SUMMER 2016 - Omnex · AS9100:2016 (rev D), ISO 14001:2015, ISO 9001:2015, ... SUMMER 2016 QMS SoftwaRE ExpER t JoinS oMnEx SyStEMS SoftwaRE ViSion foR SoftwaRE DEVElopMEnt

Omnex • 315 E. Eisenhower Pkwy, Suite 214 • Ann Arbor, MI 48108 • USA • 734.761.4940 • [email protected]

Summary of Nine New Standards Including AS9100, ISO/TS 16949, ISO 13485...

Omnex Systems is the only QMS software company that has the unique support of international subject matter experts that help write the industry standards, train the auditors, and teach organizations on business processes. This expertise drives the software development process and assures that customer implementations are fast, effective, and provide significant ROI.One of the most significant changes in the standards is clear expectations for top management. Not only is top management accountable for the “effectiveness” of the QMS and EMS, they now have specific tasks ranging from establishing objectives to supporting relevant managers in their roles.

Internationally Recognized QMS Software Expert Joins Omnex Systems

for the “effectiveness” of the QMS and EMS, they now have specific tasks ranging from establishing objectives to supporting relevant managers in their roles. Both standards require that management integrate the requirements into the “organization’s business process”, creating the immediate need for an Integrated Management System (IMS). In the QMS, they will need to work on the planning process, to ensure that the QMS/EMS meet the intended outcomes, as well as to establish performance objectives.

Omnex Vision for Software Development

There are a number of significant ISO management system standards currently under revision. Some of these standards that are being revised include: ISO/TS 16949, AS9100:2016 (rev D), ISO 14001:2015, ISO 9001:2015, ISO 13485:2016, ISO 17025, ISO 19011 and ISO 45001:2016.

ISO 9001:2015 and ISO 14001:2015 and ISO 45001:2015 have clear expectations for top management. Not only is top management accountable

by John Cachat by Dan Reid

by Chad KymalSee full aRtiCle on pg 2 ContinueD on pg 4

See full aRtiCle on pg 3 ContinueD on pg 6

SUMMER 2016

QMS SoftwaRE ExpERt JoinS oMnEx SyStEMS

SoftwaRE ViSion foR SoftwaRE DEVElopMEnt

thE RolE of lEaDERShip in iSo 9001:2015 & 14001:2015

SUMMaRy of thE nEw StanDaRDS

paGE 6

paGE 4

paGE 3

paGE 2

Omnex Systems has announced that John M. Cachat has joined the company as Managing Director. In this capacity, Cachat will lead Omnex Systems’ international marketing, business development, software development, and client management activities.To read more on John Cachat, please read the full article on page 2. For more information on how John and Omnex Systems can assist your company, write us at: [email protected] or call 734-761-4940

The Role of Leadership in ISO 9001:2015 and ISO 14001:2015

Omnex is now offering AS9100:2016 (rev. D), ISO 13485:2016, ISO 9001:2015 & ISO 14001:2015 Training Courses

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SUPPLIER PPAP MANAGEMENT MADE EASYSUPPLIER PPAP MANAGEMENT MADE EASY

Learn how organizations are making innovative changes to the PPAP Process

Direct Login and document submissions by Suppliers

ResourceAllocation

ProjectSummary

SupplierTracking Matrix

ResourceTracking

BurndownChart

TrackingMatrix

RiskRegister

Internationally recognized QMS software expert joins Omnex SystemsContinued from page 1

John M. Cachat has joined the company as Managing Director of Omnex Systems. In this capacity, Cachat will lead Omnex Systems’ international marketing, business development, software development, and client management activities. “We are very excited to have John join our team. He brings deep knowledge of quality management disciplines and the critical role that a robust software solution plays in how businesses get the most from their quality manage-ment systems.” said Chad Kymal, Chief Technology Officer and founder of Omnex Systems.

Cachat’s career spans over 30 years and has been focused on operational excellence, enterprise quality and compliance management for large and small organizations in manufacturing, healthcare, gov-ernment, and other sectors. In 1992, Cachat ran the ASQ Management Division Quality Manage-ment Information Systems Committee. In 2001, the IBM Automotive Consulting group sought out Cachat for the creation of a SaaS solution to auto-

mate the complex and rapidly evolving APQP and PPAP process. In 2005, Cachat lead the Automotive Industry Action Group’s (AIAG) eAPQP workgroup to work EDI transfer of APQP data across the au-tomotive supply chain. Cachat is sought out by the boardrooms of international companies to help drive strategic improvements.

“John’s direct experience in the quality management software business is particularly relevant to Omnex Systems.” said Kymal. “We are well positioned to continue our growth and we’re confident John can make a solid contribution to Omnex Systems global expansion. Businesses must respond to the changes happening in international quality, safety, and envi-ronmental standards. This is a real opportunity for John and the rest of our team to help businesses implement Integrated Management Systems to manage these new standards.”

“I’m honored to join Omnex and its team of re-spected experts in the quality management industry.

Omnex pioneered what is now a well-known set of disciplines used throughout the world.” said Cachat. “The Omnex software is world class and designed to manage quality, safety, environmental, and more standards in a single business operating system.”

John cachat

omnex systems managing Director



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Top help management meet these expectations, the BOSS (Business Operating System Software) capability continues to expand, including:

• Expectation categories (Interested Parties, Customers, Employees, and more)

• Benchmarking• Goals & Objectives• Vision, mission Policy • Alignment Chart• KPI & Dashboards• Meeting Management• Improvement Proposals Management

with Proposal Ratings...

The standards also require that management in-tegrate the requirements into the “organization’s business process”, creating the immediate need for an Integrated Management System (IMS). The IMS concept has immediate application with the adoption of High Level Structure (HLS) across multiple stan-dards. This change will challenge top management to re-engineer current business processes to follow a common structure and that common structure can be done with the Omnex Systems software suite.

