1WG24 Working Draft ISO9001 Revision

Document ISO/TC 176/SC 2/WG 244/N

81

1Foreword
2 3Comments received on the Annex SL common text and High Level Structure will not be considered by 4WG 24 for the develo ment of this Wor!ing "raft# 5 6Any such comments that are received will be directed to $S%&'C ()*&SC2&AHG +, -$n ut into the 7.'CG- for consideration for forwarding to the .'CG during any future revision of Annex SL /for which 8there are no lans at this time0# 9 10Comments for additions to the Annex SL common text or High Level Structure will be considered1 11 rovided that the additional text does not contradict or undermine the intent of the Annex SL text# 12

13Introduction
14 Secretar!" #o $e deve%o&ed' 15

161 Sco&e
17 18'his $nternational Standard s ecifies re2uirements for a 2uality management system where an

19organi3ation
20a0 needs to demonstrate its ability to consistently rovide roduct that meets customer and

21 23 24
26 27

licable statutory and regulatory re2uirements1 and lication of the system1 including rocesses for continual im rovement of the system and the assurance of conformity to customer

22b0 aims to enhance customer satisfaction through the effective a

and a
a0 b0

licable statutory and regulatory re2uirements#

lies to

254%'5 ( $n this $nternational Standard1 the term 6 roduct7 only a

roduct intended for1 or re2uired by1 a customer1 any intended out ut resulting from the % erations rocesses#

284%'5 2 Statutory and regulatory re2uirements can be ex ressed as legal re2uirements.

29

302 (or)ative references

31 32'he following referenced documents are indis ensable for the a

lication of this document# 8or dated

33references1 only the edition cited a lies# 8or undated references1 the latest edition of the referenced 34document /including any amendments0 a lies#
35$S% 9+++:2++;1 Quality management systems Fundamentals and vocabulary 36

373 Terms and definitions

38 398or the ur oses of this document1 the terms and definitions given in $S% 9+++ a

ly#

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5 40The Annex SL terms are currently incorporated to assist reviewers of the draft. At the moment there is

41no agreement to incorporate such terms in S! "##$% and they will be removed later into S! "###. 42Any comments received on the terms and definitions will be forwarded for S&$ to review.'
43 443.01 45organization 46person or group of people that has its own functions with responsibilities% authorities and relationships

47to achieve its objectives ().#*+

48
49,ote $ to entry- The concept of organi.ation includes% but is not limited to sole/trader% company% corporation%

50firm% enterprise% authority% partnership% charity or institution% or part or combination thereof% whether incorporated 51or not% public or private.
52 533.02 54interested party 55person or organization ().#$+ that can affect% be affected by% or perceive themselves to be affected

56by a decision or activity

57 583.03 59requirement 60need or expectation that is stated% generally implied or obligatory 61
62,ote $ to entry- 01enerally implied' means that it is custom or common practice for the organi.ation and

63interested parties that the need or expectation under consideration is implied.

64 65,ote 2 to entry- A specified re3uirement is one that is stated% for example in documented information.

66 673.04 68management system 69set of interrelated or interacting elements of an organization ().#$+ to establish policies ().#4+ and

70objectives ().#*+ and processes ().$2+ to achieve those ob5ectives

71
72,ote $ to entry- A management system can address a single discipline or several disciplines. 73 74,ote 2 to entry- The system elements include the organi.ation6s structure% roles and responsibilities% planning%

75operation% etc.
76 77,ote ) to entry- The scope of a management system may include the whole of the organi.ation% specific and

78identified functions of the organi.ation% specific and identified sections of the organi.ation% or one or more 79functions across a group of organi.ations.
80

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8 813.05 82top management 83person or group of people who directs and controls an organization ().#$+ at the highest level 84
85,ote $ to entry- Top management has the power to delegate authority and provide resources within the

86organi.ation.
87 88,ote 2 to entry-

f the scope of the management system ().#7+ covers only part of an organi.ation then top

89management refers to those who direct and control that part of the organi.ation.
90 913.0 92effectiveness 93extent to which planned activities are reali.ed and planned results achieved 94 953.0! 96policy 97intentions and direction of an organization ().#$+ as formally expressed by its top management

98().#8+
99 1003.0" 101objective 102result to be achieved 103
104,ote $ to entry- An ob5ective can be strategic% tactical% or operational. 105 106,ote 2 to entry-

!b5ectives can relate to different disciplines (such as financial% health and safety% and

107environmental goals+ and can apply at different levels (such as strategic% organi.ation/wide% pro5ect% product and 108process ().$2++. An ob5ective can be expressed in other ways% e.g. as an intended outcome% a purpose% an 109operational criterion% as a 3uality ob5ective or by the use of other words with similar meaning (e.g. aim% goal% or 110target+.
111 112,ote ) to entry- An ob5ective can be expressed in other ways% e.g. as an intended outcome% a purpose% an

113operational criterion% as a 3uality ob5ective or by the use of other words with similar meaning (e.g. aim% goal% or 114target+.
115 116,ote 7 to entry-

n the context of 3uality management systems standards 3uality ob5ectives are set by the

117organi.ation% consistent with the 3uality policy% to achieve specific results.

118 1193.0# 120ris$ 121effect of uncertainty 122

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123,ote $ to entry- An effect is a deviation from the expected positive or negative. 124,ote 2 to entry- 9ncertainty is the state% even partial% of efficiency of information related to% understanding or

125:nowledge of% an event% its conse3uence% or li:elihood.

126,ote ) to entry- ;is: is often characteri.ed by reference to potential events ( S! 1uide 4)% ).8.$.)+ and

127consequences ( S! 1uide 4)% ).<.$.)+% or a combination of these.

