HealthCare : ISO-9001-2015

ISO/CEN PARALLEL PROCESSING

This draft has been developed within the International Organization for Standardization (ISO), and processed under the ISO Lead mode of collaboration as defined in the Vienna Agreement. This draft is hereby submitted to the ISO member bodies and To the CEN member bodies for a parallel five month enquiry. Should this draft be accepted, a final draft, established on the basis Of comments received, will be submitted to a parallel two-month approval vote in ISO and formal vote in CEN. To expedite Distribution, this document is circulated as received from the committee secretariat. ISO Central Secretariat work of editing and Text composition will be undertaken at publication stage.

Quality Management systems — Requirements

Systèmes de management de la qualité — Exigences

Reference number

ISO/DIS 9001:2014(E)

DRAFT INTERNATIONAL STANDARD

ISO/DIS 9001

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141 Foreword

142 ISO (the International Organization for Standardization) is a worldwide federation of national standards

143 bodies (ISO member bodies). The work of preparing International Standards is normally carried out

144 through ISO technical committees. Each member body interested in a subject for which a technical

145 committee has been established has the right to be represented on that committee. International

146 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO

147 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

148 electrotechnical standardization.

149 The procedures used to develop this document and those intended for its further maintenance are

150 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

151 different types of ISO documents should be noted. This document was drafted in accordance with the

152 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

153 Attention is drawn to the possibility that some of the elements of this document may be the subject of

154 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

155 any patent rights identified during the development of the document will be in the Introduction and/or

156 on the ISO list of patent declarations received (see www.iso.org/patents).

157 Any trade name used in this document is information given for the convenience of users and does not

158 constitute an endorsement.

159 For an explanation on the meaning of ISO specific terms and expressions related to conformity

160 assessment, as well as information about ISO's adherence to the WTO principles in the Technical

161 Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

162 The committee responsible for this document is Technical Committee ISO/TC 176, Quality

163 management and quality assurance, Subcommittee SC2, Quality systems.

This 5th edition of ISO 9001 cancels and replaces the 4th 164 edition (ISO 9001:2008). This new edition

165 represents a technical revision compared to the earlier edition, through the adoption of a revised

166 clause sequence, the adaptation of the revised "quality management principles" and of new concepts.

167

168 NOTE TO THIS TEXT (which will not be included in the published International Standard):

169

170 This text has been prepared using the “high-level structure” (i.e. clause sequence, common text and terminology)

171 provided in Annex SL, Appendix 2 of the ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2013. This is

172 intended to enhance alignment among ISO’s management system standards, and to facilitate their

173 implementation for organizations that need to meet the requirements of two or more such standards

174 simultaneously.

175

176 The clause sequence of ISO 9001:2008 has been changed to be consistent with “Annex SL”. The text of Annex

177 SL is highlighted in the main body of the text (clauses 1 to 10) by the use of blue font. This is only to facilitate

178 analysis and will not be incorporated in the final version of ISO 9001.

179

180 This new harmonized approach allows for the addition of discipline-specific (in this case quality-specific) text

181 which has been applied by including the following:

182

183 a) specific quality management system requirements considered essential to meet the scope of the ISO

184 9001 standard;

185 b) text to reflect the use of the Quality Management Principles that form the basis for ISO’s quality

186 management system standards;

187 c) requirements and notes to clarify and ensure consistent interpretation and implementation of the

188 common text in the context of a quality management system.

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189 Introduction

190 0.1 General

191 The adoption of a quality management system ought to be a strategic decision for an organization. A

192 robust quality management system can help an organization to improve its overall performance and

193 forms an integral component of sustainable development initiatives. The design and implementation of

194 an organization's quality management system is influenced by the context of the organisation and the

195 changes in that context, particularly with respect to:

196 a) its specific objectives;

197 b) the risks associated with its context and objectives;

198 c) the needs and expectations of its customers and other relevant interested parties;

199 d) the products and services it provides;

200 e) the complexity of processes it employs and their interactions;

201 f) the competence of persons within or working on behalf of the organization;

202 g) its size and organizational structure.

203 The context of an organization can include internal factors such as organizational culture, and external

204 factors such as the socio-economic conditions under which it operates; consequently all the

205 requirements of this International Standard are generic but the ways in which they are applied can

206 differ from one organization to another. Accordingly, it is not the intent of this International Standard to

207 imply the need for uniformity in the structure of different quality management systems, or uniformity of

208 documentation to align to the clause structure of this International Standard, or to impose specific

209 terminology to be used within the organization.

210 The quality management system requirements specified in this International Standard are

211 complementary to requirements for products and services.

212 Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.

213 This International Standard can be used by internal and external parties, to assess the organization's

214 ability to consistently meet customer, statutory and regulatory requirements applicable to the products

215 and services it provides, the organization's own requirements and its aim to enhance customer

216 satisfaction.

217 0.2 The ISO standards for quality management

218 This International Standard is one of the three core standards in the ISO portfolio of quality

219 management system standards.

220

221 • ISO 9000 Quality management systems — Fundamentals and vocabulary provides an essential

222 background for the proper understanding and implementation of this International Standard. The

223 quality management principles described in detail in ISO 9000 were developed by ISO/TC 176,

224 and have been taken into consideration during the development of this International Standard.

225 These principles are not requirements in themselves, but they form the foundation of the

226 requirements specified by this International Standard. An outline of the quality management

227 principles is included in an Annex B to this International Standard.

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• ISO 9001 (this International Standard) specifies requirements aimed primarily at 228 giving confidence

229 in the products and services provided by an organization and thereby improving customer

230 satisfaction (see clause 1 Scope). Its proper implementation can also be expected to bring other

231 organizational benefits such as improved internal communication, better understanding and

232 control of the organization’s processes, and reduction in defects and waste.

233

234 • ISO 9004 Managing for the sustained success of an organization - A quality management

235 approach provides guidance for organizations that choose to progress beyond the requirements of

236 this International Standard to address a broader range of topics that can lead to continual

237 improvement of the organization's overall performance. ISO 9004 includes guidance on a self238

assessment methodology for an organization to be able to evaluate the level of maturity of its

239 quality management system.

240

241 Other standards that have been developed to support the implementation of a quality management

242 system include those in the ISO 10000 number range. These include guidelines on customer

243 satisfaction, quality plans, quality management in projects, configuration management, measurement

244 processes and measuring equipment, documentation, financial and economic benefits of quality

245 management, training, statistical techniques, the involvement and competence of people, selection of

246 quality management system consultants and auditing of management systems. These standards are

247 described further in Annex C of this International Standard.

248 0.3 Process approach

249 Consistent and predictable results are achieved more effectively and efficiently when activities are

250 understood and managed as interrelated processes that function as a coherent system. This

251 International Standard promotes the adoption of a process approach when developing, implementing

252 and improving the effectiveness of a quality management system, to enhance customer satisfaction by

253 meeting customer requirements. Clause 4.4 of this International Standard includes specific

254 requirements considered essential to the adoption of a process approach.

255 The process approach applies systematic definition and management of processes and their

256 interactions so as to achieve the intended results in accordance with the quality policy and strategic

257 direction of the organization. Management of the processes and the system as a whole can be

258 achieved using a “Plan-Do-Check-Act” (PDCA) methodology (see 0.4) with an overall focus on “Risk259

based thinking" aimed at preventing undesirable outcomes (see 0.5).

260 When used within a quality management system, the process approach ensures:

261 a) understanding and consistently meeting requirements;

262 b) consideration of processes in terms of added value;

263 c) the achievement of effective process performance;

264 d) improvement of processes based on evaluation of data and information.

265 Figure 1 illustrates the process linkages between clauses 4 to 10 of this International Standard. This

266 shows that customers play a significant role in defining the input requirements that the organization

267 needs to meet at all stages of its quality management system. In addition, the needs and expectations

268 of other relevant interested parties can also play a role in defining those requirements. Monitoring of

269 customer satisfaction requires the evaluation of information relating to customer perceptions as to

270 whether the organization has met these requirements.

271 The schematic model shown in Figure 1 covers all the requirements of this International Standard, but

272 does not show the individual processes at a detailed level. Each of these processes, and the system

273 as a whole, can be managed using the PDCA methodology described in clause 0.4 of this

274 International Standard.

275

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276

277 Figure 1 - Model of a process-based quality management system, showing the links to the

278 clauses of this International Standard

279

280 0.4 Plan-Do-Check-Act cycle

281 The methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes and to the

282 quality management system as a whole. The clauses of this International Standard broadly follow the

283 PDCA cycle which can be briefly described as follows:

284

285 ¾ Plan: establish the objectives of the system and its component processes, and the resources

286 needed to deliver results in accordance with customers’ requirements and the organization’s

287 policies.

288 ¾ Do: implement what was planned.

289 ¾ Check: monitor and (where applicable) measure processes and the resulting products and

290 services against policies, objectives and requirements, and report the results.

291 ¾ Act: take actions to improve process performance, as necessary.

292 Figure 2 shows schematically how a single process within the quality management system can be

293 managed using the PDCA cycle.

294

295

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296

297 Figure 2 - Schematic representation of a single process within the system

298

299 0.5 “Risk-based thinking”

300 Risk is the effect of uncertainty on an expected result and the concept of risk-based thinking has

301 always been implicit in ISO 9001. This International Standard makes risk-based thinking more explicit

302 and incorporates it in requirements for the establishment, implementation, maintenance and continual

303 improvement of the quality management system. Organizations can choose to develop a more

304 extensive risk-based approach than is required by this International Standard, and ISO 31000

305 provides guidelines on formal risk management which can be appropriate in certain organizational

306 contexts.

