cause iso 9001, ohsas 18001 dan iso 14001

216
4 4.1 1 4.1 2 4.1 3 4.1 4 4.1 5 4.1 OHSAS 18001:2007 Clause ISO 14001:2004 Clause Quality managemen t system 4.1 Persyarata n Umum 4.1 Persya ratan Umum General requireme nts 4.2 Kebijakan K3 4.2 Kebija kan Lingkungan Establish the quality managemen t system (QMS) 4.3 Perencanaa n 4.3 Perenc anaan Document the QMS 4.3.1 Identifika si Bahaya, Penilaian Resiko, dan Pengendali an Resiko 4.3.1 Aspek Lingkungan Implement the QMS 4.3.2 Legal dan Persyarata n Lain 4.3.2 Lega l dan Persyarata n Lain Update the QMS 4.3.3 Sasaran dan Program 4.3.3 Sasaran, Target, dan Program Improve the effective ness of the QMS

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Page 1: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

4

4.1

1 4.1

2

4.1

3 4.1

4 4.1

5 4.1

OHSAS 18001:2007 Clause

ISO 14001:2004 Clause

Quality manage

ment system

4.1 Persyaratan Umum

4.1 Persyaratan Umum

General requirements

4.2 Kebijakan K3

4.2 Kebijakan Lingkungan

Establish the quality management system (QMS)

Cf. sub-clauses 5.1 and 5.6.1

4.3 Perencanaan

4.3 Perencanaan

Document the QMS

Cf. sub-clause 4.2.3

4.3.1 Identifikasi Bahaya, Penilaian Resiko, dan Pengendalian Resiko

4.3.1 Aspek Lingkungan

Implement the QMS

Cf. sub-clauses 5.1 and 5.5.2

4.3.2 Legal dan Persyaratan Lain

4.3.2 Legal dan Persyaratan Lain

Update the QMS

Cf. sub-clause 5.4.2

4.3.3 Sasaran dan Program

4.3.3 Sasaran, Target, dan Program

Improve the effectiveness of the QMS

Cf. sub-clause 8.5

Page 2: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

6 4.1 a

7 4.1 b

8 4.1 c

4.4 Implementasi dan Operasional

4.4 Implementasi dan Operasional

Determine the necessary processes and their application

See sub-clause 1.2 of ISO 9001; identify, understand  and evaluate all core activities which form the overall look of the organization

4.4.1 Sumberdaya, Peran, Tangung Jawab, dan Wewenan

4.4.1  Sumberdaya, Peran, Tangung Jawab, dan Wewenan

Determine the sequence and interaction of processes

Although the process mapping is notexplicitly required, in practice it is the best response to this requirement

4.4.2 Kompetensi, Pelatihan, dan Kesadaran

4.4.2 Kompetensi, Pelatihan, dan Kesadaran

Determine criteria and methods for effectiveness of process operation and control

Establish the means to control processes

Page 3: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

Tidak Ada 9 4.1 d

10 4.1 d

Tidak Ada

11 4.1 e

12 4.1 e

13 4.1 e

4.4.3 Komunikasi, Partisipasi, dan Konsultasi

Ensure the necessary resources for process operation and monitoring

Cf. sub-clauses 6.1 and 6.2

4.4.3.1 Komunikasi

4.4.3 Komunikasi

Ensure the necessary information for process operation and monitoring

Cf. sub-clause 8.2.3

4.4.3.2 Partisipasi dan Konsultasi

Monitor processes

4.4.4 Dokumentasi

4.4.4 Dokumentasi

Measure processes When it

makes sense; to achieve the objectives of each process regularly monitorthe indicators

4.4.5 Pengendalian Dokumen

4.4.5 Pengendalian Dokumen

Analyse processes

Page 4: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

14

4.1 f

15 4.1 f

16

4.1

17 4.1

4.4.6 Pengendalian Operasional

4.4.6 Pengendalian Operasional

Achieve planned results of processes

4.4.7 Persiapan dan Respon Tanggap Darurat

4.4.7 Persiapan dan Respon Tanggap Darurat

Obtain continual improvement of processes

Cf. sub-clause 8.5.1

4.5 Pengecekan

4.5 Pengecekan

Manage processes

Cf. sub-clauses 7.2 and 7.5

4.5.1 Pengukuran Performa dan Monitoring

4.5.1 Monitoring and Pengukuran

Ensure control of outsourced processes

Control of an outsourced process includes the establishment of specific provisions with the subcontractor as contracts, procedures,regulations for communication and an auditagreement

Page 5: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

18 4.1

Tidak Ada

4.2

Tidak Ada

4.2.1 General

4.5.2 Evaluasi Kesesuaian

4.5.2 Evaluasi Kesesuaian

Define type and extent of control of outsourced processes

Quote or make a reference in the quality manual of the implemented control means foroutsourced processes

4.5.3 Investigasi Kecelekaan, Ketidaksesuaian, Tindakan Perbaikan dan Pencegahan

Documentation requirements

4.5.3.1 Investigasi Kecelakaan

4.5.3.2 Ketidaksesuaian, Tindakan Perbaikan dan Pencegahan

4.5.3 Ketidaksesuaian, Tindakan Perbaikan dan Pencegahan

Top of the page

Page 6: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

19 4.2.1 a

20 4.2.1 a

21 4.2.1 b

22

4.2.1 c

4.5.4 Pengendalian Rekaman

4.5.4 Pengendalian Rekaman

Document the quality policy

The quality policy and the objectives are formalized in a relevant and simple document