128,ote 7 to entry- ;is: is often expressed in terms of a combination of the conse3uences of an event (including

129changes in circumstances+ and the associated li$eli%ood ( S! 1uide 4)% ).<.$.$+ of occurrence.
130 1313.10 132competence 133ability to apply :nowledge and s:ills to achieve intended results 134 1353.11 136documented information 137information re3uired to be controlled and maintained by an organization ().#$+ and the medium on

138which it is contained
139
140,ote $ to entry- =ocumented information can be in any format and media and from any source. 141 142,ote 2 to entry- =ocumented information can refer to

143> the management system ().#7+% including related processes ().$2+? 144> information created in order for the organi.ation to operate (documentation+? 145> evidence of results achieved (records+.
146 1473.12 148process 149set of interrelated or interacting activities which transforms inputs into outputs 150 1513.13 152performance 153measurable result 154
155,ote $ to entry- @erformance can relate either to 3uantitative or 3ualitative findings. 156 157,ote 2 to entry- @erformance can relate to the management of activities% processes ().$2+% products (including

158services+% systems or organizations ().#$+.

159 1603.14 161outsource (verb+ 162ma:e an arrangement where an external organization ().#$+ performs part of an organi.ation6s

163function or process ().$2+

164

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165,ote $ to entry- An external organi.ation is outside the scope of the management system ().#7+% although the

166outsourced function or process is within the scope.

167 1683.15 169monitoring 170determining the status of a system% a process ().$2+ or an activity 171,ote $ to entry- To determine the status there may be a need to chec:% supervise or critically

172observe.
173 1743.1 175measurement 176process ().$2+ to determine a value 177 1783.1! 179audit 180systematic% independent and documented process ().$2+ for obtaining audit evidence and evaluating

181it ob5ectively to determine the extent to which the audit criteria are fulfilled
182
183,ote $ to entry- An audit can be an internal audit (first party+ or an external audit (second party or third party+%

184and it can be a combined audit (combining two or more disciplines+.

185 186,ote 2 to entry- 0Audit evidence' and 0audit criteria' are defined in S! $"#$$.

187 1883.1" 189conformity 190fulfilment of a requirement ().#)+ 191 1923.1# 193nonconformity 194non/fulfilment of a requirement ().#)+ 195 1963.20 197correction 198action to eliminate a detected nonconformity ().$"+ 199 2003.21 201corrective action 202action to eliminate the cause of a nonconformity ().$"+ and to prevent recurrence

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17 203 2043.22 205continual improvement 206recurring activity to enhance performance ().$)+

207 2084 &onte't of t%e organization

209

210
211

4.1 (nderstanding t%e organization and its conte't

212The organi.ation shall determine external and internal issues that are relevant to its purpose and that

213affect its ability to achieve the intended outcome(s+ of its 3uality management system.
214 215'he organi3ation shall ta!e into account these issues for determining ris!s and o

ortunities referred

216to in *#(#
217
2184%'5 ( >nderstanding the organi3ation?s external context can include1 but is not limited to: 219

a0 b0 c0

the social and cultural1 legal1 regulatory1 financial1 technological1 economic1 natural and com etitive environment1 whether international1 national1 regional or local@ !ey drivers and trends which can have an im act on the obAectives of the organi3ation@ including customers changing needs@ relationshi s with1 and erce tions1 values and ex ectations of1 external interested arties#

220
221

222
223 224

2254%'5 2 >nderstanding the organi3ation?s internal context can include1 but is not limited to: 226 227 228

a0 b0 c0 d0 e0 f0 g0

governance1 organi3ational structure1 roles and accountabilities@ olicies1 obAectives and the strategies that are in lace to achieve them@ ca abilities1 understood in terms of resources and !nowledge /e#g# ca ital1 time1 eo le1 rocesses1 systems and technologies0@ information systems1 information flows and decision ma!ing rocesses /both formal and informal0@ relationshi s with1 and erce tions and values of1 internal sta!eholders and the organi3ation?s culture@ standards1 guidelines and models ado ted by the organi3ation@ the form and extent of contractual relationshi s.

229
230 231 232 233 234

235
236

4.2 (nderstanding t%e needs and e'pectations of interested parties

237The organi.ation shall determine 238 239 240

2414%'5 ( 'y ical exam les of relevant interested arties could be: 242 243

the interested parties that are relevant to the 3uality management system% and the 3uality management system related re3uirements% of these interested parties.

a0 b0

"irect customers1 end users@ su liers1 distributers1 retailers1 artners1 com etitors1

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244 245 246

c0 d0 e0

shareholders1 em loyees and labour unions society1 including regulators#

247 2484%'5 2 Customer and other interested arties needs and ex ectations can include consideration of innovation

249o

ortunities# arties needs and ex ectations can include consideration of other than 2uality related1 such as re2uirements related to sustainability1 social and environmental

2504%'5 , Customer and other interested

251re2uirements 252issues# 253 254

255

4.3 )etermining t%e scope of t%e quality management system

256The organi.ation shall determine the boundaries and applicability of the 3uality management system

257to establish its scope.

258 259Ahen determining this scope% the organi.ation shall consider 260 261 262

the external and internal issues referred to in 7.$% and the re3uirements referred to in 7.2. that all re2uirements of this $nternational Standard are generic and are intended to be a to all organi3ations1 regardless of ty e1 si3e and roduct rovided# ly any licable

263
264

265When defining the sco e1 the organi3ation shall document and Austify any decision not to a

266re2uirement of this $nternational Standard and to exclude it from the sco e of the 2uality management 267system# Any such exclusion shall not affect the organi3ationBs ability or res onsibility to rovide 268conforming roduct that meets the 2uality management system re2uirements referred to in 4#2#
269 270Where an organi3ation chooses to outsource any rocess that affects roduct conformity to

271re2uirements1 these rocesses shall be included within the established sco e of the 2uality 272management system#
273 274The scope and any exclusions shall be available as documented information and shall be made

275available to interested
276

arties on re2uest#

2774%'5 'he sco e of the CDS may include the whole of the organi3ation1 s ecific functions of the organi3ation1

278s ecific sections of the organi3ation1 or one or more functions across a grou of organi3ations1 rovided it does 279not affect the organi3ationBs ability and res onsibility to rovide conforming roduct that meet the CDS 280re2uirements referred to in 4#2#
281

