ISO 9001:2008 General Requirements

4.1 General requirements

The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standards. The organization

• shall determine the processes needed for the quality management system and their application throughout the organizations,
• determine the sequence and interaction of these processes,
• determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
• ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
• monitor, measure (where applicable) and analyze these processes, and
• implement actions necessary to achieve planned results and continual improvement of these processes.

These processes shall be managed by the organization in accordance with the requirements of this International Standard.

Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.

NOTE 1: Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization and measurement, analysis and improvement.

NOTE 2: An outsourced process is identified as one being needed for the organization’s quality management system, but chosen to be performed by a party external to the organization.

NOTE 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory, and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as
a) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements,
b) the degree to which the control for the process is shared;
c) the capability of achieving the necessary control through the application of clause 7.4.

Clause 4.2 Documentation requirements

4.2.1 General

The quality management system documentation shall include
documented statements of a quality policy and quality objectives,

• a quality manual,
• documented procedures and records required by this International Standard,
• documents including records, needed determined by the organization to be necessary to ensure the effective planning, operation and control of its processes

NOTE 1: Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.

NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to the size of organization and type of activities, the complexity of processes and their interactions, and the competence of personnel.

NOTE 3: The documentation can be in any form or type of medium.

4.2.2 Quality Manual

The organization shall establish and maintain a quality manual that includes the scope of the quality management system, including details of and justification for any exclusions (see 1.2), the documented procedures established for the quality management system, or reference to them, and a description of the interaction between the processes of the quality management.

4.2.3 Control of documents

Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

A documented procedure shall be established to define the controls needed

• to approve documents for adequacy prior to issue,
• to review and update as necessary and re-approve documents,
• to ensure that the changes and the current revision status of documents are identified,
• to ensure that relevant versions of applicable documents are available at points of use,
• to ensure that documents of external origin are identified and their distribution controlled, and
• to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

4.2.4 Control of records

Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention, and disposition of records. Records shall remain legible, readily identifiable, and retrievable.

ISO 9001 Management Representative

The ISO 9001 Management Representative is appointed by the top management of an organization. Irrespective of other responsibilities, he/she is responsible and has the authority in

• ensuring that processes needed for the quality management system are established, implemented and maintained,
• reporting to top management on the performance of the quality management system and any need for improvement, and
• ensuring the promotion of awareness of customer requirements throughout the organization.

The responsibility of the Management Representative also includes liaison with external parties on matters relating to the quality management system.

The Management Representative is usually assisted at the departmental level by Quality Representatives. This position is assumed by the respective Department Managers. The Quality Representatives are responsible for the quality processes which are applicable to their respective departments.

The Quality Representatives head their respective Quality Improvement Teams which are established for the purpose of monitoring processes and identifying opportunities for improvements. Members of the Quality Improvement Teams comprise of key personnel within the departments/process areas who are appointed by the Quality Representative to assist him/her at the process-level.

The Management Representative is also assisted by an appointed Document Controller whose responsibility is to implement the Control of Documents and Control of records procedures.

Collectively, the Management Representative, Quality Representatives and the Document Controller make up the Quality Management System Committee. This committee meets regularly to provide relevant inputs and resolutions for the quality management system. The structure of the Quality Management System Committee is as follows:

• Management Representative – Chairman
• Document Controller – Secretary
• Quality Representatives – Members

[Note: The above is just an example. If you are a small organization, a QMS Committee and Quality Improvement Teams may not be necessary]

To facilitate effecetive communications, the Quality Management System Committee and the Quality Improvement Teams, respectively, meet regularly in order to ensure that communication regarding the effectiveness of the quality management system takes place. Pertinent information regarding the quality management system is then posted by the Management Representative on the Bulletin Board for the benefit of all employees. Employees are generally encouraged to provide their inputs towards the quality management system through suggestion boxes which are located at strategic locations within the organization’s premises.

Note: Some organizations employ this method but results may vary among other organizations. The key is to continually improve on these methods/processes.