newly-released cqi-19 page 2 moving haptics … · continued on pg 2 continued on pg 3 chery jaguar...

Omnex • 325 E. Eisenhower Pkwy, Suite 4 • Ann Arbor, MI 48108 • USA • 734.761.4940 • [email protected]

Chery Jaguar Land Rover Automotive Co., China Chooses Ewims as Its DigitalAudit Platform

Ammachi Labs grabbed the attention of Omnex through their innovative use of Haptics in vocational training focused on literate and semi-literate women in India. In the US Haptics has gained widespread attention for training surgeons to perform high risk expensive surgery. For example, it is used to train surgical interns how to do “high-risk procedures such as temporal bone drilling near the brain,

Management Systems are Changing in 2015 and Beyond!ISO 9001 AND ISO 14001 STANDARDS UPDATE

Omnex Environmental/Sustainability EffortPERMACULTURE CLASSES

SUMMER

SUPPLIER MANAGEMENT USING THE NEWLY-RELEASED CQI-19 PAGE 2

MOVING HAPTICS FROM THE HOSPITALS TO EMPOWERING WOMEN PAGE 2

CHERY JAGUAR LAND ROVER AUTOMOTIVE CO.,CHINA CHOOSES EWIMS AS ITS DIGITAL AUDIT PLATFORM.

MANAGEMENT SYSTEMS ARE CHANGING IN 2015 AND BEYOND!

PAGE 3

PAGE 3

OMNEX ENVIRONMENTAL/ SUSTAINABILITY EFFORT PAGE 8

2014

Continued on pg 3 Continued on pg 8

Omnex is teaming up with several local organizations and the world’s leading Permaculture Design Expert to offer courses on the subject of Permaculture theory and Practicums. Omnex has a particular interest in environmental and social responsibility and is currently incorporating these important principles into its everyday business practices.

by R. Dan Reid - Director of Consulting

Moving Haptics from the Hospitals to Empowering WomenEMPOWERING WOMEN

Continued on pg 2 Continued on pg 3

Chery Jaguar Land Rover Automotive Co., Ltd. (CJLR) is a 50:50 joint venture between Chery Automobile and Jaguar Land Rover. CJLR is headquartered in Changshu, Jiangsu Province and has office in Shang-hai as well. CJLR will produce and sell Jaguar and Land Rover-branded vehicles and also JV brandedvehicles custom-made for the Chinese market.

The International Organization for Standardization (ISO) requires that their standards be reviewed every five years to determine if they need to be revised. When the review for ISO 9001:2008 (Quality Management System Requirements) came due in 2012, ISO conducted a global user survey which indicated that 27% of survey respondents thought that ISO 9001:2008 was “fine as it is.” Another 64% said it was “OK, but with enhancement.”

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navigatorSupplier Management Using the Newly-released CQI-19

The Automotive Industry Action Group (AIAG) in Southfield, Michigan recently released a new guideline for Sub-tier Supplier Manage-ment, CQI-19, as a result of concerns raised by automakers and their suppliers. It was reported that there are not enough compe-tent resources being applied to supply chain quality so CQI-19 was developed to provide a common process for supplier management to try to leverage scarce supplier quality re-sources. CQI-19 contains the latest thinking on the subject from major automotive sup-pliers and some of their customers based on industry “best practices.” The importance of CQI-19 is that the customer specific re-quirements of GM, Ford and Chrysler require suppliers to follow CQI-19.

Dan Reid, Omnex’s Director of Consulting, was the AIAG Project Manager for CQI-19 and says “the AIAG’s APQP process does not explicitly address supplier involvement. It provides a template for supplier new product development aligned to cus-tomer program milestones, but CQI-19 provides the supplier management guidelines that are missing

from APQP. CQI-19 also addresses the production phase of supplier management.”

CQI-19 addresses supplier management in four phases:

• Pre-selection, or Qualification

• Selection

• Advanced Product Quality Planning (APQP) / Production Part Approval Process (PPAP)

• Performance Monitoring, Development and/or Escalation

It also incorporates:

• A “risk-based” supplier management ap-proach which will be a new general re-quirement in the ISO 9001 revision targeted for 2015

• Materials Management Operations Guideline-Logistics Evaluation (MMOG-LE) developed by Chrysler, Ford and GM as a logistics companion to ISO/TS16949 for quality management;

• Capacity Verification including shared ca-pacity, and;

• AIAG’s Effective Problem Solving process for practitioners.

Omnex offers a two-day workshop on the AIAG CQI-19 to explain the process and re-quirements in detail. This workshop consists of lectures and breakout exercises. CQI-19 also provides an effective way to address the ISO/TS16949 requirements for supplier development and should be widely used by manufacturing companies in the automo-tive supply chain to implement a “best prac-tice” and risk-based supplier management approach. See Omnex.com for information about this workshop.

Moving Haptics from the Hospitals to Empowering Women Continued from page 1

where the slightest deviation can create wide-spread and permanent adverse consequences”. Ammachi Labs has used this innovative and high tech method to train women plumbers in India.

http://www.youtube.com watch?v=uJODZ9nXYWM.

