Transfer from the risk assessment
In accordance with the German Product Liability Act (ProdHaftG), a main task of user documentation is to make residual risks of a product recognisable to the user and to minimise such risks with instructions. Europe has different standards here: ISO 82079-1 is for instructions, while ISO 3864-2 is for warnings on the product.
The US standard ANSI Z535 (parts 1–6) incorporates these different aspects and provides a method for creating safety and warning notices, warning signs and symbols. Both standards can be combined, but ANSI is also widely recognised in Europe. Documentation intended for the US market must comply with the US standard ANSI Z535.6.
Scriptor can transfer the residual risks described in the risk assessment into the documentation, classifies the hazard levels and formulates the required ANSI-compliant notices. In projects that accompanying the product development (but also whenever creating manuals that comply with the Machinery Directive), safety is a multi-dimensional topic: on site at the product, using safety signs, labels and mechanisms, as well as the safety-related text in the manuals.
At Scriptor, one of our key services is making sure that all of the manufacturer’s obligations are implemented.
Analysis of the safety and warning notices according to US standard ANSI Z535.6
We review your manuals and report on how your safety and warning notices comply with the US standard. The text content, danger levels, and danger keywords are checked. This necessitates a comparison with the risk assessment.
Creating safety and warning notices based on the risk assessment
We create safety instructions for your manuals according to the current US standard ANSI Z535.6 and based on the risk assessment (or as a transfer from ISO to ANSI Z535.6). ANSI provides a well developed hazard level system that our authors can skillfully implement. We understand how to assign the correct hazard level and correctly place these notices and warnings in your documentation.
Rewrite for compliance with US standard ANSI Z535.6
If your safety notices are available but do not meet the ANSI standard, we will rewrite them based on the risk assessment in close cooperation with you.
Risk assessment prepared with partners
The safety and warning notices are based on the risk assessment. Our partners handle the legally compliant preparation of this risk assessment. Cooperation then leads to automated interfaces for the formulation and transfer of these notices into the documentation.
Analysis of the safety and warning notices according to US standard ANSI Z535.6
We review your manuals and report on how your safety and warning notices comply with the US standard. The text content, danger levels, and danger keywords are checked. This necessitates a comparison with the risk assessment.
Rewrite for compliance with US standard ANSI Z535.6
If your safety notices are available but do not meet the ANSI standard, we will rewrite them based on the risk assessment in close cooperation with you.
Creating safety and warning notices based on the risk assessment
We create safety instructions for your manuals according to the current US standard ANSI Z535.6 and based on the risk assessment (or as a transfer from ISO to ANSI Z535.6). ANSI provides a well developed hazard level system that our authors can skillfully implement. We understand how to assign the correct hazard level and correctly place these notices and warnings in your documentation.
Risk assessment prepared with partners
The safety and warning notices are based on the risk assessment. Our partners handle the legally compliant preparation of this risk assessment. Cooperation then leads to automated interfaces for the formulation and transfer of these notices into the documentation.
Scriptor highlights
- Creation and assignment of the notices
- Feedback about the creation process
- Change from ISO to ANSI
Scriptor highlights
- Transfer from the risk assessment
- Creation and assignment of the notices
- Feedback about the creation process
- Change from ISO to ANSI
Your advantages
- Many years of experience with ANSI
- Direct contact between Scriptor and the creator of the risk assessment
- No discrepancies between risk assessment and documentation
Your advantages
- Many years of experience with ANSI
- Direct contact between Scriptor and the creator of the risk assessment
- No discrepancies between risk assessment and documentation
Address
Scriptor
Dokumentations Service GmbH
Krackser Strasse 12c
33659 Bielefeld
Germany
Tel: +49 521 950220
Fax: +49 521 9502225
e-mail: info@scriptor.de
Contact
Heike Hettwer
Managing Director
Scriptor Dokumentations Service GmbH+ 49 521 950220