ISO 9001:2015 Awareness Seminar

(Foundation Course)
Davao City National High School
February 5, 2018
10:00 am – 5:00 pm
Resource Speakers:

- Emmanuel Alpha D. Sicam

- Shirley Elizabeth N. Jacobe
- Maria Carmen Miranda

TÜV SÜD PSB Philippines Slide 2

Levelling of Expectations

TÜV SÜD PSB Philippines Slide 3

Course Overview:
• Target participants: “Starters” on QMS
• Representatives from:
• Science
• English
• Filipino
• Math
• Values
• Aralin Panlipunan
• TLE
• MAPEH
• Course duration: 1 day
• Course prerequisite: None
TÜV SÜD PSB
Philippines
General Objectives:
• To gain awareness or general overview on ISO 9001:2015
QMS
• To apply the concepts to Davao City NHS

TÜV SÜD PSB

Philippines
Outline:
A. What is ISO?
B. What is ISO 9001:2015?
C. ISO 9001:2015 Concepts and Methodology
1. 7 Quality Management Principles
2. PDCA
3. Process Approach
4. Risk Based Thinking

TÜV SÜD PSB

Philippines
Outline:
D. ISO 9001:2015 Requirements
1. Overview of the 10 Clauses
2. Providing evidences to meet the
requirements
E. Workshops / Exercises
1. Applying the Quality Management Principles
2. Planning a QMS considering internal and
external issues, needs and expectations of
interested parties, products and services.
F. Question and Answer
TÜV SÜD PSB
Philippines
 is..
• International Organization for Standardization
• An organization which develops and publishes
International Standards
• Started in 1946, and since then was able to publish
19500 Standards
• Currently with 162 member countries
• HQ: Geneva, Switzerland

 ISO International Standards ensure that products and

services are safe, reliable and are of good quality. For
business, they are considered as strategic ‘tools’.
TÜV SÜD PSB
Philippines
ISO 9001:2015
• Quality Management System

• Potential benefits to an organization implementing QMS

based on this standard are:
• Ability to consistently provide products and services that meet
customer and applicable statutory and regulatory
requirements
• Facilitating opportunities to enhance customer satisfaction
• Addressing risks and opportunities associated with its context
and objectives
• Ability to demonstrate conformity to specified QMS
requirements
TÜV SÜD PSB
Philippines
History of ISO 9001
1966 - Originally created to ensure quality of products
supplied to the MOD and continuity in the procedures
carried out by its workers, the concept of quality
assurance was then championed by the UK government.

1969 – Government committee submit a report

recommending suppliers be assessed against a generic
standard of quality assurance.

TÜV SÜD PSB

Philippines
History of ISO 9001
1971 – BSI (British Standards Institute) publish BS 9000
the first UK standard for quality assurance for use in the
electronics industry

1974 – BS 5179 "Guidelines for Quality Assurance" is

published. Suppliers can now demonstrate quality
assurance to customers through third-party assessment.

TÜV SÜD PSB

Philippines
History of ISO 9001
1979 – BS5750 is published as the culmination of
meetings between BSI and industry throughout the '70s. It
is agreed that this document will replace key industry's
own standards.

1987 – Initial ISO 9000 certification standard is published

as ISO 9000:1987. It had the same structure as BS5750
and was more suited to manufacturing with emphasis on
conformance to procedures rather than overall
management processes.
TÜV SÜD PSB
Philippines
History of ISO 9001
1994 – The standard undergoes its first revision and
becomes ISO 9000:1994. Emphasis is placed on creating
quality assurance by seeking to identify and prevent
possible deviations before they occur. However like its
predecessor many companies took the requirements very
literally, created a lot of substantiate paperwork and got
too caught up in the bureaucracy of it all.

TÜV SÜD PSB

Philippines
History of ISO 9001
2000 – The standard is revised again to ISO 9001:2000.
This time the standard aimed to focus predominantly on
the concept of process management in an attempt to
create 'a documented system' as opposed to 'a system of
documents'. Emphasis was now on continually improving
processes and monitoring customer satisfaction.

