BSI documentation for iso 9001-2015.pptx

documentation for quality management systems standard

1. B ritish S tandard I nstitution Learning Academy ISO 9001:2015 INTERPRETATION & DOCUMENTATION COURSE 8-9 Oktober 15 Dewi Almitrasari Lead Auditor & Trainer

2. Learning Objectives Have the skills to develop documentation : process mapping documented information such as procedure and supporting document ……QMS shall establishing the documented information for the effectiveness (Clause 7.5, ISO FDIS 9001:2015) The history and development of ISO/FDIS 9001 What is a Quality Management System (QMS) The benefits of a QMS The terms and definitions used Key concepts, principles and structure The main requirements of ISO/FDIS 9001:2015 and how to implement KNOWLEDGE SKILLS

3. Solution & Result... 8/26/16 1 2 3 4 Overview Knowledge Identification Documentation The Need for Quality Management System Understanding the requirements of the standard is your essential starting point to working with a management system. Develop your expertise to identify the document and other to comply the requirement Discover how you can develop the documentation system training journey to excellence... ( 2 days course)

4. Principle of QMS Terminology (Workshop 1) Concept of Quality Closing Module 1 Module 3 ISO 9001 - General Introduction Training Agenda 2 days Course Module 2 Overview   Historical of ISO 9001 ISO 9000, ISO 9001 & ISO 9004 Module 4 Interpretation & Documentation of Context Organisation   Interested Party Scope Process Mapping (Workshop 2) Module 7 Interpretation & Documentation of Resources   People Infrastructure Process Environment Monitoring & Measurement Knowledge Management) Competence Awareness Documented Information (Workshop 4 Module 5 Interpretation & Documentation of Leadership   Commitment Quality Policy Role & Responsibility Module 8 Interpretation & Documentation of Operation   Planning and provision of services ( (Workshop 5 ) Control of external providers Release & Control of Non Conforming Module 9 Interpretation & Documentation of Performance Evaluation   Customer Satisfaction Internal Audit Management Review Module 10 Interpretation & Documentation of Improvement   Improvement Nonconformity & Corrective action Continual Improvement) Module 6 Interpretation & Documentation of Planning   Risk Management (Workshop 3) Quality Objective Management of Change

5. Concept of Quality 1

6. 6 MUTU

7. Quality Management / Manajemen Mutu Quality Assurance / Jaminan Mutu Quality Control / Kendali Mutu Quality ? Mutu ?

8. Apa itu Mutu ?

9. Evolusi Sistem Manajemen Mutu Non Quality Culture Quality Inspection Quality Control Time Q Performance ZERO DEFECT ZERO DEFECT CONTINUOSLY ZERO DEFECT CONTINUOSLY & CUSTOMERS SATISFCATION Quality Assurance CUSTOMERS SATISFCATION CONSISTENTLY QUALITY MANAGEMENT (ISO 9001:2008) ZERO DEFECT CONTINUOSLY & INTERESTED PARTIES SATISFCATION (ISO 9001:2015) SUSTANAIBILITY COMPLIANCE PERFORMANC E

10. comprehensive portfolios ensure your corporate reputation remains secure

11. Key terms and definitions BS EN ISO 9000 BSI British Standards Quality management systems – Fundamentals and vocabulary Management ? “Coordinated activities to direct and control an organization ” Quality Management ? “Management with regard to quality ” Quality Management System ? “ Management system with regard to quality ”

12. Workshop 1a 15 minutes Click here to start Terms and Definitions

13. Sistem manajemen Integrasi dari keseluruhan sistem manajemen yang meliputi struktur organisasi, rencana kegiatan, tanggung jawab, prosedur, proses dan sumber daya untuk pengembangan, penerapan, pencapaian dan pemeliharaan kebijakan atau arah perusahaan/organisasi. VISI

