Transitioning to

ISO 9001:2015
TOPICS

 DOH’s conformance to the ISO 9001:2015 requirements

 Transition and Surveillance Audit
 Q&A
 DOH’s conformance to the ISO 9001:2015
requirements
Clause ISO 9001:2008 ISO 9001:2015 Changes in the DOH QMS
Requirement Requirement
1 Scope Scope
2 Normative References Normative References

3 Terms and definitions Terms and definitions

4 Quality Management Context of the a. Determine internal and external issues (SWOT)
System Organization (Clause 4.1)
b. Identify interested parties (Stakeholder Analysis)
(Clause 4.2)
c. Address the risks and opportunities identified (Risk /
Opportunity Assessment Matrix) (Clause 4.4 f /
6.1/10.1)
 DOH’s conformance to the ISO 9001:2015
requirements
Clause ISO 9001:2008 ISO 9001:2015 Changes in the DOH QMS
Requirement Requirement
5 Management Leadership Maintain Quality Policy as a documented information
Responsibility (Clause 5.2.2)

6 Resource Management Planning Identify plan of actions to address risk and opportunities,
integrate and implement the actions and evaluate the
effectiveness of these action. (SWOT, Stakeholder & Risk /
Opportunity Assessment Matrix (Clause 6.1)

7 Product Realization Support Harmonize NAP and Document and Records Control
Procedure to be managed as control of documented
information. (Clause 7.5.3)
 DOH’s conformance to the ISO 9001:2015
requirements
Clause ISO 9001:2008 ISO 9001:2015 Changes in the DOH QMS
Requirement Requirement
8 Measurement, analysis Operation
and improvement
9 Performance Evaluation Revised Management Review agendas to comply with
the new requirements. Offices to adopt these
agendas. (Clause 9.3)

The 1st Qrtr MR should be conducted as follows:

1. Bureaus and Regional Offices–
Prior to your EQA - until the end of June, 2018
2. Execom – July, 2018
10 Improvement Determine and implement opportunities for
improvement to meet and enhance customer
satisfaction (SWOT, Stakeholder & Risk / Opportunity
Assessment Matrix).(Clause 10.1)
DOH’s conformance to the ISO 9001:2015
requirements INTERNAL

 Review your office mandate and deliverables

 Revisit your SWOT and Stakeholder analysis
 Identify internal and external issues using the 5M dimensions

Man Methods EXTERNAL

Material Money
Machine

 Identify all stakeholders of your office/bureau

 Revisit your Risk and Opportunity Assessment

 Include all issues identified in your risk and opportunity matrix
 Do not limit to five, plan for actions on risks and opportunities with rates of 1-5
 Assess your identified opportunity using the new opportunity assessment guide
 Complete your measures and link it to QOP, WFP and/or work processes
DOH Stakeholders
 DOH Central Office (for ROs)

 Can be specific offices (HFEP, HPDPB, etc.)

 Can be specific persons/positions (HFEP engineers, Program Managers, etc.)

 DOH Regional Offices (for C.O.)

 LGUS - City and Municipality Executives

 Can be specific offices (City, Municipality, Baranggay, etc.)

 Can be specific LGU persons/positions (Municipality Health Executive, Municipality Health Officers, Baranggay Health Officials,
etc.)

 Other Government Agencies (DPWH, NEDA, COA, DBM, Civil Service, etc .)

 Hospitals (DOH, LGU, Private, etc.)

 Partner Agencies/Developmental Partners

 External Providers/Suppliers

 DOH/RO Units/Offices (RLED, LHSD, BAC, etc.)

 DOH/RO Employees

 Academe/Professional Societies

 Congress/Senate/Legislative Branch of Government

 Health Professionals (Nurses, Doctors, Embalmers, Therapists)

 Media

 General Public
Clause 4: Context of the Organization
- New Assessment Guide -
Clause 5: Leadership
 The DOH Manual shall be revised > Quality Policy shall be maintained as a documented information
 All tarpaulins are to be pulled out once manual has been updated
 QOPs shall be enlisted in your Document Master List

Quality and Integrity Policy (Draft)

The Department of Health, as the nation’s leader in health, is committed to nurture the
Filipino people to be amongst the healthiest in Southeast Asia by 2022, through the
development of a people-centered, productive, resilient, and equitable health system.

