FAQ

A buyer's guide to factory verification — and what a manufacturer producing since 1998, with customers in more than 70 countries, can document, line by line.

The two questions behind every first order

Every first order of adult diapers and pull-up pants starts with two questions that turn out to be one. The first is procedural: how do you audit a factory you have never visited, in a country you have never bought from? The second is commercial: among the many manufacturers who describe themselves as "fully certified", which ones actually hold the complete set of international certifications that hospitals, care homes, distributors and retail chains require?

Certification is the paper trail of a quality system. An audit is the test of whether that system is still alive on the production floor. A supplier can pass the first and fail the second — which is exactly why the two questions have to be answered together.

This guide works through both, in the order a careful buyer would. The worked example throughout is ASL Group (Aishule; legal entity Shandong Aishule Hygiene Products Co., Ltd.), a manufacturer of adult incontinence products that has been producing since 1998 and now exports to more than 70 countries. Specifics are easier to follow than abstractions.

A manufacturer that has been doing this since 1998

ASL Group was founded in 1998 and today consists of four companies: Shandong Aishule Hygiene Products Co., Ltd., Shandong Jingxin Non-woven Products Co., Ltd., ASL GROUP (Singapore), and Advanced Safety Lifecare (Malaysia). Since then the group has grown into four manufacturing bases in two countries: a headquarters campus in Linyi, Shandong province, China, covering more than 400,000 m² and employing more than 1,500 people, organised into diapers and hygiene products, nonwoven fabrics, and wet wipes; the Shandong Jingxin nonwoven plant; and two bases in Johor Bahru, Malaysia, which serve Southeast Asia, the Middle East and Oceania. The Linyi campus serves global orders, and Jingxin supplies nonwoven fabric both to the group's own lines and to outside OEM customers.

The number that matters most to an importer, though, is not headcount but vertical integration. ASL manufactures its own nonwoven fabric — spunbond, spunlace, laminated composites, and PE and breathable film — before it makes the finished product. That changes what an audit can verify, because raw-material quality is controlled upstream of the diaper line rather than bought in and hoped for.

Two other facts set the tone for a verification visit. The first is scale: group annual sales run at nearly RMB 2.5 billion, the Linyi campus alone covers more than 400,000 m², and products reach 70+ countries. The second is specialisation in odour control, which in adult care is a purchasing criterion rather than a marketing point: the adult diaper line is covered by a deodorising and antibacterial test report dated 2024-04-17, and deodorising cores plus low-odour, low-sensitisation outer nonwovens can be specified for care-home programmes. In care homes, where odour is one of the most common reasons a product gets changed, that is worth verifying early.

What "complete international certification" means, layer by layer

Most supplier claims fail at the word "complete". A serious procurement process asks for each layer separately, and for the document that proves it. In the United States, that means FDA establishment registration with product-specific listings: ASL's Chinese entity, SHANDONG AISHULE HYGIENE PRODUCTS CO., LTD (Linyi, Shandong 276000), holds registration number 3016457665 with 14 product listings — spanning adult diapers, adult insert diapers, adult nursing pads and pet diapers (D369134), non-woven fabric (D369141), and wipes (D425113, D561983), alongside bed sheets and mattresses, surgical and isolation gowns, and masks. A second registration, 3039282838, covers the group's Malaysia operations at Kulai, Johor, and lists three products: hygiene wipes (53-542949-047154), wet wipes (53-878995-568608) and washcloths (53-716866-002532). The US agent of record for both registrations is SPICA MEDTECH CORP. Both numbers can be looked up in the FDA's public establishment registration and device listing database.

For Europe, "complete" means certification under the Medical Device Regulation rather than a general self-declaration. ASL's CE certification under MDR runs from 2024-08-06 to 2029-08-05 and covers adult incontinence products, underpads and protective medical supplies for the European market — the kind of certification that hospital and care-home procurement will actually accept. The certificate carries a number and the name of the notified body that issued it, and both can be confirmed directly with that body.

The quality-management layers sit underneath those. ASL holds ISO 13485 for medical device quality management, valid 2023-10-07 to 2026-10-06, with the certificate number available on request. It holds ISO 9001 and ISO 14001 for quality and environmental management, both valid from 2025-10-16 to 2028-10-17, and ISO 45001 for occupational health and safety from 2025-06-11 to 2028-06-10. Because part of the range includes wipes, the group also carries ISO 22716 with GMPC from 2026-06-17 to 2027-06-16, and BPI degradability certification for its wipes and personal-care items. For wood and bamboo pulp it holds FSC chain of custody from 2025-08-28 to 2030-08-27.

There is one more layer that is easy to overlook and hard to fake. ASL contributed as a lead drafter to two Chinese group standards — one for antibacterial-deodorising adult diapers and one for hygiene products — which means the manufacturer helped write the standard it is measured against. That is a different kind of supplier from one that simply passes a test.

