ABSTRACT
Subject title ISO 9001 element
Ability to meet defined requirements 7.2.2d Administration of the Quality Management System 5.5
control of quality records 4.2.4 document control 4.2.3 general 5.5.1 internal communication 5.5.3 management representative 5.5.2 quality manual 4.2.2 responsibility and authority 5.5.1
Amendment to a contract 7.2.3b Analysis of data 8.4
customer requirements 8.4 customer satisfaction 8.4 measuring and monitoring activities 8.4 processes 8.4 products 8.4 Quality Management System 8.4 suppliers 8.4
Approval of changes to design and/or development 7.3.7 design and/or development output documents 7.3.3c 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 7.6b records 4.2.4, 7.6a, 7.6d validity of previous results 7.6e
Capability planning 5.4 to meet contracts 7.2.2
Changes to documents 4.2.3b Communication
customer 7.2.3 internal 5.4.4, 7.2.2, 7.2.3
Complaints 7.2.3c Continual improvement
management commitment to 5.1 measuring and monitoring activities 8.1 processes 5.6.3a product 5.6.3c quality management system 4.1a, 5.6.3a, 8.5.1 quality objectives 5.4.1 quality planning 5.4.1c quality policy 5.3b
Contract review 7.2.2 amendment 7.2.3b capability to meet requirement 7.2.2d definition of requirement 7.2.2a differences resolved 7.2.2c records of 7.2.2 requirements 7.2.2 supplier capability contract document
Control of customer supplied product 7.5.3 design and/or development changes 7.3.7 documents and data 4.2.3 inspection, measuring and test equipment 7.6 measuring and monitoring devices 7.6 non-conforming products 8.3
after delivery or use 8.3 consequences of 8.3 correction of 8.3 identification and control 8.3 prevention of unintended use or delivery 8.3 re-verification of 8.3
processes 4.1c
Control of – continued product, customer supplied 7.5.4 quality manual 4.2.2, 4.2.3 quality policy 5.3, 4.2.3 quality records 4.2.3, 4.2.4
Corrective action 8.5.2 determining causes of non-conformity 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 non-conformities 8.5.2a internal audits 8.2.2
verification of 8.2.2 non-conforming product 8.3 recording results 8.5.2e review 8.5.2f preventive actions status 5.6.2c
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, 7.2.1
change in 7.2.2c documented 7.2.2b non-documented 7.2.2b 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 measurement and monitoring of processes 8.2.3 product conformity 7.5.5
Customer satisfaction analysis of data 8.4 information monitoring 8.2 measurements of performance 8.2 methodologies 8.2
Damage and deterioration protection from 7.6c
Data analysis – see analysis of data Data control – see document control Delivery 7.5.5 Design and/or development 7.3
change control 7.3.7 approval 7.3.7 documentation 7.3.7 identification 7.3.7 validation 7.3.7 verification 7.3.7
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 & 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
review 7.3.4 evaluation 7.3.4a
Design and/or development – continued review – continued
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 stages 7.3.1a review 7.3.1b validation 7.3.1b verification 7.3.1b
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 identification of:
current revision status 4.2.3c, 4.2.3e external documents 4.2.3f obsolete documents 4.2.3g
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 design and/or development output 7.3.3
approval prior to release 7.3.3 verification against input 7.3.3
planning output 5.4.2 procedures 4.2a processes 7.1b purchasing 7.4.1 quality management system 4.1 quality manual 4.2.2
Documented procedures control of non-conforming product 8.3 corrective action 8.5.2 internal audit 8.2.2 preventive action 8.5.3 quality management system 4.2a quality manual 4.2.2b quality records 4.2.4
Electronic media 4.2, 7.6 Equipment 6.3b
identification, provision and maintenance of for production and service operations 7.5.1c
validation 7.5.2 Evaluation of suppliers 7.4.1
Facilities 6.3 equipment (hardware and software) 6.3b identification of 6.3 provision of 6.3 maintenance of 6.3 processes 7.1b supporting services 6.3c workspace 6.3.a
Final inspection and testing 8.2.4
Goods-inward testing 7.4.3
Handling, maintenance and storage of measuring and monitoring devices 7.6c Handling, storage, packaging, storage and delivery 7.5.5 Human resources 6.2
assignment of personnel 6.2.1 training, awareness and competency 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 status (product) 7.5.3 product 7.5.3 unique product identification 7.5.3
Improvement (also see continual improvement) 8.5 corrective action 8.5.2 planning for continual improvement 8.5.1 preventive action 8.5.3
Inspection and testing 7.1, 7.5.1, 8.1, 8.2.4 goods inwards 7.4.3 final inspection and testing 8.2.4 in-process inspection 7.5.1
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
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 5.1b quality policy 5.1b representative 5.5.2 review 5.1c, 5.6
