20200126-ISO 9001:2015-Eng.Dima Ayesh

Introduction to ISO 9001:2015 By: Eng. Dima Abdallah Ayesh

Outline Day Day 1 Subject What is Quality? Day 2 ,3,4 History of Quality Methodology Deming’s Principles Taguchi’s Contributions And Philosophy Total Quality Management Costs related to quality What is ISO? Evolution of the ISO 9000 series of Standards ISO 9001:2015 Standard.

What is Quality?

What does the word “quality” mean to you?  Think about your past experiences staying at various hotels. Did you stay at a “quality” hotel? What about the experience made it a “quality” experience for you?  Think about a product you bought. How can you define its “quality”?

Dimensions of Quality Garvin (1987) 1. Performance:  Will the product/service do the intended job? 2. Reliability:  How often does the product/service fail? 3. Durability:  How long does the product/service last? 4. Serviceability:  How easy to repair the product / to solve the problems in service?

Dimensions of Quality 5. Aesthetics:  What does the product/service look/smell/sound/feel like? 6. Features:  What does the product do/ service give? 7. Perceived Quality:  What is the reputation of the company or its products/services? 8. Conformance to Standards:  Is the product/service made exactly as the designer/standard intended?

Quality in different areas of society Area Examples Airlines On-time, comfortable, low-cost service Correct diagnosis, minimum wait time, lower Health Care cost, security Good product, fast delivery, good environment Food Services fast delivery, correct delivery, cost containment Postal Services Proper preparation for future, on-time knowledge delivery Academia Properly made, defect-free, cost effective Payoff on time, reasonable cost Consumer Products Rapid deployment, decreased wages, no graft Insurance Defect-free Military Clearer, faster, cheaper service Automotive Communications

What is Quality?  Conformance to specifications (British Defense Industries Quality Assurance Panel)  Conformance to requirements (Philip Crosby)  Fitness for purpose or use (Juran)  A predictable degree of uniformity and dependability, at low cost and suited to the market (Edward Deming)  Synonymous with customer needs and expectations (R J Mortiboys)  Meeting the (stated) requirements of the customer- now and in the future (Mike Robinson)  Tchhaeractteortisatlics comopfosite maprkroedtiuncgt, anedngineseerrvinicge, manufacturing and maintenance through which the product and service in use will meet the expectations by the customer (Armand Feigenbaum)

What is Quality?  “The degree to which a system, component, or process meets (1) specified requirements, and (2) customer or users needs or expectations” – IEEE  The totality of features and characteristics of a product or service that bears on its ability to satisfy stated or implied needs” – ISO 8402  Degree to which a set of inherent characteristics fulfils requirements – ISO 9000:2000

Definitions of Quality  Transcendent definition: excellence  Product-based definition: quantities of product attributes  User-based definition: fitness for intended use; meeting or exceeding user expectations  Value-based definition: quality vs. price  Manufacturing-based definition: conformance to specifications 10

More about Quality  Realistic but demanding STANDARDS;  Getting things RIGHT FIRST TIME; ‘It costs less to prevent a problem than it does to correct it’  Influences the relationship with CUSTOMERS;  Influences how COMPLAINTS are dealt with;  Something to do with how things LOOK and FEEL.

Modern Importance of Quality “The first job we have is to turn out quality merchandise that consumers will buy and keep on buying. If we produce it efficiently and economically, we will earn a profit.” - William Cooper Procter 12

History of Quality Methodology  Reach back into antiquity, especially into China, India, Greece and the Roman Empire : skilled crafstmanship.  Industrial Revolution (18th century): need for more consistent products that are mass-produced and needed to be interchangeable. Rise of inspection after manufacturing completed and separate quality departments. 13

History of Quality Methodology  Science of modern quality methodology started by R. A. Fisher perfected scientific shortcuts for shifting through mountains of data to spot key ccause-effect relationships to speed up development of crop growing methods.  Statistical methods at Bell Laboratories: W. A. Shewhart transformed Fisher’s methods into quality control discipline for factories (inspired W.E. Deming and J. M. Juran); Control Charts developed by W. A. Shewhart; Acceptance sampling methodology developed by H. F. Dodge and H. G. Romig 14