307

308 Not all the processes of the quality management system represent the same level of risk in terms of

309 the organization’s ability to meet its objectives, and the consequences of process, product, service or

310 system nonconformities are not the same for all organizations. For some organizations, the

311 consequences of delivering nonconforming products and services can result in minor inconvenience to

312 the customer; for others, the consequences can be far-reaching and fatal. “Risk-based thinking”

313 therefore means considering risk qualitatively (and, depending on the organization’s context,

314 quantitatively) when defining the rigour and degree of formality needed to plan and control the quality

315 management system, as well as its component processes and activities.

316

317 0.6 Compatibility with other management system standards

318 This International Standard has adopted the “high-level structure” (i.e. clause sequence, common text

319 and common terminology) developed by ISO to improve alignment among its International Standards

320 for management systems. An explanation of some of the key elements of the “high level structure” and

321 some of the key changes introduced in this International Standard is provided in Annex A.

322

323 This International Standard defines the requirements in an order that is consistent with organizational

324 planning and process management, i.e.:

325

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¾ Understanding the context of the organization, its quality management system 326 and processes

327 (Clause 4)

328 ¾ Leadership, policy and responsibilities (Clause 5)

329 ¾ Processes for planning and consideration of risks and opportunities (Clause 6)

330 ¾ Processes for support, including resources, people and information (Clause 7)

331 ¾ Operational processes related to customers and products and services (Clause 8)

332 ¾ Processes for performance evaluation (Clause 9)

333 ¾ Processes for improvement (Clause 10).

334 It is important to emphasize, however, that organizations are not required to follow an identical clause335

by-clause sequence when defining their quality management system, and they are encouraged to use

336 the Process Approach as described in clauses 0.3 to 0.5 of this International Standard.

337

338 This International Standard does not include requirements specific to other management systems,

339 such as those for environmental management, occupational health and safety management, or

340 financial management. However, this International Standard enables an organization to use the

341 process approach, coupled with the PDCA methodology and risk-based thinking to align or integrate

342 its quality management system with the requirements of other management system standards as it

343 sees fit. It is possible for an organization to adapt its existing management system in order to address

344 the requirements of this International Standard.

345 A matrix showing the correlation between the clauses of this International Standard and ISO

346 9001:2008 can be found on the ISO/TC 176/SC2 open access web site at:

347 www.iso.org/tc176/sc02/public.

348 [Note to this DIS: The matrix will only be available after the June meeting of ISO/TC 176/SC2/WG23]

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ISO (the International Organization for Standardization) is a worldwide federation of 349 national standards

350 bodies (ISO member bodies). The work of preparing International Standards is normally carried out

351 through ISO technical committees. Each member body interested in a subject for which a technical

352 committee has been established has the right to be represented on that committee. International

353 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO

354 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

355 electrotechnical standardization.

356 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives,

357 Part 2.

358 The main task of technical committees is to prepare International Standards. Draft International

359 Standards adopted by the technical committees are circulated to the member bodies for voting.

360 Publication as an International Standard requires approval by at least 75 % of the member bodies

361 casting a vote.

362 Attention is drawn to the possibility that some of the elements of this document may be the subject of

363 patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

364 ISO 9001 was prepared by Technical Committee ISO/TC 176, Quality management and Quality

365 Assurance, Subcommittee SC 2, Quality Systems.

366 This second/third/... edition cancels and replaces the first/second/... edition (), [clause(s) / subclause(s)

367 / table(s) / figure(s) / annex(es)] of which [has / have] been technically revised.

368 Copyright notice

369 This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as

370 permitted under the applicable laws of the user's country, neither this ISO draft nor any extract from

371 it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,

372 electronic, photocopying, recording or otherwise, without prior written permission being secured.

373 Requests for permission to reproduce should be addressed to either ISO at the address below or

374 ISO's member body in the country of the requester.

375 ISO copyright office

376 Case postale 56 • CH-1211 Geneva 20

377 Tel. + 41 22 749 01 11

378 Fax + 41 22 749 09 47

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381 Reproduction may be subject to royalty payments or a licensing agreement.

382 Violators may be prosecuted.

383 Quality management systems — Requirements

384 1 Scope

385 This International Standard specifies requirements for a quality management system where an

386 organization:

387 a) needs to demonstrate its ability to consistently provide product or service that meets customer and

388 applicable statutory and regulatory requirements, and

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b) aims to enhance customer satisfaction through the effective application of the 389 system, including

390 processes for continual improvement of the system and the assurance of conformity to customer and

391 applicable statutory and regulatory requirements.

392 All requirements of this International Standard are generic and are intended to be applicable

393 to all organizations, regardless of type, size and product provided.

394 NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services

395 intended for, or required by, a customer.

396 NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.

397 2 Normative references

398 There are no normative references. This clause is included to maintain clause numbering alignment

399 with other ISO management system standards,

400 3 Terms and definitions

401 For the purposes of this document, the following terms and definitions apply.

402 3.01

403 Organization

404 person or group of people that has its own functions (3.25) with responsibilities, authorities and

405 relationships to achieve its objectives (3.08)

406 Note 1 to entry: The concept of organization includes, but is not limited to sole-trader, company, corporation, firm,

407 enterprise, authority, partnership, association, charity or institution, or part or combination thereof, whether

408 incorporated or not, public or private.

409 [SOURCE: ISO DIS 9000:2014, 3.2.1]

410 3.02

411 Interested party

412 person or organization (3.01) that can affect, be affected by, or perceive themselves to be affected by

413 a decision or activity

414 EXAMPLE Customers (3.26), owners, people in an organization (3.01), suppliers (3.27), bankers, unions,

415 partners or society that may include competitors or opposing pressure groups.

416 [SOURCE: ISO DIS 9000:2014, 3.2.4]

417 3.03

418 Requirement

419 need or expectation that is stated, generally implied or obligatory

420 Note 1 to entry: “Generally implied” means that it is custom or common practice for the organization (3.01) and

421 interested parties (3.02) that the need or expectation under consideration is implied.

422 Note 2 to entry: A specified requirement is one that is stated, for example in documented information (3.11).

423 Note 3 to entry: A qualifier can be used to denote a specific type of requirement e.g. product (3.47) requirement,

424 quality management (3.30) requirement, customer (3.26) requirement, quality requirement.

425 Note 4 to entry: Requirements can be generated by different interested parties (3.02).

426 Note 5 to entry: It can be necessary for achieving high customer satisfaction (3.57) to fulfil an expectation of a

427 customer (3.26) even if it is neither stated nor generally implied or obligatory.

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[SOURCE: ISO DIS 428 9000:2014, 3.5.4]

429 3.04

430 Management system

431 set of interrelated or interacting elements of an organization (3.01) to establish policies (3.07) and

432 objectives (3.08) and processes (3.12) to achieve those objectives

433 Note 1 to entry: A management system can address a single discipline or several disciplines e.g. quality

434 management (3.30), financial management (3.29) or environmental management.

435 Note 2 to entry: The management system elements establish the organization’s (3.01) structure, roles and

436 responsibilities, planning, operation, policies (3.07), practices, rules, beliefs, objectives (3.08) and processes

437 (3.12) to achieve those objectives.

438 Note 3 to entry: The scope of a management system may include the whole of the organization (3.01), specific

439 and identified functions (3.25) of the organization, specific and identified sections of the organization, or one or

440 more functions across a group of organizations.

441 [SOURCE: ISO DIS 9000:2014, 3.4.2.1]

442 3.05

443 Top Management

444 person or group of people who directs and controls an organization (3.01) at the highest level

445 Note 1 to entry: Top management has the power to delegate authority and provide resources within the

446 organization (3.01).

447 Note 2 to entry: If the scope of the management system (3.04) covers only part of an organization (3.01), then top

448 management refers to those who direct and control that part of the organization.

449 [SOURCE: ISO DIS 9000:2014, 3.1.1]

450 3.06

451 Effectiveness

452 extent to which planned activities are realized and planned results achieved

453 [SOURCE: ISO DIS 9000:2014, 3.7.7]

454 3.07

455 policy

456 intentions and direction of an organization (3.01), as formally expressed by its top management (3.05)

457 [SOURCE: ISO DIS 9000:2014, 3.4.5]

458 3.08

459 Objective

460 result to be achieved

461 Note 1 to entry: An objective can be strategic, tactical, or operational.

462 Note 2 to entry: Objectives can relate to different disciplines (such as financial, health and safety, and

463 environmental goals) and can apply at different levels (such as strategic, organization-wide, project, product

464 (3.47), service (3.48), and process (3.12)).

465 Note 3 to entry: An objective can be expressed in other ways, e.g. as an intended outcome, a purpose, an

466 operational criterion, as a quality (3.37) objective, or by the use of other words with similar meaning (e.g. aim,

467 goal, or target).

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Note 4 to entry: In the context of quality management systems (3.33), quality objectives 468 are set by the

469 organization (3.01), consistent with the quality policy (3.34), to achieve specific results.

470 [SOURCE: ISO DIS 9000:2014, 3.7.1]

471 3.09

472 Risk

473 effect of uncertainty on an expected result

474 Note 1 to entry: An effect is a deviation from the expected — positive or negative

475 Note 2 to entry: Uncertainty is the state, even partial, of deficiency of information (3.50) related to, understanding

476 or knowledge (3.53) of, an event, its consequence, or likelihood.

477 Note 3 to entry: Risk is often characterized by reference to potential “events” (as defined in ISO Guide 73:209,

478 3.5.1.3) and “consequences” (as defined in ISO Guide 73:2009, 3.6.1.3), or a combination of these.