Omnex has entered into an agreement with Ammachi Labs located in Kerala, India

http://www2.amrita.edu/centers/ammachi/research

to develop Haptics devices for technical training around the world for Omnex and Omnex customers.

The use of Haptics has been confined to hospi-tals or the like due to the high cost of developing this training. Omnex believes this training can be used for any type of learning activity where scrap and or the expense of the practice in real tool or machine is cost prohibitive. Call Omnex to find out more information to enable your company to apply Haptics or computer based training.

Haptics is technology that is used to provide real life experience of touch and

feel using computer simulations in learning situations. Haptics is defined as a technology

that “recreates the sense of touch by applying forces, vibrations, or motions to the user. [1]This mechanical stimulation can be used to assist in the creation of

virtual objects in a computer simulation, to control such virtual objects, and to

enhance the remote control of machines and devices (telerobotics).” Wikipedia.“


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CJLR committed to standardize its entire Audit Management practices and has selected Omnex’s EwIMS – Audit Pro® to manage its integrated Audits. This contract is part of CJLR’s ambitious drive to harmonize all Audit Processes and optimize the value it produces for its customers. Within Omnex Software Group, China is one of the fastest growing countries in the world and one of the most important regions we serve. The rapid development of the automotive industry in China is well recognized and extremely exciting. We are very proud to partner with CJLR and to share our global experience within the automotive industry, helping automotive manu-facturers grow into world leading companies with strong R&D capabilities. Omnex & CJLR have created an aggressive Implementation plan to implement this solution and march towards the goal. Product Customizations will also be a part of this imple-mentation to align EwIMS to CJLR requirements.

This announcement will foster long-term coopera-tion between CJLR and Omnex Software in applying

Omnex’s solutions in the automotive industry. It will enable both parties to contribute to the de-velopment of the larger automotive industry in

China through the implementation of smart and productive manufacturing strategies.

InspectionControl

CpK

PpK

Pp

8-D/CAR

Concerns

Training Management

Personal objectives

Survey development and analysis

Actions

Performance

Customer Expectations

Corrective Action

Audit Report

Internal/External Audits

SupplierInformation

Process Flow

FMEA

Control Plan

PPAP/FAI

Meetings & Action Plan

Project Reviews

Project Plan

Project Charter

MTTR

MTBF

Maintenance Plans

MSA

Calibration

Maintenance Plans

Competence& Training

Management

AuditManagement

GAGE Management

& MSA

APQP/PPAPManagement

TotalProductive

Maintenance

Problem Solving & Concern

Management

ProcessRealization

PPAP/FAI

ContinualImprovement

& Management Review

Control of Document &

Records

Information Business Systems Product Realization Repositary

Chery Jaguar Land Rover Automotive Co., China cherry-picks EwIMS as its digital Audit Platform. Continued from page 1

Management Systems Are Changing in 2015 and Beyond!

Continued from page 1

The survey respondents represent a small sample size for such a large population. The results do not suggest a mandate for significant change, but the decision was nevertheless taken by ISO to revise the standard. Why?.

The ISO Technical Committee (TC) 176 responsible for quality management system documents has in-dicated that ISO 9001 is being revised to:

Based on the drafts to date of the revised standard, the revision will likely cause some problems. The standard is now being written more generically to increase its appeal to non-manufacturing sectors. There is less emphasis on documentation, and no longer a requirement for a quality manual. The likely result is that there will be more variability in audit results than with the current version. The revision will require auditors to perform more interviews and audit a larger sample size to determine conformity

• Account for changes in quality manage-ment systems (QMS) practices and tech-nology since the last major revision to ISO 9001 in 2000

• Provide a stable core set of requirements for the next 10 years or more

• Ensure requirements in the standard reflect changes in the increasingly complex, demanding and dynamic envi-ronments in which organizations operate

• Ensure requirements are stated to fa-cilitate effective implementation by organizations and effective conformity assessments by first, second and third parties, as applicable

• Ensure the standard is adequate to provide confidence in those organizations meeting the standard’s requirements

• Decrease the emphasis on documented procedures

• Increase the emphasis on achieving value for the organization

• Increase emphasis on risk management

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where there are fewer records or other documen-tation to provide the evidence. Some prefer this option, but it will surely drive up the cost of audits as well as allow more variation in the audit results.

Also, the removal of previously agreed-upon verbiage used in today’s standards will be objectionable to manufacturing sectors where ISO 9001 has thrived.

Annex SL is developed

Prior to drafting the text of a revised ISO standard, a design specification is developed. The design speci-fication for the next revision to ISO 9001 includes a requirement that “the revised standard will apply Annex SL to the ISO/IEC Directives, Procedures spe-cific to ISO, third edition, 2012, to ISO 9001 to enhance its compatibility and alignment with other ISO man-agement system standards.” So, what is Annex SL? ISO has long had an interest in driving the use of integrated management standards. A report of the ISO Technical Management Board Ad-Hoc Group on MSSs advocated such standards in February 2006. Annex SL is just the latest in these attempts.

