Documentation compliant with laws and standards
According to the Product Liability Act, two key tasks of user documentation are to identify a product’s residual risks to the user and to minimise such risks with the appropriate instructions.
Thus, the EU has defined a series of evolving standards as the basis for technical documentation. The standard ISO 82079-1 applies to user documentation and the ISO 3864-2 is relevant for product warnings.
As a long-standing member of the tekom professional association, Scriptor has been following the development of regulations, guidelines and standards to ensure legally compliant authoring. We actively participate in lectures on new developments (topics such as “over-warning”) and discussions among association experts.
Legally compliant documentation provides long-term protection for you and your customers/users. It also helps to mitigate your liability and risks. Our sharp focus on a few core sectors is what makes us so effective.
Legally compliant strategies
We create strategies for sector-specific documentation based on these fundamentals: IEC 82079-1, MRL 2006/42/EC, Medical Device Regulatory (MDR) 2017-745, IVDR 2017-746, as well as the Low Voltage Directive and ATEX. We take into account which content, writing style, terminology, target group and country are required for your publication. We also consider the structural specifications that must be observed to ensure standard-compliant documentation. This is where we lay the foundation based on standards – the importance of this increases significantly as your text is reused.
Risk assessments
We create safety instructions according to the specifications of the product’s risk assessment, which you provide or which we have created by our experienced partners. We communicate directly to minimise the interfaces.
Actual-state analyses: standard compliance
We check your documentation for conformity with applicable standards, identify deviations, and implement standard-compliant changes on request. New develpments, such as avoidance of “over-warning” will also be considered. Our work is based primarily on the new documentation standard IEC 82079-1 (2nd edition), the product-relevant directives MRL/MDR and the US standard ANSI.
Legally compliant authoring
Documents are not created in a legal vacuum. The Product Liability Act and the product-related regulations and directives – mainly the MRL 2006/42/EC, MDR, ATEX 2014/34/EU and the Low Voltage Directive 2014/35/EU provide the legal foundation. We also refer to the documentation guideline DIN EN 82079-1 Edition 2, which further specifies a framework for quality, target groups and competencies.
Safety notices according to ANSI Z535.6
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). 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.
Legally compliant strategies
We create strategies for sector-specific documentation based on these fundamentals: IEC 82079-1, MRL 2006/42/EC, Medical Device Regulatory (MDR) 2017-745, IVDR 2017-746, as well as the Low Voltage Directive and ATEX. We take into account which content, writing style, terminology, target group and country are required for your publication. We also consider the structural specifications that must be observed to ensure standard-compliant documentation. This is where we lay the foundation based on standards – the importance of this increases significantly as your text is reused.
Legally compliant authoring
We check your documentation for conformity with applicable standards, identify deviations, and implement standard-compliant changes on request. New develpments, such as avoidance of “over-warning” will also be considered. Our work is based primarily on the new documentation standard IEC 82079-1 (2nd edition), the product-relevant directives MRL/MDR and the US standard ANSI.
Risk assessments
We create safety instructions according to the specifications of the product’s risk assessment, which you provide or which we have created by our experienced partners. We communicate directly to minimise the interfaces.
Safety notices according to ANSI Z535.6
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). 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.
Actual-state analyses: standard compliance
We check your documentation for conformity with applicable standards, identify deviations, and implement standard-compliant changes on request. New develpments, such as avoidance of “over-warning” will also be considered. Our work is based primarily on the new documentation standard IEC 82079-1 (2nd edition), the product-relevant directives MRL/MDR and the US standard ANSI.
Scriptor highlights
- Research and presentation of legal framework
- Analysis of the safety notices for "over-warning"
- Checking the standard compliance of your documentation
- Safety notices based on the risk analysis
- Risk analysis by specialised partners
Scriptor highlights
- Documentation compliant with laws and standards
- Research and presentation of legal framework
- Analysis of the safety notices for "over-warning"
- Checking the standard compliance of your documentation
- Safety notices based on the risk analysis
- Risk analysis by specialised partners
Your advantages
- Service provider with experience and knowledge of the standards
- Contact person for legalities of technical documentation
- Network partner for risk analysis
Your advantages
- Service provider with experience and knowledge of the standards
- Contact person for legalities of technical documentation
- Network partner for risk analysis
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