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How people are contributing to the business complexity and how changes in behaviour, will help to simplify and harmonize the business process and delivers a more uniform customer experience. Building the right capacity of people and leading the people who tasked to harmonize a process is crucial to support a sustainable system and to reduce the variation during business process harmonization. Looking for a customized solutions to help with people capacity, mindset or working practices?
This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. By implementing ISO 13485 Medical Devices Quality Management Systems enable the organization identifies its role(s) under applicable regulatory requirements, identified the regulatory requirements that apply to its activities under these roles and incorporates these applicable regulatory requirements within its quality management system.
The methodology to carry out internal audit is crucial to provide an internal audits results which are useful to management to continually improve its quality management systems. One of the criteria to have effective internal audit is about the competency of the auditors. By conducting an audit for management system using process and risk-based approach, it will create an opportunity for an effective internal audit.
Sincera Mayle Consulting is Exemplar Global Recognized Training Provider. We can integrate elements of a client’s content into certain training courses in addition of conforming to the international standard requirements. Consulting services also provided in accordance to the international standard requirements with the recommendation of best industry practices. To find out more about our training and consulting services, we would be pleased to provide you with a competitive proposal based on your industry needs.
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