ISO/IEC Directives Part 1, Consolidated ISO supple-ment, 2013, Annex SL, Appendix 26 “sets out the high-level structure, identical core text, and common terms and core definitions that are to form, when pos-sible, the nucleus of future and revised management system standards such as ISO 9001, developed by the Joint Technical Coordination Group. The guidance and structure given in Appendix 2 to this Annex SL shall, in principle, also be followed” (based on ISO/Technical Management Board resolution 18/2012).

Notice the use of the qualifying phrases on two oc-casions from this directive: “when possible” and “in principle.” It was not intended that there would strictly be no deviations from this guidance. In reality, though, the drafters of the ISO 9001 revision have taken this more literally and are not considering amendments or deletions from the high-level struc-ture or common text.

The Annex SL high-level structure for all new or revised management system standards going forward will consist of 10 Clauses:

1. Scope

2. Normative References

3. Terms and Definitions

4. Context of the Organization

5. Leadership

6. Planning

7. Support

8. Operational Planning and Control

9. Performance Evaluation

10. Improvement

This mandated structure also has common text that must be used with some of these elements. New elements, such as context of the organization, and new terms, such as “documented information,” “innovation,” “risk-based thinking,” “context of the organization,” “organizational knowledge,” and “contingency actions”will likely drive the need for additional processes and training for many currently-certified organizations. Other requirements already common across the key MSSs have been deleted, such as a management representative, an MSS manual, preventive action and “exclusions”.

The current ISO standards development process takes as long as it does—five years or more—to reach consensus to ensure the standards can be accurately translated into local languages and applied to all types and sizes of organizations. This process has been bypassed by the committee that developed Annex SL. The U.S. delegation and others have objected to this but the global consensus is to proceed

Annex SL has already met significant resistance from manufacturing sectors—automotive, aerospace and medical devices. It has been viewed as a return to a “clause-based approach” even though there is now a requirement in the draft standard mandating the use of the process approach, which was introduced in ISO 9001:2000.

The automotive sector has already petitioned ISO and was granted a waiver to continue to use the current edition of ISO 9001. For organizations that have automotive and other customers, this could mean compliance with two versions of ISO 9001.

The ISO drive for integrated management systems

would not be so objectionable if it used existing text from one or more of the currently issued MSSs for the mandated common text. There is already a high degree of alignment of MSSs, such as ISO 14001, OHSAS 18001 and others issued recently. This would forego the need for new training on the terms while avoiding potential translation problems in the national versions of the new standard. It would respect the intent of the ISO consensus process for standards development.

The biggest impact of implementing Annex SL, however, is not on ISO 9001.

ISO 14001 – Environmental Management System (EMS) Requirements

ISO 14001 was also reviewed and is being revised at this time. It is also targeted for release next July. The number of clauses in the new ISO 14001:2015 will increase from four to the 10 mandated by Annex SL. The length will also in-crease considerably from the 2004 edition, for example, Committee Draft (CD)2 increased from 23 to 44 pages.

There currently is not an element in ISO 14001 for top management, but there will be in the new revision. The revision also will include a require-ment for value chain control—whether goods are procured from an outside supplier or affiliated lo-cation. The context of the organization is new for all current management system standards includ-ing ISO 14001. There are also implications for ISO 14001-related standards, such as OHSAS 18001/ANSI Z10, Responsible Care 14001.9

It remains to be seen how much appetite there is in the global community for changes to ISO 14001, especially based on Annex SL. The trend for third-party EMS certification is already on the decline with a couple of exceptions.

OHSAS 18001 / ISO 45001 – Occupational Health & Safety Management System Requirements

In March of 2013, the British Standards Institution (BSI) submitted a proposal for a new international standard that would specify requirements for an

Management Systems Are Changing in 2015 and Beyond!Continued from page 3


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What Should You Do Now?This column is not suggesting that all of the planned MSS changes are bad. However, the process and approach used to develop and mandate Annex SL is flawed and will likely have lasting ramifications if it is implemented as planned.

Do not, therefore, begin implementing any of the drafts’ new requirements just yet. There will be additional drafts of the standards now being revised, and more changes are likely. Also, don’t assume your current MSS documentation-your quality manual-procedures are obsolete. If they are still appli-cable, they can be used with the new standard to efficiently prove to auditors that processes are working and are effective. So what should you do now?

• Develop an organization position on the proposed ISO 9001 changes and communicate your position to your customers. There likely will be auditability concerns and additional auditing costs.

• Provide comments on the drafts to your national standards body. It is not too late to get revisions to the current plan. The deadline for submission of comments to the US body, ASQ, is July 15, 2014.

• Know what is going on and be ready to implement any new requirements. A transition period will be designated for implementing any new standard. In the past, this has been up to three years.

