1.iso 9002

ISO-QMS Orientation:
Understanding and Implementing

the DOH ISO Quality Management
System (QMS)
1
ISO tayo Serbisyong de Kalidad at SiguraDOH
What is ISO-QMS?
2
What is ISO?
The International Organization for

Standardization is a worldwide federation of
National Standard Bodies from some 176
countries, one from each country.
From Greek word isos : Equal

Created in February 1947 in Geneva, Switzerland
Philippines Philippine Accreditation Office
3
What is ISO 9001:2008?
Is the most popular version of the
standard for quality management
systems
Set of standards that should be
fulfilled/satisfied by an organization to
be ISO certified
Code assigned to QMS Version of the standard
ISO 9001:2008
4
Some Notes about ISO
ISO 9001 is not a product/service quality
label;
ISO does not assess or audit quality systems
to confirm that they conform to an ISO 9001
standard;
ISO does not issue ISO 9001 certificates;

ISO does not approve ISO 9001 certificates;
Certificates are issued by certification
bodies, independent of ISO
5
What is QMS?
A set of interrelated or
interacting elements that allow
the organization to establish its
policy and objectives related to
quality, and to achieve those
objectives.
6
What is Quality?
Those product features that

meet the needs and
requirements of the customer
Freedom from deficiencies and
defects
Conformance to standards
7
Session Objectives
At the end of the session, participants will
be able to:
Explain the basic concepts and principles of
ISO 9001:2008 QMS;
Determine the DOHs existing practices
that are aligned to the ISO 9001:2008
standards;
Discuss the established DOH QMS and its
implementation.
Commit on the establishment and
implementation of QMS.
8
Session Content
Why establish and implement
ISO-QMS in DOH?
The DOH Quality Journey
What is ISO-QMS?
The DOH ISO 9001:2008-
certified QMS
QMS Implementation
9
Why ISO-QMS in DOH ?
10
QMS IN THE GOVERNMENT Compelling
Reason
1. to promote integrity, accountability, proper

management of public affairs and public property
as well as to establish effective practices aimed at
the prevention of graft and corruption in
government (ARTA of 2007)
2. create conditions conducive to the growth and

competitiveness of business organizations
11
Pres. Noynoy Aquino's Social Contract
with the Filipino People
We will start to make these changes first in ourselves
by doing the right things, by giving value to excellence
and integrity and rejecting mediocrity and dishonesty,
and by giving priority to others over ourselves. We will
make these changes across many aspects of our national
life.
Continual Improvement one of the Principles

underlying the ISO 9001:2008 Standards.
Towards Matuwid na Daan Compelling

Reason
12
Compelling
Reason
Overarching theme:
Good Governance and Anti-corruption
13
THE LEGAL MANDATE
AO No. 161 : Institutionalization of
Quality Management System in
Government
EO No. 605 : Institutionalizing the
Structure, Mechanisms and
Standards to Implement the
Government Quality Management
Program, Amending for the
Purpose AO No. 161 S. 2006
14
SOME COMPELLING REASONS
The need for internal citizens trust

and confidence
The need for world
competitiveness among nations
16
QMS IN DOH
1. DOH is a service-oriented agency that

focuses on the provision of quality
health care to all Filipinos.
Kayo ang Boss Ko
Customer Focus is one of the

Principles underlying the ISO
9001:2008 Standards.
17
2. The DOH strategic thrust (Kalusugan
Pangkalahatan) towards the
attainment of the MDG for Health
Commitment of the Secretary of Health in establishing

the DOH Quality Management System for an
Enhanced Health Care Service Delivery
18
DOH Response
Institutionalize a Quality
Management System (QMS)
Certifiable to ISO 9001:2008
19
SIGNIFICANT BENEFITS
FROM ISO QMS
Better image of DOH
Improved planning and
performance review
Improved communication
Clearly defined interface among
offices
Fact-based decisions
20
DOH Employees Gains
Improved consciousness on
service quality and continual
improvement
More organized records and
offices
Pride in job
21
The DOH
Quality Journey
22
ISO
The DOH ISO-QMS 9001:2008
Certification
Road Map Certification
Audits
Final Gap Preparation for

Assessment Certification
Corrective Management
Action Review
Training on Conduct of
IQA IQA
QMS QMS Implementation

Documentation and Related Training
QMS Training on QMS

Planning Documentation
Initial Gap
Orientation Assessment
24
1. QMS Institutionalization
1. Establishment of DOH ISO QMS
Committee
2. Engagement of the services Development
Academy of the Philippines
3. Awareness Building among DOH officials
and staff
4. Capability Building of the DOH ISO Core
Team, key officials and staff
5. Establishment of DOH QMS
documentation (Quality Policy, Quality
Manual, Quality Procedure and Quality
Core Procedures)
25
2. QMS Implementation
1.Cascading of the established QMS
2.Conduct of Internal Quality Audit
3.Conduct of Management Review
4.Provide Technical Assistance on the
Implementation of DOH QMS
5.Implementation Review
6.Final Gap Assessment
26
3. DOH ISO QMS Certification
27
DOH QMS STRUCTURE
28
VSMMC QMS Organizational Structure
Medical Director/
QMR
As Appointed Deputy QMR

