Online Documentation: EZ-MES Quality Compliance

ISO 9001:2008 Quality Management System -- Requirements

In this page we will look into the compliance of EZ-MES Manufacturing Execution System with ISO 9001:2008.

7.5 Production and service provision

Only one and a half page in ISO 9001:2008 adresses the actual manufacturing of your products.

7.5.3 Identification and traceability

The original ISO text:

Where appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the organization shall control and record the unique identification of the product. NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.

• Learn more about forward and backward traceability
• How to configure EZ-MES to assign Unique Identifiers to products
• What are the EZ-MES features regarding Product Tracking
• More information about Revision Control and Configuration Management in EZ-MES
• How to define product status in EZ-MES, and how this can be a result of data collection / acquisition.
• How to define specifications for products that can be used during production operations
• Adding process spec limits to production operations

Useful Links

Click one of the following links to learn more:

• EZ-MES and Quality Standards
• 21CFR Section 11

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