• Have processes that accommodate any new clauses. This can be facilitated by implementing an integrated management system for your organization, but one that is based on an approach that makes sense for your organization. Eventually, clause cross-references can be implemented or updated to show how your system maps to any of the customer-required ISO stan-dards. There is a lot of redundancy among current ISO management system standard content, e.g. internal audit, management review, or competency that can be effectively leaned out, even now. Omnex helps companies effectively integrate various stan-dards into one lean management system. See omnex.com for more information on our training and consulting expertise.

occupational health and safety (OH&S) management system. According to the proposal, the standard would define requirements for an OH&S system, with the goal of providing organizations with in-creased control over OH&S risks and providing for improved performance in this area. The standard would not establish specific performance criteria for OH&S and would not provide detailed specifications for the design of an OH&S management system. It is expected that the standard would be applicable to any organization seeking to establish, maintain, or improve an OH&S management system. It would

not address product safety, environmental impacts, or other health and safety-related subjects.

ISO/Project Committee (PC) number 283 was estab-lished in June 2013 by the ISO Technical Manage-ment Board to develop this standard.ISO advised that the future standard will be ISO 45001 as the number 18001 has already been assigned to a dif-ferent standard. Some of the key issues the PC has to resolve within the standard concern: the appli-cation of “risk”; “people” under the control of the management system; the understanding of what

constitutes the “workplace”; and participation in the setting of policies and objectives. The target date for publication of ISO 45001 is October 2016.

Management Systems Are Changing in 2015 and Beyond! Continued from page 4

R. Dan Reid is director of consulting at Omnex Engineering and Management in Ann Arbor, MI.

He is the first delegation leader of the International Automotive Task Force, an author of ISO Technical Specification 16949, QS-9000/QSA, ISO 9001:2000, the first ISO International Workshop Agreement, and its replacement, Automotive Industry Action Group’s Business Operating Systems

for Healthcare Organizations (HF-2). Reid is an ASQ fellow and certified quality engineer.

Visit www.omnex.com for a free webinar and a paid webinar on the new standards.

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navigatorEwIMS helps you drive Continuous QualityImprovement & Business Excellence across the Enterprise.

EwIMS helps you drive Continuous QualityImprovement & Business Excellence across the Enterprise.

EwIMS Modules

APQP PPAP Manager - APQP Program Management

AQuA Pro - PPAP Document Generation

Document Pro - Document Management & Control

Audit Pro - Integrated Audit Management

MSA Pro - Gages & MSA Studies Management

Problem Solver - Internal & Customer concern Management

TPM Pro - Total Productive Maintenance Management

HR Pro - Training & Competency Management

BOSS - Continual Improvement & Dashboards

Industries served

Aerospace Automotive Food Industry Energy Management

Others.....

Semiconductor

“The Only Thing That Is Constant Is Change” - Heraclitus


navigatorN 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

Keeping close tie with ZF-Group and Omnex

ZF-Group is a leading worldwide automotive supplier for Driveline and Chassis Technology as well as being one of the most important manufacturers of transmission system products.

ZF has selected Omnex as its training and con-sulting provider for more than 20 companies in China since 2010 in an effort to emphasize the importance of product quality and staff train-ing. This includes quality improvement, research and development, Lean and Six Sigma, Supplier Chain Management, etc… So far Omnex has provided the overall training and consulting services for nearly 400 employees of ZF group.

Since Omnex began working with ZF in 2010, the number of the ZF sub-companies trained by Omnex has increased from five to more than 10.

Due to the effectiveness of the training programs

and high ratings from trained employees, ZF has viewed our cooperation as very successful, and has extended our relationship to encompass the Asia Pacific area as well as China. Omnex has also been invited to take part in ZF’s sup-plier meetings in July 2010 and May 2014 as the main supplier of their non-production material.

Omnex North America

Omnex has concluded a global contract with Magna to provide quality training for a specified global curriculum offered in English, Spanish, Korean, Hindi, Chinese, Korean and multiple European and Eastern European languages.

The International Aerospace Quality Group (IAQG) recently released an Advanced Product Quality Process Guideline patterned after the time-tested automotive version, including adop-tion of the Production Part Approval Process (PPAP). Omnex worked with the drafting com-mittee for this project and is now offering a class to support the global aerospace roll out.

Omnex is a sanctioned provider of GM’s new QSB+ Supplier Training. General Motors and

PSA Peugeot Citroen have revised their Quality System Basics (QSB) supplier manufacturing ex-pectations to include several new modules. Also revised is the QSB assessment which is now integrated with their New Supplier Assessment (NSA) and Process Control Plan Audit (PCPA). The new process renamed to QSB Plus (+) is a complete manufacturing system assessment to verify implementation of QSB+ key elements on the supplier’s shop floor. Successful imple-mentation results in a QSB+ certification status which positively impacts the supplier’s Bid List performance at GM and PSA.

Omnex India

A Dealer Management System has been de-signed and developed for use at more than 50 dealers of SKODA Automotive in India. The Dealer Management System developed for Skoda is a customized world-class system and is based on 5 broad categories of dealer performance improve-ment, aimed at increasing customer satisfaction.

South East Asia

Omnex is currently helping to develop capabil-ity of the shoe manufacturing industry with a unique supply chain strategy. In partnership with a leading worldwide shoe manufacturer, Omnex established a customized supplier development model and is implementing it across S.E. Asia and China.

