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Are you in control? Document lifecycle management software for ISO 9001 compliance

Document lifecycle management softwareISO 9001 requires you to control the document lifecycle to improve the efficiency and effectiveness of your business process, continually increasing quality and value for your customers over time.  Is your software up to the job?

ISO 9001 says that ‘documented information needs to be controlled' to create your quality management system.

In other words, you should have the processes in place to protect and share all your data and organisational knowledge  - ensuring its integrity and making it available whenever and wherever it is needed.

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For complex product development processes this can entail a high level of control across the document lifecycle:

document lifecycle diagram

Being able to control your documentation in these ways will help you maintain the integrity of the data and knowledge in your system to secure better quality outcomes.

These controls will also help you build the cycles of implementation, review and optimisation (plan, check, do and act) that you need to deliver products that more exactly meet the needs of your customers. And being able to automate these processes with the right software will bring greater velocity and flow to your operations, even as complexity grows.

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But the ISO 9001 guidelines also make it clear the controls you exercise over your documentation should reflect your specific organisational needs - and the potential risk of failure involved:

“A QMS should maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned.”

Not every process you undertake needs to be signed off by your CEO, or use the most robust electronic signature configuration to authenticate the identity of the signatory.  

Your business may only initially require basic document controls to help manage the flow of information as you ideate and brainstorm new products.  But this may evolve into the need for high level ‘phase gating’ to ensure complex projects are able to deliver output to required standards.

The best software operates as a LEAN framework for document lifecycle management allowing you to create the processes and approval mechanisms that fit the way you work, imposing tighter controls as your needs increase.

Guide Medical device for Fabless companies

Tags: ISO 9001:2015