Overall ISO Core Team
ISO Core Team
Workplace Training and Internal

Document and
Organization Education Quality
Records Control
Committee Committee Audit
Committee
Committee

Roles and Responsibilities of Top
Management
Sets direction and targets

Ensures relevance of the vision, mission, values,
quality policy and objectives to the changing needs
and requirements of customers
Communicates the importance of meeting customer
requirements and other statutory and regulatory
requirements, as well as, the effectiveness of the
quality management system
Responsible for the maintenance and continual
improvement of the QMS
Provides resources and necessary logistics
Resolves policy, procedures and resource issues.
30
Roles and Responsibilities of Overall ISO
Core Team
Harmonizes activities of the different ISO

QMS committees
Organizes and coordinates the Office ISO
QMS related activities
Facilitates the preparation and dissemination
of information on ISO QMS related activties
Coordinates with external parties in relation
to the Office ISO QMS concerns
31
Roles and Responsibilities of QMRs
Oversees the overall management of the DOH QMS
Ensures that processes needed are established, implemented,
maintained and continually improved
Ensures the conduct of Management Review at all levels
Provides feedback/update to the top management on the
status of the QMS performance
Ensures that the QMS conforms with ISO 9001:2008
requirements
Ensures that the quality policy and quality objectives are
relevant, properly disseminated and understood
Coordinates with external parties on matters relating to ISO
and the QMS
Ensures the promotion of awareness of customers
requirements
Ensures that all employees are knowledgeable on the
documented procedures relevant to their work
Initiates QMS activities and monitor its implementation
32
Roles and Responsibilities of Overall
Office ISO Point Person
Assists the QMR in ensuring the

implementation and maintenance of
the QMS
Coordinates QMS related activities
within the Office
Provides technical assistance to the
different ISO QMS committees
Provides feedback/update on the status
of QMS implementation of the Office
33
Roles and Responsibilities of Workplace
Organization Committee
Ensures the implementation and

monitoring of the 5S principles.
Coordinates the management and
maintenance of the work
environment/workplace
Provides feedback/update on the status
of management of the work
environment/workplace to the overall
QMR
34
Roles and Responsibilities of Training
and Education Committee
Coordinates the identification of training
needs of the process owners in coordination
with appropriate office/unit.
Ensures the conduct of cascading
training/seminar/workshops related to QMS
implementation and maintenance.
Assists the management in the promotion of
awareness of the quality policy and quality
objectives.
Provides feedback/updates on the status of
QMS related activities to the overall QMR
35
Roles and Responsibilities of Documents
and Records Control Committee
Manages and maintains the QMS

documents and records
Monitors the implementation and
compliance of the DOH Control of
Documents and Records Procedures
Ensures the availability of relevant and
current documents at points of use
Ensures that the master list of controlled
documents and records are updated
36
Roles and Responsibilities of Internal
Quality Audit Committee
Responsible for the planning, conducting and
reporting results of the IQA.
Ensures that all audit related Non
Conformance Performance Audit Reports
(NCPARS) are followed up and verified.
Recommends changes or areas for review in
the QMS as a result of audit.
Provides the Overall QMR an update/report
of the summary/consolidated audit findings
and status of NCPARs issued to all auditees
for monitoring purposes
37
Common Problems of a
Management System
38
39
Elements and Structure of
Management Systems
Policy
Management
Review
Plan Planning
Act Do
Implementation
Checking &
Corrective Actions
Check & Operation
40
Model of a Process-Based
Government QMS
Continual Improvement of
the Quality Management System
Management
Responsibility
Citizen/
Customer
Citizen/ Measurement,
Resource
Customer Management
Analysis and Satisfaction
Improvement
Inputs Outputs
Service
Requirements
Realization
Service Licensee
41
THE 8 QUALITY MANAGEMENT PRINCIPLES
The Eight (8) Quality Management Principles (QMP)

are developed based on the collective experience of
management experts from different countries all
over the world that represent the ISO Technical
Committee 176.
According to them, these are the principles necessary

in order for the organization to operate an effective
and efficient quality management system.
42
THE 8 QUALITY MANAGEMENT PRINCIPLES:
44
QMS Principles
Understand and meet client
1. Customer focus (internal and external) requirements
and exceed expectations
Customer Satisfaction Survey
Analysis and actions implemented on customer feedback
Public Assistance Desk (PAD)
Consultative meetings
Training and program post-implementation client evaluation
Establish unity of purpose &

