Systematic process improvement using ISO 9001:2000 and CMMI

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74 Revised Frameworks: ISO 9001:2000 and the CMMI ® Customer-related processes (7.2) 7.2.1 Determination of requirements related to the product 7.2.2 Review of requirements related to the product 7.2.3 Customer communication The customer-related processes addressed here start by identifying the applicable requirements. Obviously, the requirements explicitly identified by the customer are included, but this category also includes implied requirements, regulatory requirements, and self-imposed requirements of the quality management system. Reviewing the requirements ensures that they are understood and that the organization has the capability and capacity to meet those requirements. Records of reviews, assumptions, and conclusions must be maintained and communicated to the customer. Design and development (7.3) 7.3.1 Design and development planning 7.3.2 Design and development inputs 7.3.3 Design and development outputs 7.3.4 Design and development review 7.3.5 Design and development verification 7.3.6 Design and development validation 7.3.7 Control of design and development changes The design and development clauses cover a broad range of processes needed to realize the product. They begin with determination of the steps needed for design and development, including designation of responsibility and authority for each step. Required inputs and planned outputs must be defined. During design and development, the outputs of each step are reviewed to ensure that appropriate progress is being made toward satisfying requirements and that activities are proceeding in accordance with plans. Changes made during these activities must be controlled, recorded, and communicated. Changes may result from new customer requirements, dis-
4.1 ISO 9001:2000 75 covery of errors, or altered business circumstances, but they are virtually inevitable. Purchasing (7.4) 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product The selection of vendors is made using a systematic process. Potential suppliers are evaluated according to their ability to meet requirements. Evaluation and selection criteria must be defined to ensure that selection is not made strictly on the basis of price when other criteria are important. Interestingly, the standard directs that the degree to which the supplier is controlled should depend on the impact of that supplier’s product on design and development activities and the final product. Purchasing activities also include verification that the purchased product meets its requirements. Production and service provision (7.5) 7.5.1 Control of production and service provision 7.5.2 Validation of processes for production and service provision 7.5.3 Identification and traceability 7.5.4 Customer property 7.5.5 Preservation of product The infrastructure for controlling production must be in place. This infrastructure includes, for example, procedures, work instructions, equipment, measuring devices, and product information. Raw material, parts, work-in-progress, and finished goods must be identified and traceable. Customer-provided equipment, information, or data must be identified and safeguarded. Control of monitoring and measuring devices (7.6) Requirements for monitoring and measurement must be specified. The devices used for these measurements must be identified, calibrated, and maintained.
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Systematic Process Improvement Usin
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Systematic Process Improvement Usin
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To our wives, Mirta and Susan, and
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Contents Foreword . . . . . . . . .
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Contents ix 5.6 Summary of ISO requ
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Foreword As we began the work in 19
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Foreword xiii tion’s investment i
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xvi Preface Audience for this book
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xviii Preface organizations have pu
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CHAPTER 1 Contents 1.1 Role of fram
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Introduction 3 Figure 1.1 Framework
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1.2 Process improvement approaches
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1.3 Synergy 7 Figure 1.2 Systematic
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1.3 Synergy 9 • Educated and well
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1.3 Synergy 11 References [1] Shear
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14 Process Improvement • Identifi
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16 Process Improvement life-cycle m
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18 Process Improvement Although the
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20 Process Improvement Figure 2.2 I
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22 Process Improvement To help reso
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Page 61 and 62: 3.3 CMM ® for software 39 Figure 3
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Page 79 and 80: 3.7 Summary 57 Table 3.13 Maturity
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Page 83 and 84: 4.1 ISO 9001:2000 61 the current st
Page 85 and 86: 4.1 ISO 9001:2000 63 Principle 4: p
Page 87 and 88: 4.1 ISO 9001:2000 65 agement level
Page 89 and 90: 4.1 ISO 9001:2000 67 for understand
Page 91 and 92: 4.1 ISO 9001:2000 69 • Which tool
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Page 101 and 102: 4.2 CMMI ® 79 resistance to this p
Page 103 and 104: 4.2 CMMI ® 81 and staged represent
Page 105 and 106: 4.2 CMMI ® 83 Figure 4.4 Continuou
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Page 125 and 126: 4.2 CMMI ® 103 Interfaces between
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124 ISO 9001:2000 and CMMI ® Syner
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154 Transitioning from Legacy Stand
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206 Approaches Using ISO-CMMI ® Sy
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CHAPTER 8 8.1 SCAMPI SM Contents 8.
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8.1 SCAMPI SM 241 Appraisal Framewo
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8.1 SCAMPI SM 243 within the select
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8.1 SCAMPI SM 245 Figure 8.2 Charac
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8.1 SCAMPI SM 247 • Organizationa
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8.1 SCAMPI SM 249 relevant stakehol
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8.1 SCAMPI SM 251 time in the appra
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8.2 ISO 9001:2000 registration proc
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8.3 TickIT 259 Figure 8.5 TickIT st
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8.5 Summary 261 in Chapter 7, achie
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CHAPTER 9 Contents Document Mapping
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9.1 Mapping: ISO 9001:2000 to the C
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9.1 Mapping: ISO 9001:2000 to the C
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9.2 Inverse mapping: CMMI ® to ISO
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284 Acronyms FAM FAA-iCMM ® Apprai
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286 Acronyms SCAMPI SM Standard CMM
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Index A audience, this book, xv-xvi
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Index 291 design and development, 1
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Index 293 technical solution (TS),
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Index 295 ISO 9001:2000 transition,
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Index 297 organizational innovation
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Index 299 S supplier agreement mana
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