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ISO 9001 Quality Management Systems - Requirements

ISO 9001 is an international standard designed to provide companies and organizations with a common approach to applying a Quality Management System.  Over 150 countries have adopted the standard since its inception in 1987.  It also forms the base requirements for many other standards, including ISO 13485, AS-9100, and the ISO/Technical Specification 16949.

Please Note:  ISO 9001:2015 has been released and organizations currently registered to ISO 9001:2008 will have 3 years (September 2018) to become compliant to the revised standard.

Industry Specific Standards

There are a number of industry specific standards that apply the ISO 9001 standard to a specific industry such as Medical devices or automobiles.  These standards all have ISO 9001 at their core and add additional requirements for the specific industry. 

Examples of the more common Industry Specific Standards are:

ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes

ISO/IEC 17025 General requirements for the competency of testing and calibration laboratories

ISO/TS 16949 Quality systems - Automotive suppliers

SAE AS9100: Quality system requirements for suppliers to the aerospace industry

The International Organization for Standardization has now issued Official Sanctioned Interpretations that clarify the ISO 9001 standard. These can be obtained from the following web site: http://www.tc176.org/Interpre.asp


The intent of ISO 9001 is to provide for the development of a Quality Management System that ensures to prospective customers that the goods and services offered by the company or organization will meet the intended use or application, be free of defects, etc. 


ISO 9001 can be applied to any type of business, organization or industry.

Over a million organizations have adopted the ISO 9001 based Standards in manufacturing, medical, transportation and a variety of service industries.

Training Offered

ISO 9001:2015 Transition Training

ISO 9001 Awareness/Overview

Internal Auditor Training 

Advanced Internal Quality Auditor Training

Advanced Product Quality Planning (APQP)

Failure Mode Effects Analysis (FMEA)

Control Plan Methodology (CP)

Statistical Process Control (SPC)

Measurement Systems Analysis/Gage R & R (MSA)

Advanced Internal Quality Auditor Training

Business Operating System (BOS)

Customer Satisfaction

Implementation Workshop

Process Flowcharting Workshop

Team Oriented Problem Solving (8D)

Document Writing


Services Offered

Initial System Evaluation ("Gap Analysis")

Documentation Development

Implementation Assistance and Guidance

Final System Evaluation ("Dress Rehearsal")

Hands-on Auditing

Contract Internal Auditing Program

Compliance Auditing