ISO 9001:2008 Awareness Presentation Suitable for all kinds of interested audiences Empty your cup and enjoy the presentation Facts about ISO 9001 1. ISO 9001 is being implemented in 175 countries around the world 2. Over 1.2 million certificates issued worldwide 3. ISO has 163 member countries What is ISO 9001? • It’s a quality management system that can be adopted by any kind of organization • The system is focused towards the meeting of customer requirements and enhancing of customer satisfaction Keywords: 1. Quality 2. Management system 3. Customer requirements 4. Customer satisfaction What is ISO 9001? • This system has 4 components or elements and they are applied within your business management: a) b) c) d) Management responsibility Resource management Product realization Measurement, analysis and improvement • Before we explore these elements, why is ISO 9001 necessary for your organization? Why do we need ISO 9001? • To be effective in whatever we do, we need a system of doing things to be consistent. Just like craftsmen, managers need a good management tool to get the job done. • There are too many activities in any organization. Easy to lose track of things and focus. Easy to get distracted. Managers need a good system to keep things in order. • Systemizing of activities is a natural phenomenon. We do it all the time – privately, publicly or commercially Why do we need ISO 9001? • A business faces great risks – big investments, customer expectations, jobs, credibility, etc. The business owner must do all he can to ensure success, or he/she will fail. • Every major economy in the world adopts it! Governments give recognition to it. Because it works. Global Issuance of ISO 9001 Certificates 1,200,000 2000 1,000,000 2001 2002 800,000 2003 600,000 2004 2005 400,000 2006 2007 200,000 2008 2009 0 No of ISO 9001 certificates ISO Survey 2010 ISO 9001 Certificates issued by region You already have a system of doing things too! • But is it effective? If you keep doing what you always do, you will always get the same result. • ISO 9001 is an option, a good one. It requires your organization to document your business processes (QMS), monitor, measure, analyze and improve it. • Business owners and top management need to make a strategic decision on whether to implement the ISO 9001 QMS. Biggest benefit • The ISO 9001:2008 Standard provides managers with a tool that is designed to continually improve their business performance. • ISO 9001 requires you to: – Plan what you want to do, – Follow that plan, – Monitor, measure and analyze your execution of the plan, and – Improve the plan. Planning is the key P D C A • A well-designed and well-implemented quality management system can and should eliminate What is ISO 9001? • ISO = International Organization for Standardization • isos = Greek = equal • 9001 = unique ID number • 2008 = Year it was published Formation 23 February 1947 Type NGO Purpose Int’l standardization HQ Geneva Membership 63 countries Website www.iso.org No. of stds over 18,000 ISO 9000 Family a) ISO 9001:2008 Quality Management Systems – Requirements b) ISO 9000:2005 Fundamentals and vocabulary c) ISO 19011:2011 Guidelines for auditing management systems d) ISO 9004:2009 Managing for the sustained success of an organization — A quality management approach • The term “ISO 9000” is frequently used to refer to the ISO 9001 standard • Only ISO 9001 is auditable. The rest serves as references only. ISO 9001 History It all started when the US Military were getting sub-par products from their suppliers. Then it caught on. YEAR STANDARDS TITLE 1959 MIL-Q-9858 QUALITY PROGRAM REQUIREMENTS 1969 AQAP NATO ALLIED QUALITY ASSURANCE PUBLICATIONS 1974 BS 5179 GUIDELINES FOR QUALITY ASSURANCE 1979 BS 5750 SPECIFICATION FOR DESIGN DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING 1987 ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing ISO 9002:1987 Model for quality assurance in production, installation, and servicing ISO 9003:1987 Model for quality assurance in final inspection and test 1994 ISO 9001:1994 QUALITY SYSTEMS – MODEL FOR QUALITY ASSURANCE 2000 ISO 9001:2000 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS 2008 ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS- REQUIREMENTS What is ISO 9001:2008 Quality Management Systems - Requirements? • Quality = degree to which customer requirements have been met • Management = coordinated activities to direct and control an organization • System = set of interrelated or interacting elements • Quality management system = a system to direct and control an organization with regard to quality • Requirements = a set of management parameters your QMS More about quality • How do you know requirements have been met? – Review = confirm that requirements are accurate – Verify = measure accuracy of output against requirements – Validate = Get feedback from customer/end-user • Nonconformance = failure to fulfill requirements • Nonconformance = error • All forms of nonconformances require corrections and corrective action to prevent recurrences • Correction = Elimination of error • Corrective action = Elimination of the root causes of the error (Ask WHY 5 times) Root cause Effect 1 Effect 2 Root cause analysis 1. 2. 3. 4. 