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In 2009 the International Aerospace Quality Group (IAQG) released a revision to AS9100, the quality management system (QMS) standard for the Aviation, Space and Defense industries. The AS9100 quality standard is based on ISO 9001, adding requirements specific to Aerospace. The goal of the IAQG is to improve product quality

and on-time delivery of products through the cooperative implementation of initiatives in-tended to make significant improvements in quality and reductions in cost throughout the value stream.

The most recent initiative is the addition of

Advance Product Quality Planning (APQP) to the Supply Chain Management Handbook (SCMH) . The latest upload of documentation for this initiative is April 2014 although individual APQP Phase Checklists were made available in December 2013.

Omnex CSR initiative - Permaculture Continued from page 1

Aerospace APQP

From measuring our social impact in our consulting and training business to reach-ing out to our community partners, Omnex is working to commit itself to integrat-ing these theories into its Corporate Social Responsibility Plans.

Darren Doherty is internationally recognized as a leader and pioneer in permaculture and regenerative agriculture. He will be in Ann Arbor, MI in August to deliver a series of seminars and workshops incorporating permaculture into both urban garden and small to large scale farm sites.

Two free 1 hour seminars will be offered at local community locations. The Amma Center of Michigan and the University of Michigan Botanical Gardens will play host to those interested in either applying permaculture practices into their home gardens or farms.

Two other workshops will be offered for a minimal cost to those who wish to learn more in depth techniques from Mr. Doherty in a farm setting. Again these are divided into two distinct interest groups as above. Darren will share

his vast knowledge and experience to those in Omnex’s neighboring communities.

Information on these seminars can be located at www.omnex.com or by calling 734-761-4940. Seminars are located in the Bay Area of California, Chicago, IL and Ann Arbor, MI.

Omnex is proud to be a part of this important sharing of information to the community and will continue to work on programs of this type in the future.

Implementing Integrated Management Systems – QMS, EMS and OHSMS including Aerospace, Automotive and Food Safety Management Systems

Organizations today are implementing stand-alone systems for their QMS (ISO 9001, ISO/TS 16949, or AS9100), EMS (ISO 14001), and OHSAS (ISO 18001). Worse yet, they are duplicating systems in each of their sites – plants, design centers or sales offices.

The time for integration and standardization has arrived. Organizations are realizing that integration saves money.

Omnex estimates that integration reduces im-plementation costs by 50% and maintenance costs by 60%. Also, third party auditing costs are reduced by over 20%.

Integration and standardization can be applied in organizations from both Service to Manufac-turing for all sorts of industries including auto-motive, aerospace, and food, among others.

Implementing Integrated Management Systems Omnex Consultants Chad Kymal, Dan Reid and Greg Gruska will be authors of this exciting new book.

What are Integrated Management Systems including PAS 99?Integration vs Standardization, Why we need both?Integrating Processes between QMS, EMS, OHSAS, and Food Safety Management SystemsIntegrated Risk Management for Quality, Environmental and Health and Safety

Conducting Integrated Audits

How an integrated and standardized management system performs for maximum effectiveness? Integration with GFSI Standards in the Food Industry – a case studyIntegration in an automotive organization - a case study. Integration in a service environment- a case study Integration in an Aerospace organization - a case study.Integration in a Semiconductor Organization – a case studyIntegrating QMS, EMS, OHSAS and Social ResponsibilityLessons learned from IMS ImplementationsEnterprise Integrated Management System (EwIMS) Software and its key principles

HIGHLIGHTSCHAPTER 1

CHAPTER 2

CHAPTER 3

CHAPTER 4

CHAPTER 5

CHAPTER 14

CHAPTER 13

CHAPTER 12

CHAPTER 11

CHAPTER 10

CHAPTER 9

CHAPTER 8

CHAPTER 7

CHAPTER 6

NEW BOOK


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Automotive

Aerospace

Chemical

Commercial Vehicle

Manufacturing

TransportationSoftware

Food Safety

Pharmaceutical

Healthcare

Oil & Gas

CONSULTING | TRAINING | SOFTWARE

“Building Business Excellence Globally - USA, SE Asia,China, India, Europe and S America.”

“Building Business Excellence Globally - USA, SE Asia,China, India, Europe and S.America.”

ISO Standards, Sector Standards and Guidelines, includingISO Standards, Sector Standards and Guidelines, including

ISO 9001

ISO 14001

ISO 26262

ISO 50001

ISO 17025

ISO 13485

ISO/TS 16949

AS 9100

VDA 6.3

FSSC 22000

SQF 2000

BRC

Expert Training and Consulting

Omnex Engineering and Management Inc,.

Quality Tools, includingQuality Tools, including

APQP/PPAP

MSA

SPC

FMEA (System, Design & Process)

Error-Proofing

Effective Problem Solving

Risk Management

GD&T

Lean/Six SigmaLean/Six Sigma

Global Headquarters

325 E. Eisenhower Parkway Suite 4,

Ann Arbor, MI 48108, USA

Phone: (734) 761-4940 | Fax: (734) 761-4966

Email: [email protected] | Web: www.omnex.com

9


navigatorJune 2014 – ISO 17025 Revision Proposed!During the 2013 ILAC General Assembly, the ILAC Laboratory Committee (LC) requested that ILAC submit a New Work Item Proposal to ISO/CASCO to revise ISO/IEC 17025:2005 as soon as practicable.