4.5.5 Internal Audit

4.5.5 Internal Audit

Document the quality objectives

4.6 Rapat Tinjauan Manajemen

4.6 Rapat Tinjauan Manajemen

Document the quality manual

Cf. sub-clause 4.2.2

Document the procedures

The 6 mandatory procedures are:

- control of documents (cf. sub-clause 4.2.3)

- control of records (cf. sub-clause 4.2.4)

- internal audit (cf. sub-clause 8.2.2)

Page 7: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

22

4.2.1 c

23 4.2.1 c

24

4.2.1 d

4.2.2

Document the procedures

- nonconforming product (cf. sub-clause 8.3)

- correctives actions (cf. sub-clause 8.5.2)

- preventive actions (cf. sub-clause 8.5.3)

Determine the records related to procedures

Cf. sub-clause 4.2.4

Determine the documents ensuring the planning, operation and control of processes

The bare minimum is often the best choice

Quality manual

Page 8: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

25 4.2.2

26 4.2.2

27 4.2.2 a

Establish the quality manual

In the quality manual clearly identify the scope of application of the QMS (include key products and customers). Do not forget to indicate and justify the exclusion of clause 7- for example the design

Update the quality manual

Determine the scope of the QMS and the exclusions

See sub-clause 1.2 of ISO 9001

Page 9: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

28

4.2.2 b

29 4.2.2 c

Determine the documented procedures or a refernece to them

Cf. sub-clause 4.2.1; if procedures are not part of the quality manual then there is a reference to them and the place where you can find them is defined (this may be theIntranet)

Describe interactions between processes

A process map meets this requirement. You can also use a table showing the interactions between processes

Page 10: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

4.2.3

30 4.2.3

31 4.2.3

Control of

documents

Top of the page

Control the documents Before

starting to use a document, it is approved (verified, validated) by a personwith defined responsibilities and authorities

Control the records

Cf. sub-clause 4.2.4

Page 11: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

32 4.2.3 a

33 4.2.3 b

Document the procedure control of documents

Cf. sub-clause 4.2.1; the mandatory procedure for documents answers the questions who, when, how, under what conditions write, verify, validate, update, distribute and maintain documents

Review, update and approve again documents

The documents live with products and processes

Page 12: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

34

4.2.3 c

35 4.2.3 c

36 4.2.3 d

37

4.2.3 e

38 4.2.3 e

Control changes

Control of changes and versions ofdocuments is done by a person withestablished responsibilities and authorities

Control the relevant version

Ensure the availability

"The right document, at the right place at the right moment" and with the right version

Ensure the legibility

Chaque document est clair, simple à comprendre, facile à catégoriser

Identify documents

Method for coding documents

Page 13: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

39 4.2.3 f

40

4.2.3 g

41 4.2.3 g

4.2.4

Control documents of external origin

External documents (standards, specifications) are controlled (list, location, version)

Prevent use of obsolete documents

Expired documents (obsolete) are maintained, archived, destroyed or locked upso that we can not use them normally

Identify retained obsolete documents

Control of

recordsTop of the page

Page 14: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

42 4.2.4

43 4.2.4

Control conformity records The

records are filled daily (without delay).Without them it's hard (or impossible) todemonstrate compliance with therequirements of the QMS

Control effectiveness records

Page 15: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

44 4.2.4

45 4.2.4

46 4.2.4

47 4.2.4

Document the procedure control of records

Cf. sub-clause 4.2.1; the mandatory procedure for records answers the questions who, when, how, under what conditionsidentify, use, store, distribute, protect, maintain and dispose of records

Store records

"Spoken words fly away, written ones stay. Latin proverb"

Protect recordsEnsure availability of records

Page 16: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

48 4.2.4

49 4.2.4

50 4.2.4

5

5.1

51 5.1 a

Define retention time of records

Number of years or life of the product plus number of years

Define hte method of retrieval and disposition of records

Ensure legibility of records

Management

responsibility

Planifier (Plan), Agir (Ac

t)

Management

commitment

Communicate the importance of meeting customer requirements

"When you sweep the stairs, you start at the bottom. Romanian proverb"

Page 17: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

52 5.1 a

53 5.1 b

Communicate the importance of meeting legal requirements

Establish the quality policy Define t

he quality policy is an unavoidablecommitment, direct and documented by top management to implement and improve the effectiveness of the QMS

Page 18: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

54 5.1 c

55 5.1 d

Establish the quality objectives

Quantify quality objectives in each department consistent with the quality policy and customer requirements

Conduct management reviews

Cf. sub-clause 5.6; keep records ofmanagement reviews, which are evidence that the QMS is relevant, effective andcontinually improving

Page 19: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

56 5.1 e

5.2

57

58 5.2

5.3

59 5.3 a

Ensure availability of resources

Cf. sub-clause 6.1; top management provides the resources to achieve the quality objectives

Customer focus

Top of the page

5.2 

Determine customer requirements

Cf. sub-clauses 7.2.1 and 8.2.1

Meet customer requirements

Cf. sub-clause 7.2

Quality policy

Adapt the quality policy to the purpose of the organization

The quality policy is consistent with customer satisfaction and continual improvement of the QMS

Page 20: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

60 5.3 b

61 5.3 b

62 5.3 c

63 5.3 d

Determine the commitment to comply with requirements of the QMS

The quality policy is a direct and documentedcommitment of top management at itshighest level

