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A.P. Lyon

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QMSR & ISO 9001:2026 Updates

QMSR took effect February 2, 2026 and ISO 9001:2026 was published September 16, 2026. Editable ISO 13485 & FDA QMSR, dual-standard and ISO 9001:2026 systems with manual, procedures and forms. Returning customers: check your email for an upgrade code.
QMSR took effect February 2, 2026 and ISO 9001:2026 was published September 16, 2026. Editable ISO 13485 & FDA QMSR, dual-standard and ISO 9001:2026 systems with manual, procedures and forms. Returning customers: check your email for an upgrade code.…

Two changes are driving quality system updates this year. The FDA Quality Management System Regulation (QMSR) took effect February 2, 2026, replacing the Quality System Regulation and incorporating ISO 13485:2016 by reference. ISO 9001:2026 was published September 16, 2026, with an approximately three-year transition for certified organizations.


Who should update

  • Medical device manufacturers whose procedures still cite the former 21 CFR 820 Quality System Regulation

  • Organizations certified to ISO 9001:2015 planning their move to ISO 9001:2026

  • Dual-standard companies maintaining both ISO 9001 and ISO 13485


What is here

Complete, editable systems written to ISO 13485 and FDA QMSR, to ISO 9001:2026 + ISO 13485:2016 for dual-standard companies, and to ISO 9001:2026. Each package includes the quality manual, procedures and forms in Word and Excel. Open any package to review its full contents list before buying.


Returning customers

If you bought from A.P. Lyon before, check your email for your returning-customer upgrade code, or contact us and we will send it.

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