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, TL 9000 and the ISO/Technical Specification 16949.
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
TL 9000 Quality Management System - This standard is for the Telecommunications Industry requirements
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
Intent
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.
Applicability
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 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
On-line Training Courses
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
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