Documentation For UTM

ISO 9001:2000
QUALITY
MANAGEMENT SYSTEM
DOCUMENTATION
By
Roslan Hashim 1
uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

Course Objectives
• To understand the ISO 9001 Requirements
for Documentation
• To look at how practical and effective a
Quality Management System (QMS) may
be established to ensure customers as well
as Business Needs may be met
• To understand the process of Preparing &
Controlling QMS Documentation
2

Section 1
ISO 9000 Requirements

for Documentation
• Reasons for Documenting A QMS
•Documentation Foundation
•Terminology
•Standard Requirements

Documenting a QMS - Reasons
✔ Improve Internal Communication
✔ Define Organizational Structures and Responsibilities
of personnel
✔ Standardize Work Methods - Consistency
✔ Control Inputs into a process, Monitoring of a process
and Process Correction
✔ Achieving Quality in Work Practices
✔ Maximize opportunity for improvement
✔ Achieve Quality System Certification
✔ Reference for Training
✔ Provide Auditable Criteria
✔ Minimize Dependence on staff
4

Documentation Foundation
✔ The fundamental concept that relates
documentation to its implementation is :
DOCUMENT WHAT YOU DO

DO WHAT YOU DOCUMENT

Process
A set of interrelated or interacting activities

which transforms inputs into outputs
• Inputs:
Material, information, document,
instruction, manpower, time, other
resources
• Outputs:
Parts (finished or semi-finished), 6
information, documents, records, service

Product
Result or output of a process
Product/output can be:
Tangible
* Hardware (eg. Mechanical parts, Assembled goods )
* Processed materials (eg. Petrol, Sugar, Plywood)
Intangible
* Software/ Intellectual property ( eg. Computer prog.,
Designs)
* Services (eg. Transportation, Medical care, 7
Repair works, )
Process & Procedure
• A process is an Activity
Delivery process
Inspection process
• A procedure is a Description of a
process
How do you deliver a product?
How do you inspect a product?
8

ISO 9001:2000 Requirements on
Documentation
4.2.1 The QMS documentation shall include:
a) documented statements of a quality policy &
quality objectives,
b) a quality manual,
c) documented procedures required by this std.,
d) documents needed…to ensure effective
planning, operation & control of processes,
e) records required by this std.
9

Document
Document
Information and its
supporting medium which can be
amended anytime
Example: QM, specification, procedure, plans
drawing, report, guidelines, standard
Medium - Paper, magnetic,electronic or optical
computer disc, photograph, master sample etc.
10

Forms & Records
Forms
Blank format for capturing data
Records
Evidence of activities performed . Once
confirmed, cannot be amended
Eg. Test result, training certificate
11

Specific References to Required
Documented Procedures in ISO 9001:2000
4.2.3 Control of documents

4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action
12

ISO 9000 Requirements on Documentation
- How much to document?
Extent of QMS documentation shall be

dependent on :
– size & type of the organization
– complexity & interaction of the
processes
– competence of the personnel
Clause 4.2.1
13

Documentation
4.2.2 – Quality Manual
 Scope of QMS
 Justification for exclusions
 Documented procedures/reference
 Description of interaction between processes
14

Documentation
4.2.3 Control of Documents
 Approve, Review & Update

 Identify Changes & Current Revision Status
 Ensure availability
 Legible, Identifiable
 Control External Documents
 Control Obsolete Documents
15

Mapping ISO 9001 onto the
Processes
✔ Identifying where the particular
paragraphs of the Standard have an
impact on the various processes
✔ Ensures all requirements of the Standard

are appropriately addressed throughout
the Network of Process
16

Establish Procedure
Development Schedule
•Identify procedures
•Identify process owners & reviewers
•Establish datelines
•Monitor progress
17

Section 2
How To Document
Your QMS
• Process of Preparation of QMS Documentation
•Documentation Structure of QMS
•Preparation of Procedure
•Preparation of Support Documents
•Preparation of Quality Manual
18

Preparation of QMS Documentation
- the Process
Project Planning
Work Preparation
Work Preparation
Document Writing
Document Review
Implement 19

Route
:
To Documentation Process
Project Planning
-
• Plan for the documentation project – procedure
development schedule
•Identify software system & back-up facilities
• Typing facilities
•
20

Route
:
Work Preparation
-
• Identify style & format to be used throughout
documentation
• Evaluate the adequacy of the current documentation
• Analyse the process & interfaces
•
21

Route
:
Document Writing
-
• Delegate to process owners
• Provide supervision & training
• Identify responsibility for document preparation &
authoriztion
•Use flowcharts and symbols, where applicable
•
22

