Standards

ISO 17025

What Is ISO 17025? How Did It Start? The ISO 17025 standard helps maintain the quality of laboratory services by

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MDD/MDR

Medical Device, Pharmaceutical, and GMP Auditing Division Quality Auditing was originally founded to serve the Medical Device, Pharmaceutical, and Biotechnology industries.

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21 CFR 820

What Is 21 CFR Part 820? FDA 21 CFR Part 820 outlines Current Good Manufacturing Practice (cGMP) regulations that govern

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21 CFR 211

What Is GMP? Good manufacturing Practices (GMP) is a system for ensuring that products are consistently produced and controlled according

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MDSAP

What Is MDSAP? How Did It Start? The Medical Device Single Audit Program (MDSAP) is a harmonized approach to evaluating

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ISO 13485

What Is ISO 13485? How Did It Start? ISO 13485 is a standard related to quality management systems specifically for

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NQA-1

What is NQA-1? How Did it Start?   The NQA-1 quality assurance standard relates to the design, construction and operation

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ISO 14001

What Can ISO 14001 Do For A Company? How Did It Start? The ISO 14001 standard is related to environmental

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AS9100

AS9100 – How Did It Start? Prior to AS9100 aerospace-specific standard being established, companies used ISO 9001, Boeing’s D1-9000, or

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