The ISO 9001:2008 standard contains numerous requirements affecting virtually all aspects of the operations of any company.
Because ISO 9001 is designed for any company (or other organization) of any size and in any industry, the ISO 9001 requirements are rather broad and the text of the ISO 9001 standard is quite hard to read. The following is a summary of the ISO 9001:2008 requirements in lay man's terms.
This section of the ISO 9001:2008 standard outlines the necessary steps to implement the ISO 9001 quality management system:
Measure, monitor and analyze these processes, and implement action necessary to correct the processes and achieve continual improvement.
In this section, ISO 9001:2008 requires that the quality management system is documented through a prescribed set of ISO 9001 documentation that includes:
a quality manual,
a quality policy,
quality objectives, as well as
These ISO 9001 documents describe how the ISO 9001:2008 requirements are implemented within the company. This means that the ISO 9001 documentation is specific to the individual company and its work processes, while it addresses each of the ISO 9001 requirements.
This section of ISO 9001:2008 also includes requirements that affect virtually every employee and every part of the company: the requirements on the control of all documents and records - both hardcopies and electronic files. ISO 9001:2008 contains several requirements regarding document control, and all these requirements must be adopted and described through a document control procedure and a record control procedure.
Also in this section, ISO 9001 emphasizes the need for continuous improvement and requires that the company continually improves its ISO 9001 quality management system.
ISO 9001:2008 places great emphasis on top management's commitment to quality and to the ISO 9001 quality management system. This section contains requirements on the various ways in which management must remain involved in the ISO 9001 quality management system.
This section also contains the requirements according to which management needs to set up a corporate quality policy and quality objectives; further, it reinforces the involvement of top management with customer requirements.
This ISO 9001 section also requires top management to clearly establish all responsibilities and authorities within the company. This includes the appointment of an ISO 9001 management representative who is the company's point person on ISO 9001 related matters.
This section of ISO 9001:2008 clarifies the requirement for a company to determine and provide, in a timely manner, resources (for example, equipment, facilities, etc) needed to implement and improve the processes of the ISO 9001 quality management system and to address customer satisfaction. This section also includes requirements on the work environment.
ISO 9001 recognizes in this section that human resources are key resources of any company. Therefore, ISO 9001 contains numerous requirements regarding the competence and education of staff and management, as well as ongoing employee training.
The ISO 9001:2008 standard defines Product Realization as “that sequence of processes and sub processes required to achieve the product.” Thus, this extensive section contains numerous requirements on how your company's products are designed, produced, tested, handled, shipped, etc. Note that this section also applies to service providers who should simply understand “product” as “service provision”.
In this section, ISO 9001:2008 addresses how the company needs to ensure that all the requirements of their customers are properly defined and reviewed when a contract is negotiated or an order placed.
ISO 9001:2008 sets requirements on the communications with customers and how any customer complaints are treated.
If the customer order requires some special design work, ISO 9001:2008 specifies the various steps in the design process, ranging from the establishment of responsibilities to testing procedures.
Since most companies purchase products or make use of subcontractors, ISO 9001:2008 includes requirements for the selection and control of subcontractors, the purchasing of products or services and the controls to ensure that any purchased products and services meet their specifications.
This is also the section in which ISO 9001:2008 sets various requirements for the key function of the company: the production of its products or the provision of its services. These requirements are extensive, ranging from equipment to work instructions to quality control; also included are requirements on calibration, on the treatment of customer property, and on the handling of product or service failures.
Note that quality control and quality assurance are only a small part of the extensive ISO 9001:2008 quality management system.
The last section of the ISO 9001:2008 standard closes the loop by providing requirements for measurement and monitoring activities, so that the company can immediately identify when not on track and so that the company can continuously improve. Measuring and monitoring allows the company to manage by fact, not by guess.
In this section, ISO 9001:2008 contains many requirements on metrics. Any ISO 9001 quality management system needs to monitor and measure both its work processes as well as its products or services. And since the satisfaction of its customers is crucial for any company, this section of ISO 9001:2008 also contains requirements on measuring customer satisfaction.
This is also the section in which ISO 9001:2008 requires internal audits to check if the ISO 9001:2008 QMS continuous to be properly implemented and effective. These internal ISO 9001 audits are performed by company employees that have been trained as internal auditors. The company's internal audit system must be described in a documented procedure.
Further, ISO 9001:2008 sets requirements on how to analyze the results of the various audits and measurements taken. Also included are requirements on how to handle any problems that have been identified during the measurements and audits.
A key part of ISO 9001:2008 are the requirements concerning corrective and preventive action. Both corrective action and preventive action focus on how to identify systemic problems in the company and how to prevent them in the future. The difference is that corrective action is based on problems that have already occurred, while preventive action takes a more proactive approach by identifying any possible problems. Since both corrective action and preventive action are such key concepts of the ISO 9001 QMS, documented procedures on their implementation within the company are required.