Understanding ISO Certifications and What they Mean for Manufacturers and Customers

When contracting for work, how can you be sure that work will be performed up to standards? If you perform the work, how can you easily inform potential customers that you are able to meet certain requirements? Holding a certification from a valued and trusted source is the perfect way to address each question.

The leading standards developer, the International Organization for Standardization (ISO), is an independent, non-governmental international organization that has a membership of 162 national standards bodies. They publish international standards to ensure that products and services are reliable, safe, and of good quality.

For the manufacturing industry, ISO standard 9001 is the generic manufacturing standard for a Quality Management System (QMS). It applies to all organizations regardless of the products provided. Implementation and adherence to a QMS ensures best practices, effective processes, and highest quality standards.

While most manufacturers are ISO 9001 certified, not all hold ISO 13485:2003  certification. This standard is the preferred or required method of meeting QMS requirements for medical device manufacturers. ISO 13485 is based off of ISO 9001 but changes the focus from continual improvement and customer satisfaction to standardizing regulatory requirements for medical device manufacturers. Compliance with ISO 13485 is the first step in meeting European regulatory requirements.

Metal Craft and Riverside also hold FDA Registration allowing us to produce and distribute medical devices that are commercially distributed in the U.S.

Metal Craft and Riverside hold additional certifications for specific industries. Below is a list of our certifications at each facility:

  • Metal Craft: ISO 9001; Medical device manufacturing certification ISO 13485 and FDA registration
  • Riverside: ISO 9001; ISO 13485, Aerospace industry AS9100C standard certification, and FDA registration.

We work diligently toward, and are extremely proud of, the certifications we have attained.  Standards are developed to protect and inform both the customer and the manufacturer. The high-quality products and services Metal Craft and Riverside deliver on a daily basis consistently exceed the expectations of our customers.  Certifications are proof of our dedication to upholding our own, as well as industry, standards.

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