479 Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including

480 changes in circumstances) and the associated “likelihood” (as defined in ISO Guide 73:2009, 3.6.1.1) of

481 occurrence.

482 Note 5 to entry: The term “risk” is sometimes used when there is only the possibility of negative consequences

483 [SOURCE: ISO DIS 9000:2014, 3.7.4]

484 3.10

485 Competence

486 ability to apply knowledge (3.53) and skills to achieve intended results

487 Note 1 to entry: Demonstrated competence is sometimes referred to as qualification.

488 [SOURCE: ISO DIS 9000:2014, 3.6.6]

489 3.11

490 Documented information

491 information (3.50) required to be controlled and maintained by an organization (3.01) and the medium

492 on which it is contained

493 Note 1 to entry: Documented information can be in any format and media and from any source.

494 Note 2 to entry: Documented information can refer to:

495 - the quality management system (3.33), including related processes (3.12);

496 - information (3.50) created in order for the organization (3.01) to operate (documentation);

497 - evidence of results achieved (records).

498 [SOURCE: ISO DIS 9000:2014, 3.8.1.1.1]

499 3.12

500 Process

501 set of interrelated or interacting activities which transforms inputs into outputs (3.46)

502 Note 1 to entry: Inputs to a process are generally outputs (3.46) of other processes.

503 Note 2 to entry: In some processes, some inputs become outputs (3.46) without any transformation e.g. a

504 blueprint used in a manufacturing process or a catalyst in a chemical process.

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Note 3 to entry: Processes in an organization (3.01) are generally planned and carried out 505 under controlled

506 conditions to add value.

507 Note 4 to entry: A process where the conformity (3.18) of the resulting output (3.46) cannot be readily or

508 economically validated is frequently referred to as a “special process”.

509 [SOURCE: ISO DIS 9000:2014, 3.6.1]

510 3.13

511 Performance

512 measurable result

513 Note 1 to entry: Performance can relate either to quantitative or qualitative findings.

514 Note 2 to entry: Performance can relate to the management (3.29) of activities, processes (3.12), products (3.47),

515 services (3.48), systems (3.31) or organizations (3.01).

516 [SOURCE: ISO DIS 9000:2014, 3.7.5]

517 3.14

518 Outsource (verb)

519 make an arrangement where an external organization (3.01) performs part of an organization’s

520 function (3.25) or process (3.12)

521 Note 1 to entry: An external organization (3.01) is outside the scope of the management system (3.04), although

522 the outsourced function (3.25), or process (3.12), is within the scope.

523 [SOURCE: ISO DIS 9000:2014, 3.6.3]

524 3.15

525 Monitoring

526 determining (3.67) the status of a system (3.31), a process (3.12) or an activity

527 Note 1 to entry: To determine the status, there may be a need to check, supervise or critically observe.

528 Note 2 to entry: Monitoring is generally a determination (3.67) of the object (3.36) being monitored, carried out at

529 different stages or at different times.

530 [SOURCE: ISO DIS 9000:2014, 3.13.1.2]

531 3.16

532 Measurement

533 process (3.12) to determine (3.67) a value

534 Note 1 to entry: According to ISO 3534-2:2006 the value determined is generally the value of a quantity.

535 [SOURCE: ISO DIS 9000:2014, 3.13.3]

536 3.17

537 Audit

538 systematic and independent process (3.12) for obtaining objective evidence (3.61) and evaluating it

539 objectively to determine the extent to which the audit criteria (3.60) are fulfilled

540 Note 1 to entry: An audit can be an internal audit (first party), or an external audit (second party or third party),

541 and it can be a combined audit or a joint audit.

542 Note 2 to entry: Internal audits, sometimes called first-party audits are conducted by, or on behalf of, the

543 organization (3.01) itself for management (3.29) review (3.68) and other internal purposes, and may form the

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basis for an organization’s declaration of conformity (3.18). In many cases, particularly in smaller 544 organizations,

545 independence can be demonstrated by the freedom from responsibility for the activity being audited.

546 Note 3 to entry: External audits include those generally called second and third-party audits. Second party audits

547 are conducted by parties having an interest in the organization (3.01), such as customers (3.26), or by other

548 persons on their behalf. Third-party audits are conducted by external, independent auditing organizations such as

549 those providing certification/registration of conformity (3.18) to ISO 9001 or ISO 14001.

550 [SOURCE: ISO DIS 9000:2014, 3.10.1, modified – the definition has been modified and the original

551 Note 1 to entry has been deleted]

552 3.18

553 Conformity

554 fulfilment of a requirement (3.03)

555 Note 1 to term: In English the word 'conformance' is synonymous but deprecated. In French the word 'compliance'

556 is synonymous but deprecated.

557 [SOURCE: ISO DIS 9000:2014, 3.5.6]

558 3.19

559 Nonconformity

560 Non-fulfilment of a requirement (3.03)

561 [SOURCE: ISO DIS 9000:2014, 3.5.5]

562 3.20

563 Corrective action

564 action to eliminate the cause of a nonconformity (3.19) and to prevent recurrence

565 Note 1 to definition: There can be more than one cause for a nonconformity (3.19).

566 Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent

567 occurrence.

568 [SOURCE: ISO DIS 9000:2014, 3.11.2]

569 3.21

570 Continual improvement

571 recurring activity to enhance performance (3.13)

572 Note 1 to entry: The process (3.12) of establishing objectives (3.08) and finding opportunities for improvement

573 (3.28) is a continual process through the use of audit findings (3.62) and audit conclusions, analysis of data

574 (3.49), management (3.29) reviews (3.68) or other means and generally leads to corrective action (3.21) or

575 preventive action.

576 3.22

577 Correction

578 action to eliminate a detected nonconformity (3.19)

579 Note 1 to entry: A correction can be made in conjunction with a corrective action (3.21).

580 Note 2 to entry: A correction can be, for example, rework or regrade.

581 [SOURCE: ISO DIS 9000:2014, 3.11.3]

582 3.23

583 Involvement

584 engagement in, and contribution to, shared objectives (3.08)

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[SOURCE: ISO 585 10018:2012, 3.5]

586 3.24

587 Context of the organization

588 business environment

589 combination of internal and external factors and conditions that can have an effect on an

590 organization's (3.01) approach to its products (3.47), services (3.48) and investments and interested

591 parties (3.02)

592 Note 1 to entry: The concept of context of the organization is equally applicable to not-for-profit or public service

593 (3.48) organizations (3.01) as it is to those seeking profits.

594 Note 2 to entry: In English this concept is often referred to by other phrases such as business environment,

595 organizational environment or ecosystem of an organization (3.01).

596 [SOURCE: ISO DIS 9000:2014, 3.2.3]

597 3.25

598 Function

599 role to be carried out by a designated unit of the organization (3.01)

600 [SOURCE: ISO DIS 9000:2014, 3.2.5]

601 3.26

602 Customer

603 person or organization (3.01) that could or does not receive a product (3.47) or a service (3.48) is

604 intended for or required by this person or organization

605 EXAMPLES Consumer, client, end-user, retailer, input to internal process (3.12), beneficiary and purchaser.

606 Note to entry: A customer can be internal or external to the organization (3.01). Customers outside of the

607 organization are external customers. The output (3.46) of each internal process (3.12) is the input of the next

608 process. The next process is the internal customer of the preceding process.

609 [SOURCE: ISO DIS 9000:2014, 3.2.6]

610 3.27

611 Supplier

612 Provider

613 person or organization (3.01) that provides a product (3.47) or a service (3.48)

614 EXAMPLE Producer, distributor, retailer or vendor of a product (3.47) or a service (3.48) or information (350).

615 Note 1 to entry: A provider can be internal or external to the organization (3.01).

616 Note 2 to entry: In a contractual situation, a supplier is sometimes called a “contractor”.

617 [SOURCE: ISO DIS 9000:2014, 3.2.7]

618 3.28

619 Improvement

620 activity to enhance performance (3.13)

621 Note to entry: Improvement can be achieved by a recurring or by a singular activity.

622 [SOURCE: ISO DIS 9000:2014, 3.3.1]

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623 3.29

624 Management

625 coordinated activities to direct and control an organization (3.01)

626 Note 1 to entry: Management can include establishing policies (3.07) and objectives (3.08) and processes (3.12)

627 to achieve these objectives.

628 Note 2 to entry: The term “management” sometimes refers to people, i.e. a person or group of people with

629 authority and responsibility for the conduct and control of an organization (3.01). When “management” is used in

630 this sense, it should always be used with some form of qualifier to avoid confusion with the concept of

631 “management” as a set of activities defined above. For example, “management shall…” is deprecated whereas

632 “top management (3.05) shall…” is acceptable. Otherwise different words should be adopted to convey the

633 concept when related to people e.g. managerial or managers.

634 [SOURCE: ISO DIS 9000:2014, 3.3.2]

635 3.30

636 Quality management

637 management (3.29) with regard to quality (3.37)

638 Note to entry: Quality management generally includes establishment of the quality policy (3.34) and quality

639 objectives (3.45), quality planning, quality control, quality assurance and quality improvement.

640 [SOURCE: ISO DIS 9000:2014, 3.3.2.1]

641 3.31

642 System

643 set of interrelated or interacting elements

644 [SOURCE: ISO DIS 9000:2014, 3.4.1]

645 3.32

646 Infrastructure

647 system (3.31) of facilities, equipment and services (3.48) needed for the operation of an organization

648 (3.01)

649 3.33

650 Quality management system

651 management system (3.04) with regard to quality (3.5.2)

652 [SOURCE: ISO DIS 9000:2014, 3.4.1.2.1]

653 3.34

654 Quality policy

655 policy (3.07) related to quality (3.37)

656 Note 1 to entry: Generally the quality policy is consistent with the overall policy (3.07) of the organization (3.01),

657 can be aligned with the organization’s vision and mission and provides a framework for the setting of quality

658 objectives (3.45).