Determine the commitment to continually improve the effectiveness of the QMS

Cf. sub-clauses 5.1 and 8.5.1

Provide a framework for establishing the quality objectives

Cf. sub-clause 5.6; the management review is the best answer for this requirement

Communicate and explain the quality policy

Cf. sub-clause 5.5.3

Page 21: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

64 5.3 e

5.4

5.4.1

65

5.4.1

66 5.4.1

Review the quality policy

Cf. sub-clause 5.6; the quality policy is constantly evolving. It is a goal of the management review

Planning

Quality objective

sEstablish the quality objectives

Cf. sub-clause 7.1

Determine quality objectives for product requirements

Cf. sub-clause 7.2

Page 22: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

67 5.4.1

68 5.4.1

5.4.2

69 5.4.2 a

70 5.4.2 a

Be able to measure the quality objectives

Quality objectives are quantified, translated(broken down) into indicators and monitoredregularly (dashboards). A criterion ofmeasurability can be "Yes / No"

Adapt the quality objectives with the quality policy

Quality manage

ment system

planning

Follow the process approach when planning the QMS

Cf. sub-clause 4.1

Plan the QMS so as to meet quality objectives

Page 23: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

71 5.4.2 b

5.5

5.5.1

Keep the integrity of the QMS when changes are implemented

Cf. sub-clause 7.3.7; play special attentionon control of changes and their impact on the performance of the QMS

Responsibility, authorit

y and communication

Top of the page

Responsibility and

authority

Page 24: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

72 5.5.1

73 5.5.1

5.5.2

74 5.5.2

75 5.5.2 a

Define responsibilities and authorities

"Responsibility can not be shared. RobertHeilein"; clear and available internally job descriptions (also organizational chart,competency matrix)

Communicate responsibilities and authorities

Management

representative

Appoint a management representative

He is a member of management and is notnecessarily from the quality department

Establish the processes

Cf. sub-clauses 7.2 and 7.5

Page 25: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

76 5.5.2 a

77 5.2.2 a

78 5.5.2 b

79 5.5.2 b

80

5.5.2 c

5.5.3

81 5.5.3

82 5.5.3

5.6

5.6.1 General

Implement the processes

Cf. sub-clause 4.1

Update the processes

Report to top management on the performance of the QMS

Cf. sub-clause 5.6

Report to top management on any need for improvement

Cf. sub-clause 5.6

Promote awareness of customer requirements

Internal communication

Establish communication processes

Play special attention to feedback (surveys,suggestion box)

Communicate on the effectiveness of the QMS

Management

review

Page 26: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

5.6.1 General

83 5.6.1

84 5.6.1

85 5.6.1

5.6.2

Review the QMS by top management

"No system is perfect", usually once or twicea year, review the whole QMS to monitor the achievement of quality objectives

Evaluate the improvement opportunities

Review the opportunities (cases, conditions,options, circumstances) for continual improvement of the QMS

Maintain the records from management reviewsCf. sub-clause 4.2.4

Review input

Top of the page

Page 27: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

86 5.6.2 a

87 5.6.2 b

Include information audit results

The internal audit reports and their proposals are an important source of information to improve the QMS

Include information on customer feedback

"Love your customers more than your products", all data on customer satisfaction and non satisfaction are an important source of information to improve the QMS

Page 28: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

88 5.6.2 c

89 5.6.2 c

90

5.6.2 d

91

5.6.2 e

Include information on process performance

Results of the achievement of qualityobjectives and data analysis related to theprocess malfunctions (nonconformities) 

Include information on product conformity

Same for the products

Include information on preventive and corrective actions

Results of actions, their follow-up, the obtained improvements

Include information on follow-up actions

Results of decisions made during the lastmanagement review and their follow-up

Page 29: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

92 5.6.2 f

93 5.6.2 g

5.6.3

Include information on changes

Consider, evaluate and analyze any changesthat may impact on the QMS (new products /processes, new customers, new features and / or responsibilities, legal and regulatory changes)

Include information on improvement recommendations

Suggestions, opinions, proposals from all staff and external intersted parties

Review output

Page 30: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

94 5.6.3 a

95 5.6.3 b

Decide actions related to improvement of the effectiveness of the QMS and its processes

Decisions to improve the QMS, its effectiveness and its processes are input data of the continual improvement process

Decide actions related to product improvement

After analysis, the decisions of product improvement, in line with customer requirements, are formalized (performance objectives)

Page 31: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

96 5.6.3 c

6

6.1

97 6.1 a

Decide actions related to resources needs

After analyzing the decisions of ensuringnecessary human and material resources are formalized

Resource

management

Planifier (Plan)

Provision of

resources

Top of the page

Determine and provide resources to implement the QMS

To Improve the effectiveness of theQMS identify and ensure the needs of present and future resources:

Page 32: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

97 6.1 a

98

99

Determine and provide resources to implement the QMS

- human (quantity and quality - skills)

- infrastructure (buildings, equipment)

- work environment (ergonomics, hygiene,health and safety)

- financial resources

 6.1 a Determine and provide resources to update the QMS

 6.1 a Determine and provide resources to improve continually the effectiveness of the QMS

Page 33: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

100 6.1 b

6.2

6.2.1 General

Determine and provide resources to enhance customer satisfaction

Priority to the resources that are directly related to customers and meeting theirrequirements (commercial, reception, sales,scheduling, design and development, testing,inspection)

