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.
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
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
Combination lecture and classroom exercises
Available at QSG’s training facilities and on-site at your organization
Course Evaluations Set 1
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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.
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:
- 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.