History of Quality Methodology  World War II: Acceptance of statistical quality-control concepts in manufacturing industries (more sophisticated weapons demanded more careful production and reliability); The American Society for Quality Control formed (1946).  Quality in Japan: W.E. Deming invited to Japan to give lectures; G. Taguchi developed “Taguchi method” for scientific design of experiments; The Japanese Union of Scientists and Engineers (JUSE) established “Deming Price” (1951); The Quality Control Circle concept is introduced by K. Ishikawa (1960). 15

History of Quality Methodology  Quality awareness in U.S. manufacturing industry during 1980s: “Total Quality Management”; Quality control started to be used as a mangement tool.  Malcolm Baldrige National Quality Award (1987)  International Standard Organization’s (ISO) 9000 series of standards: in 1980s Western Europe began to use; interest increase in US industry in 1990s; Became widely accepted today: necessary requirement to world-wide distribution of product and a significant competitive advantage. 16

History of Quality Methodology  Quality in service industries, government, health care, and education  Current and future challenge: keep progress in quality management alive  To sum up: A gradual transition Statistical Quality Quality Quality Assurance Management Control 17

Deming’s 14 Principles. 1. “Create Constancy of Purpose”  Define the problems of today and the future  Allocate resources for long-term planning  Allocate resources for research and education  Constantly improve design of product and service 2. “Adopt A New Philosophy”  Quality costs less not more  Superstitious learning  The call for major change  Stop looking at your competition and look at your customer instead 3. “Cease Dependence On Inspection For Quality”  Quality does not come from inspection  Mass inspection is unreliable, costly, and ineffective  Inspectors fail to agree with each other  Inspection should be used to collect data for process control

Deming’s 14 Principles. 4. “End Proactive Awarding Of Business Based On PriceAlone”  Price alone has no meaning  Change focus from lowest inital cost to lowest cost  Work toward a single source and long term relationship  Establish a mutual confidence and aid between purchaser and vendor 5. “Improve Every Process Constantly / Forever”  Quality starts qith the intend of management  Teamwork in design is fundamental  Forever continue to reduce waste and continue to improve  Putting out fires is not improvement of the process 6. “Institute Training”  Management must provide the setting where workers can be succesful  Management must remove the inhibitors to good work  Management needs an appreciation of variation  This is management’s new role

Deming’s 14 Principles. 7. “Adopt And Institute Leadership”  Remove barriers to pride of workmanship  Know the work they supervise  vKanroiwatitohne difference between special and common cause of 8. “Drive Out Fear”  The common denominator of fear:  Fear of knowledge  Performance appraisals  Management by fear or numbers 9. “Break Barriers Between Staff Areas”  Know your internal suppliers and customers  Promote team work 10. “Eliminate Slogans, Exhortations And Targets”  They generate frustration and resentment  Uwsoerkpoesntveirrsontmhaetnetxplain what management is doing to improve the

Deming’s 14 Principles. 11. “Eliminate Numerical Quotas”  They impede quality  They reduce production  The person’s job becomes meeting a quota 12. “Remove Barriers That Rob Pride Of Workmanship”  Performance appraisal systems  Production rates  Financial management systems  Allow people to take pride in their workmanship 13. “Institute Programs For Education And Self Improvement”  Commitment to lifelong employment  Work with higher education needs  Develop team building skills 14. “Put Everybody In The Company To Work For This Transformation”  Struggle over the 14 points  Take pride in new philosophy  Include the critical mass of people in the change

QUALITY DOES NOT OCCUR BY ACCIDENT  What does the customer actually want?  Identify, understand and agree customer requirements  How are you going to meet those requirements?  Plan to achieve them

Deming’s Cycle What are we trying to AIM accomplish? MEASURE How will we know that a change is an improvement? Selecting Change What change can we make that Plan will result in improvement? P Plan P Do P A AD D Act Do C A D C C Check Check

Taguchi’s Contribution  In the early 1980s, Prof. Genechi Taguchi introduced his approach to using experimental design for 1) Designing products or processes so that they are robust to environmental conditions. 2) Designing/developing products so that they are robust to component variation. 3) Minimizing variation around a target value.  By robust, we mean that the product or process performs consistently on target and is relatively insensitive to factors that are difficult to control.

