Trust begins with not presenting an unfinished process as finished. That is why, on our Compliance and trust page, we list every document and process with its status, the body involved and the date. As of 28 October 2026 the picture is: 8 completed, 5 ongoing, 1 planned.

What the statuses mean

  • Completed: The certificate or verification report has been received; its scope is as stated in the document.

  • Ongoing: The application, contract or testing process is under way; the related marks and logos are not used until it is completed.

  • Planned: On our roadmap; not yet started.

Management systems

Our quality (ISO 9001), environmental (ISO 14001), occupational health and safety (ISO 45001) and customer satisfaction and complaints handling (ISO 10002) management systems were certified by TÜV SÜD as an integrated system on 13 March 2026. The process for a quality management system for medical devices (ISO 13485) is ongoing.

Environmental measurement and verification

  • ISO 14067, product carbon footprint verification: TÜV Austria, 14 August 2026, report TR-PCF-671. Cradle-to-gate in scope and valid only for the single product named in the document.

  • ISO 14040/44, life cycle assessment: Completed.

  • ISO 14064-1, corporate carbon footprint (2025 base year): Completed.

  • ISO 14046, water footprint: Completed.

  • ISO 14068-1, climate target approach and measurable reduction plan: Planned.

Product and regulatory conformity

All of the following processes are ongoing:

  • Testing for harmful substances in textile products under OEKO-TEX® STANDARD 100

  • (EU) 2016/425 Personal Protective Equipment Regulation, Module B–D (with SZUTEST)

  • (EU) 2017/745 Medical Device Regulation (with SZUTEST)

  • Product testing for surgical drapes and gowns under EN 13795

Until these processes are completed, we do not present our products as “CE certified”, “MDR approved” or “certified”, and we do not use the related marks and logos.

A result applies only to its own product

Working with a body does not mean that every one of our products holds that body's certificate. When we share a certificate or test result, we state the product, method, report number, date and scope of validity together; we do not extend one product's result to the whole brand family. We prepare our environmental claims with regard to the framework of EU Directive 2024/825.

For a copy of a document or details of its scope, write to info@opia.eco.