659 Note 2 to entry: Quality management (3.30) principles presented in this International Standard can form a basis

660 for the establishment of a quality policy (3.34)

661 [SOURCE: ISO DIS 9000:2014, 3.4.5.1]

662 3.35

663 Strategy

664 planned activities to achieve an objective (3.08).

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[SOURCE: ISO DIS 665 9000:2014, 3.4.8]

666 3.36

667 Object

668 entity

669 anything perceivable or conceivable

670 [ISO 1087-1:2000]

671 EXAMPLES Product (3.47), service (3.48), process (3.12), person, organization (3.01), system (3.31),

672 resource.

673 Note 1 to entry: Objects may be material (e.g. an engine, a sheet of paper, a diamond), immaterial (e.g.

674 conversion ratio, a project plan) or imagined (e.g. a unicorn).

675 [SOURCE: ISO DIS 9000:2014, 3.5.1]

676 3.37

677 Quality

678 degree to which a set of inherent characteristics (3.65) of an object (3.36) fulfils requirements (3.03)

679 Note 1 to entry: The term “quality” can be used with adjectives such as poor, good or excellent.

680 Note 2 to entry: “Inherent”, as opposed to “assigned”, means existing in the object (3.36).

681 [SOURCE: ISO DIS 9000:2014, 3.5.2]

682 3.38

683 Etatutory requirement

684 obligatory requirement (3.03) specified by a legislative body

685 [SOURCE: ISO DIS 9000:2014, 3.5.4.2]

686 3.39

687 Regulatory requirement

688 obligatory requirement (3.03) specified by an authority mandated by a legislative body

689 [SOURCE: ISO DIS 9000:2014, 3.5.4.3]

690 3.40

691 Defect

692 Nonconformity (3.19) related to an intended or specified use

693 Note 1 to entry: The distinction between the concepts defect and nonconformity (3.19) is important as it has legal

694 connotations, particularly those associated with product (3.47) and service (3.48) liability issues.

695 Note 2 to entry: The intended use as intended by the customer (3.26) can be affected by the nature of the

696 information (3.50), such as operating or maintenance instructions, provided by the supplier (3.27).

697 [SOURCE: ISO DIS 9000:2014, 3.5.5.1]

698 3.41

699 Traceability

700 ability to trace the history, application or location of an object (3.36)

701 Note 1 to entry: When considering a product (3.47) or a service (3.48), traceability can relate to:

702 - the origin of materials and parts;

703 - the processing history; and

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- the distribution and location of the product (3.47) or service (3.48) 704 after delivery.

705 Note 2 to entry: In the field of metrology the definition in ISO/IEC GUIDE 99: 2007, is the accepted definition.

706 [SOURCE: ISO DIS 9000:2014, 3.5.8]

707 3.42

708 Innovation

709 process (3.12) resulting in a new or substantially changed object (3.36)

710

711 Note 1 to entry: The object (3.36) for the purpose of innovation can be e.g. a management system (3.04), a

712 process (3.12),a product (3.47), a service (3.48) or technology.

713 [SOURCE: ISO DIS 9000:2014, 3.6.1.2]

714 3.43

715 Contract

716 binding agreement

717 [SOURCE: ISO DIS 9000:2014, 3.6.4]

718 3.44

719 Design and development

720 set of processes (3.12) that transforms requirements (3.03) for an object (3.36) into more detailed

721 requirements

722 Note 1 to entry: The requirements (3.03) forming input to design and development can be expressed in a broader,

723 more general sense than the requirements forming the output (3.46) of design and development. In a

724 project there can be several design and development stages.

725 Note 2 to entry: In English the words “design” and “development” and the term “design and development” are

726 sometimes used synonymously and sometimes used to define different stages of the overall design and

727 development. In French the words “conception” and “development” and the term “conception et development” are

728 sometimes used synonymously and sometimes used to define different stages of the overall design and

729 development.

730 Note 3 to entry: A qualifier can be applied to indicate the nature of what is being designed and developed,

731 e.g. product (3.47) design and development, or process (3.12) design and development.

732 [SOURCE: ISO DIS 9000:2014, 3.6.5]

733 3.45

734 Quality objective

735 objective (3.08) related to quality (3.37)

736 Note 1 to entry: Quality objectives are generally based on the organization's (3.01) quality policy (3.34).

737 Note 2 to entry: Quality objectives are generally specified for relevant functions (3.25) and levels in the

738 organization (3.01).

739 [SOURCE: ISO DIS 9000:2014, 3.7.1.1]

740 3.46

741 Output

742 result of a process (312)

743 Note 1 to entry “output”: There are four generic output categories, as follows:

744 — services (e.g. transport);

745 — software (e.g. computer program, dictionary);

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— hardware (e.g. engine 746 mechanical part);

747 — processed materials (e.g. lubricant).

748

749 Many outputs comprise elements belonging to different generic output categories. Whether the output is then called

750 service, product, software, hardware or processed material depends on the dominant element. For example, a car consists

751 of hardware (e.g. tires), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver's

752 manual), and service (e.g. operating explanations given by the salesman).

753

754 Note 2 to entry “output”: The ownership of a product can usually be transferred. This is not necessarily the case for a

755 service.

756

757 [SOURCE: ISO DIS 9000:2014, 3.7.3]

758

759 3.47

760 Product

761 output (3.46) that is a result of activities where none of them necessarily is performed at the interface

762 between the provider (3.27) and the customer (3.26)

763 Note 1 to entry “product”: Hardware is generally tangible and its amount is a countable characteristic. Processed materials are

764 generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as

765 goods. Software consists of information and is generally intangible and can be in the form of approaches, transactions or

766 documented information (3.11).

767

768 [SOURCE: ISO DIS 9000:2014, 3.7.3.1, modified – Note 1 to entry has been modified]

769

770 3.48

771 Service

772 intangible output (3.46) that is the result of at least one activity necessarily performed at the interface

773 between the provider and the customer

774 Note 1 to entry “service”: Provision of a service can involve, for example, the following:

775 — an activity performed on a customer-supplied tangible product (e.g. a car to be repaired);

776 — an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax

777 return);

778 — the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission);

779 — the creation of ambience for the customer (e.g. in hotels and restaurants);

780 A service is usually experienced by the customer.

781 [SOURCE: ISO DIS 9000:2014, 3.7.3.2]

782

783 3.49

784 Data

785 facts about an object (3.36)

786

787 [SOURCE: ISO DIS 9000:2014, 3.8.1]

788

789 3.50

790 Information

791 meaningful data (3.49)

792 [SOURCE: ISO DIS 9000:2014, 3.8.1.1]

793 3.51

794 Objective evidence

795 data (3.49) supporting the existence or verity of something

796 Note 1 to entry: Objective evidence may be obtained through observation, measurement (3.16), test, or other

797 means.

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Note 2 to entry: Objective evidence for the purpose of audit (3.17) generally consists of records, 798 statements of

799 fact or other information (3.50) which are relevant to the audit criteria (3.60) and verifiable

800 [SOURCE: ISO DIS 9000:2014, 3.8.1.2]

801 3.52

802 Information system

803 <QMS> network of communication channels used within an organization (3.01)

804 [SOURCE: ISO DIS 9000:2014, 3.8.2]

805 3.53

806 Knowledge

807 available collection of information (3.50) being a justified belief and having a high certainty to be true

808 [SOURCE: ISO DIS 9000:2014, 3.8.3]

809 3.54

810 Verification

811 confirmation, through the provision of objective evidence (3.51), that specified requirements (3.03)

812 have been fulfilled

813 Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other

814 forms of determination (3.67) such as performing alternative calculations or reviewing documented information

815 (3.11).

816 Note 2 to entry: The activities carried out for verification are sometimes called a qualification process (3.12)

817 Note 3 to entry: The word “verified” is used to designate the corresponding status.

818 [SOURCE: ISO DIS 9000:2014, 3.8.5, modified – Note 1 to entry has been modified]

819 3.55

820 Validation

821 confirmation, through the provision of objective evidence, that the requirements (3.03) for a specific

822 intended use or application have been fulfilled

823 Note 1 to entry: The objective evidence (3.51) needed for a validation is the result of a test or other form of

824 determination (3.67) such as performing alternative calculations or reviewing documented information (3.11).

825 Note 2 to entry: The word “validated” is used to designate the corresponding status.

826 Note 3 to entry: The use conditions for validation can be real or simulated.

827 [SOURCE: ISO DIS 9000:2014, 3.8.6, modified – Note 1 to entry has been modified]

828 3.56

829 Feedback

830 opinions, comments and expressions of interest in a product, a service or a complaints-handling

831 process

832 [SOURCE: ISO DIS 9000:2014, 3.9.2]

833 3.57

834 Customer Satisfaction

835 customer’s (3.26) perception of the degree to which the customer’s expectations have been fulfilled

836 Note 1 to entry: It can be that the customer’s (3.26) expectation is not known to the organization (3.01), or even to

837 himself/herself until the product (3.47) or service (3.48) is delivered. It can be necessary for achieving high

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customer satisfaction to fulfil an expectation of a customer even if it is neither stated nor generally 838 implied or

839 obligatory.

840 Note 2 to entry: Complaints (3.58) are a common indicator of low customer satisfaction but their absence does not

841 necessarily imply high customer satisfaction.

