3 2:00 PM - 3:00PM ISO 9001: Elements Overview 3:00 PM - 4:00 PM ISO Risk and Metrics Metric Work Shop 4:00 PM 4:30 PM Open Discussion 12:00PM - 1:00PM Lunch Both Days AGENDA Day 2 ISO-9001 Implementation and Auditor Mechanics 8:30 AM - 9:15 AM Audit Mechanics Work Shop 5 Documentation Review Quality Manual Audit 9:15 AM 9:45 AM Audit Mechanics Preparing For An Audit, The Audit Sample 10:00AM to 10:30AM Work Shop 6 Application Of The Elements To A Sample Process (Process Audit Methods) 10:30 AM - 11:00 AM Audit Mechanics Preparing for An Audit, The Process Audit Checklist 11:00 AM - 12:00 PM Work Shop 7 Audit Checklist 1:00 PM - 1:45 PM Audit Mechanics Audit Management, Process Based Audit Plan/Schedule, Investigation &Psychology 1:45 PM - 2:30 PM Audit Reporting The Audit Report, Corrective Action Report, and Effectiveness Analysis 2:45 PM 3:00 PM Audit Reporting Nonconformity Statement 3:00 PM - 4:00PM Work Shop 8 Internal Audit Role Play 4:00 PM - 4:30 PM Course Summary and Open Discussion

3 SAE AS-9100C AS-9101D/E Supporting Audit Criteria Quality Management Systems - Requirements for Aviation, Space and Defense Organizations 2015 Course Offering Description: This course concentrates on the AS-9100 revision C, aerospace supplements over and above the requirements of the ISO Standard, the application of AS9101D/E Audit Criteria/Requirements, and implementation strategies for certification preparation. This course also includes review of the requirements of AS9104/1. The AS9101E Audit Criteria; The QMS Matrix, Process Evaluation Assessment Report as both a compliance report and effectiveness metric report, Risk Management Requirements, Project and Configuration Management, Process Diagram & Metrics Work Shop. Internal Auditing to the AS9100C/AS9101 Applications. Prerequisite: Review of the AS-9100C and AS-9101E Standards prior to attendance is strongly suggested. Bring a copy to the training class. IAQG AEA Aerospace, CMDCAS LA Medical Devices Certifications, AS9100C IAQG AATT Transition 20 Years ISO 9000, AS-9100, ISO Practicing Registrar Lead Auditor, 10 years QS9000 LA. RABQSA Technical Advisory Group (TAG) ; Examiner Aerospace personnel and training certification schemes Course Outline Introduction AS 9100 revision C Applicability & Scope Overview of the Key Aspects of AS9100C AS9104/1 Rules Application of AS9101D/E Process Evaluation Assessment Process Diagram & Metrics Work Shop Risk Management Requirements Project and Configuration Management Review of the AS9100 Revision C elements. Cost: 450 per person - 10% Discount for 3 or more attendees. Includes training materials and continental breakfast. Lunch is on your own. Cancellations received less than 10 days prior to course date will be assessed 250/person. Location: Courtyard by Marriott, 1737 Sumneytown Pike, Lansdale, PA 19446, Ph At Exit 31 (Lansdale) Northeast Extension of the PA Turnpike; Left at light off exit ramp. Hotel is on the left. Please register the following for the one day AS-9100 Rev. C/AS-9101D/E Standard Training. Check which dates you/they will attend: July 30, 2015 October 16, 2015 December 10, 2015 Print or Type of Payment:

