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ISO 9000, 9001, 14001, 13485, 16949, 19011, AS 9000, TL 9100, FDA, GMP Certification
Provide ISO 9000, 9001, 14001, 13485, 16949, 19011, AS 9000, TL 9100, FDA, GMP certification services and quality management system
ISO 9000 GMP FDA Quality Management Requirements
The implementation of ISO Standards requires aligning the Quality Management System with the customer’s requirements and streamlining the operational and manufacturing processes within the organization. Simplifying processes enables an organization to take full advantage of the benefits of the ISI Standards. But, fully complying with ISO and GMP-FDA International Standards requires from an organization to perform the Quality Manual, which describes all processes, defines all policies and procedures, establishes all work instructions, and collects all records. For all Quality Management Systems, there are some common rules to be applied, the documentation typically consists of fours levels:
- Level 1 - Responsibilities Quality and Environmental System Manual (Policies)
- Level 2 - Who, What and When Business Processes and Controls (Procedures)
- Level 3 - How Activities are Performed (Work Instructions)
- Level 4 - Objective Evidence of the Activities Performed (Records)
Benefits of Implementing ISO 9000 GMP FDA Standard
An organization that implements Quality Management Systems demonstrates its capability and commitment to doing things right. Meanwhile, complying with ISO or GMP-FDA International Standard enables your company to show customers that your quality products have wide acceptance on the market. ISO and GMP-FDA International Standards enable an organization to increase:
- Business opportunities by penetrating new markets
- Customers’ satisfaction by deceasing product defects
- Quality Systems effectiveness by implementing better processes
- Cost-savings by deploying six sigma statistical process control
- Staff responsibility, commitment and motivation to Quality
- Brand-name recognition in the eyes of stakeholders
Companies using ISO and GMP FDA International Standards are competing on many more markets around the world. The label ISO certification demonstrate that you have implemented business process best practices to continually perform excellence.
ISO 9001 Six Sigma Control Measure Six Sigma measure to control quality management system

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