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Content
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Introduction
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Quality System Model (manual,
procedures, flowcharts, work instructions, master lists, forms, templates)
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Checklist of ISO 9001:2008 requirements
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Documentation Development
Guide -for manual, procedures, forms
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Implementation Plan and Schedule
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Documentation Development Files
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Documents
and Procedures
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Quality Manual (1)
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Operating Procedures (49), including
70 control forms
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Work Instructions (6),
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Document master lists (16)
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ISO 9001:2008 Quality Manual
Table of Content |
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1
1.1
1.2
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About
this manual
Distribution
Approvals
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2
3
3.1
3.2
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Introduction
General
Scope
References
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4
4.1
4.1.1
4.2
4.2.1
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Quality
management system
Quality management system
General requirements
Documentation requirements
General
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4.2.2
4.2.3
4.2.4
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Quality manual
Control of documents
Control of records
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5
5.1
5.2
5.3
5.4
5.4.1
5.4.2
5.5
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Management
responsibility
Management
commitment
Customer focus
Quality policy
Planning
Quality objectives
Quality management system planning
Responsibility, authority and communication
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5.5.1
5.5.2
5.5.3
5.6
5.6.1
5.6.2
5.63
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Responsibility and
authority
Management representative
Internal communication
Management review
General
Review input
Review
output
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6
6.1
6.2
6.2.1
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Resource
management
Provision of resources
Human resources
General
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6.2.2
6.31
6.4 |
Competence, training and awareness
Infrastructures
Work environment |
7
7.1
7.2
7.2.1
7.2.2
7.2.3
7.3
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
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Product
realization
Planning of
product realization
Customer-related
processes
Determination
of requirements related to the product
Review of requirements related to the product
Customer communication
Design and development
Design
and development planning
Design and development inputs
Design and development outputs
Design and development review
Design and development verification
Design and development validation
Control of design and development changes
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7.4
7.4.1
7.4.2
7.4.3
7.5
7.5.1
7.5.2
7.5.3
7.5.4
7.5.5
7.6 |
Purchasing
Purchasing process
Purchasing information
Verification of purchased product
Production and service provision
Control
of production and service provision
Validation of processes for production and service provision
Identification and traceability
Customer property
Preservation of product
Control of monitoring and measuring equipment
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8
8.1
8.2
8.2.1
8.2.2
8.2.3
8.2.4
8.3
8.4
8.5
8.5.1
8.5.2
8.5.3
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Measurement,
analysis and improvement
General
Monitoring and
measurement
Customer satisfaction
Internal audit
Monitoring and measurement of processes
Monitoring and measurement of product
Control of nonconforming product
Analysis of data
Improvement
Continual improvement
Corrective action
Preventive action
Revision control page
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ISO 9001:2008 Operating Procedures
and Work Instructions by Department
The standard ISO 9001 requires
6 mandatory documented procedures. It is up to the discretion of
the organization to document additional procedures included in this quality
system model, or just to implement them in order to meet the requirements
of the standard. |
Engineering
EG 01 Design Activities,
Coordination and Control
EG 02 Document and Data
Control (Engineering)
EG 03 Quality Planning Process
EG 04 Request for Design
Initiation and Design Change
Manufacturing
MF 01 Health and Safety
Training
MF 02 Cycle Counts
MF 03 Traceability of Manufactured
Product
MF 04 Production Scheduling
MF 05 Material Resource
Planning
MF 06 Manufacturing Process
Control
MF 07 Set-Up Procedure
MF 08 Preventive Maintenance
of Equipment
MF 09 Regulatory Requirements,
compliance
Purchasing
PU 01 Purchase Orders, processing
and follow-up
PU 02 Supplier Database,
set-up and maintenance
PU 03 Purchasing Product-Database
PU 04 Assessment, Eval.,
Appr., Rating of Suppliers
PU W 01 Suppliers Performance
Rating System
Quality Assurance
QA 01 Control of Nonconforming
Product
QA 02 Receiving Inspection
QA 03 In-Process Inspection
QA 04 Inspection and Testing
of Finished Product
QA 05 Control of Monitoring
and Measuring Equipment
QA 06 Out Of Calibration
Report
QA 07 Measurement Equipment
Analysis
QA 08 Customer Return Analysis
QA 09 Positive Recall Control
QA 10 Customer Approval
of Production Parts |
Quality
System Administration
QS 01 Document Review
QS 02 Training
QS 03 Document and Data
Control
QS 04 Operational Performance
QS 05 Evaluation of Customer
Satisfaction
QS 06 Customer Complaints
QS 07 Customer Satisfaction
Survey
QS 08 Internal Quality Audits
QS 09 Preventive Action
QS 10 Corrective Action
QS 11 Continual Improvement
QS 12 Control of Records
QS W 01 Corrective Action
Request
QS W 02 Problem Analysis
QS W 03 Quality Improvement
Proposal
QS W 04 Document Identification
Sales
SA 01 Warranty Control
SA 02 Review of Quotations
and Contracts
SA 03 Product/Price File
and Customer File
SA 04 Order Taking and Processing
SA 05 Delivery Performance,
order entry
SA 06 Customer Returns
SA 07 Service Requirements
Warehouse
WH 01 Shipping of Product
WH 02 Receiving of Product
WH 03 Handling and Storage
of Product
WH 04 Temperature Control |
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Forms
Forms or control forms are
part of operating procedures or work instructions. These forms facilitate
the performance of activities, document results, and provide evidence of
compliance with requirements of the standards ISO 9001:2008. In most cases, these forms can be used without
documenting the applicable procedure, and it is up to the organization
to document the procedure or only to implement the procedure and using
the control form to ensure compliance and create records.