282
283

4.4 *uality management system

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23 284The organi.ation shall establish% implement% maintain and continually improve a 3uality management

285system% including the processes needed and their interactions% in accordance with the re3uirements 286of this nternational Standard.
287 288'he organi3ation shall 289a0 determine the rocesses needed for the 2uality management system and their a

lication

290

throughout the organi3ation1 ta!ing into account 4#( to 4#,1

291b0 determine the in uts re2uired and the out uts ex ected from each rocess1 292c0 determine the se2uence and interaction of these rocesses1 293d0 determine the ris!s to 2uality erformance if unintended out uts are roduced or rocess

294 296
297f0

interaction is ineffective1 control of these rocesses are effective1 ensure the availability of resources referred to in )1

295e0 determine criteria1 methods and measurements needed to ensure that both the o eration and

298g0 allocate res onsibilities and authorities for articular rocesses or sets of rocesses# 299h0 monitor1 analyse and review these rocesses1 300i0

im lement actions necessary to achieve lanned results and continual im rovement of these rocesses# and ensure that new or revised rocesses continue to deliver the intended outcomes #

301
302A0 303

3045 +eaders%ip
305

306
307

5.1 +eaders%ip and commitment

308Top management shall demonstrate leadership and commitment with respect to the 3uality

309management system by
310

ensuring that policies and ob5ectives are established for the 3uality management system and are compatible with the strategic direction of the organi.ation based on the Cuality Danagement Erinci les ensuring the integration of the 3uality management system re3uirements into the organi.ation6s business processes ensuring that the resources needed for the 3uality management system are available communicating the importance of effective 3uality management and of conforming to the 3uality management system re3uirements as well as statutory and regulatory re2uirements ensuring that the 3uality management system and its rocesses achieve its intended outcome(s+ ensuring that the ris!s which could affect the meeting of a identified1 assessed and managed involving% directing and supporting persons to contribute to the effectiveness of the 3uality management system licable roduct re2uirements are

311 312
313

314
315 316

317
318 319

320
321

322

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ensuring that customer re2uirements are determined and are met with the aim of enhancing customer satisfaction promoting continual improvement supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility ensuring the 2uality olicy referred to in ;#2 is understood and followed within the organi3ation

324
325 326

327
328

329 330,!TB ;eference to 0business' in this nternational Standard should be interpreted broadly to mean those

331activities that are core to the purposes of the organi.ation6s existence.

332

333
334

5.2 ,olicy

335Top management shall establish a 3uality policy that 336 337 338 339 340 341The 3uality policy shall 342 343 344 345 346
3474%'5 'he 2uality olicy should not contradict the Cuality Danagement Erinci les

is appropriate to the purpose of the organi.ation and its intended outcome? provides a framewor: for setting 3uality ob5ectives? includes a commitment to satisfy applicable re3uirements% and includes a commitment to continual improvement of the 3uality management system.

be available as documented information be communicated within the organi.ation be available to interested parties% as appropriate. be reviewed for continuing suitability

348

349
350

5.3 -rganizational roles. responsibilities and aut%orities

351Top management shall ensure that the responsibilities and authorities for relevant roles are assigned

352and communicated within the organi.ation.

353 354Top management shall assign the responsibility and authority for355a+

ensuring that the 3uality management system conforms to the re3uirements of this nternational Standard and% reporting on the performance of the 3uality management system to top management and any need for improvement% ensuring the romotion of awareness of customer re2uirements throughout the organi3ation1 and ensuring that the rocesses are delivering the re2uired out uts and that the interactions between rocesses are roducing the re2uired 2uality management system outcomes

356
357b+

358
359c+ 360d+

361
362

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363
364

,lanning
.1 /ctions to address ris$s and opportunities

365
366

367Ahen planning for the 3uality management system% the organi.ation shall consider the issues

368referred to in 7.$ and the re3uirements referred to in 7.2 and determine the ris:s and opportunities 369related to roduct conformity and customer satisfaction that need to be addressed to
370 371 372 373 374The organi.ation shall plan375a+ actions to address these ris:s and opportunities and 376b+ how to 377 378 379 380 'he organi3ation shall ensure that the need to consistently rovide roduct that meets customer

assure the 3uality management system can achieve its intended outcome(s+ prevent% or reduce% undesired effects achieve continual improvement.

integrate and implement the actions into its 3uality management system processes /see 4#40 evaluate the effectiveness of these actions

381 re2uirements and enhance customer satisfaction is a deciding factor when determining actions to 382 address ris!s1 e#g# when choosing between o tions such as ris! avoidance1 ris! mitigation or ris! 383 acce tance 384 385 .2 *uality objectives and planning to ac%ieve t%em
386 387The organi.ation shall establish 3uality ob5ectives at relevant functions and levels and in accordance

388with its overall business obAectives and roduct conformity and customer satisfaction#
389 390The 3uality ob5ectives shall 391G 392G 393G 394G 395G 396G 397 398Cuality obAectives that im act on roduct conformity or customer satisfaction shall be im lementedin a

be consistent with the 3uality policy be measurable (if practicable+ ta:e into account applicable re3uirements be monitored be communicated% and be updated as appropriate

399timely and effective manner.

400 401The organi.ation shall retain documented information on the 3uality ob5ectives.

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32 402 403Ahen planning how to achieve its 3uality ob5ectives% the organi.ation shall determine 404 405 406 407 408

what will be done what resources will be re3uired (see 4.$+ who will be responsible when it will be completed how the results will be evaluated.

