Integrated Management Systems - Updated to the latest standard changes including ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018
There is a proliferation of management system standards and requirements globally. These management system standards are either customer or industry mandated. Many standards are becoming a requirement for doing business (for example, ISO 9001, a Quality Management System standard with industryspecific versions such as ISO TS 16949 for Automotive, ISO 13485 for Medical Devices, and AS 9100 for the Aerospace industry; ISO 14001, an environmental management system standard; and ISO 45001, an occupational health and safety management system standard). There are yet other standards waiting in the wings that may soon become industry requirements for social responsibility or sustainability, laboratory management systems, and energy management systems. Typically, these standards are seen as hindrances or obstacles in the way of doing business and not beneficial.
Top management assigns these management standards to specialists in the company who then write manuals and procedures around quality, environmental, and health and safety management systems. The results are hundreds of procedures that impact the organization with multiple requirements for conducting a task (see Figure A1.1). How can a business manage these standards most economically? Are there efficient methods for managing them?
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Author
Chad Kymal
Chad Kymal is the CTO and Founder of Omnex Inc. He is the author of seven books and more than 100 papers including several on integrated management systems. Chad is currently on the writing committees for several standards including TC 22/ SC 32/WG 8 for ISO 26262 (Functional Safety), ISO/TC 176 for ISO 9001:2015 (Quality Management), ISO/TC 207 for ISO 14001:2015 (Environmental Management), and PC283 for ISO 45001 (Health and Safety Management Systems). He founded and was the CEO of an Automotive registrar for over 10 years and is familiar with conducting audits, being witnessed for audits, and also evaluating auditors and assessors. He authored and teaches a course for 3rd Party Auditors for Automotive Registrars on behalf of International Automotive Certification Bodies Association (IACBA). This course explains how 3rd Party Auditors audit IATF 16949 in an environment that includes ASPICE, Functional Safety and Product Cybersecurity. He is currently rolling out the course to global 3rd Party Auditors for IATF 16949. Chad has spent over 20 years in system, hardware and software development in various capacities. He assesses and works in automotive system, hardware and software for Agile, ASPICE, and Functional Safety ISO 26262. Chad is also currently an intacsTM certified Principal Assessor for Automotive SPICE.
Gregory Gruska
Greg Gruska - Omnex Champion for ISO 26262, and a Fellow of the American Society for Quality (ASQ) • Omnex Inc. Greg Gruska, Omnex Champion for Functional Safety and ASQ Fellow, specializes in ISO 26262 engagement, systems engineering, and reliability/safety analysis. With experience spanning various industries worldwide, including automotive, he excels in integrating Functional Safety into development processes. Formerly of General Motors, he managed Quality Engineering, focusing on statstics and new technology development. Greg’s expertise extends to Functional Safety, SOTIF, and hardware metrics, offering guidance to OEM teams. A prolific writer and speaker, he has published numerous works on quality management, statistical analysis, and risk control. Greg, a licensed Professional Engineer and ASQ certified Quality Engineer, is highly regarded as a risk management authority and active member of industry committees. He provides consulting, training, and software services in Ann Arbor, MI, with a specialization in Automotive Software and ISO compliance.