Taguchi Philosophy  3 stages in a product’s (or process’s) development: 1) System design: uses scientific and engineering principles to determine the basic configuration. 2) Parameter design: specific values for the system parameters are determined. 3) Tolerance design: determine the best tolerances for the parameters.

Taguchi Philosophy  Recommends: statistical experimental design methods have to be used for quality improvement, particularly during parameter and tolerance design phases.  Key component: reduce the variability around the target (nominal) value.

Quality Management Quality Management System: Management system to direct and control an organisation with regard to quality – ISO 9000:2000 Quality Management Quality Planning Quality Assurance Quality Control Criteria driven Prevention driven Inspection driven

Quality Management Components  Quality Planning  It identifies the standards and determines how to satisfy those standards.  It lays out the roles and responsibilities, resources, procedures, and processes to be utilized for quality control and quality assurance.  Quality Assurance  It is the review to ensure aligning with the quality standards. An assessment will be provided here.  Planned and systematic quality activities.  Provide the confidence that the standards will be met.

Quality Control – Inspection Driven  Quality Control  It addresses the assessment conducted during Quality Assurance for corrective actions.  Measure specific results to determine that they match the standards.  Use of Statistical Process Control (SPC) : a methodology for monitoring a process to identify special causes of variation and signal the need to take corrective action when appropriate.  SPC relies on control charts.

Quality-related costs  Prevention costs  activities to keep unacceptable products from being generated and to keep track of the process  Appraisal costs  activities to maintain control of the system  Correction costs  activities to correct conditions out of control, including errors

Prevention costs  Quality planning and engineering  New products review  Product/process design  Process control  Burn-in  Training  Quality data acquisition and analysis

Appraisal costs  Inspection and test of incoming material  Product inspection and test  Materials and services consumed  Maintaining accuracy of test equipment

Correction costs 1. Internal Failure Costs:  Scrap  Rework  Retest  Failure analysis  Downtime  Yield losses  Downgrading (off-specing)

Correction costs 2. External Failure Costs:  Complaint adjustment  Returned product/material  Warranty charges  Liability costs  Indirect costs

Cost of implementing quality management, accreditation and quality assurance c correction o s quality management t and assurance total time

Internal and External Benefits of Quality Internal Benefits External Benefits Reduces costs Customer gets correct Increases dependability product or service Correct specifications Increases speed Appropriate intangibles Boosts moral Customer satisfaction Customer retention Increases customer retention Increases profit

Drawbacks  Long way to establish in the organisation  QM design not always fit for purpose (loss of cost effectiveness)  Substantial efforts  Maintain system, otherwise reject it.

What is ISO  International Organization for Standardization

Evolution of the ISO 9000 series of Standards  ISO 9000 Quality management systems – Fundamentals and vocabulary  ISO 9001:2015 Quality management systems – Requirements

The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard. 1987 version  ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three \"models\" for quality management systems, the selection of which was based on the scope of activities of the organization:  ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.  ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.  ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.  ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards (\"MIL SPECS\"), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management, which was likely the actual intent

1994 version  ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system.[2000 version

2000 version  ISO 9001:2000 replaced all three former standards of 1994 issue, ISO 9001, ISO 9002 and ISO 9003. Design and development procedures were required only if a company does, in fact, engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing front and center the concept of process management(the monitoring and optimization of a company's tasks and activities, instead of just inspection of the final product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.  ISO 9000 Requirements include:  Approve documents before distribution;  Provide correct version of documents at points of use;  Use your records to prove that requirements have been met; and  Develop a procedure to control your records.

