How We Review and Maintain Our Templates
Short answer: every template range and guide is written and reviewed by a named person against the published standard and the regulator's own guidance, re-checked when that guidance changes, versioned, and corrected for every buyer when we find an error. This page explains how, including where we have got something wrong.
Who is responsible
Ishan Maharaj, Founder and Principal Consultant, writes and technically reviews the ISO 9001:2026, ISO 13485:2016 and ISO 14971 ranges and the related articles. He holds a BSc Engineering (Honours) in Industrial Engineering and an MSc in Engineering Management, and has hands-on experience running quality management systems in medical device manufacturing. More on the about page.
The ISO/IEC 42001, SOC 2 and CMMC ranges are built from the primary sources listed below and reviewed by the same person. They are newer ranges; we say so, and we recommend buyers pair them with their own auditor or assessor's view.
Sources we check against
| Range | Primary sources |
|---|---|
| ISO 9001:2026 | The published ISO 9001:2026 text, ISO 9000 vocabulary, accreditation body transition guidance (IAF), certification body transition guidance |
| ISO 13485 and ISO 14971 | ISO 13485:2016, ISO 14971:2019 and ISO/TR 24971, FDA QMSR (21 CFR Part 820, effective 2 February 2026) and FDA's inspection compliance program 7382.850, EU MDR 2017/745 |
| ISO/IEC 42001 | ISO/IEC 42001:2023 and its Annex A controls |
| SOC 2 | AICPA Trust Services Criteria |
| CMMC | NIST SP 800-171 Rev 2 and SP 800-171A, the CMMC program rule (32 CFR Part 170) and DoD guidance |
Templates describe requirements in our own words and refer to clause numbers. They never reproduce copyrighted standard text.
When templates are reviewed
- Before release: clause-by-clause check against the published standard, plus a consistency check that procedures, forms and registers reference each other correctly.
- When guidance changes: for example a new edition, an amendment, or a regulator changing how it inspects.
- When a buyer reports a problem: every report is checked, and confirmed errors are fixed.
- At least once a year for every active range.
How corrections reach you
Each correction gets a new version number and date, is recorded on the version history page, and is emailed free to every buyer of that product. Articles carry a review date and a correction note when something material changed.
Corrections we have made
- 19 October 2026, FDA QMSR article: an earlier version said FDA would keep using the QSIT inspection technique after QMSR took effect. FDA stopped using QSIT on 2 February 2026 and now inspects under compliance program 7382.850. The article was corrected and the ISO 13485 templates were checked for the same statement.
- October 2026, ISO 9001:2026 range (v1.1): checked line by line against the published standard after release.
Found a problem?
Email isocloudconsulting@outlook.com with the file name, page and what looks wrong. We reply within 2 business days.