EFFECTIVE

DOCUMENT
CONTROL &
MANAGEMENT
(BASED ON ISO
9001)

AZLINA AMER HAMZAH
Session 1A
Introduction to
Quality
Management
System
FUNDAMENTALS OF ISO9001 QMS
These concepts embraced in ISO 9001

High Level Structure QMS Principles Process Approach

1. High Level Structure
The structure is aligned to other management system standards
2. Quality Management Principles
7 Quality Management Principles (refer ISO 9000) have been identified as a framework
towards improved performance of an organization.

Evidence
Customer Engagement Process based Relationship
Leadership Improvement
Focus of people Approach decision management
making
2. Quality Management Principles
a. Customer Focus
The primary focus of quality management is to meet requirements and t strive to exceed
customer expectation.

b. Leadership
Leaders at all levels establish unity of purpose and direction and create conditions in which
people are engaged in achieving organization quality objectives

c. Engagement of people
Competent, empowered and engaged people at all levels throughout the organization are
essential to enhance the organization capability to create and deliver value
2. Quality Management Principles
d. Process Approach
Consistent and predictable results are achieved more effectively and efficiently when activities
are understood and managed as interrelated processes that function as a coherent system

e. Improvement
Successful organizations have an ongoing focus on improvement

f. Evidence based decision making

Decisions based in the analysis and evaluation of data and informations are more likely to
produce desired results

g. Relationship manahement
For sustained success, organizations manage their relationship with interested parties, such as
providers
3. Process Approach
Systematic definition and management of processes and their interaction to achieve
intended results in accordance with policy and strategic direction
Plan-Do-Check-Act Framework
Application of PDCA

Plan
Establish objective of the system and its processes and the resources needed to deliver results in
accordance with customer requirement and organizations policies, and to identify risk and
opportunities

Do
Implement what was planned

Check
Monitor and (where applicable) measure processes and the resulting products andservices
against policie, objectives, requirements and planned activities and report the result

Act
Take actions to improve performance
Session 1B
Introduction to
Quality
Management
System
Clause 1.0 Scope

• Providing Products and Services that meet customer

requirements and applicable Statutory & Regulatory Requirements
• Enhancing Customer Satisfaction

• Section 1 no longer covers item “Exclusions”

Organization decide on which requirements of the standard
are needed.
Described in clause 4.3
Clause 2.0 Normative Reference

• Reference to the latest terms and definitions given in ISO

9000:2015, Quality Management System – Fundamentals and
vocabulary
Clause 3.0 Terms and Definition

• The term & definitions given in ISO 9000:2015 apply

 Annex SL (High Level Structure)

4.0 5.0 6.0 7.0 8.0 9.0

10.0
Context of Leadership Planning Support Operation Performance
Improvement
Organization And Evaluation
8.1
4.1 5.1 6.1 7.1 9.1 10.1
Ops planning and control
Understanding Leadership Actions to Resources Monitoring, General
context and commitment address risks 8.2 Req for products and measurement,
and 7.2 services 10.2
analysis and
4.2 5.2 opportunities Competence Nonconformity
evaluation
Interested Policy 8.3 Design and and corrective
parties 6.2 7.3 development action
9.2
5.3 Quality Awareness
8.4 Control of Internal audit
4.3 Org roles, objectives and 10.3
Scope responsibilities 7.4 externally provided Continual
planning 9.3
and authorities Communication processes products improvement
Management
4.4 6.3 and services
7.5 review
QMS Planning of
Documented 8.5 Production and
changes
information service provision

8.6 Release of
products and service
8. 7 Control of NC
Outputs
Risk Based Thinking
An organization needs to plan and implement actions to address risks and opportunities – a
basis for increasing effectiveness of the QMS, achieving improved results and preventing
negative effects.