Requirements Module Comments

4.1 Context BOSS Internal and External Issues

4.2 Needs and Expectations of Interested Parties

BOSS Interested Expectations

4.3 Scope Doc Pro Quality Manual

4.4 QMS and Its Processes

BOSS Process Risk Analysis

6.0 Planning BOSS for setting objectives and AQuA Pro for Process Risk;

Risk Management;AQUA Pro

Alignment Chart

7.1 Resources (7.1.1 to 7.1.4)

Doc Pro Processes in Level II

7.1.5 Monitoring and Measuring

MSA Pro Incudes measuring equipment calibration, identification and traceability. In addition includes GRR, Linearity and Bias. Best in Class techniques for gages and measuring equipment

7.1.6 Organizational Knowledge

Doc Pro, AQuA Pro, APQP/PPAP Manager, and Problem Solver

Family of parts, 8-D Internal, External, and Warranty and then show linkage back to FMEA; successful projects; use of FMEA to capture improvements in products and processes

7.2 Competence HR Pro Competence and Competence ratings; training administered

7.5 Documented Information

Doc Pro Documents and Records (levels, table of contents, and tables of records)

8.1 Operational Planning and Control

APQP/PPAP Manager

APQP Planning and Templates- Planning of a project

8.3 Design and Development of Products and Services

APQP and PPAP Manager

APQP Planning and Templates – Phase II of APQP

DFMEA and DVPR, Process Flow, PFMEA, Control PLan

8.4 Externally Provided Processes, Products, and Services

Supplier Portal and KPIs

Measuring New and Existing Suppliers

8.5.1 Production and Service Provision

Inspection Control and Doc Pro

Work Instructions and Inspection Sheets

9.1 Monitoring, Measurement, Analysis and Evaluation

BOSS Including Customer Satisfaction

Multiple Dashboards for different meetings

9.2 Internal Audit Audit Pro Manage Supplier audits and internal audits, registrar audits etc.

9.3 Management Review

BOSS MR meeting and team meetings (CI)

10.2 Nonconformity and Corrective Action

Problem Solver External, Internal and Supplier Problems and corrective action

10.3 BOSS Teams working on making improvements

Top management is looking for IMS solutions for several reasons, including, the fact that IMS provides:

• Avoids confusion and duplication of efforts

• 60% reduction in Maintenance costs

• 50% reduction of Risk Analysis for QMS, EMS, and OHSMS

• 50% reduction in implementation cost

• 25% reduction in internal and external auditing costs

Real Time Shop Floor Control from Advanced Quality Planning

Real time shop floor control is another effort un-derway, as part of the existing capability of connect-ing Engineering with Shop Floor documentation by Linking VOC to Design to DVPR for all requirements

and flowing down the BOM will take product design to the next level. Linking Design to Manufacturing Engineering to Shop Floor Controls will revolutionize manufacturing as we know it. This will be complet-ed by ensuring every part leaving the factory was produced as per the control plan and then linking failures back to improved controls in a closed loop. This process will be unprecedented and measuring process capability of each process and signaling failures will improve products dramatically.

Mobility, RFID, IOT & Big Data

These disruptive technologies will overturn ex-isting design and manufacturing departments. Omnex Systems is currently expanding the role of mobile devices from tablets to smart phones. Radio-frequency identification (RFID) research is underway, for example, to better understand how RFIDs attached to all components of an automobile during production can be used to track its progress through the assembly, including PPAP information, inspection data, and more.

Omnex Systems is looking even further ahead with the vision to leverage the Internet of Things (IoT) which is a network of physical objects—devices, vehicles, buildings and other items embedded with electronics, software, sensors, and network con-nectivity—that enables these objects to collect and exchange data. The IoT may enable rapid manu-facturing of new products, dynamic response to product demands, and real-time optimization of manufacturing production and supply chain net-works, by networking machinery, sensors and control systems together, including key QMS information from APQP, inspection, data, supplier problems, customer issues and more.

Big data is a broad term for data sets so large or complex that traditional data processing applica-tions are inadequate. Challenges include analysis, capture, data curation, search, sharing, storage, transfer, visualization, and querying. Current Big Data efforts rarely include the wealth of informa-tion learned during APQP, PPAP, inspection, audits, and other key QMS knowledge. Omnex Systems is trying to understand how to incorporate this vital information in the organizations DNA.

Omnex Vision for Software Development Continued from page 1

Business Operating System (BOS)

ContextMission, Vision,

PoliciesInterested Party

Expectations

Goals and Objectives

KPI 1

Key Process Key Process

Process KPI Process KPI

KPI2 KPI X

Key Process

Process KPI

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navigatorThe High Level Structure, or HLS, leads to common expectations for top management across several management system standards (MSS). In addition to Section 5.0 Leadership in the high level structure, there are many areas that top management must tackle in the implementation and maintenance of the standard that are of a strategic nature or that which is “required” of them. See the island on High Level Structure and Annex SL.

The Need for Consistency Between Standards

The International Organization for Standardization Technical Board understood the need for consistency between the standards and asked the Joint Technical Coordination Group (JTCG) to create a directive for the different management teams. The result is the ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2013, Annex SL, Appendix 2. It sets out the high level structure, identical core text, common terms and core definitions that are to form, when possible, the nucleus of future and revised management system standards such as ISO 9001, developed by JTCG.

• “All MSS shall, in principle, use consistent structure, common text and terminology so that they are easy to use and compatible with each other.

• The guidance and structure given in Appendix 2 to this Annex SL shall, in principle, also be followed (based on ISO/TMB Resolution 18/2012).”

Let us start with the model that shows the PDCA structure of the standard. The model shows interested party and customer expectations influencing planning. Though the standard does not use the words top management in 6.0 Planning, this section definitely seems to be something top management must be involved in, since 5.1.1 requires top management to be accountable for the effectiveness of the QMS. In planning, the organization determines the “intended results” of the management system including the risks and opportunities that may influence it. Also, in this section the organization determines the quality objectives and the changes to the management system. Once the plan is made, it is resourced, supported, and implemented in the next Sections 7.0 and 8.0. There are no explicit requirements for top management in these sections of the HLC. In Section 9.0 on Performance Evaluation is where

the performance of the management system is evaluated. In this section, Management Review 9.3 is where top management reviews the overall progress of the management system and “acts” to improve it. Where is leadership in this model? Leadership is in the middle of the things, leading and directing the organization. This is the role of Leadership as envisioned by ISO 9001:2015 and ISO 14001 Environmental Management Systems.

Figure 1: PDCA Model for ISO 9001:2015

Accountability for the effectiveness of the QMS & EMS

One of the first responsibilities of top management in Section 5.0 on Leadership is for top management to take “Accountability for the effectiveness of the QMS and EMS.” In the previous versions of the standard it was always the Management Representative who reported to top management on the performance of the QMS and the EMS. So the responsibility for the accountability for the effectiveness was delegated to someone reporting to top management in previous versions of the standard. This is a very important and expanding role for top management. This will require top management to understand what the QMS or EMS represents and how “effectiveness” is determined and then to know whether the QMS or EMS is performing satisfactorily.

What is a QMS?

The idea of quality has been changing over time from “inspection” to “strategy”, see Figure 2. Today, quality represents meeting the needs and expectations of interested parties (includes customers, suppliers, government, workers, and others) within the context of the organization in ISO 9001:2015. The management is defined in ISO 9000 in a note as “Management can include establishing policies, and objectives, and processes to achieve these objectives.” Quality Management is then “management with regard to quality.”

