SPECIAL REPRINT

your source for the latest information on international management system standards

How Can You Move From QS-9000 to TS 16949:2002?

The Impact of ISO 9001:2000 on QS-9000 and ISO/TS 16949

By Chad Kymal and Dave Watkins
Publishers Note: This article has been reprinted with permission from THE INFORMED OUTLOOK Newsletter, May 2001 issue. Will I have to change my system to ISO/TS 16949? When will the revision of TS 16949 come out? The lack of clear direction from the automotive original equipment manufacturers (OEMs) in regard to QS-9000 and TS 16949 has left the supply base in limbo. As it stands, organizations registered to ISO 9001/2/3:1994 and/or any set of sector-specific requirements based on ISO 9001:1994, have three years to make the transition to ISO 9001:2000. Meanwhile, the International Automotive Task Force (IATF) has announced that there will be no revisions to EAQF, VDA 6.1, AVSQ or QS-9000the French, German, Italian and US automotive catalogs to which registration has been required of suppliers. At the same time, TS 16949:1999, which is considered equivalent to the four catalogs, is on track to be revised in early 2002.

any organizations registered to ISO 9001/2/3:1994 have begun planning for the transition of their quality management systems (QMSs) to ISO 9001:2000, Quality management systemsRequirements. While this major shift in standards usage is taking place slowly but steadily in many industries, suppliers to the automotive sector have by and large not begun planning for the transition. The reason is that automotive suppliers are confused about what is happening with the third edition of Quality System Requirements QS-9000 and ISO Technical Specification (TS) 16949:1999, Quality systemsAutomotive suppliersParticular requirements for the application of ISO 9001:1994, in response to the changes to their base document, ISO 9001. In large part, this confusion is the result of concerns about the implications of this change and its potential impact on them. Automotive suppliers are left to wonder, Is QS-9000 going away?

QS-9000 Will Not Be Revised; TS 16949 Deadlines Ahead?

The fact remains that the only OEM to have clearly stated its future intentions is Italys Fiat, which reportedly informed its suppliers in July 2000 that they should pursue registration to TS 16949 in place of AVSQ (see IATF Provides Limited Transition Insight, THE OUTLOOK, February 2001). The broadest

hint that all the OEMs may follow suit is the indication that they will not revise the four national catalogs but are close to completing a draft of TS 16949:2002. This draft will contain the verbatim text of ISO 9001:2000 and have the same transition period as ISO 9001. The seemingly obvious implication is that QS-9000 will become less and less relevant as organizations adopt the process approach model of ISO 9001:2000 and migrate away from the 20-clause/element structure of QS9000/ISO 9001:1994. As a result, QS9000 will probably succumb to a natural death during this three-year period. The changes in ISO 9001:2000 will be captured in TS 16949 which, for all practical purposes, will become the fourth edition of QS-9000. Because ISO/TS 16949 is an ISO document developed with ISO Technical Committee (TC) 176, the version based on ISO 9001:2000 will require TC 176 approval. Therefore, even though the draft of TS 16949:2002 is expected to be completed by June 2001, it will probably not be released until the beginning of 2002, so as to permit the participating member bodies of TC 176 to review and ballot the TS. While a draft TS might be released for information only in the next few months, the final document will be released in less than a year. By the third or fourth quarter of 2001, most of the Big Three are expected to announce deadlines for their supply bases to make the transition to TS 16949. In effect, QS-9000-registered companies should become familiar with ISO 9001:2000 and TS 16949 very soon.

This reprint is provided with the compliments of

Omnex, Inc.
734-761-4940 4 www.omnex.com

2001 by INFORM & ASQ

2 4 THE INFORMED Outlook

These standards are in the future of many automotive suppliers, who will need to devote a lot of effort to making the transition, although the benefits of doing it right will benefit their organizations tremendously and make the effort worthwhile. To help you prepare for the coming transition, we will discuss the impact of ISO 9001:2000, in terms of both the structure and the process approach model, and examine approaches to QMS implementation in the transition to TS 16949:2002, with a detailed examination of what we refer to as the Process Review methodology.