Human resourc

es

Page 34: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

101 6.2.1

6.2.2

102 6.2.2 a

Ensure competence of staff

Priority to identify and review (annual performance) skills of persons with a direct impact on quality

Competence,

training and

awareness

Determine competence of personnel

Identify requirements (job descriptions) in competence of persons with a direct impact on quality

Page 35: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

103 6.2.2 b

104

6.2.2 c

Provide training Identify

and meet the needs of competence improvement (training programme)

Evaluate the effectiveness of training

Review the improvement in competence (evaluate trainings, measure their effectiveness 3 to 6 months later)

Page 36: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

105

6.2.2 d

106

6.2.2 e

6.3

Ensure that personnel is aware of the way they contribute to the achievement of the quality objectives

"Quality is everybody's business"; staff awareness of the link between training and individual responsibility to achieve qualityobjectives

Maintain records of initial and professional training, knwo-how and experience

Cf. sub-clause 4.2.4

Infrastructure

Top of the page

Page 37: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

107

108 6.3

109

6.4

 6.3 Determine the infrastructure

As appropriate identify buildings, facilities, equipment (machines and documentations)and support services that impact on product conformity

Provide the infrastructure

 6.3 Maintain the infrastructure

Control the maintainance of the infrastructure

Work environment

Page 38: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

110 6.4

111 6.4

7

7.1

Determine the work environment Identify 

human and physical factors that affect product conformity (motivation, work organization, workstation ergonomics,lighting, hygiene, temperature, security)

Control the work environment

Control these factors

Product realizati

onDérouler (Do)

Planning of

product realizati

on

Page 39: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

112 7.1

113 7.1

114

7.1

Plan the processes for product realization

These are all processes that meet the needsand expectations of customers (fromquotation to after sales service). Process mapping can lighten the overall image ofproduct realization

Develop the processes for product realization

Plan the product realization in conformity with the requirements of the other processes

Cf. sub-clause 4.1; take into accountprevention wherever possible

Page 40: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

115

7.1 a

116 7.1 a

117

7.1 b

118 7.1 b

119 7.1 b

Determine  the quality objectives

Cf. sub-clause 5.4.1

Determine  the requirements for the product

Cf. sub-clause 7.2

Determine the  processes specific to the product

Establish and implement processes and documentation for each product

Establish the documents specific to the product

Provide resources specific to the product

Page 41: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

120

7.1 c

121 7.1 c

122

7.1 d

123 7.1 d

124

7.1

7.2

Determine the activities specific to the product such as verification, validation, monitoring, measuring, inspection and test

Establish and implement monitoring and measuring processes for each product

Determine criteria for product acceptance

Determine process specific records

Cf. sub-clause 4.2.4

Determine product specific records

Cf. sub-clause 4.2.4

Ensure that planning outputs are in a suitable form

Usually it's the quality plan or any other similar document

Customer-

related process

es

Top of the page

Page 42: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

7.2.1

125 7.2.1 a

Determination of requirem

ents related to the

product

Determine requirements specified by the customer

"The only measure of quality is customer satisfaction", identify and implement customer needs and expectationsinto internal product requirements(production, delivery and after delivery)

Page 43: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

126 7.2.1 b

127 7.2.1 c

Determine requirements for intended use

Identify and apply the implicit customerneeds and expectations (lifetime warranty,exemplary reliability, easy maintenance)

Determine product statutory and regulatory requirements

Identify all requirements applicable to the product (including recycling and disposal)and establish a regulatory watch

Page 44: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

128 7.2.1 d

7.2.2

129 7.2.2

130 7.2.2

Determine requirements considered necessary by the organization

Identify internal requirements (constraints,rules, confidentiality, health and safety,hygiene)

Review of

requirements

related to the

product

Review product requirements

Review beforehand product requirements(feasibility, profitability)

Conduct the review before committing to supply a product to the customer

Beforehand means before any productioncommitment

Page 45: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

131 7.2.2 a

132 7.2.2 b

133 7.2.2 c

134 7.2.2

Define product requirements

Identify and approve all requirements internally

Resolve gaps between requirements

Any change is taken into account (approved)before completion of  production commitment

Ensure that the organization has the ability to meet the requirements

The requirements are defined and approved

Maintain the records of the results of the review

Cf. sub-clause 4.2.4

Page 46: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

135 7.2.2

136 7.2.2

137 7.2.2

7.2.3

Confirm not stated customer requirements

In this case internal approval of requirementsbefore notifying the customer

Amend documents when product requirements are changed

Each change of a product requirementinvolves updating internal documents and distribution of information to those concerned

Inform the personnel about changed requirements

Customer

communication

Top of the page

Page 47: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

138 7.2.3 a

139 7.2.3 a

140 7.2.3 b

Determine arrangements for communicating with customers on product information

"Good news walk, bad ones run. Swedish proverb"

Implement arrangements for communicating with customers on product information

Establish effective methods of communication with the customer

Determine arrangements for communicating with customers on consulting, contracts, orders and amendments

Job description of sales manager

Page 48: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

141 7.2.3 b

142 7.2.3 c

143 7.2.3 c

7.3

7.3.1

Implement arrangements for communicating with customers on consulting, contracts, orders and amendments

Determine arrangements for communicating with customers on feedback

Identify methods of communication with the customer on satisfaction and complaints

