ISO/IEC 17011:2017 Conformity Assessment - Requirements for accreditation bodies accrediting conformity assessment bodies

Содержание

Слайд 2

Introduction This presentation has been developed by the Convenors of ISO

Introduction

This presentation has been developed by the Convenors of ISO CASCO

WG42.
The aim is to support all interested parties concerned by the implementation of this new standard, ISO/IEC 17011: 2017 Conformity assessment – Requirements for accreditation bodies accrediting conformity assessment bodies.
This is an open presentation without any copyrights and can be used by anyone.
ISO CASCO Secretary ISO CASCO Convenors WG42
Sean MacCurtain Alister Dalrymple
Cynthia Woodley
Слайд 3

Purpose of ISO/IEC 17011 Scope This document specifies requirements for the

Purpose of ISO/IEC 17011

Scope
This document specifies requirements for the competence, consistent

operation and impartiality of accreditation bodies assessing and accrediting conformity assessment bodies.
NOTE: In the context of this document, activities covered by accreditation include, but are not limited to, testing, calibration, inspection, certification of management systems, persons, products and services, provision of proficiency testing, production of reference materials, validation and verification.
Слайд 4

ISO/IEC 17011 Background The first edition was ISO/IEC Guide 58 and

ISO/IEC 17011 Background

The first edition was ISO/IEC Guide 58 and 61

and TR 17010.
The 1st edition of ISO/IEC 17011 was published in 2004.
The current edition is 2017.
Слайд 5

Development stages of ISO/IEC 17011 Working draft WD Committee draft 1

Development stages of ISO/IEC 17011

Working draft WD

Committee draft 1 (CD)

Committee draft

2 (CD)

Draft International Standard (DIS)

Publication 30 November 2017

1771 comment 82% positive votes CASCO members

1410 comments - 82% positive votes CASCO members

2014

2017

583 comments –96% positive votes CASCO members 96% in IEC

Oct 2015

Mar 2016

Nov 2016

Oct 2017

Final Draft International Standard (FDIS)

583 comments –95% positive votes CASCO members 90% in IEC

Слайд 6

History

History

Слайд 7

Key Issues and Major Edits The main changes compared to the

Key Issues and Major Edits

The main changes compared to the previous

edition are as follows:
alignment with the common structure for the 17000 series standards and incorporation of CASCO Common Elements in clauses on impartiality, confidentiality, complaints and appeal and management system;
Recognition of proficiency testing as an activity covered by accreditation;
addition of new definitions for “accreditation scheme” (see 3.8), “flexible scope of accreditation” (see 3.7), “remote assessment” (see 3.26) and “assessment programme” (see 3.27);
introduction of the concept of risk and risk-based assessments;
Incorporation of the IAF and ILAC documents where appropriate;
incorporation of competence criteria in the document, including an informative annex on knowledge and skills; and
Did not include a principles section in the new version.
Слайд 8

Structure of ISO/IEC 17011 ISO/IEC 17011:2017 Scope Normative references Terms and

Structure of ISO/IEC 17011

ISO/IEC 17011:2017

Scope
Normative references
Terms and definitions
General

requirements
Structural requirements
Resource Requirements
Process requirements
Information requirements
Management systems Requirements
Informative Annex

ISO/IEC 17011:2004

Scope
Normative references
Terms and definitions
Accreditation Body
Management
Human resources
Accreditation process
Responsibilities of the AB

Слайд 9

CASCO Common Elements Text

CASCO Common Elements

Text

Слайд 10

Terms and definitions (3) Accreditation (3.1) Third party attestation related to

Terms and definitions (3)

Accreditation (3.1)
Third party attestation related to a conformity

assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks
Accreditation body (3.2)
Authoritative body that performs accreditation
Conformity assessment body (3.4)
Body that performs conformity assessment activities and that can be the object of accreditation
In context of ISO/IEC 17011, conformity assessment activities include but are not limited to testing, calibration, inspection, certification (management systems, persons, products, processes and services), provision of proficiency testing, production of reference materials, validation and verification
Слайд 11

Terms and definitions - Terms Deleted from 2004 Version 3.4 -

Terms and definitions - Terms Deleted from 2004 Version

3.4 - accreditation

certificate
3.15 - lead assessor replaced by 3.31 Team leader
3.18 - surveillance
Слайд 12

Terms and definitions – New Terms (3) 3.5 – conformity assessment

Terms and definitions – New Terms (3)

3.5 – conformity assessment activity
3.7

– flexible scope of accreditation
3.8 - accreditation scheme
3.9 - accreditation activity
3.10 – impartiality
3.11 - accreditation process
3.13 - accreditation decision
Слайд 13

New terms 3.14 - granting accreditation 3.15 - maintaining accreditation 3.23

New terms

3.14 - granting accreditation
3.15 - maintaining accreditation
3.23 – reassessment
3.24 -

assessment techniques
3.26 - remote assessment
3.27 - assessment programme
3.28 - assessment plan
3.29 - accreditation body personnel
Слайд 14

Terms and definitions – Modified Terms (3) Several terms were slightly

Terms and definitions – Modified Terms (3)

Several terms were slightly modified.

