February Voice 2017

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February 2017

theVoice rockfordchamber.com

ISO updates, upgrades, deadlines Changes in automotive, aerospace, medical devices ISO/TS 16949:2009, the automotive quality requirements followed by thousands of companies worldwide, has been revised and will become an automotive task force requirement, IATF 16949:2016. The standard, released this fall, will be applicable for all automotive OEMS and suppliers. Significant changes have been made in the standard, in line with the ISO 9001:2015 and the Automotive Functional Safety update. The automotive industry uses international standards to ensure quality, safety and reliability in vehicle parts and assemblies. These standards are reviewed and updated periodically to align with global manufacturing quality standards, such as those maintained by the International Organization for Standardization (ISO). In 2015, ISO released a new overarching quality standard, ISO 9001:2015, to expand the prior emphasis on accurate documentation to include more leadership involvement and risk assessment in the quality process. The new automotive standard IATF 16949:2016 has been released by the International Automotive Task Force to support the objectives of ISO 9001:2015 and replaces the previously used automotive standard ISO/TS 16949:2009. The IATF standard also differs in that it does not include the underlying ISO 9001:2015 standard imbedded within. 16949:2016 is only published with the automotive requirements. The IATF comprises automotive industry organizations from Italy, United States, United Kingdom, Germany and France. The IATF published IATF 16949:2016 in October 2016 and issued rules for achieving IATF recognition in November 2016. Certification to the new standard must be achieved by September 2018.

Changes in Aerospace In the air with the aerospace industry, AS 9100:2016, released Sept. 20, 2016, has the same deadline as the aerospace standards, but this is where things get interesting. Since the trio of aerospace standards was not released until late 2016, and the third party auditors now are being trained, this leaves less than two years for your company to meet the requirements of these new standards. But it gets worse. In order to be considered fully upgraded to the new aerospace standards, your company must have an upgrade audit, respond to and close out any nonconformances, have your audit

report reviewed by NQA, and have your new audit report uploaded and published in OASIS by the close of business, Sept. 14, 2018. To allow for all of those activities to occur, your upgrade must be conducted by June 2018. So in actuality, aerospace companies have roughly an 18-month window to upgrade, not the 36 months you might have thought you had. The majority of the changes to the standard can be found in the ISO 9001:2015 standard. First and foremost is the change in structure. The ISO 9001:2015 standard has adopted the annex SL format. Companies that have not completed the transition to the new standard by Sept. 14, 2018, to include the uploading of their new certificate into the OASIS database, will no longer be valid and shall have a certification status of “expired” in OASIS. In addition, they will no longer be eligible for transition and an initial certification audit (stage I and II) will be required to establish conformance with the 2016 editions of the AS standards.

management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations Bernie Luecke can be involved in one or more RVC BPI stages of the lifecycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, Changes in Medical Devices the requirements apply equally to associated services as For our final review, let’s look at medical devices. supplied by the organization. Yes, that is changing as well. The processes required by ISO 13485:2016 that ISO 13485:2016 specifies requirements for a quality are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining and controlling the processes. Interestingly, after all the hubbub that all ISO standards would now follow the new Annex SL, ISO 13485:2016 does not. Annex SL is a high-level structure created by ISO to provide a universal structure, with identical core text, and common terms and definitions for all management system standards. It was designed to make it easier for organizations that have to comply with more than one management system standard. In addition, the whole series of standards is about to change for Safe Quality Foods. Stayed tuned for information on those changes and the release dates. Interested in knowing more about the ISO training offerings, contact Bernie Luecke at 815921-2067 or B.Luecke@RockValleyCollege.edu. Note: Contents of this article were provided by Chuck Jenrich, trainer, auditor and ISO consultant for the Business and Professional Institute. Bernie Luecke is the director at the Business & Professional Institute at Rock Valley College. Manufacturing News is sponsored by RVC BPI