4. Quality Management System (QMS) ISO 9001:2008 REQUIREMENTS 4. Quality Management System (QMS) 5. Management Responsibility 7. Product Realisation Processes 6. Resource Management 8. Measurement, Analysis & Improvement ISO 9001 Std: 1) Scope & application, 2) References, 3) Terms & Definitions There are four key elements forming the QMS Mgmt Responsibility Resource Mgmt Product Realisation Processes Measurements, Analysis & Improvement Mgmt Responsibility is very important for ISO 9001 implementation Mgmt to provide adequate Resource for the establishment, implementation and improvement of the QMS / Product Realisation Processes The major portion of the QMS should cover the Product Realisation processes or the organisation’s business activities Measurements & Monitoring is required for effective QMS implementation; Many of the procedures in such a QMS will not be followed and are used merely as guidelines if there is no regular monitoring or audit After the monitoring process, deficiencies are analysed and improvements are recommended to top mgmt for implementation Top mgmt will then allocate the resources for the improvements (& changes to the QMS) and the cycle continues.

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 To cover why various ISO 9001 requirements are present and common deficiencies encountered External training ISO 9001 requires 2 full days – Can only summarise the key requirements during today’s briefing The basic QMS requirements are to Have the processes for key business activities documented Documented procedures are also under proper document control Documented procedures have been reviewed and approved by appropriate mgmt staff Proper versioning and effective implementation date have been established Records also have to be properly filed and easily retrievable Key business process activities may include purchasing, training, infrastructure supt activities, etc.

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 Top mgmt has many responsibility for effective QMS implementation Question: Who has the ultimate responsibility of the final quality of the delivered product/service top mgmt (answer) middle mgmt staff level everyone The quality of the final delivered product / service is dependent on the top mgmt direction and emphasis Quality policy and objectives to be established by top mgmt staff to provide direction to staff Top mgmt have to ensure roles and responsibility are clearly defined to reduce the level of ambiguity in the required scope of work (although quite difficult in today’s complex world) The mgmt representative is accountable for the successful and effective implementation of the QMS Regular mgmt review is required to ensure the suitability and effectiveness of the QMS.

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 Resource mgmt is important in the context of ISO 9001 implementation Staff needs adequate resources to get their work done For example, it is considered a non-conformance to have a staff who consistently work 20% over-time over a period of more than 6 months as this is likely tp affect the quality of the work done by the staff Staff or other personnel (temp staff, supplier, etc.) also have to be properly trained to performed their assigned tasks Adequate facilities, equipment and supporting services also have to be provided for the employee The work environment must also be managed to enable the employee to work productively / effectively (e.g. furnace inspection: appropriate protective clothings and materials to be provided; safety boots to be provided at warehouse, etc.) These requirements will benefit each employee in the organisation

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 Documentation of key business processes Product realisation planning are more applicable for one-time projects where customised product requirements and processes are adopted (e.g. e.g. Project Document, Work Instruction documents, etc.) Post-delivery activities include 1) Actions under warranty provisions, 2) Contractual obligations such as maintenance activities and 3) Supplementary services such as recycling or final disposal This new ISO 9001:2008 requirement is meant more for the application teams Also need to consider recycling or final disposal requirements for procured IT equipment Channels for customer communications include helpdesk phone number, fax number, email address, web-site, etc. Purchasing process will also have to be controlled if it affects the final quality of the delivered product or service Production and service operations will have to be performed under controlled conditions - meaning the same production or servicing operations can be repeated with minimal variance Monitoring and measuring devices also have to be verified to ensure that they are working properly (otherwise they may give us problems; e.g. pressure gauge at oil refinery not working properly, giving rise to explosion which could otherwise be prevented

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 Measurement, analysis and improvement is an important part of the QMS implementation Ensure QMS is suitable and effective for current use Measurements to be collected and analysed must be pre-defined. The statistical technique for analysing the measures should also be pre-determined It is mandatory to collect and analyse measures on customer satisfaction and internal audits There must also be mechanism to ensure that non-conforming products are prevented from inadvertent use or delivery (e.g. through segregation) Appropriate data should be analysed to determine characteristics or trends of products or processes QMS improvements, correvtive and prevetive actions are usually derived from the analysis of data

