ISO Document Review Service: Fixed Scope, Fixed Price
Short answer: you send up to 5 documents you have adapted from templates. Within 5 business days you get them back with comments, plus a one-page summary ranking what an auditor is most likely to raise. You revise, and we re-review once. Fixed price: $349.
Why a review helps
Most template problems are not missing text. They are leftovers: example content that doesn't match your company, forms the procedure never mentions, sections that don't apply but weren't justified, and roles that don't exist in your organization. These are exactly what auditors notice. A second pair of eyes before the audit is cheaper than a finding after it.
What you get
- Comments in the documents themselves, each tied to a clause and saying what to change.
- A one-page summary ranking findings as likely nonconformity, observation or improvement.
- A check that your procedures, forms and records link up, and that your quality manual and scope are consistent.
- One re-review of the revised documents, with written confirmation of what is closed.
- An optional 30-minute call to walk through the feedback.
What it does not include
- Writing or rewriting your documents (see consulting).
- Device-specific technical content such as test methods, biocompatibility or clinical evaluation.
- Legal advice or any guarantee of a certification outcome.
- Standards other than ISO 9001 and ISO 13485 (ISO 14971 risk files are included as part of an ISO 13485 review).
Good documents to send
- Quality manual (sets the scope everything else is checked against)
- Document control procedure
- CAPA procedure and CAPA log
- Internal audit procedure and audit program
- Whichever procedure covers your last audit finding
Who reviews
Ishan Maharaj, Founder and Principal Consultant, who writes and maintains the templates (BSc Engineering (Honours) Industrial, MSc Engineering Management). See how we review templates.
Confidentiality and refunds
Your documents are used only for the review and deleted on request. We sign your NDA before you send anything. If you cancel before sending documents, or we cannot start within 10 business days of your order, you get a full refund.