The rationale being that ISO/IEC 17025 is scheduled for systematic review in 2015 which means that after the ISO formal processes have concluded it will most likely be 2016 before the actual revision of the document will be able to commence. The ILAC Labora-tory Committee, which is a committee made up of ILAC Stakeholder members with a labo-ratory focus as opposed to accreditation body members felt the need to encourage some further action as the standard was 8 years old at that time and it is likely to take several years to finalize a revision.

As a result of the General Assembly discus-sion on the LC proposal, the draft resolu-tion was amended to take into account the request from members, to consult with their accredited laboratories before being asked to vote on whether or not to proceed with submitting a proposal for the revision of ISO/IEC 17025 to ISO/CASCO. The resolution was subsequently amended to reflect this request.

The current standard is nine years old and contains references to documents that no longer exist under the designation shown in the current standard, e.g. ISO/IEC Guide 43-1 and Guide 43-2; ISO/IEC Guide 58:1993 and ISO/IEC Guide 65, while other references are not to the most recent versions, eg ISO 9001:2000.

In the wider market place it has been noted that there are examples of regulators and specifiers hesitating to adopt a system that

relies on such an out of date standard.

The ILAC Executive Committee subsequently agreed that the information below was to be used in support of the NWIP for the revision of ISO/IEC 17025.

Clauses of ISO/IEC 17025 that require revision:

The clauses of ISO/IEC 17025 where there is con-sensus amongst the ILAC AIC that revision is needed include:• 5.4 Calibration, Measurement Uncertainty &

Validation/Verification• 5.5 Equipment (possibly)• 5.6 Traceability*• 5.7 Sampling• 5.9 Quality Assurance including

Proficiency Testing• 5.10 Reporting Results

(opinions/interpretation)

Other areas that should be considered in the re-vision include, not listed in order of importance:• The terminology used in the current standard is

outdated and causes confusion in today’s world, e.g. changes to VIM terminology and the fact that hard copy is now rarely used for manuals, records and reports;

• The scope requires revision and updating to cover new areas;

• ISO/IEC 17025 takes a prescriptive approach and is out of step with the modern standards approaches which are performance-based or process-based. The formatting should also be matched to newer standards such as ISO 9001, ISO 15189, ISO/IEC 17020, ISO/IEC 17043, ISO/IEC 17021, ISO/IEC 17065;

• Bio-security and bio-safety considerations associated with laboratory work should be added;

• Impartiality needs to be addressed in a more informed way;

• Subcontracting circumstances need to be clari-fied (reference to how this is handled in ISO/IEC 17043 would be helpful);

• Traceability requirements should be expanded/clarified along more informed lines;

• Sampling and sub-sampling needs to be con-sidered with more recognition that reliable test results are directly related to sampling;

• Consider pre- and post- analysis requirements;• Reconsider the handling of testing and calibration

as separate parts of the standard. The reasons for any different approaches in the standard between these areas should be clarified;

• Review ISO/IEC 17000 and its relevance to ISO/IEC 17025;

• Incorporate and recognize the use of com-puter systems, electronic records and report issue, as well as remote issue, of results/reports;

• Address software validation to allow for its rel-evance to testing and result generation, as well as records management;

• Clarify further the possible conflict that may exist between ISO/IEC 17025 and na-tional regulations and the need to establish precedence;

• Consider the relevance of the product certifica-tion standard (ISO/IEC 17065) to ISO/IEC 17025;

• Ensure that notes are avoided in the future standard version. There are too many notes included in the current version which make it difficult to use;

• Update the Bibliography.

The proposal states that ISO 17025 is not a manage-ment system standard (MSS) so it will not have to follow the mandatory clause structure and common text that is now required for all new or revised MSS’s.

UPCOMINGWEBINARS

Strategies for Next-Generation Enterprise Quality Management – July 21, 2014 2-3pm EDT

CQI-19: Understanding Supplier Management – September 5, 2014

Aerospace Risk Management – September 5, 2014

Customer-Specific Requirements of Select American and European OEMs – TBD 4th Quarter 2014

Prepare for ISO 14001:2015 – TBD 4th Quarter 2014

Prepare for ISO 45001 (formerly OHSAS 18001) – TBD 4th Quarter 2014

Contact us for information on how to register for these webinars or to view recorded versions


navigatorKOC Launches Lean Six Sigma Program

Kuwait Oil Company (KOC) has embarked on an ambitious Lean Six Sigma (LSS) program t o wa rd s a c h i e v i n g t h e o rga n i za t i o n a l excellence as part of KOCs strategic objective goal . Lean Six Sigma methodology is an approach with a view to improve efficiencies, reduce errors & defects and generate savings. Lean six sigma that originated in the USA is a proven methodology that has generated

billions of dollars of savings for companies across the world, including most fortune 500 companies.

