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Subject title ISO 9001 element Ability to meet defined requirements 7.2.2c Amendment to a contract 7.2.3b Analysis of data 8.4
conformity to product requirements 8.4b continual improvement 8.4 customer satisfaction 8.4a measuring and monitoring activities 8.4 Quality Management System 8.4 suppliers 8.4
Approval of changes to design and development 7.3.7 documents 4.2.3a
Audit internal quality 8.2.2 review input 5.6.2a
Authority for quality organisation 5.5.1 Calibration
corrective action 7.6e of measuring and monitoring devices 7.6 safeguard from adjustment 7.6d records 4.2.4, 7.6a validity of previous results 7.6a
Capability planning 5.4 to meet contracts 7.2.2
Changes to documents 4.2.3c Communication
customer 7.2.3 internal 7.2.2
Competence, awareness and training 6.2.2 awareness of quality objectives 6.2.2d competency 6.2.2a evaluation 6.2.2c provision of training 6.6.2b records 4.2.4, 6.2.2e requirements 6.2.1
Continual improvement 8.5.1
analysis of data 8.4 management commitment to 5.1 measuring and monitoring activities 8.1c processes 5.6.3a Quality Management System 4.1f, 5.6.3a, 8.5.1 quality objectives 5.4.1 quality planning 5.4.2a quality policy 5.3b
Contract review 7.2.2 amendment 7.2.3b capability to meet requirement 7.2.2c definition of requirement 7.2.2a differences resolved 7.2.2b records of 7.2.2 requirements 7.2.2 supplier capability 7.2.2
Control of customer property 7.5.4 design and development changes 7.3.7 documents and data 4.2.3 inspection, measuring and test equipment 7.6 measuring and monitoring devices 7.6 nonconforming products 8.3 processes 4.1c product, customer supplied 7.5.5 quality manual 4.2.2, 4.2.3 quality policy 4.2.3, 5.3 records 4.2.3, 4.2.4
Corrective action 8.5.2 determining causes of nonconformity 8.5.2b determining and implementing 8.5.2d documented procedure 8.5.2 evaluation of actions to be taken 8.5.2c identification of nonconformities 8.5.2a internal audits 8.2.2
verification of 8.2.2 nonconforming product 8.3 preventive actions recording results 8.5.2e review 8.5.2f
Criteria for acceptability
in processes 7.1c Customer
approval of product release 8.2.4 communication 7.2.3
of product information 7.2.3a complaints 7.2.3c, 8.5.2a contracts/order handling (inc. amendments) 7.2.3b enquiries 7.2.3b feedback 5.6.2b, 7.2.3c focus 5.2 needs and expectations 5.2 requirements 5.1a, 5.2, 7.2.1a
change in 7.2.2b documented 7.2.2 nondocumented 7.2.2 review 7.3.4a
satisfaction 5.2 resources for 6.1b
supplied product 7.5.4 Customer property (supplied product) 7.5.4
identification 7.5.4 maintenance 7.5.4 protection of 7.5.4 records 7.5.4 unsuitability for use 7.5.4 verification 7.5.4
Customer requirements analysis of data 8.4 identification of 7.2.1
product requirements 7.2.1a monitoring and measurement of processes 8.2.3 product conformity 7.5.5
Customer satisfaction analysis of data 8.4 information monitoring 8.2.1 measurements of performance 8.2.1 methodologies 8.2.1
Damage and deterioration protection from 7.6e
Data control – see Document control
Delivery 7.5.5
Design and development 7.3 change control 7.3.7
approval 7.3.7 identification 7.3.7 validation 7.3.7 verification 7.3.7
communication 7.3.1 control 7.3.1 inputs 7.3.2
essential requirements 7.3.2d function and performance 7.3.2a information from previous designs 7.3.2c regulatory and legal requirements 7.3.2b review 7.3.2
outputs 7.3.3 documentation – approval of 7.3.3 information for production and service
operations 7.3.3b meeting input requirements 7.3.3a product acceptance criteria 7.3.3c product characteristics 7.3.3d verification 7.3.3
records 4.2.4, 7.3.7 review 7.3.4
evaluation 7.3.4a follow-up actions 7.3.4b identification of problems 7.3.4b participants 7.3.4 records 4.2.4, 7.3.4
validation 7.3.6 records 4.2.4, 7.3.6
verification 7.3.5 follow-up actions 7.3.5 records 4.2.4, 7.3.5
planning 7.3.1 responsibility and authority 7.3.1c review 7.3.1b stages 7.3.1a validation 7.3.1b
Design and development – continued
review 7.3.4 validation 7.3.6 verification 7.3.5
Design control 7.3 Despatch, held until tested 8.2.4 Deterioration, prevention 7.6c Development – see Design Document control 4.2.3
approval 4.2.3a availability 4.2.3d changes 4.2.3c external documentation 4.2.3f external documents 4.2.3f
