ISO 9001 2008 REQUIREMENTS 4 Quality Management System

ISO 9001: 2008 REQUIREMENTS 4. Quality Management System (QMS) 5. Management Responsibility 6. Resource Managemen t 7. Product Realisation Processes 8. Measurement, Analysis & Improvement

ISO 9001: 2008 REQUIREMENTS 4 QUALITY MGMT SYSTEM (QMS) REQUIREMENTS Key processes documented � � � � 4. 2. 3 Control of Documents 4. 2. 4 Control of Records 8. 2 Internal Audit 8. 3 Control of Non-conforming Products 8. 5. 2 Corrective Actions 8. 5. 3 Preventive Actions Key business processes / activities Document control in place Records properly maintained & retrievable

ISO 9001: 2008 REQUIREMENTS 5 MANAGEMENT RESPONSIBILITY QMS development, implementation and improvement commitment Customer-focus Quality policy / mission Quality objectives & planning Quality responsibility , authorities & accountabilities Appoint QMR to implement & improve QMS Communicate QMS requirements QMS Mgmt review of deficiencies & possible improvements

ISO 9001: 2008 REQUIREMENTS 6 RESOURCE MANAGEMENT Provide adequate human resources Staff or personnel are competent & properly trained for assigned duties Adequate supporting infrastructure & facilities Work environment does not affect performance

ISO 9001: 2008 REQUIREMENTS 7 PRODUCT REALISATION PROCESSES Product realisation planning Determine product/customer requirements Channels for customer communication Design and development processes � Planning, inputs, outputs, review, verification, validation changes Procurement Production and service operations � Include handling of customer property (include intellectual properties Control of measuring and monitoring devices

ISO 9001: 2008 REQUIREMENTS 8 MEASUREMENT, ANALYSIS & IMPROVEMENT Measurement and Analysis Planning Measures on customer satisfaction, internal audits and other process/product measures Control of non-conformity Analysis of data QMS Improvements, corrective and preventive actions Verify effectiveness

ISO 9001: 2008 REQUIREMENTS 4 QMS REQUIREMENTS (DOCUMENT KEY PROCESSES) 4. 1 General QMS Requirements � Document sequence/interaction of key processes � Document criteria & methods to ensure effective operation 4. 2. 1 QMS documentation � � Quality policy & objectives, Quality Manual Control documents such as checklists & work instructions Required procedures and records Levels of details depends on competence of staff, size of organisation & complexity of processes 4. 2. 2 Quality Manual � Scope of QMS, including details of and justifications for any exclusions

ISO 9001: 2008 REQUIREMENTS 4. 2. 3 CONTROL OF DOCUMENTS Review & approve document before issue Identify changes & current revision status Relevant versions available at point of use Documents legible & Identifiable Documents of external origins are identified and distribution controlled

ISO 9001: 2008 REQUIREMENTS 4. 2. 4 CONTROL OF RECORDS Records legible, readily identifiable & retrievable Mgmt review records, training records, purchase evaluation records, audit records, customer complaints and other process related records

ISO 9001: 2008 REQUIREMENTS 5. 1 MANAGEMENT COMMITMENT Development, implementation & improvement of QMS Establish quality policy Ensure quality objectives are met Conduct mgmt review of QMS deficiencies / improvements Ensure availability of resources for QMS implementation and improvements

ISO 9001: 2008 REQUIREMENTS 5. 2 CUSTOMER FOCUS Top mgmt ensure customer requirements are determined and fulfilled Customer satisfaction is also achieved or enhanced

ISO 9001: 2008 REQUIREMENTS 5. 3 Quality Policy Appropriate to organization’s core purpose Include commitment to meet customer and regulatory requirements Include commitment for continual improvement & meeting quality objectives Communicated to all staff Reviewed for continuing adequacy suitability and effectiveness

ISO 9001: 2008 REQUIREMENTS 5. 4 QUALITY OBJECTIVES / QMS PLANNING Quality objectives set at relevant functions & levels Quality objectives measurable and consistent with quality policy QMS Planning: � Ensure QMS requirements & quality objectives are met � Ensure integrity of QMS is maintained when changes are implemented

ISO 9001: 2008 REQUIREMENTS 5. 6 MANAGEMENT REVIEW Conducted at planned intervals to ensure continuing suitability, adequacy and effectiveness of the QMS Review inputs include: � Audit results, customer complaint, customer satisfaction, process performance & product conformity, follow-up actions, changes / improvement to QMS Review Outputs: � Improvement of the effective of the QMS & its processes � Improvement of products � Resource needs

ISO 9001: 2008 REQUIREMENTS 6 RESOURCE MANAGEMENT 6. 1 Provision of Resources � Determine & provide resources to implement, maintain, improve the QMS & enhance customer satisfaction 6. 2 Human Resources � Ensure staff or other personnel are adequately competent & trained for assigned roles � Maintain training records 6. 3 Infrastructure: � Determine, provide & maintain infrastructure (include bldg, workspace, equipment and supporting services) needed to achieve conformity to product requirements 6. 4 Work Environment � Determine & manage the work environment needed to achieve conformity to product requirements

ISO 9001: 2008 REQUIREMENTS 7. 1 PLANNING OF PRODUCT REALISATION Plan & develop the product realisation processes Determine quality objectives & requirements for product Establish product-specific processes, documents, resources Document required verification, validation and criteria for product acceptance

