Introduction to ISO9001:2008 Have a quality manual – the system framework Create documents including a quality policy, core processes, objectives, procedures, and records Control documents - Ensure that right documents are being used at the right time by the right people Create and maintain records of the system - Identify records and keep them as evidence of performance and conformity with standards

What are the ISO 9000 standards? The ISO 9000 standards are a collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks and web based documents on Quality Management. There are 25 documents in the collection altogether 7/25/20152

What are the main ISO 9000 standards? ISO 9000:2005 Quality management systems – Fundamentals and vocabulary. Covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. A guidance document used for reference to understand terms and vocabulary related to quality management systems. ISO 9001:2008 Quality management systems – Requirements This is the only ISO9000 standard for which certification can be gained. Intended for use in any organization regardless of size, type or product including service. It provides a number of Quality Management System requirements which an organization needs to fulfil to achieve customer satisfaction. It includes a requirement for the continual improvement. ISO 9004:2000 Quality management systems - Guidelines for performance improvements. Covers continual improvement. This gives you advice on what you could do to enhance a mature system. This standard very specifically states that it is not intended as a guide to implementation. 7/25/20153

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. 7/25/20154

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 7/25/20155

What are the ISO 9001:2008 Quality Management System requirements? The ISO9001:2008 Standard consists of the following sections: Section 1: Scope Section 2: Normative Reference Section 3: Terms and definitions Section 4: Quality Management System Section 5: Management Responsibility Section 6: Resource Management Section 7: Product Realization Section 8: Measurement, analysis and improvement 7/25/20156

ISO 9001:2008 Quality Management System requirements: Section 4: Quality Management System from our Manual Quality Management System Section 4 ISO9001:2008 Section 4.1 Introduction to the Quality Management System Document Hierarchy Section 4.2 Documentation Requirements Customer, Statutory and Regulatory Requirements Document Control Procedure Record Control Procedure 7/25/20157 ISO 9001:2008 Clause Our Procedure

ISO 9001:2008 Quality Management System requirements: Section 5: Management Responsibility from our Manual Management Responsibility Section 5 ISO9001:2008 Section 5.1Senior Management Commitment Section 5.2Customer Focus Section 5.3Quality Policy Section 5.4 Quality Management System Planning Quality Objectives Section 5.5 Responsibility, Authority and Communication Responsibility & Authority Management Representative Internal Communication Section 5.6Management Review 7/25/ ISO 9001:2008 Clause Our Procedure

ISO 9001:2008 Quality Management System requirements: Section 6: Resource Management from our Manual Resource Management Section 6 ISO9001:2008 Section 6.1Provision of Resources Section 6.2Human Resources Section 6.3Infrastructure Section 6.4Work Environment 7/25/20159 ISO 9001:2008 Clause Our Procedure

ISO 9001:2008 Quality Management System requirements: Section 7: Product Realisation from our Manual Product Realisation Section 7 ISO9001:2008 Section 7.1Planning of Product Realisation Section 7.2 Customer Related Processes Contract Review Production Planning Communication Customer Communication Authority Communication Section 7.3Design and Development Section 7.4 Purchasing Purchasing Documents Supplier Assurance and Approval Verification of Purchased Materials Supplier Performance Review Suppliers and Contractor Communication 7/25/ ISO 9001:2008 Clause Our Procedure

ISO 9001:2008 Quality Management System requirements: Section 7: Product Realisation from our Manual Product Realisation Section 7 ISO9001:2008 Section 7.5 Control of Production and Service Provision Identification and Traceability Customer Property Systems of Preservation of Product Housekeeping Policy Cleaning Policy Pest Control Policy Control of Visitors and Contractors Despatch and Distribution Maintenance Waste Management Crisis Management Section 7.6 Control of Monitoring and Measurement Equipment 7/25/ ISO 9001:2008 Clause Our Procedure

ISO 9001:2008 Quality Management System requirements: Section 8: Measurement, Analysis and Improvement from our Manual Measurement, Analysis and Improvement Section 8 ISO9001:2008 Section 8.1 Measurement, Analysis and Improvement of the Quality Management System Section 8.2 Monitoring and Measurement Customer Satisfaction Internal Audits Monitoring and Measurement of Processes Monitoring and Measurement of Product Section 8.3 Control of Non-Conforming Product Product Recall Section 8.4Analysis of Data Section 8.5 Corrective Action Preventative Action Improvement 7/25/ ISO 9001:2008 Clause Our Procedure

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. 7/25/

What are the ISO 9001:2008 Quality Management System requirements? The standard specifies six compulsory documents: Control of Documents (4.2.3) Control of Records (4.2.4) Internal Audits (8.2.2) Control of Nonconforming Product / Service (8.3) Corrective Action (8.5.2) Preventive Action (8.5.3) In addition to these ISO 9001:2008 requires a Quality Policy and Quality Manual 7/25/201514

