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Quality audit

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areas. For the benefit of the organization, quality auditing should not only report non-conformances and corrective actions, but also highlight areas of good practice. In this way other departments may share information and amend their working practices as a result, also contributing to continual improvement.
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Several countries have adopted quality audits in their higher education system (New Zealand, Australia, Sweden, Finland, Norway and USA) Initiated in the UK, the process of quality audit in the education system focused primarily on procedural issues rather than on the results or the efficiency of a
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Audits can also be used for safety purposes. Evans & Parker (2008) describe auditing as one of the most powerful safety monitoring techniques and 'an effective way to avoid complacency and highlight slowly deteriorating conditions', especially when the auditing focuses not just on compliance but
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Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly defined internal system monitoring procedures linked to effective action. This can help determine if the organization complies with the defined quality system processes and can involve
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Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined target levels, to provide evidence concerning reduction and elimination of problem
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The processes and tasks that a quality audit involves can be managed using a wide variety of software and self-assessment tools. Some of these relate specifically to quality in terms of fitness for purpose and conformance to standards, while others relate to
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series of standards from the 1994 to 2008 series, the focus of the audits has shifted from purely procedural adherence towards measurement of the actual effectiveness of the
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carried out by an internal or external quality auditor or an audit team. It is an important part of an organization's
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Quality audits can be an integral part of compliance or regulatory requirements. One example is the US
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EVANS, ANDY & PARKER, JOHN (2008) Beyond Safety Management Systems, AeroSafety World, May p12-17
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http://www.flightsafety.org/asw/may08/asw_may08_p12-17.pdf
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Procedures of FDA quality auditing for medical devices
49:. Unsourced material may be challenged and removed. 328:Godfrey, A. B., "Juran's Quality Handbook", 1999, 318:Pyzdek, T, "Quality Engineering Handbook", 2003, 149:procedural or results-based assessment criteria. 350: 338:Seaver, M., "Implementing ISO9001:2000", 2001, 179:(QSR) for medical devices (Title 21 of the US 124:is the process of systematic examination of a 274:not according to ISO 9001 and 19011 standards 16:Examination of quality systems by auditors 109:Learn how and when to remove this message 351: 47:adding citations to reliable sources 18: 13: 14: 375: 23: 187:quality system implementation. 34:needs additional citations for 289: 277: 268: 257: 245: 1: 239: 200:or, more accurately, to the 173:Food and Drug Administration 132:and is a key element in the 7: 207: 181:Code of Federal Regulations 10: 380: 143: 297:The Cost of Quality Audit 190: 177:Quality System Regulation 158:Quality Management System 136:quality system standard, 130:quality management system 152:With the upgrade of the 295:Howard, W. Jeffery. 202:Cost of poor quality 43:improve this article 219:Final quality audit 224:Quality management 364:Types of auditing 119: 118: 111: 93: 371: 307: 293: 287: 284:(Spanghel, 2001) 281: 275: 272: 266: 261: 255: 249: 114: 107: 103: 100: 94: 92: 51: 27: 19: 379: 378: 374: 373: 372: 370: 369: 368: 359:Quality control 349: 348: 310: 294: 290: 282: 278: 273: 269: 262: 258: 250: 246: 242: 210: 193: 164:effectiveness. 146: 115: 104: 98: 95: 58:"Quality audit" 52: 50: 40: 28: 17: 12: 11: 5: 377: 367: 366: 361: 347: 346: 336: 326: 315: 314: 309: 308: 288: 276: 267: 256: 243: 241: 238: 237: 236: 231: 226: 221: 216: 209: 206: 192: 189: 145: 142: 126:quality system 117: 116: 31: 29: 22: 15: 9: 6: 4: 3: 2: 376: 365: 362: 360: 357: 356: 354: 345: 344:0-566-08373-6 341: 337: 335: 331: 327: 325: 324:0-8247-4614-7 321: 317: 316: 312: 311: 306: 305:1-902433-62-9 302: 298: 292: 285: 280: 271: 265: 260: 254: 248: 244: 235: 234:TÜV Rheinland 232: 230: 227: 225: 222: 220: 217: 215: 212: 211: 205: 203: 199: 198:Quality costs 188: 184: 182: 178: 174: 169: 165: 161: 159: 155: 150: 141: 139: 135: 131: 127: 123: 122:Quality audit 113: 110: 102: 91: 88: 84: 81: 77: 74: 70: 67: 63: 60: –  59: 55: 54:Find sources: 48: 44: 38: 37: 32:This article 30: 26: 21: 20: 296: 291: 279: 270: 259: 247: 194: 185: 170: 166: 162: 151: 147: 121: 120: 105: 96: 86: 79: 72: 65: 53: 41:Please help 36:verification 33: 183:part 820). 353:Categories 334:007034003X 240:References 69:newspapers 99:July 2007 299:. 2001. 229:SGS S.A. 208:See also 138:ISO 9001 313:Sources 154:ISO9000 144:Purpose 83:scholar 342:  332:  322:  303:  214:DQS-UL 191:Format 85:  78:  71:  64:  56:  90:JSTOR 76:books 340:ISBN 330:ISBN 320:ISBN 301:ISBN 62:news 134:ISO 45:by 355:: 140:. 286:. 112:) 106:( 101:) 97:( 87:· 80:· 73:· 66:· 39:.

Index


verification
improve this article
adding citations to reliable sources
"Quality audit"
news
newspapers
books
scholar
JSTOR
Learn how and when to remove this message
quality system
quality management system
ISO
ISO 9001
ISO9000
Quality Management System
Food and Drug Administration
Quality System Regulation
Code of Federal Regulations
Quality costs
Cost of poor quality
DQS-UL
Final quality audit
Quality management
SGS S.A.
TÜV Rheinland
http://www.flightsafety.org/asw/may08/asw_may08_p12-17.pdf
Procedures of FDA quality auditing for medical devices
(Spanghel, 2001)

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