842 Note 3 to entry: Even when customer (3.26) requirements (3.03) have been agreed with the customer and

843 fulfilled, this does not necessarily ensure high customer satisfaction.

844 Note 4 to entry: See ISO 10004, Quality Management — Customer satisfaction — Guidelines for monitoring and

845 measuring.

846 [SOURCE: ISO DIS 9000:2014, 3.9.3]

847 3.58

848 Complaint

849 <customer satisfaction> expression of dissatisfaction made to an organization (3.01), related to its

850 product (3.47) or service (3.48), or the complaints-handling process (3.12) itself, where a response or

851 resolution is explicitly or implicitly expected

852 [SOURCE: ISO DIS 9000:2014, 3.9.4]

853 3.59

854 Audit Programme

855 set of one or more audits (3.17) planned for a specific time frame and directed towards a specific

856 purpose

857 [SOURCE: ISO DIS 9000:2014, 3.10.9]

858 3.60

859 Audit criteria

860 set of policies (3.07), documented information (3.11) or requirements (3.03) used as a reference

861 against which audit evidence (3.61) is compared

862 [SOURCE: ISO DIS 9000:2014, 3.10.12, modified]

863 3.61

864 Objective / audit evidence

865 records, statements of fact or other information (3.50), which are relevant to the audit criteria (3.60)

866 and verifiable

867 [SOURCE: ISO DIS 9000:2014, 3.10.13]

868 3.62

869 Audit findings

870 results of the evaluation of the collected audit evidence (3.61) against audit criteria (3.60)

871 Note 1 to entry: Audit findings indicate conformity (3.18) or nonconformity (3.19).

872 Note 2 to entry: Audit findings can lead to the identification of opportunities for improvement (3.28) or recording

873 good practices.

874 Note 3 to entry: In English, if the audit criteria (3.60) are selected from statutory requirements (3.38) or regulatory

875 requirements (3.39), the audit finding can be called compliance or non-compliance.

876 [SOURCE: ISO DIS 9000:2014, 3.10.14]

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877 3.63

878 Concession

879 permission to use or release (3.64) a product (3.47) or service (3.48) that does not conform to

880 specified requirements (3.03)

881 Note to entry: A concession is generally limited to the delivery of products (3.47) and services (3.48) that have

882 nonconforming (3.19) characteristics (3.65) within specified limits and is generally given for a limited quantity of

883 products and services, for a period of time, and for a specific use.

884 [SOURCE: ISO DIS 9000:2014, 3.11.5]

885 3.64

886 Release

887 permission to proceed to the next stage of a process (3.12)

888 Note to entry: In English, in the context of software and documented information (3.11), the word “release” is

889 frequently used to refer to a version of the software or the documented information itself.

890 [SOURCE: ISO DIS 9000:2014, 3.11.7, modified – The Note to entry has been modified]

891 3.65

892 Characteristic

893 distinguishing feature

894 Note 1 to entry: A characteristic can be inherent or assigned.

895 Note 2 to entry: A characteristic can be qualitative or quantitative.

896 Note 3 to entry: There are various classes of characteristic, such as the following:

897 a) physical (e.g. mechanical, electrical, chemical or biological characteristics);

898 b) sensory (e.g. related to smell, touch, taste, sight, hearing);

899 c) behavioural (e.g. courtesy, honesty, veracity);

900 d) temporal (e.g. punctuality, reliability, availability).

901 e) ergonomic (e.g. physiological characteristic, or related to human safety);

902 f) functional (e.g. maximum speed of an aircraft).

903 [SOURCE: ISO DIS 9000:2014, 3.12.1]

904 3.66

905 Performance indicator

906 performance metric

907 characteristic (3.65) having significant impact on realization of the output (3.46) and customer

908 satisfaction (3.57)

909

910 EXAMPLES Nonconformities (3.19) per million opportunities, first time capability, nonconformities per unit.

911 Note to entry: The characteristic (3.65) can be quantitative or qualitative

912 [SOURCE: ISO DIS 9000:2014, 3.12.1.2]

913 3.67

914 Determination

915 activity to find out one or more characteristics (3.65) and their characteristic values

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[SOURCE: ISO DIS 916 9000:2014, 3.13.1]

917 3.68

918 Review

919 determination (3.67) of the suitability, adequacy or effectiveness (3.06) of an object (3.36) to achieve

920 established objectives (3.08)

921 EXAMPLES Management (3.29) review, design and development review, review of customer (3.26)

922 requirements (3.03), nonconformity (3.19) review and peer review.

923 Note to entry: Review can also include the determination (3.67) of efficiency.

924 [SOURCE: ISO DIS 9000:2014, 3.13.1.1]

925 3.69

926 Measuring equipment

927 measuring instrument, software, measurement standard, reference material or auxiliary apparatus or

928 combination thereof necessary to realize a measurement (3.16) process (3.12)

929 [SOURCE: ISO DIS 9000:2014, 3.13.5]

930

931 4 Context of the organization

932 4.1 Understanding the organization and its context

933 The organization shall determine external and internal issues that are relevant to its purpose and its

934 strategic direction and that affect its ability to achieve the intended result(s) of its quality management

935 system.

936 The organization shall monitor and review the information about these external and internal issues.

937 NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal,

938 technological, competitive, market, cultural, social, and economic environments, whether international, national,

939 regional or local.

940 NOTE 2 Understanding the internal context can be facilitated by considering issues related to values, culture

941 knowledge and performance of the organization.

942 4.2 Understanding the needs and expectations of interested parties

943 Due to their impact or potential impact on the organisation’s ability to consistently provide products

944 and services that meet customer and applicable statutory and regulatory requirements, the

945 organization shall determine:

946 a) the interested parties that are relevant to the quality management system;

947 b) the requirements of these interested parties that are relevant to the quality management system.

948 The organization shall monitor and review the information about these interested parties and their

949 relevant requirements.

950 4.3 Determining the scope of the quality management system

951 The organization shall determine the boundaries and applicability of the quality management system

952 to establish its scope.

953

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When determining this scope, the organization 954 shall consider:

955

956 a) the external and internal issues referred to in 4.1;

957 b) the requirements of relevant interested parties referred to in 4.2;

958 c) the products and services of the organization.

959 Where a requirement of this International Standard within the determined scope can be applied, then it

960 shall be applied by the organization.

961

962 If any requirement(s) of this International Standard cannot be applied, this shall not affect the

963 organization’s ability or responsibility to ensure conformity of products and services.

964

965 The scope shall be available and be maintained as documented information stating the:

966

967 ¾ products and services covered by the quality management system;

968 ¾ justification for any instance where a requirement of this International Standard cannot be applied.

969 4.4 Quality Management System and Its Processes

970 The organization shall establish, implement, maintain and continually improve a quality management

971 system, including the processes needed and their interactions, in accordance with the requirements of

972 this International Standard.

973 The organization shall determine the processes needed for the quality management system and their

974 application throughout the organization and shall determine:

975 a) the inputs required and the outputs expected from these processes;

976 b) the sequence and interaction of these processes;

977 c) the criteria, methods, including measurements and related performance indicators needed to

978 ensure the effective operation, and control of these processes;

979 d) the resources needed and ensure their availability;

980 e) the assignment of the responsibilities and authorities for these processes;

981 f) the risks and opportunities in accordance with the requirements of 6.1, and plan and implement

982 the appropriate actions to address them;

983 g) the methods for monitoring, measuring, as appropriate, and evaluation of processes and, if

984 needed, the changes to processes to ensure that they achieve intended results;

985 h) opportunities for improvement of the processes and the quality management system.

986 The organization shall maintain documented information to the extent necessary to support the

987 operation of processes and retain documented information to the extent necessary to have confidence

988 that the processes are being carried out as planned.

Leadership for Quality Management System

989 5 Leadership

990 5.1 Leadership and Commitment

991 5.1.1 Leadership and commitment for the quality management system

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Top management shall demonstrate leadership and commitment with respect to the quality
992 management system by:

993

994 a) taking accountability of the effectiveness of the quality management system;

995 b) ensuring that the quality policy and quality objectives are established for the quality management

996 system and are compatible with the strategic direction and the context of the organization;

997 c) ensuring that the quality policy is communicated, understood and applied within the organization;

998 d) ensuring the integration of the quality management system requirements into the organization’s

999 business processes;

1000 e) promoting awareness of the process approach;

1001 f) ensuring that the resources needed for the quality management system are available;

1002 g) communicating the importance of effective quality management and of conforming to the quality

1003 management system requirements;

1004 h) ensuring that the quality management system achieves its intended results;

1005 i) engaging, directing and supporting persons to contribute to the effectiveness of the quality

1006 management system;

1007 j) promoting continual improvement;

1008 k) supporting other relevant management roles to demonstrate their leadership as it applies to their

1009 areas of responsibility.

1010 NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those

1011 activities that are core to the purposes of the organization’s existence; whether the organization is public, private,

1012 for profit or not for profit.

1013 5.1.2 Customer focus

1014 Top management shall demonstrate leadership and commitment with respect to customer focus by

1015 ensuring that:

1016 a) customer requirements and applicable statutory and regulatory requirements are determined and

1017 met;

1018 b) the risks and opportunities that can affect conformity of products and services and the ability to

1019 enhance customer satisfaction are determined and addressed;

1020 c) the focus on consistently providing products and services that meet customer and applicable

1021 statutory and regulatory requirements is maintained;

1022 d) the focus on enhancing customer satisfaction is maintained.

