2017 Quarter 1. Topics covered in this issue: AS91XX:2016, IATF 16949, Early Adopters, Food Safety, ISO 13485:2016, and ISO 14001:2015

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1 Topics covered in this issue: AS91XX:2016, IATF 16949, Early Adopters, Food Safety, ISO 13485:2016, and ISO 14001:2015 AS9100:2016, AS9110:2016, and AS9120:2016 Transition With the recent release of AS9100:2016, AS9110:2016, AS9120:2016, AS9101:2016, and introduction of the Next Generation OASIS; the AS&D Industry is now entering the very aggressive implementation of these standards. As DQS Inc. has been sharing, this aggressive timing will coincide with the transition timing for ISO 9001:2015. The industry also released SR-003 last month. This Supplemental Rule provides requirements for all stakeholders to facilitate the transition to the 9100/9110/9120:2016 Aerospace Quality Management Systems (AQMS) standards. It is available on the home page of OASIS at sae.org/iaqgdb/oasishelp/sr003_ supplemental_rule.pdf? We highly encourage you to review this document as it has rules that apply to certified organizations. Additionally, we will be providing information on a regular basis on the rules and timelines to support a smooth transition of the certification. In accordance with SR-003, the AS&D Industry has required all Certification Bodies (CBs) to obtain documented evidence of their certified organization s intent to transition and required all certified organizations to communicate this information. The information is required to be and will be used as an input in determining the timescale, the audit team, and audit duration. SR-003 requires that all transition audits must have additional audit time added for the transition activity. Customers should have received a request for information in regards to the impact of the revised standard on your AQMS. This information must be communicated prior to March 1, Please ensure you provide this information by this date as it is required in order to maintain compliance under the ICOP (Industry Control Other Party) scheme. An NCR will have to be issued if this information is not received by this date. All audits after June 15, 2017 are required to be performed to the 2016 revisions of the AS standards. In ensuring the readiness of your AQM and reducing risks, we will be replacing our normal ½ day off-site audit planning with a 1 day off-site readiness review for the transition audit. This will need to be completed a minimum of three months prior to the transition audit. During this review we will review the current status of the AQMS and the impact of the new standard on your system. If there are significant changes in performance or impact to the AQMS, further adjustment to the audit duration will be determined. We encourage having your transition audit at the time of your normal cycle audit. This will minimize the Continued on page 4

2 2 DQS IATF Certified Client Transition Plan As most of you are aware, the IATF standard was issued on October 3. The IATF Rules 5 th edition was issued on November 1. The IATF also has posted a Transition document on their website, which has gone through a couple of revisions, so check it frequently ( Significant changes to the IATF standard include: The IATF standard is no longer a standalone standard. It is an add-on to the ISO 9001:2015 standard; so the ISO 9001:2015 is integral to the IATF upgrade audit. Risk based thinking is a core concept in the ISO 9001 standard. Automotive companies are used to this thinking for production processes, but now they must extend this thinking to all processes. Understanding the context of the organization and its interested parties is another core change to the ISO 9001 standard and must be understood and managed within the automotive QMS. There is a higher focus on sub-suppliers, as the OEM s have seen many issues over the years where the tier one would explain that a subtier had caused the issue and they failed to catch it. The focus includes 2 nd party audits depending on what level of certification the supplier has, along with the sub-supplier s performance. Another significant addition relates to embedded software. There are millions of lines of code in vehicles today, and the OEM s have seen problems in this area, so they have addressed this topic in the new standard. Product Safety has also become a focal point. This was driven by the recent quantity and severity of safety related recalls which have hit the automotive industry. There are several other less critical items related to TPM, capacity checks, contingency plans, etc., so it is critical to read through the standard and identify those items. The Rules were also updated and the previous Sanctioned Interpretations and FAQs were incorporated. Significant changes to the IATF Rules include: Accessory part suppliers are now eligible for certification, as long as the parts are procured or released by the OEM. Manufactured parts must meet OEM specs. Some clarifications were made regarding the transfer process and when the old CB is notified and what their responsibilities are. Transition process to the IATF standard: We have all been anxiously awaiting the release of the IATF standard, knowing that we were up against a certificate expiration date that wasn t moving (9/14/18). Once the release date was communicated, the IATF published the Transition guidelines, which have already been revised twice. The basic rules are: The certified organization needs to upgrade to the new IATF standard in their normal audit timing. On the initial release of the transition plan, the IATF was allowing clients to upgrade whenever they wanted, but then they realized that too many organizations would wait until the last minute and there wouldn t be enough Continued on page 3

