History of ISO • IOS : The International Organization for Standardization • • • • • • IOS : ISOS (equally) -> ISO Establishment: 14 Oct, 1946 (2489) 25 countries had a meeting at London General assembly: Geneva, Switzerland Members > 137 countries TISI: Thai Industrial Standards Institute Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 History of ISO • Responsibility: – Support & development for trade/ service standard – Development & collaboration of Science & Technology, economic – Consumer policy • International Standard in 1987 – QMS : Quality Management System – Guideline from BS 5750 (UK) – ISO 9000 series – Revise every years Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 History of ISO • 1st Revision in 1994 – ISO 9000-1994 • 2nd Revision in 2000 – ISO 9001-2000 • 3rd Revision in 2005 – ISO 22000: 2005 (FSMS) – GMP/HACCP + ISO 9001 • 4th Revision in 2008 – ISO 9001-2008 (Nov., 2008) • 5th Revision in 2015 – ISO 9001-2015 (Sep., 2015) Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 ISO 9001-2000, 2008 • Quality Management System, QMS (Not product standard) • International standard • Can be use in all businesses • Involvement of people in organization • Requirements of quality standard • Continual improvement / flexible • System approach to management ISO 9001-2000/2008 (requirements) 1.Scope 2.Normative0Reference 3.Terms0and0Definition 4.Quality0Management0System 5.Management0Responsibility 6.Resource0management 7.Product0realization 8.Measurement,0analysis0and0improvement Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 ISO 9001-2000/2008 (requirements) Scope Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 4.10General0requirements 1.10General 1.20Application 4.20Documentation0requirements 4.2.10General 2.0Normative0References 4.2.20Quality0Manual J 4.2.30Control0of0document ISO$9000:2005,$Quality$management$systems$– Fundamentals$and$ vocabulary 4.2.40Control0of0records 3.0Terms0and0Definitions ? “Products”$can$also$mean$“Service” Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 5.10Management0commitment 5.20Customer0focus 5.30Quality0policy 5.40Planning 10 6.10Provision0of0resources 6.20Human0resources 6.2.10General 5.4.10Quality0objectives 5.4.20QMS0planning 6.2.20Competence,0training0and0awareness 6.30Infrastructure 5.50Responsibility,0authority0and0communication 5.5.10Responsibility0and0authority 5.5.20Management0representative 5.5.30Internal0communication 6.40Work0environment 5.60Management0review 5.6.10General 5.6.20Review0input 5.6.30Review0output Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 11 7.10Planning0of0product0realization 7.20CustomerJrelated0processes 12 7.40Purchasing 7.4.10Purchasing0process 7.2.10Determination0of0requirements0related0to0the0product 7.2.20Review0of0requirements0related0to0the0product 7.2.30Customer0communication 7.30Design0and0development 7.3.10Design0and0development0planning 7.3.20Design0and0development0inputs 7.3.30Design0and0development0outputs 7.3.40Design0and0development0review 7.3.50Design0and0development0verification 7.3.60Design0and0development0validation 7.3.70Control0of0design0and0development0changes Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 7.4.20Purchasing0information 7.4.30Verification0of0purchased0product 7.50Production0and0service0provision 7.5.10Control0of0production0and0service0provision 7.5.20Validation0of0processes0for0production0and0service0 provision0 7.5.30Identification0and0traceability 7.5.40Customer0property 7.5.50Preservation0of0product 7.60Control0of0monitoring0and0measuring0equipment Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 13 14 8.10General (4)0Continual0 improvement0of0QMS 8.20Monitoring0and0measurement 8.2.10Customer0satisfaction Customers 8.2.30Monitoring0and0measurement0of0processes 8.2.40Monitoring0and0measurement0of0product 8.30Control0of0nonconforming0product 8.40Analysis0of0data Management0 responsibility0(5) Resource0 Management(6) 8.50Improvement Requirements 8.5.10Continual0improvement 8.5.20Corrective0action Input Measurement,0 analysis0and0 improvement0(8) Product0 realization0(7) Output Customers 8.2.20Internal0audit Satisfaction 8.5.30Preventive0action Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 Implementation Step of ISO 9001 Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 15 Steering committee/QMR Evaluating quality system of organization Determining of Quality Policy Training for management & staff Preparing Quality Manual Implementation and practice Internal Audit Quality improvement and correction Pre-audit 10 External Audit Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 16 ISO 9001: 2015 Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 17 18 The introduction of a requirement to understand the “Context of the Organization” as well as the expectations of interested parties, as it impacts on the objective of the system which is to achieve customer satisfaction Leadership includes most of the existing “management responsibility” requirements Greater emphasis on “Planning”, which focuses on the identification of risks and opportunities as they impact on the scope of the system This removes the need for preventive action as defined in the 2008 version, but includes strengthened requirements for the management of change and risk management HLS = High Level Structure Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 19 “Support” includes most of the requirements of the previous clause – resource management but includes a new requirement to manage “organizational knowledge” TERMINOLOGY ISO 9001:62008 ISO 9001:62015 Products Products0and0services “Operations” replaces the previous Product realization clause but contains most of the previous requirements The intention is to make it more relevant to the service