2015 Interested Party Expectations, and Expanded Top Management Role in Quality

2000 ISO 9001:2000- Process Focus and Customer Focus

1993 Quality Operating System

1987 Malcolm Baldrige National Quality Award launched

1985 Omnex started in Michigan

1972 Quality Function Deployment–Kobe Shipyard

1968 Fishbone Cause and Effect Diagram –Ishikawa

1962 Quality Circle in Japan

1957 Reliability Engineering–Department of Defense

1956 Total Quality Control (TQC)–Arman Feigenbum

1951 Cost of Quality–Joseph Juran

1950 Deming goes to Japan

1931 Statistical Quality Control–W.A. Shewhart

Figure 2: What is Quality?

Quality is no longer just product quality because product quality is only one of the expectations of the customers. The QMS needs to meet product quality, delivery, regulations, new products launched on time, resolving customer problems on time, and or any other needs or expectations of interested parties (deemed important to the business).

In this context, the “Quality Management System” is the ‘Business Management System” and Quality Planning is akin to Business Planning. And the effectiveness of the QMS is really the effectiveness of the business itself. Something top management performs as their primary responsibility.

Large organizations that have functions that are responsible for Business Planning and quality functions that do “Quality Planning” and environmental activities that do “Environmental Planning” will need to determine corporate activities and relevant functional responsibilities. They will need to work together synergistically to prevent redundant activities.

Since top management is accountable for the effectiveness of the QMS and EMS, then they should also be involved in setting the effectiveness measures in 6.0 Planning. This is not a requirement of the standard, but it is a logical extension of their accountability for its effectiveness. Keep in mind the standard has multiple requirements for top

The Role of Leadership in ISO 9001:2015 and ISO 14001:2015 (continued from page 1)


navigatorThe Role of Leadership in ISO 9001:2015 and ISO 14001:2015 (continued from page 4)

management to ensure results including:

• 5.1 e, where they have to communicate the importance of meeting and conforming to QMS and EMS requirements

• 5.1 f, ensuring that the QMS and EMS “achieve its intended outcomes”

• 5.1 g, making sure subordinates contribute to the effectiveness of the QMS or EMS

Rethinking the Quality and Environmental Policies

Top management is asked to make sure that the quality policy and quality objectives are “compatible” with the context and organization’s strategic direction. This will require the organization not only to rethink the Quality Policy and to update it, but also to consider its relevance each year as the strategy of the organization is formulated. The environmental policy not only needs to be aligned to the context and strategy but has to now support “protecting the environment.” The standard which was first formulated to prevent pollution now has added one more key feature that each organization needs to embrace, i.e., protecting the environment. Protecting the environment includes sustainable resource use, climate change mitigation, and protecting biodiversity and ecosystems. This change in the environmental policy will not only require changes in the Environmental policy, but also changes in the environmental objectives and EMS programs. Top management will need education and training and the organization will need to add new competencies to meet the changes in ISO 14001: 2015 in 5.2 Environmental Policy.

Integrated Management Systems (IMS)

A high level structure requirement that is embedded in ISO 9001:2015, ISO 14001:2015, and ISO 45001:2016 requires top management to ensure that the QMS, EMS and or OHSAS requirements are integrated into the organization’s business processes. (5.1 c). The standard is asking for one set of business processes that satisfy all the requirements, i.e., “shalls” of ISO 9001:2015,

ISO 14001:2015, and ISO 45001: 2016. This is a defacto requirement for organizations to adopt an IMS. Omnex defines IMS as integrated processes, integrated risk, and integrated audits. See Chad Kymal’s book “Implementing Integrated Management Systems – QMS, EMS and OHSMS Including Aerospace, Automotive and Food Safety Management Systems” for more information on the requirements for implementing Integrated Management Systems.

Promoting Process Approach, Risk Based Thinking and Customer Focus

Top management will need to understand both the process approach and risk based thinking to be able to promote it effectively. Not only will they need training in the topic, but they will need to understand how these topics were applied within the organization. Promotion of a topic requires their understanding of the process and risk based approaches and supporting it when needed in the organization. Organizations typically are functionally based and have not embraced risk based thinking in the decision making process. Promotion of both these topics are a part of the culture change that ISO 9001:2015 started with the revision of the standard in the year 2000.

Additionally, top management is required by the standard to ensure that risks and opportunities of product and service conformance and customer satisfaction are determined. The standard has also required that top management keep the organization focused on the customer and the customer’s satisfaction (Ref. 5.1.2). Top management is also asked to ensure the promotion of customer focus throughout the organization (Ref. 5.3, d).

These responsibilities of top management in ISO 9001:2015 require a good understanding of processes, process approach, risk, risk based thinking, customer needs and expectation, and customer satisfaction as it pertains to their

organization.

Top Management Expanding Leadership Responsibilities

Top management may be surprised to learn that the standard holds them accountable for the effectiveness of the QMS or the EMS. This expanding top management accountability is considered by some to be the biggest change in the standard and the biggest challenge for compliance. There are several themes requiring top management to be involved in improvements taking place and to work with others in the organization in making this happen. Top management is also asked to play an important role in promoting the process approach, risk based thinking, and customer focus in the organization. They will also need to be involved in the rethinking of the Quality and Environmental policy and aligning with the business direction.

Some of the new and expanding responsibilities of leadership include:

• Accountability for the effectiveness of the QMS and EMS

• Rethinking the Quality and Environmental Policies

• Integrating QMS and EMS requirements into the business processes (IMS - Integrated Management Systems)

• Promoting Process Approach, Risk Based Thinking and Customer Focus

note: this paper is not comprehensive and does not address all the requirements for leadership in iso 9001:2015 and iso 14001:2015

chad Kymal is the cto and Founder of omnex inc. he has worked for over 30 years implementing management systems in Automotive, Aerospace, Food, Medical Devices, Semiconductor/High Tech, and various manufacturing and service industries. He worked with top management implementing performance based systems working with Ford and the Ford Supply Base globally training and implementing Quality Operating Systems (QOS). He conducts top management training and implementations in various management systems.

OMNEX HAS MOVED!

315 E. Eisenhower parkway, Ste. 214 ann arbor, Mi 48108

our new and updated offices and training facilities are now located here:

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navigatorSummary of the New Standards Overview of updates to ISO Standards

Subject ISO 9001 ISO 14001 ISO 45001 ISO 13485 ISO 17025 AS9100 ISO/TS 16949

Subject Matter Quality Environment OH&S Quality Competency Quality Quality

Sector All All All Medical Device Laboratories Aerospace Automotive

Draft Stage IS IS DIS IS CD FDIS Pilot

Draft Status Approved Approved Balloting Approved Balloting in draft

Status Date Jul-15 Jul-15 May-15 Jan-16 Mar-16 Mar-16 Mar-16

Uses ISO HLS (Annex SL)? Yes Yes Yes No Yes Yes Yes

Publication Target Date Sep-15 Sep-15 1Q2016 Mar-16 TBD Apr-16 4Q2015

Omnex Training Available Sep-15 Sep-15 TBD Apr-16 TBD TBD TBD

There are a number of significant ISO management system standards currently under revision. In the ISO standards development process, there are key draft stages:

•Working Draft (WD)First internal Committee draft

•Committee Draft (CD)First public draft for comment

•Draft International Standard (DIS)Some changes allowed

•Final Draft International Standard (FDIS) No changes allowed; Just a “yes or no” vote. Now is an optional process step.