An effect can be positive and negative

A positive deviation arising from a risk can provide an opportunity, but not all positive effects of
risk results in opportunity.
What is RISK?
Effect of Uncertainty

Risk is often characterized by reference

to potential events and consequences,
or a combination of these.
Risk Examples

Human
• Non availability/long leave
• Inadequate skill/competence
Technical
• Process failure or capability utilization not achieve
• Delay in delivery
Customer related
• Delay in payment
• Delay in communication and approval
Physical
• Theft, Willful Damage
Environmental
• Power failure, Fire, Water
Opportunity Examples

Allow an organization to attract

customers, develop new products &
services, reduce waste, improve
productivity, reduce cycle time, reduce
tool set-up time and etc.
Importance of QMS?
Advantages of a well run QMS
a) Lower cost and wastage
b) Easier to manage and more responsive to change
c) Easier to train staff
d) Clear responsibilities
e) Less time spent on ‘fire-fighting’
f) More satisfied customer
g) Continual improvement
h) Everyone follow ‘best practice’ as per process documentation
Strategic Planning of QMS
Session 2
QMS
Documentation
Requirements
Documented QMS
Documented information shall be available where :
a) It is required by the standard
b) Necessary for the organization’s to achieve effectiveness of the QMS

Clause 4.4.2(a) requires an organization to :

a) Maintain documented information to support the operation of its processes
b) Retain documented information to have confidence that the processes are carried
out as planned.
Documented QMS
Clause 7.5.1 Note
The amount of documentation required depends on
a) Size of the organization and type of activities, processes, products and services
b) The complexity of processes and their interaction
c) The competence of persons
Documented Information
Maintain Documented Information
a) Contains information about
what needs to be done
b) Example : policy statement,
manual, procedures, forms
Retain Documented Information
a) Stating results achieved
b) Evidence of activities
performed or done
c) Examples : records stating
traceability, verification or
corrective action.
 Documented Information Specified in ISO 9001:2015
Standard

1. Scope (4.3)
2. Documented information to support operations of its processes and to have
confidence that the processes are being carried out as planned (4.4.2)
3. Policy (5.2.2)
4. Objectives (6.2.1)
5. Evidence of fitness for purpose of the monitoring and measurement resources
(7.1.5.1)
6. Basis used for calibration and verification of measuring eqp (7.1.5.2)
7. Competence (7.2)
8. Documented information required by QMS, documented information of external
origin (7.5.3)
9. Process has been carried out as planned and to demonstrate conformity of products
and services (8.1)
10. Results of product and services requirement review and/or when there is new
requirements (8.2.3.2)
11. Demonstrate design and development requirements have been met (8.3.2)
12. Changes to requirements for products and services (8.2.4)
Documented Information Specified in ISO 9001:2015
Standard

13. Design and development inputs (8.3.3)

14. Design and development control (8.3.4)
15. Design and development output (8.3.5)
16. Design and development changes (8.3.6)
17. Evaluation, selection, monitoring performance and reevaluation of external
providers and resulting actions
18. Define the characteristic of the products to be produced, services to be provided or
the activities to be performed (8.5.1)
19. Traceability (8.5.2)
20. Report on loss, damage or unsuitability of customer or external providers’ property
(8.5.3)
21. Control of changes (8.5.6)
22. Release of product and services (8.6)
23. Control of non-conforming outputs (8.7.2)
24. Results of evaluation of performance and effectiveess of QMS (9.1.1)
25. Internal audit programme implementation and audit results (9.2.2)
26. Management review results (9.3)
27. NC, action taken and results of corrective action (10.2.2)
Session 3
Planning and
Controlling
Documentation
System
Requirements You Need to be Aware of with ISO 9001

Documents can be in any media

“Any Media” means document scan be written in paper, electronic, even video formats.
The documents can be written, pictorials, flow charts, or a combination of these. Just
remember it needs to make sense to your organization.
Requirements You Need to be Aware of with ISO 9001

Documents Need to be Identified

There is no need to have document numbers unless you believe these are needed and
are helpful to your business. A simple identifier is the title of the document and if this
appears in the footer or header of each page, the document is indeed identified.
Requirements You Need to be Aware of with ISO 9001

Documents Need to be Approved

Designate a person or group of people with the authority to determine suitability for
your business. Ideally, that person is always aligned to the strategic direction of the
business and understands the implications of such a document.
Requirements You Need to be Aware of with ISO 9001

Documents Need to be Controlled

• Version Control: Documents must have an identifiable version
visible throughout the document. This allows you to determine if the right
version of the document is being used. The version can be alphanumeric or by
date.