sector Documentation,0Records Documented0information Work0environment Environment for0the0operation0of0 processes “Performance evaluation” replaces the previous clause and withdraws the need for preventive action which has now been subsumed into clause Planning Purchased0product Externally provided0products0and0services Supplier External0provider Monitoring0and measuring0equipment Monitoring0and measuring0resources Management0representative Not used Exclusion Not0used 10.Increases the focus on “Improvement” and includes nonconformities and corrective action previously in clause Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 20 Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 21 ISO 9001: 2015 Concepts • • • • PDCA model Process approach concept Risk Base Thinking Annex SL- Standardised High Level Structure (HLS) Starting0point Source0of0 Inputs Inputs 22 Risk Base Approach - PDCA End0point Activities Outputs Receivers0of0 Outputs Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 23 ผศ.ดร.สุทัศน์ สุระวัง ผศ.ดร.สุทัศน์ สุระวัง PDCA in High Level Structure (HLS) 24 ผศ.ดร.สุทัศน์ สุระวัง 25 26 • ISO 9001 requirements encourage organizations to use more external focus in a broader risk-based approach to Quality Management • Adoption of the Annex SL framework will help with alignment and integration of other management system standards • Gives grater flexibility to individual organization’s QMS structure and content ผศ.ดร.สุทัศน์ สุระวัง Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 27 ISO 9001-2015 • In this International Standard, the following verbal forms are used: • “shall” indicates a requirement; • “should” indicates a recommendation; • “may” indicates a permission; • “can” indicates a possibility or a capability Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 28 Annex SL- Framework Scope Normative references Terms and definitions Context of the organization Leadership Planning Supporting Operation Performance evaluation 10 Improvement Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 29 Leadership 5.1 Leadership and commitment Scope Normative reference Terms and definition 5.1.1 Leadership and commitment for the QMS 5.1.2 Customer focus Context of the organization 4.1 4.2 4.3 4.4 Understanding the organization and its context Understanding the needs and expectations of interested parties Determining the scope of the quality management system Quality management system and its processes 5.2 Quality policy 5.3 Organizational roles, responsibilities and authorities Planning for the quality management system 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes Leadership 5.1 Leadership and commitment 5.1.1 Leadership and commitment for the quality management system 5.1.2 Customer focus 5.2 Quality policy 30 Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 31 Support Operation 7.1 Resources 7.2 7.3 7.4 7.5 7.1.1 7.1.2 7.1.3 7.1.4 7.1.5 7.1.6 32 8.1 Operational planning and control General People Infrastructure Environment for the operation of processes Monitoring and measuring resources Organizational knowledge 8.2 Requirements for products and services 8.2.1 Customer communication 8.2.2 Determination of requirements related to products and services 8.2.3 Review of requirements related to the products and services Competence Awareness Communication Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented Information Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 33 8.3 Design and development of goods and services 8.3.1 8.3.2 8.3.3 8.3.4 8.3.5 8.3.6 34 8.5 Production and service provision General Design and development planning Design and development inputs Design and development controls Design and development outputs Design and development changes 8.5.1 8.5.2 8.5.3 8.5.4 8.5.5 8.5.6 8.4 Control of externally provided products and services Control of production and service provision Identification and traceability Property belonging to customers or external providers Preservation Post-delivery activities Control of changes 8.6 Release of products and services 8.4.1 General 8.4.2 Type and extent of control of external provision 8.4.3 Information for external providers 8.7 Control of nonconforming process outputs, products and services Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 35 Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 Annex SL- ISO 9001: 2015 36 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 9.2 Internal audit 9.3 Management review 10 Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual Improvement Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 ISO 9001:2015 Model 37 • • • • • • • • • • • • Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 ISO Terminology • • • • • • • • • • • • 39 ISO Terminology 38 QMS (Quality Managent System) FSMS (Food Safety Management System) QMR (Quality Management Representative) PRP (pre-requisite program) OPRP (Operational Pre-requisite Program) Quality Policy Quality manual / Procedure / Work instruction (WI)/ SD Validation (การยืนยัน หรือรับรองสภาพความใช้ได้) Verification (การทวนสอบ) Mornitoring (การเฝ้าระวัง หรือ การตรวจติดตาม) Calibration (การสอบเทียบ) Audit (Internal audit / External audit / third party audit) Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 40 Recall (การเรียกคืนสินค้า) Withdrawal (การถอดถอนสินค้า) Correction (การแก้ไข) Corrective action (การปฏิบัตกิ ารแก้ไข) Certification Body (CB) Accreditation Body (AB) CAR (Corrective Action Request) DAR (Document Action Request) Outsource (ผู้รับจ้างภายนอก- part of production process) Subcontactor (ผู้รับเหมาช่วง-services) OEM (Original Equipment Manufacturer) CSR (Corporate Social Responsibility) Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001 Asst.Prof.Dr.Suthat Surawang-NLU-QA-05-ISO 9001