Process Validation IQ/OQ/PQ Pack (ISO 13485 Clause 7.5.6)

Validate a production process the way auditors expect, without starting from a blank page. This pack gives you the procedure, the plan, the IQ, OQ and PQ protocols, the summary report and the statistics, all written for ISO 13485:2016 clause 7.5.6, plus sterilization and sterile barrier templates. A completed pouch heat-seal validation shows you what "done" looks like.

What's inside (27 files)

• Process Validation Procedure (Word): scope, the verify-or-validate decision, IQ, OQ and PQ, sample size rationale, deviations, revalidation, production software and outsourced processes, with a clause 7.5.6 a) to g) traceability table.
• Validation Master Plan and Validation Determination Form (Word).
• IQ, OQ and PQ Protocol and Report templates (Word): checks, study design, acceptance criteria, results tables, deviations and sign-offs.
• Validation Summary Report, Deviation and Revalidation Assessment Forms (Word).
• Production Software Validation Protocol (Word): risk-based, in line with FDA's 2025 Computer Software Assurance guidance.
• Validation Toolkit Workbook (Excel): process register, screening, pFMEA, zero-failure sample sizes, sampling plans that allow failures, tolerance intervals, Ppk, revalidation log and traceability.
• Worked Example: a complete, realistic (fictional) pouch heat-seal validation: IQ, an 8-run OQ design, 3 PQ runs, the validated window and a monitoring plan.
• Sterilization and Sterile Barrier Templates (11 files): sterilization SOP, sterile barrier system validation plan and master pack, sterilization IQ, OQ and PQ protocols and reports, load and biological indicator log, load configuration templates.
• Equipment Qualification Extras (4 files): user requirement specification, IQ checklist, validation traceability matrix, process FMEA.
• Start Here guide (PDF).

Who it's for

Quality and manufacturing engineers at medical device manufacturers and contract manufacturers who need to validate sealing, bonding, moulding, marking, sterilization or similar processes, or who have a process validation finding to close.

Built on

ISO 13485:2016 clauses 7.5.6 and 7.5.7, the FDA QMSR (21 CFR Part 820, effective 2 February 2026), GHTF/SG3/N99-10:2004 process validation guidance, ISO 11607-2 for sterile barrier sealing, and ISO/TR 80002-2 for software.

Good to know

• Instant download. Editable Microsoft Office files, no macros.
• Licensed for one organization, including its sites.
• Templates don't reproduce ISO standards. You need your own licensed copies.
• Need production records and product release too? See the Production & Traceability Kit, or get everything in the Complete QMS Kit.