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 One of the key ISO 9001 requirements is ensure that all key business activities are properly documented in terms of sequence / interactions of key processes A business process is normally documented from start to end The following should be used to guide the documentation of the business process: WHO perform the activity WHEN is the activity performed WHAT record is produced For important situation, the following areas can be covered: HOW is the activity performed WHY is the activity performed Any exclusion to the ISO 9001 implementation must be justified (partial ISO 9001 certification is discouraged) in the past, partial ISO 9001 certification is allowed through the use of the ISO 9001, 9002 and 9003 standard this is no longer allowed and most companies do not make use of partial certification anyway a complete product or service must be certified (partial not allowed)

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 Document control is important because we need to ensure that staff are following only approved and the correct version of the procedures Normal a document will need to have a unique title for unique identification an issue date and/or issue number page numbering and total page numbering to eliminate possibility of not being aware of missing pages approval signature/record indicating that the document has been approved for use Superceded documents must also be indicated as such

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 All records should have a title and a date to make it readily identifiable Filed records should also be indexed to make the records readily retrievable (through through use of the File Index form) All important records provide evidence that the business processes have been properly carried out should be maintained (e.g. end-products and intermediate end-products) product mkg plans quotations customer ‘s PO invoices and delivery notes, etc.

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 As emphasized earlier, top mgmt commitment is very important for effective ISO 9001 implementation Top mgmt is required to provide evidence of their commitment to the development, implementation & improvement of the QMS through their actions (e.g. send staff for training, directing staff on relevant corrective/preventive actions, etc.) Top mgmt also to establish the quality policy or company mission statement so that staff know their key work objective the moment they step into the company E.g. To continually improve all business processes so as to meet changing requirements and expectations of all internal and external customers To provide customers with quality and cost-effective solutions (product/service) in a timely manner Top mgmt should be set quality related objectives for middle mgmt to achieve (e.g. based on efficiency and effectiveness measures) Efficiency: Amount of work done per unit time Effectiveness: Number of mistakes made per month Top mgmt should allocate resources to areas that can improve the capability of the organisation It is easy to increase revenues or production level by elimination all long term measures such as maintenance, R&D, continual improvements It is more difficult to improve the capability of the organisation

ISO 9001:2008 REQUIREMENTS 5.2 CUSTOMER FOCUS Top mgmt ensure customer requirements are determined and fulfilled Customer satisfaction is also achieved or enhanced Being customer-focus is important to the survival of an organisation The customer is the reason which a company exists Old Trend: Let the customer beware Buy the goods at your own risk Supplier takes no responsibility for poor quality goods produced Customers have little choice as there are limited suppliers for the same product / service New Trend: Let the Suppliers Beware Many suppliers can now provide the same product/services The supplier that provide poor quality product/services have to be careful; It will steadily lose its market share if nothing is done

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 Regulatory requirements is emphasised or given more attention in the new ISO 9001:2000 standard Quality policy must include commitment for continual improvement status quo is no longer okay in the new ISO 9001:2000 standard The rest are implied in the old ISO 9001 standard

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 Quality objectives now have to be set at all functions and level (high level objectives no longer adequate) Objectives should be SMART to meet the ISO 9001 requirements QMS planning refers more on resource and schedule planning for improvement activities

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 Mgmt review is an important process to facilitate continual improvement of the QMS Many measures (e.g. customer satisfaction, complaints, audit results, etc.) are analysed to identify required corrective and preventive actions to improve the QMS The review process will highlight key QMS deficiencies and required corrective and preventive actions strengths of QMS are also sometimes highlighted to inform staff to continue to do what we have done well Resource and schedule plan for improvements should also be made

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 Responsibility and authorities for all staff to be defined Good to have a job specification for all job designation; Job specification can contain: Educational, job experience, skill and/or training requirements Key required work activities Mgmt representative is accountable for the successful implementation of the ISO 9001 standard member of top mgmt should be appointed for this to improve chances of successful ISO 9001 implementation Communication channels must be established to highlight quality problems and required follow-up actions

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