ISO 9001 Certification for Medical Device Manufacturers
ISO 9001 Certification is the best quality system certification for Medical Device Manufacturers. ISO 9001 Certificate is one of the acceptable documents for the vendor approval process. Submitting ISO 9001 Certificate to the customer will help avoid customer audits and get faster approval.
Medical Device Manufacturers usually outsource parts and component manufacturing to contract manufacturers. It is important to ensure that the outsourced parts and components are manufactured as per the specifications supplied. To avoid periodic auditing of contract manufacturers, the buyer verifies and approves their quality system, ensuring the minimum quality of the components manufactured.
ISO 9001 certification is the most widely accepted quality system standard for manufacturing industries without product or industry-specific standards.
How to get ISO 9001 Certification
Getting ISO 9001 certification is a long process; it may take a minimum of three to four months to complete the certification process. As an experienced ISO 9001 consultant , LMG can help you achieve the ISO 9001 certification process at a reasonable cost and a minimum timeframe.
Evidence of ISO 9001 Certification
The international organization for standardization (ISO) only develops the standards, and certification is not a requirement. Still, manufacturing companies require a document to present to their customers as evidence of ISO 9001 implementation. Third-party certification bodies issue the ISO 9001 certificate as evidence of ISO implementation after conducting an audit per ISO guidelines.
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