2. Leadership direction
Approved Quality Policy
Establish a clear vision of the organizations future and set challenging goals and
targets (Quality Objectives)
Conduct of Management Review
Implement strategies in achieving goals and targets (Quality Planning)
Strategic road map and quality plans
ISO tayo Serbisyong de Kalidad at SiguraDOH 45

QMS Principles
3. Involvement of Full involvement enables their
abilities to be used for the
people organizations benefit
Job descriptions
Organizational structure
Procedures and quality manual
Cascading sessions
Control of Nonconformity and
Corrective/Preventive Actions
Quality objectives at all levels

QMS Principles
4. Process approach Resources and activities are
managed as a process
Business process maps

Quality core procedures
Control for outsourced processes
All processes are monitored and analyzed
Identifying, understanding, &
5. Systems approach to managing a system of
management interrelated processes
Updated quality manual
Quality policy regularly reviewed
Quality plans established and monitored
QMS Principles
6. Continual improvement A permanent objective of

the organization
Internal quality audit

Corrective and preventive actions
Management reviews
Root cause analysis
Brainstorming
7. Factual approach to Decisions based on analysis of
decision making data and information
Customer feedback data and analysis

Process performance measurement

QMS Principles
An organization & its suppliers are
8. Mutually beneficial interdependent. It enhances ability of
supplier relationships both to create value
Purchase requirements/
specifications
Criteria for supplier selection
Per RA 9184 Guidelines
Supplier evaluation
Monitoring supplier performance

WRONG APPROACH
Company
Operation & QMS
RIGHT APPROACH
Company QMS
Operation
BETTER THAN RIGHT APPROACH
Company
Operation
50
Mandatory Requirements
Control of Documents
Control Of Records
Internal Quality Audit
Control of Non-conforming
products/services
Corrective Action
Preventive Action
51
QMS Documentation Structure
Approach 1 Quality Manual
Why, What, Who,

When & Where 2 Procedures
How, Who, What, Operational

When & Where 3
Instructions
Objective Evidence 4 Records
52
The DOH ISO 9001:2008
Certified QMS
53
QUALITY POLICY
Vicente Sotto Memorial

Medical Center as a center of
excellence is committed to
provide equitable, accessible
and quality health services,
training and research to our
clientele in consonance with
the existing statutory and
regulatory requirements.
We shall continually
improve our quality
management systems to the
satisfaction of our customers.

CASCADING OF
OBJECTIVES & MEASURES
DEPLOYMENT
Product/
Service
Objective
Process
Objective
MEASUREMENT
55
The DOH Documentation Structure
Scope and Exclusions

Quality Process Descriptions
Manual Reference to procedures
Quality Procedures and

Quality Core Procedures Documents that provide
information about how to
perform activities and
Bureau / Office Level processes consistently
Instructions / Work Instructions
Documents that provide

Records objective evidence of activities
performed or results achieved
56
Maintained by the Overall DC
Quality Policy
Quality Manual
Quality Procedures (6 mandatory procedures)
Quality Core Procedures Manual
Work Instructions
Related External Documents (e.g. ISO
Requirements, NAP Guidelines, etc.)

Maintained by the Office DC
Quality Policy
Quality Manual
Quality Procedures (4 mandatory procedures)
Quality Core Procedures Manual
Office Manual of Operations/SOPs
Work Instructions
Related External Documents specific to the
Office (e.g. Procurement Law, CSC Rules &
Regulations, DBM & COA guidelines, etc.)
58
Creation/ Revision of
DOH-QP-01 documents
Review and Approval

Control of Documents of Documents
This document aims to standardize the

Registration and
process of management and control of Stamping of
Documents
quality documents in the DOH and ensure
that appropriate versions are identified
Distribution and
and made available at point of use. Maintenance of
Copies
Retrieval of
Documents
Disposal of
ISO tayo Serbisyong de Kalidad at SiguraDOH Documents 59
Therefore, Control of Document means:
Ensuring that we have a system of
creation/revision, approval, review and
identification of documents
Registering documents to be controlled in the
Master List of Documents (
Distributing/Updating documents to the
authorized copy holders through the Document
Distribution List
Ensuring that relevant versions of documents are
available at points of use
Logging revisions in the Revision Log (
DOH-QP-02
Collection and
Identification
Control of Records
Storage and
This document aims to provide a system of
Protection
managing, controlling, disposing and
maintaining records within the
Retrieval and
organization. Retention
Maintenance and
Disposal

Therefore, Control of Records means:
Having a system of retention and disposition of
records consistent with the National Archives of
the Philippines guidelines
Managing the records/evidences generated
through the Records Retention and Disposition
Schedule
Establishing a system for the storage and easy
retrieval of records
- labelling/coding of files records
- designating records custodian
- identifying storage area
Selection and
DOH-QP-03 Management of Audit

