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CLUASE ISO
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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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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"
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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:
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
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
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
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)
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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)
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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)
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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"
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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)
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?
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