Route
:
Document Review
-
• Check & review documents to ensure consistency
• Should be user friendly & simple
• Check interfaces – usually these are the weak
points
• Identify areas of overlap & duplication – remove
•
them
• Cross check references
• Circulate drafts for comments
23

Route
:
Implement
-
• Provide necessary training
• Ask users to implement as per written
documentation – trial usage if necessary
• Identify issues related to contents, understanding,
user’s perception & specific problems
•
• Rewrite, simplify or clarify documentation
• Maintain appropriate records
• Check effectiveness
• Correct & improve 24

Typical Documentation
Structure of a QMS
ISO 9000 standards does not make any reference on how to document a
quality system and it does provide a recommendation on its structure
Defines Policy, Objective
and Approach
Level 1
QUALITY (Non-specific)
MANUAL
Level 2 Defines Who,

PROCEDURES What and When
Level 3 Answers
SUPPORTING DOCUMENTS
How
25

Documents Link
Quality manual
Procedures
Support
documents
W.I
Guidelines 26

Level 1 - Quality Manual
Purpose To inform all staff, and often customers, of
the management policy and objectives for quality
Contents - Company’s Quality Policy & Objectives
- Description of the overall QMS of the company
- Scope of the QMS
- Justification for permissible exclusions
- Reference to documented procedures
- Description of processes
27

Level 2 - Procedures
Purpose To instruct the staff in broad terms how the
policies and objectives expressed in the Quality Manual
are to be addressed and achieved
Contents - Description on methods and sequence of
activities
- Provides information on who is responsible for
the activity, what tools to use, what records need
to be kept and the interface with any other
activity in the system
28

Quality Plan
Purpose Provides control of the construction process for
each project undertaken.
Updated and ‘live’ document which incorporates
an outline of planned actions needed to meet the
quality requirements of the project at the outset
and in the light of any subsequent changes to
them that may arise during the progress of the
project.
Contents Project particulars,organization structure, schedule
of contract documents, project schedules,
QMS documentation, ITP, special
29
requirements, etc.
Level 3 – Support Documents
Purpose To describe in detail how a specific activity
is to be undertaken
To define the acceptance criteria for the
product or service
Contents These may be take the form of drawings,

flow diagrams, models, pictures or any
other suitable form
30

Level 2 - Procedure
Should provide clear description of an activity, including the
following information about the procedure :
✔ What is the intention?

✔ Who is responsible ?
✔ What is the input and output ?
✔ What are the skills and equipment needed ?
✔ What is the sequence of activities ?
✔ Any special environment or safety requirements ?
✔ Any other documents referred to ?
31

Level 2 –
Procedures
Procedures can be in the form of: -
• Text / essay type
• Flowcharts
• Pictures and videos
• Audio tapes
• Software
32

Level 3 - Support Documents
Types of Support Documents:

•Work Instructions
•Codes of Practice (Guides)
•User Manuals
•Technical Documentation
•Workmanship Standards
33

Work Instructions
This level consists of technical process, inspection
& test instructions process, product
specifications, etc. Needed to carry out Level 2
procedures
These supporting documents describe

METHODS OF DOING IT
34

Work Instructions - Mandatory?
NOT needed in all cases

Decision based on :
✔ Experience of the people doing the job

✔ Qualification required
✔ Risk of failure
✔ Complexity of the task
35

Work Instructions - Examples
✔ How to operate a Spectrometer Machine

✔ How to do concreting
✔ How to conduct a Cube Test
✔ How to calibrate a measuring tape
Can be in the form of pictures, line

drawings, photographs, samples, etc.
36

Quality Manual
Your quality manual should have:
✔ Title, reference number and a table of
contents
✔ Introduction of the QM
✔ Scope of the QMS
✔ Justification for exclusions
✔ Overview of the QMS
37

Quality Manual
✔ Information on company background
✔ Organization charts
✔ Terms of reference of key personnel
✔ Quality policy
✔ Quality objectives
38

Quality Manual
✔ Network of processes
✔ Explanation on how the QMS meets
the ISO requirements
✔ Summary or reference to procedures
39

ISO 9001 Documentation
Reminders
✔ Does NOT dictate quality
✔ Is NOT a one-time unamen-
dable process [dynamic]
✔ Is NOT easy, but does not
have to be difficult
✔ Requires commitment
✔ Requires resources
40

Section 3
Document Preparation
&
Control
• Preparation & Authorization
•Registration
•Document Distribution
•Administration of Document Changes
41