2008 – Minor adjustments are made to clarify existing

points and to strengthen the links between other
management standards.
TÜV SÜD PSB
Philippines
History of ISO 9001
2015 Sept – the latest version ISO 9001:2015 is released.

 Technical Committee ISO/TC 176, Quality management

and quality assurance, Subcommittee SC 2, Quality
Systems.

TÜV SÜD PSB

Philippines
The 7 Quality Management Principles
1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence based decision making
7. Relationship management

TÜV SÜD PSB

Philippines
1. Customer focus
• Primary focus of QMS is to meet customer requirements
and to strive to exceed customer expectations.
• Some key benefits:
• Increased customer value and satisfaction
• Enhanced repeat business
• Expanded customer base
• Increased revenue

TÜV SÜD PSB

Philippines
2. Leadership
• Leaders at all levels establish unity of purpose and
direction and create conditions in which people are
engaged in achieving the organization’s quality
objectives.
• Some key benefits:
• Increased effectiveness and efficiency of processes
• Improved communication between levels

TÜV SÜD PSB

Philippines
3. Engagement of People
• Competent, empowered and engaged people at all levels
are critical to enhance capability to create and deliver
value.
• Some key benefits:
• Improved understanding of quality objectives
• Enhanced personal development
• Enhanced people satisfaction

TÜV SÜD PSB

Philippines
4. Process Approach
• Interrelated processes function as a coherent system.
• Some key benefits:
• Consistent and predictable outcomes
• Optimized performance
• Opportunities for improvement

TÜV SÜD PSB

Philippines
5. Improvement
• Ongoing focus on improvement.
• Some key benefits:
• Enhanced focus on root cause investigation for corrective and
preventive actions
• Enhanced ability to anticipate and react to risks and
opportunities
• Enhanced drive for innovation

TÜV SÜD PSB

Philippines
6. Evidence based Decision Making
• Decision based on analysis and evaluation of data and
information.
• Some key benefits:
• Improved decision making process
• Improved assessment of process performance
• Increased ability to demonstrate effectiveness of decisions

TÜV SÜD PSB

Philippines
7. Relationship Management
• Manages relationship with interested parties, including
suppliers.
• Some key benefits:
• Common understanding of goals and values
• Well managed supply chain

TÜV SÜD PSB

Philippines
Concepts Used in ISO 9001:2015
Three main concepts together form an integral part of the
ISO 9001:2015 Standard:
• PDCA
• Process approach
• Risk based thinking

TÜV SÜD PSB

Philippines
PDCA
PDCA is a tool to manage processes and systems:
• Plan – set the objectives of the system and processes to
deliver results
• Do – implement and control what was planned
• Check – monitor and measure processes and results
against criteria and report results
• Act – take action to improve the performance of
processes

TÜV SÜD PSB

Philippines
PDCA
 PDCA enables an organization to ensure that its
processes are adequately resourced and managed, and
that opportunities for improvement are determined and
acted on.

TÜV SÜD PSB

Philippines
Process Approach
• Define the context of the organization
• Define the scope, objectives and policies
• Determine the processes
• Determine the sequence of processes
• Define ownership and accountability
• Define need for documented information
• Define interfaces, risks and activities within process
• Define monitoring and measuring requirements

TÜV SÜD PSB

Philippines
Process Approach
• Implement
• Define the resources needed
• Verify the process against its planned objectives
• Improvement

TÜV SÜD PSB

Philippines
Process Approach
 The Process Approach enables an organization to plan
its processes and their interactions.

TÜV SÜD PSB

Philippines
Risk Based Thinking
Risk based thinking is used throughout the process
approach to:
• Decide how risk is addressed in establishing processes
and to prevent unintended outputs
• Define extent of process planning and controls needed
based on risk
• Improve effectiveness of QMS
• Maintain and manage system that addresses risk and
meets objectives

TÜV SÜD PSB

Philippines
Risk Based Thinking
 Risk based thinking enables an organization to
determine the factors that could cause its processes and
its QMS to deviate from planned results, to put preventive
controls to minimize negative effects and to make
maximum use of opportunities as they arise.