3 3 Continued from page 2 auditors available to do the audits. As a result of the first bullet item, DQS is planning all audits happening past 6/15/2017 will be upgrade audits. This allows DQS and the client to close all nonconformances, do a technical review, and issue the new certificate before the current ISO/TS certificate expires. DQS auditors started the training / requalification process in mid-december (when made available by the IATF) and they must all complete the requalification by 6/30/2017. We will plan for the auditors to complete the training sooner rather than later and will be ready to upgrade whenever you need your audit. Clients are expected to perform an internal audit to all requirements of the IATF standard (including ISO 9001:2015) and perform a management review of the results prior to the upgrade audit. Regarding Remote Locations, if the RL has not had their upgrade audit, the CB can still issue the new certificate as long as the client provides the internal audit / gap assessment results and any action plans (with timelines and responsibilities assigned) at the remote location. Clients may not transfer to a new CB and upgrade at the same audit. If clients are interested in transferring, they would first have to transfer to the current 2009 standard and then do an upgrade audit later. The IATF did this to provide some stability and to make sure that auditors were available to do all of the upgrades at the designated CB. The IATF certificate will be issued and have a 3 year validity from the date of issuance. As part of audit planning, the organizations will be required to submit their updated quality manual, updated/ new procedures and evidence about conformity to IATF to the certification body prior to the start of the transition audit for an offsite documentation review. To enable lead auditors to complete these additional reviews, an additional half day will be added to the planning activity and billed accordingly. There is the option to perform this activity on-site, so just let the lead auditor know how you want to do it. Once you know when you want to complete the upgrade audit, please contact your Customer Service Professional to confirm your audit dates. What should certified organizations do now? Get copies of ISO 9001:2015, IATF 16949, and IATF Rules 5 and familiarize yourselves thoroughly with the requirements. Perform internal audits / gap assessments to the new standard(s). Develop action plans with timing and responsibilities to close the gaps. Schedule your upgrade assessment. Monitor the DQS website and communications for training events and webinars.

4 4 Continued from page 1 interruption to your organization and require the least amount of additional audit time. Next Generation OASIS was also released. For audits performed to 2009 revisions of the standard, you will find the functionality to be very similar to the OASIS you currently know. For all audits to the 2016 revision, you will be interfacing with the auditors through OASIS. This includes activities such as receiving your audit documentation and responding to any issued NCRs. As we continue to learn more about the Next Generation OASIS, we will share more information with you. We look forward to working together with you during this transition period. Please feel free to send your questions to ASQuestions@dqsus.com. Food Safety Updates Just as there are exciting revisions happening with the automotive and aerospace standards, there are revisions taking place in the food safety standards as well. The draft of the SQF Code Edition 8 has been published for public comment. You can read through the proposed changes and submit feedback through the SQF website until February 6, Also as of December 22, 2016, FSSC launched Version 4 of its International Food Safety and Quality Management System Certification Scheme. Changes were made to improve consistency and stringency, and key highlights include: conducting unannounced audits introductions of critical NC s prevention of intentional product contamination a standardized audit report template transport and storage food service/catering retail/wholesale industries Audits to this new version will begin in January 2018, and the scheme requirements are available via free download from the FSSC website, with no increase in certificate fees. DQS is now accredited to ISO 13485:2016 ISO 13485:2016 was released February 25, 2016, and DQS Inc. is proud to say that as of January 18, 2017, we have attained accreditation to offer certificates to this updated standard. Clients currently certified to ISO 13485:2003 are required to have their current certificate transitioned to ISO 13485:2016 by March 1, All remaining ISO 13485:2003 certificates will be withdrawn on that date. To complete this, all upgrade audits must be completed by December 1, Customers may upgrade during their regularly scheduled recertification or surveillance audits or during a special audit. Stage 1 audits are not required for the upgrade, but we can conduct an optional Stage 1 or gap assessment if requested. The certificate renewal date will not be reset upon renewal unless it is done during a recertification audit. The number of audit days required for the upgrade audit is as follows: Recertification audit: Recertification time with no reductions. Surveillance audit or special audit: Annual surveillance time with no reductions plus one day If conducted at the same time as an ISO 9001:2015 S1/S2 upgrade/ recertification audit with same scope and same or lower employee count, no additional time for ISO 13485:2016 upgrade is required. Scopes that differ only by clarifying it is for the medical device industry or similar wording with same or lower employee count will also not require additional time for ISO 13485:2016 upgrade. Other scenarios will be reviewed on a case by case basis to determine if additional time is needed. Please contact your Customer Service Professional with any questions or to start scheduling upgrade audit activities. You can also review our recorded ISO 13485:2016 revisions webinar for additional information. We look forward to continuing to work with you during this transition.

