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ISO 9001 Blog

List of mandatory documents required by ISO 13485:2016

The new ISO 13485 is based on ISO 9001:2008, which means that the requirements for documentation are based on the requirements of the previous version of ISO 9001, with the addition of documents specific to the medical device industry. So, here is the list – below you will see the …

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Making the best out of ISO 9001 Quality Plan

The new version of ISO 9001 has a new approach to documents and records (see also New approach to document and record control in ISO 9001:2015) and this opportunity should definitely be seized. Without so many mandatory procedures as the previous version of the standard, requirements for documenting processes to …

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7 steps in writing QMS policies and procedures for ISO 9001

At some point during your implementation of an ISO 9001 quality management system (QMS), you will have to write down some policies and procedures. There is no avoiding this. While it is useful and important to make sure you don’t have too much documentation, there are definitely some policies and procedures …

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Using Competence, Training and Awareness to Replace Documentation in your QMS

Have you wondered how to reduce the amount of documentation in your Quality Management System, while making sure that key information is still maintained? Fortunately, Section 6.2.2 of ISO9001:2008 gives you this flexibility and identifies three areas where this can be accomplished with the application of the human resources components …

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Deciding Which Procedures to Document in QMS

If you are implementing a Quality Management System, you may struggle with the decision of what needs to be written down, and this is common. While only six documented procedures are required (see List of mandatory documents for ISO 9001), any remaining procedure documentation is at the discretion of the company …

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