Pioneer has performed hundreds of ISO 9001 designs & implementations which includes the implementation of current ISO 9001:2015 standard using our unique Lean Quality Management implementation approach which ensures everything we do adds value to the operations. We have a track record of our clients being recommended for registration on their first attempt. We guide, facilitate and coach with every step of the process, right from determining your processes to manual creation to external audit support which includes
Pioneer may be an expert in development and implementation of ISO 9001:2015, ultimately it is your leadership which will be expected to:
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Pre-assessment & Project Plan: This session represents the kickoff meeting for the project which can be few hours or a full day. The Client assigns the core team to handle the project and our Consultants start with understanding the strategic direction of the business which includes reviewing the vision, mission and values. This helps to understand the context of the organization, identify their stakeholders (interested parties), discuss the internal and external issues and ensures risk based thinking concept is understood by the leadership and this approach is followed during the ISO 9001:2015 development and implementation project.
We will use a state of art process tooling software to capture as-is processes, and discuss the processes improvement with input from the organization’s multidiscipline teams. The improved process flow charts will show the improved process which conforms to ISO 9001:2015 requirements and is much more effective to produce efficient results. The number of processes depends on the complexities of the organization.
The required documented information (manuals / policies / procedures) is created depending on the risk based thinking and requirements of the organization. All the current documentation is taken into consideration during creation of documented information.
The timeline of quality management system depends on the needs and requirements of the organization. A typical development can be completed in 6 to 8 weeks and implementation may take another 8 to 10 weeks. During the development and implementation phase of the project, we will transform your developed documented information into an effective quality management system which conforms to ISO 9001:2015. We highly recommend to complete the process within 3-6 months to keep the focus on the project. Our consultants will be leading the development and prepare your team to lead the implementation, providing support as and when needed.
We can train your staff as Internal Auditors or can perform internal audits if required. Our team will facilitate the management review meeting to ensure inputs are collected to discuss and the evidence of informed decision making is evident. A record of management review including outputs, is to be retained. As you are ready for your certification audit, our consultants will perform a pre-certification audit to ensure all the required processes are effectively implemented. As all of our consultants are also working as external auditors, this process will give you confidence to pass your certification audit with ease.
We will provide coaching on how to pass an audit which will help to remove the stress from the event by providing strategies and techniques for working with the external auditors effectively. We have a perfect record of successful registration. We guarantee you will pass your first ISO 9001:2015 audit if you follow our plan.