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Engineering
- Design Activities, Coordination
and Control
- Design Project Plan and
Schedule
- Design Review Checklist
- Engineering Document and
Data Control
- Documeent Distribution
Log
- Document Receiving Log
- Quality Planning – Project
Plan and Schedule
- Process FMEA
- Manufacturing Plan
- Design Project Request
Manufacturing
- Training Attendance Record
Form
- Cycle Count Records Form
- Material Requirement for
Production Form
- Process Sheet
- Manufacturing Order Form
- Material Supply Order
Form
- Product Identification
Tag
- Tools and Fixture Requisition
Sheet
- Request for QC-Approval
(first-off/last-off) Form
- Preventive Maintenance
- Master List of Equipment
- Preventive Maintenance
Checklist
- Equipment Replacement
Parts - MIN / MAX inventory
- Weekly Maintenance Schedule
of Equipment Sheet
- Maintenance Record
Purchasing
- Supplier Database - Setup
and Maintenance Form
- Product Database - Setup
and Maintenance Form
- Supplier Self Assessment
Questionnaire
- Supplier Evaluation and
Approval Sheet
- Approved Supplier List
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Quality
Assurance
- Quarantined Product Tag
- Quarantine Order Sheet
- Receiving Inspection Report
- Rejected Product Tag
- In-Process Inspection
Report
- In-Process Inspection
Report - Master List
- First – Off Tag
- Approved for Shipping
Tag
- Last–Off Tag
- Final Inspection Report
- Final Inspection Report
– Master List
- Master List of Measuring,
Monitoring, Testing Equipment
- Calibration Status Tag
- Calibration and Maintenance
Record Sheet
- Out Of Calibration Report
- Authorization for Positive
Recall Form
- Under Positive Recall
Control Tag
Quality System Administration
- Training Record
- Templates: manual, procedures,
work instructions
- Performance Statistics
Form
- Customer Complaints Log
- Customer Satisfaction
Survey Form
- Internal Quality Audit
Plan / Schedule
- Audit Report Form
- Corrective Action Request
Sheet
- Problem Analysis Form
- Quality Improvement Proposal
Sheet
Sales
- Quotation Sheet
- Project Order Form
- Customer File Setup and
Maintenance Form
- Product/Price Record Form
- Customer Order Sheet
- Material Return Authorization
Form
- Service Report Form
Warehouse
- Temperature Record Sheet
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Checklist
of ISO 9001:2008 requirements
This detailed checklist of 31pages assists with
the identification of - and compliance with - the
requirements of ISO 9001:2008. A handy tool for
the development of documentation, procedures and
auditing processes, as well as the identification
of documents that address specific related
requirements of ISO 9001:2008.
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Sample
Pages
ISO 9001:2008 Quality System Model
- quality manual - operating procedure - flowchart - form - ISO
9001:2008 requirements checklist
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| Sample
page of the quality manual IS0 9001:2008 |
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RC
General
Manufacturing
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Quality
Manual |
Page No. : 28 of 28
Page Revision
: 00
Issued
: 2009/01/05 |
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8.5.2 Corrective action
It
is the responsibility of the Management
Representative to implement and maintain the
documented procedure QS10 Corrective Action
which defines a corporate approach for
corrective action.
Following
the established procedure for corrective
action (QS10), nonconformities are
identified, root causes are determined
(QSW02), corrective action is evaluated and
defined, recurrence of the nonconformity is
prevented, corrective actions and their
results are recorded, and the effectiveness
of corrective action taken is reviewed.
Corrective actions are appropriate to the
importance and impact of the addressed
nonconformity.
It
is the responsibility of the department
heads to inform the Sales/Service department
of all customer complaints (QS06) and
related corrective actions.
It
is the responsibility of the department
heads to establish and maintain records of
corrective actions and their results.
8.5.3
Preventive Action
It
is the responsibility of the Management
Representative to implement and maintain the
documented procedure QS09 Preventive Action
which defines a corporate approach for
preventive action to prevent the occurrence
of potential nonconformities, deficiencies
or problems. Any employee can suggest a
preventive action to the responsible
department head by initiating a CAR (QSW01).
The
process of preventive action includes the
following steps:
·
identify
potential nonconformities, deficiencies or
problems
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determine
the root causes
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determine
the necessary preventive action
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implement
the action
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follow-up
on status and results
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review
the effectiveness of preventive action
taken.
Department
heads analyze and evaluate data of
statistics (QS04) and perform periodic
reviews of procedures (QS01) in order to
detect deficiencies and problems, and to
take preventive action as required.
