Handout Training Iso 9001 2015

8/17/2019 Handout Training Iso 9001 2015

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1. Structure and Terminology

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2. Products and Services

2008: The term “product” to include all output

categories.

2015: The term “products and services” includes alloutput categories (hardware, services, software andprocessed materials.

In most cases, the terms “products” and “services” areused together. Most output that organizations provideto customers, or are supplied to them by externalproviders, include both products and services.

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• 3. Context of the organisation

There are two new clauses relating to the context of theorganization:

4.1 Understanding the organization and its context

4.2 Understanding the needs and expectation of interestedparties.

The titles of clauses 4.1 and 4.2 provide for alignment withother management system standards. They do not implyextension of quality management system requirementsbeyond the Scope of this International Standard.

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4. Documented Information

The terms “documented procedure” and “record” haveboth been replaced throughout the requirements text by“documented information”.

Where ISO 9001:2008 would have referred to documentedprocedures (e.g. to define, control or support a process) this is nowexpressed as a requirement to maintain documented information.

Where ISO 9001:2008 would have referred to records this is nowexpressed as a requirement to retain documented information.

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5. Risk-based ApproachIt requires the organization to understand its context (clause 4.1) and determine the risks and opportunitiesthat need to be addressed (clause 6.1).

With the inclusion of this approach, it has facilitatedsome reduction in prescriptive requirements and theirreplacement by performance-based requirements.

Although risks and opportunities have to be determined andaddressed, the standard does not require for formal riskmanagement or a documented risk management process.

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6. Applicability This Standard no longer makes specific reference to‘exclusions’ when determining the applicability of itsrequirements to the organization’s quality managementsystem.

When a requirement can be applied within the scope of its QMS, theorganization cannot decide that it is not applicable.

Where a requirement cannot be applied (for example where the relevantprocess is not carried out) the organization can determine that the

requirement is not applicable.However, this is non-applicability cannot be allowed to result in failureto achieve conformity of products and services or meet theorganization’s aim to enhance customer satisfaction.

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7. Organizational knowledge Clause 7.1.6 Organizational knowledge addresses theneed to determine and maintain the knowledge obtainedby the organization, including by its personnel, toensure that it can achieve conformity of products andservices.

The process for considering and controlling past, existing andadditional knowledge needs to take account of the organization’scontext, including its size and complexity, the risks and opportunities

it needs to address, and the need for accessibility of knowledge.The balance between knowledge held by competent people andknowledge made available by other means is at the discretion of theorganization, provided that conformity of products and services canbe achieved.

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8. Control of externally provided products andservices

This addresses all forms of external provision, whetherit is by purchasing from a supplier , through anarrangement with an associate company, through theoutsourcing of processes and functions of theorganizations or by any other means.

The organization is required to take a risk-based approach todetermine the type and extent of controls appropriate to particularexternal providers and externally provided products and services.

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Purpose: Clothing manufacturer

Intended outcome: Production of men’s suits

Internal issues•Automation

•Workforce

•Design secrets

•Capacity

•Company culture

•Innovation

External issues•Customers

•Fashion

•New markets

•Deadlines

•Competition

•Regulators

•Utilities

(Relevant) interested parties•Consumers

•Employees

•Owners/shareholders

•Society

•Suppliers and partners

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':8 10;6.5K6e1. <:677 8</6X75<:W 5DE78D8./W D65./65. 6.2 41.e.3677M 5DE01S8 6

V3675/M D6.6;8D8./ <M</8DW 5.47325.; /:8 E0148<<8< .88282 6.2 /:850

5./8064e1.<W 5. 6441026.48 F5/: /:8 08V3508D8./< 19 /:5< )./80.6e1.67

&/6.2602^

':8 10;6.5K6e1. <:677 28/80D5.8 /:8 E0148<<8< .88282 910 /:8 V3675/M

D6.6;8D8./ <M</8D 6.2 /:850 6EE7546e1. /:013;:13/ /:8 10;6.5K6e1. 6.2

<:677 28/80D5.8A

6] /:8 40AC>3 08V35082 6.2 /:8 "C>AC>3 8JE84/82 901D /:8<8 E0148<<8<a

X] /:8 32HC20=2 6.2 40>2#5=l"0 19 /:8<8 E0148<<8<a4] /:8 405/8056W D8/:12<W 5.47325.; B253C#2B20>3 6.2 0876/82 A2#!"#B50=2

4014=5>"#3 .88282 /1 8.<308 /:8 8f84eS8 1E806e1.W 6.2 41./017 19 /:8<8

E0148<<8<a

2] /:8 #23"C#=23 .88282 6.2 8.<308 /:850 6S6576X575/Ma

C1EM05;:/ +)C !?@H



WF /"0>2\> "! '#7504g5>4"0

WFW aC5@4>E B50572B20> 3E3>2B 501 4>3 A#"=233238] /:8 6<<5;.D8./ 19 /:8 #23A"034;4@4l23 6.2 5C>?"#4l23 910 /:8<8 E0148<<8<a

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;] /:8 B2>?"13 !"# B"04>"#407N B253C#407N 53 5AA#"A#45>2N 501 295@C5l"0 19

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/@5C32 - T h2512#3?4A

-F* h2512#3?4A 501 ="BB4>B20>-F*F* h2512#3?4A 501 ="BB4>B20> >" >?2 HC5@4>E B50572B20> 3E3>2B

-F*F, /C3>"B2# !"=C3

-F, aC5@4>E A"@4=E

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C1EM05;:/ +)C !?@H



Y50572B20> i3 h2512#3?4A

?



