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The ISO standard is one such set of requirements that is accepted worldwide, and which defines and outlines all the typical policies, processes, documented procedures, and records that are needed for a successful QMS, and can be used and tailored for the needs of any organization. ISO provides the best practices for a Quality Management System, including data management needs, and focuses on product quality and service quality to meet customer needs. Other standards exist for the creation of a QMS in different specific industries, and these standards include: AS for the aerospace industry, ISO for the medical devices industry, and IATF for the automotive industry.
What all of these standards have in common is that they are based on the ISO standard; however, each has added additional requirements that are mandatory for its industry.
Some of these standards include a quality manual as a necessary document, while others have removed this requirement along with the latest update to ISO Note that the medical devices QMS requirements standard, ISO , is aligned to a previous version of ISO and therefore includes this requirement for a quality manual. Quality Management System development can sometimes be challenging. One of the first challenges to overcome is the misconception of thinking a QMS only refers to the processes necessary to deal with inspection and disposition of non-conforming products, often designated to members of a quality control department.
Such a system only manages the inspection of product, while not managing the inputs that help a product or service to be compliant in the first place, effectively trying to inspect quality into the product or service.
The next big challenge in implementing the Quality Management System is demonstrating the commitment of management by having the overlying policies defined and communicated to all levels of the organization.
Then the QMS can be made to work as a method of ensuring that all necessary requirements are defined and met, and improvements are made.
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