ISO 9001:2000 Clauses Documentation suggestions/recommendations Refer also to: Doc Assigned to:
1 Scope Title
1.1 General n/a
1.2 Application n/a 4.2.2; 7
2 Normative reference n/a ISO 9000:2000
3 Terms and definitions n/a
4 Quality management system Title
4.1 General requirements Documented QMS, further explained below
Provisions for control of outsourced processes 7.4.1 P
4.2 Documentation requirements Title
4.2.1 General Quality policy statement 5.1 b; 5.3 D
Quality objectives 5.4.1; 5.1 c D
Quality manual 4.2.2 M
Documented procedures required by this standard 4.2.3; 4.2.3; 8.2.2;
8.3; 8.5.2; 8.5.3
Documents required by the organization
Records required by this standard 4.2.4
4.2.2 Quality manual Quality manual (content requirements are given below) 1.2; 4.2.1 b
- Scope of the quality system
- Details and justifications of any exclusions 1.2
- Documented procedures or references to them 4.2.1 c; 4.2.1 d
- Description of interaction of processes (flowcharts)
4.2.3 Control of documents Procedure for control of documents P
Procedure for control of computer data P
4.2.4 Control of records Procedure for control of records P
5 Management responsibility Title
5.1 Management commitment Provisions for the communication of requirements 5.5.2 c; 5.5.3
Quality policy statement 4.2.1 a; 5.3
Quality objectives 5.4.1; 4.2.1 a
Provisions for management review meetings 5.6
Provisions for resources 6.1
5.2 Customer focus Provisions for determining customer requirements 7.2.1; 8.2.1
5.3 Quality policy Quality policy statement (policy requirements are given) 4.2.1 a; 5.1 b
5.4 Planning Title
5.4.1 Quality objectives Quality objectives (measurable) 4.2.1 a; 5.1 c
Quality objectives related to the product (measurable) 7.1 a
5.4.2 Quality management system Procedures for QMS planning P
planning Quality management system implementation plans 4.1; 5.4.1 D
5.5 Responsibility, authority and Title
communication
5.5.1 Responsibility and authority Function/job descriptions D
Organizational charts D
5.5.2 Management representative Management representative's responsibilities and D
authority statement
5.5.3 Internal communication Newsletters, memos, flyers, bulletin (boards), e-mails, D
intranet, website, etc.
5.6 Management review Title
5.6.1 General Management review procedure 5.1 d P
Records of management reviews 4.2.4 R
5.6.2 Review input Information mentioned in a to g (refer to other clauses) 8.2.2; 7.2.3; 8.2.1
8.2.3; 8.2.4; 8.5.3
8.5.2; 5.4.2; 8.5.1
5.6.3 Review output Information mentioned in a to c
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ISO 9001:2000 Clauses Documentation suggestions/recommendations Refer also to: Doc Assigned to:
6 Resource management Title
6.1 Provision of resources Provisions for resource planning D
6.2 Human resources Title
6.2.1 General
6.2.2 Competence, awareness Provisions for determining competence of personnel P
and training Training plans D
Provisions to determine training/action effectiveness
Records of training, education, skills, and experience 4.2.4 R
6.3 Infrastructure Provisions for determining infrastructure needs
6.4 Work environment Provisions for determining work environment needs
7 Product realization Title
7.1 Planning of product realization Provisions for planning and developing processes 4.1
(Consider a-d) 8.2.4; 4.2.4 R
Quality plans D
7.2 Customer-related processes Title
7.2.1 Determination of requirements Procedure for determination of product requirements P
related to the product Documented requirements specified by the customer
Statutory and regulatory requirements
Requirements determined by the organization
7.2.2 Review of requirements Procedure for review of product requirements P
related to the product Records of requirement reviews and subsequent actions 4.2.4 R
Procedure for handling contract changes P
7.2.3 Customer communication Provisions for communications with customers 8.2.1; 5.2
