Key Concepts

Quality Management Systems:
These are designed to provide mechanisms for assuring that product and processes meet the requirements of a company and its customers.  It achieves this through setting and communicating these requirements and having mechanisms to verify the results and correct and prevent mistakes.  The main aims of a QMS are to provide quality assurance - finding errors before they happen, continual improvement and, most importantly, to meet your customers’ needs.

The most important elements of a well-functioning QMS are:
Management commitment and review - when management is aware and involved in the quality system and providing their expertise, things get done.

Corrective action and risk mitigation - not just fixing problems as they come up, but finding the root cause and preventing it and similarly caused issues from occurring in the future and learning to identify and reduce risk before any error occurs.
Internal audits - these should be done based on process, not elements of the standard. This provides confirmation that processes are functioning correctly and identifies areas for correction and improvement. This is a primary input for the management review and correction actions processes.

If these three processes are functioning well, is highly likely that nonconformances and risk will be detected, identified and corrected.

ISO 9001:
This is the most widely used and recognized standard, both in the US and the world.  It is primarily used in manufacturing, but can be used for any type of business or organization.  The standard has relatively few specific requirements.  Instead, it requires you to choose what you want to achieve, how you instead to achieve it and that you have mechanisms for ensuring these goals and activities are met. Requirements are centered around measurement (objectives and KPIs) and improvement, with a focus on customer satisfaction and meeting customer requirements.

AS9100:
This is an industry specific standard used in aerospace.  The current revision contains the exact text of ISO 9001 with many additional requirements.  These were incorporated to meet the industry specific needs of organizations such as the Department of Defense, NASA and the FAA and major commercial manufacturers such as Boeing and Lockheed Martin.

Major additions and strengthening of requirements include; supplier monitoring, design validation, control of nonconforming product, identification and traceability and risk and configuration management.

ISO 13485:
This is the standard for the medical device industry.  It is based on the previous revision of ISO 9001 and is closely aligned with the requirements of 21 CFR 820 from the FDA and 93/42/EEC from the European Union.

Major differences include; risk management and design control during product development, record retention requirements, cleanliness and safety of the work environment and requirements connected with sterile working environments and implantable devices.

ISO 14001:

This is the framework for an EMS (environmental management system). It employs similar concepts to other standards: measurement of objectives, improvement, corrective action, etc..  However, requirements are not focused on customers.  Implementation does not necessarily involve buying carbon offsets, but identifying material use and waste how things can be done more efficiently.