Shanghai Zimai Safety Technology Co.、Ltd.
A model-specific PPE compliance file is a set of papers for one product model. Each paper names the same model. The set has the declaration of conformity, the test report, the user instructions, 製品ラベル, and a technical documentation reference.
This is not a workplace inspection list. It is a check that buyers do before they order. This PPE compliance file checklist helps you ask for the right papers and spot the wrong ones.
Why PPE Papers Must Match One Exact Model
A product family is not one product. Each paper must name the exact model you buy.
Two items on the ZIMAI site show this. の DR300 half mask lists EN140:1998. It can only be used with a filter. の DF030 P3 filter lists EN 143:2021. The mask and the filter are two models. Each one needs its own set of papers.
A company certificate is different. ISO 9001:2015 とISO 14001:2015 show how a firm runs its work. They do not cover each model. Good model identification keeps the two apart.
The PPE Compliance File Checklist for Buyers
A buyer needs eight items in the file. All items must be the same model. This checklist of PPE compliance files includes them in the order that purchasers request them.
Eight Items to Ask For
- Model identification (the same name and code on every paper)
- EU 適合宣言
- Test report with scope
- EU type-examination certificate (for Category II and III)
- User instructions
- Product label and marking
- Technical documentation reference
- Document traceability (a batch or serial number link)
Quick Reference Table for Each Document
| Document | What to confirm | Who issues it |
| Model identification | Same name and code on every paper | Manufacturer |
| EU 適合宣言 | モデル, manufacturer, Regulation, standards | Manufacturer or authorized representative |
| Test report | Exact model, standard edition, tests run | Test laboratory |
| EU type-examination certificate | Model and notified body number | Notified body |
| User instructions | Same model and standard, readable language | Manufacturer |
| Product label and marking | Maker name, type, batch or serial number | Manufacturer |
| Technical documentation reference | File index or reference number | Manufacturer |
| Document traceability | Batch or serial number linked to the papers | Manufacturer and supplier |
Model Identification Across Every Document
The model name and code must be consistent on the declaration, report, label and instructions. A tiny modification in the code might imply a different product even.
If the size, color or version are different, contact the provider to confirm in writing. They should mention the documents are still valid. また, put the precise code on your purchase order. This prevents a switch to a comparable model.
One Good Example and One Bad Example
- 良い: The declaration, report, label and instructions all show “Model X200.”
- Bad: The declaration says “X200.” The label says “X200-B.” The report is for a different mask.
Reading a Declaration of Conformity
A declaration of conformity is a statement from the manufacturer. It states that the product complies with Regulation (欧州連合) 2016/425. It’s not a grade. It is not a test grade.
The declaration identifies the product and the maker. It specifies the name of the authorized representative, if any. It also identifies the regulation and the standards employed. If a notified body was involved, its information is also included. The layout is given forth in Annex IX to the Regulation.
The declaration must be with the PPE. Or the instructions must provide a URL where it may be read.
What a Test Report Scope Covers
One model is proof of a test report. It is not a CE certification.
Check three things in the test report scope. 初め, the specific model used for testing. Second, the version of the harmonized standard . Third, the tests performed. A standard may be replaced by a new edition. If the report is an outdated edition, inquire why.
Conformity Routes by PPE Category
| PPE category | Conformity route |
| Category I | モジュールA |
| Category II | Module B plus Module C |
| Category III | Module B plus Module C2 or Module D |
カテゴリ II および III の場合, ask for the notified body number. Then check it in the NANDO database.
User Instructions: 確認すべきこと
User instructions are information provided by the manufacturer with the PPE. 附属書 II, point 1.4 sets the rule.
They must be in a user-readable language. They shall be subject to the same model and standard as the declaration.
Check out the usage limitations too. 例えば, the DR300 mask works with a filter. A customer who overlooks this may order the incorrect set. If the instructions refer to a different model, that’s a red flag.