Reprint: May 2001

the requirements that brings together some requirements from different elements and breaks up the requirements in some elements and spreads them throughout the 5 sections. Thus, for an organizations QS-9000based quality system, the new structure is not simply a matter of regrouping procedures or putting a matrix in front of the procedures manual. It is more of a significant reorganization or a complete rewrite of documentation for companies that wrote their documentation to match the 20 clauses in ISO 9001:1994. The intent of ISO 9001:2000 was to streamline an organizations processes, avoid the previous compartmentalization of quality system requirements and instill the cross-functional nature of a QMS. This fundamental change will significantly affect the documentation structure of an organizations QMS. Although ISO 9001:2000 also provides for greater flexibility regarding the need for documented procedures and documentation, you can expect that TS 16949:2002 will reestablish some of the documentation requirements in QS-9000/ISO 9001 to suit automotive OEM needs. At a minimum, the traditional policy-based Quality Manual will need to be rewritten and reoriented. Key changes to TS 16949:2002 are likely to involve the process mapping and process orientation required by ISO 9001:2000. In all probability, the second edition of TS 16949 will not prescribe elementbased procedures from the first edition. As a result, organizations that have structured their procedures to mimic the QS-9000 elements can expect some major document rework ahead. TS 16949:2002 will likely require companies to document their product realization process (i.e., the process of creating and producing new products, from concept to delivery to the customer). This process is larger in scope than the current Advanced Product Quality Planning (APQP) process. It also may require organizations to start

ISO 9001:2000s Structure and the Process Approach

ISO 9001:2000s structure is based on five principal componentssectionsrather than the 20 clauses in ISO 9001:1994the elements in TS 16949/QS-9000. The new structure is not simply a matter of grouping several elements together into 1 of 5 sections. It involves a significant reorganization of

Figure 1. Process Map

Reprinted with permission from THE INFORMED OUTLOOK May 2001 issues

Contact us TODAY for a FREE sample issue and a SPECIAL subscription offer (code TS-0105)!

THE INFORMED OUTLOOK 4 15913 Edgewood Drive 4 Montclair, VA 22026 Tel: (703) 680-1436 4 Fax: (703) 680-1356 E-Mail: INFORMINTL@EROLS.COM 4 Web Site: HTTP: WWW.INFORMINTL.COM
2001 by INFORM & ASQ Web Site: HTTP :// WWW .INFORM INTL . COM

Volume 6, Number 5
with the very act of forming ideas about a potential product or the product concept and may end only with the shipping of that product. In addition, support processes that affect the capability of the product realization process (e.g., procurement, staffing), QMS processes (e.g., internal audit, corrective and preventive action, document control) and business processes (e.g., marketing, advertising) will need to be identified, as shown in Figure 1 on the previous page. The process map in Figure 1 is an example of what a manufacturing organization can develop to show the sequence and interaction of its processes. This is a requirement of both Clause 4.1b, Quality Management SystemGeneral Requirements, and Subclause 4.2.2c, Documentation RequirementsQuality Manual. This map is helpful to understanding how the processes in the organization are related to each other. An organization implementing ISO 9001:2000 will need to reorient its documentation and the QMS to understand that its business is a series of interrelated processes. We see this as a culture change within a company the breaking down of the walls of the hierarchical organization and gaining of an understanding of the cross-functional nature of the business. proved. This is a major new expectation, even for organizations registered to QS9000 or TS 16949. Most well-managed automotive suppliers will recognize the need to document these processes. Your organization should consider using Process Review, a methodology that uses APQP tools to improve and control nonmanufacturing processes. Process Review employs Process Flow (PF), Process Failure Modes and Effects Analysis (PFMEA), a Control Plan and an Improvement Plan for all the processes identified by the organization. Of course, the key to effectively employ-

THE INFORMED Outlook

4 3

ing this approach involves efficiently adapting these tools for service process flows, something that has been done effectively for several years in a wide variety of nonmanufacturing industries. These PFs can also be used to effectively document a process and serve as its written procedures, as shown in the example in Figure 2 below. Figure 2 shows a sample procedure that documents a process for corrective and preventive action. The flowchart shows each step of the process, who is responsible and any specific notes on each step. Each step of the process is investigated for prob-

Figure 2. Sample Procedure

Documenting Processes
Even though procedurally documenting all these processes is not required, ISO 9001:2000 requires evidence to ensure the effective planning, operation and control of its processes (Subclause 4.2.1b, Documentation RequirementsGeneral). In addition, organizations will need to ensure the availability of resources and information necessary to support the operation and monitoring of these processes (Clause 4.1d, Quality Management SystemGeneral Requirements). Clause 4.1e also requires all processes to be measured, monitored and imINFORM: (703) 680-1436; ASQ: (800) 248-1946 2001 by INFORM & ASQ