409 410+,- .%anning and contro% of c/anges

411 412'he organisation shall underta!e change in a lanned and systematic manner1 reviewing the otential

413conse2uences of changes and ta!ing action as necessary1 to ensure the integrity of the 2uality 414management system is maintained#
415 416'he organi3ation shall ensure that changes to roduct1 infrastructure1 2uality management system

417 rocesses1 documented information or other changes arising from considerations as art of 418management review are assessed for suitability and a roved rior to im lementation# 'he 419assessment shall include
420a0 identification of ris!s and ris! control measures associated with the change1 421b0 conse2uences for resource needs1 422c0 any necessary verification or validation1 and 423d0 confirmation that the desired effect has been achieved without adverse effects to roduct

424

conformity# rove changes shall be identified#

425Eersonnel authori3ed to a

426"ocumented information describing the results of the review of changes and any necessary actions

427shall be maintained# /see )#;0

428

429! 0upport
430

431!.1 1esources 432 4330,1,1 Genera%

434 435The organi.ation shall determine and provide the resources needed for the establishment%

436implementation% maintenance and continual improvement of the 3uality management system to 437enhance customer satisfaction by meeting customer re2uirements# 438
439$n determining the resource re2uirements the organisation shall consider 440

current inGhouse ca abilities and limitations

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which rocess or roduct needs can be su under the organisations own direct control

orted with existing resource

which rocess or roduct needs re2uire additional or changed resource that is to be de loyed which rocess or roduct needs are to be satisfied by outsourcing to an external arty#

443
444 445

446'he organisation shall ensure that the introduction of any new or additional resource to be de loyed

447under its direct control shall be subAect to change management in accordance with the re2uirements 448of Clause *#, = Elanning and control of changes /see *#,0
449 450'he organi3ation shall establish1 im lement and maintain the controls needed tem orarily or

451 ermanently to utili3e external arties# 'he ty e and extent of control to be a lied to outsourced 452 rocesses or roduct shall be defined within the 2uality management system#
453 454 'he organi3ation shall ensure that externally rovided rocesses or roduct conform to s ecified

455re2uirements#
456
4574%'5 ( An 6outsourced rocess7 is a rocess that the organi3ation needs for its 2uality management system

458and which the organi3ation chooses to have

459

erformed by an external arty#

4604%'5 2 5nsuring control over outsourced rocesses does not absolve the organi3ation of the res onsibility of

461conformity to all re2uirements for the

462 4634%'5 , Consideration of su

roduct that is delivered to its customers

ort and resource re2uirements can include the necessary infrastructure1 entence as well as the necessary financial su orts in order to meet Cuality

464e2ui ment1 resources H com 465obAectives, 466

468

4670,1,2 Infrastructure and work environ)ent

469'he organi3ation shall determine and rovide the infrastructure and wor! environment needed to

470achieve conformity to roduct re2uirements# $nfrastructure includes1 as a licable1

471a0 buildings1 wor!s ace and associated utilities1 472b0 474 475'he infrastructure shall be maintained#
476 4774%'5 ( 'he term 6wor! environment7 relates to those conditions under which wor! is erformed including

rocess e2ui ment /both hardware and software01 orting services /such as trans ort1 communication or information systems0#

473c0 su

478

hysical1 environmental and other factors /such as noise1 tem erature1 humidity1 lighting or weather0#

479 4804%'5 2 Where it im acts on roduct or service 2uality1 the organi3ation needs to consider those who are

481wor!ing remotely1 irres

482

ective of where the wor! is done there should be controls in lace

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4834%'5 , Similar controls need to be considered for outsourcing

484

4850,1,- 1onitoring and )easuring instru)ents

486 487'he organisation shall ensure the availability of the monitoring and measuring instruments needed to

488verify conformity to roduct re2uirements and shall ensure that it is controlled and maintained fit for 489 ur ose#
490 491Where necessary to ensure valid results1 measuring instruments shall 492a0 be verified at s ecified intervals1 or rior to use1 against measurement standards traceable to

493 494

international or national measurement standards@ where no such standards exist1 the basis used for calibration or verification shall be recorded @

495b0 be adAusted or reGadAusted as necessary@ 496c0 have identification in order to determine its calibration status@ 497d0 be safeguarded from adAustments that would invalidate the measurement result@ 498e0 be rotected from damage and deterioration during handling1 maintenance and storage# 499 500$n addition1 the organi3ation shall assess and record the validity of the revious measuring results

501when the instrument is found not to conform to re2uirements# 'he organi3ation shall ta!e a ro riate 502action on the instruments and any roduct affected#
503 504"ocumented information of the results of calibration and verification shall be maintained# 505 506When used in the monitoring and measurement of s ecified re2uirements1 the ability of com uter

507software to satisfy the intended a lication shall be confirmed# 'his shall be underta!en rior to initial 508use and reconfirmed as necessary#
509
5104%'5 Confirmation of the ability of com uter software to satisfy the intended a

lication would ty ically include

511its verification and configuration management to maintain its suitability for use
512

5130,1,4 2now%edge re3uire)ents

514 515'he organi3ation shall determine1 rovide and maintain the !nowledge resources needed to

516consistently rovide roduct that meets customer needs and ex ectations and enhance customer 517satisfaction#'his shall include consideration of the !nowledge resources to res ond to changing 518business environments referred to in 4#(1 changing customer and interested arty needs and 519ex ectations referred to in 4#2 and1 where a licable1 related innovation and im rovement initiatives #
520

521!.2 &ompetence
522

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41 523The organi.ation shall524G 525

determine the com etence re2uirements associated with each rocess or set of rocesses determine the necessary competence of person(s+ doing wor: under its control that affects its 3uality performance% and ensure that these persons are competent on the basis of appropriate education% training% or experience? where applicable% ta:e actions to ac3uire the necessary competence% and evaluate the effectiveness of the actions ta:en% and retain appropriate documented information as evidence of competence

526
527

528
529

530
531 532

533,!TB$ Applicable actions may include% for example- the provision of training to% the mentoring of% or the re/

534
535

assignment of currently employed persons? or the hiring or contracting of competent persons.