The Management Support Group (MSG) has signed a contract with global consultant Omnex Inc. USA to assist KOC in this journey.

T h i s L S S p ro j e c t i s s p o n s o re d b y KO C leadership and facilitated by the Manager-

Management Support Group. The LSS project shall be implemented across KOC covering all directorates in a phased manner in the next three (3) years.

T h e p r o g ra m e s h a l l b e l e d b y s e n i o r management at each directorate and shall have project teams consisting of representatives from various KOC functions.

Omnex and ERAM International Announce Partnership

Eram International, Saudi Arabia and Omnex Inc. announced the formation of a Global Training and Consulting partnership between the two companies to offer Quality and Manufacturing improvement Training and Consulting programs in the Middle East. As part of the agreement, Eram-Omnex will have the capability to deliver more than 240

workshops created by Omnex that include accreditation training programs in Saudi Arabia, Bahrain, Qatar, and Kuwait. The Al-Khobar office will be the second office of Omnex in Middle East.

Eram International is a member of the Eram Group, headed by its Chairman, Dr. Siddeek

Ahmed. Eram Group currently has operations in most of the Middle Eastern countries and has successfully made its mark in Inspection, Training, Oil & Gas, Construction, Engineering, Healthcare and Hospitality industries.

11


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VISIT THE OMNEX RESOURCE CENTER ONLINE!The Omnex Resource Center provides you with valuable information on business management systems and quality initiatives. You will find timely articles, presentations, whitepapers, archived Navigators, and Quality Reference Links.

visit: www.omnex.comRESOURCE

CENTER


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Aerospace and Defense

AS9100C Internal Auditor Training (Exemplar Global-certified training provider)

ANN ArBOr, MI August 11-13, December 1-3

SEAttlE, WAAugust 11-13, September 29-October 1

AS9100C Lead Auditor Training (Exemplar Global-certified training provider)

ANN ArBOr, MIAugust 11-15, December 1-5

HuNtSvIllE, AlOctober 13-17

SEAttlE, WAAugust 11-15, September 29-October 3

AS9110B Internal Auditor Training (Exemplar Global-certified training provider)



AS9110B Lead Auditor Training (Exemplar Global-certified training provider)

ANN ArBOr, MIAugust 11-15, October 13-17 , December 1-5,

AS9120A Internal Auditor Training (Exemplar Global-certified training provider)

ANN ArBOr, MIAugust 11-13, October 13-15 , December 1-3,

AS9120A Lead Auditor Training (Exemplar Global-certified training provider)

ANN ArBOr, MIAugust 11-15, October 13-17, December 1-5,

Understanding and Documenting AS9100C Quality Management Systems (Exemplar Global-certified training provider)


SEAttlE, WA August 11-12, September 29-30

Understanding and Documenting AS9110B Quality Management Systems (Exemplar Global-certified training provider)



Understanding and Documenting AS9120A Quality Management Systems



Automotive and Production/Manufacturing Core Tools

Core Tools Training Module 1 - APQP & DFMEA (Exemplar Global-certified training provider) ANN ArBOr, MISeptember 23-27

SAN JOSE, CAAugust 4

Core Tools Training Module 2 - FMEA/Control Plan

ANN ArBOr, MISeptember 30


Core Tools Training Module 3 - Production Part Approval Process (PPAP)

ANN ArBOr, MIOctober 1


Core Tools Training Module 4 - Statistical Process Control (SPC)



Core Tools Training Module 5 - Measurement Systems Analysis (MSA) 4th Edition



Core Tools Understanding (CTU) (APQP & DFMEA, FMEA/Control Plan, PPAP, SPC, MSA)

ANN ArBOr, MISeptember 29-October 3

SAN JOSE, CAAugust 4-8

Effective Problem Solving

ANN ArBOr, MISeptember 8-9

Machine Failure Mode Effect Analysis (MFMEA)

ANN ArBOr, MIAugust 25-26, November 3-4

Measurement Systems Analysis (MSA) and Advanced Analysis (ANOVA)

SAN JOSE, CAAugust 24-25, October 20-21

Energy Management (ISO 50001) Series

ISO 50001:2011 Internal Auditor Training


ISO 50001:2011 Lead Auditor Training


Understanding and Documenting ISO 50001:2011


2014OMNEXOMNEX 20142014NORTH AMERICA TRAINING COURSE SCHEDULENORTH AMERICA TRAINING COURSE SCHEDULE

CQI – 19


NEW COURSES

QSB+

ANN ArBOr, MIJuly 30-August 1

GD&T

ANN ArBOr, MINovember 10-11

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navigatorOMNEX 2014 NORTH AMERICAN TRAINING COURSE SCHEDULE

Environmental Management (ISO 14001) Series

ISO 14001:2004 Internal Auditor Training (Exemplar Global-certified training provider)

ANN ArBOr, MISeptember 22-24, November 3-5

DAllAS, tXSeptember 8-10

rutHErfOrD, NJSeptember 8-10

SAN JOSE, CANovember 3-5

ISO 14001:2004 Lead Auditor Training (Exemplar Global-certified training provider)