4 4 THE INFORMED Outlook

lems using PFMEA and analyzed for possible measurement, monitoring or other controls in the control plan. These approaches to documentation, measurement, monitoring and improvement of processes do not have to wait for TS 16949:2002. Automotive companies should start employing them immediately as effective ways to enhance competitive capability and improve the bottom line. After all, that should be why an organization does any of this! 3, are identified and tracked through Process Measurables. The Key Processes need to be improved to impact the Goal and Objective. The Process Measurables serve the purpose of measuring the processes as required by Clause 4.1e. An example that illustrates the customer focus process is a typical customer expectation of on-time delivery (OTD). An organization translates this to an objective of 100% of shipments will be received by all customers on scheduled day. This is measured by a result measurable% On Time. The organization studies the objective and identifies three key processes that drive OTD: maintenance, shipping and training. Process measurables, such as % Downtime, Shipment Accuracy and Setup Jobs Filled, are then tracked for each of the key processes. What the customer focus process accomplishes is the translation of a customer requirement into an objective that is then converted within the company into metrics and processes. The key to overall improvement is the identification and improvement of processes. Organizations cannot directly improve the results, they can only improve processes that improve the results.

Reprint: May 2001

when the ISO 9001:2000 and TS 16949:2002 transition periods will end, your organization really has only two options if it is registered to QS-9000: q Upgrade to TS 16949 and ISO 9001:2000, which will satisfy existing and future customer requirements q Lose your registration status. On December 15, 2003, the members of the International Accreditation Forum (IAF), which includes all accreditation bodies that accredit QMS registrars and qualify those competent to audit automotive suppliers and issue QS-9000 registrations, will cease to recognize ISO 9001/2/3:1994 certificates of registration. Thus, certificates that cite QS9000 and any other sector requirements still based on ISO 9001:1994 will become invalid to the IAF members, the registrars they have accredited and most customers. As discussed above, the third edition of QS-9000 is not going to be upgraded to ISO 9001:2000, only the first edition of TS 16949 is, and there are no indications that any of the OEMs presently requiring registration to TS 16949 or one of the four national catalogs plans to drop that requirement. Previous experience assisting organizations with implementation of QS9000and recent experience with ISO 9001:2000 and TS 16949tells us that most large corporations will need at least two years to successfully complete the migration from QS-9000/ISO 9001/ 2:1994 to TS 16949. The best advice is that all QS-9000-registered organizations start their migration todayand not just to TS 16949, but with ISO 9001:2000. This will put them in the position to make the transition to TS 16949:2002/ ISO 9001:2000 with minimal changes to the QMS when the TS is published in 2002. The IATF is not expected to make major changes to TS 16949:1999 beyond its restructuring to include and flow with ISO 9001:2000. In a second article on the impact of ISO 9001:2000, which will appear in the near future, we will explore the structure and organization of the requirements in ISO 9001:2000 and show a practical approach to upgrading a QS9000-conforming quality system to conform to ISO 9001:2000 and TS 16949:1999 with minimal disruption and reworking of the system and maxiWeb Site: HTTP :// WWW .INFORM INTL . COM

Customer Focus
What is the impact of ISO 9001:2000 on TS 16949? Whatever way QS-9000 or TS 16949:1999 are sliced, neither has the customer focus of ISO 9001:2000. Customer expectations and requirements need to be ascertained when it comes to product quality, delivery, lead time, communication, etc. These expectations must be met and should be surpassed to improve customer satisfaction. Does your current system accomplish this? What process are you using? The customer focus process presented in Figure 3 is an effective way to satisfy ISO 9001:2000 and meet and exceed the requirements of QS-9000 and TS 16949:1999. The process illustrated in Figure 3 shows that Customer Need and Expectation (Clause 5.2, Management ResponsibilityCustomer Focus) are driving the Goal and Objective (Clause 5.4, Planning) for the organization. The Goal and Objective are then subsequently translated by what is called a Result Measurable into metrics for use in management review. Key Processes that impact the Goal and Objective, as shown in Figure