5. Why did the nonconformity occur? Why did the direct cause occur? Why did effect 3 occur? Why did effect 2 occur? Why did effect 1 occur? Effect 3 Direct cause Nonconformity 8 Quality Management Principles 1. 2. 3. 4. 5. Customer focus The ISO 9001 Standard is based Leadership on these principles Involvement of people Process approach System approach to management 6. Continual improvement 7. Factual approach to decision making 8. Mutually beneficial supplier relationships System approach • Quality must be managed by a system to be effective • This system is done for you, as represented by the ISO 9001:2008 standard • Recall: A system is a set of interrelated or interacting elements • System approach is described in Clause 4.1 • The description of Clause 4.1 matches the PDCA approach to process management - Plan, Do, Check, Act System and process approach • Quality must be managed by a system • The system must be managed using the process approach because the system is made up of processes • These processes are linked to each other • A process has inputs , resources, activities, outputs and customers. Manage them all. ISO Lingo input process output • Product = Any output- physical product or services • Output = product • Product = result of a process • Process = a set of inter-relating activities focused towards producing the output • Input = requirements Process approach Can be applied to any other process that you manage input Your process output Process approach • Every process require specific inputs, resources, activities, outputs and customers • What you can do now is: – Define and document the inputs – Define and document the kinds of resources that your process use – Define and document the activities and their interactions – Define and document the responsibilities – Define and document the outputs • You can name this document as Department Control Plan • Then execute this plan, and monitor, measure, analyze and improve its performance (KPI) • Thus, Plan – Do - Check – Act (Edward Demmings) Anatomy of a process Resources Inputs Process Outputs Activities Every process has an owner Process management ISO 9001:2008 ELEMENTS input Your QMS output ISO 9001:2008 Structure • • • • • • • • Clause 1 Scope Clause 2 Normative references Clause 3 Terms and definitions Clause 4 Quality management system Clause 5 Management responsibility Clause 6 Resource management Clause 7 Product realization Clause 8 Measurement, analysis and improvement Quality management system Resource management Your QMS Product realization Measurement, analysis and improvement General requirements Documentation requirements Clause 1 Scope • Your organization should consider to adopt the ISO 9001 standard if it – needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and – aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. • In this International Standard, the term “product” only applies to a) product intended for, or required by, a customer, b) any intended output resulting from the product realization processes. • All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Clause 1.2 Application • Where exclusions are made, • Where any claims of conformity to this requirement(s) of this International Standard are not acceptable unless these International Standard exclusions are limited to cannot be applied due to requirements within Clause 7. the nature of an organization and its • And such exclusions do not affect the organization's product, this can be ability, or responsibility, to considered for exclusion. provide product that meets customer and applicable statutory and regulatory requirements. Clause 2 Normative references • This document is indispensable in the application of the ISO 9001 standard: – ISO 9000 – Fundamentals and vocabulary Clause 3 Terms and definitions • Wherever the term “product” occurs, it can also mean “service”. 4.1 QMS General Requirements 1. Determine the QMS processes 2. Determine the sequence and interactions 3. Determine the methods of operations and control 4. Provide resources to ensure effective operations (Clause 6) 5. Monitor, measure and analyze processes (Clause 8.2 to 8.4) 6. Improve the effectiveness of the processes (Clause 8.5) QMS processes are in the circle Clause 4.2 Documentation requirements a) Quality Policy b) Quality Manual – to describe the system c) Quality Objectives Register – to document your quality objectives d) Control of Documents Procedure e) Control of Records Procedure f) Internal Audit Procedure Note: Templates are available. g) Control of Nonconforming Product h) Corrective Action Procedure i) Preventive Action Procedure j) Quality Plan k) Control plans l) Other documents, as necessary m) Records (to show evidence of work performed in all QMS processes) Control of documents Create document Get approval Register document Distribute document Review document Amend document Get reapproval Update register Identify external documents Register external documents Check for updates Update register Dispose obsolete document Stamp obsolete document if retained Clause 4.2.4 Control of records • Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. • Process owners must identify, classify and maintain all process records in good and secure conditions throughout retention