Responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits. ISO 9001:2015 states an organisation must plan, establish, implement and maintain an audit programme(s) including the frequency, methods,.What is an Internal Audit Plan? Why do I need it in my Quality Management System (QMS)? All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which can then be modified to suit your company branding/marketing requirements. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider.
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