For an organization to become ISO 9001 registered, there is a need to review and assess the effectiveness of the quality management system and measure if it is working as it is supposed to. This will also pave the way for the determination of areas of improvement that has to be focused on, which will later on correct identified problems.
There are two types of auditing that organizations can consider (a) external audit and (b) internal audit. External audit means that auditing will be done by an external certification body. On the other hand, internal audit is performed by internal staff trained for the auditing process. But then again, it would be much better and healthier for internal auditors to audit outside their usual management line, resulting to a more constructive and accurate judgment.
ISO 9001 outlined three distinct areas in measuring the systems efficiency and effectiveness. These are (a) general requirements, (b) documentation requirements and (c) quality management principles.
General requirements refer to the process applications that will be used in the quality management system.
Documentation requirements include all documents that affect the quality of product and service. A very good example is the quality manual that is being used for quality system documentation.
Quality management principles are also known as the eight well-recognized practices used to ensure a successful quality system. These are (a) customer focus, (b) leadership, (c) people involvement, (d) process approach, (e) systems approach, (f) continual improvement, (g) factual decision making and (h) supplier-vendor relations.
If in any case that an organization is not active in any of three areas, then most likely, quality system will be ineffective. This also means not passing the standards of ISO 9001.