DOCUMENTING & AUDIT OF QUALITY MANAGEMENT SYSTEMS

Transcription

1 DOCUMENTING & AUDIT OF QUALITY MANAGEMENT SYSTEMS Lecture 5: Requirements for a quality management system set in ISO 9001:2008 Zofia Krokosz-Krynke, Ph.D., MBA zofia.krokosz-krynke@pwr.edu.pl Wroclaw University of Technology, Building B4 Room 521

2 Sub-clause 1.1 general requirements for a quality management system applicable to any type of organization that: wants to demonstrate its ability to provide a product/service compliant with customer requirements and with applicable regulatory requirements & aims to enhance customer satisfaction through effective application of the system, including processes for continual improvement of the system and assurance of conformity to requirements (customer and applicable regulations) 55

3 Clause 4: Quality Management System 4.1. General Requirements(system and processes) 4.2. Documentation Requirements Clause 5: Management Responsibility 5.1. Management Commitment 5.2. Customer Focus 5.3. Quality Policy 5.4. Planning(quality objectives ans QMS planning) 5.5. Resposibility, Authority, and Communication (including management representative) 5.6. Management Review Clause 8: Measurement, Analysis and Improvement 8.1. General 8.2. Monitoring and Measurement(including customer satisfaction and internal audit) 8.3. Control of Nonconforming Product 8.4. Analysis of Data 8.5. Improvement(including correctiveand preventive action) Clause 6: ResourceManagement 6.1. Provision of Resouces 6.2. HumanResources (including -competence, training, and awareness) 6.3. Infractructure 6.4. Work Environment Clause 7: Product Realization 7.1. Planning of Product Realization 7.2. Customer-related Processes 7.3. Design and Development 7.4. Purchasing 7.5. Production and Service Provision 7.6. Control of Monitoring and Measuring Devices 56

4 Clause 4: Quality Management System 4.1. General Requirements(system and processes) the organization shall establish, document and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard process approach identified and properly managed organization processes basis of the system of quality management o r g a n i z a t i o n organization processes: management activities provision of resources product realization measurement sequences and relationships availability of: resources (personnel and means) information (documents, records) process outsourced to operation identified defined ensured control criteria and methods necessary to ensure effective operation and effective control the organization has to implement actions necessary to achieve planned results of the processes and the actions aiming at their continual improvement management of all processes must be carried out in accordance with all the requirements contained in all clauses of ISO

5 Clause 4: Quality Management System 4.2. Documentation Requirements the organization shall document its system of quality management in a degree indispensable to prove efficient planning, operation, control, and continual improvement of the quality management system and its operation information meaningful data group #1 quality policy documented quality objectives documented group #2 quality manuals document specyfying the qualitymanagement system of an organization group #3 document information and its supporting medium procedure document (not defined, the document that contains a procedure) group #4 records document stating results achieved or providing evidence of activities perfomed other documents 58

6 Clause 4: Quality Management System 4.2. Documentation Requirements quality management system documentation scope form media depend on the organization size type of activities complexity of realized processes competence of personel documented procedure the procedure which is established, documented, implemented, and maintained control of documents control of records required only for control of nonconforming product internal audit corrective action preventive action quality manual obligatory includes information about the scope of the QMS including the details about any exclusions, with their justification documented procedures of the QMS or appropriate references a desrciption of interactions between the processes of QMS 59

7 Clause 4: Quality Management System 4.2. Documentation Requirements document something that gives you information or instruction to do something comes before the event documents control documented procedure of 1. approving of documents for their adequacy(before forwarding to use) 2. review of documents and updating and re-approval(where necessary) 3. ensuring that the changes and the current revision status of the document are easy to identify 4. ensuringavailabilityof currentversionsof thedocumentsatpointsof their use 5. ensuring that the documents stay legible and readily identifiable 6. ensuringthatthedocumetsof externalorigin determinedas necessary for the organization are identified and their distribution is comtrolled 7. preventing an accidental use of obsolete documents or documents invalid for any reasons and applying suitable identification to them if they are retained for any purpose record evidence that the event took place comes after the event records control 1. unambiguous identification 2. secure storage 3. easy and fast lookup 4. appropriate protection 5. retentionof recordsfor a particular period of time 6. availability of records 60

8 Clause 5: Management Responsibility Top management commitment necessary for establishing effective and profitable quality management system top management provides evidence of their personal involvement in establishing, implementation and continual improvement of the QMS Evidence includes: communicating within the organization the information on the importance of meeting customer and legal requirements to enhance the customer growing satisfaction establishing personally a documented quality policy (formally expressed set of intentions and arrangements of the organization, concerning quality (according to ISO 9000) in compliance with the purposes of the organization s existence) establishing documented objectives concerning quality (subjects of efforts and arrangements relating to quality) personal and documented reviews of management system at planned intervals in order to ensure continual suitability, adequacy and effectiveness of the QMS applied in the organization to determine if the QMS used in the organization is still useful, suitable and effective at achieving planned purposes to evaluate the need of changes and opportunities for improvement 61

9 Clause 5: Management Responsibility minimum of information for determining suitability,., of the QMS: audits conducted in the organization customers opinions analysis of the organization s processes functioning analysis of achievement of products and services conformity and the cases when such conformity is not achieved, evidenced as the result of control, complaints, service activities extent and status of conducted preventive and corrective actions status of realization of the follow-up actions from previous management reviews analysis of possible effects of changes in organization and its surroundings on the QMS and recomendations comcerning improvement 62

10 Clause 5: Management Responsibility the two first compulsory documents of quality management system mentionedby ISO 9001:2008 and ISO 9001:2000 definedby ISO 9000:2000 and ISO 9000:2005 as terms relatingto top management top management person orgroup of peoplewho directs and controls an organization at the highest level quality policy overallintentionsand directionof an organizationrelatedto qualityas formallyexpressedby top management quality objectives somethingsought,oraimedfor, related to quality source: B.Sujak-Cyrul Quality Management Systems, Wroclaw

11 Clause 5: Management Responsibility responsibilities and authorities are defined and communicated within the organization moretasksof thetop management: to ensure that to appoint to developeand implement the management representative appointed management member, who shall watchovertheqms internalcommunicationsystem developed and implemented within the entire organization, includescommunicationon efficiency of the QMS source: B.Sujak-Cyrul Quality Management Systems, Wroclaw

12 Clause 6: ResourceManagement QMS to be implemented, maintained, and continually improved requires resources an organization defines and provides assets: human resources infrastructure work environment other resources according to the needs to obtain conformity to product requirement 65