TÜV SÜD PSB

Philippines
Workshop 1
“Identifying interested parties (internal and external) and
their expectations from DCNHS”

TÜV SÜD PSB

Philippines
 Requirements

1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership

TÜV SÜD PSB

Philippines
 Requirements

6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement

TÜV SÜD PSB

Philippines
0.1 Introduction
Potential benefits to an organization of implementing a
QMS based on this Standard:
• Ability to provide products and services that meet
customer and applicable statutory and regulatory
requirements
• Facilitating opportunities to enhance customer
satisfaction
• Addressing risks and opportunities associated with its
context and objectives
• Ability to demonstrate conformity to specified QMS
requirements
TÜV SÜD PSB
Philippines
0.1 Introduction
Take note:
• “shall” = requirement
• “should” = recommendation
• “may” = permission
• “can” = possibility or capability

• “NOTE” = guidance for understanding or clarifying the

associated requirement

TÜV SÜD PSB

Philippines
0.2 Quality Management Principles
1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Improvement
6. Evidence based decision making
7. Relationship management

TÜV SÜD PSB

Philippines
0.3.1 Process Approach

TÜV SÜD PSB

Philippines
0.3.2 PDCA Cycle

TÜV SÜD PSB

Philippines
0.3.3 Risk Based Thinking
• Opportunities = can arise as a result of a situation
favorable to achieving an intended result
• Risk = effect of uncertainty can have (+ or -)

TÜV SÜD PSB

Philippines
0.4 Relationship with other MSS
• ISO 9000 Quality management systems – fundamentals
and vocabulary

• ISO 9004 Managing for the sustained success of an

organization

TÜV SÜD PSB

Philippines
1 Scope
For Organizations with:
• Need to demonstrate its ability to consistently provide
products and services that meet customer and
applicable statutory and regulatory requirements
• Aims to enhance customer satisfaction through effective
application of system, including processes for
improvement and assurance of conformity to customer
and applicable statutory and regulatory requirements

TÜV SÜD PSB

Philippines
2 Normative Reference
• ISO 9000:2015 Quality management systems –
Fundamentals and vocabulary

TÜV SÜD PSB

Philippines
3 Terms and Definitions
• The terms and definitions in ISO 9000:2015 apply.

TÜV SÜD PSB

Philippines
4 Context of the Organization
4.1 Understanding the organization and its context
• Internal issues
• External issues

4.2 Understanding the needs and expectations of

interested parties
• Relevant to the organization
• Monitor and review information

TÜV SÜD PSB

Philippines
4 Context of the Organization
4.3 Determining the scope of the QMS
• Consider internal and external issues
• Consider requirements of relevant interested parties
• Consider products and services

4.4 QMS and its processes

4.4.1 Shall establish, implement, maintain and improve a
QMS, including processes needed and their interactions,
in accordance with the Standard.

TÜV SÜD PSB

Philippines
4 Context of the Organization
4.4.2 To the extent necessary:
• Shall maintain documented information to support the
operation of its processes
• Shall retain documented information to have confidence
that the processes are being carried out as planned

TÜV SÜD PSB

Philippines
5 Leadership
5.1 Leadership and commitment
Top Management shall demonstrate leadership and
commitment with respect to QMS:
• Take accountability on effectiveness of QMS
• Ensure resources
• Promote integration into business processes
• Communicate importance of QMS
• Engage, direct and support persons to contribute to
QMS
• Promote improvement
TÜV SÜD PSB
Philippines
5 Leadership
5.1.2 Customer focus
Top Management to ensure that:
• Customer and applicable statutory and regulatory
requirements are determined, understood and
consistently met
• Risks and opportunities determined and addressed
• Focus on enhancing customer satisfaction maintained

TÜV SÜD PSB

Philippines
5 Leadership
5.2 Policy
5.2.1 Establishing the quality policy
• Appropriateness
• Commitments
• Framework for objectives

TÜV SÜD PSB

Philippines
5 Leadership
5.2.2 Communicating the quality policy
• Documented information
• Communicated and understood
• Available to interested parties, as appropriate