14. VISI & MISI Plan Do Check Action KEBIJAKAN SASARAN/TARGET STRATEGI SISTEM DOKUMENTASI PENERAPAN PROGRAM PEMANTAUAN, EVALUASI & TINDAK LANJUT Kemana tujuan kita ? Uraian dari visi & misi ? Indikator pencapaian visi & misi ? Rencana Manajemen Mutu Metode pencapaian sasaran : prosedur, juklak, juknis, form dll

15. Mengapa kita perlu sistem ?

16. Integrasi = Keterkaitan TUJUAN SASARAN MUTU PROSES DOKUMENTASI

17. Personel Tg . Jawab&wewenang Kompetensi / Kualifikasi Pelatihan Record Ketersediaan Peralatan Kebutuhan Ketersediaan Kemampuan Pemeliharaan Kondisi PROSES Kondisi lingkungan Penetapan Pengelolaan Material Spesifikasi Ketersediaan Penyimpanan Pengadaan Informasi/Metode Kebutuhan Spesifikasi Akurat Analisa Komunikasi Ketersediaan VISI HARAPAN CUSTOMER KEBIJAKAN & SASARAN, PROGRAM PLAN DO ACTION CHECK

18. Pengukuran efektifitas sistem manajemen mutu Sasaran mutu organisasi Hasil pencapaian % 100 75 50 25 0 Peningkatan

19. Management Principle 2

20. Key concepts : Management Principles

21. “Organisasi tergantung pada pelanggan” Kepuasasn Pelanggan !!! “Persyaratan Pelanggan” Menetapkan harapan pelanggan sekarang dan akan datang ” Prinsip 1: Customer Focus / “Fokus Pelanggan”

22. Prinsip 2: Leadership / Kepemimpinan Pemimpin harus menetapkan keseragaman tujuan dan arah organisasi. Harus menciptakan kesadaran semua orang untuk ikut serta terlibat mencapai sasaran

23. Setiap orang di setiap level adalah bagian penting dari organisasi. Keterlibatan penuh dari karyawan sangat menguntungkan bagi organisasi. Prinsip Ke-3 Engagement of people

24. Hasil yang diinginkan dapat dicapai lebih efisien bila sumber daya dan kegiatan yang terkait dikelola sebagai suatu proses . Identifikasi , pemahaman dan pengelolaan suatu sistem dari proses-proses yang saling berhubungan untuk mencapai sasaran yang ditetapkan meningkatkan efektifitas dan efisiensi organisasi . Prinsip Ke-4 Pendekatan proses

25. Key concepts : Process Approach A C oherent System: Understanding requirements Intended results Consistent, predictable results Meeting requirements Customer satisfaction Activities understood and managed as interrelated processes Processes adding value Processes providing effective performance Improvements (through evaluation) of data/information PDCA (process) methodology (Fig. 2) (Interactions) ( Outputs) (Inputs) Process

26. Peningkatan berkelanjutan haruslah menjadi sasaran tetap dari organisasi Prinsip Ke-5 Peningkatan

27. Pengukuran efektifitas sistem manajemen mutu Sasaran mutu organisasi Hasil pencapaian % 100 75 50 25 0 Peningkatan

28. Keputusan yang efektif adalah yang berdasarkan pada analisa terhadap data dan informasi. Prinsip Ke 6 Pendekatan Fakta / bukti untuk keputusan

29. Organisasi dan pemasoknya selalu tergantung satu sama lain dan hubungan yang saling menguntungkan meningkatkan kemampuan dari kedua belah pihak untuk menghasilkan nilai tambah yang lebih besar. Prinsip Ke-7 Relationship Management

30. Workshop 1b 15 minutes Click here to start Quality Management Principle

31. ISO 9000 Family 3

32. ISO 9001 – History BS 5750: Part 1 : 1987 ISO 9001 – 1987 EN 29001 - 1987 British Standard Quality systems Part 1. Specification for design/development, production, installation and servicing BSI BS 5750: Part 2 : 1987 ISO 9002 – 1987 EN 29002 - 1987 British Standard Quality systems Part 1. Specification for production and installation BS 5750: Part 3 : 1987 ISO 9003 – 1987 EN 29003 - 1987 British Standard Quality systems Part 1. Specification for final inspection and test BSI D & D Pellentesque mollis felis dolor, quis aliquet sapien dapibus tempus lectus. Nulla sed posuere velit, ut gravida nibh.