Management commitment 5.1 availability of resources 5.1d customer requirements 5.1a quality objectives 5.1b quality policy 5.1b regulatory/legal requirements 5.1a review 5.1c
Management responsibility 5 commitment 5.1 customer focus 5.2 objectives 4.1 organisational responsibilities 4.1, 5.5.1 quality policy 5.1b, 5.3 management representatives 4.1 verification resources and personnel 4.1
Management representative 5.5.2 customer requirements 5.5.2c liaison with external parties 5.5.2 responsibility and authority 5.5.2 reporting to top management 5.5.2b quality management system processes 5.5.2a
Management review input 5.6.2 changes that could affect the Quality Management System 5.6.2e customer feedback 5.6.2b process performance 5.6.2c product conformance 5.6.2c 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, 5.6.3 resource needs 5.6.3c
Measurement, analysis and improvement 8 analysis of data 8.4 control of non-conformity 8.3 improvement 8.5
corrective action 8.5.2 planning for continual improvement 8.5.1 preventive action 8.5.3
measurement and monitoring 8.2 customer satisfaction 8.2.1 internal audit 8.2.2 measurement and monitoring of processes 8.2.3 measurement and monitoring 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 measurement and monitoring activities 8.1 statistical techniques
Measurement and monitoring of processes 8.2.3 customer requirements 8.2.3 intended purpose 8.2.3 suitable methods 8.2.3
Measurement and monitoring of product authority for release of a product 8.2.4
with customer approval 8.2.4 delivery 8.2.4 evidence of conformity 8.2.4 documentation 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
control of 7.6 corrective action 7.6e damage and deterioration 7.6c handling, maintenance and storage 7.6c identification of measurements to be made 7.6 implementation 7.5.1e output cannot be verified 7.5.2 product status 7.5.3 re-assessment 7.6e records 4.2.4, 7.6d protection 7.6c 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
Non-conforming 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 re-verification 8.3
Obsolete documents 5.5.6g Operations control 7.5.1
availability of product information 7.5.1a measuring and monitoring devices 7.5.1d monitoring activities 7.5.1e processes 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 System 5.5.2b
Personnel assignment of 6.2.1 training, awareness and competency 6.2.2 validation of 7.5.2
Planning 5.4 continual improvement 8.5.1
processes 8.5.1 quality management system 8.5.1
design and/or development 7.3.1 quality objectives 5.4.1 quality planning 5.4.2
Preservation of product 7.5.5
Preventive action 8.5.3 determining causes of non-conformity 8.5.3a determining and implementing 8.5.3b documented procedure 8.5.3 identification of non-conformities 8.5.3a internal audits 8.2.2
verification of 8.2.2 non-conforming product 8.3 recording results 8.5.3c review 8.5.3f status 5.6.2d
Problem identification 7.3.4b Procedures
corrective action 8.5.2 control of non-conformity 8.3 preventive action 8.5.3 quality management system 4.2.2 validation of 7.5.2
Process control 7.1, 7.5.1, 7.5.2 performance 5.6.2c provision of resources 6.1a
Processes analysis of data 8.4 availability of information 4.1d criteria for acceptability 7.1c customer-related 7.2 criteria and methods 4.1c deficiencies 7.5.2 delivery of product 7.5.1f
design and/or development 7.3.1a documentation 7.1b identification 4.1a improvement 5.6.3b measurement, monitoring and analysis 4.1e, 8.2.3
suitable methods of 8.2.3 operation and control 4.1c planning of 7.1 planned results 7.5.2 post delivery activities 7.5.1f product release 7.5.1f provision of facilities 7.1b provision of resources 7.1b purchasing 7.4 quality management system 4.1 quality manual 4.4.2c quality objectives 7.1a quality planning 5.4.2a realisation 7.1 records 7.1d re-validation 7.5.2 satisfy intended purpose 8.2.3 sequence and interaction 4.1b, 4.2.2c verification and validation 7.1c, 7.5.2
Product acceptance criteria 7.3.3c analysis of data 8.4 characteristics for safe and proper use 7.3.3d conformance 5.6.2b, 7.5.5
control 7.5.3 function and performance 7.3.2a identification and traceability 7.5.3 information 7.5.1a measuring and monitoring 8.2.4 measuring and monitoring devices 7.6 non-conformance 8.3 obligations (legal and regulatory) 5.2, 7.2.1c product identification and traceability 4.8 procedures during production, delivery & installation 4.8 purchasing 7.4
conformance to requirements 7.4.1 verification 7.4.3
realisation 7
Product – continued realisation – continued
customer-related processes 7.2 design 7.3 development 7.3 measuring and monitoring devices 7.5 planning of realisation processes 7.1 production and service operations 7.5
release purchased 8.2.4 requirements 7.1, 7.2.1
availability, delivery and support 7.2.1a confirmation of 7.2.2b definition of 7.2.2a differences resolved 7.2.2c necessary for intended use 7.2.1b records 4.2.4, 7.2.2 review 7.2.2
