What are the basics of an enterprise maintenance-focused Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001, the international standard for Quality Management Systems for all business or industrial systems worldwide.

This webinar will discuss basic requirements of a QMS. It will then develop those areas of QM that specifically guide CAPA (Corrective and Preventative Action), preventive / predictive (proactive rather than reactive) maintenance, routine and urgent maintenance / repairs, inspections, and continuous improvement, and some of the basic tools under SPC and 6 Sigma to achieve those goals. The emphasis of this webinar will be maintenance activities that work under the QMS "umbrella".

Why You Should Attend

"This webinar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ISO 9001m and how a company's preventative and predictive maintenance programs can be enhances by the QMA requirements, as outlined in ISO 9001. Subject areas considered are:

  • Systems, Personnel
  • Buildings and Equipment, Preventive and Predictive Maintenance
  • Documentation and Records
  • Materials Management
  • Production and Laboratory
  • Validation
  • Material Rejections / Reuse
  • Post-production Issues; Analytics (descriptive, diagnostic, predictive, prescriptive)

Webinar Takeaway

  • A QMS overview
  • Systems, Personel, the Physical Plant
  • If it isn't documented, it didn’t Happen
  • Control of material, product, manufacturing
  • Preventive and Predictive Maintenance
  • Validations
  • Material /product rejection, fall-off, scrap issues
  • Complaint handling and other post-production issues

Who Will Benefit

  • Senior management in business / industry
  • QA / RA
  • R&D
  • Engineering
  • Facilities and Maintenance
  • Production
  • Operations
  • Marketing

Faculty John E Lincoln

Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.


RAPS - This course has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.

World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria

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