33. ISO Standards for Q uality M anagement BS EN ISO 9004 BSI British Standards Managing for the sustained success of an organization — A quality management approach BS EN ISO 9000 BSI British Standards Quality management systems – Fundamentals and vocabulary BS EN ISO 9001 BSI Standards Publication Quality Management systems – Requirements

34. Evolusi Seri ISO 9000 Sejarah perubahan ISO 9001: 1 st edition : ISO 9001:1987 ISO 9002:1987 ISO 9003:1987 2 nd edition : ISO 9001:1994 ISO 9002:1994 ISO 9003:1994 3 rd edition : ISO 9001:2000 4 th edition : ISO 9001:2008 BS 5750 Part 2:1979 5 th edition : ISO 9001:2015 release 9 Sep. 2015 BS EN ISO 9004 BSI British Standards Managing for the sustained success of an organization — A quality management approach BS EN ISO 9000 BSI British Standards Quality management systems – Fundamentals and vocabulary BS EN ISO 9001 BSI Standards Publication Quality Management systems – Requirements

35. Accredited Certification Accreditation Body Certification Body Organization Accredits BSI , or esteemed competitor UKAS, or equivalent local national body Personnel Certification Body eg IRCA Auditor User Audits Certificates Training Course, Tutor, Training Body Accredits Trains International Accreditation Forum Certified once, accepted everywhere Establishes Multilateral Recognition Arrangements Mandatory Documents

36. Receive Manual & Procedure Stage 1 Audit Corrective Actions Pre- Audit Corrective Action Stage 2 Audit Corrective Actions Follow-up audit 6-monthly Surveillance Audit Corrective Actions Follow-up audit 3 year major Y Renewal Certification Process CERTIFICATION PROCESS – ISO 9001 Min. 3 weeks before audit OPTIONAL major major Max. 3 months N Y Y Max. 3 months

37. Clause of ISO 9001:2015 8/26/16 1 2 3 4 5 6 7 8 9 10 Scope Normative references Terms and definitions Context of the organization Leadership Planning Support Operation Performance evaluation Improvement 1 2 3 4 5 6 7 8 9 10

38. Scope Normative references Terms and definitions cites ISO 9000:2015 Quality Management Systems – Fundamentals and vocabulary as indispensable for its application this particular Management System Standard (MSS) is addressed, and this includes the ‘intended result(s)’ of the application of this Standard. These have already in the main been addressed through the promotion of the process approach, namely: Consistent provision of products and services that meet customer and applicable statutory and regulatory requirements (legal requirements) ‘ Intended outcome’ is that which is ‘intended’ as a result of the application of the standard, or process etc. ‘Expected outcome’ is that which is ‘expected’ by interested parties

39. Context of Organisation Clause 4 - ISO 9001:2015 4

40. Clause 4: Context of the Organization (1) Understanding the organization and its context

41. Understand the ‘Context of your Organization’ Intended result(s) of QMS Requirements of these interested parties Purpose and strategic direction Boundaries and applicability (Scope) External and internal issues Interested parties relevant to the QMS Organization Products and services Applicability Determine:

42. Clause 4: Context of the Organization (2) 4.2. Understanding the needs and expectations of interested parties Citizens Customers Distributors Shareholders Investors Owners Insurers Government Regulators Recovery service suppliers The Organization Management Top Management Those accountable for Quality policy and implementation Those who implement and maintain the QMS Those who maintain QMS and risk procedures Other Staff Contractors Competitors Media Commentators Trade groups Neighbors Pressure groups Emergency services Other response agencies Transport services Staff dependents