TÜV SÜD PSB

Philippines
5 Leadership
5.3 Organizational roles, responsibilities and authorities
Top Management assignments:
• Ensuring QMS conformity
• Ensuring processes with intended outputs
• Reporting performance of QMS
• Ensuring promotion of customer focus
• Ensuring integrity of QMS is maintained

TÜV SÜD PSB

Philippines
6 Planning
6.1 Actions to address risks and opportunities
6.1.1 When planning QMS, consider the risks in 4.1 and
the requirements in 4.2

6.1.2 The organization shall plan:

• Actions to address risks and opportunities
• How to integrate actions to QMS
• How to evaluate the actions

TÜV SÜD PSB

Philippines
6 Planning
6.2 Quality objectives and planning to achieve them
6.2.1 Quality objectives at relevant functions, levels and
processes needed for QMS
6.2.2 Determine needed resources

6.3 Planning of changes

Changes carried out in a planned manner.

TÜV SÜD PSB

Philippines
7 Support
7.1 Resources
7.1.1 General
• Consider capabilities and constraints on existing internal
resources
• Consider needs from external providers

7.1.2 People
• Determine and provide persons necessary for the
effective implementation of QMS

TÜV SÜD PSB

Philippines
7 Support
7.1.3 Infrastructure
• Building and associated facilities
• Equipment – hardware and software
• Transportation and resources
• Information and communication technology

TÜV SÜD PSB

Philippines
7 Support
7.1.4 Environment for the operation of processes
A suitable environment can be a combination of human
and physical factors:
• Social
• Psychological
• Physical

TÜV SÜD PSB

Philippines
7 Support
7.1.5 Monitoring and measuring resources
7.1.5.1 General
• Suitability for specific type of monitoring and
measurement
• Maintained for continuing fitness

7.1.5.2 Measurement traceability

• Calibrated or verified
• Identified
• Safeguarded from damage or deterioration
TÜV SÜD PSB
Philippines
7 Support
7.1.6 Organizational knowledge
• Determine the knowledge necessary
• Be maintained and made available to the extent
necessary

Organizational knowledge = knowledge specific to the

organization, generally gained by experience. Information
used and shared to achieve organization’s objectives.
Sources: internal or external

TÜV SÜD PSB

Philippines
7 Support
7.2 Competence
• Determine necessary competence
• Ensure personnel competence
• Take actions to acquire competence
• Retain appropriate documented information as evidence
of competence

TÜV SÜD PSB

Philippines
7 Support
7.3 Awareness
Awareness of personnel doing work under the
organization’s control:
• On Quality policy
• On relevant Quality objectives
• Contribution to the effectiveness of QMS, benefits of
improved performance
• Implication of not conforming to QMS

TÜV SÜD PSB

Philippines
7 Support
7.4 Communication
Determine internal and external communication relevant
to QMS:
• What?
• When?
• With whom?
• How?
• Who communicates?

TÜV SÜD PSB

Philippines
7 Support
7.5 Documented information
7.5.1 General
• Documented information required by the Standard
• Documented information determined by the
organization as necessary for effectiveness of QMS

7.5.2 Creating and updating

Ensure appropriate identification, format and media,
review and approval

TÜV SÜD PSB

Philippines
7 Support
7.5.3 Control of documented information
7.5.3.1 Available and adequately protected

TÜV SÜD PSB

Philippines
7 Support
7.5.3.2 Address:
• Distribution
• Storage
• Control
• Retention and disposition

Consider:
External origin, unintended alterations, access

TÜV SÜD PSB

Philippines
8 Operation
8.1 Operational planning and control
• Determine requirements for products and services
• Establish criteria for processes and acceptance
• Determine resources
• Implement control of processes
• Determine, maintain and retain documented
information

*Ensure outsourced processes are controlled.

