Every company has their own system of archiving, filing and maintaining documents. And some don’t have any system at all, creating quite the handicap when engaging with an electronics manufacturing company.
However, for companies to achieve such certifications as ISO9001, AS9100C, ISO13485, etc., they should not only identify their document management methods at a policy/ procedural level, they must also be capable of routinely demonstrating these controls.
Many certifications such as AS9100C and ISO13485 have similar document standards which require the manufacturing company to have a system for collecting data, managing and maintaining documents, and records.
Below is a quick look at just some of the requirements of an established document management system.
Develop quality management system documents.
Develop documents to implement your quality system.
Develop an independent file for each project.
Develop a file for each type of related service.
Prepare a quality management system manual.
Document your procedures.
Describe how your processes interact.
Specify the scope of your quality system.
Justify exclusions and reductions in scope.
Describe how your documentation is structured.
Control quality management system documents.
Approve documents before you distribute them.
Provide the correct version of documents at points of use.
Review and re-approve documents when you update them.
Specify the current revision status of your documents.
Monitor documents that come from external sources.
Prevent the accidental use of obsolete documents.
Preserve the usability of your quality documents.
Maintain quality management system records.
Use your records to prove that requirements have been met.
Develop a procedure to control records.
Ensure that your records are useable.
Retain project records.
These standards are met through the continuous monitoring, staffing awareness, adequate project planning, training to standards, and routine audits.
There are key steps in the design and assembly phase where discrepancies and out-of-date information are identified. At each juncture the manufacturing company must collect or even create documents to meet the standards before proceeding with the manufacturing project.
The challenge is that many companies who need design and manufacturing services, are not certificated with ISO or similar standards. And upon ordering manufacturing, they are faced with a realization they have out-of-date documents or are lacking key information for manufacturing standards to be met, which is required for their project to move into production.
What documentation is required?
The documentation required is based on the project. For example a manufacturing project will require a BOM (Bill of Materials). If the customer doesn’t have one, preparation of the BOM can be added as a service to the overall project. The customer may be asked for schematics and electronic files as well. In the case of an engineering project, the customer may be asked for a written project specification along with a list of desired outcomes. A trusted and accredited manufacturing firm will be able to guide the document process and assure all standards are met.
If you have concerns about the documentation you have or don’t have, there is no need to worry. At MJS Designs, our team of experts is ready to help you with your project. Learn more at www.mjsdesigns.com or join the conversation on facebook.com/mjsdesignsinc.