43. Clause 4: Context of the Organization (3) 4.3. Determining the scope of the QMS 4.4. QMS and its Processes

44. Organisasi harus : mengidentifikasi proses-proses yang diperlukan menetapkan tahapan dan interaksi dari proses-proses menetapkan kriteria dan metoda untuk menjamin operasi dan pengendalian menjamin ketersediaan dari sumber daya dan informasi memonitor , mengukur dan menganalisa proses-proses menerapkan tindakan yang dibutuhkan untuk mencapai hasil yang direncanakan dan peningkatan berkesinambungan . Peta Proses 4.4. QMS and its Processes

45. Key concepts : Process With what? (resources) Outputs? (what, t o whom) What results? (monitoring, measurements, p erformance i ndicators) Inputs? (what, from whom) How done? (criteria, methods/controls d ocumentation) With who ? (responsibilities, a uthorities) PROCESS

46. Key concepts Process Approach A C oherent System: Understanding requirements Intended results Consistent, predictable results Meeting requirements Customer satisfaction Activities understood and managed as interrelated processes Processes adding value Processes providing effective performance Improvements (through evaluation) of data/information PDCA (process) methodology (Fig. 2) (Interactions) ( Outputs) (Inputs) Process

47. Representation of the structure of this International Standard in the PDCA cycle Leadership (5) Support and Operation ( 7,8) Improvement (10) Planning (6) Performance evaluation (9) Plan Do Check Act Quality Management System (4) Organization and its context (4) Customer requirements Needs and expectations of relevant interested parties (4) Customer satisfaction Products and services Results of the QMS

48. Contoh Generik Business Process Business process mapping sebagai peta aliran fungsi untuk menjelaskan interaksi antar fungsi dan menjadi fondasi dalam menetapkan key performance indikator yang efektif dengan berlandaskan kaidah “next process is our customer” dan kaidah “quality built by every proceses within organization”

49. Contoh Generik Context Diagram Context Diagram adalah menjadi landasan penyusunan prosedur yang efektif. Prosedur yang efektif adalah prosedur yang dibangun bukan berdasarkan klausul ISO tapi sebuah prosedur yang disusun dari nature of business proses organisasi yang disempurnakan untuk memastikan compliance dengan ISO Requirement.

50. Business Process Order Processing Logistics Litbang Planning Umum QA, MR CP-01 CP-02 PP-01 RID-01 SP-01 SP-02 SP-03 WI-XX-01 (Penerimaan Mhs baru ) WI-XX-02 (Pembuatan Kartu Tanda Peserta Test )

51. <Process > < Procedure> < W.I. > Human resource management process Equipment control procedure Purchasing procedure Production procedure Inspection procedure Purchasing information control instruction Supplier evaluation criteria Products inspection criteria Purchasing criteria Inquiry, negotiation and comparison of price Sales marketing process Production management process Design and research process Financial management process ISO 9001 Quality Management System Structure of quality management system and documentation Sample 1

52. Contoh MATRIKS KORESPONDENSI "DOKUMENTASI - STANDARD" No Departemen / Proses Nama Dok. No Dok. Klausul ISO 9001 Prosedur Regulasi …….                                                        

53. Leadership Clause 5 - ISO 9001:2015 5

54. 5.1 LEADERSHIP & Commitment

55. 5.2 Kebijakan Mutu

56. Planning Clause 6 - ISO 9001:2015 6

57. Clause 6: Planning for the QMS Plan actions to address risks and opportunities Determine risks and opportunities 4.1 9.2 6.1 6.1 Issues 6.1. Actions to address risks and opportunities 6.2. Quality objectives and planning to achieve them 6.3. Planning of changes

58. One can “slice and dice” these multiple dimensions of risk* Portfolio Concentration Risk Transaction Risk Counterparty Risk Issuer Risk Trading Risk Gap Risk Equity Risk Interest Rate Risk Currency Risk Commodity Risk Risks Operational Risk Reputational Risk Business and strategic risks Market Risk Credit Risk “Specific Risk” General Market Risk Issue Risk

