Quality and Regulatory

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Quality and Regulatory

Epichem generates world class innovative products, services and research in synthetic and medicinal chemistry. Our Quality Policy supports our commitment to provide exceptional customer service and value.

 

The International Organization for Standardization (ISO) has provided a level playing field for all manufacturers to officially state the quality of their products and business practices.

 

Epichem’s Quality Management System is certified to ISO9001 and the Company is accredited to the following ISO standards:

  • ISO17025: General requirement for the competence of testing and calibration laboratory
  • ISO 17034: General requirements for the competence of reference material producers

These are the most valuable accreditations for reference material manufacturers globally today.

 

Maintaining our quality certification and accreditations ensures robust procedures and practices are in place for all aspects of Epichem’s operations. It is the basis for reliably providing customers with products and services of the highest quality, consistently. You can have confidence that Epichem will provide complete quality assurance throughout your supply chain.

 

Click here to view our quality policy.

 

Epichem’s Quality Management System documents the key processes and procedures involved in:

  • Management and control of facilities and equipment.
  • Monitoring and control of incoming goods such as raw materials and consumables
  • Purchasing of goods and services from third parties.
  • Producing high quality products and documentation.
  • Providing a specialised service to customers.
  • Maintaining a customer focus in all customer-related activities.
  • Continually improving the company’s products, services, systems and processes.

As a commitment to quality, we have a dedicated Quality Manager on-site to provide expertise in aspects of quality assurance to the company and its customers. Please contact us with your questions on QA/QC matters related to your product purchase.

DOWNLOADS

ISO 9001:2015 Certificate of Registration

NATA ISO 17025 Certificate of Accreditation

NATA ISO 17034 Certificate of Accreditation


FAQ

  • ISO9001 certifies that a company has official written procedures and training documentation in the areas of customer service, product design, manufacturing, analysis, change management, certification, packaging, shipping, and purchasing. 
  • This standard is very customer service oriented.
  • Certifies that quality-oriented tests are performed correctly. These tests establish that the product is indeed a quality product.
  • All aspects of quotations and contracts, the Research and Design operation, and Manufacturing and Quality Control activities are examined by this standard. The qualification, education, and training of all associates are scrutinized against their job responsibilities. Even the qualifications of vendors and subcontractors are checked, as well as every Quality Critical specification and purity requirement.
  • Epichem’s NATA ISO 17025 Certificate of Accreditation
  • Epichem’s 17025 Scope of Accreditation
  • This accreditation deals directly with Reference Material (RM) manufacturers to provide the highest level of quality assurance, confidently stating that the manufacturer’s Reference Standards are produced correctly and competently.
  • All methods that the manufacturer uses to certify their Standards must be validated and proven to be accurate.
  • Requires that a “homogeneity” and “stability” assessment on all reference material produced.
  • Ensure Reference Materials produced are fit-for-purpose.
  • Epichem’s NATA ISO 17034 Certificate of Accreditation
  • Epichem’s 17034 Scope of Accreditation
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