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What are the ISO 9001 requirements for a Quality Management System?
The organisation needs to demonstrate its ability to consistently provide product that meets customer and regulatory requirements . The organisation must aim to enhance customer satisfaction through the effective application of the quality management system. This includes processes for continual improvement of the system.
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What are the requirements of ISO 9001? The requirements in ISO 9001 include: a set of procedures that cover all key processes in a business monitoring processes to ensure they are effective keeping adequate records checking output for defects, with appropriate and corrective action where necessary regularly reviewing individual processes and the quality system itself for effectiveness Focus on continual improvement
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ISO 9001:2008 Quality Management System requirements: Section 4: Quality Management System from our Manual
Quality Management System Section 4 ISO9001:2008
ISO 9001:2008 Clause Our Procedure Introduction to the Quality Management System Document Hierarchy Documentation Requirements Customer, Statutory and Regulatory Requirements Section 4.2 Document Control Procedure Record Control Procedure
Section 4.1
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ISO 9001:2008 Quality Management System requirements: Section 5: Management Responsibility from our Manual
Management Responsibility Section 5 ISO9001:2008
ISO 9001:2008 Clause Section 5.1 Section 5.2 Section 5.3 Our Procedure Senior Management Commitment Customer Focus Quality Policy Quality Management System Planning Section 5.4
Quality Objectives
Responsibility, Authority and Communication Responsibility & Authority Section 5.5 Management Representative Internal Communication Section 5.6
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Management Review
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ISO 9001:2008 Quality Management System requirements: Section 6: Resource Management from our Manual
Resource Management Section 6 ISO9001:2008
ISO 9001:2008 Clause Section 6.1 Section 6.2 Section 6.3 Section 6.4 Our Procedure Provision of Resources Human Resources Infrastructure Work Environment
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ISO 9001:2008 Quality Management System requirements: Section 7: Product Realisation from our Manual
Product Realisation Section 7 ISO9001:2008
ISO 9001:2008 Clause Section 7.1 Our Procedure Planning of Product Realisation Customer Related Processes Contract Review Section 7.2 Production Planning Communication
Customer Communication
Authority Communication Section 7.3 Design and Development Purchasing
Purchasing Documents
Section 7.4 Supplier Assurance and Approval Verification of Purchased Materials Supplier Performance Review Suppliers and Contractor Communication
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ISO 9001:2008 Quality Management System requirements: Section 7: Product Realisation from our Manual
Product Realisation Section 7 ISO9001:2008
ISO 9001:2008 Clause Our Procedure Control of Production and Service Provision Identification and Traceability Customer Property Systems of Preservation of Product Housekeeping Policy Section 7.5 Cleaning Policy Pest Control Policy Control of Visitors and Contractors Despatch and Distribution Maintenance Waste Management Crisis Management Control of Monitoring and Measurement Equipment
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Section 7.6
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ISO 9001:2008 Quality Management System requirements: Section 8: Measurement, Analysis and Improvement from our Manual
Measurement, Analysis and Improvement Section 8 ISO9001:2008
ISO 9001:2008 Clause Section 8.1 Our Procedure Measurement, Analysis and Improvement of the Quality Management System Monitoring and Measurement Customer Satisfaction
Section 8.2
Internal Audits
Monitoring and Measurement of Processes Monitoring and Measurement of Product Control of Non-Conforming Product Product Recall Analysis of Data Corrective Action Preventative Action Improvement
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What are the ISO 9001:2008 Quality Management System document requirements?
ISO 9001:2008 refers specifically to only 6 documented procedures (See next Slide). Other documentation may be required by an organization in order to manage the processes that are necessary for the effective operation of the quality management system. This will vary depending on the size of the organization, the kind of activities in which it is involved and their complexity. Our small business manual covers all the basic clauses of ISO 9001:2008 with 9 procedures/documents our ISO9001:2008 is much more detailed and has 30 documents. Both include 14 records.
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Internal Audit Record Records of Non-conforming Product Corrective Action Request Form Preventative Action Request Form * All of these records are provided in our manual packs
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Involvement of people
Process approach
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PDCA Cycle
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Auditors should be able to demonstrate competency in: Quality Management Systems. The requirements of the ISO 9001:2008. A general understanding of ISO 9000:2005 and ISO 9004. Auditing techniques.
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View our Guide to the process of Implementing an ISO9001:2008 compliant manual at www.9001manual.com
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