Effective and user friendly ISO 9001 documentation is the backbone of a good QMS. But why documentation is so crucial? There are two reasons behind this. Firstly, company needs to demonstrate compliance to quality management system and secondly company needs to make meaningful analysis for identification of improvement opportunities. This is an imperative consideration as most of the companies waste their time in coming up with complex ISO 9001 QMS which is bulky, not employee / user friendly and absolutely not aligned to their business processes, but it is suggested to keep the documents as simple as possible and if you are using ISO 9001 Quality Manual, ISO 9001 templates, or ISO 9001 forms available online to design your QMS then choose them appropriately and wisely.
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ISO 9001 quality manual is a top level document describing quality management system. It’s format, structure and layout depends on you. One can have a simple 4-page quality manual document or a bunch of many pages but the point of concern is that, documentation should cover all the points of standard which suits your business if you decide to have quality manual at all because it is no longer a mandatory documented information required by the standard.
Well written and properly maintained ISO 9001 SOP (Standard Operation Procedures), defining how various processes will be executed and work instruction describing how various tasks should be performed, are crucial for following compliance and customer requirements. These documentations also guide employees, how to perform their daily work. The main goal of these procedures and work instructions is to maintain quality, uniformity and effectiveness in the business, while minimizing gap or failure in the processes / order execution / government compliances.
Along with appropriate departmental / functional / process documentation, there are some ISO 9001 procedures which should be included in the quality management system as appropriate as they are good to have but not mandatory documented information to be maintained as per ISO 9001:2015 standard. These procedures are:
Documentation in the latest ISO 9001 QMS standard is really simple, organization friendly and performance oriented. Now there is no need to have written or documented procedures for everything you do or keep records in a specific format. If you can demonstrate compliance to the quality management system requirements in a manner appropriate and suitable to your organization, you meet ISO 9001 documented information clause requirements. So, it might be clear to you now, the role of documentation in ISO 9001 and why it is a necessary to have appropriate documentation.
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MyEasyISO is your best choice for ISO document management software, as there are two million companies which are ISO certified and there is no such product or software which can take care of 100% compliance to ISO implementation requirements and maintain all documented information completely. So, one can utilize this software which gives assurance of compliance and ensures your organization is audit ready all the time.