• Distribution Control: Documents must be made available and

accessible for use. They need to be maintained in a manner so points of use can
be readily updated when changes occur, that only authorized changes are made,
and documents remain legible over time.
Requirements You Need to be Aware of with ISO 9001

Keeping Document Control Effective

Over the years some of the most infamous controls deployed by overly careful document
control administrators have been:
i. Document Stamps: Stamps showing the document status such as: “Reference Only,”
“Uncontrolled,” “Not a Controlled Document,” “Master Copy,” etc.
ii. Footer Controls: “Not valid if printed,” “Check system for latest version,” “Not valid after 24
Hours,” etc.
iii. Watermark Controls: Using watermark to notate “Draft”, “Controlled”, “Uncontrolled”, etc.

All these are methods of control but can be misunderstood by those using them. For example, could
you have the correct stamp, footer, or watermark, but have no way to ensure that people do not change
the document, even on accident? Can these controls show that the document approvals were
adequate? Can a stamp prevent someone from receiving an outdated version of the process?
Session 4
Procedures and
Instruction Writing
Principles
Documentation Structure

Quality Policy

Quality
Manual

Quality
Procedures

Work Instruction

Records
Quality Policy
A policy represents a declarative statement by an organization.

A Quality Policy should state the commitment of the organization to quality and
continual improvement.

The Quality Policy defines the quality objectives to which the organization strives. The
quality goals of organizations are defined by quantifying the quality objectives.
Quality Manual
The structure and the content of the manual can vary depending on the size of the
organization, the complexity of its operations, and the competence of the personnel.

Generally, the manual includes the QMS scope, exclusions from the standard,
references to relevant documents, and the business process model.

The Quality Policy and the objectives can be part of the manual as well.
Quality Procedure
Quality Procedures can be narrative, i.e., described through text; they can be more
structured by using tables; they can be more illustrative, i.e., flow charts; or they can be
any combination of the above.
Quality procedures should include the following elements:
• Title – for identification of the procedure
• Purpose – describing the rationale behind the procedure
• Scope – to explain what aspects will be covered in the procedure, and which
aspects will not be covered
• Responsibilities and authorities of all people/functions included in any part
the procedure
• Document control – identification of changes, date of review, and approval and
version of the document
• Description of activities
• Appendices may be included, if needed.
Work Instruction
Work instructions can be part of a procedure, or they can be referenced in a procedure.
Generally, work instructions have a similar structure to the procedures and cover the
same elements; however, the work instructions include details of activities
that need to be realized, focusing on the sequencing of the steps, tools,
and methods to be used and required accuracy.

Training of personnel and the use of competent personnel can decrease the need for
highly detailed work instructions
Record
A record is what has been chosen by the process owner to demonstrate that the
process and activities have been conducted in the way prescribed in the
procedures and work instructions.
Forms are the blank templates to be filled in with information that will become these
records. Make your records and forms practical by being concise and simply recording
the information required.
Characteristic of Effective Documentation
Effective documentation is documentation that is used by its users.
Five specific characteristics of effective documentation:
a) Available: The documentation must be available in a form and place whereby
users can refer to it when necessary.
b) Easy to use: The documentation must be a pleasure to use and the information in
it must be easy to find.
c) Easy to understand: Information in the documentation must be easy to
understand.
d) Up to date: The documentation must be up to date, reflecting latest changes and
revisions to the system.
e) Reliable and convincing: The information must be reliable and convincing.
Effective documentation also looks attractive, is well designed, and is well produced.
Unattractive or unprofessional documentation might be rejected by users before they
even attempt to use it.
Writing Procedures and Work Instruction
Before you write effective documentation, you must understand what you are writing
about.