L?5> 43 6'b Y:J:.KYKJ6

DEFINITIONS (ANNEX SL)

a person or group of people who directs and controls anorganisation at the highest level

J">2 * '1E D6.6;8D8./ :6< /:8 E1F80 /1 2878;6/8 63/:105/M 6.2 E01S528

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J">2 , )9 /:8 <41E8 19 /:8 D6.6;8D8./ <M</8D \c^?H] 41S80< 1.7M E60/ 19 6.

10;6.5K6/51. /:8. /1E D6.6;8D8./ 08980< /1 /:1<8 F:1 25084/ 6.2 41./017 /:6/

E60/ 19 /:8 10;6.5K6/51.^

C1EM05;:/ +)C !?@H

1 ?4 1 4



-F* h2512#3?4A 501 /"BB4>B20>

-F*F* h2512#3?4A 501 ="BB4>B20> !"# >?2 HC5@4>E B50572B20>

3E3>2B

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/1 /:8 V3675/M D6.6;8D8./ <M</8D XMA

6] /6Y5.; 64413./6X575/M 19 /:8 89984/5S8.8<< 19 /:8 V3675/M D6.6;8D8./

<M</8DaX] 203C#407 /:6/ /:8 V3675/M E1754M 6.2 V3675/M 1X[84/5S8< 608 8</6X75<:82 910

/:8 V3675/M D6.6;8D8./ <M</8D 6.2 608 41DE6/5X78 F5/: /:8 </06/8;54

25084/51. 6.2 /:8 41./8J/ 19 /:8 10;6.5K6/51. a

4] 203C#407 /:6/ /:8 V3675/M E1754M 5< 41DD3.546/82W 3.280</112 6.2 6EE7582

F5/:5. /:8 10;6.5K6/51.a

2] 203C#407 /:8 5./8;06/51. 19 /:8 V3675/M D6.6;8D8./ <M</8D 08V3508D8./<

5./1 /:8 10;6.5<6/51.d< X3<5.8<< E0148<<8<a

8] E01D1/5.; 6F608.8<< 19 /:8 E0148<< 6EE0164:a

C1EM05;:/ +)C !?@H

1 ?4 1 4



-F* h2512#3?4A 501 /"BB4>B20>

9] 203C#407 /:6/ /:8 08<13048< .88282 910 /:8 V3675/M D6.6;8D8./ <M</8D 608

6S6576X78a

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41.910D5.; /1 /:8 V3675/M D6.6;8D8./ <M</8D 08V3508D8./<a

:] 203C#407 /:6/ /:8 V3675/M D6.6;8D8./ <M</8D 64:58S8< 5/< 5./8.282

08<37/<a

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89984/5S8.8<< 19 /:8 V3675/M D6.6;8D8./ <M</8Da

[] E01D1/5.; 41./5.367 5DE01S8D8./a

Y] <3EE10/5.; 1/:80 0878S6./ D6.6;8D8./ 0178< /1 28D1.</06/8 /:850

786280<:5E 6< 5/ 6EE758< /1 /:850 6086< 19 08<E1.<5X575/M̂

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10 .1/ 910 E0195/^ C1EM05;:/ +)C !?@H

- * h 1 ?4 1 / 4



-F* h2512#3?4A 501 /"BB4>B20>

-F*F, /C3>"B2# O"=C3

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/1 43</1D80 9143< XM 8.<305.; /:6/A

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08V3508D8./< 608 28/80D5.82 6.2 D8/a

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6.2 62208<<82a

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C1EM05;:/ +)C !?@H

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-F, aC5@4>E A"@4=E

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B^!^! ':8 V3675/M E1754M <:677A

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X] X8 41DD3.546/82W 3.280</112 6.2 6EE7582 F5/:5. /:8 10;6.5K6e1.a4] X8 5954@5;@2 >" #2@2950> 40>2#23>21 A5#l23W 6< 6EE01E056/8^

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10;6.5K6e1.^

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19 /:5< )./80.6e1.67 &/6.2602a

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23A2=45@@E !"# #2A"#l07 >" >"A B50572B20>k

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F:8. 4:6.;8< /1 /:8 V3675/M D6.6;8D8./ <M</8D 608 E76..82 6.2

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VF* :=>4"03 >" 511#233 #43P3 501 "AA"#>C04>423

VF, aC5@4>E ";<2=>4923 501 A@500407 >" 5=?4292 >?2B

VF_ b@500407 "! =?50723

C1EM05;:/ +)C !?@H

L? > 4 R%&]



L?5> 43 R%&]

DEFINITIONS (ANNEX SL)

effect of uncertainty

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VF* :=>4"03 >" 511#233 #43P3 501 "AA"#>C04>423

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a E < A 7

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VF_ b@500407 "! =?50723

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UF*F* .202#5@

UF*F, b2"A@2

UF*F_ %0!#53>#C=>C#2

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UF* R23"C#=23

C1EM05;:/ +)C !?@H

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UF* R23"C#=23

C1EM05;:/ +)C !?@H

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UF* R23"C#=23

C1EM05;:/ +)C !?@H

UF*F- Y"04>"#407 501 B253C#407 #23"C#=23

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D86<305.; 08<37/<^

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Additional updates and information will be madeavailable as the change process proceeds.

Meanwhile, you can check www.iso.org for details

Guardian Independent Certification (GIC) Indonesia

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Date post:	06-Jul-2018
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