5364%'5 2 A ga analysis could be a useful tool for determining com etences 537

538!.3 /2areness
539 540@ersons doing wor: under the organi.ation6s control shall be aware of 541 542

the 3uality policy their contribution to the effectiveness of the 3uality management system% including the benefits of improved 3uality performance the implications of not conforming with the 3uality management system re3uirements

543
544 545

546!.4 &ommunication
547 548The organi.ation shall determine the need for internal and external communications relevant to the

5493uality management system including

550 551 552 553

on what it will communicate when to communicate with whom to communicate

554!.5 )ocumented information

555

5560,4,1 Genera%
557 558'he organi3ationBs 2uality management system shall include 559 560

documented information re2uired by this $nternational Standard documented information determined by the organi3ation as being necessary for the effectiveness of the 2uality management system# a descri tion of the interaction between the rocesses of the 2uality management system#

561
562

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44 563
564,!TB The extent of documented information for a 3uality management system can differ from one organi.ation

565to another due to

566 567 568

the si.e of organi.ation and its type of activities% processes% products and services% the complexity of processes and their interactions% and the competence of persons.

569

5700,4,2 5reating and u&dating

571 572When creating and u dating documented information the organi3ation shall ensure a 573 574 575 576

ro riate

identification and description (e.g. a title% date% author% or reference number+ format (e.g. language% software version% graphics+ and media (e.g. paper% electronic+ review and approval for suitability and ade3uacy.

577!.5.3 &ontrol of documented 3nformation

578 579=ocumented information re3uired by the 3uality management system and by this nternational

580Standard shall be controlled to ensure

581 582 583 584For the control of documented information% the organi.ation shall address the following activities% as

it is available and suitable for use% where and when it is needed it is ade3uately protected (e.g. from loss of confidentiality% improper use% or loss of integrity+.

585applicable
586 587 588 589 590 591=ocumented information of external origin determined by the organi.ation to be necessary for the

distribution% access% retrieval and use% storage and preservation% including preservation of legibility control of changes (e.g. version control+ retention and disposition

592planning and operation of the 3uality management system shall be identified as appropriate% and 593controlled.
594
595,!TB Access implies a decision regarding the permission to view the documented information only% or the

596permission and authority to view and change the documented information% etc. 597 598" -peration
599

600".1 -perational planning and control

601

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ISO* WD (; 9001

46WG24 Working Draft ISO9001 Revision

47 602The organi.ation shall plan% implement and control the processes needed to meet re3uirements% and

603to implement the actions determined in <.$% by

604 605 606

establishing criteria for the processes implementing control of the processes in accordance with the criteria :eeping documented information to the extent necessary to have confidence that the processes have been carried out as planned.

607
608

609The organi.ation shall control planned changes and review the conse3uences of unintended

610changes% ta:ing action to mitigate any adverse effects% as necessary.

611 612The organi.ation shall ensure that outsourced processes are controlled /see F#40# 613

6146,2 Interactions wit/ custo)ers and ot/er interested &arties 615 6166,2,1 Deter)ination of re3uire)ents re%ated to t/e &roduct
617 618'he organi3ation shall determine 619a0 re2uirements s ecified by the customer including the re2uirements for delivery and ostGdelivery

620 622

activities1 !nown1 licable to the roduct1 including ris!s and ris! controls

621b0 re2uirements not stated by the customer but necessary for s ecified or intended use1 where 623c0 statutory and regulatory re2uirements a

624d0 re2uirements that are related to the roduct arising from other relevant interested arties referred

625
627

to in 4#21 and

626e0 any additional re2uirements considered necessary by the organi3ation#

6286,2,2 Review of re3uire)ents re%ated to t/e &roduct

629 630'he organi3ation shall review the re2uirements related to the roduct# 'his review shall be conducted

631 rior to the organi3ation?s commitment to su ly a roduct to the customer /e#g# submission of 632tenders1 acce tance of contracts or orders1 acce tance of changes to contracts or orders0 and shall 633ensure that
634a0

roduct re2uirements are defined1

635b0 contract or order re2uirements differing from those reviously ex ressed are resolved1 and 636c0 the organi3ation has the ability to meet the defined re2uirements 637 638"ocumented information describing the results of the review and actions arising from the review shall

639be maintained#
640

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ISO* WD (* 9001

49WG24 Working Draft ISO9001 Revision

50 641Where the customer rovides no documented statement of re2uirement1 the customer re2uirements

642shall be confirmed by the organi3ation before acce tance#

643 644Where roduct re2uirements are changed1 the organi3ation shall ensure that relevant documented

645information is amended and that relevant ersonnel are made aware of the changed re2uirements#
646
6474%'5

$n some situations1 such as internet sales1 a formal review is im ractical for each order# $nstead the roduct information such as catalogues or advertising material#

648review can cover relevant

649

6506,2,- 5usto)er co))unication

651 652'he organi3ation shall determine and im lement effective arrangements for communicating with

653customers in relation to
654a0

roduct information1

655b0 en2uiries1 contracts or order handling1 including amendments1 656c0 customer feedbac!1 including customer com laints /see 9#(0 657d0 ex ectations for handling customer ro erty and 658e0 emergency and contingency needs

659
6604%'5

Customer ro erty can include intellectual ro erty and ersonal or confidential data#

661 6626,- O&erationa% &re&aredness

663 664$n re aring for im lementation1 the organi3ation shall determine the following1 as a 665a0 2uality obAectives and re2uirements for the roduct@ 666b0 ris! identification1 evaluation and control actions necessary on an ongoing basis 667c0 the need to establish rocesses and documented information1 668d0 the resources re2uired arising from the re2uirements for the roduct@ 669e0 the criteria for roduct acce tance@ 670f0

ro riate1

re2uired verification1 validation1 monitoring1 measurement1 ins ection and test activities s ecific to the roduct@ meet re2uirements@ and licable#

671 673
675

672g0 documented information to be retained to rovide evidence that rocesses and resulting roduct 674h0 contingency lans1 as a

676'he out ut of this re aration shall be in a form suitable for the organi3ation?s method of o erations# 677
6784%'5 ( "ocumented information s ecifying the rocesses of the 2uality management system /including the