Example : When writing a user manual for an application, be sure that you know how the
application works.

Know your audience.

“Who are my users?”
“What is important to them?”
“How do they think?”
“Why are they using these?”
“What do they know?”
“What don’ t they know?”
“What are their expectations?
Writing The Documentation
a) Make it user-friendly
Effective documentation is easy to use and is tailored to its readers.Always keep the
users in mind and evaluate the documentation from the user’s perspective.
Determine what they know, what they need to know, and whether the documentation will
give them what they want and will answer the questions they may have.

b) Make it easy to understand

This may entail using language that will be easily understood by the reader and using
graphics, diagrams, graphs, etc to convey information in a more meaningful way.
Writing The Documentation
c) Specific guidelines and be clear
• To write clearly, follow these rules:
• Use simple, familiar words.
• Avoid jargon and technical terms. If you have to use them, make sure that they are
clearly defined. If the user does not need to know about a jargon word, do not use it.
• Avoid using abbreviations unless you know that the reader will be familiar with them.
If you use them, always include the full word or phrase the first time it appears and
include the abbreviation in parentheses.
• Use simple sentences and paragraphs. Avoid long sentences (more than 30 words)
and long paragraphs. Each sentence and paragraph must convey a single idea.
Writing The Documentation
d) Be concise
• Write what needs to be said in the fewest number of words, but without sacrificing
clarity. Ensure that main points are stated directly, possibly by making use of
numbered or bulleted lists.
• Replace phrases with single words. Reduce words to a minimum.
• Remove all repetition. Avoid tautology (unnecessary repetition of words). Instead of
“merge together” use “merge”, and instead of “absolutely essential” use “essential”.
Writing The Documentation
e) Be concrete
Be specific and express and illustrate the content fully to ensure that readers completely
understand it.
Avoid vague terms and generalizations.
When possible and appropriate, keep to provable facts and figures.
Use strong action verbs. Write in active voice as it brings interest and a sense of activity
to the writing.
Use actual examples of key features to take the user step-by-step through the process
of invoking a function, using it, and then turning it off or moving to something else.
Writing The Documentation
f) Be coherent
Organize parts well and ensure that content flows logically. Always divide the content
into logical, clearly labelled sections to assist the reader in finding information quickly.
Be consistent with terminology, abbreviations and overall design elements, such as
colours and formatting.
Provide references to related supporting information
Writing The Documentation
Ensure consistency
All documents must look and read like they belong together and like one person wrote
them.
Ensure style, look, structure, etc is similar across documents.
Look for hierarchical heading inconsistencies.
Look for factual mistakes and inconsistencies. Look for jargon inconsistencies.
Check the language: Check grammar, spelling, punctuation, and language form and
structure.
Check all cross-references: Look for cross-referencing mistakes and omissions.
Session 5
Improvement
Why Some Documentation Fail?
Documentation that does not serve its purpose effectively is a failure.
Ineffective documentation decreases productivity, reduce efficiency and waste
resources. Also increases training costs.
Documentation that is difficult to understand or use may be rejected by users. This can
cause negative feelings amongst users when future documentation or systems are
released.
Reasons Why Documentation Might Fail
Users might reject the documentation because:
• They cannot find the information they want and therefore give up.
• They cannot understand the information they have found.
• They realize that the information is out of date.
• They are too lazy to look for the information.
• The documentation is too thick.
• The documentation is difficult to access (for example, the only copy of a manual
might be locked in a supervisor’s office).
Reasons Why Documentation Might Fail
The writer may be the cause of the failure because:
• He or she does not spend enough time understanding the system before starting to
write the documentation.
• He or she is more concerned about the look and design of the manual and not the
manual’s content.
• He or she fails to clarify statements that could be misunderstood.
ATTACHMENT