Eastwest MedicoContact sales
Documentation

Everything we certify, published in full.

Our management system certificates, policies and trading conditions, downloadable without a form or a request. Each entry states the certifying body, the certificate number and the dates it is valid between, so that it can be checked against the certifying body's own register rather than taken on our word.

3
ISO management systems
10documents
available without a request
Management systemsPoliciesSales and delivery conditionsProduct documentation

Management systems

Three certified systems, audited by an accredited certification body with surveillance audits between recertifications. Certificate scope matters as much as the standard number, so the scope statement is quoted rather than summarised.

Standard
Certified scope
Body and certificate
Download
ISO 9001:2015
Quality management
Manufacturing, sales, distribution, and technical support of Medical Devices
Valcert ApS, Middelfart, Denmark
Certificate DK50220433
Initial certification 31 October 2022. Issued 2 April 2026. Valid until 29 October 2028.
ISO 13485:2016
Medical devices
Manufacturing, sales, distribution and technical support of medical devices.
LiberoAssurance, accredited to ISO 17021
Certificate DN3117001022132
Initial certification 19 April 2023. Issued 19 January 2026. Valid until 22 January 2029.
ISO 14001:2015
Environmental management
Manufacturing, sales, distribution, and technical support of Medical Devices
Valcert ApS, Middelfart, Denmark
Certificate DK60120085
Initial certification 19 April 2023. Issued 2 April 2026. Valid until 22 January 2029.
Policies

The policies our own people are held to.

A policy that is not published is a policy no one can hold you to. These are the documents our staff, our manufacturing partners and our customers are entitled to read in full, including the parts that commit us to something.

Quality Policy

What we commit to on product conformity, documentation and corrective action, and the authority our quality team has to stop a shipment.

Version KBL/2022-10-30/v03. Dated 30 October 2022.
Environmental Policy

Our environmental commitments under ISO 14001, including material choice, packaging and the reduction targets we report against.

Version KBL/2023-01-15/v01. Dated 15 January 2023.
Supplier qualification policy

The requirements a manufacturer must meet to be qualified, and the grounds on which qualification is withdrawn. Employee rights and environmental compliance are assessed alongside quality and delivery capability.

Signed by the Managing Director, 14 March 2022.
Code of Conduct

The conduct we require of ourselves and of our partners on human rights, labour, anti-corruption and the environment. Applies to every manufacturer we place an order with.

Issued 1 January 2023, signed by the Executive Vice President.
UN Global Compact commitment

Participant since December 2022, committed to the ten principles with annual public progress reporting. Our Communication on Progress is filed with the UN Global Compact and published there in full.

Participant since December 2022. Annual reporting.
Carbon reduction plan

A nine-step reduction plan across our own operations and our value chain, with the measurement basis stated so that progress can be judged against it.

2026 edition.
Trading conditions

Sales and delivery conditions.

Our general conditions of sale and delivery apply to every order unless a framework agreement or tender contract says otherwise, in which case the contract governs. They are published here rather than referenced in small print on an order confirmation.

Delivery terms are quoted per shipment under Incoterms® 2020. Which term applies decides who carries the cost and the risk at each stage, and it is worth reading before it matters.

General conditions of sale and delivery

Applies to every order placed with Eastwest Medico ApS unless a framework agreement or tender contract states otherwise.

Current edition. Supersedes the 2022 version.
Delivery terms

Quoted per shipment under Incoterms® 2020. Our three explainers cover the origin, freight and delivered term groups and what each one shifts onto whom.

Incoterms® 2020.
Privacy notice

How we handle personal data under the GDPR for customers, tender contacts and site visitors.

Version 1.0. Dated 28 July 2026.
Product documentation

Per product, not per company.

Company certificates say how we are organised. They say nothing about whether a specific glove meets EN 455. That evidence is product-specific and batch-specific, so it lives with the product rather than on this page.

Declaration of conformity

Issued per product, naming the legal manufacturer, the classification and the standards applied. Held on file for every item we sell and supplied on request.

Third-party test reports

Accredited laboratory reports against the standard each product claims, cited by edition. Where we hold a report against a superseded edition we say so rather than quoting it as current.

Batch documentation

Pre-shipment inspection reports from SGS or TÜV, and the AQL result for the production run your goods came from. Available per delivery, by item code and batch number.

How to check that any of this is true.

A PDF is an image of a certificate, not proof of one. Anyone evaluating us as a supplier should verify independently, and these are the four checks we would run on ourselves.

01
Check the certificate in the issuing body's register

Every accredited certification body publishes a searchable register of valid certificates. Search the certificate number there rather than trusting the PDF. If a number does not resolve, the certificate is not valid, whatever the document looks like.

02
Read the scope, not the standard number

ISO 13485 held for warehousing is not ISO 13485 held for placing devices on the market. The scope statement decides what the certificate actually covers, and it is the line most often skipped.

03
Check the dates, including the surveillance audit

A certificate has an expiry date, and between recertifications it depends on surveillance audits being passed. An in-date certificate from a supplier who has missed an audit is a document, not an assurance.

04
Separate the company from the product

Our ISO certificates say nothing about whether a given glove passes EN 455. Ask for the product declaration of conformity and the test report by product name, and check the edition cited against the current one.

Niels Kristian Bitsch, chief executive officer of Eastwest Medico ApS
Maintained by Niels Kristian Bitsch, Chief Executive Officer. Reviewed on recertification and at least annually. If a certificate here has expired, that is our error and we would like to hear about it:info@ewmedico.com.

Need a complete tender documentation pack?

Tell us the item codes and the tender reference and we will assemble company certificates, declarations of conformity and test reports as one bundle, usually within one working day.