ISO Six Sigma Step-Process Method To Deliver ISO GMP FDA Certification
Provide ISO six sigma steps-process tools to deliver ISO 9000 certification or comply with GMP FDA regulations, and deliver high quality results
What is Six Sigma Steps-Process Approach?
The ISO six sigma steps-process approach is often applied to succeed in Desk-Audit ISO certification. No matter what ISO GMP FDA certification is required this methodology is designed to address each step from GAP assessment to system upgrade in your process of certification. Various elements merge with each other seamlessly and so effortlessly that the end result is a TOP-NOTCH quality product or management system. Therefore, the application of such a methodology:
- Takes typically from 3 to 6 months for first-time certification
- Takes typically 3 months for transitioning to ISO 9001:2000 standards
ISO six sigma steps-process methodology meets or exceeds the requirements of any Registrar and promotes a CULTURE around QUALITY through out the organization. Experts use ISO six sigma steps-process model to achieve products and management systems certification.
Who uses Six Sigma for System Certification?
A company requires ISO six sigma steps-process approach to use most efficiently staff resources when they strive to comply with ISO International Standards and FDA GMP Regulations. The personnel of the company collaborate, provide input, and approve all documentation related to quality six sigma that is prepared by a third-party consulting firm. The amount of time required for these activities is minimal compared to allocating release time for key personnel (and replacing those people) while they work on documentation.
The ISO six sigma program is jointly managed by an ISO expert and a six sigma expert. They both schedule the activities and collaborate with the staff in place to achieve the product and management system certification. The third-Party does most of the work for you, and ensures that your personnel is trained on ISO and Six Sigma quality concepts.
Why apply Six Sigma for System Certification?
ISO six sigma steps-process methodology provides the right tools for organizations that plan to comply with ISO 9001:2000 or GMP FDA Regulations to develop and improve business processes, and align these processes to best achieve desired results in quality management systems. The end result increases customer loyalty, improve operational results such as revenue and market share. ISO six sigma steps-process approach brings your organization total flexibly to appropriately and quickly comply with ISO Standards and GMP FDA Regulations.
- You are ensured to improve costs and cycle times through the effective use of resources.
- You achieve competitive advantage through improved organizational capabilities.
- you create VALUE for the organization and its suppliers by the optimization of constant resources.
Finally, people are motivated to achieve the organization's goals and objectives and participate in ISO and quality six sigma program to continually improve business processes and quality management systems.
What is Six Sigma Result in System Certification?
ISO six sigma steps-process approach enables an organization to establish a productive and proactive relationship with the registrar. The end-result is the gain of a fast and accurate certification in ISO, and GMP FDA regulation, and the reduction of certification costs with precise communication with the Notified Body. What are the results:
- Obtain better certification audit lead times with appropriate coordination
- Minimizing risks of audit failures
- Expedite the post-audit activities to be able to receive the certificates you need quickly
Some companies have to wait months to get it, and be authorized to start advertising their certification. So, it is recommended to optimize the referral and advertising process by the Registrar once certification is achieved.
In the context of total quality, ISO six sigma steps-process method enables meeting or exceeding ISO certification or GMP FDA compliance requirements and proves the establishment of a culture of continual improvement and Quality in your organization. In addition to that, ISO certification or GMP FDA regulation, with the requirements of a market opens opportunities for international development and sales opportunities. Check the Master Tools Box for more information about the six sigma tools used in ISO certification or GMP FDA regulation.
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