1023 5.2 Quality policy

1024 5.2.1 Top management shall establish, review and maintain a quality policy that:

1025 a) is appropriate to the purpose and context of the organization;

1026 b) provides a framework for setting and reviewing quality objectives;

1027 c) includes a commitment to satisfy applicable requirements;

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d) includes a commitment to continual improvement of the quality 1028 management system.

1029 5.2.2 The quality policy shall:

1030 a) be available as documented information;

1031 b) be communicated, understood and applied within the organization;

1032 c) be available to relevant interested parties, as appropriate.

1033 5.3 Organizational roles, responsibilities and authorities

1034 Top management shall ensure that the responsibilities and authorities for relevant roles are assigned,

1035 communicated and understood within the organization.

1036 Top management shall assign the responsibility and authority for:

1037 a) ensuring that the quality management system conforms to the requirements of this International

1038 Standard;

1039 b) ensuring that the processes are delivering their intended outputs;

1040 c) reporting on the performance of the quality management system, on opportunities for

1041 improvement and on the need for change or innovation, and especially for reporting to top

1042 management;

1043 d) ensuring the promotion of customer focus throughout the organization;

1044 e) ensuring that the integrity of the quality management system is maintained when changes to the

1045 quality management system are planned and implemented.

Do Planning for The Quality Management System

1046 6 Planning for The Quality Management System

1047 6.1 Actions to address Risks and Opportunities

1048 6.1.1 When planning for the quality management system, the organization shall consider the issues

1049 referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that

1050 need to be addressed to:

1051 a) give assurance that the quality management system can achieve its intended result(s);

1052 b) prevent, or reduce, undesired effects;

1053 c) achieve continual improvement.

1054 6.1.2 The organization shall plan:

1055 a) actions to address these risks and opportunities;

1056 b) how to:

1057 1) integrate and implement the actions into its quality management system processes (see 4.4);

1058 2) evaluate the effectiveness of these actions.

1059 Actions taken to address risks and opportunities shall be proportionate to the potential impact on the

1060 conformity of products and services.

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NOTE Options to address risks and opportunities can include: avoiding risk, taking risk in 1061 order to pursue an

1062 opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining

1063 risk by informed decision.

1064 6.2 Quality objectives and planning to achieve them

1065 6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes.

1066 The quality objectives shall:

1067 a) be consistent with the quality policy,

1068 b) be measurable;

1069 c) take into account applicable requirements;

1070 d) be relevant to conformity of products and services and the enhancement of customer satisfaction;

1071 e) be monitored;

1072 f) be communicated;

1073 g) be updated as appropriate.

1074 The organization shall retain documented information on the quality objectives.

1075 6.2.2 When planning how to achieve its quality objectives, the organization shall determine:

1076 a) what will be done;

1077 b) what resources will be required;

1078 c) who will be responsible;

1079 d) when it will be completed;

1080 e) how the results will be evaluated.

1081 6.3 Planning of changes

1082 Where the organization determines the need for change to the quality management system (see 4.4)

1083 the change shall be carried out in a planned and systematic manner.

1084 The organization shall consider:

1085 a) the purpose of the change and any of its potential consequences;

1086 b) the integrity of the quality management system;

1087 c) the availability of resources;

1088 d) the allocation or reallocation of responsibilities and authorities.

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Principle of The New Standard of QMS

1089 7 Support

1090 7.1 Resources

1091 7.1.1 General

1092 The organization shall determine and provide the resources needed for the establishment,

1093 implementation, maintenance and continual improvement of the quality management system.

1094 The organization shall consider:

1095 a) the capabilities of, and constraints on, existing internal resources;

1096 b) what needs to be obtained from external providers.

1097 7.1.2 People

1098 To ensure that the organization can consistently meet customer and applicable statutory and

1099 regulatory requirements, the organization shall provide the persons necessary for the effective

1100 operation of the quality management system, including the processes needed.

1101 7.1.3 Infrastructure

1102 The organization shall determine, provide and maintain the infrastructure for the operation of its

1103 processes to achieve conformity of products and services.

1104 NOTE Infrastructure can include:

1105 a) buildings and associated utilities;

1106 b) equipment including hardware and software;

1107 c) transportation;

1108 d) information and communication technology.

1109 7.1.4 Environment for the operation of processes

1110 The organization shall determine, provide and maintain the environment necessary for the operation of

1111 its processes and to achieve conformity of products and services.

1112 NOTE Environment for the operation of processes can include physical, social, psychological, environmental

1113 and other factors (such as temperature, humidity, ergonomics and cleanliness).

1114 7.1.5 Monitoring and measuring resources

1115 Where monitoring or measuring is used for evidence of conformity of products and services to

1116 specified requirements the organization shall determine the resources needed to ensure valid and

1117 reliable monitoring and measuring results.

1118 The organization shall ensure that the resources provided:

1119 a) are suitable for the specific type of monitoring and measurement activities being undertaken;

1120 b) are maintained to ensure their continued fitness for their purpose.

1121 The organization shall retain appropriate documented information as evidence of fitness for purpose of

1122 monitoring and measurement resources.

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Where measurement traceability is: a statutory or regulatory requirement; a customer 1123 or relevant

1124 interested party expectation; or considered by the organization to be an essential part of providing

1125 confidence in the validity of measurement results; measuring instruments shall be:

1126 ¾ verified or calibrated at specified intervals or prior to use against measurement standards

1127 traceable to international or national measurement standards. Where no such standards exist, the

1128 basis used for calibration or verification shall be retained as documented information;

1129 ¾ identified in order to determine their calibration status;

1130 ¾ safeguarded from adjustments, damage or deterioration that would invalidate the calibration

1131 status and subsequent measurement results.

1132 The organization shall determine if the validity of previous measurement results has been adversely

1133 affected when an instrument is found to be defective during its planned verification or calibration, or

1134 during its use, and take appropriate corrective action as necessary.

1135 7.1.6 Organizational knowledge

1136 The organization shall determine the knowledge necessary for the operation of its processes and to

1137 achieve conformity of products and services.

1138 This knowledge shall be maintained, and made available to the extent necessary.

1139 When addressing changing needs and trends, the organization shall consider its current knowledge

1140 and determine how to acquire or access the necessary additional knowledge.

1141 NOTE 1 Organizational knowledge can include information such as intellectual property and lessons learned.

1142 NOTE 2 To obtain the knowledge required, the organization can consider:

1143 a) internal sources (e.g. learning from failures and successful projects, capturing undocumented knowledge

1144 and experience of topical experts within the organization);

1145 b) external sources (e.g. standards, academia, conferences, gathering knowledge with customers or

1146 providers).

1147 7.2 Competence

1148 The organization shall:

1149 a) determine the necessary competence of person(s) doing work under its control that affects its

1150 quality performance;

1151 b) ensure that these persons are competent on the basis of appropriate education, training, or

1152 experience;

1153 c) where applicable, take actions to acquire the necessary competence, and evaluate the

1154 effectiveness of the actions taken;

1155 d) retain appropriate documented information as evidence of competence.

1156 NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the re1157

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

1158 7.3 Awareness

1159 Persons doing work under the organization’s control shall be aware of:

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a) the 1160 quality policy;

1161 b) relevant quality objectives;

1162 c) their contribution to the effectiveness of the quality management system, including the benefits of

1163 improved quality performance;

1164 d) the implications of not conforming with the quality management system requirements.

1165 7.4 Communication

1166 The organization shall determine the internal and external communications relevant to the quality

1167 management system including:

1168 a) on what it will communicate;

1169 b) when to communicate;

1170 c) with whom to communicate;

1171 d) how to communicate.

1172 7.5 Documented Information

1173 7.5.1 General

1174 The organization’s quality management system shall include

1175 a) documented information required by this International Standard;

1176 b) documented information determined by the organization as being necessary for the effectiveness

1177 of the quality management system.

1178 NOTE The extent of documented information for a quality management system can differ from one

1179 organization to another due to:

1180 a) the size of organization and its type of activities, processes, products and services;

1181 b) the complexity of processes and their interactions;

1182 c) the competence of persons.

1183 7.5.2 Creating and updating

1184 When creating and updating documented information the organization shall ensure appropriate:

1185 a) identification and description (e.g. a title, date, author, or reference number);

1186 b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);

1187 c) review and approval for suitability and adequacy.

1188 7.5.3 Control of documented Information

1189

1190 7.5.3.1 Documented information required by the quality management system and by this International

1191 Standard shall be controlled to ensure:

1192 a) it is available and suitable for use, where and when it is needed;

1193 b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

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7.5.3.2 For the control of documented information, the organization shall address 1194 the following

1195 activities, as applicable:

1196 a) distribution, access, retrieval and use;

1197 b) storage and preservation, including preservation of legibility;

1198 c) control of changes (e.g. version control);

1199 d) retention and disposition.

1200 Documented information of external origin determined by the organization to be necessary for the

1201 planning and operation of the quality management system shall be identified as appropriate, and

1202 controlled.

1203 NOTE Access can imply a decision regarding the permission to view the documented information only, or

1204 the permission and authority to view and change the documented information.

ISO Benefits

1205 8 Operation

1206 8.1 Operational planning and control

1207 The organization shall plan, implement and control the processes, as outlined in 4.4, needed to meet

1208 requirements for the provision of products and services and to implement the actions determined in

1209 6.1, by:

1210 a) determining requirements for the product and services;

1211 b) establishing criteria for the processes and for the acceptance of products and services;

1212 c) determining the resources needed to achieve conformity to product and service requirements;

1213 d) implementing control of the processes in accordance with the criteria;

1214 e) retaining documented information to the extent necessary to have confidence that the processes

1215 have been carried out as planned and to demonstrate conformity of products and services to

1216 requirements.