679 roduct reali3ation rocesses0 and the resources to be a 680referred to as a 2uality lan#

lied to a s ecific roduct1 roAect or contract can be

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ISO* WD () 9001

52WG24 Working Draft ISO9001 Revision

53
681 6824%'5 2 'he organi3ation may also a

ly the re2uirements given in "esign and "evelo ment to the

683develo
684

ment of rocesses for im lementation#

6866,4 5ontro% of e7terna% &rocesses or &roduct

687 688'he ty e and extent of control a

lied to the external arty and the externallyG rovided rocess or

689 roduct shall be de endent u on

690a0 the ris!s identified 691b0 the otential im act of the rovided rocesses or roduct on im lementation activities or the

692 694
696

organi3ation?s ca ability to rovide roduct that conforms to re2uirements involved

693c0 the degree to which the control for the externally rovided rocess is shared between the arties 695d0 the ca ability of achieving the necessary control through other means 697'he organi3ation shall establish criteria for selection1 evaluation and reGevaluation of external arties

698based on the ris!s and ris! controls identified and their ability to rovide rocesses or roduct in 699accordance with the organi3ation?s re2uirements# 'he organi3ation shall evaluate and select external 700 arties based on these criteria#
701 702"ocumented information describing the results of evaluations and any necessary actions arising from

703the evaluation shall be maintained#

704 705"ocumented information shall be rovided to the external arty describing the roduct to be rovided1

706including1 where a ro riate:

707a0 re2uirements for a

roval of roduct1 rocedures1 rocesses or e2ui ment1

708b0 re2uirements for com etence of 2ualification of ersonnel1 including necessary 2ualification1 709c0 2uality management system re2uirements1 710d0 re2uirements for handling of su 712 713'he organi3ation shall ensure the ade2uacy of s ecified re2uirements rior to their communication to

lierBs ro erty rovided to the organi3ation1 and

711e0 any activities that the organi3ation intends to erform at the external artyBs remises

714the external arty

715
7164%'5 Ero erty belonging to external arties can include intellectual ro erty and confidential or ersonal data#

717

7186,4 Design and deve%o&)ent

719

7206,4,1 Define
721

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ISO* WD (F 9001

55WG24 Working Draft ISO9001 Revision

56 722'he organi3ation shall identify re2uirements of customers and other relevant interested arties and

723re2uirements related to the roduct referred to in F#2#(# $n uts relating to roduct re2uirements shall 724be determined and documented information retained /see )#;0# 'hese in uts shall include
725a0 functional and erformance re2uirements1 726b0 a 728d0 if a

licable statutory and regulatory re2uirements1 licable1 information derived from revious similar designs1 identified o ortunities for

727c0 ris!s&ha3ards related to or arising from roduct

729
731

im rovement1 or identified o

ortunities to innovate1 including those from external sources1 and

730e0 other re2uirements essential for design and develo ment# 732'he in uts shall be reviewed for ade2uacy# Ie2uirements shall be com lete1 unambiguous and not in

733conflict with each other#

734

7356,4,2 8na%!9e
736 737'he organi3ation shall lan and control the design and develo ment of roduct1 including the rocess

738for lanning and control of design and develo ment changes#

739 740'he organi3ation shall determine 741a0 the res onsibilities and authorities for design and develo ment 742b0 the design and develo ment stages1 743c0 internal and external resource needs for design and develo ment and subse2uent o erations

744
746

arising from the identified roduct re2uirements1 and ro riate to each design and develo ment stage#

745d0 the review1 verification and validation that are a

747'he organi3ation shall manage the interfaces between different grou s involved in design and

748develo ment to ensure effective communication and clear assignment of res onsibility#
749Elanning out ut shall be u dated1 as a 750 751A systematic review shall be erformed in accordance with lanned arrangements 752a0 to evaluate the ability to meet re2uirements for the roduct1 753b0 to identify any roblems and ro ose necessary actions1 and 754c0 to evaluate design and develo ment changes1 including the effect of the changes on constituent

ro riate1 as the design and develo ment rogresses#

755
756

arts and roduct already delivered#

757"ocumented information describing the results of the review and any necessary actions shall be

758maintained /see )#;0#

759

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ISO* WD (9 9001

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59
7604%'5

"esign and develo ment verification and validation referred to in F#;#4 have distinct ur oses# 'hey arately or in any combination1 as suitable for the roduct and the

761can be conducted and recorded se 762organi3ation#

763

7646,4,- I)&%e)ent
765 766'he organi3ation shall im lement the rocess for design and develo ment and design and

767develo ment changes# 'he out uts of the design and develo ment rocess shall be in a form suitable 768for verification against the design and develo ment in ut and shall be a roved rior to release to 769o erations#
770 771"esign and develo ment out uts shall 772a0 meet the in ut re2uirements for design and develo ment1 773b0

rovide a

ro riate information for identification and control of external resources1 im lementation

774

and roduct rovision1

775c0 contain or reference roduct acce tance criteria1 verification and validation methods and criteria1 776d0 identify ris! control measures1 and 777e0 s ecify the characteristics of the roduct that are essential for its safe and ro er use# 778
7794%'5 $nformation for roduction and service rovision can include details for the reservation of roduct#

780 781A systematic review shall be erformed in accordance with lanned arrangements to 782a0 evaluate the ability of meet roduct re2uirements1 783b0 identify any roblems and ro ose necessary actions1 and 784c0 evaluate design and develo ment changes1 including the effect of the changes on constituent

785
786

arts and roduct already delivered#

787"ocumented information describing the results of the reviews and any necessary actions shall be

788maintained#
789

7906,4,4 :erif! and va%idate

791 792"esign and develo ment verification shall be erformed in accordance with lanned arrangements to

793ensure that the design and develo ment out uts have met the design and develo ment in ut 794re2uirements# "ocumented information describing the results of the verification and any necessary 795actions shall be maintained
796 797"esign and develo ment validation shall be erformed in accordance with lanned arrangements

798referred to in F#;#2 to ensure that the resulting roduct is ca able of meeting the re2uirements for the 799s ecified a lication or intended use1 where !nown# Wherever racticable1 validation shall be 800com leted rior to the delivery or im lementation of the roduct#
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ISO* WD 2+ 9001