Following table cross- references terms from 2017 version to 2004 version.
Слайд 15

Terminology Cross Reference Table - Summary

Terminology Cross Reference Table - Summary

Слайд 16

ISO/IEC 17011: 2017 Clause 4 Changed from Accreditation Body to General

ISO/IEC 17011: 2017 Clause 4

Changed from Accreditation Body to General Requirements
Minor

edits to the Clause 4.1 on Legal Entity (used to be Legal Responsibility)
Clause 4.2 Accreditation Agreement moved from Clause 8.1 in 2004 version
Clause 4.2 Accreditation Agreement:
New requirement to have legally enforceable arrangements with clients to commit to access (4.2.e) and to commit to the Accreditation Body’s policy for the use of the accreditation symbol (4.2.g).
New requirement to assist in investigation and resolution of accreditation-related complaints (4.2.k).
Слайд 17

ISO/IEC 17011: 2017 Clause 4 Clause 4.3 Use of Accreditation Symbol

ISO/IEC 17011: 2017 Clause 4

Clause 4.3 Use of Accreditation Symbol moved

from Clause 8.3 in 2004 version.
New requirements regarding discontinuing reference to accreditation upon withdrawal (4.3.1.c), ensure accreditation of product, process, service or management system is not implied (4.3.1.d), and legally protecting symbol (4.3.2).
New requirements regarding the use and monitoring of the symbol in combination with other conformity assessment marks (4.3.3.a).
New requirements regarding reproduction of the accreditation symbol (4.3.3.c) and reference to accreditation (4.3.3.d).
New requirements regarding use of the symbol and claims of accreditation in communication media (4.3.3.e).
Слайд 18

ISO/IEC 17011: 2017 Clause 4 Clause 4.4 Impartiality Several new clauses

ISO/IEC 17011: 2017 Clause 4

Clause 4.4 Impartiality
Several new clauses regarding impartiality

including requirement to undertake accreditation impartially (4.4.1), accreditation body being responsible for the impartiality of its accreditation activities (4.4.2), being organized to ensure that accreditation is provided impartially (4.4.2), having top management commitment to impartiality (4.4.3) and making public an impartiality policy (4.4.3).
New Clauses pertaining to identifying risks to impartiality (4.4.6) and documenting how it eliminates or minimizes such risks (4.4.7) and documenting residual risk (4.4.7), having top management review risks (4.4.8), and not providing accreditation if the risk to impartiality is unacceptable (4.4.9).
Слайд 19

ISO/IEC 17011: 2017 Clause 4 Clause 4.6 Accreditation Schemes New requirement

ISO/IEC 17011: 2017 Clause 4

Clause 4.6 Accreditation Schemes
New requirement for accreditation

bodies to have a policy and documented procedures to determine the suitability of the conformity assessment schemes and standards for accreditation purposes (4.6.3).
New requirement for accreditation body to consider the feasibility of launching or extending an accreditation scheme (4.6.4.a).
New requirement for accreditation bodies to consider implementation or transition arrangements (4.6.4.f), and views of interested parties when establishing accreditation schemes(4.6.4.g).
New requirements regarding accreditation body discontinuing accreditation schemes in part or in full (4.6.5).
Слайд 20

ISO/IEC 17011:2017 Clause 5 Clause 5 Structural requirements (was Clause 4.2

ISO/IEC 17011:2017 Clause 5

Clause 5 Structural requirements (was Clause 4.2 in

2004 version)
New requirement if accreditation body is part of a larger entity (5.3)
Слайд 21

ISO/IEC 17011: 2017 Clause 6 Clause 6 Resource Requirements New requirements

ISO/IEC 17011: 2017 Clause 6

Clause 6 Resource Requirements
New requirements for the

competence of personnel (6.1)
New requirements regarding the accreditation body having a process to ensure its personnel have the appropriate knowledge and skills (6.1.1)
New requirements regarding determination of competence criteria (6.1.2)
New requirements for identifying training needs and providing access to specific training (6.1.3.3)
Слайд 22