obsolete documents 4.2.3g identification of
current revision status 4.2.3c legibility 4.2.3e modifications 4.2.3b obsolete 4.2.3g removal 4.2.3g update 4.2.3b
Documentation change control 7.3.7 procedures 4.2.1c processes 4.1a, 7.1b purchasing 7.4.1 Quality Management System 4.1
planning output 5.4.2 quality manual 4.2.1b, 4.2.2 quality policy 4.2.1a records 4.2.1e, 4.2.4
Documented procedures control of nonconforming product 8.3 corrective action 8.5.2 internal audit 8.2.2 preventive action 8.5.3 Quality Management System 4.1, 4.2.1a quality manual 4.2.2b
Electronic media 4.2.1, 7.6
Equipment identification, provision and maintenance of 6.3
for production and service provision 7.5.1c validation 7.5.5
Evaluation of suppliers 7.4.1
Final inspection and testing 8.2.4
Goods-inward testing 7.4.3
Handling maintenance and storage
of measuring and monitoring devices 7.6e storage, packaging, protection and delivery 7.5.5
Human resources 6.2 assignment of personnel 6.2.1 competence, awareness and training 6.2.2
Identification and traceability 7.5.3 control (product) 7.5.3, 7.5.5 customer property 7.5.4 measuring and monitoring requirements 7.5.3, 7.6 product 7.5.3 status (product) 7.5.3 unique product identification 7.5.3
Improvement (also see continual improvement) 8.5 continual improvement 8.5.1 corrective action 8.5.2 preventive action 8.5.3
Infrastructure 6.3 equipment (hardware and software) 6.3b identification of 6.3 maintenance of 6.3 provision of 6.3 supporting services 6.3c workspace 6.3.a
Inspection and testing 7.1, 7.5.1, 8.1, 8.2.4 final inspection and testing 8.2.4 goods inwards 7.4.3
Inspection and test status 7.5.1
authorised stamps, tags and labels 7.5.3 inspection records 7.5.3 product testing 7.5.1 production control 7.5.1 use of markings 7.5.3
Inspection, measuring and test equipment – control of 7.6
Internal audits (of the Quality Management System) 8.2.2
corrective action 8.2.2 frequency 8.2.2 implementation and maintenance 8.2.2 methodologies 8.2.2 planning 8.2.2 procedure 8.2.2 records 8.2.2 reporting of results 8.2.2 requirements 8.2.2 scope 8.2.2 verification 8.2.2
Internal communication 5.5.3 Job descriptions 5.5.1 Maintenance of
customer property 7.5.4 equipment 7.5.1c quality management system 8.2.2b
Management commitment 5.1 customer focus 5.2 quality objectives 5.1c quality policy 5.1b, 5.3 representative 5.5.2 review 5.1d, 5.6
Management commitment 5.1 availability of resources 5.1d customer requirements 5.1a quality objectives 5.1c quality policy 5.1b regulatory/legal requirements 5.1a
Management responsibility 5
authority and communication 5.5 commitment 5.1 customer focus 5.2 internal communication 5.5.3 management representative 5.5.2 objectives 5.1c organisational responsibilities 4.1, 5.5.1 planning 5.4 quality policy 5.1b, 5.3 review of the Quality Management System 5.6 verification resources and personnel 4.1
Management representative 5.5.2 customer requirements 5.5.2c liaison with external parties 5.5.2 Quality Management System processes 5.5.2a responsibility and authority 5.5.2 reporting to top management 5.5.2b
Management review input 5.6.2 changes that could affect the Quality
Management System 5.6.2f customer feedback 5.6.2b follow-up actions 5.6.2e process performance 5.6.2c product conformity 5.6.2c recommendations for improvement 5.6.2g results of audits 5.6.2a status of corrective actions 5.6.2d status of preventive actions 5.6.2d
Management review output 5.6.3 improvement of
processes 5.6.3a product 5.6.3b the Quality Management System 5.6.3a
records 4.2.4 resource needs 5.6.3c
Measurement, analysis and improvement 8 analysis of data 8.4 continual improvement 8.5.1
Measurement, analysis and improvement – continued
improvement 8.5 corrective action 8.5.2 preventive action 8.5.3
monitoring and measurement 8.2 customer satisfaction 8.2.1 internal audit 8.2.2
monitoring and measurement of processes 8.2.3 monitoring and measurement of product 8.2.4
planning 8.1 applicable methodologies 8.1 conformity 8.1 definition 8.1 determination of need 8.1 improvement 8.1 monitoring and measurement activities 8.1 statistical techniques 8.1
Monitoring and measurement of processes 8.2.3 customer requirements 8.2.3 intended purpose 8.2.3 suitable methods 8.2.3
Monitoring and measurement of product authority for release of a product 8.2.4
