Quality Systems Quality Systems


Global harmonization efforts have dramatically changed the approach to Quality Management Systems in many industries. International standards, many representing specialized derivatives of ISO 9001, are either well-established or rapidly emerging for many product categories and services. Some efforts have been driven organically via supply chain or customer efforts, while others have been championed through cooperating regulatory agencies.

One goal of this site is to simplify the navigation of these standards and regulations and provide guidance for compliance within the broader framework of prominent quality and business management methodologies and initiatives such as Operational Excellence, Lean and Six Sigma.

The ISO 9000 Influence

  • Million Registrations: Near the end of 2009, the number of companies achieving registration for ISO 9001 reached the 1,000,000 mark globally.
  • ISO 13485 is specialized for medical device quality systems and is either an accepted standard or has greatly influenced the quality system regulations for more than 85% of the global regulated medical device market.
  • AS 9100 builds upon the ISO 9000 framework by adding special quality and safety requirements relevant to the aerospace industry (aviation, space and defense).
  • ISO/TS 16949, together with ISO 9001:2008 specifies the quality system requirements for automotive related products.

Business Management Strategies

  • Six Sigma utilizes a quality management approach, including statistical methods, to measure and reduce process variation, to identify and remove the cause of errors (defects) and to improve the quality of process outputs, customer satisfaction and profitability while reducing costs.
  • Lean methodologies focus upon key processes to continuously increase customer value while also reducing waste and non-value added activities in an organization.
  • Operational Excellance is an unbrella philosophy, integrating Lean and Six Sigma methodologies, seeking a sustainable improvement culture with an emphasis on the use of rigorous problem-solving tools and metrics to improve customer satisfication and the bottom line. The Institute for Operational Excellence defines it as “… when each and every employee can see the flow of value to the customer, and fix that flow when it breaks down,” adding that “Lean provides the road map to get there.”

Regulations & Standards

Document Description Comments
ISO 9001:2000 Standard – includes Annex A with comparision by element to ISO 14001:2004 and Annex B comparison to ISO 9001:2000. For more on ISO 9001:
ISO 13485:2003 requirements are specific to medical devices and exclude some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, a firm’s quality management systems may conform to ISO 13485, but may not necessarily conform to ISO 9001. For more information:
IAQG’s standard covering general quality systems expectations as well as aerospace supplements agreed upon at an international level. For more AS 9100 information:
CE Marking Before many products can be placed on the European market, they must meet the requirements of the relevant European Economic Community product Directive. These Directives may include product classification/requirements, certification, post-market monitoring, incident reporting and other CE Marking requirements. For more information:
ISO 10007:2003 provides guidance for configuration management planning, configuration identification, change control, configuration status accounting and configuration auditing.
ISO 19011:2002 provides guidance for auditing against requirements of ISO 9001 and ISO 14001 Standards.

Related Tools & Topics

Document Description Comments
An overview and compilation of reference information, tools, and presentations – including access to a 14 session video course taught at MIT covering the complementary use of these methodologies. For more information:
Guidance and training resources covering the Balanced Scorecard and other Operational Excellence tools. For more information:

Resources for:

  • Design for Assembly (DFA)
  • Design for Manufacturability (DFM)
  • Design for Testability (DFT)
  • Design for Serviceability (DFS)

For more information:

A little-known, but very useful e-Handbook published online and jointly maintained by the US National Institute of Standards and Technology (NIST) and SEMATECH, a consortium of major semiconductor manufacturers, covering a great variety of statistical tools and techniques – including process control, sampling plans, design of experiments, etc.
An article by Gottfredson and Aspinall published in the Harvard Business Review discussing how to get to the roots of profit-destroying complexity to reach a point of balance where innovation maximizes revenue and profits.
An article by Thomas Davenport published in the Harvard Business Review that describes how companies are building success on their ability to collect, analyze and act on data.
A short (7 minutes), but information-packed video providing a comprehensive overview of the Agile/Scrum Software Development framework.
A link to AmbySoft’s overview of the Agile approach to software development – including several detailed illustrations revealing the full software development life cycle under the Agile approach.
IPC standards that are widely accepted within the Electronics industry. For IPC information:
An adequate ESD Control program is essential for any company manufacturing or otherwise handling static-sensitive electronic products. Experienced auditors will thoroughly examine the implementation of a firm’s ESD Control program. For more ESD Control information:
Harvard Business Review analyzing how inventory-driven costs can have a significant impact on margins in unexpected ways.
An 11 minute video interview with Ron Ashkenas identifying the sources of complexity and ideas how to undertake complexity-reduction efforts.
Harvard Business Review by Jeanie Duck addressing how to overcome the anger and confusion that often accompany change initiatives.