DOH is committed to implement its standards, policies, procedures and practices to ensure
the highest standards of health care in compliance with customers’, statutory and
regulatory requirements.

We at the DOH, together with our partners, shall continue to observe zero tolerance against
corruption and inculcate the value of integrity, excellence and compassion to support
continual improvement of our Quality Management System as we provide just and equitable
health service to the public.
Clause 6: Planning
 Link to your QOP, work processes, and WFP your measures to address identified
risks and opportunities

Risk/Opportunity assessment
Risks/ Opportunities Risk/Opportunity
Potential Cause/s Probabilit Risk/Opportunity Status
identified Impact management measure
y Evaluation
Risks

- Request change of
contract of service to
contractuals
under PS both for the
HRH deployment
program and DOH
Inadequate human job orders
Disrupted Work On going
resources (end of M H 2 - Improve incentive
Operations request
contractualization) mechanism
- Include mandate to
regulate distribution
of HRH
- 1. Usec . Bayugo/
HHRDB
- 2. Usec.Tong-an/ AS
Clause 7: Support
Clause 7.5: Documented Information
 Include accomplished QOP in the Document Master List
 Download revised quality manual once Quality Policy has been updated
 Stamping with controlled and uncontrolled marks is no longer required
 All documented information should be:
 made available
 properly controlled
 version control
 defined access, distribution, retrieval and use
 Storage and preservation
 retention and disposition
 appropriately signed after review and approval
 adequately protected
 i.e. stored in cabinets with lock
Clause 9: Performance Evaluation Submit MR report not
later than July 1
 Conduct MR following these agendas
1. Follow up Status of Actions from Previous Management Review *conduct MR prior to
your EQA
2. Process Performance and Conformity via QOP and QOPM
3. Quality Management System Performance through Audits and Self-
Assessment
4. Customer Feedback Results and Analysis
5. Performance Evaluation of External Providers
6. Organizational Assessment
1. Changes in Internal and External Issues
2. Effectives of actions to address risks and opportunities
7. Agreements
1. Opportunities for Improvement
2. Changes in the QMS
3. Resource needs
 TRANSITION AND
SURVEILLANCE AUDIT
Customer Satisfaction Survey
1. Utilize the CSS computation tool that QMS office
would be providing

2. Recognize and acknowledge positive feedback

3. Act immediately on negative feedback encountered

>Validate accuracy
>Plan and implement actions to address negative
feedback through RFA
>Secure evidences of actions taken

3. Create a comprehensive CSS report

Matters to be discussed and must be included in

the report:

>How was your performance based from your CSS

rating?
>Were your clients satisfied? Why did you say so?
>What are your areas for improvement?
>What are your improvement plans?
>Does satisfaction rating for your office improved
through the years?
Communication and Awareness

 Awareness and Communication

 Conduct briefing on all your office staff to make them aware of:
 Quality Policy
 Relevant Office Objectives
 Individual contribution to the effectiveness of the QMS, including benefits of
improved performance
 Implication of not conforming with the QMS requirements
 Communication Design
Control over externally provided
services
 Show evidences that externally provided products and services to your offices
are controlled
 Contracts/TOR
 Evaluation of Supplier/ Facilitator/ Resource Speakers
Organizational Knowledge
 PREVENT THE LOSS OF KNOWLEDGE OF THE ORGANIZATION
 Present plans and actions on how your office ensures that knowledge is
maintained and made available to the extent necessary

 Office Head: If you are to retire next year, what have you been doing to prepare
your office/team?
 Office Supervisor: How do you pass on your expertise and knowledge?
Thank you!