with customer approval 8.2.4 delivery 8.2.4 documentation 8.2.4 evidence of conformity 8.2.4 frequency 8.2.4 product requirements 8.2.4 records 4.2.4, 8.2.4
Measuring and monitoring activities analysis of data 8.4 conformity 8.1 customer satisfaction 8.2 definition, planning and implementation 8.1 improvement 8.1
Measuring and monitoring equipment availability and use of 7.5.1d calibration 7.6a conformity of product 7.6
corrective action 7.6 damage and deterioration 7.6e handling, maintenance and storage 7.6e identification of measurements to be made 7.6 implementation 7.5.1e output cannot be verified 7.5.2 product status 7.5.3 protection 7.6d reassessment 7.6 records 4.2.4, 7.6 safeguarded from adjustments 7.6b
Methodologies customer satisfaction 8.2 determination of 8.2 planning 8.1 use of 8.1, 8.2 validation of 7.5.2
Nonconforming product actions 8.5.3c control 8.3 corrective action 8.3, 8.5.2 detection after delivery or use 8.3 determining causes 8.5.2b, 8.5.3b identification 8.3, 8.5.2a, 8.5.3a prevention of unintended use or delivery 8.3 preventive action 8.5.3 procedure 8.3 reverification 8.3
Obsolete documents 4.2.3g
Operations control 7.5.1 availability of product information 7.5.1a measuring and monitoring devices 7.5.1d monitoring activities 7.5.1e release, delivery and post-delivery 7.5.1f use and maintenance of equipment 7.5.1c work instructions 7.5.1b
Packaging 7.5.5
Performance monitoring of Quality Management
Personnel assignment of 6.2.1 competence, awareness and training 6.2.2 validation of 7.5.2b
Planning 5.4 continual improvement 8.5.1 design and development 7.3.1 quality objectives 5.4.1 Quality Management System 5.4.2
Preservation of product 7.5.5
Preventive action 8.5.3 determining causes of nonconformity 8.5.3a determining and implementing 8.5.3c documented procedure 8.5.3 evaluating need for 8.5.3b internal audits 8.2.2
verification of 8.2.2 nonconforming product 8.3 recording results 8.5.3c review 8.5.3e status 5.6.2d
Problem identification 7.3.4b
Procedures corrective action 8.5.2 control of nonconforming product 8.3 preventive action 8.5.3 Quality Management System 4.2.2b
Processes analysis of data 8.4 availability of information 4.1d customer-related 7.2 criteria and methods 4.1c, 7.5.2 deficiencies 7.5.2 equipment approval 7.5.2 identification 4.1a
measurement, monitoring and analysis 4.1e, 8.2.3
suitable methods of 8.2.3 operation and control 4.1c performance 5.6.2c planned results 7.5.2 purchasing 7.4.1 qualification of personnel 7.5.2 Quality Management System 4.1 quality manual 4.2.2c records 7.5.2 revalidation 7.5.2 satisfy intended purpose 8.2.3 sequence and interaction 4.1b, 4.2.2c validation 7.5.2 verification 7.5.2
Product acceptance criteria 7.1c, 7.3.3c analysis of data 8.4 characteristics for safe and proper use 7.3.3d conformance 5.6.2c control 7.5.3 design and development 7.3
control of changes 7.3.7 input 7.3.2 output 7.3.3 planning 7.3.1 review 7.3.4 validation 7.3.6 verification 7.3.5
function and performance 7.3.2a identification and traceability 4.8, 7.5.3 information 7.5.1a measuring and monitoring 8.2.4 measuring and monitoring devices 7.6 nonconformance 8.3 obligations (legal and regulatory) 7.2.1c post-delivery activities 7.5.1f provision of facilities 7.1b provision of resources 7.1b purchasing 7.4
conformance to requirements 7.4.1 verification 7.4.3
Product – continued
realisation 7 customer-related processes 7.2 design 7.3 development 7.3 measuring and monitoring devices 7.5 planning of 7.1 production and service operations 7.5
release 7.5.1f release purchased 8.2.4 requirements 7.1, 7.2.1
confirmation of 7.2.2b customer 7.2.1a definition of 7.2.2a delivery and post-delivery 7.2.1a differences resolved 7.2.2b necessary for intended use 7.2.1b records 4.2.4, 7.2.2 review 7.2.2
status 7.5.3 traceability 4.2.4, 7.5.3
Production and service provision 7.5 control of 7.5.1 customer property (supplied product) 7.5.4 design and development output 7.3.3b identification and traceability 7.5.3 operations control 7.5.1 preservation of product 7.5.5 validation of processes 7.5.2
Protection of customer property 7.5.4 product 7.5.5
Purchasing 7.4 documentation 7.4.2 information 7.4.2 processes 7.4.1 records 4.2.4, 7.4.1 supplier assessment 7.4.1
criteria for assessment 7.4.1 periodic evaluation 7.4.1