ISO/IEC 17011: 2017 Clause 7 Clause 7 Process Requirements New requirement

ISO/IEC 17011: 2017 Clause 7

Clause 7 Process Requirements
New requirement regarding evidence

of fraudulent behavior, false information or concealing information (7.2.4).
New requirement for the accreditation body to establish documented procedures to assess regardless of where activities are performed (7.4.4).
New requirement for the accreditation body to consider the risk associated with the activities, locations and persons (7.4.6).
New requirement for the accreditation body to develop an assessment plan (7.4.7).
New requirement for the accreditation body to have documented procedures for describing the assessment techniques used (7.6.1).
Accreditation body must conduct the assessment based on the assessment plan (7.6.3)
Слайд 23

ISO/IEC 17011: 2017 Clause 7 Clause 7 Process Requirements New requirement

ISO/IEC 17011: 2017 Clause 7

Clause 7 Process Requirements
New requirement for the

accreditation body to provide an explanation to the conformity assessment body if the report on the outcome of the assessment differs from the outcome delivered at the assessment (7.6.6.c).
New requirement for the accreditation body to describe its process for all types of accreditation decisions (7.7.1).
New requirement to review further information that may assist in determining the competence of the conformity assessment body (7.7.3.i).
New requirement specifying the effective date of accreditation shall be the date of or a date after the accreditation decision (7.8.2).
New scopes of accreditation identification added for proficiency testing (7.8.3.e), reference materials produces (7.8.3.f), validation and verification bodies (7.8.3.g) and other conformity assessment bodies (7.8.3.h).
Слайд 24

ISO/IEC 17011: 2017 Clause 7 Clause 7.9 Accreditation Cycle replaces Clause

ISO/IEC 17011: 2017 Clause 7

Clause 7.9 Accreditation Cycle replaces Clause 7.11

(reassessment and surveillance) in the 2004 version.
Clause 7.11 Suspending, withdrawing or reducing accreditation
New requirement for withdrawing of accreditation where there is evidence of fraudulent behavior or if the conformity assessment body intentionally provide false information or conceals information (7.11.2)
New requirement to have a documented procedure and criteria for lifting suspension of accreditation (7.11.3).
Слайд 25

ISO/IEC 17011 Clause 8 Clause 8 Information Requirements Common elements for

ISO/IEC 17011 Clause 8

Clause 8 Information Requirements
Common elements for confidential information

added (Clause 8.1)
Clause 8.2 Publicly available information
New requirement for the accreditation body to make public information about the accreditation body’s other activities, other than accreditation (8.2.1.
Слайд 26

ISO/IEC 17011 Clause 9 Clause 9 Management Systems Common elements added for Clause 9

ISO/IEC 17011 Clause 9

Clause 9 Management Systems
Common elements added for Clause

9
Слайд 27

Cross Reference Table The following tables cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011: 2004

Cross Reference Table

The following tables cross reference ISO/IEC 17011: 2017 to

ISO/IEC 17011: 2004
Слайд 28

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 29

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 30

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 31

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 32

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 33

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 34

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 35

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 36

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 37

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 38

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 39

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 40

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 41

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 42

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 43

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 44

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 45

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 46

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Слайд 47

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

Cross reference ISO/IEC 17011: 2017 to ISO/IEC 17011 2004

- Предыдущая
Лекция № 6. Традиции красноречия в России
Следующая -
Технологии эффективного общения и рационального поведения в конфликте

Похожие презентации

Вершина развития восстановительной науки и технологий StemRenu. Быстрое старение и антистарение
Производственная структура гостиницы. (Лекция 5.3)
Плиты с деревянным каркасом. Конструирование и расчет. Пластмассовые плиты
Психические состояния. Эмоции и воля
Языки программирования высокого уровня
Мастер класс – Батик (Дети совместно с родителями)
Способы преобразования чертежа
Л 19 Раздел 6.Тема 6.2. Медико-демографические показатели
Плюрингвальное образование в Европе
Шэжэрэ Юлмухаметовых из Аминево. Родовое дерево
Проведение Нового года в разных странах мира
Презентация Понятие и предмет административного права
Сочинение-описание. Васнецов. Богатыри
Презентация Цена как элемент комплекса маркетинга
Упражнение «выпады»
Язык программирования Pascal. Ветвление
Презентация+Профобучение
Организация контроля качества при строительстве транспортных сооружений
Ислам. Основные идеи ислама
Своя игра. Латынь
Педагогические методики применения ИКТ на уроке Выполнила: Поспелова И. В. учитель начальных классов Шарыпово МОУ СОШ №7
Технология ATM. (Лекция 3)
Теория электрических цепей
Олимпийский огонь «Сочи-2014» в цифрах и фактах
ВИЧ-инфекция. Парэнтеральные гепатиты
Лицензирование ПО
Роль маркетинга в процессе формирования новых типов бизнеса на примере мирового рынка настольных игр
5. Метрология.ppt
Вы можете прислать нам Вашу презентацию и мы опубликуем ее на сайте.
Обратная связь
Для правообладателей
Email: Нажмите что бы посмотреть