Documentation
Documentation is what makes production controllable, repeatable and audit-ready. At Move we work with batch documentation, SOPs, assembly and test instructions, and the basis for certification, all grounded in ISO 13485, so every product can be traced, quality-assured and delivered with the documentation the market requires.
Documentation
Documentation is part of production – not an afterthought
Production is only really strong when it can be repeated, documented and explained. That applies especially to technical products, medical devices and solutions where quality, traceability and regulatory requirements are part of everyday life. That is why documentation is not something we lay on top of production at the end. It is an integrated part of the way we manufacture.
ISO 13485
Quality considered from the start
Full traceability
Documentation at component and batch level
Audit-ready
Test instructions and acceptance criteria
Documentation
Updated on changes, new versions and processes
Documented production based on ISO 13485
At Move we work with documented production based on ISO 13485. The standard is internationally recognised for quality management systems for medical devices and sets requirements for processes, documentation, control and the ability to deliver products that meet customer and regulatory requirements, among other things.
In practice that means we work in a structured way with the documents and records needed to ensure the product is manufactured correctly every time. That can be batch documentation, incoming inspection, production records, test results, assembly instructions, SOPs, component traceability and documentation for the release of finished products.
Batch documentation and traceability
Batch documentation is an important part of this work. When a product or a series is manufactured, it has to be possible to see what was built, when it was built, which components were used, who carried out the work, which tests were completed, and whether the product was released according to the defined requirements. That creates traceability and makes it possible to document quality internally, towards customers and in connection with audits.
SOPs, assembly and test instructions
SOPs, or Standard Operating Procedures, are another central element. A good SOP describes not just what has to be done, but how it has to be done, when it has to be done, and who is responsible. We maintain SOPs so they follow the actual processes in production and do not end up as static documents that only exist in a quality system. When processes change, the documentation has to follow.
The same applies to assembly and test instructions. A product can only be manufactured consistently if the assembly is well defined. That is why we work with clear instructions describing assembly, visual inspection, test points, measurement requirements and acceptance criteria. That reduces the risk of errors, makes training easier and ensures quality does not depend on any one person's memory or experience.
Documentation that follows the product throughout its lifetime
Documentation also plays an important role when a product has to be certified, updated or moved between manufacturing setups. If the baseline is in order, it becomes easier to document changes, handle component replacements, validate new processes and show that the product still meets the relevant requirements. That is especially important for products with a long lifetime, several variants or market-specific versions.
Because our production sits close to development, quality and sourcing, we can keep the documentation alive. If a test procedure has to be improved, an assembly instruction has to be clarified, or a component change requires updated documentation, we can react quickly. That gives a more agile production without compromising on control, traceability or quality.
For us, good production documentation is not bureaucracy. It is a practical tool that makes production more robust. It helps us build correctly the first time, find root causes faster, release products more safely, and give customers a stronger basis when they have to document their own product to the market, partners or authorities.
FAQ
Frequently asked questions
What is batch documentation?
Batch documentation is the documentation showing how a particular series or batch was manufactured. It can contain information about components, assembly, testing, inspection, deviations and release, among other things.
Why do SOPs matter in production?
SOPs ensure that processes are carried out consistently and under control. They make it clear who does what, how the work is to be performed, and which requirements the process has to meet.
Can you help with assembly and test instructions?
Yes. We can produce and maintain assembly instructions, test instructions, acceptance criteria and the manufacturing baseline, so the product can be manufactured stably and with documentation.
Do you work to ISO 13485?
Yes. Our production works on the basis of ISO 13485, which means a focus on documentation, traceability, process control and quality in manufacturing.
Can the documentation be used for certification?
Yes. Good production documentation can be an important part of the basis for certification, audits, customer requirements and later product changes.
Shall we turn your idea into reality?
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