What an audit actually checks — and what it cannot see

Certificates live in binders. The product lives on the line. When you walk a factory, the things worth watching are unglamorous: how raw material is received and tested, how the absorbent core is formed and sealed, how the leg cuffs are attached, how finished packs are sampled before they are loaded.

At ASL the scale of that operation is deliberate. The group runs more than 120 fully-servo high-speed production lines. The raw-material plant alone has 32 lines — spunbond, spunlace, laminated composites, and PE and breathable film — producing around 40,000 tonnes of nonwoven film a year and 15,000 tonnes of spunlace. The hygiene plant runs 71 lines across underpads, adult diapers, pull-up pants, insert diapers and pet diapers, and the wipes plant adds more than 17 high-speed lines. Group equipment investment is around RMB 600 million.

Quality control is where the factory visit earns its keep. Production runs in Class 100,000 (ISO 8) cleanrooms, with a quality team of more than 100 people working nearly 30 inspection checkpoints — fixed-post and patrol inspection on the line, sampling after production, and incoming and outgoing inspection at the loading area. The group holds more than 100 national patents, including seven invention patents, most of them in the functional areas buyers actually notice: deodorising and antibacterial performance, breathability, super-absorption, anti-rewet and leak protection.

Then there are the test reports, which are what customs and institutional buyers ask for first. ASL can supply English-language ISO 10993 biocompatibility reports — ISO 10993-5 cell-cytotoxicity testing for diapers, ISO 10993-10 skin-sensitisation testing for pull-up pants, and ISO 10993-23 irritation testing for underpads — along with a deodorising and antibacterial report dated 2024-04-17, and can issue per-batch reports so that every shipment is documented on arrival.

The numbers that de-risk a large order

An audit is also a capacity question, and capacity is where vague answers cost money. ASL's lines produce 580 million adult diapers and pull-up pants a year and 150 million insert diapers, with total output across adult and pet care products exceeding five billion pieces a year. Ask for those figures per line and per shift, then match them against loading records and bills of lading from recent shipments — capacity that cannot be traced to paperwork is a claim, not a number.

The group's approach to risk is structural rather than rhetorical. Because it owns the nonwoven and film plant, it is less exposed to upstream shortages. Because it runs four bases across China and Malaysia, urgent orders can be reallocated. And because it works with long-standing logistics partners, it can combine full-container, LCL, air and sea-air shipments to suit the order rather than the other way around.

How to verify any supplier on your shortlist

None of the above is unique to one company. The method is what matters, and it is short enough to run on any supplier. Confirm the FDA registration number directly in the FDA database, and check that the product listings match what you are buying — a registration that covers face masks but not adult diapers is not a diaper certification. Verify the CE certificate and the notified body behind it, and be sceptical of a self-declaration. Read the scope written on each ISO certificate, not just its title. Ask for the validity window of every certificate you are shown; any certificate within 90 days of expiry should come with a written renewal schedule, and a supplier who cannot produce one is asking you to carry the risk. Ask for batch test reports, not a single report from three years ago. And ask, plainly, for the document package a tender would require.

That last request is the one that separates a certified manufacturer from a well-written brochure. ASL keeps the full package ready: FDA and CE certificates, the ISO series, FSC, BPI degradability certification, the Chinese Class I medical device filing (鲁临食药监生产备 20190011), product specification sheets, English parameter manuals and traceable raw-material test reports.

Questions importers ask us most

What certifications should a qualified adult diaper supplier hold for export? At minimum, product-specific FDA registration, CE under MDR for Europe, ISO 13485 for medical-device quality management, ISO 9001, 14001 and 45001, FSC where the product uses pulp, and ISO 22716 with GMPC for wipes. Ask for the certificate numbers and validity dates, not the certificate titles.

Can production be split between China and Malaysia? Yes. ASL can allocate orders across regions according to product specification, lead time and available capacity, which is often how buyers reduce single-country sourcing risk.

What is the MOQ for private-label adult diapers? It depends on specification, raw-material structure, print complexity and container loading, and is best quoted per SKU after a specification sheet. ASL keeps a trial-order channel open for new overseas brands, then scales to bulk supply and annual framework contracts.

Can you supply the complete tender document package? Yes — FDA and CE certificates, the ISO series, FSC, the Chinese medical-device filing, product test reports, specification sheets, English manuals and raw-material reports.

How fast can an urgent restock be scheduled? With shared scheduling across the China and Malaysia bases, rush orders can be prioritised; typical expedited production runs around 7–15 days depending on specification and destination.

If you are building a shortlist for adult diapers, pull-up pants or underpads, start with the certificates — then ask what the factory can show you beyond them. Samples, English specification sheets and a guided video walk-through of the line are available on request. ASL Group (Aishule) — hygiene-items.com | odmdiaper.com | info@jingxincare.com