Workshop on QMS Documentation

Development of ISO 9001:2015 Quality

Management System for the Department of
Energy

May 28 – 31, 2018

DOE Bldg., Bonifacio Global City, Taguig City
Approved Quality Manual
1. Approved Quality Policy
2. Statement of QMS Scope including the Process Model/Map showing the
processes, products and services covered by the QMS
3. Justification for ISO 9001 requirement(s) that is (are) not applicable to the
scope of the QMS, if there is any
4. Description of the organizational context, e.g. PESTLE (Political, Economic,
Social, Technological, Legal and Environmental), SWOT (Strength,
Weakness, Opportunity and Threat) or other framework or tool to analyze
and monitor internal and external issues that have impact in the
organization
5. Description of relevant interested parties and their requirements
6. Description of the processes covered by the QMS, e.g. management,
operational and support processes, including the responsibilities and basic
controls applied to ensure effective operations
7. Description of type of control of external providers to ensure that externally
provided processes, products and services meet requirements

Requirements for the Performance-Based Bonus; Based on GQMC MC 2016-01

Approved Quality Manual
8. Approved list of identified risks and opportunities with corresponding
action plans
9. Approved list of identified relevant interested parties including their
issues, and corresponding action plans to address the issues
10. Approved quality objectives of all offices/units, e.g. OPCR and DPCR,
quality objectives and plans, balanced scorecards, and other
documented performance targets demonstrating current Administration’s
directive to improve frontline or core processes’ performance
11. List of internal and externally-generated references/ documents
necessary for the effective planning and operations of the QMS, include
the document title, document code, originator (source of document),
effective date, and revision number, if applicable

Requirements for the Performance-Based Bonus; Based on GQMC MC 2016-01

Approved PAWIM
1. Standard Operating Procedures/Process Flow Charts
2. Tools, forms, templates, guidelines or procedures, for the
following processes:
a. Control of Documented Information
b. Internal Audit for the QMS
c. Control of Non-Conforming Outputs
d. Nonconformity and Corrective Action
e. Monitoring and Measurement of Client Satisfaction
f. Management Review

Requirements for the Performance-Based Bonus; Based on GQMC MC 2016-01

Session Objectives
 Draft the process map
 Develop an in-depth understanding of the Agency’s mission,
vision, commitment to quality, and relevant issues that it may need
to address through risk-based quality planning
 Identify risks and opportunities related to organizational context,
i.e. internal and external issues, and issues of the relevant
interested parties
 Formulate action plans to address risks and take advantage of
opportunities
 Review the existing quality objectives
Target Outputs
1) Finalized Process Map
2) Finalized Quality Policy
3) Draft Risk Register and Action Plans
Workshop on Quality Manual and PAWIM
Session Objectives
 Formulate/Review the structure and controls
for QMS information necessary for the effective
implementation of QMS
 Develop an in-depth understanding of the
information management approaches
 Workshop 2: 15-19 Nov 2016

Expected Outputs
 Draft QMS Manual
 Draft Procedures, Tools or Forms for the following
Control of Documents
Control of Records
Internal Audit
Control of NC outputs
Corrective action
Monitoring and measuring customer satisfaction
Management review
Typical QMS Document Structure
Governing Rules of the Organization
Policies

Guide to Organization’s QMS QMS Manual

Maintained information on
Organization’s QMS and Operational
processes Procedures , Process
Flow Charts, etc.