Implement arrangements for communicating with customers on feedback

Design and

development

Design and

development

planning

Page 49: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

144 7.3.1

145 7.3.1

146 7.3.1 a

Plan the design and development of product

Manage the design and product developmentupstream by prevention (FMEA, risk analysis)

Control the design and development of product

"I have not failed. I just found 10,000 waysthat do not work. Thomas Edison"

Determine the design and development stages

Identify and formalize the key stages ofproduct design and development

Page 50: Cause Iso 9001, Ohsas 18001 Dan Iso 14001

147 7.3.1 b

Determine review, verification and validation activities at each stage

and formalize the verification,design validation and product developmentsteps. For each key step plan the action, the manager, the expected result, the criteria to be met, the materials required, the time

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148 7.3.1 c

149

Determine the responsibilities and authorities for design and development

Identify and formalize the persons with responsibilities and authorities specified foreach key stage of product design anddevelopment

7.3.1 

Manage the interfaces between different groups

Identify and formalize the relationshipsbetween all actors in the product design anddevelopment (meetings and reviews at key stages)

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150

7.3.2

151 7.3.2

152 7.3.2

7.3.1 

Update planning output

Planning is updated after each major change of the product design anddevelopment

Design and

development inputs

Determine inputs relating to product requirements

Identify, formalize and keep the information needed to start the product design anddevelopment

Maintain records

Cf. sub-clause 4.2.4

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153

7.3.2 a

154

7.3.2 b

Determine functional and performances requirements

The functional requirements found in the specifications (dimensions, operating conditions, tests)

Determine statutory and regulatory requirements

Requirements (qualifications or recommendations) related to transportation, packaging, labels, instructions for use, expiry date, traceability, componentsused

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155

7.3.2 c

156

7.3.2 d

Determine information derived from previous designs

The results of design reviews of previous similar products (tests, reliability, feasibility)and feedback from users (sales,recommendations, suggestions)

Determine other requirements essential for design and development

Specific requirements of the product, components (selected suppliers, prohibited materials), environmental aspects (disposal of products)

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157

7.3.2

158

7.3.2

7.3.3

Review inputs

The project leader or another person verify and validate the consistency of the input

Ensure that requirements are complete, unambiguous and not in conflict with each other

The project leader or another person verify and validate for all input requirements the lack of ambiguity and contradiction

Design and

development

outputs

Top of the page

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159 7.3.3

160 7.3.3

161 7.3.3 a

Ensure that outputs are in a suitable form

Identify measures that can determinecompliance between input and output

Approve outputs

Always confirm (approve) the outputs by the project leader or another person prior to use

Ensure that outputs meet input requirements

Conformity between outputs and inputrequirements

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162 7.3.3 b

163 7.3.3 c

164 7.3.3 d

7.3.4

Ensure that outputs provide information for purchasing, production and service provision

Full information from the BOM (component specifications, raw materials, consumables)

Ensure that outputs contain product acceptance criteria or a reference to it

Identify the steps of monitoring (inspections)and measurement (testing) of production processes

Ensure that outputs specify product characteristics essential for its safe and proper use

Information about the intended and unintended use, security, maintenance

Design and

development

review

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7.3.4

165 7.3.4 a

166 7.3.4 b

Design and

development

review

Evaluate the ability of results to meet requirements

Cf. sub-clause 7.3.1

Identify problems "A probl

em shared is a problem halved"; theplanned reviews can predict potential problems and propose appropriate preventive actions

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167 7.3.4

168 7.3.4

7.3.5

Determine participants in reviews

The reviews conducted by the project leaderor another person are multidisciplinary withappropriate participants for each step

Maintain records of the results of the reviews

Cf. sub-clause 4.2.4

Design and

development

verification

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169 7.3.5

170 7.3.5

7.3.6

Perform verification of the design and development

The reviews enable at key steps to verify(trials, tests, measurements, calculations)whether results are in line with objectives

Maintain records of the results of verification

Cf. sub-clause 4.2.4

Design and

development

validation

Top of the page

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171 7.3.6

172 7.3.6

173 7.3.6

7.3.7

7.3.7

Perform validation of design and development

After verification the design and development are validated. This implies that all customer requirements are met

Complete validation before the delivery or implementation of the product

In practice almost always the validation is carried out upstream

Maintain records of the results of the validation

Cf. sub-clause 4.2.4

Control of design

and develop

ment changes

 174 Identify design and development changes

The changes are clearly identified

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7.3.7

7.3.7

177 7.3.7

 175 Maintain records of changes

Cf. sub-clause 4.2.4

 176 Review, verify and validate changes before implementation

Each change is reviewed, verified and validated by the project leader or another person. The same person or another personin charge gives final approval

Approve changes before implementation

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178 7.3.7

179 7.3.7

7.4

7.4.1

Evaluate the effect of changes

Each change can affect the product (BOM,sales support). Assess risks and potential impacts (simulation method)

Maintain records of the results of change review

Cf. sub-clause 4.2.4

Purchasing

Purchasing

process

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180 7.4.1

181 7.4.1

Ensure that purchased product conforms to requirements

"If you buy quality, you only cry once.English proverb"; the purchase processincludes activities to ensure compliance ofcomponents, materials and suppliespurchased

Determine supplier control

Compared to the impact on the production and the final product

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182 7.4.1

Evaluate and select suppliers

purchasing process includes the evaluation and selection of suppliers(incoming inspection, audit at supplier premises, product purchased with supplierquality assurance = product inspection is made at supplier premise