period. • Records shall remain legible, readily identifiable and retrievable. Good records management • Enables you to a) conduct business in an orderly, efficient and accountable manner b) support and document decision making c) provide continuity in the event of a disaster d) meet legislative and regulatory requirements e) protect the interests of customers, employees and stakeholders Types of records to maintain • Go through the ISO 9001 standard or your Quality Manual • Identify the following phrases where they appear: “Records …… shall be maintained (see 4.2.4)” • Most of the records requirements are readily available, such as product planning records, product design records, purchasing records, production records, monitoring records, analysis records, employee performance appraisal and training records, job descriptions, organization chart, infra maintenance records, contract/sales records, marketing records, customer complaints records, etc. • Records pertaining to the mandatory SOP’s and quality objectives shall be created. Clause 5 Management Responsibility • Top management must a) b) c) d) Be committed to the QMS Be customer focused Establish a quality policy Plan for the QMS in terms of establishing quality objectives and management of change e) Assign responsibility, authority and provide suitable communication channels f) Review the QMS performance What to do • • • • • • • • • • • Read the ISO 9001:2008 Standard Establish a Quality Policy Appoint a Management Representative (from mgt rank) Establish a QMS Committee Establish your Quality Manual Establish the 6 mandatory procedures (Clause 4.2) Establish your Quality Plan Establish your Department/Process Control Plans Establish and document your quality objectives Establish your KPI’s and start collecting data Implement all the procedures Key Performance Indicators • Ask this question when determining KPI’s: • As the CEO/Manager of this organization, what data will instantly give me the ability to assess overall performance at any given point of time? • Then list all them down and select your desired KPI’s. Financials Human capital Balanced scorecard Customers Processes • Can be used to benchmark performance based on input requirements (customer wants 100 units per month, so give them 100 units per month) Quality objectives • Can be used to improve KPI performance levels – decision must be based on past performance data and existing capacity to be realistic • You can use existing performance levels to establish your quality objectives • Use quality objectives to improve on productivity levels, decrease errors, improve speed, reduce costs, reduce complaints, etc. Employee responsibility • Know the Quality Policy • Aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives • Comply with the requirements of the QMS, as stated in the Quality Manual, procedures, Quality Plan, etc. • Provide feedbacks or ideas about the QMS • Report any nonconformities Clause 6 Resource management • Clause 6.1 Provision of resources • The organization shall determine and provide the resources needed a) to implement and maintain the quality management system and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements. Types of resources • Determine , provide and manage the following: a) Clause 6.2 Competent human resources (competency assessment, training needs analysis) b) Clause 6.3 Suitable and well-maintained infrastructures (maintenance of buildings, hardware, software, transportation, utilities) c) Clause 6.4 Suitable and well-maintained work environment (5S program) d) Consider including financial management in your QMS to ensure product conformity PLAN Establish Job Description Hire employee DO Appraise performance CHECK Identify training needs ACT Conduct training Assess effectiveness of training • Clause 6.2.1 • Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience. Sometimes, work activities are not defined. So there’s a lot of confusion Defining staff duties and responsibilities and analyzing training needs to ensure competence is essential • Create a survey form which contains these columns: 1. 2. 3. 4. 5. 6. 7. 8. • • • • Employee’s name Job position List of routine activities List of non-routine activities Key performance indicators Skills required Competency assessment per skill (use score ratings) Recommendation for training Employees fill in columns 1 to 4 Manager fills in columns 5 to 8 Benefits: Manager can identify work redundancies, activity gaps, competency gaps, need for training and maybe the need to reengineer the work processes Output: ? 