Retained information as
evidence of performing the Records
Organization’s processes
QMS Manual
 Notes in Writing the QMS Manual
 No required quality manual in ISO 9001:2015, the 2008 version
required it
 Documented information may be in any form, e.g. Memo, Office
Order, etc.
 Most auditors still find it useful to have a QMS manual to
systematically address the documented information required by the
standard
 The form of documentation of the required information is decided
by the organization based on existing documentation practices and
suitability to the type of operations
 Quality Manual
1. Approved Quality Policy
2. Statement of QMS Scope including the Process Model/Map showing the
processes, products and services covered by the QMS
3. Justification for ISO 9001 requirement(s) that is (are) not applicable to the
scope of the QMS, if there is any
4. Description of the organizational context, e.g. PESTLE (Political, Economic,
Social, Technological, Legal and Environmental), SWOT (Strength,
Weakness, Opportunity and Threat) or other framework or tool to analyze
and monitor internal and external issues that have impact in the
organization
5. Description of relevant interested parties and their requirements
6. Description of the processes covered by the QMS, e.g. management,
operational and support processes, including the responsibilities and basic
controls applied to ensure effective operations (Narrative Description or
Flow Charts)
7. Description of type of control of external providers to ensure that externally
provided processes, products and services meet requirements
 Quality Manual
8. Approved list of identified risks and opportunities with corresponding
action plans
9. Approved list of identified relevant interested parties including their
issues, and corresponding action plans to address the issues
10. Approved quality objectives of all offices/units, e.g. OPCR and DPCR,
quality objectives and plans, balanced scorecards, and other
documented performance targets demonstrating current Administration’s
directive to improve frontline or core processes’ performance
11. List of internal and externally-generated references/ documents
necessary for the effective planning and operations of the QMS, include
the document title, document code, originator (source of document),
effective date, and revision number, if applicable (Reference Matrix)
 Proposed Outline of QMS Manual
A. Introduction
B. History
C. Organizational Structure and Functional Descriptions
D. Scope of QMS: Process Map and the Narrative Description
(Include justification for exclusion, if there is any)
E. List of Interested Parties’ Requirements
F. Risk Identification and Planning Guidelines
G. Risk Registry
H. Quality Policy
I. Control of External Providers
J. QMS Reference Matrix
Annex: OPCRs/ DPCRs
 Let’s draft the QMS Manual…
Section To Do Assigned
Team
A. Introduction Give a short introduction on the content and
purpose of the manual
B. History Provide a brief history of the agency; emphasize
the significant milestones
C. Organizational Structure Capture the updated approved org structure and
and Functional provide narrative descriptions of the offices
Descriptions
D. Scope of QMS: Process Provide introductory statement for the process
Map and the Narrative map; give a narrative description of the process
Description (Include map, and mention the responsible units and how
justification for exclusion, they interact to be able to deliver the outputs of
if there is any) the agency and finalize the process map
E. List of Interested Parties’ Provide introductory statement and review the
Requirements list
Use the template/matrix provided please.
 Proposed Outline of QMS Manual
Section To Do Assigned Team
E. List of Interested Parties’ Provide introductory statement and
Requirements review the list
F. Risk Identification and Provide introductory statement; mention
Planning Guidelines the process of identifying risks and what
are the stages of planning to address the
risks; mention if risks are identified at
various levels
G. Risk Registry Review and finalize
H. Quality Policy Review and finalize (as needed)
I. Control of External Provide introductory statement; mention
Providers the applicable statutory and regulatory
laws and the responsible units
L. QMS Reference Matrix Develop a reference matrix using the
template for each office.
Use the template/matrix provided please.
Let’s draft the other documented
information…
Plenary Review of
the Outputs
QMS Procedures, Guidelines and Tools
 PAWIM
Tools, forms, templates, guidelines or procedures, for the
following processes:
a. Control of Documented Information
b. Organizational Knowledge
c. Internal Audit for the QMS
d. Control of Non-Conforming Outputs
e. Nonconformity and Corrective Action
f. Monitoring and Measurement of Client Satisfaction
g. Management Review
What is Documented Information?
 Information required to be controlled and
maintained by an organization and the
medium on which it is contained
 Refers to documents and records
Document – information and Record – special type of
the medium on which it is
contained document stating results
• QMS Manual achieved or providing
•SOPs (Procedures and Work evidence of activities
Instructions Manual / performed
Operations Manual) • Reports
• Guidelines
• Accomplished Forms
• Plans
• Contracts
Clause 6
Control of Documented Information

o Appropriate identification and description

o Appropriate format and media
o Review and approval for suitability and
adequacy
o Controlled to ensure availability and
suitability for use where and when it is needed
o Adequately protected (e.g. from loss of
confidentiality, improper use, or loss of
integrity)
Clause 6
Documented Information

Address the following, as applicable:

oDistribution, access, retrieval and use

oStorage and preservation, including legibility
oControl of changes (e.g. version control)
oRetention and disposition
oIdentification and controls for documented
information of external origin
oProtection from unintended alterations

Clause 6
Tips in Writing Control of Documents Procedure
o Study the template provided
o Integrate in the template the existing practices
o Note that the procedure, , as well as to the
forms and templates, only apply to the QMS
documents
o Existing controls for policies, memo, office
orders, and the like shall be maintained
o Identify responsibilities considering existing
responsible units
o Only write implementable and practical
activities
Tips in Writing Control of Records Procedure

o Study the template provided

o Integrate in the template the existing practices
o Note that the procedure applies the records
management of all offices in CO, RSSOs and
PSOs
o Identify responsibilities considering existing
responsible units
o Only write implementable and practical
activities
9.2 Internal Audit

9.2.1 The organization shall conduct internal audit at

planned intervals to provide information on whether
the quality management system:
a. conforms to:
1. The organization’s own requirements for its
QMS;
2. The requirements of this International Standard;
b. is effectively implemented and maintained.
9.2 Internal Audit
9.2.1 The organization shall conduct plan, establish,
implement, and maintain an audit programme/s
including the:
• Frequency
• Methods
• Responsibilities
• Planning requirements and reporting
9.2 Internal Audit
9.2.1 Factors to consider in Audit Programme
• Importance of the processes concerned
• Changes affecting the organization
• Results of previous audit
• Define the audit criteria and scope for each audit
• Select auditors and conduct audits
• Select auditors and conduct audits
• Ensure that the results of the audits are reported to
the relevant management
• Take appropriate correction and corrective actions
without undue delay.
Tips in Writing Internal Quality Audit
Procedure
o Study the template provided
o Integrate in the template the existing
practices
o Identify responsibilities considering existing
responsible units
o Indicate timelines for the submission of
reports
o Only write implementable and practical
activities
8.7 Control of Nonconforming Outputs
o Ensure that outputs that do not conform to
requirements are identified and controlled to
prevent unintended use or delivery
o Correct nonconforming outputs and subject to re-
verification to demonstrate conformity
o Take action when nonconforming outputs are
identified after delivery or use
Defining
Nonconformity

IMPLEMENTATION

REQUIREMENT FULFILLED?