7.3 Design and development Title
7.3.1 Design and development Design and development plans and procedures P
planning Design failure mode effects analysis (DFMEA's) D
7.3.2 Design and development Documented design inputs 7.2.1
inputs (Consider a-d)
Records R
7.3.3 Design and development Product drawings 7.3.2
outputs Specifications 7.4.1; 7.5.1
Bills of material
Inspection and test instructions 8.2.4
Product and/or equipment user manuals
(Consider a-d)
7.3.4 Design and development Design and development review procedure 7.3.1 P
review Records 4.2.4 R
7.3.5 Design and development Design and development verification procedure 7.3.1 P
verification Records 4.2.4 R
7.3.6 Design and development Design and development validation procedure 7.3.1 P
validation Records 4.2.4 R
7.3.7 Control of design and Design and development changes procedure P
development changes Records 4.2.4 R
7.4 Purchasing Title
7.4.1 Purchasing process Purchasing procedure P
Procedure for evaluation and selection of suppliers P
Supplier evaluation criteria D
Records of suppliers 4.2.4; 8.4 d R
7.4.2 Purchasing information Purchase orders (content and review) procedure P
7.4.3 Verification of purchased Receiving inspection procedure 8.2.4
product Procedure for inspections at supplier's premises P
Records 4.2.4 R
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Note: (see clause 4.2.1 NOTE 2) Jan Roovers Associates, Inc.
For reference only. Your documentation needs Charlotte, N.C.
ISO 9001:2000 Clauses Documentation suggestions/recommendations Refer also to: Doc Assigned to:
7.5 Production and service provision Title
7.5.1 Control of production and Product specifications 7.3.3 d D
service provision Inspection instructions 7.3.3 c W
Procedures and work instructions P/W
(Consider a-f) 6.3 b; 7.6; 8.2
7.5.2 Validation of processes for Doumented process validation criteria D
production and service Personnel qualifications 6.2.2
provision Equipment approvals
Procedures P
Work instructions W
Revalidation instructions
Records 4.2.4 R
(Consider a-e)
7.5.3 Identification and traceability Procedure P
Tags, labels, barcodes, markings, travellers D
Documentation showing inspection and test status D
Documentation allowing traceability (records) 4.2.4 R
7.5.4 Customer property Procedure to control customer property P
Records 4.2.4 R
7.5.5 Preservation of product Procedures P
Work instructions for identification 7.5.3 W
Work instructions for handling W
Work instructions for packaging W
Work instructions for storage W
Work instructions for protection/preservation W
Work instructions for delivery W
7.6 Control of monitoring and Provisions for determining M&M activities and devices needed 7.2.1; 8.2.3; 8.2.4
measurement devices Calibration procedures and instructions P
Records of standards for calibration R
Procedure to validate measuring results P
Records of measurement validation R
Calibration records 4.2.4 R
Procedure to validate inspection and testing software P
8 Measurement, analysis and Title
improvement
8.1 General Procedures for inspection (product and process) 8.2.3; 8.2.4
Procedures for internal audits 8.2.2
Procedures for analysis of data 8.4
Procedures for continual improvement 8.5.1
Procedures for the use of statistical techniques 8.2.3 P
(Consider a-c)
8.2 Monitoring and measurement Title
8.2.1 Customer satisfaction Procedure for determining customer satisfaction 7.2.3 P
Customer survey data, records 4.2.4 R
Customer survey data analysis results 8.4 a
8.2.2 Internal audit Procedure for internal audits including follow-up audits P
Internal audit schedule D
Internal audit records 4.2.4 R
Procedure for internal auditor selection and training 6.2.2 P
Internal auditor training records 4.2.4; 6.2.2 e R
Prepared by:
Note: (see clause 4.2.1 NOTE 2) Jan Roovers Associates, Inc.
For reference only. Your documentation needs Charlotte, N.C.