5S Program for work environment management SEIRI SEITON SEISO SEIKETSU SORT SET IN ORDER SHINE STANDARDIZE SHITSUKE SUSTAIN Product realization processes Clause 7.1 Planning of product realization • The organization shall plan and develop the processes needed for product realization, in terms of a) quality objectives and requirements for the product b) the need to establish processes and documents, c) providing resources specific to the product d) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance e) records needed to provide evidence that the realization processes and resulting product meet requirements Clause 7.1 Create a Quality Plan • With the following contents: a) Assigned responsibilities (who’s doing what) b) Quality objectives (productivity/quality targets) c) Customer requirements/Product characteristics, features, etc. d) References to procedures to control production/creation, storage, release, delivery, etc. e) Required resources- HR, materials, equipment, etc. f) Required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance g) Types of records needed to provide evidence that the realization processes and resulting product meet requirements What’s a Plan? Duties and responsibilities KPI & Quality objectives SOP’s and records Description of activities Flow of activities PLAN Required physical resources Quality control activities Output description Clause 7.2 Determination of customer requirements Customer related process Review of customer requirements Customer communication Planning Clause 7.3 Create a Design Plan Input Output Design & development Review Verify • This clause can be excluded from your QMS if you don’t design the your products Validate Control of changes Design & development • • Review activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives • Verification confirmation, through the provision of objective evidence, that specified requirements have been fulfilled • • Validation confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled Design & development • • Review activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives • Verification confirmation, through the provision of objective evidence, that specified requirements have been fulfilled • • Validation confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled Clause 7.4 PURCHASING Purchasing process Purchasing information Verification of purchased product PLAN Determine purchase requirements Issue RFQ DO Evaluate quotes CHECK Issue PO ACT Inspect DO Assess supplier’s performance • Keep records of your purchase orders, suppliers’ quotations & delivery orders and inspection forms for purchased products. Monitor, measure and analyze their performance (only those who supply materials/equipment/services used within the product creation process Clause 7.5 - Create a Production/Service Plan Production & service provision Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer property Preservation of product Clause 7.6 Control of monitoring and measuring equipment • The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements. • Calibrate the monitoring and measuring equipment at suitable intervals. • Verify the monitoring and measuring equipment at suitable intervals. • Segregate those equipment which are not calibrated yet or not used within the process. Tag or cage them. • This clause can be excluded from your QMS if you don’t use such equipment in your product creation process. Product realization process controls a) Quality Plan – to document how you intend to meet your customers’ requirements b) Customer & Legal Requirements c) Customer complaints handling procedure d) Design Plan e) Purchasing Procedure f) Production/Service Plan g) Monitoring & Measuring Equipment Plan (can be included in Production/Service Plan) Clause 8 Measurement, analysis and improvement • The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed a) b) c) to demonstrate conformity to product requirements, to ensure conformity of the quality management system, and to continually improve the effectiveness of the quality management system. • This shall include determination of applicable methods, including statistical techniques, and the extent of their use. Why monitor and measure? • If you cannot measure it, you cannot improve it. Lord Kelvin • Measurements provide you with a baseline to improve upon. What do you measure? 1. Customer satisfaction (Survey, returns rate, complaints, lost business, etc) 2. Process conformance and effectiveness (internal audit) 3. Process performance (Key Performance Indicators and quality objectives) 4. Product characteristics (QC inspection before release to customer) where nonconforming products must be controlled Clause 8.3 Control of nonconforming products Where applicable, the organization shall deal with nonconforming product by one or more of the following ways: a) by taking action to eliminate the detected nonconformity; b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; c) by taking action to preclude its original intended use or application; d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started. Internal audit process Establish annual audit schedule Distribute Audit Plan Perform audit Report findings Follow-up actions • Purpose is to verify whether your QMS a) b) c) d) Conforms to your Quality Plan, Conforms to ISO 9001 requirements, Conforms to your QMS requirements, and is effectively implemented and maintained. Audit defined • Audit is a systematic and documented process for gathering audit evidence and evaluating it against the audit criteria to determine whether it has been fulfilled • Audit criteria is a set of policies, procedures or requirements • Audit evidence is records, statements of fact or other information which are relevant to the audit criteria and verifiable • Audit conclusion is the outcome of an audit provided by the audit team after consideration of the audit objectives and all audit findings • What to ask? • What records to inspect? • What activities to observe? 