It
is the responsibility of the department
heads to establish and maintain records of
preventive actions and their results. The
Management Representative ensures that
relevant information on preventive action is
on the agenda of management reviews.
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Sample
page of ISO 9001:2008 operating procedure (text -
format)
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RC
General
Manufacturing
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Operating
Procedure
QS 09 |
Page No. : 01
of
01
Page Revision
: 00
Issued
: 2009/01/05 |
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Title: Preventive Action
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Prepared by
Date
Herb
S.
January 05/2009 |
Reviewed/approved by
Date
Department Head:
John
K.
January 05/2009
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eviewed/approved by
Date
Management Representative:
Herb
S.
January 05/2009 |
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Changes
made:
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New
issue
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Purpose:
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Establish and
document the procedure for preventive action, using
the appropriate information to detect, analyze and
eliminate potential causes of nonconformities and
deficiencies.
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Scope:
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Products,
processes, activities, operational performance
within RCGM. Quality management systems, customer
satisfaction.
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| Procedure
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General
A
professional judgment should be applied by
all functions to ensure that preventive
actions are appropriate and proportional to
the importance of the potential problem to
be addressed. It is the responsibility of
the department heads to approve preventive
actions. Procedures and documents affected
by the implementation of preventive actions
shall be updated, and new procedures shall
be established as required.
To identify and analyze nonconformities and
deficiencies, and to prevent their
occurrence, the following approach for
preventive actions shall be taken as a
minimum:
1 At
least once within 24 months, each department
head reviews all procedures issued by
his/her department, following the operating
procedure Document Review.
2 Statistics
prepared by the Management Representative as
per operating procedure Operational Performance, are analyzed by the responsible department
head(s). As a result from these analysis,
performance trends on product quality,
manufacturing processes, technical service,
delivery, customer concerns and customer
satisfaction are identified and preventive
action is taken by issuing a CAR
or as appropriate.
3 As
per established operating procedure Evaluation
of Customer Satisfaction, the General Manager
evaluates customer dissatisfaction and takes
preventive action as appropriate.
4 The
suitability and effectiveness of preventive
actions is reviewed and evaluated by
management during management reviews and
action is taken as required. The
effectiveness of implemented preventive
actions shall also be monitored for an
appropriate period by department heads, and
results shall be recorded.
5 Department
heads ensure that records of preventive
actions are made available to the Management
Representative who ensures that they are
part of management reviews.
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Sample
page of ISO 9001:2008 operating procedure - flowchart format |
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RC
General
Manufacturing
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Operating
Procedure
QS 09 |
Page No. : 01
of
01
Page Revision
: 00
Issued
: 2009/01/05 |
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Title: Preventive Action
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Prepared by
Date
Herb
S.
January 05/2009 |
Reviewed/approved by
Date
Department Head:
John
K.
January 05/2009
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eviewed/approved by
Date
Management Representative:
Herb
S.
January 05/2009 |
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Changes
made:
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New
issue
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Purpose:
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Establish and
document the procedure for preventive action, using
the appropriate information to detect, analyze and
eliminate potential causes of nonconformities and
deficiencies.
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Scope:
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Products,
processes, activities, operational performance
within RCGM. Quality management systems, customer
satisfaction.
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Sample
Page
of a Form "Corrective Action
Request" - ISO 9001:2008 Quality Management System
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RC
General
Manufacturing
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Work Instruction
QS W01 |
Page No. : 04 of
05
Page Revision
: 00
Issued
: 2009/01/05 |
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Title: Corrective
Action Request
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Sample Page
of the ISO 9001:2008 Requirements Checklist
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Requirements
Checklist for ISO 9001:2008
For internal use only
Page 3 of 31
Important: This checklist shall assist with the
assessment of compliance with requirements
of ISO 9001:2008. The standard ISO 9001:2008
shall be used for the interpretation of the
standard.
Review performed by:
_______________________________________________
Date:________________________________________
Y = yes, I = improvement needed, N
= no, X
= not applicable
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ISO
9001 System Clauses / Requirements
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M
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Procedures
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Y
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I
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N
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X
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(continues
4.2.2 Quality Manual)
The
manual shall include
a) - the scope of the quality
management system
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- details
of any exclusions
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-
justification for any exclusions
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- documented procedures, or reference
to them
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c)
- a description of the interaction of
the processes
included in the quality management
system
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4.2.3 Control of Documents
Documents
required for the quality management
system
- shall be controlled
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Records
- shall be controlled according to the
requirements in clause 4.2.4
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For
the control of documents
- a documented procedure shall be
established
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The
documented procedure shall define the
controls needed
a) - to approve documents for adequacy
prior to issue
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- to review documents as necessary
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- to
update documents as necessary
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- to
re-approve documents as necessary
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| c)
- to identify changes of documents
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- to
identify current revision status of
documents
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d)
- to have applicable revisions of
documents
available at use
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| e)
- to maintain documents legible
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- to
maintain documents readily
identifiable
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| f)
- to identify documents of external
origin
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- to
control the distribution of external
documents
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| g)
- to prevent unintended use of
obsolete documents
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- to
properly identify obsolete documents
that are
retained for any purpose
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product information
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