verification of purchased product 7.4.3
Quality Management System 4
continual improvement 5.4.2c control of records 4.2.4 data collection and analysis 8.4 document requirements 4.2 document control 4.2.3 effectiveness 8.4 general requirements 4.1 internal audits 8.2.2 internal communication 5.5.3 management commitment 5.1 management representative 5.5.2 management review 5.6 monitoring and measurement 8.2 procedures 4.2 processes 4.1 provision of resources 6.1a quality manual 4.2.2 quality objectives 5.4.1 quality planning 5.4.2a, 7.1 responsibility and authority 5.5.1
Quality Manager – management representative Quality Manual 4.2.2
scope of 5.5.2a
Quality objectives 5.1c, 5.4.1 commitment to continual improvement 5.4.1 consistency 5.4.1 measurement of 5.4.1 product requirements 7.1 resources 5.4.2
Quality policy 5.1b, 5.3, 5.4.1 appropriateness 5.3a commitment to 5.3b communication of 5.3e continual improvement 5.3b control of 4.2.3, 5.3 documented statements 4.2.1a establishing a 5.3c framework 5.3c requirements 5.3b
Records 4.2.4
competence, awareness and training 6.2.2 control of 4.2.3, 4.2.4 control of monitoring and measuring devices 7.6 control of nonconforming product 8.3 corrective action 8.5.3e customer property 7.5.4 design and development
change control 7.3.7 input 7.3.2 review 7.3.4 validation 7.3.6 verification 7.3.5
education and qualifications 6.2.2e identification and traceability 7.5.3 identification of 4.2.4 management reviews 5.6.1 monitoring and measurement of product 8.2.4 planning of product realisation 6.2.2 preventive action 8.5.3c protection 4.2.4 purchasing 7.4.1 retention 4.2.4 requirements 4.2.1e retrieval 4.2.4 review of product requirements 7.2.2 storage 4.2.4 training and experience 6.2.2 type of 4.2.4 validation of process for production and
service provision 7.5.2
Regrading of a nonconforming product 8.3
Regulatory and legal requirements design and development input 7.3.2b management commitment 5.1a product obligations 7.2.1c Quality Management System 4.1
Reinspection of a nonconformity 8.3
Rejected or scrapped work caused by
Requirements
customer 7.2.1a design and development input 7.3.2d product 7.2.1 purchased product 7.4.1, 7.4.2 quality objectives 5.4.1 regulatory and legal 5.1a, 8.2.2a
Resource management 6 infrastructure 6.3 provision of 6.1 personnel 6.2 work environment 6.4
Resources 6.1, 6.3 availability 5.1d processes 7.1b provision of 6.1
to enhance customer satisfaction 6.1b to implement/improve the Quality
Management System 6.1a Repair 8.3
Representative, management 5.5.2 Responsibility and authority 5.5.1
communication of 5.5.1 competency 6.2.1 design and development activities 7.3.1c definitions of 5.5.1 internal audits 8.2.2
Revalidation of processes 7.5.2
Reverification of products 8.3
Review contract 7.2.2 corrective action 8.5.2f design and development 7.3.4 design and development planning 7.3.1b input 5.6.2 management 5.6 output 5.6.3 preventive action 8.5.3e
Statistical techniques 8.1, 8.4 Storage
general 7.5.5 of customer-supplied product 7.5.4
Subcontractor – see Supplier Supplier
evaluation 7.4.1 records of 4.2.4, 7.4.1 selection criteria 7.4.1 supply of goods 7.4.1
Supporting services identification, provision and maintenance of 6.3c
Testing accuracy 7.6a calibration 7.6a final 8.2.4 process control 7.1, 7.5.1, 7.5.2 status 7.5.1
Traceability of product 7.5.3 Unintended use or delivery of nonconforming
product 8.3 Unsuitability for use
customer property 7.5.4 Urgent release of goods 8.2.4 Validation
changes in design and development 7.3.7 design and development 7.3.6 design and development planning 7.3.1b in products 7.1c partial 7.3.6 prior to delivery 7.3.6 production and service processes 7.5.2 qualification of
equipment 7.5.2b personnel 7.5.2b processes 7.5.2a
records 4.2.4, 7.3.6, 7.5.2d
Verification
changes in design/development 7.3.7 customer property 7.5.4 design and development 7.3.5 design and development planning 7.3.1b in products 7.1c lack of 7.5.2 of corrective action from internal audits 8.2.2 purchased product 7.4.3
at supplier’s premises 7.4.3 records 7.3.5 reporting of results 8.2.2
Work environment 6.4 Work instructions
availability of 7.5.1b Workspace
identification, provision and maintenance of 6.3a
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