2008 version  ISO 9001:2008 in essence re-narrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.  ISO 9001 is supplemented directly by two other standards of the family:  ISO 9000:2005 \"Quality management systems. Fundamentals and vocabulary\"  ISO 9004:2009 \"Managing for the sustained success of an organization. A quality management approach\"  Other standards, like ISO 19011 and the ISO 10000 series, may also be used for specific parts of the quality system.

2015 version  In 2012, ISO TC 176 - responsible for ISO 9001 development - celebrated 25 years of implementing ISO 9001 and concluded that it was necessary to create a new QMS model for the next 25 years.  They subsequently commenced the official work on creating a revision of ISO 9001, starting with the new QM principles. This moment was considered by important specialists in the field as \"beginning of a new era in the development of quality management systems.  As a result of the intensive work from this technical committee, the revised standard ISO 9001:2015 was published by ISO on 23 September 2015. The scope of the standard has not changed; however, the structure and core terms were modified to allow the standard to integrate more easily with other international management systems standards.  The new ISO 9001:2015 management system standard helps ensure that consumers get reliable, desired quality goods and services. This further increases benefits for a business.  The 2015 version is also less prescriptive than its predecessors and focuses on performance. This was achieved by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.

ISO 9001:2015

‫سلسلة مواصفات الايزو ‪9000‬‬ ‫‪ ‬كيف وضعت ‪ ..........‬و ما هي مراحلها ؟‬

‫في عام ‪ 1946‬اجتمع ممثلوا دول اتحاد ‪ ISA‬الاتحاد الوطني‬ ‫للاجهزه الوطنية للمواصفات القياسية ‪ ISA‬في لندن مع ممثلي‬ ‫هيئات التوحيد القياسي لبعض الدول مثل اميركا( بضمنها وكالة ناسا)‬ ‫واليابان وألمانيا وفرنسا وكندا و قرروا انشاء المنظمة العالمية‬ ‫للمواصفات و التقييس و التي تأسست رسميا عام ‪ 1947‬و تتمثل بما‬ ‫يلي‪:‬‬ ‫‪ ‬اتحاد لهيئات المواصفات و التقييس في الدول الاعضاء و كما‬ ‫ذكرنا سابقا ‪.‬‬ ‫‪ ‬العراق عضو دائم في هذه المنظمة انتمى سنة ‪. 1973‬‬ ‫‪ ‬تقوم المنظمة بإصدار مواصفات في جميع الاختصاصات‬ ‫الصناعية و الهندسية و الزراعية و غيرها ‪.‬‬

‫‪ ‬قامت المنظمة عام ‪ 1987‬بتشكيل اللجنة الفنية الرئيســــــية‬ ‫والتي تسمى بلجنة الايزو ‪:‬‬ ‫‪ISO/TC 176‬‬ ‫‪ ‬و ذلك بسبب زيادة الطلب على استخدام الموصفات و‬ ‫تطبيقها في الانشطة الانتاجية المختلفة ‪.‬‬

‫شروط اللجنة في المواصفات الموضوعة‬ ‫‪ -1‬وضوح المواصفة ويسهل فهمها وشفافة ‪.‬‬ ‫‪ -2‬التكامل في المضمون والمعنى مما يبعد اجتهادات الافراد‬ ‫‪ -3‬الواقعية أي سهلة التطبيق وان لا يقود تطبيقها الى رفع‬ ‫التكاليف وانحسا فرص المنتج او الخدمة عدا تكاليف التأهيل‪.‬‬ ‫‪ -4‬تحقق الربحية في تطبيقها وخفض التكاليف بالإنتاج ورفع‬ ‫كفاءة الاداء وزيادة حجم المبيعات ‪.‬‬ ‫‪ -5‬ملائمة المواصفة في التطبيق لفترة طويلة‬