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183 7.4.1

184 7.4.1

7.4.2

Establish selection, evaluationand re-evaluation criteria

The purchasing process includes thecontinual evaluation criteria (monthly or quarterly) of suppliers (% of nonconformingpurchased products detected at reception inspection, production and after sales service)

Maintain records of results of evaluation

Cf. sub-clause 4.2.4

Purchasing

information

Top of the page

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185 7.4.2

186 7.4.2 a

187

7.4.2 b

Describe the product to be purchased

Are taken into account all data on thepurchased product (specifications, transport conditions, packing, receiving, testing,storage and other)

Determine approval requirements

Determine requirements for qualification of personnel

For specific cases staff receive appropriate training (new type product, machine orequipment not previously used)

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188

7.4.2 c

189 7.4.2

7.4.3

Determine QMS requirements Everythi

ng concerning the control ofnonconformities related to purchasedproduct  and actions, person in charge andtime frame to implement

Ensure adequacy of purchase requirements

Communicate requirements to the supplierwich are realistic and appropriate with theQMS

Verification of

purchased

product

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190 7.4.3

191 7.4.3

7.5

Ensure that purchased product meets purchase requirements

The purchasing process includes the identification and implementation ofinspections at receiving and during production

Include in the purchasing information arrangements of verification at supplier's premises

In the particular case of inspection andrelease at supplier premises all these activities are formalized (contract,specifications with acceptance criteria)

Production and service provisio

n

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7.5.1

192 7.5.1

193 7.5.1

194

7.5.1 a

195

7.5.1 b

Control of

production and service

provision

Plan production and service provision activities

Identify, develop and plan all stages ofproduct realization process

Control the production and service provision activities

Ensure the availability of information describing the product

The product specification information isfreely available to staff

Ensure the availability of work instructions

Work instructions, record sheets and others are where needed

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196

7.5.1 c

197

7.5.1 d

198 7.5.1 d

199

7.5.1 e

Ensure the use of suitable equipment

Equipment maintenance is regularly carried out

Ensure the availability of monitoring and measuring equipment

Monitoring and measurement equipment aremaintained in good condition and the staff are trained in their use

Ensure the use of monitoring and measuring equipment

Implement monitoring and measuring equipment

Monitoring  and measurement equipment are used regularly

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200

7.5.1 f

201 7.5.1 f

202 7.5.1 f

7.5.2

Implement release activites

The release, transport and after sale serviceare formalized and managed

Implement delivery activities

Implement post-delivery activities

Validation of

processes for

production and service

provision

Top of the page

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203 7.5.2

204 7.5.2

205 7.5.2 a

Validate special processes (where the output cannot be verified)

When the product cannot be measured (price too high, can be done only after use) the process is checked and validated

Demonstrate the ability of these processes to achieve planned results

The validation of the process ensurescompliant products

Define criteria for process review

The criteria for process monitoring and measuring are strengthened

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206 7.5.2 a

207

7.5.2 b

208 7.5.2 b

209

7.5.2 c

210

7.5.2 d

211 7.5.2 e

7.5.3

Define criteria for process approval

Approve equipment

Checking equipment and staff training are reinforced

Approve qualification of personnel

Use specific methods and procedures

Establish record requirements

Cf. sub-clause 4.2.4

Establish provisions for revalidation

Every change require  a new validation of the process

Identification and

traceability

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212 7.5.3

213 7.5.3

Identify the product When

appropriate identification of the product and components shows its statusrelative to the production stages (bar code,card, label)

Identify product status throughout product realization

The identification of the product also showsits status (results) relative to monitoring and measuring stages

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214 7.5.3

215 7.5.3

7.5.4

216 7.5.4

Control the unique identification of the product

Product traceability (who, when, with which batch) shows the history of production stages

Maintain recordsCf. sub-clause 4.2.4

Customer

propertyTake care with customer property

Customer property includes:

- raw materials

- components

- packaging materials

- equipment

- testers and software (intellectual property)

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217 7.5.4

218 7.5.4

219

7.5.4

220 7.5.4

Identify customer property

Verify customer property

Protect customer property

Inspection of customer property in reception (where appropriate), specific storage andprotection when requested by customer

Safeguard customer property

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221

7.5.4

222 7.5.4

7.5.5

When property is lost or damaged report it to the customer

Any concern with customer property iscontrolled as a nonconformity (identification,analysis, decision, recording) and more than that required communication with the customer

Maintain records of reports to the customer

Cf. sub-clause 4.2.4

Preservation of

product

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223 7.5.5

224 7.5.5

Preserve conformity of product to requirements

The product is protected internally and up to delivery to the customer (packaging, storage conditions)

Provide product identification, handling, packaging, storage and protection

Preservation of the product includes all stages of product life cycle (receiving,production, handling, storage, delivery)

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225 7.5.5

7.6

226 7.6

227 7.6

Apply product preservation to components

Components, raw materials and semi finishedproducts are part of the product

Control of

monitoring and measuri

ng equipm

ent

Determine monitoring and measuring activities to be undertaken

The process of monitoring and measurementare in place to collect evidence of product compliance

Determine monitoring and measuring equipment

Equipment list with serial numbers

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228 7.6

229 7.6 a

230 7.6 a

231 7.6 b

232 7.6 c

Establish monitoring and measuring processes

Monitoring and measuringdevices meet internal, customer and regulatory requirements