•International Standard (IS)To be reviewed every five years for continuing suitability.

ISO 9001:2015 (Quality Management System)

iSo 9001:2015 was released on September 22, 2015 after iSo member body approval (>92%). Organizations certified to ISO 9001 will have until September 2018 to upgrade to the new edition to maintain ISO 9001 certification. The new edition features the use of the now mandated ISO High Level Structure (HLS) which requires use of designation clause titles, clause ordering, base text under the clauses and some common definitions of key terms. There are also new requirements, e.g. context of the organization, needs and expectations of interested parties and identification of risks and opportunities. Previous requirements for a quality manual, a management representative and preventive action have been deleted.

ISO/TS 16949

The International Automotive Task Force (IATF), responsible for ISO/TS16949 and its automotive certification scheme have elected to revise the

Standard to incorporate the new iSo 9001 in whole after initially taking the position that they would stay with the 2008 version going forward. the Standard is in draft and will be piloted over the next few months.

At the time of publication, there will be a global stakeholder meeting in April with the 50 suppliers involved in the drafting process and 44 iatf-recognized certification bodies to review the changes and announce the transition requirements, which are likely going to be manditory in less than three years, which is the norm for iSo management system standards (MSS).

Key changes at this time:

• Safety-related parts/processes added;

• P r o d u c t t r a c e a b i l i t y a d d i t i o n a l requirements;

• Embedded software addressed including SPICE requirements;

• Warranty management inc lud ing requirements pertaining to the ”No Trouble Found” (NTF) process and a reference to the now revised aiag CQi-14 on Warranty Management;

• Sub-tier Supplier Management clarification;

• Quality manual is still a requirement;

• Corporate responsibility requirements.

there is also a proposal to be considered by IATF to change the calculation of the auditor day requirement from the number of employees to a risk-based calculation.

Target release is 4Q2016 pulled ahead from 2017.

AS9100D

The International Aerospace Quality Group (IAQG) recently approved the draft of AS9100D

with 95% approval. They plan at the time of this publication to release it with the companion auditing requirements standard, AS9101 in April 2016. No certifications will be allowed to the revision until at least August when the revised auditor training materials are to be available. Support materials on the IAQG website (iaqg.org) will also be revised.

Key changes at this time:

• Product safety requirements enhanced;

• Counterfeit parts prevention requirements added;

• Risk in operational processes emphasized;

• Configuration management requirements clarified and simplified;

• Awareness requirements enhanced;

• Human factors added.

ISO 14001:2015 (Environmental Management System)

The new edition of the ISO 14001 was released in September 2015. it too incorporates the new ISO-mandated HLS so it is much easier to integrate with ISO 9001:2015 now. Use of the HLS also drives the incorporation of new requirements for context of the organization, needs and expectations of interested parties, identification of risks and opportunities as well as new requirements for top management under the Leadership clause. This is a significant change from the last edition which did not have a clause of leadership requirements.

Other key changes include:

• New Environmental Concepts such as Protecting the Environment, not just preventing pollution;

• Strategic environmental Management


navigatorSummary of the New Standards Overview of updates to ISO Standards

including Context and EMS performance requirements;

• Life-cycle thinking;

• Enhanced communication requirements.

there will be a three year transition period for organizations currently certified to ISO 14001 to upgrade to the new edition.

ISO 45001:2016 (Occupational Health and Safety System)

iSo is planning to release its first standard for OH&S later this year. ISO 45001 will be a generic international standard that specifies requirements for an OH&S management system with guidance for its use to enable an organization to provide safe and healthy working conditions for preventing work-related injury and ill-health and to improve OH&S performance. It will have an informative Annex to provide guidance in understanding the new requirements. It will also use the new ISO-mandated HLS which will facilitate integration with other iSo management system standards, e.g. iSo 9001, iSo 14001.

Key points of emphasis emerging from the draft Standard:

• top management needs to demonstrate leadership and commitment to the OH&S management system

• Participation and consultation with workers (and worker representatives as applicable) in:

ෙ Development, implementation and improvement of the OH&S mgmt. system

ෙ Hazard identification and risk assessment

ෙ Actions to control hazards and risks

ෙ Identification of needs of competence, training and training evaluation

ෙ Incident and nonconformity investigation and corrective action

ෙ establishing policy

ෙ assigning roles, responsibilities and authorities as applicable

ෙ Determining controls for purchased product and services

ෙ others

• proactive hazard identification and assessment of OH&S risks

The International Labour Organization (ILO) has

historically objected to ISO publishing an OH&S standard and continues to voice objections to the draft ISO 45001 content. The draft has been produced with organized labor participation and it is not clear if the ISO standard will be blocked from publication if ILO does not agree. Negotiations are continuing.

Since it is the first ISO standard for this topic and is being developed by a new iSo Committee, largely populated with organized labor and OH&S practitioners, it is a fairly immature document compared to other ISO standards. Many Committee members may not be well versed in the content and intent of the new HLS and/or the ISO drafting conventions. In the current draft, there is significant redundancy in requirements, ambiguity around terms and requirements that will make consistent auditing difficult and mis-located content compared to how other iSo standards have addressed their specific content around the new HLS, and a number of controversial requirements, e. g. requiring consultation with workers and worker participation in policy and OH&S decision-making.

ISO 13485:2016 (Medical Device Quality Management

System Standard)

The new edition of ISO 13485 was released on March 1, 2016. Changes in this edition are considered to be minimal. it does not incorporate the new iSo-mandated HLS since the revision process began prior to the release of this ISO requirement. The original DIS draft was rejected by ISO member bodies and it required a second DIS to be approved (94%) for release. According to the drafting ISO Committee (tC 210), this revision incorporates “state of the art” QMS approaches that have been identified since the original text was written in 2003

• Risk-based thinking

• Complaint handling

• Supplier controls

Much of the restructuring, text, and scope has been done in support of regulators to facilitate the Medical Device Single Audit Program (MDSAP) program and other regulatory framework. Software as a medical device has been addressed but the drafting Committee acknowledges that it does not have subject matter expertise to provide guidance on this subject.

ISO 17025:20XX (Test and Calibration Laboratory Competence)

The first CD of the ISO 17025 revision was approved by ISO members in November 2015 but due to the large number of comments (2600) received, the drafting Committee elected to issue a second CD draft rather than proceed to DIS stage in the ISO drafting process.