Checking Product Labels Against the Papers
The label should carry the name and address of the maker. It must have the kind and a batch or serial number on it. It also must have the CE certification. カテゴリーⅢの場合, the notified body number is after the mark.
If the goods is too tiny, the mark is placed on the packaging and on the papers. Mark the labels of the products next to the statement. The wording should be the same word for word.
Technical Documentation: What to Ask For
The technical documentation is the whole file of evidence for one model. The manufacturer makes it. Annex III states what it contains.
The file contains the product description, design data, and a risk analysis. It also contains the applicable standards, test reports, certifications, and user instructions. The maker retains it for 10 years from the launch of the product.
The buyer may not get the whole file. Instead, ask for the file index or a reference number.
Document Traceability From Batch to Buyer
Document traceability relates a delivery to its paperwork. The order is the first in the chain. Then the batch or serial number, the label, and the declaration.
Keep the file with the purchase order. Write the version and date of each document. A PPE compliance file checklist only works if the paperwork matches the things that come in.
“私たちの quality system and plant audit provide customers security on product quality and traceability,” claims ZIMAI’s site.
Warning Signs in a Supplier’s PPE Papers
A weak file often shows problems early.
Five Signs of a Weak File
- A CE mark but no declaration
- A certificate for a different model
- An old or missing standard edition
- Only a company certificate
- A label that does not match the papers
Just because something is there doesn’t mean it’s defective. That being said, it’s a valid excuse to pause and inquire more. Include these signals in the checklist for your PPE compliance file. 次, compare all of the vendors in the same manner.
Where ZIMAI Fits in Your Document Check
ZIMAI is a Shanghai manufacturer and supplier of PPE. Its site says:
- 以上 30 長年にわたる個人用保護具の輸出経験
- ISO 9001:2015 とISO 14001:2015 認定された
- Some plants audited under SEDEX and BSCI
- Most 手袋 , 安全靴, masks and Hi-Vis workwear are CE certified
- その他の PPE の場合, tests and certificates are shared with strategic suppliers in China
For the last point, ask which papers cover your exact model. Also ask who holds them. The site is a good start. Then run your own PPE compliance file checklist on the papers you get.
Start with the その他の PPE カテゴリ そして 証明書ページ . Then use the Inquiry or 見積もりを取得します ページ. sales@zmsafety.cn に電子メールを送信するか、電話で問い合わせることもできます。 +86 21 67766378.
よくある質問
Which PPE documents should match the exact product model?
The declaration of conformity, test report, user instructions, product label, and reference to the technical documentation must be the same for the particular model. In case of Category II and III, the type-examination certificate should also match. A single inaccurate model name will break the chain of evidence.
Is a generic supplier certificate enough for a PPE order?
いいえ. A company certificate such as ISO 9001:2015 illustrates how a company does its job. It doesn’t show one model conforms to the rules. Company papers and model papers solve two separate problems. Order, but ask for documentation for your model
Does a test report prove that PPE meets CE rules?
あ: いいえ. A test report is model evidence. The certificate is not CE. The CE mark also requires a written declaration and the appropriate route of compliance. A recognized body also issues a type-examination certificate for categories II and III.
Must the declaration of conformity come with the PPE?
はい. PPE must be accompanied by a declaration. Or the directions have to include a web URL where you may read it. If it hasn’t and the pack hasn’t got one, ask the provider for the URL before you accept the products.
Who keeps the technical documentation for PPE?
The maker should preserve the technical documentation for 10 years after the placing of the product on the market. Buyers often don’t receive the whole file. Request the file index or reference number. Keep it with your order paperwork.
結論
Put every paper side by side before you pay. 名前, code, standard and edition must match across the file. A PPE compliance file checklist takes little time. It can stop a failed shipment.
Papers that name your exact model protect your order and your budget. If you want a supplier that names standards on its product pages, look at Shanghai Zimai Safety Technology Co.、Ltd . Ask for the papers for your model. Then send a request through the お問い合わせページ .