59. Threat map

60. Business Risk Assessment Process Identify Risk Assessment of Risk Assessment of Controls Business Management Understand and analyse the business Assess business risk Assess implemented risk control Strategy Planning Implementation Monitoring Improvement Focus on strategic issues Prioritising of critical risk Improved internal control Managed Business

61. Risk context, assessment and treatment Relevant Issues (from context) red = -ve green = +ve Risk Identification Risk Analysis Risk Evaluation Risk Treatment Residual risk Neighbourhood disruption in street cabling New fibre technology available Workforce retention Share holders: Stock market crash Economic – Significant effect on profit objectives and liquidity if share price collapses Impact significant but likelihood unknown (high uncertainty) Unable to qualify as likelihood unknown Subscribe to Economic indicators service for horizon scanning economic conditions and global trends Unknown pending horizon scan. Re-evaluate on report receipt. Tolerate risk . Transfer emergency funds to holding company

62.             SAMPLE - LIST OF RISK ITEMS Design Engineering Risks Procurement Risks HSE Risks Project Management Risks Organizational Risks Terms & Conditions Contract Risks FEED Docs in ITB Docs are not detail and incomplete additional some procentage for Bill of Quantity calculation may required. RFQ & RFP documents are not clear such as : Scope of Supply, Data Sheet, Bill of Quantity, Specification, Test Witness, Chemical /Oil/Grease Supply, Spare Part For Commissioning & 2 Years Operations, engineering document should be supply, Fabrication Schedule, Packaging Specification, General Condition, etc are not clear. HSE Project Plan Implementation. High standard will impact to project cost and schedule Project purpose and need is not well-defined Inexperienced staff assigned Refer To Legal Analysis on Draft of Contract from Legal Department or Refer to Analysis from Contract Engineer Plot Plan, P&ID, One Line Diagram & Hazardous Area Change Critical Items and Very tight Schedule that need special attentions Risk Register and Risk Management Execution are not well done since Engineering Design Stage. Project scope, schedule, objectives, cost, and deliverables are not clearly defined or understood Losing critical staff at crucial time of the project   Inaccurate assumptions on technical issues in planning stage Increase in material cost due to market forces Environmental analysis (AMDAL) incomplete Unreasonably high expectations from stakeholders Insufficient time to plan   Surveys incomplete Political Situation is unstable, War, Riot, Embargo Environmental regulation or local regulation is not Clear or Changed Vendor or contractor delays Unanticipated project manager workload   Changes to Capacity, Materials or Specification Economic is Unstable, Depression, Inflasion, Currency Rate is unstable, Oil Price is unstable or increase. Construction Waste Treatment Availability Estimating and/or scheduling errors Internal “red tape” causes delay getting approvals, decisions   SIL, HAZID & HAZOP Study have potensial to add more materials, instrument & equipments. Disaster, Climate, High/Low Tide and Other Nature Conditions. Availability of project data and mapping at the beginning of the environmental study is insufficient Unplanned work that must be accommodated Functional units not available, overloaded   Basic Engineering Design Data & Detail Engineering Design Data are wrong. Massive Development or Massive Construction in some country or Province that requires a lot of Cosntruction materials New information after Environmental Document is completed may require re-evaluation or a new document (i.e. utility relocation beyond document coverage) Lack of coordination/communication Lack of specialized staff or Skilled MP resources are limited.   P&ID and Plot Plan Review Meeting are not so carefully done so it does not find a crucial problem Loading & Unloading and Transportation Plan which need special attentions New alternatives required to avoid, mitigate or minimize impact Underestimated support resources or overly optimistic delivery schedule Overlapping of one or more projects   Don't Consider Operability, Maintainability & Constructability Import & Export Regulations are changed Design changes require additional Environmental analysis Inaccurate contract time estimates     Approval Procedure for Engineering Products is very long Procurement Planning & Control are wrong Unanticipated Noise, Air Quality and Waste impacts Unresolved project conflicts not escalated in a timely manner         Project causes an unanticipated barrier to wildlife Unanticipated escalation in right of way values or construction cost    

