Procurement & Sourcing 3 min read
Validating a Sialkot OEM partner: 8 documents to request before the first PO
Specific document list AJ Brothers sends every serious OEM buyer before any NDA — including registrar audit summary, lot-trace SOP, named QC head CV, AQL specification, and sample-kit pricing. Score any Sialkot OEM partner against this list.
By Hassan Ali , Director of Quality Assurance
The eight documents below are what we send a serious OEM buyer before the mutual NDA is signed. The list deliberately includes nothing proprietary — drawings, tooling specs, and active CAPA records sit behind NDA — but it does include everything a procurement-team-of-one needs to decide whether AJ Brothers is even worth the NDA cycle. Steal the list. Use it against any Sialkot OEM partner.
1. Registrar audit summary
The first-page summary of the most recent ISO 13485:2016 surveillance audit by our registrar. Includes the registrar name, certificate number, audit date, scope of audit, and outcome. Full audit report sits behind NDA. The summary is enough to tell you whether the certification is current, whether the scope covers the product you want manufactured, and whether the auditor flagged anything material.
2. Lot-trace SOP
The standard operating procedure document describing how a lot is traced from raw-material certificate through forging temperature log, dimensional inspection, polishing sign-off, marking, packaging, and outer-carton lot card. This is the SOP itself, not an example lot — the example lot follows after NDA. Reading the SOP tells you whether the system can survive an EU MDR or FDA inspection.
3. Factory floor plan
A simple line drawing of the factory: forging area, machining area, polish station, QC station, marking station, packing area, raw-material store, finished-goods store, document control office. Square-meter footprint per area. This document tells you whether the manufacturing is on a single plot under one quality system, or sub-contracted across multiple locations.
4. Named QC head — CV summary
The name, role title, years on the bench, professional credentials (SIMAP framework, ISO 13485 lead auditor certification, etc.), and direct email of the person who signs CAPA reports and audit responses. This is the human you will deal with for the next five years. You should know who it is before signing.
5. AQL specification
The standard AQL inspection levels we operate to — currently 1.0 visible defects, 0.65 critical defects, 4.0 minor defects per ISO 2859-1. If you require a tighter specification (e.g. AQL 0.65 visible for high-volume sterile-packaged devices), we can quote that level separately. Knowing the default AQL up-front lets you compare like-for-like across Sialkot suppliers — most do not publish their inspection levels.
6. UDI marking capability
One-page summary of our laser-marking capability: marking method (Yb fibre laser, 20W), readable line minimum height (0.4 mm), data fields supported (manufacturer mark, model number, lot number, expiry where required, custom buyer marks), and an example of a marked instrument photographed alongside its UDI. Confirms we can satisfy EU MDR UDI and FDA UDI labelling obligations on your behalf.
7. Sample kit pricing schedule
Standard sample-kit pricing: three samples per SKU, your spec, your finish, your marking, packed in a Tyvek pouch. Pricing is published, not “contact for quote” — and the sample-kit fee is fully credited against the first production order. This is the document that converts “we are interested in your manufacturing” into “we are committed enough to send our drawings.” Most Sialkot peers do not publish sample pricing.
8. Mutual NDA template
Our standard mutual non-disclosure agreement, in editable Word format, in plain English. Three-year confidentiality term, applies to drawings, tooling, pricing, and any business intelligence exchanged during the engagement. Send back signed (or with redlines) and the technical exchange begins the next business day. See OEM and private label for the full engagement workflow.
What follows after NDA
Once the mutual NDA is signed, we exchange: full ISO 13485 audit report, custom drawings against your supplied spec, packaging dieline mock-ups, the named production line owner (if dedicated line), and a first-production timeline against your target ship date. The list above is the “before NDA” gate — the documents you can score AJ Brothers against without committing to a confidentiality obligation.
Ready to start? Email oem@ajbrothersent.com or submit a quote request with “OEM / private label” ticked. The eight documents above arrive in your inbox within one business day — Sialkot office hours, Mon–Sat.