status 7.5.2 traceability 4.2.4, 7.5.2
Production and service operations 7.5 customer property (supplied product) 7.5.3 design and/or 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
Purchased product 7.4.1 Purchasing 7.4
control of a product or service obtained from a third party 7.4.1 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 at supplier’s premises 7.4.3
Quality audits 8.2.2 control 4.2.3d manual 4.2.2 objectives 5.4.1, 7.1a planning 5.4.2 plans, general 4.2.3a policy 5.3
Quality Management System 4 continual improvement 5.4.2c data collection and analysis 8.4 documents 4.2 internal audits 8.2.2 management commitment 5.1 management review 5.6.1 measurement of performance 8.2 processes 4.1 quality manual 4.2.2 quality objectives 5.4.1 quality planning 5.4.2a, 7.1 procedures 4.2 provision of resources 6.1a working instructions 4.2
Quality Manager 5.5.2 Quality Manual
control of 4.2.2, 4.2.3 documented procedures 5.5.2b processes 4.2.2c scope of 4.2.2a
Quality objectives 5.1b, 5.4.1 commitment to continual improvement 5.4.1 consistency 5.4.1 measurement of 5.4.1 planning of processes 7.4.1a product requirements 7.1 resources 5.4.2
Quality planning continual improvement 5.4.2c control of 5.4.2 resources needed 5.4.2b processes 5.4.2a
Quality Plans 7.1 Quality policy 5.1, 5.3, 5.4.1
appropriateness 5.2a commitment to 5.2b communication of 5.2d continual improvement 5.2b control of 5.3, 4.2.3 establishing a 5.2c framework 5.2c requirements 5.2b review 5.3e
Quality records 4.2.4 control 4.2.4 education and qualifications 6.2.2 identification 4.2.4 management reviews 5.6.2 protection 4.2.4 retention 4.2.4 retrieval 4.2.4 training and experience 6.2.2 storage 4.2.4 type of 4.2.4
Receiving of goods 7.4.3 Records
change control 7.3.7 corrective action 8.5.3e customer property 7.5.4 design and/or development review 7.3.4 management reviews 5.6.3 preventive action 8.5.3c processes 7.1d product release 8.2.4 quality 4.2.4 validation 7.3.6
of process requirements 7.5.2 verification 7.3.5
Regrading of a non-conforming product 8.3 Regulatory and legal requirements
design and/or development input 7.3.2b management commitment 5.1a quality management system 4.1 product obligations 7.2.1c
Re-inspection of a non-conformity 8.3 Rejected or scrapped work caused by non-conforming product 8.3 Release of purchased and/or subcontracted products 7.4.3 Requirements
customer 7.2.1 quality objectives 5.4.1 design and/or development input 7.3.2d legal and regulatory 5.1a, 8.2.2a product 7.2.2 purchased product 7.4.1, 7.4.2
Resource management 6 provision of 6.1 personnel 6.2 facilities 6.3 work environment 6.4
Resources 6.1, 6.3 availability 5.1d processes 7.1b provision of 6.1
to address customer satisfaction 6.1b to implement/improve processes 6.1a to implement/improve the Quality Management System 6.1a
quality planning 5.4.2 Repair 8.3 Representative, management 5.5.3 Responsibility and authority 5.5.1
communication of 5.5.1 competency 6.2.1 design and/or development activities 7.3.1c definitions of 5.5.1 internal audits 8.8.2
Re-validation of processes 7.5.2 Re-verification of products 8.3 Review
corrective action 8.5.3f design and/or development planning 7.3.1b design and/or development 7.3.4 contract 7.2.2 input 5.6.2 management 5.6 output 5.6.3 preventive action 8.5.3d product requirements 7.2.2
Servicing 7.1, 7.5.1 Statistical techniques 8.1, 8.4
use of 8.1 records 8.2.4
Status, inspect and test 7.5.1 Storage
general 7.5.5 of customer-supplied product 7.5.4
Subcontractor – see supplier Supplier
analysis of data 8.4 control 4.6.2b 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
System, quality 4
Tampering with test equipment 7.6b 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 Training, awareness and competency 6.2.2
awareness of quality objectives 6.2.2d competency 6.2.2a evaluation 6.2.2b personnel 6.2.2 provision 6.6.2b records 4.2.4, 6.2.2e requirements 6.2.1
Unintended use or delivery of non-conforming product 8.3 Unsuitability for use
customer property 7.5.4 Urgent release of goods 8.2.4
Validation changes in design/development 7.3.7 design and/or development 7.3.6 design and/or development planning 7.3.1b methodologies and procedures 7.5.2c partial 7.3.6 prior to delivery 7.3.6 in processes 7.1c 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 re-validation 7.5.2e
Verification changes in design/development 7.3.7 of corrective action from internal audits 8.2.2 customer property 7.5.4 design and/or development 7.3.5 design and/or development planning 7.3.1b in processes 7.1c lack of 7.5.2 purchased product 7.4.3
at supplier’s premises 7.4.3 records 7.5.2, 7.3.5 reporting of results 8.2.2
Work environment 6.4 human and physical factors 6.4 identification 6.4 management 6.4
Work instructions availability of 7.5.1b
Workspace identification, provision and maintenance of 6.3a