What is Controlled Documentation?
✔ If a controlled document is changed, a record of the
change has to be made. This means there must be a
record of all changes.
✔ If a document is changed, people who use it
MUST know about the change. This means there
has to be a distribution list or other effective way to
let everyone who uses it know the document has
changed.
✔ Every employee must know how to check to see if
documentation they are using is the most current
version.
42

Preparation & Authorization
Responsibilities to be defined for :

✔Preparation & Amendments
✔Checking
✔Authorization
43

Approval Authority
Organization to determine who is responsible and at which
level of the organization.
A typical arrangement is as follows :
Quality Manual - Managing Director/CEO
Departmental Procedures - Departmental Manager
Work Instructions (other Support Documents) -
Senior Executives/Supervisor
44

Registration
✔ To ensure that changes and the current revision
status of documents are identified
Clause 4.2.3 c
Master list
– a listing of all current documents that make
up the quality system
– purpose is to provide a quick reference to
preclude the use of invalid and/or
obsolete documents 45

Document Distribution
✔ Ensure relevant versions of applicable documents are

available at points of use
(Clause 4.2.3 d)
The availability of task-specific

documents may be limited to
those who are involved in the
activity
46

Document Distribution
Required:
- to decide who should need what document
- identify and list all document holders (unique no.)
- recall from all holders when documents are obsolete
- issue updated documents and get holders to acknowledge
receipt
- obsolete documents, if retained, to be suitably identified
47

Administration of Document
Changes
Typical Steps:
1. Change Initiated 2. Obtain
3. Produce
& Defined Approval
Amended
Copy
-Identify pages & text - New Issue/Revision No.
affected or inclusions allocated to amended copy
-consult users
6. Update 5. Distribute 4. Obtain

- Amendment New Copies
Record & Masterlist Authorization
- Obtain acknowledgement
from recipients
- Collate, destroy/identify OBSOLETE 48
documents
Amendment Record - Example
✔ A record detailing
Rev. No. Document Change Effective
all changes that No. Description Date
have taken place

and is usually
attached with the
original copy of
the Quality
Manual or the
Procedures
Manual
49

Issue / Revision Control
✔ Quality system documents are subjected
to change to reflect current needs of
customers, technological changes and
improvements
✔ Issue/revision control provides a way of

administering change
50

Section 4
IMPLEMENTATION
OF
QUALITY MANAGEMENT
SYSTEM
51

Implementation Problems
✔ Leadership and Commitment
-priority, involvement
✔ Culture
-strategy, unclear organization, fire fighting
management, tight costs, lowest price purchasing,
short cuts to maximize profit
✔ Cost
-resources, training, consultancy
52

Implementation Problems
✔ Development
-staff knowledge, unclear structure & process,
lack of time, low priority, no interest, resistance
✔ System
-procedures not clear & do not work, too much
paper, does not meet standard requirements,
audits not effective
53

Maintenance
Auditing
Update Documentation
according to practice
Management Review
Continuous Training
Continuous Improvement
54

Key Success Factors
What is successful implementation?
Implementing an effective ISO 9000 compliant

system at minimal development cost, with
minimal disruption & within the desired time
frame. An effective system is one which results
in improvements in quality and/or productivity
which, in turn, result in improvement in the
organization’s competitive position.
55

Key Success Factors
1. Leadership adopts a positive mind set

2. Executive management gets educated
3. Leadership sets the standard
4. Leadership stays in touch

with the process
5. Generate & follow a realistic plan

56

Key Success Factors
6. Choose the right person to coordinate
the ISO effort
7. Recognize that ISO is not a quality

department program
8. Get the right people involved
9. Develop a strong ISO knowledge base

within the organization
10. Use the ISO continuous improvement process

57

QUALITY MANAGEMENT
SYSTEM
58

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ISO 9001:2000

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

ISO 9000 Requirements

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

DOCUMENT WHAT YOU DO

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

A set of interrelated or interacting activities

information, documents, records, service

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

4.2.3 Control of documents

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

Extent of QMS documentation shall be

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

 Approve, Review & Update

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

✔ Ensures all requirements of the Standard

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

Level 2 Defines Who,

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

Contents These may be take the form of drawings,

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

✔ What is the intention?

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

• Pictures and videos

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

Types of Support Documents:

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

These supporting documents describe

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

NOT needed in all cases

✔ Experience of the people doing the job

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

✔ How to operate a Spectrometer Machine

Can be in the form of pictures, line

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

Responsibilities to be defined for :

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val

uality Expert Sdn.Bhd. “Assisting Customer In Maximizing Val