63. The FMEA Form Identify failure modes and their effects Identify causes of the failure modes and controls Prioritize Determine and assess actions A Closer Look

64. Workshop 3 45 minutes Click here to start Risk Management

65. 6.2. Quality objectives and planning to achieve them

66. Institusional objectives progressing Current Situation Objective and Effort of the whole institution Future Situation Risk Analysis Vision Mission Performance indicators Risk A Objectives A Risk B Objectives B Risk C Objectives C

67. Planning/implementing QMS changes (6.3), Controlling operational changes, planned and unintentional (8.1) Addressing unplanned changes affecting products & services (8.5.6) See also 7.1.6 Organizational knowledge - for addressing changing needs and trends, with respect to knowledge 6.3 . ‘Planning of Changes’

68. Resources Clause 7 - ISO 9001:2015 7

69. 7.1 – Resources Determine and provide the necessary resources including people, infrastructure, operational processes, and knowledge 7.2 – Competence Identify and maintain competence 7.3 – Awareness Make objectives known, and ensure awareness of QMS 7.4 – Communication What, when, how, who, and to whom 7.5 – Documented information Reflects variety of sources and need to back up information Clause 7: Support

70. 7.1.1. Organisasi harus menetapkan dan menyediakan sumber daya yang diperlukan organisasi harus menyediakan orang-orang yang diperlukan untuk efektifitas operasi dari sistem manajemen mutu , termasuk proses yang diperlukan . Organisasi harus menetapkan , menyediakan dan memelihara infrastruktur untuk operasi dari proses dalam mencapai kesesuaian produk dan jasa . Infrastruktur dapat mencakup : bangunan dan utilitas terkait ; peralatan termasuk perangkat keras dan perangkat lunak ; transportasi ; teknologi informasi dan komunikasi . Organisasi harus menetapkan , menyediakan dan memelihara lingkungan yang diperlukan untuk operasi dari proses untuk mencapai kesesuaian produk dan jasa . Lingkungan dapat mencakup fisik , sosial , psikologis , lingkungan dan faktor lainnya ( seperti suhu , kelembaban , ergonomi dan kebersihan

71. These need to be determined/provided to ensure valid and reliable results. Controls will include: suitable resources, maintenance, documented information, measurement traceability (if required) including: verification, calibration status, adjustment safeguards, and appropriate corrective action on equipment malfunction. 7.1.5 Monitoring and measuring resources Dimana pemantauan atau pengukuran yang digunakan untuk bukti kesesuaian produk dan jasa dengan persyaratan yang ditentukan , organisasi harus menentukan sumber daya yang dibutuhkan untuk memastikan kevalidan dan kehandalan dari hasil pemantauan dan pengukuran . Organisasi harus memastikan bahwa sumber daya yang disediakan : cocok untuk jenis tertentu kegiatan pemantauan dan pengukuran yang dilakukan ; dipelihara untuk memastikan kesesuaian tujuan mereka .

72. Defined as ‘available collection of information (meaningful data – facts about an object) being a justified belief and having a high certainty to be true’. This can include information such as intellectual property and lessons learned. The requirement here is to determine, maintain and make available (extent necessary) the knowledge necessary for the operation of its processes, AND to achieve conformity of products and services . Knowledge necessary to address changing needs and trends will also need considering, and how to acquire or access any additional knowledge necessary. Sources : (Internal) learning from failure/success, capturing knowledge of experts, etc. ( External) academia, standards, conferences, customers, external providers etc. 7.1.6. Organisational Knowledge