ISO 9001:2000 Clauses Documentation suggestions/recommendations Refer also to: Doc Assigned to:
8.2.3 Monitoring and measurement Procedures P
of processes Proces failure mode effects analysis results (PFMEA's)
Process control plans D
Statistical process control (SPC) charts 8.1 D
Process capability study records R
Inspection and testing records 4.2.4 R
8.2.4 Monitoring and measurement Receiving inspection procedure and instructions 7.1; 7.4.3 P/W
of product In-process inspection procedure and instructions 7.1 P/W
Final inpection and testing procedures and instructions 7.1 P/W
Inspection and testing records 4.2.4 R
8.3 Control of nonconforming product Procedure for handling nonconforming product P
Procedure for review and disposition of nonconforming P
product
Records 4.2.4 R
Procedure for rework and reinspection
Procedure for handling nonconforming product P
after delivery or use has started
8.4 Analysis of data Procedure for the analysis of data including: P
- Customer satisfaction data 8.2.1
- Inspection and test data 7.2.1
- Product and process performance data 8.5.3
- Supplier performance data 7.4.1
8.5 Improvement Title
8.5.1 Continual improvement Procedure for continual improvement which includes P
the use of:
- Quality policy 5.3
- Quality objectives 5.4.1
- Audit results 8.2.2
- Analysis of data 8.4
- Corrective action 8.5.2
- Preventive action 8.5.3
- Management review 5.6
8.5.2 Corrective action Procedure for corrective action 8.2.2 P
Records of corrective action 4.2.4 R
(Consider a-f)
8.5.2 Preventive action Procedure for preventive action P
Records of preventive action 4.2.4 R
(Consider a-e)
Prepared by:
Note: (see clause 4.2.1 NOTE 2) Jan Roovers Associates, Inc.
For reference only. Your documentation needs Charlotte, N.C.
Notes
Prepared by:
Note: (see clause 4.2.1 NOTE 2) Jan Roovers Associates, Inc.
For reference only. Your documentation needs Charlotte, N.C.
Notes
Prepared by:
Note: (see clause 4.2.1 NOTE 2) Jan Roovers Associates, Inc.
For reference only. Your documentation needs Charlotte, N.C.
Notes
Prepared by:
Note: (see clause 4.2.1 NOTE 2) Jan Roovers Associates, Inc.
For reference only. Your documentation needs Charlotte, N.C.
Notes
Prepared by:
Note: (see clause 4.2.1 NOTE 2) Jan Roovers Associates, Inc.
For reference only. Your documentation needs Charlotte, N.C.
# Doc. # Procedure Title Clause
1 XPUR-P01 Control of outsourced processes 4.1
2 XADM-P01 Control of documents 4.2.3
3 XADM-P02 Control of computer data 4.2.3
4 XADM-P03 Document and data changes 4.2.3
5 XADM-P04 Control of records 4.2.4
6 XMGT-P01 Quality management system planning 5.4.2
7 XMGT-P02 Management review 5.6
8 XHUM-P01 Determination of personnel competence 6.2.2
9 XHUM-P02 Training 6.2.2
10 XMNG-P01 Quality planning 7.1
11 XPNG-P01 Determination of product requirements 7.2.1
12 XPNG-P02 Review of product requirements 7.2.2
13 XCUS-P01 Contract management 7.2.2
14 XCUS-P02 Customer communication 7.2.3
15 XCUS-P03 Handling customer complaints 7.2.3
16 XPNG-P03 Design and development, new products 7.3
17 XPNG-P04 Design and development, modifications 7.3
18 XPUR-P02 Purchasing 7.4.1
19 XPUR-P03 Supplier evaluation, selection and monitoring 7.4.1
20 XPUR-P04 Purchase order review 7.4.2
21 XPUR-P05 Verification of purchased product 7.4.3
22 XMNG-P02 Control of processes 7.5.1
23 XPRD-P01 Production control 7.5.1
24 XMNG-P03 Control of special processes 7.5.2
25 XPRD-P02 Identification, traceability and test status 7.5.3
26 XPRD-P03 Control of customer property 7.5.4
27 XWRH-P01 Preservation of product 7.5.5
28 XQAL-P01 Control of monitoring and measuring devices 7.6
29 XQAL-P02 Validation of measurement results 7.6
30 XQAL-P03 Validation of inspection and test software 7.6
31 XQAL-P04 Statistical techniques 8.1
32 XCUS-P04 Customer satisfaction 8.2.1
33 XAUD-P01 Internal audit 8.2.2
34 XAUD-P02 Internal auditor selection and training 8.2.2
35 XQAL-P05 Process monitoring and measurement 8.2.3
36 XQAL-P06 Receiving inspection and testing 8.2.4
37 XQAL-P07 In-process inspection and testing 8.2.4
38 XQAL-P08 Final inspection and testing 8.2.4
39 XQAL-P09 Control of nonconforming product 8.3
40 XQAL-P10 Review and disposition of nonconf. product 8.3
41 XQAL-P11 Rework and repair of nonconf. product 8.3
42 XQAL-P12 Nonconforming product recall 8.3
43 XMGT-P03 Analysis of quality management system data 8.4
44 XMGT-P04 Continual improvement 8.5.1
45 XQAL-P13 Corrective action 8.5.2
46 XQAL-P14 Preventive action 8.5.3
Note: (see clause 4.2.1 NOTE 2) Prepared by:
For reference only. Your documentation needs Jan Roovers Associates, Inc.
