Clause_4
Clause_4
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00:00What is ISO 9001 Clause 4? Clause 4 defines what is required in a QMS
00:21Quality Management System. Under Clause 4 there are two major categories,
00:26General Requirements and Documentation Requirements. The Documentation Requirements include general
00:32provisions, the need for a quality manual, control of documents and appropriate control
00:37of records. 4.1 General Requirements. The organisation
00:42shall establish, document, implement and maintain a quality management system and continually
00:48improve its effectiveness in accordance with the requirements of this international standard.
00:544.1 General Requirements. The organisation shall, a. Determine the processes
01:01needed for a QMS and their application throughout the organisation, b. Determine the sequence
01:08and interaction of these processes, c. Determine the criteria and methods needed
01:14to ensure that both the operations and control of these processes are effective, d. Ensure
01:20the availability of resources and information necessary to support the operation and monitoring
01:25of these processes, e. Monitor, measure where applicable and analyse these processes, and
01:33f. Implement actions necessary to achieve planned results and continuous improvements
01:39of these processes. 4.1 General Requirements. These processes
01:46shall be managed by the organisation in accordance with the requirements of the international
01:50standard. Where an organisation chooses to outsource any process that affects product
01:56conformity to requirements, the organisation shall ensure control over such processes.
02:02The type and extent of control to be applied to these outsourced processes shall be defined
02:08within the Quality Management System. 4.2 Documentation Requirements. 4.2.1 General.
02:18a. Documented Statements of Equality Policy and Quality Objectives, b. Equality Manual,
02:26c. Documented Procedures and Records required by this international standard, and d. Documents
02:36including records determined by the organisation to be necessary to ensure the effective planning,
02:42operation and control of its processes. 4.2.2 Quality Manual. a. The scope of the
02:50Quality Management System includes details of and justification for any exclusions, b.
02:59The documented procedures established for the Quality Management System or reference
03:03to them, and c. A description of the interaction between the processes of the Quality Management
03:11System. 4.2.3 Control of Documents. Documents required
03:20by the Quality Management System should be controlled. Records are a special type of
03:25document and should be controlled according to the requirements given in 4.2.4.
03:314.2.3 Control of Documents. A documented procedure shall be established to define the controls
03:39needed. a. To approve documents for adequacy prior
03:43to issue, b. To review and update as necessary and re-approve documents, c. To ensure that
03:51changes and the current revision status of documents are identified, d. To ensure that
03:58relevant versions of applicable documents are available at any point of use, e. To ensure
04:08that documents remain legible and readily identifiable, f. To ensure that documents
04:14of external origin determined by the organisation shall be necessary for the planning and operations
04:20of the Quality Management System are identified and their distribution controlled, and g.
04:28To prevent the unintended use of obsolete documents and to apply suitable identification
04:33to them if they are retained for any purpose. 4.2.4 Control of Records. Records established
04:42provide evidence of conformity to requirements and of the effective operation of the Quality
04:47Management System shall be controlled. The organisation shall establish a documented
04:52procedure to define the controls needed for the identification, storage, protection,
04:58retrieval, retention and disposition of records. Records shall remain legible, readily identifiable
05:05and retrievable. All of these documents encompass the Quality
05:10Management System which is made up of Clause 4.1 General Requirements and Clause 4.2 Documentation
05:20Requirements which is made up of General, Quality Manual, Control of Documents and Control
05:31of Records.