73. Other support Kompetensi (7.2) Kepedulian (7.3) Komunikasi (7.4) Organisasi harus : menentukan kompetensi yang diperlukan untuk orang (s) yg . melakukan pekerjaan di bawah kendalinya dapat mempengaruhi kinerja mutu ; memastikan bahwa orang-orang ini kompeten atas dasar pendidikan , pelatihan , atau pengalaman ; di mana berlaku , mengambil tindakan untuk memperoleh kompetensi yang diperlukan , dan mengevaluasi efektivitas tindakan yang diambil ; menyimpan informasi terdokumentasi sebagai bukti kompetensi . CATATAN tindakan Berlaku dapat meliputi , misalnya , penyediaan pelatihan , mentoring, atau re- assigment orang saat ini bekerja ; atau mempekerjakan / mengontrak orang yang kompeten . Orang yang melakukan pekerjaan di bawah kendali organisasi harus peduli terhadap : kebijakan mutu ; sasaran mutu yang relevan ; kontribusi mereka terhadap efektivitas SMM , termasuk manfaat dari peningkatan kinerja mutu ; implikasi ketidaksesuaian persyaratan sistem manajemen mutu Organisasi harus menetapkan komunikasi internal dan eksternal yang relevan dengan sistem manajemen mutu termasuk : pada apa yang akan dikomunikasikan ; kapan berkomunikasi ; dengan siapa berkomunikasi ; bagaimana berkomunikasi .

74. 7.5. Documented Information

75. 7.5. Documented Information

76. 8/26/16 85 7.5. Documented Information

77. Workshop 4 30 minutes Click here to start Documentation

78. Operational Clause 8 - ISO 9001:2015 8

79. Clause 8: Operation Operational planning and control Requirements for products and services Design and development of product‘s’ and services Production and service provision, including release Control of externally provided products and services Control of nonconforming process…

80. 8.1. Operational planning and control 8.1 Perencanaan dan Pengendalian Operasional Merencanakan, menerapkan dan mengendalikan proses yang diperlukan untuk realisasi produk. Perencanaan realisasi produk harus taat azas dengan persyaratan Menetapkan : Kriteria proses Kriteria keberterimaan produk dan pelayanan kebutuhan sumber daya Pengendalian proses antara lain aktifitas verifikasi , validasi , monitoring , measurement inspeksi dan test yang diperlukan spesifik teradap produk dan kriteria keberterimaan produk ; Informasi dokumen yang diperlukan termasuk rekaman diperlukan untuk menyediakan bukti bahwa proses-proses realisasi dan produk yang dihasilkan memenuhi persyaratan Pengendalian perubahan Pengendalian “outsource”

81. 8.2. Requirement for product and Services

82. 8.2. Requirement for product and Services

83. 8.2. Requirement for product and Services

84. 8.3.5. KELUARAN DISAIN & PENGEMBANGAN Sesuai Masukan Dapat diproses secara efektif dan efesien 8.3.4. PENGENDALIAN DISAIN & PENGEMBANGAN Evaluasi kemampuan pemenuhan persyaratan VERIFIKASI (Self-checking, Pemeriksaan oleh personel /Team yang independent , Metode pembanding ( Kalkulasi atau evaluasi design yang serupa ), Test , simulasi atau uji coba VALIDASI, Memastikan sesuai dengan keinginan Identifikasi masalah dan tindak lanjut 8.3.3. MASUKAN DISAIN & PENGEMBANGAN Persyaratan Pelanggan & Pasar Peraturan Disain sebelumnya Sumber daya (material, peralatan , Skill yang diminta , Evaluasi & pemeriksaan ) 8.3.6. . PENGENDALIAN PERUBAHAN Identifikasi Pengendalian dokumen terkait Informasi harus akurat & benar Komunikasi yang efektif Perubahan harus diverifikasi dan validasi 8.3.2. PERENCANAAN DISAIN & PENGEMBANGAN Tahapan proses tinjauan , verifikasi & validasi untuk setiap desain tanggung jawab & wewenang komunikasi dengan bagian terkait 8.3. Design & Development