What are the ISO 9001:2008 Quality Management System requirements? The standard specifies six compulsory documents: Control of Documents (4.2.3) The ISO9001:2008 standard requires that an organization needs a documented procedure to control quality documents. All employees must have access to up-to-date documents and be aware of how to use them. 7/25/201515

What are the ISO 9001:2008 Quality Management System requirements? The standard specifies six compulsory documents: Corrective Action (8.5.2) The ISO9001:2008 standard requires that you take Corrective Action to rectify non-conformances. It is a requirement to keep records of these activities and monitor their effectiveness. Preventive Action (8.5.3) The ISO9001:2008 standard requires that you need to take Preventative Action to eliminate potential causes of problems. It is a requirement to keep records of these activities and monitor their effectiveness. 7/25/201516

What are the ISO 9001:2008 Quality Management System requirements? ISO 9001:2008 requires a Quality Policy and Quality Manual: The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards. Your procedures will be maintained in your Quality Manual. 7/25/201517

What are the ISO 9001:2008 Quality management systems requirements? The ISO9001:2008 standard has an absolute requirement to maintain the following records: Management Review Minutes Training Record Product Release Record Design and Development Records - Results of the review of customer requirements - Design and development inputs relating to product requirements - Results of design and development reviews and actions - Results of design and development verification and actions - Results of design and development validation and actions - Results of the review of design and development changes Supplier Assessment Record * All of these records are provided in our manual packs 7/25/201518

What are the ISO 9001:2008 Quality Management System requirements? The ISO9001:2008 standard has an absolute requirement to maintain the following records: Validation Record Identification and Traceability Record Register of Customer Property Calibration Record - Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist - Validity of the previous measuring results when the measuring equipment is found not to conform to requirements - Results of calibration and verification of measuring equipment 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 7/25/201519

What are the 8 Quality Management Principles? 7/25/ Quality Managemen t Principles Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships

Why is customer satisfaction included in ISO 9001? "Customer satisfaction" is one of the main driving criteria for any organization. In order to evaluate if a product meets customer needs and expectations, it is necessary to monitor and measure customer satisfaction. Improvements can be made by taking action to address any identified issues and concerns. Your customers will gain confidence that your products will meet their needs and increase their satisfaction. 7/25/201521

ISO 9001:2008 Process Approach to Management What is a process approach? The systematic identification and management of the processes within an organization and the interactions between the processes is known as a process approach to management. The process approach is a key element of the ISO 9000 standards. 7/25/201522

ISO 9001:2008 Process Approach to Management 7/25/201523

What is the PDCA cycle? The PDCA cycle is an established, logical, method that can be used to improve a process. This requires: (P) planning (what to do and how to do it), (D) executing the plan (do what was planned), (C) checking the results (did things happened according to plan) and (A) act to improve the process (how to improve next time). The PDCA cycle can be applied within an individual process, or across a group of processes. 7/25/201524

PDCA Cycle 7/25/201525

What do you need to do to comply with ISO 9001:2008? When initially starting to use ISO 9001, you should familiarize yourself with the Quality Management System standards, especially ISO 9000, ISO 9001 and ISO 9004, and consider their requirements. If you wish to proceed to certification, you should follow our guides and checklists and implement the procedures and records in our manual pack then use Gap Analysis Checklist to determine if your system meets the requirements of ISO Developing and implement additional procedures or processes to address any shortfalls. 7/25/201526

What are the requirements for auditors? The standards require that auditors are able to understand the organization's activities and processes and appropriately audit against the requirements of the ISO 9001 in relation to the organization's objectives. 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 Auditing techniques. 7/25/201527

How will the implementation of the ISO9001:2008 standard help us? Improves Efficiency and Streamlines operations: Your quality management system focuses on your objectives and operating processes. This encourages you to improve the efficiency of your business, the quality of your products, the service you provide and helps to reduce your waste and customer complaints levels. 7/25/201528

How will the implementation of the ISO9001:2008 standard help us? It increases customer satisfaction: The structure of ISO 9001 ensures that the needs of the customer are being considered and met and your company focus is on constantly increasing customer satisfaction. "Customer satisfaction" is one of the main driving criteria for any organization. In order to evaluate if a product meets customer needs and expectations, it is necessary to monitor and measure customer satisfaction. Improvements can be made by taking action to address any identified issues and concerns. Your customers will gain confidence that your products will meet their needs and increase their satisfaction. 7/25/201529

What is the next stage for us? View our Guide to the process of Implementing an ISO9001:2008 compliant manual at 7/25/201530