TÜV SÜD PSB

Philippines
8 Operation
8.2 Requirements for products and services
8.2.1 Customer communication
• Product or service information
• Handling enquiries, contracts, changes
• Customer feedback, including complaints
• Handling customer property
• Contingency actions, when necessary

TÜV SÜD PSB

Philippines
8 Operation
8.2.2 Determining requirements for products and services
Consider:
• Applicable statutory and regulatory requirements
• Those necessary by the organization
• Organization can meet the claims for products and
services it offers

TÜV SÜD PSB

Philippines
8 Operation
8.2.3 Review of requirements for products and services
8.2.3.1 Consider:
• Review before committing supply of product or service
• Define and resolve changes from previous agreements
• Confirm requirements before acceptance when
customer does not provide documented statements.

TÜV SÜD PSB

Philippines
8 Operation
8.2.3.2 Retain documented information:
• Results of review
• Any new requirements

TÜV SÜD PSB

Philippines
8 Operation
8.2.4 Changes to requirements for products and services
• Relevant documented information is amended
• Relevant persons are made aware

TÜV SÜD PSB

Philippines
8 Operation
8.3 Design and development of products and services
8.3.1 General
Establish, implement and maintain a D&D process
appropriate to ensure subsequent provision of products
and services.

TÜV SÜD PSB

Philippines
8 Operation
8.3.2 D&D planning
Consider:
• Nature, duration and complexity
• Required process stages
• Required verification and validation
• Responsibilities and authorities
• Internal and external resources
• Control interfaces
• Need for customer involvement
• Requirement for subsequent provision
• Level of control expected by customers and relevant
interested parties
• Documented information TÜV SÜD PSB
Philippines
8 Operation
8.3.3 D&D inputs
Consider:
• Functional and performance requirements
• Information from previous design
• Statutory and regulatory requirements
• Standards or codes of practice
• Potential consequences of failure
*retain documented information

TÜV SÜD PSB

Philippines
8 Operation
8.3.4 D&D controls
Ensure:
• Results to be achieved are defined
• Reviews conducted
• Verification conducted
• Validation conducted
• Necessary actions on problems determined
• Documented information retained

TÜV SÜD PSB

Philippines
8 Operation
8.3.5 D&D outputs
Ensure outputs:
• Meet inputs
• Adequate for subsequent processes for provision
• Include reference monitoring and measurement
requirements
• Specify characteristics of products and services

*retain documented information

TÜV SÜD PSB

Philippines
8 Operation
8.3.6 D&D changes
Retain documented information on:
• D&D changes
• Results of reviews
• Authorization of changes
• Actions taken to prevent adverse impacts

TÜV SÜD PSB

Philippines
8 Operation
8.4 Control of externally provided processes, products and
services
8.4.1 General
• For incorporation into core products or services
• Provided directly to the customer on behalf of the
organization
• Provided as a result of a decision of the organization

*evaluation, selection, monitoring of performance, re-

evaluation of external providers
TÜV SÜD PSB
Philippines
8 Operation
8.4.2 Type and extent of control
• Externally provided processes remain within the control
of QMS
• Define controls for external provider and those for
outputs
• Consider: potential impact to organization, effectiveness
of controls
• Determine verification

TÜV SÜD PSB

Philippines
8 Operation
8.4.3 Information for external providers
Communicate:
• Processes, products and services to be provided
• Approval considerations
• Competence of personnel
• Interactions with organization
• Control and monitoring of performance
• Verification and validation activities

TÜV SÜD PSB

Philippines
8 Operation
8.5 Production and service provision
8.5.1 Control of production and service provision
Controlled conditions:
• Availability of documented information on product
characteristics and results to be achieved
• Suitable monitoring and measuring equipment
• Monitoring and measuring activities
• Appointment of competent persons
• Validation and re-validation activities
• Implementation of actions to prevent human error
• Release, delivery and post-delivery activities
TÜV SÜD PSB
Philippines
8 Operation
8.5.2 Identification and traceability
• Identify the outputs
• Identify the status of outputs
• Retain documented information to enable traceability

TÜV SÜD PSB

Philippines
8 Operation
8.5.3 Property belonging to customers or external
providers
Exercise care:
• Identify
• Verify
• Protect
• Safeguard
• Report when damaged or unsuitable
*Retain documented information

