Projects leading to certification - carried out on-site or remotely!
Quality
ISO 9001 certification
ISO 9001 certification is a way to demonstrate, both internally and externally, that the organization is dedicated to systematically improving and meeting and exceeding the expectations of its customers and stakeholders. A certified management system provides a stronger brand and increased trust from customers and the outside world.
We have extensive experience in helping organizations create effective management systems that meet the requirements of ISO 9001.
ISO 39001 - Road Traffic Safety Management System
An ISO 39001 certification is a way of demonstrating, both internally and externally, that the organization is dedicated to ensuring road safety and systematically improving in this area. A certified management system provides a stronger brand and increased confidence from customers and the outside world.
We have extensive experience in helping organizations create effective management systems that meet the requirements of ISO 39001.
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ISO 13485 - Management systems for medical devices
ISO 13485 is a quality management standard for medical devices. The standard is based on ISO 9001 but has higher requirements for formal documentation and specific requirements for product safety.
Certification to ISO 13485 helps organizations meet the needs of their customers while complying with regulatory requirements for the manufacture of medical devices.
EN 1090 - Quality assurance of steel and aluminum structures
Project management and service contracts
We offer projects where we create and implement the required documentation and create an efficient work process to comply with ISO 9001, ISO 13485 and EN 1090 in the daily work. The documentation includes stakeholder analysis, risk assessment, policy, processes and procedures and related templates. We work with you to set up procedures that work in practice and allocate responsibilities within the organization. We also train your staff internally during the project.
We also offer a service contract where we take ongoing responsibility as an external quality manager. We handle annual quality audits, regulatory monitoring, documentation, internal training and general support on various issues.
In the service agreement, we take responsibility for, among other things:
- Implementation of the management system
- Annual internal review/audit
- Documentation and drafting of procedures
- Internal training
- Support in various day-to-day matters
A quality management system provides benefits such as
- Higher productivity
- Fewer complaints
- Better precision in the management of operations
- Lower costs
- Staff have a better understanding of the big picture
- Increasing competitiveness
- Stronger brand