, is an internationally accepted standard related to business quality management. According to independent studies, companies earning certification under ISO 9001 gain a number of advantages in the marketplace, including more efficient operations, increased profits, enhanced productivity and greater customer satisfaction.
To become certified under ISO 9001:2015, a company must conform to a list of requirements, verified by a third-party audit from an approved certification body. These requirements include the following:
· Management must have a formal, written statement defining their quality policy.
· This quality policy must be closely tied to the business marketing plan and to the needs of customers.
· The quality policy must be understood by all company employees at all levels and followed toward the achievement of specific and measurable objectives.
· The system must be audited regularly to evaluate conformity and effectiveness.
· The source for all products and raw materials must be recorded so any problems that develop can be traced back to the source.
· The business must determine customer requirements and have systems in place for communicating with these customers. This includes a means for disseminating product information and for efficiently handling contracts, orders, inquiries, customer feedback and complaints.
· All new product development must be planned in stages, with necessary testing completed at each stage. Testing and documentation must show that the new product meets design and regulatory requirements and satisfies customer needs.
· Regular meetings and internal audits must be accomplished following documented procedures. These are to determine the effectiveness of the quality system and to uncover what improvements can or should be made.
· Records are kept relating to any past or potential problems, what decisions were made to mitigate these problems and the outcome of actions taken.
· Documented procedures are in place for any non-conformance to ISO 9001 requirements.