85. 8.4. Control of externally provided products and services

86. 8.4. Control of externally provided products and services

87. 8.4. Control of externally provided products and services

88. 8.5.1. Pengendalian penyediaan produk dan pelayanan

89. Workshop 5 30 minutes Click here to start Process Identification

90. Organisasi harus : identifikasi produk dengan cara sesuai diseluruh realisasi produk , jika diperlukan identifikasi status produk berkaitan dengan persyaratan pengukuran dan pemantauan mengendalikan dan merekam identifikasi khas dari produk , bila mampu telusur dipersyaratka n 8.5.2. Identifikasi & Mampu Telusur

91. harus : diidentifikasi diverifikasi dilindungi dan dijaga milik pelanggan atau provider eksternal yang hilang , rusak atau karena suatu hal tak layak pakai harus direkam dan dilaporkan Property mencakup “ intelektual property” 8.5.3. property belonging to Customers or External providers

92. P reservasi kesesuaian produk selama proses internal dan penyerahan Mencakup : identifikasi penanganan pengemasan penyimpanan perlindungan bagian-bagian yang menjadikan produk 8.5.4. Preservasi

93. 8.5.5. Post Delivery Activities

94. 8.5.6. Control of Changes

95. 8.6. Release of Product and Services

96. 8.7. Control of NonConforming Output

97. Performance Evaluation Clause 9 - ISO 9001:2015 9

98. Clause 9 – Performance evaluation 9.1 – Monitoring, measurement, analysis and evaluation What needs to be monitored and measured, how and when 9.2 – Internal audit To establish whether the QMS conforms to requirements and is effectively implemented and maintained 9.3 – Management review Top management must regularly review the QMS

99. Clause 9 – Performance evaluation 9.1. Monitoring , measurement, analysis and evaluation 9.1.1 9.1.2 9.1.3 (General) (Customer satisfaction) (Analysis and evaluation) What needs to be monitored and measured, how and when

100. 9.1.2. Customer Satisfaction Faktor loyalitas pelanggan BASIC EXPECTED DESIRED UNANTICIPATED Faktor Kepuasan Standar minimun yg diterima Nilai rata-rata ( sama seperti jasa lainnya ) Apa yang diinginkan pelanggan Melebihi apa yang diinginkan pelanggan

101. Clause 9 – Performance evaluation 9.2. Internal Audit To establish whether the QMS conforms to requirements and is effectively implemented and maintained At planned intervals (status and importance) Ensure system conforms to planned arrangements Ensure system conforms to ISO 9001 Effectively implemented and maintained Follow-up actions Audit criteria, scope, frequency, methods defined in documented information

102. 9.3. Management Review Sistem harus ditinjau oleh top managemen : dalam interval yang direncanakan untuk menjamin berlanjutnya kesesuaian , kecukupan dan keefektivan untuk menilai kesempatan untuk peningkatan dan kebutuhan untuk perubahan sistem , kebijakan dan sasaran mutu

103. Management Review Previous actions/ status External/ internal issues N/C’s , corrective actions Monitoring / Measurement Audit results Customer satisfaction External providers Adequacy of resources CONSIDER: REVIEW Process performance Risks and opportunities Continual improvement (C.I) Opportunities ( C.I ) Changes to QMS Resource needs Doc. Information WHAT NEEDS TO CHANGE? ! !

104. Improvement Clause 10- ISO 9001:2015 10

105. Clause 10 : Improvement Improvement Nonconformity and corrective action Continual improvement

106. Improvement

107. What to evaluate ? Action Policy Critical Success Factor Measurement Program Data collected Responsibility Frequency Method Corrective Correction Improvement How to evaluate ? Analyze

108. Nonconformity and corrective action

109. QUALITY PROBLEM Operational Cost Customer satisfaction Result Non conformity Performance Health & Safety CORRECTIVE ACTION Coordination between function Caused identification Analysis & corrective action plan Follow up Implementation monitoring, efficiency and evaluation on its effectiveness POTENTIAL PROBLEMS CONTINUAL IMPROVEMENT PREVENTIVE ACTIONS Caused identification Analysis & preventive action plan Implementation Implementation monitoring, efficiency and evaluation on its effectiveness (Management Review) Continual improvement

110. Continual improvement