1217 The output of this planning shall be suitable for the organization's operations.

1218 The organization shall control planned changes and review the consequences of unintended changes,

1219 taking action to mitigate any adverse effects, as necessary.

1220 The organization shall ensure that outsourced processes are controlled in accordance with 8.4.

1221 8.2 Determination of requirements for products and services

1222 8.2.1 Customer communication

1223 The organization shall establish the processes for communicating with customers in relation to:

1224 a) information relating to products and services;

1225 b) enquiries, contracts or order handling, including changes;

1226 c) obtaining customer views and perceptions, including customer complaints;

1227 d) the handling or treatment of customer property, if applicable;

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e) specific requirements for contingency actions, 1228 when relevant.

1229 8.2.2 Determination of requirements related to products and services

1230 The organization shall establish, implement and maintain a process to determine the requirements for

1231 the products and services to be offered to potential customers.

1232 The organization shall ensure that:

1233 a) product and service requirements (including those considered necessary by the organisation),

1234 and applicable statutory and regulatory requirements, are defined;

1235 b) it has the ability to meet the defined requirements and substantiate the claims for the products

1236 and services it offers.

1237 8.2.3 Review of requirements related to products and services

1238 The organization shall review, as applicable:

1239 a) requirements specified by the customer, including the requirements for delivery and post-delivery

1240 activities;

1241 b) requirements not stated by the customer, but necessary for the customers' specified or intended

1242 use, when known;

1243 c) additional statutory and regulatory requirements applicable to the products and services;

1244 d) contract or order requirements differing from those previously expressed.

1245 NOTE Requirements can also include those arising from relevant interested parties.

1246 This review shall be conducted prior to the organization’s commitment to supply products and services

1247 to the customer and shall ensure contract or order requirements differing from those previously

1248 defined are resolved.

1249 Where the customer does not provide a documented statement of their requirements, the customer

1250 requirements shall be confirmed by the organization before acceptance.

1251 Documented information describing the results of the review, including any new or changed

1252 requirements for the products and services, shall be retained.

1253 Where requirements for products and services are changed, the organization shall ensure that

1254 relevant documented information is amended and that relevant personnel are made aware of the

1255 changed requirements.

1256

1257 8.3 Design and development of products and services

1258 8.3.1 General

1259 Where the detailed requirements of the organization’s products and services are not already

1260 established or not defined by the customer or by other interested parties, such that they are adequate

1261 for subsequent production or service provision, the organization shall establish, implement and

1262 maintain a design and development process.

1263 NOTE 1 The organization can also apply the requirements given in 8.5 to the development of processes for

1264 production and services provision

1265 NOTE 2 For services, design and development planning can address the whole service delivery process. The

1266 organization can therefore choose to consider the requirements of clauses 8.3 and 8.5 together.

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1267 8.3.2 Design and development planning

1268 In determining the stages and controls for design and development, the organization shall consider:

1269 a) the nature, duration and complexity of the design and development activities;

1270 b) requirements that specify particular process stages, including applicable design and development

1271 reviews;

1272 c) the required design and development verification and validation;

1273 d) the responsibilities and authorities involved in the design and development process;

1274 e) the need to control interfaces between individuals and parties involved in the design and

1275 development process;

1276 f) the need for involvement of customer and user groups in the design and development process;

1277 g) the necessary documented information to confirm that design and development requirements

1278 have been met.

1279 8.3.3 Design and development Inputs

1280 The organization shall determine:

1281 a) requirements essential for the specific type of products and services being designed and

1282 developed, including, as applicable, functional and performance requirements;

1283 b) applicable statutory and regulatory requirements;

1284 c) standards or codes of practice that the organization has committed to implement;

1285 d) internal and external resource needs for the design and development of products and services;

1286 e) the potential consequences of failure due to the nature of the products and services;

1287 f) the level of control expected of the design and development process by customers and other

1288 relevant interested parties.

1289 Inputs shall be adequate for design and development purposes, complete, and unambiguous.

1290 Conflicts among inputs shall be resolved.

1291 8.3.4 Design and development controls

1292 The controls applied to the design and development process shall ensure that:

1293 a) the results to be achieved by the design and development activities are clearly defined;

1294 b) design and development reviews are conducted as planned;

1295 c) verification is conducted to ensure that the design and development outputs have met the design

1296 and development input requirements;

1297 d) validation is conducted to ensure that the resulting products and services are capable of meeting

1298 the requirements for the specified application or intended use (when known).

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1299 8.3.5 Design and development outputs

1300 The organization shall ensure that design and development outputs:

1301 a) meet the input requirements for design and development;

1302 b) are adequate for the subsequent processes for the provision of products and services;

1303 c) include or reference monitoring and measuring requirements, and acceptance criteria, as

1304 applicable;

1305 d) ensure products to be produced, or services to be provided, are fit for intended purpose and their

1306 safe and proper use.

1307 The organization shall retain the documented information resulting from the design and development

1308 process.

1309 8.3.6 Design and development changes

1310 The organization shall review, control and identify changes made to design inputs and design outputs

1311 during the design and development of products and services or subsequently, to the extent that there

1312 is no adverse impact on conformity to requirements.

1313 Documented information on design and development changes shall be retained.

1314 8.4 Control of externally provided products and services

1315 8.4.1 General

1316 The organization shall ensure that externally provided processes, products, and services conform to

1317 specified requirements.

1318 The organization shall apply the specified requirements for the control of externally provided products

1319 and services when:

1320 a) products and services are provided by external providers for incorporation into the organization’s

1321 own products and services;

1322 b) products and services are provided directly to the customer(s) by external providers on behalf of

1323 the organization;

1324 c) a process or part of a process is provided by an external provider as a result of a decision by the

1325 organization to outsource a process or function.

1326 The organization shall establish and apply criteria for the evaluation, selection, monitoring of

1327 performance and re-evaluation of external providers based on their ability to provide processes or

1328 products and services in accordance with specified requirements.

1329 The organization shall retain appropriate documented information of the results of the evaluations,

1330 monitoring of the performance and re-evaluations of the external providers.

1331 8.4.2 Type and extent of control of external provision

1332 In determining the type and extent of controls to be applied to the external provision of processes,

1333 products and services, the organisation shall take into consideration:

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a) the potential impact of the externally provided processes, products and 1334 services on the

1335 organization’s ability to consistently meet customer and applicable statutory and regulatory

1336 requirements;

1337 b) the perceived effectiveness of the controls applied by the external provider.

1338 The organization shall establish and implement verification or other activities necessary to ensure the

1339 externally provided processes, products and services do not adversely affect the organisation's ability

1340 to consistently deliver conforming products and services to its customers.

1341 Processes or functions of the organization which have been outsourced to an external provider remain

1342 within the scope of the organization’s quality management system; accordingly, the organization shall

1343 consider a) and b) above and define both the controls it intends to apply to the external provider and

1344 those it intends to apply to the resulting process output.

1345 8.4.3 Information for external providers

1346 The organization shall communicate to external providers applicable requirements for the following:

1347 a) the products and services to be provided or the processes to be performed on behalf of the

1348 organization;

1349 b) approval or release of products and services, methods, processes or equipment;

1350 c) competence of personnel, including necessary qualification;

1351 d) their interactions with the organization's quality management system;

1352 e) the control and monitoring of the external provider’s performance to be applied by the

1353 organization;

1354 f) verification activities that the organization, or its customer, intends to perform at the external

1355 provider’s premises.

1356 The organization shall ensure the adequacy of specified requirements prior to their communication to

1357 the external provider.

1358 8.5 Production and service provision

1359 8.5.1 Control of production and service provision

1360 The organization shall implement controlled conditions for production and service provision, including

1361 delivery and post-delivery activities.

1362 Controlled conditions shall include, as applicable:

1363 a) the availability of documented information that defines the characteristics of the products and

1364 services;

1365 b) the availability of documented information that defines the activities to be performed and the

1366 results to be achieved;

1367 c) monitoring and measurement activities at appropriate stages to verify that criteria for control of

1368 processes and process outputs, and acceptance criteria for products and services, have been

1369 met.

1370 d) the use, and control of suitable infrastructure and process environment;

1371 e) the availability and use of suitable monitoring and measuring resources;

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f) the competence and, where applicable, required qualification 1372 of persons;

1373 g) the validation, and periodic revalidation, of the ability to achieve planned results of any process

1374 for production and service provision where the resulting output cannot be verified by subsequent

1375 monitoring or measurement;

1376 h) the implementation of products and services release, delivery and post-delivery activities.

1377 8.5.2 Identification and traceability

1378 Where necessary to ensure conformity of products and services, the organization shall use suitable

1379 means to identify process outputs.

1380 The organization shall identify the status of process outputs with respect to monitoring and

1381 measurement requirements throughout production and service provision.

1382 Where traceability is a requirement, the organization shall control the unique identification of the

1383 process outputs, and retain any documented information necessary to maintain traceability.

1384 NOTE Process outputs are the results of any activities which are ready for delivery to the organization’s

1385 customer or to an internal customer (e.g. receiver of the inputs to the next process); they can include products,

1386 services, intermediate parts, components, etc.

1387 8.5.3 Property belonging to customers or external providers

1388 The organization shall exercise care with property belonging to the customer or external providers

1389 while it is under the organization's control or being used by the organization. The organization shall

1390 identify, verify, protect and safeguard the customer’s or external provider’s property provided for use or

1391 incorporation into the products and services.

1392 When property of the customer or external provider is incorrectly used, lost, damaged or otherwise

1393 found to be unsuitable for use, the organization shall report this to the customer or external provider.