ISO 9001: 2008 REQUIREMENTS 7. 2 CUSTOMER- RELATED PROCESSES Determine product requirements Review product requirements � Requirements are defined � Requirements differing from what customer wants are resolved � Organisation has ability to fulfilled defined requirements Customer Communication � Communication channels available to provide product information, answer queries, taking orders and amendments, customer feedback

ISO 9001: 2008 REQUIREMENTS 7. 3 DESIGN AND DEVELOPMENT Design and development planning � Update plan as design and development progresses Design and development inputs � Functional, performance and regulatory requirements to be documented and reviewed Design and development outputs � In form suitable for verification against for design & dev. Inputs* � Include details for preservation of products* Design and development review, verification, validation and changes � Procedures to be defined

ISO 9001: 2008 REQUIREMENTS 7. 4 PURCHASING Evaluate and select suppliers based on their ability to meet purchase requirements Purchasing information to contain level of adequate purchasing requirements Verification of purchased products Key Records: � Purchase specifications � Supplier evaluation records � Evidence of satisfaction receipt

ISO 9001: 2008 REQUIREMENTS 7. 5 PRODUCTION & SERVICE PROVISION 7. 5. 1 Control of Production & Service Provision � Plan and carry out production and service provision under controlled conditions repeatable processes � Ensure availability of work instructions, as necessary 7. 5. 2 Validation of processes for production and service provision � Required when resulting output cannot be verified or tested (e. g. packing of parachutes) � Processes, equipment, personnel needs to be qualified

ISO 9001: 2008 REQUIREMENTS 7. 5 Production & Service Provision 7. 5. 3 Identification & Traceability �Identify product by suitable means throughout the product realisation �Also know as configuration mgmt for some industry sector 7. 5. 4 Customer property �Exercise care of customer property (include intellectual property �Identify, verify, protect and safeguard customer property �If lost, damaged or otherwise found unsuitable for use, this shall be reported to the customer & records maintained

ISO 9001: 2008 REQUIREMENTS 7. 5 PRODUCTION & SERVICE PROVISION 7. 5. 5 Preservation of product � Preserve conformity of product during internal processing and delivery to intended destination � Include identification, handling, packaging, storage & protection

ISO 9001: 2008 REQUIREMENTS 7. 6 MONITORING AND MEASURING DEVICES Measuring devices to be calibrated at specific intervals Calibration records to be maintained � Equipment ID � Calibration date � Calibration accuracy � Next calibration date Calibration to be safeguarded from adjustments

ISO 9001: 2008 REQUIREMENTS 5. 5 RESPONSIBILITY, AUTHORITY & COMMUNICATION Responsibility , authorities& accountabilities for all various staff Quality Mgmt Representative appointed � Ensure QMS is established, implemented & maintained � Report to top mgmt on the performance of the QMS and any need for improvement � Promote awareness of customer requirements throughout the organisation Effectiveness of QMS communicated through established channels

ISO 9001: 2008 REQUIREMENTS 8 MEASUREMENT, ANALYSIS & IMPROVEMENT 8. 1 Monitoring and Measurement Planning �Required to demonstrate product conformity, conformity to QMS and continually improve the QMS 8. 2 Monitoring and Measurements � 8. 2. 1 Methods for obtaining measures on customer satisfaction shall be determined which may be derived from - Customer satisfaction survey - Customer data - User opinion - Lost business analysis - Compliments - Warranty claims - Dealer reports

ISO 9001: 2008 REQUIREMENTS 8 Measurement, Analysis & Improvement � 8. 2. 2 Internal audit �Conducted at planned interval to determine if QMS requirements have been implemented �Planned Audit programme �Defined Audit criteria, scope and methods �Auditors shall not audit their own work �Documented Audit results & follow-up actions

ISO 9001: 2008 REQUIREMENTS 8 MEASUREMENT, ANALYSIS & IMPROVEMENT 8. 2. 3 Monitoring & measurement of processes � To monitor QMS processes, to verify conformity to product requirements & the effectiveness of the quality mgmt systems 8. 2. 4 Monitoring & measurement of product � To monitor characteristics of product to verify if the product requirements have been met 8. 3 Control of non-conforming product � Ensure that product which does not conforms to product requirements is identified and prevented from unintended use or delivery

ISO 9001: 2008 REQUIREMENTS 8 MEASUREMENT, ANALYSIS & IMPROVEMENT 8. 4 Analysis of Data � Determine, collect and analyse appropriate data to demonstrate suitability and effectiveness of the QMS � Evaluate where continual improvement can be made through trend analysis 8. 5. 1 Continual Improvement � Continually improve the QMS through quality policy, objectives, audit results, analysis of data, corrective / preventive actions and mgmt review

ISO 9001: 2008 REQUIREMENTS 8 MEASUREMENT, ANALYSIS & IMPROVEMENT 8. 5. 2 Corrective Action � Determine root cause of non-conformities in order to prevent recurrence � Effort should be proportionate to the effects of the non-conformities � Corrective actions taken to be recorded & their effectiveness verified 8. 5. 3 Preventive Action � Determine root cause of potential non-conformities to prevent their occurrence � Effort should be proportionate to the effects of the potential non-conformities � Preventive actions taken to be recorded & their effectiveness* verified