4 NEW 1 DAY ISO TRAINING 2015 Course Offering Description: This program is designed to introduce the quality management systems requirements for implementation to meet the requirements of the ANSI/ISO/ASQ standard. Focus of the training will examine the key changes between ISO versus the ISO Overview of the 10 element configuration, expectations of specific business operational processes tied to metrics (Key Performance Indicators, KPI s ). The application of Risk Management Process, implementation examples of Risk and Mitigation Methodologies/Techniques will be discussed, which forms a New key aspect of 2015 standard. The training will be presented in terms of concepts and interpretation from the Registrar s perspective. 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, discussion, and development of process based metric workshop. Prerequisite: Bring a copy of the ISO 9001:2015 Standard to the Training. Agenda Introduction-Transition-Higher Level Structure (HLS)-QMS Principles ISO 9001:2008 and ISO 9001:2015 ISO 9001:2015 Methodology, Structure and Metrics ISO 9001:2015 Risk Requirements ISO 9001:2015 Requirements Planning for Implementation IAQG AEA Aerospace, CMDCAS LA Medical Devices Certifications 20 Years ISO 9000, AS-9100, ISO Practicing Registrar Lead Auditor, 10 years QS9000 LA Member: RABQSA Technical Advisory Group (TAG), Examiner Aerospace personnel training certification schemes Cost: 450 per person. 10% Discount for 3 or more attendees. Includes training materials and continental breakfast. Lunch is on your own. Cancellations received less than 10 days prior to course date will be assessed 250/person. Location: Courtyard by Marriott, 1737 Sumneytown Pike, Lansdale, PA 19446, Ph At Exit 31 (Lansdale) Northeast Extension of the PA Turnpike; Left at light off exit ramp. Hotel is on the left. Please register the following for the one day ISO 9001:2015 Training. Check the date you/they will attend: July 16 October 8 December 3

5 ½ Day Quality Management System Management Training Customize Applications of ISO 9001, AS9100, TS16949, ISO 13485, Baseline for many others: NADCAP, FAA, FDA, URAC, EHNAC, etc. On-Site Training/Off-Site Training Description: This program is designed to provide an understanding of Management s role for implementation of the Quality Management System base line requirements of the ISO Series Standards; which provide the basis for many other standards and regulations. The scope of the training will include a review of quality management systems (QMS) concepts with specific focus on Management responsibilities, how the standard provides value added processes for bottom line results, business operations effectiveness, productivity and risk management. 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; the Registrar s expectations as to what must be in place from a management perspective; how best to prepare for certification, certification upgrade, or to maintain certification status. Course format is lecture with selected process metric workshop. Prerequisite: None IAQG AEA Aerospace, CMDCAS LA Medical Devices Certifications, AS9100C IAQG AATT Transition 20 Years ISO 9000, AS-9100, ISO Practicing Registrar Lead Auditor, 10 years QS9000 LA. RABQSA Technical Advisory Group (TAG) ; Examiner Aerospace personnel and training certification schemes Course Agenda Introduction, Concept and The Process Model Management s Role and Responsibility The Process Diagram & Metric Development Process Effectiveness Assessments Risk Management For on-site Training please contact us for pricing: deidradoc@aol.com, or mikedocrt@aol.com Ph: Cost For Public Training: 295/person Location: Holiday Inn, Inn At Towamencin, 1750 Sumneytown Pike, Kulpsville, PA Phone: At Exit 31 (Lansdale), of the Northeast Extension of the PA Turnpike. Left off exit ramp. Hotel on immediate right. Please register the following for the ½ Day Quality Management System Management Training Course

6 1 Day ISO Quality Management Systems Requirements for Regulatory Purposes Description: This course concentrates on the ISO Medical Device Regulation supplements and includes the base-line requirements of the ISO Standard. Overview of the essential regulatory requirements associated with European Medical Device Directive (MDD), for CE Mark, Canadian Medical Device Regulations (CMDR), GD210 Focus links to the ISO13485 Standard, & FDA s 21CFR 820. The course is conducted by a practicing Registrar Lead Auditor and Business Manager, providing first-hand information; the Registrar s expectations as to what must be in place; how best to prepare for certification, certification upgrade, or to maintain certification status. Prerequisite: None IAQG AEA Aerospace, CMDCAS LA Medical Devices Certifications 20 Years ISO 9000, AS-9100, ISO Practicing Registrar Lead Auditor, LA 10 years QS9000 RABQSA Technical Advisory Group (TAG). Examiner Aerospace personnel training certification schemes Course Outline and Objectives Develop an understanding of the specific requirements of ISO Standard GD210 linkage to the ISO The Process Diagram/Metric Development/Process Effectiveness Assessments Risk Management Overview of the essential regulatory requirements, Device History Records, Medical Device Technical File Contents For on-site Training please contact us for pricing: deidradoc@aol.com, or mikedocrt@aol.com Ph: Cost For Public Training: 450/person Location: Holiday Inn, Inn At Towamencin, 1750 Sumneytown Pike, Kulpsville, PA Phone: At Exit 31 (Lansdale), of the Northeast Extension of the PA Turnpike. Left off exit ramp. Hotel on immediate right. Please register the following for the one day ISO Quality Management System Training Course Return to: DBS Quality Management Int l.,