At press time, CD2 was to be released in late March, followed by a two month ballot which will expire in June. The ISO Committee will then meet in July and September to process comments on CD2. one goal for this revision is to minimize the number of changes but they elected to use the new ISO-mandated HLS so there were many comments from users who do not understand the extent of changes in the draft that were driven by its use.

ISO 19011 (Management System Standard Auditing)

iSo approved the revision of iSo 19011:2011 “Guidelines for auditing management systems” last October. Justification for the revision included: In the year after its last publication, ISO 19011 was the second highest seller at by both quantity and revenue for ISO. The standard has potential to become increasingly popular because there are now almost fifty ISO management system standards (MSSs) published, with more being developed. Since ISO 19011 gives direction on how to audit to an MSS standard, it should be revised within a new and broader focus than its placement in the ISO Quality Management Committee (TC 176).

Omnex can provide various training courses for these standards and the transition to the new standards at your location. See omnex.com for our free webinars and more information on training or consulting.

R. DAN REID is the director of standards and consulting at Omnex Engineering and Management in Ann Arbor, MI. He is an author of ISO Technical Specification 16949, QS-9000/QSA, ISO 9001:2000, the first International Organization for Standardization international workshop agreement, the Chrysler, Ford, GM Advanced Product Quality Planning With Control Plan, Production Part Approval Process and Potential Failure Modes and Effects Analysis manuals and the AIAG Business Operating Systems for Healthcare Organizations. Reid was the first delegation leader of the International Automotive Task Force. He is an ASQ fellow and an ASQ-certified quality engineer.

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N E W S F R O M O M N E X A R O U N D T H E W O R L DN E W S F R O M O M N E X A R O U N D T H E W O R L D


US NEWS

• Omnex moved its headquarters to a new state of the art facility located at: 315 E. Eisenhower Parkway, Ste. 214

Ann Arbor, MI 48108

• New courses being offered by Omnex uSa in 2016:

ෙ Soft Skills

ෙ 9001:2015 U&D/IA/LA

ෙ 14001:2015 U&D/IA/LA

ෙ Risk and Implementing Risk Strategies for ISO Management Systems

ෙ ISO 13485:2016 U&D/IA/LA

ෙ AS9100:2016 (rev D) U&D/IA/LA

• Omnex now offers new IRCA ISO 17025 Lead Auditor Training

• Omnex Systems introduced new Requirements Flow Down and ISO 26262 modules to their EwQIMS suite.

• On October 19-22, 2015, Omnex CTO, Chad Kymal attended the IAQG Meeting in Madrid, Spain.

• On September 29-30, 2015 Omnex CTO, Chad Kymal attended the AAMI/FDA Risk Management Summit in Herndon, Va.

• On October 15, 2015, Omnex CTO, Chad Kymal attended and was the keynote speaker for ISM-SEM Member Meeting: Understanding Lean Six Sigma and its Use in Supply Chain Development. Chad’s topic for this presentation was

“Understanding Lean Six Sigma and its Use in Supply Chain Development.”

• On September 22-23, 2015 Omnex CTO, Chad Kymal attended and gave a key presentation for the AIAG Quality Summit held in Novi, Michigan. Chad presented on “Implementing Integrated Management Systems for Efficiency and Effectiveness.”

• On September 22-24, 2015 Omnex CTO, Chad Kymal and Omnex Senior Consultant, Greg Gruska attended and gave a key presentation for the iQpC 26262 conference in ann arbor, Michigan. Chad and Greg’s presentation was on “integrating iSo 26262 and Advance Product Quality Planning.”

• Dan Reid attended US TAG to ISO PC 283 Meeting in Dallas, TX in February 2016

• On April 25-30, 2016, Omnex CTO, Chad Kymal attended the IAQG Meeting in Singapore.

• On March 22-24, 2016 Omnex CTO, Chad Kymal attended and gave a key presentation for the IQPC 26262 conference in Berlin, germany. Chad’s presentation was on “Integrating ISO 26262 and Advance Product Quality Planning.”

• ASQ published Omnex CTO, Chad Kymal’s book “How to Audit: ISO 9001:2015: A Handbook for Auditors” in early Spring 2016.

• On March 21-22, 2016, Omnex’s Dan Reid attended the ISO 9000 Conference in Orlando, FL and gave an informative presentation on preparing your top management for an audit.

OMNEX CHINA NEWSDuring October 2015 and January 2016, Tata Motors partnered with Omnex, to give a series of training to their primary suppliers in China on the 5 Tools of automobile industry. Omnex’s globally integrative training standard helped its customers meet Tata’s high requirements of global operation and business development localization.

On Nov. 5th, 2015, Omnex held a seminar on “The Organization Risk Prevention and Control” in Shanghai. Omnex’s CTO Chad Kymal gave the keynote speech for the event.

During the 4-hour seminar, Chad Kymal explained how ISO 9001:2015 will require and apply to risk management, based on his abundant experience. Reception to the seminar was extremely positive, with many participants communicating with Omnex that it was “very good training, and a great platform for communication and

knowledge improvement.”

In 2015, a top 500 Chinese Automotive Part Suppler sought Omnex’s help to improve their product design and development. This company has a total investment of uSD 50 million engaged in the R&D and manufacturing of automobile gear box, fuel pump, engine components and casting piece parts. The enterprise has a strong design for engine and AWD gear box, capacity of finite element analysis, project management and experiment. Product design and development is the core of this manufacturing enterprise. Through the observation and analysis in the process of design and manufacturing, top management found that the current product data management can no longer meet the requirements confidentiality of materials such as technology documents and blueprints, thus making the design efficiency slow to improve. To solve this problem, Omnex developed APQP/FMEA quality management software for this company, implementing professional software services and providing solutions for enterprise technology management.

on December 2nd 2015, Omnex attended AIAG 2015 Automotive OEM & Suppliers Purchasing Leadership Summit in China. The summit has been divided into an oeM session in the morning and an aftermarket session in the afternoon. Among the attending guests were AIAG CEO, Representative of US Commerce Department, AASA vice president & CSO as well as the top purchasing and supply chain management from OEMs and component suppliers.

Omnex, as one of the main sponsors of the summit, has dispatched a number of high rank executives including our Vice President of Asia Pacific Region, General Manager of China and Vice General Manager of China to attend this summit. As AIAG’s exclusive official authorized Lean / Six Sigma training and consulting institute in Asia, Omnex has been devoted itself to providing the leading and influential knowledge in the fields of R&D, product, quality and supply chain management by combining cutting edge professional standards together with localized experience in the automobile industry.

Chad Kymal and ulrich reuther at iaQg meeting in madrid, Spain

omnex team at aiag Vip dinner

omnex’s top management and consultants at yearly meeting in december 2015


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OMNEX EUROPE NEWS• Ulrich Reuther, Head of Marketing

and Business Development at Omnex Europe is pleased to announce a new plan to provide Magna powertrain with ten courses both in German and English. Other Languages and offerings are also planned in the latter half of 2016.