1. Remember your purpose is to verify conformance and effectiveness against a specific requirement. 2. That requirement may come from the ISO 9001 Standard, your Quality Manual, SOP, etc. 3. So the answer depends on what audit criteria you want to verify 4. Remember, your job as an auditor is to look for the audit evidence, that’s all 5. So use the ISO 9001 Audit Checklist and start auditing. Audit methodology a) Interviewing the auditee b) Inspection of documents and records, etc. c) Observation of ongoing activities What do you analyze? • Analyze what you measured: a) Customer satisfaction levels b) Internal audit results c) Product QC inspection results d) KPI results e) Suppliers’ performance. How do you analyze? • Line Chart/Trend Chart/Control Chart - used to detect trends and unusual activities within the data set, • Pareto Chart Analysis - used to analyze the different components that make up the data value in a descending order, complete with the cumulative percentage line superimposed on it, • SWOT Analysis - used to analyze process strengths, weaknesses, opportunities and threats based on the characteristics of the data set - whether internal or external, • Arithmetic average or mean - used to identify the average performance value of the process, • Median - used to identify the actual middle value of the data set, • Mode - used to identify the most frequent value occurring within the data set, • Range - used to identify the difference between the lowest and highest values , • Standard deviation – used to identify the SD from the mean • Cause and Effect Analysis - used to analyze the causes and effects of a given data set, • Risk Analysis - used to identify potential risks given the data set Trend chart Use it to identify potential problems Errors 12 10 8 6 4 2 0 What caused this spike? Pareto Principle • • • • 20% of the causes contributes to 80% of the effects • Analyze your sales Identify and classify figures and identify all problems the contributors Calculate cumulative • Focus your efforts on occurrences up to customers who 80% contribute 80% of Focus on solving those sales those problems • Focus your efforts on Continually improve the sales personnel who are managing the management of those customers those causes Joseph M. Juran suggested the principle and named it after Italian economist Vilfredo Pareto, who observed in 1906 that 80% of the land in Italy was owned by 20% of the population; he developed the principle by observing that 20% of the pea pods in his garden contained 80% of the peas. What to improve? • The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. • All nonconformities require corrective actions • All potential nonconformities require preventive actions. Corrective action process Detect nonconformity Report nonconformity Review nonconformity against criteria Evaluate need for corrective action Perform root cause analysis Issue CAR Implement corrective action Record the results of actions taken Verify effectiveness of actions taken Preventive action process Detect potential nonconformity Report potential nonconformity Review against criteria Evaluate need for preventive action Perform root cause analysis Issue PAR Implement preventive action Record the results of actions taken Verify effectiveness of actions taken Risk analysis Performing a risk analysis on your business processes can help you detect potential nonconformities • Describe the risk • Describe the potential effects • Quantify likelihood of occurrence (consider frequency) • Quantify severity of consequence (consider harm or damage) • Assign risk rating (likelihood x severity) • Risk rating > 4 shall be controlled (ALARP = as low as reasonably practicable) Score ratings 1 = very low 2 = low 3 – moderate 4 = high 5 = very high Root cause analysis causes Root cause Effect effect Effect Direct cause Sources of direct causes: 1. Human error, 2. Material defect, 3. Equipment malfunction, 4. Ineffective methods of operation or control, or 5. Flawed management policies. Nonconformity Nonconformities • Don’t fear them because – We detect and report them because we don’t want them to recur – We report and record them because we want to document the improvements made to the QMS ISO 9001 Certification • Performed by independent Certification Body, such as SIRIM QAS, BVQI, LRQA, SGS • Client gets a renewable 3-year certificate • Phase 1 audit = Adequacy audit = Documentation audit • Phase 2 audit = Conformance audit = Physical audit of personnel, records and processes ISO 9001 Certification • First year = Certification audit • 2nd year = Surveillance audit • 3rd year = Surveillance audit and/or recertification audit • If after 3 months, nonconformities were not corrected (via the corrective action procedure) by the client, the ISO 9001 certificate will be revoked by the CB. • Decide if ISO 9001 is for you • Purchase the standard online • Purchase a Quality Manual template • Appoint a Management Representative • Appoint a QMS Committee • Read the ISO 9001 Standard and the Quality Manual • Plan your QMS by customizing the Quality Manual • Plan and implement every clause within the Quality Manual Plan of action Hope you benefited from that presentation
© Copyright 2024