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ISO 9000, 9001, 14001, 13485, 16949, 19011, AS 9000, TL 9100, FDA, GMP Desk-Audit Solution
Provide ISO 9000, 9001, 14001, 13485, 16949, 19011, AS 9000, TL 9100, FDA, GMP desk-audit solution for product system certification
Desk-Audit ISO 9000 GMP FDA Certification Solution
If your company has internal resources including staff management representative, Quality Assurance Manager/Supervisor, and needs exacts guidance on what needs to be done to comply with the ISO GMP-FDA International Standards, desk-audit consulting service is the right solution. We review your Quality Management System documentation including business process maps, quality policies, procedures, work instructions, and records to determine if the Quality Management system in place complies with the ISO 9000 and GMP-FDA International Standards. We generate all the required documentation to meet the requirements of:
Desk-Audit ISO 9000 GMP FDA Certification Compliance
Comprehensive, accurate QA Manual documentation is the foundation of every successful Quality Management System. The documents describe the organization's business system and processes as well as related controls associated to them. Poorly written or incomplete documents can have a significant negative impact on the operations of your organization and jeopardize your ability to achieve ISO or GMP-FDA certification and Registration. Affordable desk-audit consulting services are designed to ensure your documentation complies with the applicable ISO or GMP-FDA International Standard of your industry.
Desk-Audit ISO 9000 GMP FDA Certification Approach
During the Pre-Assessment and Registration audits we help your organization address Registrar concerns. We utilize our proven quality Six Sigma approach methodology and implement training courses to quickly prepare your organization. We study your work flows and tailor the Quality Manual (Level 1) and Quality Management Procedures (Level 2) to reflect your operations and Management System requirements. Finally, we ensure that your organization gets ISO or GMP-FDA certification and Registration.
After we gather and analyze company profile and operations data our experts determine which ISO or GMP-FDA element, if any, may be excluded from your Quality Management System. We review the Quality Assurance Manual to ensure that the Quality Management System complies with the applicable ISO or GMP-FDA Standard. This review includes identification of missing and unnecessary documentation. The report includes recommendations to streamline the process, update the documentation, and ensure that you are ISO compliance. We also incorporate our recommendations into a draft of your documentation for your ISO or GMP-FDA Certification review and approval.
Desk-Audit ISO 9000 GMP FDA Certification Implementation
- Plan your ISO Quality Assurance Manual review
- Determine reasonable ISO project milestones
- Collect policies, procedures, and organization chart for further review
- Allocate personnel to the ISO or GMP Desk-Audit certification process
- Provides audit training to the management staff and employees
- Give support during the Registrar Certification audit
Desk-Audit ISO GMP FDA Certification Time Delivery
Preparing the system documentation is typically the most difficult and most important hurdle for organizations seeking ISO or GMP-FDA registration. But, our Quality Six Sigma approach is designed to accelerate the review of your documentation with little or no impact to your daily operations, effectively saving you time and money. However, the duration of the project depends on the size and complexity of your organization, as well as the quality of the QA manual and all documents associated to it.
We have partnered with Caliso Consulting to extend our network of experts not only in the USA but also in Canada, Mexico, France, Brazil and North Africa. Check our ISO GMP FDA Certification Success Stories
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Clients that our Xperts have helped!
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ISO CERTIFICATION GUARANTEE
We offer “Total Satisfaction Refund Policy” for all eConsulting services that you purchase from CompetitiveXpert. If for any reason you are not satisfied with our eBusiness services or one of our experts, we will refund you. We will not charge you for our remaining time, and we will discontinue our collaboration. We are proud of our achievement, and want to show it through the explicit satisfaction of the clients that we have helped.
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CUSTOMER TESTIMONIAL
" CompetitiveXpert proposes cost-effective and comprehensive solutions, which are affordable for mid-sized companies. And, experts are flexible and smart enough to adapt to any business or mission"
M. Saoudi Asmir
Chief Financial Officer
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