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62 801 802"esign and develo ment changes shall be verified and validated1 as a

ro riate1 and a

roved

803before im lementation#
804"ocumented information describing the results of validation and any necessary actions shall be

805maintained#
806

8076,4,4 #ransfer to O&erations

808 809'he organi3ation shall ensure that design and develo ment out uts identified during the design and

810develo ment rocess ensure that they are suitable for o erations before final a roval#
811

8126,+ ;7ecution*I)&%e)entation
813

8146,+,1 5ontro% of &roduction and service &rovision

815 816'he organi3ation shall lan and im lement roduction and service rovision under controlled

817conditions# Controlled conditions shall include1 as a licable1

818a0 the availability of information that describes the characteristics of the roduct1 819b0 the availability of wor! instructions1 as necessary1 820c0 the use of suitable e2ui ment1 821d0 the availability and use of monitoring and measuring e2ui ment1 822e0 the im lementation of monitoring and measurement1 823f0

the re2uirements for com etence of ersonnel or their 2ualification1 if necessary 1

824g0 the im lementation of roduct release1 delivery and ostGdelivery activities1 and 825h0 the im lementation of ris! controls# 826

8276,+,2 :a%idation of &rocesses for &roduction and service &rovision

828 829'he organi3ation shall validate any rocesses for roduction and service rovision where the resulting

830out ut cannot be verified by subse2uent monitoring or measurement and1 as a conse2uence1 831deficiencies become a arent only after the roduct is in use or the service has been delivered#
832 833Jalidation shall demonstrate the ability of these rocesses to achieve lanned results# 834'he organi3ation shall establish arrangements for these rocesses including1 as a 835a0 defined criteria for review and a 836b0 a

licable1

roval of the rocesses1

roval of e2ui ment and 2ualification of ersonnel1

837c0 use of s ecific methods and rocedures1 838d0 re2uirements for documented information1 and 839e0 revalidation# 840

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ISO* WD 2( 9001

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65

8416,+,- Identification and tracea$i%it!

842 843Where a

ro riate1 the organi3ation shall identify the roduct by suitable means throughout

844im lementation
845 846'he organi3ation shall identify the roduct status with res ect to monitoring and measurement

847re2uirements throughout im lementation#

848 849Where traceability is a re2uirement1 the organi3ation shall control the uni2ue identification of the

850 roduct and maintain documented information#

851
8524%'5

$n some industry sectors1 configuration management is a means by which identification and traceability

853are maintained#
854

8556,+,4 1onitoring and )easure)ent of &roduct <see a%so 9,1=

856 857'he organi3ation shall monitor and measure the characteristics of the roduct to verify that roduct

858re2uirements have been met# 'his shall be carried out at a ro riate stages of the im lementation 859 rocess in accordance with the lanned arrangement# 5vidence of conformity with the acce tance 860criteria shall be maintained#
861 862'he organi3ation shall establish and im lement the ins ection or other activities necessary for

863ensuring that externally rovided rocesses or roduct meet s ecified re2uirements#

864 865Where the organi3ation or its customer intends to erform verification at the external artyBs remises1

866the organi3ation shall state the intended verification arrangements and method of roduct release in 867documented information rovided to the external arty#
868 869"ocumented information shall indicate the erson/s0 authori3ing release of roduct for delivery to the

870customer#
871 872'he release of roduct and delivery of service to the customer shall not roceed until the lanned

873arrangements have been satisfactorily com leted1 unless otherwise a roved by a relevant authority 874and1 where a licable1 by the customer
875

8766,+,4 5ontro% of nonconfor)ing &roduct <see a%so 10,1=

877 878The organization shall ensure that product which does not conform to product requirements is

879identified and controlled to prevent its unintended use or delivery (see 10.1). Documented information

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ISO* WD 22 9001

67WG24 Working Draft ISO9001 Revision

68 880shall be established to define the controls and related responsibilities and authorities for dealing with

881nonconforming product.
882

8836,+,+ .ro&ert! $e%onging to e7terna% &arties

884 885'he organi3ation shall exercise care with ro erty belonging to external arties while it is under the

886organi3ation?s control or being used by the organi3ation# 'he organi3ation shall identify1 verify1 rotect 887and safeguard customer ro erty rovided for use or incor oration into the roduct# $f any external 888 artyBs ro erty is lost1 damaged or otherwise found to be unsuitable for use1 the organi3ation shall 889re ort this to the external arty and maintain documented information#
890
8914%'5

Ero erty belonging to external arties can include intellectual ro erty and confidential or ersonal data#

892

8936,+,0 .reservation of &roduct

894 895'he organi3ation shall reserve the roduct during internal rocessing and delivery to the intended

896destination in order to maintain conformity to re2uirements# As a licable1 reservation shall include 897identification1 handling1 ac!aging1 storage and rotection# Ereservation shall also a ly to the 898constituent arts of a roduct#
899

9006,+,6 .ost de%iver! activities

901 902'he organi3ation shall establish and im lement rocesses to conduct necessary ost delivery

903activities associated with the nature and intended lifetime of the roduct# 'he extent of ost delivery 904activities that are re2uired shall be established on the basis of ris!s associated with the roduct1 905customer feedbac! and statutory and regulatory re2uirements and shall include necessary actions 906when nonconforming roduct is detected after delivery or use has started
907
9084%'5 EostGdelivery activities include1 for exam le1 actions under warranty rovisions1 contractual obligations

909such as maintenance services1 and su

910

lementary services such as recycling or final dis osal#

911# ,erformance evaluation

912

913#.1 4onitoring. measurement. analysis and evaluation

914

9159,1,1 Genera%
916 917The organi.ation shall determine 918 919

what needs to be monitored and measured. 'his shall include but not limited to a0 conformity to roduct re2uirements1