may be significantly different depending Charlotte, N.C.
# Doc. # Record Title Clause
1 XPUR-R01 Records of outsourced processes 4.1
2 XADM-R01 Document master list (or computer file) 4.2.3
3 XADM-R02 Electronic data master list 4.2.3
4 XADM-R03 Document and data change records 4.2.3
5 XMGT-R01 QMS planning meeting minutes 5.4.2
6 XMGT-R02 Management review records 5.6.1
7 XHUM-R01 Education, training, skills, experience records 6.2.2 e
8 XMNG-R01 Process records 7.1 d
9 XMNG-R02 Product records 7.1 d
10 XPNG-R01 Product requirements/specifications 7.2.1
11 XPNG-R02 Records of product requirement reviews 7.2.2
12 XCUS-R01 Contracts 7.2.2
13 XCUS-R02 Records of customer complaints 7.2.3
14 XPNG-R03 Design and development input records 7.3.2
15 XPNG-R04 Design and development review records 7.3.4
16 XPNG-R05 Design and development verification records 7.3.5
17 XPNG-R06 Design and development validation records 7.3.6
18 XPNG-R07 Records of design and development changes 7.3.7
19 XPUR-R02 Supplier records 7.4.1
20 XPUR-R03 Purchase order review records 7.4.2
21 XPUR-R04 Purchased product verification records 7.4.3
22 XMNG-R03 Records of (special) process validation 7.5.2 d
23 XPRD-R01 Traceability records 7.5.3
24 XPRD-R02 Records of customer property 7.5.4
25 XQAL-R01 Records of standards for calibration 7.6 a
26 XQAL-R02 Calibration records 7.6
27 XQAL-R03 Measurement validation records 7.6
28 XQAL-R04 Inspection and test software validation records 7.6
29 XQAL-R05 Statistical process control charts 8.1
30 XCUS-R03 Customer satisfaction analysis results 8.2.1
31 XAUD-R01 Internal audit records 8.2.2
32 XAUD-R02 Internal auditor training records 8.2.2
33 XQAL-R06 Process capability analysis results 8.2.3
34 XQAL-R07 Inspection and testing records 8.2.4
35 XQAL-R08 Receiving inspection and testing records
36 XQAL-R09 In-process inspection and testing records
37 XQAL-R10 Final inspection and testing records
38 XQAL-R11 Records of nonconforming product 8.3
39 XQAL-R12 Review and disposition of nonconf. product 8.3
40 XQAL-R13 Reworked product inspection/testing records 8.3
41 XMGT-R03 QMS data analysis reports 8.4
42 XMGT-R04 Continual improvement projects results 8.5.1
43 XQAL-R12 Corrective action records 8.5.2
44 XQAL-R13 Preventive action records 8.5.3
Note: (see clause 4.2.1 NOTE 2) Prepared by:
For reference only. Your documentation needs Jan Roovers Associates, Inc.
may be significantly different depending Charlotte, N.C.