• Beginning this spring, Omnex Europe has further plans to develop and offer five new open enrollment courses in the city of Berlin.

• During the week of March 21, Chad Kymal presented his global view of integrated processes for implementing ISO 26262 functional safety requirements. The conference attendees came to germany from near and far and included numerous Functional Safety Experts and members of Cyber Security community. During the iSo 26262 conference many exciting and controversial views were presented

• Given the opportunity to present, Omnex was pleased to rollout its latest software tool to support development of functional safety plans that link directly back to customer requirements.

OMNEX INDIA NEWS• Omnex was awarded a contract from

a leading brake manufacturer for their 5 year Operational Excellence journey. The OPEX journey which was kicked off by the Korean top management in Jan 2016 would go on until December of 2021. The overall factory efficiency improvement is one of the main goals of the journey.

• Omnex signed 2 culture-change Operational Excellence contracts with leading companies in india. this project aimed at employee culture change and Operational Efficiency improvement.

• Leading Tire manufacturer contracted Omnex for Automotive Core Tools workshops across all of their 6 plants in india.

• After successful completion of Phase 1 & 2 of Dealer Management Systems implementation project, Omnex signed phase 3 of DMS for pan india dealers of SKODA Automotive in India.

• For the 8th year in succession, Leading SuV oeM awarded training contract to

Omnex covering over 400+ employees in various tools and techniques.

• Leading Bearing Manufacturer signed up for capability building training with Omnex for the 4th year in succession.

• Leading Auto / Truck manufacturer contracted Omnex for another 100 ppap assessments and 100 parts ppap development of suppliers own TATA motors contract for ppap assessment.

• Leading German Brake manufacturer contracted Omnex for development of more than 160 parts ppap with suppliers.

• Omnex trained key suppliers of leading Indian OEM in China on customized APQP process. Modules for training include topics like APQP, PPAP, FMEA, MSA, SPC, EPS and GD&T.

• Omnex trained 60 employees from Advance Quality Department of leading OEM. It was a customized module which covers topics like APQP, PPAP, FMEA, MSA, SPC, EPS and GD&T.

• Omnex trained 100+ employees from Product Launch team of OEM on Effective Problem Solving.

• Omnex signed contracts for 6 supplier implementations on customer specific supplier qualification program of a leading american oeM.

• Omnex & leading Medical Devices company signed an agreement of outsourcing SQE services. Omnex will provide qualified personnel to carry out supplier development activities in line with corporate requirement.

• Omnex completed 150 process audits at various suppliers of leading OEM. Another 200 process audits are scheduled be conducted by March ‘16.

• Omnex conducted various process audits at leading Telecom Company across india. every month over 100 process compliance and improvement audits are being undertaken.

• New clients added include Sandisk, Tata Lockheed Martin, Dover India, Xelerate Suspension, Talbros, Butterfly appliances, Eveready Batteries, Larsen and Toubro, Faurecia and many more…

OMNEX MIDDLE EAST NEWS • Omnex successfully helped Noor

Bank, UAE to achieve ISO 9001:2015 certification. Noor Bank is probably the 1st bank in the world to get certified to the new standard.

• Omnex completed Lead Auditor workshop for Aero-Pak.

• Omnex conducted 2nd round of Enhanced auditing skills training workshop for Qatar Foundation in February of 2016. This course is built around the idea of auditing as a form of value addition rather than a requirement for maintaining ISO certification.

• Omnex signed 3 year contract for Lean Six sigma deployment at leading retail giant in Dubai.

• Omnex completed wave 1 of Lean Six Sigma transformation for a leading oil company in Me. the net savings reported are around US$ 240 Million from the 1st year of transformation projects. the project, which is of 3 years in duration, is well underway with many employees of the corporation being trained and over 45 projects are underway.

OMNEX EAST ASIA NEWS• Omnex completed Des ign for

Manufacturing and Design for Assembly workshops for leading government enterprise in Singapore.

• Omnex signed Operational Excellence project with a tire manufacturer in Sri Lanka. The culture-change project is being executed currently and involves consultants from India, Singapore and S.E. Asia offices.

• DELTA Electronics Thailand signed up with Omnex for Lean Six Sigma project execution and capability building.

• Omnex conducted CQI training workshops for leading Tier 1 company in thailand .

• Leading jewelry manufacturer in Thailand adopted EWQIMS software for their Business Excellence and Process improvements.

• Omnex completed Lean Six sigma project at a leading Bpo in philippines. The client who works with the airline industry has improved their overall standing in business over competitors and are well underway to acquire new businesses from other airlines.

• O m n e x h e l p e d l e a d i n g s h o e manufacturers in Vietnam and Indonesia in improving their product and process quality.

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aerospace and DefenseAS9100D Internal Auditor Training (Exemplar Global-certified training provider)

Aug 1-3-Ann Arbor, MIAug 8-10-Huntsville, ALSep 19-21-Seattle, WaOct 17-19-Ann Arbor, MINov 7-9-Seattle, WANov 14-Nov 16-Huntsville, AL Dec 12-14-Seattle, Wa

AS9100D Lead Auditor Training (Exemplar Global-certified training provider)

Aug 1-5-Ann Arbor, MIAug 8-12-Huntsville, ALSep 19-23-Seattle, WaOct 17-21-Ann Arbor, MINov 7-11-Seattle, WANov 14-Nov 18-Huntsville, AL Dec 12-16-Seattle, Wa

Understanding and Documenting AS9100D Quality Management Systems (Exemplar Global-certified training provider)

Aug 1-2-Ann Arbor, MIAug 8-9-Huntsville, ALSep 19-20-Seattle, WaOct 17-18-Ann Arbor, MINov 7-8-Seattle, WA Nov 14-Nov 15-Huntsville, ALDec 12-13-Seattle, Wa

automotive and production/Manufacturing Core tools

Core Tools Understanding (CTU) (APQP & PPAP, DFMEA & DVP&R, PFMEA & Control Plan, SPC, MSA)

Jun 06-10, 2016-Mississauga, ON Jun 06-10, 2016-Ann Arbor, MI Aug 01-05, 2016-San Jose, CA Sep 12-16, 2016-Mississauga, ON Sep 12-16, 2016-ann arbor, Mi

Understanding AIAG Sub-tier Supplier Management (CQI-19)

Jun 13-14, 2016-San Jose, CA Jul 18-19, 2016-Mississauga, ON

Jun 27-28, 2016-Ann Arbor, MI Oct 17-18, 2016-San Jose, CA oct 24-25, 2016-ann arbor, Mi Nov 14-15, 2016-Mississauga, ON

Energy Management (iSo 50001) Series

ISO 50001:2011 Internal Auditor Training

Apr 25-27, 2016-Ann Arbor, MI Jun 27-29, 2016-Ann Arbor, MI Aug 29-31, 2016-Ann Arbor, MI Nov 07-09, 2016-Ann Arbor, MI