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71 920 921 922 923 924

b0 conformity of the 2uality management system1 c0 effectiveness of the 2uality management system and its rocesses1 d0 achievement of 2uality obAectives and e0 customer feedbac! & satisfaction the methods for monitoring% measurement% analysis and evaluation% as applicable% to ensure valid results# 'his shall include determination of a licable a0 monitoring and measuring instruments and b0 statistical techni2ues1 and the extent of their use# when the monitoring and measuring shall be performed when the results from monitoring and measurement shall be analysed and evaluated. what indicators of 2uality management system erformance referred to in 9#, d are necessary for re orting within the management review#

925
926 927 928 929 930

931
932

933The organi.ation shall establish processes to ensure that monitoring and measurement can be

934carried out and are carried out in a manner that is consistent with the monitoring and measurement 935re3uirements.
936 937'he organi3ation shall consider the ty e and extent of monitoring and& or measurement in relation to

938ris! encountered and on the effectiveness of the 2uality management system#

939 940The organi.ation shall retain appropriate documented information as evidence of the results. 941 942The organi.ation shall evaluate the 3uality performance and the effectiveness of the 3uality

943management system. When lanned results are not achieved1 correction and corrective action shall 944be ta!en1 as a ro riate#
945
9464%'5 Iesults of evaluation may generate o

ortunities for im rovement#

947

9489,1,2 5usto)er satisfaction

949 950'he organi3ation shall monitor customer feedbac! to determine customer erce tions of the degree to

951which their re2uirements have been fullfilled#

952 953'he results of this monitoring shall include information related to 954 955 956 957'he methods for obtaining and using this information shall be determined#
958

the customerBs needs and ex ectations the customerBs views and erce tions of the organi3ation1 its rocesses and its roducts@

9599,1,- 8na%!sis of data

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73WG24 Working Draft ISO9001 Revision

74 960 961'he organi3ation shall analyse a

ro riate data from monitoring1 measurement and other relevant

962sources of information to
963 964

demonstrate the suitability and effectiveness of the 2uality management system and evaluate where continual im rovement of the effectiveness of the 2uality management system can be made#

965
966

967'he results of analysis and evaluation shall be used to re are an in ut to the management review# 968

969#.2 3nternal /udit

970 971The organi.ation shall conduct internal audits at planned intervals to provide information on whether

972the 3uality management system?

973a+ conforms to 974 975 977 978The organi.ation shall979a+ plan% establish% implement and maintain an audit programme(s+% including the fre3uency%

the organi.ation6s own re3uirements for its 3uality management system and the re3uirements of this nternational Standard?

976b+ is effectively implemented and maintained.

980 981 982 983

methods% responsibilities% planning re3uirements and reporting. The audit programme(s+ shall ta:e into consideration the importance of the processes concerned 1 the related 2uality management system ris!s & o of previous audits? ortunities1 2uality management system obAectives and the results

984b+ define the audit criteria and scope for each audit? 985c+ select auditors and conduct audits to ensure ob5ectivity and the impartiality of the audit process? 986d+ ensure that the results of the audits are reported to relevant management% and 987e+ retain documented information as evidence of the implementation of the audit programme and the

988
989

audit results.
See $S% (9+(( for guidance#

9904%'5

991

992#.3 4anagement revie2

993 994Top management shall review the organi.ationCs 3uality management system% at planned intervals% to

995ensure its continuing suitability% ade3uacy and effectiveness. Danagement review shall be timely and 996relevant to o erational outcomes#
997 998The management review shall include consideration of 999a+ the status of actions from previous management reviews?

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77 1000b+ changes in external and internal issues that are relevant to the 3uality management system

1001 1003 1004 1005 1006 1007 1008

1010

including any determined ris!s and o

ortunities@

1002c+ information on the 3uality performance% including trends in-

nonconformities and corrective actions monitoring and measurement results% and audit results? customer feedbac!1 rocess erformance and roduct conformity

opportunities for continual improvement.

1009d+ indicators of 2uality management system erformance 1011The outputs of the management review shall include decisions related to continual improvement

1012opportunities and% im rovement of roduct related to customer re2uirements1 resource needs and any 1013need for changes to the 3uality management system including 2uality olicy and 2uality obAectives#
1014The organi.ation shall retain documented information as evidence of the results of management

1015reviews.
1016
10174%'5 'he management review can be integrated into the organisationBs management meeting structure#

1018

101910 3mprovement
1020

102110.1 5onconformity and corrective action

1022 1023Ahen a nonconformity occurs% the organi.ation shall1024a+ react to the nonconformity% and as applicable

1025 1026 1028 1029 1030 1031 1032 1033 1034

1035

ta:e action to control and correct it% and deal with the conse3uences? recur or occur elsewhere% by reviewing the nonconformity determining the causes of the nonconformity% and determining if similar nonconformities exist% or could potentially occur? implement any action needed? review the effectiveness of any corrective action ta:en? and ma:e changes to the 3uality management system% if necessary.

1027b+ evaluate the need for action to eliminate the causes of the nonconformity% in order that it does not

1036&orrective actions shall be appropriate to the effects of the nonconformities encountered. 1037

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80 1038The organi.ation shall retain documented information as evidence of

1039 1040
1041

the nature of the nonconformities and any subse3uent actions ta:en% and the results of any corrective action.

104210.2 &ontinual improvement

1043 1044The organi.ation shall continually improve the suitability% ade3uacy and effectiveness of the 3uality

1045management system#
1046 1047'he organisation shall define a structured a 1049 1050'he organisation shall maintain control over its rocesses in all areas of its 2uality management

roach for continual im rovement of 2uality management

1048system rocess and&or roduct through the use of the outcomes of erformance evaluation /see 90#

1051system during continual im rovement im lementation# Elans shall be established for change 1052im lementation to ensure consideration of the im act in all relevant areas#
1053
10544%'5 Continual im rovement may include rocesses &a

roaches such as innovation1 lean1 six sigma etc

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83

1055 1056
1058 1057 Secretar!" #o $e deve%o&ed> if re3uired'

8nne7 8 <infor)ative=

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86

1059
1060 Secretar!" #o $e deve%o&ed' 1061

?i$%iogra&/!

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