Team
Internal Quality Audit

Planning for the IQA
This document describes the procedure
and resource requirements for the Preparing for the IQA
objective evaluation of the effectiveness
of the established quality management
Conducting the IQA
system of DOH.
Reporting the IQA
Verifying Actions Taken

Therefore, Internal Quality Audit means:
Planning for the conduct of audit

Assessing the conformity of the organizations
QMS
Reporting the results of audit to the Top
Management
Assisting the organization in maintaining the
effective and efficient QMS implementation

DOH-QP-04
Identification of NCs
Control of Nonconformity
The procedure on control of

Documentation of NC
nonconformity aims to ensure that all
nonconformities within the DOH are
identified and controlled.
Registration of RFA

Therefore, Control of Nonconforming Services means:
Having a system of identifying and

addressing the nonconformities in our
products/services
Documenting the identified
nonconformities through the NCPAR

Review and
DOH-QP-05 Disposition
Corrective and
Preventive Action Cause Analysis and
Determination of
Action
This procedure has been established to
ensure that appropriate corrective and
Correction, CA and
preventive actions are determined to PA Implementation
eliminate the causes of nonconformities.
Verification of
Effectiveness of
Action Taken

Therefore, Corrective and Preventive Action means:
Understanding the
nonconformities/possible
nonconformities and including the sources
Analyzing the root causes
Identifying correction,
corrective/preventive actions
Verifying the effectiveness of the
correction, corrective/preventive actions
69
Quality Core Procedures
Aims to provide clear and standard guidelines
Defines the interface of the offices on a
specific process
Applicable to all DOH offices/ bureaus/
attached agencies and shall cover general
concepts and procedures
Administrative and Department Orders, and
other DOH issuances are referred to in the
procedure
70
Manual of Operations/ SOIs/ WIs
Instructions that are specific to the

bureau or office
Provides the details of how processes
should be done and what the expected
results are
71
Everyones Role
Understand and internalize the quality

policy and objectives
Implement documented procedures
and work instructions
Help make improvements to the
processes
Ensure to keep records
72
Elements of Success
Top management commitment
Core team commitment
Organization-wide employee
participation, cooperation, and
support
Proper time management
Close coordination
73
Pledge of
Commitment

To take my part in the ISO QMS
Journey, I commit to
To take my part in the ISO QMS Journey, I

commit to
Name:
__________________
Signature:
__________________
75

1.iso 9002

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1.iso 9002

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ISO-QMS Orientation:

Understanding and Implementing

The International Organization for

From Greek word isos : Equal

Code assigned to QMS Version of the standard

ISO does not issue ISO 9001 certificates;

Those product features that

1. to promote integrity, accountability, proper

2. create conditions conducive to the growth and

Continual Improvement one of the Principles

Towards Matuwid na Daan Compelling

The need for internal citizens trust

1. DOH is a service-oriented agency that

Kayo ang Boss Ko

Customer Focus is one of the

Commitment of the Secretary of Health in establishing

Final Gap Preparation for

QMS QMS Implementation

QMS Training on QMS

As Appointed Deputy QMR

ISO Core Team

Workplace Training and Internal

ISO tayo Serbisyong de Kalidad at SiguraDOH

Sets direction and targets

Harmonizes activities of the different ISO

Assists the QMR in ensuring the

Ensures the implementation and

Manages and maintains the QMS

The Eight (8) Quality Management Principles (QMP)

According to them, these are the principles necessary

Establish unity of purpose &

ISO tayo Serbisyong de Kalidad at SiguraDOH 45

ISO tayo Serbisyong de Kalidad at SiguraDOH 46

Business process maps

6. Continual improvement A permanent objective of

Internal quality audit

Customer feedback data and analysis

ISO tayo Serbisyong de Kalidad at SiguraDOH 48

ISO tayo Serbisyong de Kalidad at SiguraDOH 49

BETTER THAN RIGHT APPROACH

Approach 1 Quality Manual

Why, What, Who,

How, Who, What, Operational

Objective Evidence 4 Records

Vicente Sotto Memorial

ISO tayo Serbisyong de Kalidad at SiguraDOH 54

Scope and Exclusions

Quality Procedures and

Documents that provide

ISO tayo Serbisyong de Kalidad at SiguraDOH 57

Review and Approval

This document aims to standardize the

ISO tayo Serbisyong de Kalidad at SiguraDOH 61

DOH-QP-03 Management of Audit

Internal Quality Audit

Reporting the IQA

Verifying Actions Taken

ISO tayo Serbisyong de Kalidad at SiguraDOH 63

Planning for the conduct of audit

ISO tayo Serbisyong de Kalidad at SiguraDOH 64

The procedure on control of

ISO tayo Serbisyong de Kalidad at SiguraDOH 65

Having a system of identifying and