ISO 9001:2000s Impact and a QS-9000 Action Plan

The overall changes in ISO 9001:2000 present challenges in terms of the significant change in the documentation requirements (as described earlier), the use of a process approach and the role of a customer focus on the QMS. Between now and the end of 2003,

Figure 3. Customer Focus

2001 by INFORM & ASQ

Volume 6, Number 5
mum results and benefits from the new and improved system. In the meantime, we recommend that QS-9000-registered organizations start today in moving the designs of their systems toward TS 16949 and ISO 9001:2000. There are many savings your organization can achieve with this re-focus on improvement. ### Chad Kymal is Chief Executive Officer of Omnex, Inc., an international consulting, training and software organization specializing in business quality improvement methodologies. Omnex has worked with hundreds of organizations to meet the requirements of ISO 9001/2/3, QS9000 and ISO/TS 16949 worldwide and obtain registration. He assists organizations worldwide in his capacity as a consultant and trainer. Mr. Kymal recently served on the Malcolm Baldrige National Quality Award Board of Examiners, has a BSME from General Motors Institute and has an MS in Industrial Operations Engineering and an MBA from

THE INFORMED Outlook

4 5

the University of Michigan. He can be contacted by e-mail (ckymal@omnex.com). David Watkins is President of Omnex, Inc., and is a senior trainer/consultant. He has a wide range of international experience focused on enhancing the ability of organizations to create value for their customers and stockholders and integrating QMSs and other management systems to enhance performance. Mr. Watkins can be contacted by e-mail (dwatkins@omecconsultants.com).

ABOUT OMNEX
MNEX Inc., along with its affiliates is an international consulting, training and software organization, which from the outset has specialized in business quality improvement methodologies. Among our family of companies are OMNEX-which provides training, OMNEX Management and Engineering Consultants for quality systems implementations and OMNEX Systems, LLC. OMNEX, as a leader in Quality Systems consulting, training and software, is uniquely qualified to assist companies in increasing their market share. We provide leading Quality focused consulting and training to the automotive, truck, semiconductor and service industries. Headquartered in Ann Arbor, Michigan, OMNEX & its affiliates also operate in: q Bangkok, Thailand CONTACT OMNEX: q Toronto, Canada Call 734/668-1000 q Sao Paulo, Brazil Fax 734-668-9414 q Argentina Email info@omnex q Mexico Web www.omnex.com q Venezuela q Chennai, India q Shanghai, China q Malaysia q Philippines q Europe and we have targeted Korea and Japan for future expansions.

not only for manufacturing organizations but also for improving quality of service for organizations like hospitals, transportation companies & construction companies. It is encouraging for us that the service quality for these organizations has improved their performance indices over their competitors dramatically.

OMNEX in the Competitive World

Thousands of companies worldwide who have aggressively sought a competitive advantage have implemented the OMNEX approach to quality systems and reaped the benefits. OMNEX typically conducts an initial assessment which culminates in an improvement plan. Implementation can begin after the companys executive team evaluates and fine-tunes this plan. We then use business and quality systems methodologies and tools to implement the plan. Close to 15 % of waste reduction, reductions in customer complaints, internal and external rejections etc are not unusual in an Omnex quality improvement project. OMNEX not only improves the client's product quality but also facilitates cost savings in improvements to business processes, while meeting and exceeding customer expectations. This enables our clients to maintain and expand their existing business in the face of ever-increasing competition. We are interested in demonstrating to your top management how our capabilities in Quality management systems world wide can be combined with your resourceful business system, to successfully penetrate and sustain in the competitive global market.

The OMNEX Mission

The OMNEX mission has been to transfer our extensive knowledge and experience in the industry to the advantage of our clients who can utilize quality systems in their work environment. OMNEX offers unparalleled commitment to meeting the quality related training and consulting requirements of our global customers. OMNEX implements quality improvement methodologies

OMNEX Clients
Our automotive clients include Ford Motor Company, DaimlerChrysler, General Motors, Visteon, Delphi and many more. Other clients include Philips Semiconductor, Motorola, Siemens, Ameritech and many more. All in all, we have dealt with over 50% of the top 25 Fortune 500 companies.

FOR SPECIAL SUBSCRIPTION OFFER, CALL INFORM AT (703) 680-1436

INFORM: (703) 680-1436; ASQ: (800) 248-1946 2001 by INFORM & ASQ