Calibrate and verify measuring equipment

Measuring equipment (hardware and software) are calibrated or verified regularly

Record calibration and verification methods

Cf. sub-clause 4.2.4

Agjust measuring equipment

Measuring equipment are adjusted regularly

Identify calibration status

The validity date is available on the equipment

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233

7.6 d

234 7.6 e

235 7.6

Safeguard adjustments of measuring equipment

Protection against actions of intended or unintended misadjustment

Safeguard measuring equipment from damage and deterioration

Effective protection not only during their use(travel, maintenance, storage)

Assess nonconforming equipment

This concerns the potentially nonconforming products

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236

7.6

237 7.6

238 7.6

Take appropriate actions on nonconforming product

Equipment is verified and calibrated.Products are inspected, validated (with or without concession) or identified as nonconforming

Maintain records of the results of calibration and verification

Cf. sub-clause 4.2.4

Confirm the ability of monitoring and measuring software to satisfy intended application

Monitoring and measurement software isvalidated before use

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239 7.6

8

8.1 General

240 8.1 a

Undertake confirmation before initial use

Make a second validation if the first one is not satisfactory

Measurement, analysis

and improve

ment

Constater (Check), Agir 

(Act)

Top of the page

Plan the processes necessary to demonstrate conformity to product requirements

"If you can't measure it, you can't manage it.Peter Drucker"; control of product compliance is demonstrated by inspection processesthroughout the production stages

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241

242

8.1 b

243

 8.1 a Implement the processes necessary to demonstrate conformity to product requirements

Plan the processes necessary to ensure conformity of the QMS

Control of the conformity of the QMS is ensured among other things on management processes (strategy, auditing, continual improvement, self assessment)

 8.1 b Implement the processes necessary to ensure conformity of the QMS

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244

8.1 c

245

Plan the processes necessary to continually improve the effectiveness of the QMS

The overall improvement in the effectiveness of the QMS is the result of all improvement activities (audits, data analysis, new objectives, corrective and preventive actions)

 8.1 c

Implement the processes necessary to continually improve the effectiveness of the QMS

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246

8.1

8.2

8.2.1

Determine monitoring, measurement, analysis and improvement methods

Data analysis, statistical techniques (SPC,statistical process control), Kaizen, Ishikawa diagram (5 M)

Monitoring and measurement

Customer

satisfaction

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247 8.2.1

248 8.2.1

8.2.2

Monitor customer perception

Measure the level of satisfaction of customerneeds and  expectations (congratulations,returns, complaints, recommendations). The customer may be the direct customer(distributor) or the end customer (consumer)

Determine monitoring of customer satisfaction methods

Examples: surveys, feedback, open doors,tracking returns and customer complaints,benchmarking

Internal audit

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249 8.2.2 a

250 8.2.2 a

251 8.2.2 a

Conduct internal audits to determine whether the QMS conforms to the planned arrangements

Cf. sub-clause 7.1

Conduct internal audits to determine whether the QMS conforms to the requirements of the ISO 9001 standard

Annual programme of internal audits

Conduct internal audits to determine whether the QMS conforms to the requirements of the organization

Audits specific to the organization

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252 8.2.2 b

253 8.2.2 b

254 8.2.2

Conduct internal audits to determine whether the QMS is effectively implemented

Internal audits allow measuring the performance of the QMS

Conduct internal audits to determine whether the QMS is effectively maintained

The frequency of audits is appropriate

Plan the audit programme

The audit programme focuses on sensitiveprocesses and areas without forgetting theresults of previous audits

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255 8.2.2

256 8.2.2

257 8.2.2

Define the audit criteria, scope, frequency and methods

Mandatory information included in the procedure "Internal Audit"

Ensure objectivity and impartiality of internal audits

Training and selection of auditors

Ensure that auditors don't audit their own work

"No one is a judge in his own case. Latin proverb"

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258 8.2.2

259 8.2.2

Establish a documented procedure for internal audits

Cf. sub-clause 4.2.1; the mandatory procedure for audits answers the questionswho, when, how, under what conditions plan(audit programme), define the criteria, scope, frequency and methods of audits

Maintain records of the audit results

Cf. sub-clause 4.2.4; audit report

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260 8.2.2

261 8.2.2

262 8.2.2

8.2.3

Ensure that the corrections and correctives actions are taken without undue delay

The person in charge of the actions is on schedule to identify and eliminate the causesof nonconformities

Verify the taken actions

The results of the follow-up of the corrective actions are verified and recorded

Record the report of the results of the verification

Cf. sub-clause 8.5.2

Monitoring and

measurement of processe

s

Top of the page

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263 8.2.3

264 8.2.3

265 8.2.3

Monitor and measure QMS processes

Monitor and measure the processobjectives and indicators using an established method

Demonstrate the ability of the processes to achieve planned results

When objectives  and indicators are achieved the process is effective (inspections at key stages)

Undertake corrections and corrective actions when planned results of processes are not achieved

Cf. sub-clause 8.5.2

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8.2.4

266

8.2.4

267

8.2.4

268

8.2.4

269

8.2.4

Monitoring and

measuremnt of product

Monitor and measure product characteristics

Monitoring of product characteristics verifysatisfaction to product requirements(inspections at key stages)