ISO 50001:2011 Lead Auditor Training

apr 25-29, 2016-ann arbor, Mi Jun 27-Jul 01, 2016-Ann Arbor, MI Aug 29-Sep 02, 2016-Ann Arbor, MI Nov 07-11, 2016-Ann Arbor, MI

Understanding and Documenting ISO 50001:2011

apr 25-26, 2016-ann arbor, Mi Jun 27-28, 2016-Ann Arbor, MI Aug 29-30, 2016-Ann Arbor, MI Nov 07-08, 2016-Ann Arbor, MI

Environmental Management (iSo 14001) Series

ISO 14001:2015 Internal Auditor Training (Exemplar Global-certified training provider)

May 02-04, 2016-Mississauga, ON May 02-04, 2016-ann arbor, Mi Jul 25-27, 2016-Ann Arbor, MI Aug 22-24, 2016-Mississauga, ON Sep 19-21, 2016-ann arbor, Mi Oct 24-26, 2016-Mississauga, ON Dec 05-07, 2016-Ann Arbor, MI

ISO 14001:2015 Lead Auditor Training (Exemplar Global-certified training provider)

May 02-06, 2016-Mississauga, ON May 02-06, 2016-ann arbor, Mi Jul 25-29, 2016-Ann Arbor, MI Aug 22-26, 2016-Mississauga, ON Sep 19-23, 2016-ann arbor, Mi Oct 24-28, 2016-Mississauga, ON

Dec 05-09, 2016-ann arbor, Mi

Understanding and Documenting ISO 14001:2015 (Exemplar Global-certified training provider)

May 02-03, 2016-Mississauga, ON May 02-03, 2016-ann arbor, Mi Jul 25-26, 2016-Ann Arbor, MI Aug 22-23, 2016-Mississauga, ON Sep 19-20, 2016-ann arbor, Mi Oct 24-25, 2016-Mississauga, ON Dec 05-06, 2016-ann arbor, Mi

food industry Quality Standards Series

FSSC 22000 Internal Auditor Training (Exemplar Global-certified training provider) (FSSC 22000 Licensed Training Organization)

May 02-05, 2016-Mississauga, ON May 02-05, 2016-ann arbor, Mi Nov 28-Dec 01, 2016-Mississauga, ON nov 28-Dec 01, 2016-ann arbor, Mi

FSSC 22000 Lead Auditor Training (Exemplar Global-certified training provider) (FSSC 22000 Licensed Training Organization)

May 02-06, 2016-Mississauga, ON May 02-06, 2016-ann arbor, Mi Nov 28-Dec 02, 2016-Mississauga, ON nov 28-Dec 02, 2016-ann arbor, Mi

Understanding and Documenting FSSC 22000

May 02-03, 2016-Mississauga, ON May 02-03, 2016-ann arbor, Mi Nov 28-29, 2016-Mississauga, ON nov 28-29, 2016-ann arbor, Mi

integrated Management Systems Series

Integrated Management Systems for the Automotive Sector - Internal Auditor Training (ISO/TS 16949:2009, ISO 14001:2004 and OHSAS 18001:2007) (Exemplar Global-certified training provider)

apr 25-28, 2016-ann arbor, Mi

Jul 11-13, 2016-Ann Arbor, MI oct 31-nov 02, 2016-ann arbor, Mi

Integrated Management Systems for the Automotive Sector - Lead Auditor Training (ISO/TS 16949:2009, ISO 14001:2004 and OHSAS 18001:2007) (Exemplar Global-certified training provider)

Jun 20-24, 2016-Ann Arbor, MI Sep 26-30, 2016-ann arbor, Mi oct 31-nov 04, 2016-ann arbor, Mi

iSo 9001:2015 SeriesISO 9001:2015 Internal Auditor Training for Manufacturing or Service. (Exemplar Global-certified training provider)

Jun 06-08, 2016-Ann Arbor, MI Jun 13-15, 2016-San Jose, CA Jun 20-22, 2016-Miami, FL Jun 20-22, 2016-Houston, TX Jun 27-29, 2016-Pittsburgh, PA Jul 11-13, 2016-Mississauga, ON Jul 18-20, 2016-Chicago, IL Aug 08-10, 2016-Rutherford, NJ Sep 19-21, 2016-Houston, TX Sep 26-28, 2016-Chicago, il Sep 26-28, 2016-Miami, fl Oct 03-05, 2016-Rutherford, NJ Oct 17-19, 2016-Mississauga, ON nov 14-16, 2016-San Jose, Ca Dec 05-07, 2016-Chicago, IL

ISO 9001:2015 Lead Auditor Training for Manufacturing or Service (Exemplar Global-certified training provider)

Jun 06-10, 2016-Ann Arbor, MI Jun 13-17, 2016-San Jose, CA Jul 11-15, 2016-Mississauga, ON Jun 20-24, 2016-Miami, FL Jun 20-24, 2016-Houston, TX Jun 27-Jul 01, 2016-Pittsburgh, PAJul 18-22, 2016-Chicago, IL Aug 08-12, 2016-Rutherford, NJ Sep 19-23, 2016-Houston, TX Sep 26-30, 2016-Chicago, il Sep 26-30, 2016-Miami, fl Oct 03-07, 2016-Rutherford, NJ Oct 17-21, 2016-Mississauga, ON nov 14-18, 2016-San Jose, Ca Dec 05-09, 2016-Chicago, il

2016OMNEXOMNEX 20152016NORTH AMERICA TRAINING COURSE SCHEDULENORTH AMERICA TRAINING COURSE SCHEDULE

visit omnex.com/training to access our full training schedule


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Jun 06-07, 2016-Ann Arbor, MI Jun 13-14, 2016-San Jose, CA Jun 20-21, 2016-Miami, FL Jun 20-21, 2016-Houston, TX Jun 27-28, 2016-Pittsburgh, PA Jul 11-12, 2016-Mississauga, ON Jul 18-19, 2016-Chicago, IL Aug 08-09, 2016-Rutherford, NJ Sep 19-20, 2016-Houston, TX Sep 26-27, 2016-Chicago, IL Sep 26-27, 2016-Miami, FL Oct 03-04, 2016-Rutherford, NJ Oct 17-18, 2016-Mississauga, ON nov 14-15, 2016-San Jose, Ca Dec 05-06, 2016-Chicago, il

Risk and Implementing Risk Strategies for ISO Mgmt. Systems

Apr 07, 2016-Ann Arbor, MI Jun 09, 2016-Ann Arbor, MI Jul 14, 2016-Mississauga, ON Jun 16, 2016-San Jose, CA Sep 15, 2016-San Jose, Ca oct 06, 2016-ann arbor, Mi Nov 17, 2016-San Jose, CA Dec 01, 2016-Mississauga, ON

iSo/iEC 17025:2005 Series

Internal Auditor Training for ISO/IEC 17025:2005

May 02-04, 2016-ann arbor, Mi Aug 08-10, 2016-San Jose, CA Sep 26-28, 2016-ann arbor, Mi Nov 07-09, 2016-San Jose, CA Dec 05-07, 2016-Ann Arbor, MI

QMS Lead Auditor Training for ISO/IEC 17025:2005

apr 25-29, 2016-ann arbor, Mi Jul 18-22, 2016-Ann Arbor, MI oct 10-14, 2016-ann arbor, Mi

iSo 26262 for functional Safety

Understanding ISO 26262

May 16-20, 2016-San Jose, Ca Sep 12-16, 2016-Mississauga, ON oct 24-28, 2016-San Jose, Ca

iSo/tS 16949:2009 Series

Customer Specific Requirements and Core Tools - Effect on Process Approach To Auditing.

