Every kit is an instant download with editable Word and Excel files plus PDF guides. Checkout is handled by Payhip. Kits marked "Coming soon" aren't in the store yet.
A clause-by-clause readiness checklist (48 points), internal audit plan and report templates, 8D/CAPA and NCR forms, an Excel tracker and a 30-day prep plan. Editable Word and Excel. Templates, not certification.
Excel template for FAI Forms 1, 2 and 3 with automatic PASS/FAIL, a ballooning guide, an editable FAI procedure, a partial/delta FAI decision guide and a common-rejection-reasons checklist.
Plain-English notes on what each AS9100D clause asks for, what auditors look for and what evidence to show. Does not reproduce the standard; you still need your own licensed copy.
For MRO shops and repair stations: RSM and QCM skeletons mapped to 14 CFR 145 sections, a capability list with gap flags, work order register, training, tool calibration and FAA notification logs, traveler and RTS checklist. Templates, not legal or regulatory advice.
System Security Plan template, a self-assessment workbook covering the 110 requirements with a live SPRS score, a POA&M tracker and 14 policy templates. Templates, not legal advice or certification.
Quality system, risk, design controls, validation, complaints, cleanroom and EU MDR templates for small medical device makers and contract manufacturers. All files are templates, not regulatory advice or certification.
Risk plan, hazard analysis tied to an editable acceptability matrix, FMEA, benefit-risk and the risk management report. Templates, not regulatory advice.
Endpoint matrix with gap flags, device categorization, materials inventory, biological evaluation plan and report shell. Templates, not regulatory advice.
Validation tracker for EO, steam and radiation, requalification calendar, BI and dose release log, protocol and report. Templates, not regulatory advice.
Packaging gap tracker by ISO 11607-1/-2 clause, seal-strength workbook with Ppk, accelerated-aging calculator, validation master plan, sealer IQ/OQ/PQ protocol and distribution/aging test plan. Templates, not regulatory advice.
Not eligible for NQT documentation review (all kits in this bundle). 15 medical device quality kits in one download of editable Word and Excel templates for small device makers and contract manufacturers. $975 if bought separately: save $678.
Quality and compliance kits for dental labs, dental practices and dental device makers: case tracking, sterilization and spore logs, waterlines, OSHA, X-ray QA, aligners, implants and 3D printing. Templates, not regulatory or legal advice.
IATF 16949 and the automotive core tools: APQP/PPAP, PFMEA and control plans, MSA, customer-specific requirements, layered process audits and warranty. Templates, not regulatory advice.
HACCP, FSMA preventive controls, SQF/BRCGS/FSSC 22000 audit prep, sanitation, allergens, environmental monitoring and traceability for food plants. Templates, not regulatory advice; food safety plans need a PCQI where the rule applies.
21 CFR 210/211 GMP tools: deviations, CAPA and change control, batch record review, data integrity and Part 11, cleaning validation, stability and OOS. Templates, not regulatory advice.
API Spec Q1 and Q2 audit prep, management of change and contingency planning, welding, NDT and material traceability. Templates, not regulatory advice. API specs are not included; buy them from API.
Program tracker by ISO 3834 clause and AWS D1.1 topic, WPS/PQR register, welder continuity clock, consumable and preheat/interpass logs, weld map and WPS/PQR/WPQ forms. Templates, not engineering advice or certification; no AWS or CWI certification.
Updated for ISO 14001:2026 with a transition plan. Aspects and impacts with significance scoring, compliance obligations register, objectives tracker. Templates, not legal advice.
Field QA/QC for contractors, a USACE/NAVFAC three-phase CQC plan kit for federal work and an NQA-1 starter for shops entering nuclear supply. Templates, not legal, engineering, regulatory or nuclear safety advice.
Program tracker by ISO 3834 clause and AWS D1.1 topic, WPS/PQR register, welder continuity clock, consumable and preheat/interpass logs, weld map and WPS/PQR/WPQ forms. Templates, not engineering advice or certification; no AWS or CWI certification.
Readiness checklist, internal audit plan and report templates, corrective action and NCR forms, context/risk/objectives and management review templates, and an Excel tracker with example rows. Templates, not certification.
Quality manual template plus procedures for document and record control, internal audit, nonconformance and corrective action, management review, training and competence, and control of external providers, with a risk and opportunity register in Excel. Templates, not certification.
Relative viscosity, gate-seal and pressure-drop worksheets, process window map, 3-factor DOE planner, OQ/PQ capability sheet with Ppk, mold PM and drying logs, qualification plan and setup sheet. Templates, not engineering or regulatory advice.
Not eligible for NQT documentation review (all kits in this bundle). 15 medical device quality kits in one download of editable Word and Excel templates for small device makers and contract manufacturers. $975 if bought separately: save $678.
Every kit we make, every future update, a monthly audit-trend brief and a members-only template each month, for about the price of one kit a month. Want to hear when it opens? Grab the free checklist and you'll be on the list.
Free AS9100 audit readiness checklist
24 checks to see where you stand before the auditor shows up. Free 2-page PDF.