1394 NOTE Customer property can include material, components, tools and equipment, customer premises,

1395 intellectual property and personal data.

1396 8.5.4 Preservation

1397 The organization shall ensure preservation of process outputs during production and service provision,

1398 to the extent necessary to maintain conformity to requirements.

1399 NOTE Preservation can include identification, handling, packaging, storage, transmission or transportation,

1400 and protection.

1401 8.5.5 Post-delivery activities

1402 As applicable, the organization shall meet requirements for post-delivery activities associated with the

1403 products and services.

1404 In determining the extent of post-delivery activities that are required, the organisation shall consider:

1405 a) the risks associated with the products and services;

1406 b) the nature, use and intended lifetime of the products and services;

1407 c) customer feedback;

1408 d) statutory and regulatory requirements.

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NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations 1409 such as

1410 maintenance services, and supplementary services such as recycling or final disposal.

1411 8.5.6 Control of changes

1412 The organization shall review and control unplanned changes essential for production or service

1413 provision to the extent necessary to ensure continuing conformity with specified requirements.

1414 The organization shall retain documented information describing the results of the review of changes,

1415 the personnel authorizing the change, and any necessary actions.

1416 8.6 Release of products and services

1417 The organization shall implement the planned arrangements at appropriate stages to verify that

1418 product and service requirements have been met. Evidence of conformity with the acceptance criteria

1419 shall be retained.

1420 The release of products and services to the customer shall not proceed until the planned

1421 arrangements for verification of conformity have been satisfactorily completed, unless otherwise

1422 approved by a relevant authority and, as applicable, by the customer. Documented information shall

1423 provide traceability to the person(s) authorizing release of products and services for delivery to the

1424 customer.

1425 8.7 Control of nonconforming process outputs, products and services

1426 The organization shall ensure process outputs, products and services that do not conform to

1427 requirements are identified and controlled to prevent their unintended use or delivery.

1428 The organization shall take appropriate corrective action based on the nature of the nonconformity and

1429 its impact on the conformity of products and services. This applies also to nonconforming products and

1430 services detected after delivery of the products or during the provision of the service.

1431 As applicable, the organization shall deal with nonconforming process outputs, products and services

1432 in one or more of the following ways:

1433 a) correction;

1434 b) segregation, containment, return or suspension of provision of products and services;

1435 c) informing the customer;

1436 d) obtaining authorization for:

1437 ¾ use “as-is’;

1438 ¾ release, continuation or re-provision of the products and services;

1439 ¾ acceptance under concession.

1440 Where nonconforming process outputs, products and services are corrected, conformity to the

1441 requirements shall be verified.

1442 The organization shall retain documented information of actions taken on nonconforming process

1443 outputs, products and services, including on any concessions obtained and on the person or authority

1444 that made the decision regarding dealing with the nonconformity.

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Working in a Team we Together
1445 9 Performance Evaluation

1446 9.1 Monitoring, measurement, analysis and evaluation

1447 9.1.1 General

1448 The organization shall determine:

1449 a) what needs to be monitored and measured;

1450 b) the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid

1451 results;

1452 c) when the monitoring and measuring shall be performed;

1453 d) when the results from monitoring and measurement shall be analysed and evaluated.

1454 The organization shall ensure that monitoring and measurement activities are implemented in

1455 accordance with the determined requirements and shall retain appropriate documented information as

1456 evidence of the results.

1457 The organization shall evaluate the quality performance and the effectiveness of the quality

1458 management system.

1459 9.1.2 Customer satisfaction

1460 The organization shall monitor customer perceptions of the degree to which requirements have been

1461 met.

1462 The organization shall obtain information relating to customer views and opinions of the organisation

1463 and its products and services.

1464 The methods for obtaining and using this information shall be determined.

1465 NOTE Information related to customer views can include customer satisfaction or opinion surveys, customer

1466 data on delivered products or services quality, market-share analysis, compliments, warranty claims and dealer

1467 reports.

1468 9.1.3 Analysis and evaluation

1469 The organization shall analyse and evaluate appropriate data and information arising from monitoring,

1470 measurement and other sources.

1471 The output of analysis and evaluation shall be used to:

1472 a) demonstrate conformity of products and services to requirements;

1473 b) assess and enhance customer satisfaction;

1474 c) ensure conformity and effectiveness of the quality management system;

1475 d) demonstrate that planning has been successfully implemented;

1476 e) assess the performance of processes;

1477 f) assess the performance of external provider(s);

1478 g) determine the need or opportunities for improvements within the quality management system.

1479 The results of analysis and evaluation shall also be used to provide inputs to management review.

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1480 9.2 Internal audit

1481 9.2.1 The organization shall conduct internal audits at planned intervals to provide information on

1482 whether the quality management system;

1483 a) conforms to:

1484 1) the organization’s own requirements for its quality management system;

1485 2) the requirements of this International Standard;

1486 b) is effectively implemented and maintained.

1487 9.2.2 The organization shall:

1488 a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods,

1489 responsibilities, planning requirements and reporting, which shall take into consideration the

1490 quality objectives, the importance of the processes concerned, customer feedback, changes

1491 impacting on the organisation, and the results of previous audits;

1492 b) define the audit criteria and scope for each audit;

1493 c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;

1494 d) ensure that the results of the audits are reported to relevant management;

1495 e) take necessary correction and corrective actions without undue delay;

1496 f) retain documented information as evidence of the implementation of the audit programme and the

1497 audit results.

1498 NOTE See ISO 19011 for guidance.

1499 9.3 Management review

1500 9.3.1 Top management shall review the organization's quality management system, at planned

1501 intervals, to ensure its continuing suitability, adequacy, and effectiveness.

1502 The management review shall be planned and carried out taking into consideration:

1503 a) the status of actions from previous management reviews;

1504 b) changes in external and internal issues that are relevant to the quality management system

1505 including its strategic direction;

1506 c) information on the quality performance, including trends and indicators for:

1507 1) nonconformities and corrective actions;

1508 2) monitoring and measurement results;

1509 3) audit results;

1510 4) customer satisfaction;

1511 5) issues concerning external providers and other relevant interested parties;

1512 6) adequacy of resources required for maintaining an effective quality management system;

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7) process performance and conformity of products 1513 and services;

1514 d) the effectiveness of actions taken to address risks and opportunities (see clause 6.1);

1515 e) new potential opportunities for continual improvement.

1516 9.3.2 The outputs of the management review shall include decisions and actions related to:

1517 a) continual improvement opportunities;

1518 b) any need for changes to the quality management system, including resource needs.

1519 The organization shall retain documented information as evidence of the results of management

1520 reviews.

ISO Chart of Process

1521 10 Improvement

1522 10.1 General

1523 The organization shall determine and select opportunities for improvement and implement necessary

1524 actions to meet customer requirements and enhance customer satisfaction.

1525 This shall include, as appropriate:

1526 a) improving processes to prevent nonconformities;

1527 b) improving products and services to meet known and predicted requirements;

1528 c) improving quality management system results.

1529 NOTE Improvement can be effected reactively (e.g. corrective action), incrementally (e.g. continual

1530 improvement), by step change (e.g. breakthrough), creatively (e.g. innovation) or by re-organisation (e.g.

1531 transformation).

1532 10.2 Nonconformity and corrective action

1533 10.2.1 When a nonconformity occurs, including those arising from complaints, the organization shall:

1534 a) react to the nonconformity, and as applicable:

1535 1) take action to control and correct it;

1536 2) deal with the consequences;

1537 b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does

1538 not recur or occur elsewhere, by:

1539 1) reviewing the nonconformity;

1540 2) determining the causes of the nonconformity;

1541 3) determining if similar nonconformities exist, or could potentially occur;

1542 c) implement any action needed;

1543 d) review the effectiveness of any corrective action taken;

1544 e) make changes to the quality management system, if necessary.

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Corrective actions shall be appropriate to the effects of the nonconformities 1545 encountered.

1546 NOTE 1 In some instances, it can be impossible to eliminate the cause of a nonconformity.

1547 NOTE 2 Corrective action can reduce the likelihood of recurrence to an acceptable level.

1548 10.2.2 The organization shall retain documented information as evidence of:

1549 a) the nature of the nonconformities and any subsequent actions taken;

1550 b) the results of any corrective action.

1551 10.3 Continual Improvement

1552 The organization shall continually improve the suitability, adequacy, and effectiveness of the quality

1553 management system.

1554 The organization shall consider the outputs of analysis and evaluation, and the outputs from

1555 management review, to confirm if there are areas of underperformance or opportunities that shall be

1556 addressed as part of continual improvement.

1557 Where applicable, the organization shall select and utilise applicable tools and methodologies for

1558 investigation of the causes of underperformance and for supporting continual improvement.

ISO 9001:2015 - Preparation & Implementation :Video Tutorial

ISO 9001:2015 Presentation : Video Tutorial

To See & To Download ISO-9001-2015 New Version Auditors Training In Power Point Presentation

To Download ISO-9001 -2015 Training & Audit Manual & Guide Book In PDF

1 Available from website:http://www.iso.org
The world’s quality management systems standard, ISO 9001, has been revised. Here, Kevin McKinley, Acting ISO Secretary-General, and Nigel Croft, Chair of the subcommittee that revised ISO 9001, tell you everything you need to know about the new edition of this landmark standard that enhances an organization’s ability to satisfy its customers and provides a coherent foundation for growth and sustained success.

ISO 9001:2015 Training Presentation video. The online course Covers all requirements of the latest version of the ISO standard.

** { Courtesy: ISO-Geneva,Switzerland. }

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