Monitor and measure the product at appropriate stages

Cf. sub-clause 7.1

Maintain evidence of conformity with the acceptance criteria

Cf. sub-clause 4.2.4

Record the person having authorised the product release

Cf. sub-clause 4.2.4

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270

8.2.4

8.3

271

8.3

Release of product only after planned arrangements have been satisfied

Cf. sub-clause 7.1

Control of

nonconforming product

Ensure that nonconforming product is identified and controlled to prevent its unintended use

"Any problem hides an opportunity for improvement "; identification and isolation of nonconforming product for treatment

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272

8.3

273

8.3 a

274

8.3 b

Establish the documented procedure control of nonconforming product

"Quality shine from afar, defects from up close. Victor Hugo", cf. sub-clause 4.2.1,the mandatory procedure for nonconforming product answers the questions who, when, how, under what conditions eliminatenonconformities, root causes, prevent the use

Undertake actions to eliminate the detected nonconformity

Identify nonconformities and treat them likescrap

Authorize its use, release or acceptance under concession

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275

8.3 c

276

8.3 d

277

8.3

Undertake actions not allowing intended use

Correction, repair, rehabilitation or scrap

Undertake actions when a nonconforming product is detected after delivery

Recall (prevent use after delivery),withdrawal (prevent the distribution),communication, batch identification,isolation, root cause analysis, corrective and preventive actions

Maintain records of the nature of nonconformities and actions taken

Cf. sub-clause 4.2.4

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278

8.3

8.4

279

8.4

Verify again the corrected nonconforming product

Any corrected nonconforming product isalways verified before being returned with other products

Analysis of data

Top of the page

Determine data to demonstarte the suitability and effectiveness of the QMS

preparation of the management reviewincludes the collection and analysis of data(indicators, audit results, level of customer satisfaction). After synthesis decisions of the management review about continual improve

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280 8.4

281 8.4

282 8.4

283

8.4

Collect data to demonstarte the suitability and effectiveness of the QMS

Analyse data to demonstarte the suitability and effectiveness of the QMS

Evaluate the opportunities to improve the effectiveness of the QMS

Any opportunity for improvement is evaluated before its implementation

Include data from monitoring and measuring activities

Analysis of indicators related among other things to monitoring and measurement

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284

8.4 a

285

8.4 b

286

8.4 c

287

8.4 d

8.5

8.5.1

Provide information on customer satisfactionCf. sub-clause 8.2.1

Provide information on conformity to product requirements

Cf. sub-clause 8.2.4

Provide information on trends of processes and products

Cf. sub-clauses 8.2.3 and 8.2.4

Provide information on on suppliers

Cf. sub-clause 7.4

Improvement

Continual

improvement

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288 8.5.1

8.5.2

289

8.5.2

Continually improve the effectiveness of the QMS

is a journey not a destination";apply the process continual improvement of the QMS (turn the Deming wheel). Identify opportunities for improvement, find anderadicate the root causes of nonconformities,promote preventive

Corrective action

Undertake action to eliminate the causes of nonconformities

Analysis and eradication of the causes of nonconformities in the process, product orQMS

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290

8.5.2

291

8.5.2 a

Adapt corrective actions to the effects of nonconformities

Make arrangements with respect to real effects (watch out for excessive zeal)

Establish the documented procedure for corrective action and review nonconformities

Cf. sub-clause 4.2.1; the mandatory procedure for corrective action answers the questions who, when, how, under what conditions identify and treat nonconformities.Determine and eliminate causes, assess the need for corrective actions, implementcorrective actions and review actions

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292

8.5.2 b

293

8.5.2 c

Determine the causes of nonconformities

Include in the procedure methods to find the causes of nonconformities (Ishikawa diagram, MSP)

Evaluate the need to undertake corrective action

What could be achieved if an action is applied? The resources needed are theyavailable? (Some nonconformities do not require corrective actions)

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294

8.5.2 d

295 8.5.2 d

296

8.5.2 e

Determine the necessary action

Include the procedure the method for determining responsibilities, authorities, time frames, resources and monitoring of actionsto implement

Implement the necessary action

Record the results of the corrective action

Cf. sub-clause 4.2.4

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297

8.5.2 f

8.5.3

8.5.3

8.5.3

Review the effectiveness of the corrective action undertaken

Analyse the monitoring of actions (possibility of a new audit), improve documentation

Preventive action

Top of the page

 298 Determine the action allowing the elimination of the causes of potential nonconformities

Analysis and elimination of potential causesof nonconformities of processes or of the QMS

 299 Adapt preventive actions to the effects of the potential problems

Make arrangements with respect to potential effects (stay within available resources)

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8.5.3 a

8.5.3 b

 300 Establish the documented procedure preventive action and determine potential nonconformities and their causes

Cf. sub-clause 4.2.1; the mandatory procedure for preventive actions answers the questions, who, when, how, under what conditions identify potential nonconformities,determine their causes, evaluate the need for preventive actions, implement preventive actions and monitor actions

 301 Evaluate the need to undertake preventive action

Will the occurence avoided? The resources needed are they available?

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8.5.3 c

8.5.3 d

8.5.3 e

 302 Determine the necessary action

Include in the procedure the method for determining responsibilities, authorities, time frames, resources and monitoring of actionsto implement

 303  8.5.3 c Implement the necessary action

Find the causes

 304 Record the results of the preventive action

Cf. sub-clause 4.2.4

 305 Review the effectiveness of the preventive action undertaken

Analyse the monitoring of actions (possibility of a new audit), improve documentation