Presentation on theme: "DOCUMENTATION REQUIREMENTS Based on ISO 9001:2008 1."— Presentation transcript:
DOCUMENTATION REQUIREMENTS Based on ISO 9001:2008 1
The quality management system documentation shall include the following. Documented statements of a quality policy and quality objective. The quality policy ensures clear focus of quality across the organization and direct employee activities on quality, customer focus and continual improvement. The quality objective ensures that customer requirements are met and also continually improve the performance of the organization through the quality management system. They will be set and they will be reviewed in management review meetings. A quality manual. The quality manual shows the scope of quality management system; incorporating details of justification for any exclusion (it shows functional organization structure) Documented procedures and records required by the international standards. Documents including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.(quality manuals & quality procedures) 2
The extent of quality management system documentation can differ/change from one organization to another due to the following factors- The size of organization and type of activities The complexity of processes and their interactions. The competence /ability of personnel/workers. The 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/explanation for any exclusion /leaving out. The documented procedures established for quality management system, or reference to them. A Description of interaction between the processes of the quality management system. 3
Control of document Documents required by the quality management system shall be controlled, and documented procedures 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 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 remain legible and readily identifiable. To ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled. To prevent the unintended use of obsolete documents and to apply suitable identifiable to them if they are retained for any purpose. 4
Controls of records Records established to provide evidence of conformity to requirements and of 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. Storage of records, Records shall be stored in either soft or hard copy. Protection, All records shall be protected against damage; soft copy shall be protected from heat, dust, water and magnetic field. Hard copy records shall be protected from heat, dust, water, and kept in a safe place. Records shall remain legible, readily identifiable and retrievable. 5
6 EXTRA INFORMATION
D EMONSTRATING CONFORMITY WITH QMS S TANDARD & O BJECTIVE E VIDENCE It may be able to demonstrate conformity without the need for extensive documentation. The organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.” Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d) Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence. Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes. 7
O BJECTIVES OF DOCUMENTATION : a) Communication of Information as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization’s products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture. b) Evidence of conformity provision of evidence that what was planned, has actually been done. c) Knowledge sharing to disseminate and preserve the organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product. Documents may be in any form or type of medium, examples: paper, magnetic electronic or optical computer disc, photograph, master sample 8
DOCUMENTATION the amount and detail of documentation required to be more relevant to the desired results of the organization’s process activities. the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. It is stressed that ISO 9001 requires (and always has required) a “Documented quality management system”, and not a “system of documents”. Any documentation approach that you adopt should always provide value-added for the management of your quality system, not simply meet the auditor’s/ registrar's requirements. 9
T ERMS AND D EFINITIONS RELATING TO D OCUMENTS Document - Information and its supporting medium Procedure - Specified way to carry out an activity or a process (Note: Procedures can be documented or not) Quality Manual - Document specifying the quality management system of an organization Quality Plan - Document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract Record - Document stating results achieved or providing evidence of activities performed Specification - Document stating requirements 10
QMS- DOCUMENTATION Documentation requirement – Systematic and orderly – Written policies and procedures – Ensure common understanding – Shall include provision for: Identification Distribution Collection Update Withdrawal Archiving Retention/retrieval 11
D OCUMENTS REQUIRED The quality management system documentation shall include: documented statements of a quality policy and quality objectives; a quality manual documented procedures required by this International Standard 4.2.3 Control of documents 4.2.4 Control of records 8.2.2 Internal audit 8.3 Control of nonconforming product 8.5.2 Corrective action 8.5.3 Preventive action documents needed by the organization to ensure the effective planning, operation and control of its processes, and records required by this International Standard; All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4. 12
A DDITIONAL D OCUMENTS TO ADD VALUE An organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include: - Process maps, process flow charts and/or process descriptions - Organization charts - Specifications - Work and/or test instructions - Documents containing internal communications - Production schedules - Approved supplier lists - Test and inspection plans - Quality plans All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable 13
R ECORDS R EQUIRED BY ISO 9001:2008 14 CLAUSE RECORD REQUIRED 5.6.1Management reviews 6.2.2(e)Education, training, skills and experience 7.1(d)Evidence that the realization processes and resulting product fulfil requirements 7.2.2Results of the review of requirements related to the product and actions arising from the review 7.3.2Design and development inputs relating to product requirements 7.3.4Results of design and development reviews and any necessary actions 7.3.5Results of design and development verification and any necessary actions 7.3.6Results of design and development validation and any necessary actions 7.3.7Results of the review of design and development changes and any necessary actions 7.4.1Results of supplier evaluations and any necessary actions arising from the evaluations 7.5.2(d)As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement 7.5.3The unique identification of the product, where traceability is a requirement 7.5.4Customer property that is lost, damaged or otherwise found to be unsuitable for use 7.6(a)Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist 7.6Validity of the previous measuring results when the measuring equipment is found not to conform to requirements 7.6Results of calibration and verification of measuring equipment 8.2.2Internal audit results and follow-up actions 8.2.4Indication of the person(s) authorizing release of product. 8.3Nature of the product nonconformities and any subsequent actions taken, including concessions obtained 8.5.2(e)Results of corrective action 8.5.3(d)Results of preventive action
QMS- DOCUMENTATION HIERARCHY 15 I LevelPolicyWhat do we do? Why? Policy Objectives Stated once II LevelProceduresWho? When? Where? Calibration QA Procedures Audit Processes III LevelWork Instructions or Practices, Technical Data How?Work Instructions, Inspection Instructions, Standard Operating Practices, Drawings, Specifications, Standards IV LevelRecords or Proof Evidence-; all the records and forms which are generated by the working system.
16 RBS - Quality Management Systems Requirements for service quality by public service organisations.
17 DOCUMENTATION REQUIREMENTS General The organization shall document the following: Service quality manual; Citizens’ charter; Any other document needed by the organization for effective planning, operation and control of its service and service delivery processes; and Records required by this standard (see 4.4).
18 Service Quality Manual The organization shall establish and maintain a service quality manual which includes: Scope of service quality management system; Service quality policy; Service quality objectives; Complaints handling objectives; Responsibility and authority of personnel at relevant levels within the scope of this standard; Documented procedures required by this standard; Other documents, needed by the organization for effective planning, operation and control of its service and service delivery processes, or reference to them; and Description of service processes including service delivery processes at the customer interface and those needed to directly support them (see 7.2).
19 Control of Documents All the documents required by this standard shall be approved for adequacy prior to issue; reviewed periodically, updated as necessary and re-approved. The changes made shall be identified; and legible and identifiable indicating their current revision status. The organization shall maintain a master list of all documents related to the scope of this standard which also identifies their current revision status; maintain distribution list of all such documents; ensure that the current versions of applicable documents are available at points of use; ensure that obsolete documents, if retained for any purpose, are suitably identified to prevent their unintended use; and ensure that the documents of external origin are identified and their distribution controlled. A documented procedure shall be established to define the controls needed for the above.
20 Control of Records: Records (including files) shall be established and maintained to provide evidence of conformity to requirements and for the effective operation of the management system for service quality. The records shall remain legible, readily identifiable and easily retrievable. The method of identification, storage, protection, disposition of each record, their retention time and responsibility for each of these activities shall be established in a documented procedure.
PREPARED BY Note: All the above companies are ISO certified BRALIRWANAKUMATT RWANDA SULFO RWANDA INDUSTRIES