5 Congratulations to ISO 9001:2015 Early Adopters! 5 The ISO 9001:2015 standard was published on September 15, Since then, we have had customers scheduling their transition to the new standard, and some of those customers have been very eager to complete the transition. The following customers have completed the transition to ISO 9001:2015 by the end of 2016: - Schenck Process, LLC - Micro Plastics, Inc. - Soft Tech Consulting Inc. - Schafer Driveline, LLC - Oriental Motor USA Corporation - Intorq US, Inc. - Unissant, Inc. - AECOM Management Services Group - The Royal Group-Midwest - Schafer Driveline, LLC - Unilin Flooring - Vantage Specialty Ingredients, - A1 Jays Machining - Neenah Foundry Company D Ino Tech Laser - Camco Machining, Inc. - Extron Logistics, LLC dba Extron, Inc. - Tyler Union - The Chemours Company - Fracht FWO - Sonderhoff USA Corporation - AER Technologies - B & Z Manufacturing Co., Inc. - Automotive Industrial Marketing Corp. (AIMCO) - Lumentum Operations LLC - Sequoia Brass & Copper, Inc. - Darcoid Nor-Cal Seal - CSRA, Inc. - Cosemi Technologies Extron Logistics, LLC was the first DQS customer to achieve an ISO 9001:2015 certificate. DQS Inc. President and CEO Ganesh Rao traveled to their office to present the certificate. Inc - MFG Chemical, Inc. - DU Technologies, Inc. - American Extruded Plastics, Inc. - Badger Meter Inc. - Dell International Services India Private Limited (ILP) - Willerding Acquisition Corp. dba: WB Industries - Dell Marketing L.P. PTC - Siemens Industry, Inc. - ABB INC., PGTR TRES U.S. - Synergetic Information Systems, Inc. - JAS Forwarding (Japan) Co., Ltd. - ANA Laboratories, Inc. - Capstone Turbine Corp. - Dell Business Process Solutions India PVT LTD - Powell Electrical Systems, Inc. - Evansville Tool & Die - PPC Broadband INC - Bivar, Inc. - MonoSol, LLC - Eaton s Cooper Wiring Devices - Yakshna Solutions, Inc. Continued on page 6

6 Congratulations to ISO 14001:2015 Early Adopters! 6 The ISO 14001:2015 standard was also released on September 15, 2015, and the following customers have completed the transition to ISO 14001:2015 by the end of 2016: - Blue Ridge Metals Corp. - Fracht FWO - Pioneer North America - Cashco Incorporated - Siemens Industry, Inc. - Benchmark Electronics Manufacturing Solutions (Moorpark), Inc. - FXI, Inc. - Capstone Turbine Corp. - Los Angeles County Metropolitan Transportation Authority - Bivar, Inc. Congratulations to all! ISO 14001:2015 Clarifications of Intent The Clarifications of Intent developed by the US TAG to ISO TC 207 in regard to ISO 14001:2015 with five new items since the last publication. These items are found at the end of the document. Please note Section III is in regard to the new revision while Sections I and II are for prior versions but may also continue to be applicable where the requirement did not change. In addition, customers can submit questions to the US TAG through the process at the beginning of the document. All of this can be found on the ASQ Website. The five new items answer the following questions: 1. Is an organization required to establish a process in order to meet the requirements in 4.1 and 4.2. that it determine its context, relevant interested parties and their needs and expectations? Is an organization required to develop and maintain documented lists of its external and internal issues, its relevant interested parties and their needs and expectations? 2. Does the organization have to identify at least one risk or opportunity that needs to be addressed, i.e. at least one potential adverse effect (threat) or beneficial effect (opportunity) that needs to be addressed? 3. What is an outsourced process? Is every process or service obtained from an external provider an outsourced process? 4. In Clause A(3), which risks and opportunities is an organization required to plan actions to address? 5. Does the phrase, consistent with a life cycle perspective in Clause 8.1, Operational Planning and Control mean than an organization needs to consider a life cycle perspective a second time, with regard to operational planning and control? Continued from page 5 - Isostatic Pressing Services, LLC - Polymax TPE - Dal-Tile Gettysburg Operations - Eaton Crouse-Hinds - Neenah Paper FR, LLC - Inserso Corporation - BASF Corporation - LabVantage Solutions, Inc. - Novus Law, LLC - BTI Solutions, Inc. dba Blue Telcom, Inc. - U.S. Tsubaki Power Transmission - Elster Solutions, LLC - Quality Filtration LLC - Schafer Gear Works - South Bend - Delta Power Company Congratulations to all customers who have completed this transition.