TÜV SÜD PSB

Philippines
8 Operation
8.5.4 Preservation
Can include:
• Identification
• Handling
• Contamination control
• Packaging
• Storage
• Transmission or transportation
• Protection
TÜV SÜD PSB
Philippines
8 Operation
8.5.5 Post delivery activities
Consider:
• Statutory and regulatory requirements
• Potential undesired consequences
• Nature, use and intended lifetime of product or services
• Customer requirements
• Customer feedback

TÜV SÜD PSB

Philippines
8 Operation
8.5.6 Control of changes
Retain documented information:
• Results of review
• Person authorizing change
• Necessary actions from the review

TÜV SÜD PSB

Philippines
8 Operation
8.6 Release of products and services
Implement planned arrangements before release of
products and services, unless otherwise approved.

TÜV SÜD PSB

Philippines
8 Operation
8.7 Control of nonconforming outputs
8.7.1 Use of one or more of the following ways:
• Correction
• Segregation, containment, return or suspension
• Informing the customer
• Obtaining authorization for acceptance under
concession

Conformity shall be verified when outputs are corrected.

TÜV SÜD PSB

Philippines
8 Operation
8.7.2 Retain documented information:
• Describing the nonconformity
• Describing the actions taken
• Describing the concessions obtained
• Identifying the authority deciding the action taken

TÜV SÜD PSB

Philippines
9 Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
• What needs to be monitored and measured?
• What methods?
• When to be done?
• When to be analyzed?

*Retain documented information.

TÜV SÜD PSB

Philippines
9 Performance Evaluation
9.1.2 Customer satisfaction
Determine the method for obtaining, monitoring and
reviewing this information.

TÜV SÜD PSB

Philippines
9 Performance Evaluation
9.1.3 Analysis and evaluation
Results of analysis used to evaluate:
• Conformity of products and services
• Degree of customer satisfaction
• Performance of effectiveness of QMS
• Planning implementation
• Actions taken for risks and opportunities
• Performance of external providers
• Need for improvement of QMS
TÜV SÜD PSB
Philippines
9 Performance Evaluation
9.2 Internal audit
9.2.1 Internal audit at planned intervals

9.2.2 Shall:
• Establish, implement and maintain an audit programme
• Define audit criteria and scope
• Select auditors
• Report to Management
• Take appropriate correction and CA without delay
• Retain documented information
TÜV SÜD PSB
Philippines
9 Performance Evaluation
9.3 Management review
9.3.1 General
• Top Management shall review at planned intervals.
• Alignment with strategic direction of the company.

TÜV SÜD PSB

Philippines
9 Performance Evaluation
9.3.2 Management review inputs
Consider:
• Status of actions from previous Management review
• Changes in external and internal issues
• Information on QMS performance
• Resource adequacy
• Effectiveness of actions for risks and opportunities
• Opportunities for improvement

TÜV SÜD PSB

Philippines
9 Performance Evaluation
9.3.3 Management review outputs
Decisions and actions for:
Opportunities for improvement
Any need for changes in QMS
Resource needs

*Retain documented information as evidence of

Management review.

TÜV SÜD PSB

Philippines
10 Improvement
10.1 General
Determine and select opportunities for improvement.
Include:
• Improve products and services
• Correct / prevent / reduce undesired effects
• Improve performance of QMS

TÜV SÜD PSB

Philippines
10 Improvement
10.2 Nonconformity and corrective action
10.2.1 Shall:
• React to the NC as applicable
• Evaluate need to eliminate the cause(s)
• Implement actions
• Review effectiveness
• Update risks and opportunities, if necessary
• Make changes to QMS

TÜV SÜD PSB

Philippines
10 Improvement
10.2.2 Retain documented information:
• Nature of NC and actions taken
• Results of corrective action

TÜV SÜD PSB

Philippines
10 Improvement
10.3 Continual improvement
• Continually improve suitability, adequacy and
effectiveness of the QMS
• Consider the results of analysis and evaluation
• Consider the outputs from Management reviews

TÜV SÜD PSB

Philippines
Workshop 2
“Planning a QMS ”

Consider:
• Internal and External Issues
• Needs and expectations of interested parties
• Products and services

TÜV SÜD PSB

Philippines
Q&A / Course Wrap-Up