Jun 06, 2016-San Jose, CA Jun 27, 2016-Ann Arbor, MI Jul 25, 2016-Mississauga, ON Aug 01, 2016-San Jose, CA Aug 29, 2016-Ann Arbor, MI Sep 26, 2016-Mississauga, ON oct 03, 2016-San Jose, Ca oct 31, 2016-ann arbor, Mi Dec 05, 2016-San Jose, Ca Dec 12, 2016-ann arbor, Mi

ISO 9001:2008 Internal Auditor Training for the Automotive Sector (ISO/TS 16949:2009). (Exemplar Global-certified training provider)

Jun 06-08, 2016-Mississauga, ON Jun 13-15, 2016-Rutherford, NJ Jun 20-22, 2016-Houston, TX Jun 27-29, 2016-Ann Arbor, MI Jul 25-27, 2016-Ann Arbor, MI Aug 08-10, 2016-Mississauga, ON Aug 22-24, 2016-Ann Arbor, MI Sep 12-14, 2016-Mississauga, ON Sep 12-14, 2016-Houston, TX Sep 19-21, 2016-ann arbor, Mi Sep 26-28, 2016-San Jose, Ca Oct 17-19, 2016-Ann Arbor, MI Dec 05-07, 2016-Ann Arbor, MI

ISO 9001:2008 Lead Auditor Training for the Automotive Sector (ISO/TS 16949:2009) (Exemplar Global-certified training provider)

Jun 06-10, 2016-Mississauga, ON Jun 13-17, 2016-Rutherford, NJ Jun 20-24, 2016-Houston, TX Jun 27-Jul 01, 2016-Ann Arbor, MI Jul 25-29, 2016-Ann Arbor, MI Aug 08-12, 2016-Mississauga, ON Aug 22-26, 2016-Ann Arbor, MI Sep 12-16, 2016-Mississauga, ON Sep 12-16, 2016-Houston, TX Sep 19-23, 2016-ann arbor, Mi Sep 26-30, 2016-San Jose, Ca Oct 17-21, 2016-Ann Arbor, MI Dec 05-09, 2016-ann arbor, Mi

Understanding and Documenting ISO/TS 16949:2009 (Exemplar Global-certified training provider)

Sept 21-22

Soft Skills SeriesTeam Building and Facilitation Skills

Jun 06, 2016-San Jose, CA Jun 20, 2016-Ann Arbor, MI Jul 18, 2016-Mississauga, ON oct 03, 2016-San Jose, Ca oct 24, 2016-ann arbor, Mi Nov 21, 2016-Mississauga, ON

Mentoring


Social Media


Presentation Skills

Jun 14, 2016-San Jose, CA Jun 28, 2016-Ann Arbor, MI Jul 26, 2016-Mississauga, ON oct 11, 2016-San Jose, Ca nov 01, 2016-ann arbor, Mi Nov 29, 2016-Mississauga, ON

Negotiation Skills


Conflict Resolution

Jun 09, 2016-San Jose, CA Jun 23, 2016-Ann Arbor, MI Jul 21, 2016-Mississauga, ON oct 06, 2016-San Jose, Ca Oct 27, 2016-Ann Arbor, MI Nov 24, 2016-Mississauga, ON

Developing New Managers

Jun 10, 2016-San Jose, CA Jun 24, 2016-Ann Arbor, MI Jul 22, 2016-Mississauga, ON Oct 07, 2016-San Jose, CA oct 28, 2016-ann arbor, Mi Nov 25, 2016-Mississauga, ON

iSo 13485:2016 Medical Devices Series

ISO 13485:2016 Internal Auditor Training (Exemplar Global-certified training provider)

June 20-22-Ann Arbor, MIJune 27-29-San Jose, CAAug 8-10-Irvine, CAAug 15-17-Minneapolis, MNSep 12-14-San Jose, CaSep 19-21-ann arbor, MiSep 26-28-irvine, Caoct 24-26-Minneapolis, Mn Nov 7-9-San Jose, CA nov 14-16-ann arbor, Mi

ISO 13485:2016 Lead Auditor Training (Exemplar Global-certified training provider)

June 20-24-Ann Arbor, MIJune 27-31-San Jose, CAAug 8-12-Irvine, CAAug 15-19-Minneapolis, MNSep 12-16-San Jose, CaSep 19-23-ann arbor, MiSep 26-30-irvine, Caoct 24-28-Minneapolis, Mn Nov 7-11-San Jose, CA nov 14-18-ann arbor, Mi


June 20-21-Ann Arbor, MIJune 27-28-San Jose, CAAug 8-9-Irvine, CAAug 15-16-Minneapolis, MNSep 12-13-San Jose, CaSep 19-20-ann arbor, MiSep 26-27-Irvine, CAoct 24-25-Minneapolis, MnNov 7-8-San Jose, CA nov 14-15-ann arbor, Mi

2016OMNEXOMNEX 20152016NORTH AMERICA TRAINING COURSE SCHEDULENORTH AMERICA TRAINING COURSE SCHEDULE

visit omnex.com/training to access our full training schedule

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navigatorWho in the world is OMNEX?

ISO 9001 & ISO / TS16949 | AS9100 | ISO 26262 | ISO 14001 | OHSAS 18001ISO 50001 | FSSC 22000 | ISO 13485 | APQP | Risk Management | Lean Enterprise

Our global clients will tell you. We’ve implementedmanagement systems for many of the world’s top companies.

OMNEX INC

Global Headquarters315 E. Eisenhower ParkwaySuite 214, Ann Arbor, MI 48108, USAPhone: (734) 761-4940Fax: (734) 761-4966Email: [email protected]: www.omnex.com

Difficulties with

ISO 26262 for Functional Safety?

omnex can help.

Omnex has a team of Functional Safety experts and world class training courses to help you implement the highest quality Functional Safety for your Enterprise.