Understanding and Documenting ISO 14001:2004 (Exemplar Global-certified training provider)





Excelerated Six Sigma® Series

Excelerated Six Sigma® Green Belt Training

ANN ArBOr, MISeptember 22-26,

Food Industry Quality Standards Series

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

ANN ArBOr, MIAugust 4-7, October 6-9

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


Understanding and Documenting FSSC 22000


Integrated Management Systems Series

Integrated Management Systems Internal Auditor Training (OHSAS 18001, ISO 14001 and ISO 9001) (Exemplar Global-certified training provider)


Integrated Management Systems Lead Auditor Training (OHSAS 18001, ISO 14001 and ISO 9001) (Exemplar Global-certified training provider)

ANN ArBOr, MIJuly 28-August 1, October 13-17

Understanding and Documenting Integrated Management Systems of ISO 9001:2008 with ISO 14001:2004 and/or OHSAS 18001:2007 Including System Documentation Integration


ISO 13485:2003 Series

ISO 13485:2003 Internal Auditor Training (Exemplar Global-certified training provider)

ANN ArBOr, MIAugust 4-6, October 20-22, December 15-17

MINNEApOlIS, MNOctober 13-15,

SAN JOSE, CASeptember 15-17 ISO 13485:2003 Lead Auditor Training (Exemplar Global-certified training provider)


BOStON, MAAugust 18-22, November 10-14

HuNtSvIllE, AIAugust 11-15, November 3-7

MINNEApOlIS, MNOctober 13-17

rutHErfOrD, NJAugust 25-29, November 17-21

SAN JOSE, CASeptember 15-19



MINNEApOlIS, MNOctober 13-14,


ISO 26262 Series Auditing to ISO 26262 Functional Safety Management Systems Standards


Understanding ISO 26262: Functional Safety Management System

ANN ArBOr, MIAugust 11-15, November 17-21, December 15-17


ISO 9001:2008 Series ISO 9001:2008 Internal Auditor Training for Manufacturing or Service (Exemplar Global-certified

training provider)

ANN ArBOr, MIAugust 18-20, September 15-17, October 20-22, November 10-12, December 8-10

DAllAS, tXOctober 13-15

lOS ANgElES, CAAugust 11-13, November 17-19

rutHErfOrD, NJOctober 13-15

SAN JOSE, CAAugust 18-20, November 6-8

SEAttlE, WAOctober 13-15

ISO 9001:2008 Lead Auditor Training for Manufacturing or Service (Exemplar Global-certified training provider)








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ISO/IEC 17025:2005 Series

Internal Auditor Training for ISO/IEC 17025:2005


ISO/TS 16949:2009 Series

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


lOS ANgElESAugust 11-13, November 17-19,

SAN JOSE, CAAugust 18-20, October 6-8,

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




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




OHSAS 18001:2007 Series

OHSAS 18001:2007 Internal Auditor Training (Exemplar Global-certified training provider)


DAllAS, tXSeptember 8-10,

rutHErfOrD, NJSeptember 8-10,

SAN JOSE, CA November 3-5,

OHSAS 18001:2007 Lead Auditor Training (Exemplar Global-certified training provider)





OHSAS 18001:2007 Understanding and Documenting (Exemplar Global-certified training provider)





Permaculture Design

Applied Permaculture Design Workshop

ANN ArBOr, MIAugust 21-24,

CHICAgO, IlAugust 16-19,

Permaculture Practicum Workshop

ANN ArBOr, MIAugust 23-24

CHICAgO, IlAugust 18-19

Permaculture Theory Workshop

ANN ArBOr, MIAugust 21-

CHICAgO, IlAugust 16-17

Practicing Permaculture in Home Gardens and Urban Settings

ANN ArBOr, MIAugust 25

Successful Farm Enterprises using Permaculture Design


Urban Gardens with Permaculture Design


Drought-Proofing Farms in California

SAN rAMONAugust 9

From Orchard Tom Stacked Enterprise

SAN rAMONAugust 11

Reforestation for Profit

SAN rAMONAugust 10

QOS/BOS SeriesQuality System Basics Plus (QSB+)

ANN ArBOr July 30-August 1

R&D SeriesGeometric Dimensioning & Tolerance (GD&T) Gage Design

ANN ArBOr, MINovember 10-11

Social Responsibility/Sustainability (ISO 26000) Series

Understanding and Documenting ISO 26000


VDA SeriesConducting Process Audits to VDA 6.3

ANN ArBOr, MISeptember 10-12, November17-19

OMNEX 2014 NORTH AMERICAN TRAINING COURSE SCHEDULE

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Omnex is an Exemplar Global-certified Training Provider for the Understanding

and Documenting, Internal Auditor and Lead Auditor courses as noted

15

Who 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 Headquarters325 E. Eisenhower ParkwaySuite 4, Ann Arbor, MI 48108, USAPhone: (734) 761-4940Fax: (734) 761-4966Email: [email protected]: www.omnex.com

newly-released cqi-19 page 2 moving haptics … · continued on pg 2 continued on pg 3 chery jaguar...

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