CONFORMITY NONCONFORMITY
8.7 Control of Nonconforming Outputs

Deal with nonconforming outputs through any or

combination of the following:
o Correction
o Segregation, containment, return, or suspension of
provision
o Informing the customer
o Obtaining authorization for acceptance under
concession
* Verify nonconforming outputs when corrected
8.7 Control of Nonconforming Outputs

Description of the NC Retain documented

information
Description of the Actions
Taken

Description of any
concession obtained

Deciding Authority for the

action/s taken

Concession – Permission to use or release nonconforming outputs

Tips in Writing Control of Non-Conforming
Outputs Procedure
o Study the template provided
o Integrate in the template the existing
practices
o Identify who will be responsible in
monitoring this procedure
o Indicate timelines for the submission of
reports
o Complete the Control of NC Matrix
10.2 Nonconformity and Corrective Action
When a nonconformity occurs, the organization shall:
a) react to the nonconformity, and as applicable
 take action to control and correct it, and
 deal with the consequences;
b) evaluate the need for action to eliminate the causes of the
nonconformity, in order that it does not recur or occur elsewhere,
by
 reviewing the nonconformity
 determining the causes of the nonconformity, and
 determining if similar nonconformities exist, or could potentially
occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken; and
e) make changes to the quality management system, if necessary.”
Tips in Writing Corrective Action Procedure

o Study the template provided

o Integrate in the template the existing
practices
o Identify who will be responsible in
monitoring this procedure
o Identify timelines for the submission of
action plan
9.1.2 Customer Satisfaction

• Monitor information relating to customers’

perception of the degree to which their
needs and expectations have been fulfilled.
• Determine the methods for obtaining,
monitoring, and reviewing the information.
9.1.2 Customer Satisfaction
This requirement can be demonstrated through
the following examples:
Structured Approach:
1.Training/program evaluation
2.Project /program evaluation
3.Client satisfaction/dissatisfaction survey
4.Project deliverable acceptance
Unstructured Approach:
1.Regular meetings (briefings/debriefings/ assessment)
with clients
2.Website feedback tab/window
3.Suggestion box
4.Focus Group Discussions (FGD)
Tips in Writing Guidelines for Monitoring and
Measuring Customer Satisfaction
o There is no template provided
o Make an inventory of the existing practice of
monitoring and measuring customer satisfaction in
CO, RSSOs and PSOs
o Review the existing tools
o Do you need to develop more feedback or customer
satisfaction tool? What are these?
o Develop a guideline (maybe specific to each tool) to
systematically gather data and link to Corrective
Action Procedure
o Establish responsibilities (in CO, RSSOs and PSOs)
and frequency of reporting and analysis
9.3.1 Management Review

Top management shall review the

organization’s QMS, at planned intervals, to
ensure its continuing suitability, adequacy,
effectiveness, and alignment with the strategic
directions of the organization.
9.3 Management Review
9.3.2 Inputs
a. Status of actions from previous Management
Reviews
b. Changes in QMS-relevant internal and external
issues
c. Information on the performance and effectiveness
of the QMS (next slide)
d. Adequacy of resources
e. Effectiveness of actions taken to address risks and
opportunities
f. Opportunities for improvement
9.3 Management Review
Information on the performance and effectiveness of
the QMS
• Customer satisfaction and feedback from stakeholders
• Quality objectives attainment
• Process performance and conformity of products &
services
• Nonconformities and corrective actions
• Monitoring and measurement results
• Audit results
• Performance of external providers
9.3 Management Review

9.3.3 Outputs
The outputs of the management review shall include
decisions and actions related to:
• Opportunities for improvement
• Any need for changes in the QMS
• Resource needs
9.3 Management Review

9.3.3 Outputs
The organization shall retain documented information
as evidence of the results of management reviews.

Examples of Documented Information

•Minutes of Meeting (MOM)
•Action Plan
•Resolutions
Tips in Writing Guidelines for Management
Review
o There is no template provided
o Consider existing practices in conducting
Management Meetings
o Review the existing tools
o Are there practices that need improvement? What are
these?
o Develop a guideline to systematically conduct and
record management reviews
o Establish responsibilities and frequency of meeting
o Ensure that MR inputs indicated in the ISO 9001
requirement are part of the agenda
 Let’s draft the documents…

Document Assigned Team

Control of Documents
Control of Records
Organizational Knowledge
Internal Audit for the QMS
Control of Non-Conforming Outputs
Nonconformity and Corrective Action
Monitoring and Measurement of Client
Satisfaction
Management Review

Use the template/matrix provided please.

Plenary Review of
the Outputs