Understanding the Context - ISO9001:2015

Understanding the Context of the Organization for
an Effective QMS
Facilitator
Engr. Seema Zaman
Dy. General Manager
Corporate Quality Assurance
21st December 2018 1seema.zaman@gmail.com

Quality Management System - QMS
• Objective
– One of the key goals of any
QMS is to improve quality of
products or services.
– Quality in such a system has
three components.
• High quality means high accuracy,
• compliance with applicable
standards, and
• high customer satisfaction.

Benefit of Certification
1. Provides an internationally acceptable
structured framework to run the
business proven to make the
organization efficient.
2. Certifications reflect that the
organization is maintaining certain
standards, for brand positioning.
3. Reflects confidence to interested
parties that the organization is quality
and safety conscious and help in
reducing the insurance premiums.
4. Are required to meet the pre-
condition for operational
contracts/agreements and participate
in tenders.
21st December 2018 seema.zaman@gmail.com 3

Why do we need a management
system focused on quality?
• To have the ability to consistently provide quality products
and services.
• To have the ability to meet customer and applicable statutory
and regulatory requirements;
• To facilitate opportunities to enhance customer satisfaction;
 To have the ability to identify & address risks and
opportunities associated with the context and objectives;
• To have the ability to demonstrate conformity to quality
management system requirements. ISO9001:2015 Section 0.1
Scope of this
workshop

QMS Principles
• customer focus + catering to the expectation of
interested parties;
• leadership;
• engagement of people;
• process approach;
• improvement;
• evidence-based decision making;
• relationship management.
ISO9001:2015 Section 0.2
If ANY ONE of these
elements is missing in an
organization, organization
cannot truly benefit from
QMS Framework.

What is required by the Standard
ISO9001:2015
Understanding the organization and its context
The organization shall determine external and
internal issues that are relevant to its purpose and its
strategic direction and that affect its ability to
achieve the intended result(s) of its quality
management system.
The organization shall monitor and review
information about these external and internal issues.

Understanding the needs and expectations of interested
parties
Due to their effect or potential effect on the organization’s
ability to consistently provide products and services that meet
customer and applicable statutory and regulatory
requirements, the organization shall determine:
a) the interested parties that are relevant to the quality management
system;
b) the requirements of these interested parties that are relevant to the
quality management system.
The organization shall monitor and review information about
these interested parties and their relevant requirements.
ISO9001:2015

ISO9001:2015
Determining the scope of the quality management system
The organization shall determine the boundaries and applicability of the quality
management system to establish its scope. When determining this scope, the
organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
Customer focus
Top management shall demonstrate leadership and commitment with respect to
customer focus by ensuring that:
a) customer and applicable statutory and regulatory requirements are
determined, understood and consistently met;
b) the risks and opportunities that can affect conformity of products and services
and the ability to enhance customer satisfaction are determined and
addressed;
c) the focus on enhancing customer satisfaction is maintained.
ISO9001:2015 Section 5.1.2

ISO9001:2015
Planning : Actions to address risks and opportunities
When planning for the quality management system,
the organization shall consider the issues referred to
in 4.1 and the requirements referred to in 4.2 and
determine the risks and opportunities that need to be
addressed to:
a) give assurance that the quality management system can
achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
ISO9001:2015 Section 6.1.1

ISO9001:2015
The organization shall plan:
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality
management system processes (see 4.4);
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities
shall be proportionate to the potential impact on
the conformity of products and services.
ISO9001:2015 Section 5.1.2

ISO9001:2015
Quality objectives and planning to achieve them
The organization shall establish quality objectives at relevant functions, levels and
processes needed for the quality management system. The quality objectives shall:
a) be consistent with the quality policy;
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services and to enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
The organization shall maintain documented information on the quality objectives.
When planning how to achieve its quality objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
ISO9001:2015 Section 6.2.1 & 6.1.2

ISO9001:2015
Planning of changes
When the organization determines the need for changes to
the quality management system, the changes shall be
carried out in a planned manner (see 4.4).
The organization shall consider:
a) the purpose of the changes and their potential consequences;
b) the integrity of the quality management system;
c) the availability of resources;
d) the allocation or reallocation of responsibilities and authorities.

ISO9001:2015

Understanding the Context
• New Business/Operation
– Preparations &
Establishment
– Launching
– Marketing
– Offerings
– Energy
– Resources
– Targets
– New internal & external
relationships
• Existing
Business/Operation
– Routine Management
– Innovation
– Learning from experience
– Targets for Continual
Improvement
– Organizational Culture
– Level and extent of
communication between
departments/functions.
Different business-stages have different challenges

• What is your role in the organization?
• What is expected of us by your interested
parties?
– Internally & Externally
• What changes are planned and anticipated?
• What are applicable statutory & regulatory
requirements?
• What are requirements of standards?
• What are your challenges?
Your Section’s or Division’s or Dept’s Role

• Keeping in view the role of
your section, unit, division
or department in the overall
organization.
• Capabilities & Capacities
• Limitations
• Interrelationships &
Interdependencies.
• Infrastructure
• Expectations
• Job Requirement
You?
You?
You?

• Context of PIA
• Context of a Department in PIA
• Context of a Division in a
Department
• Context of a Section in a
Division
• Context of a Unit in a Division
• Context of an Employee in a
Unit
You?
You?
You?

• Functional Perspective
– Training
– Sales & Market Planning
– Flight Services
– Ground Handling
– Technical Ground Support
– Cargo Operations
• Geographic Perspective
– Head Office/Base
– Station
You?
You?
You?

Why customers are not satisfied?
• Do we not meet their expectations?
• Do we not follow the company procedures?
• Are our procedures not linked with reality?
• Is there lack of competence?
• Do we have lack of resources?
• Do we have lack of manpower?
– Try women-power ;)
• Are we are working in silos?
• Is there lack of knowledge?
• Are there wrong persons appointed for the job?
• Is there organizational capacity or capability issues?
• Have we over committed with our customers?

Before anyone else ….Who is the
Most Interested Party?
•Youare the most important interested
party.
– Willing to take initiative & bring about a positive
change.
– Willing to engage with your fellow colleagues for
productive brain-storming sessions.
– Willing to day-dream about a better tomorrow.
– Willing to work, try, try and try again! Lead +ve
change.

Keep the Perspective in Mind
• Organizational Role
• Functional Role
• Geographical
Now Please Lock this Perspective:
E.g.,
Flight Operation Unit of PTC at Head Office.
Training Section of PHS in ASD at Head Office.
TGS Operations at New Islamabad Intl’ Airport.

Identifying Interested Parties
• Internal Interested Parties
– ?
– ?
– ?
• External Interested Parties
– Customers
– Regulators (regulations)
– ?
• Needs & Expectations
– ?
– ?
– ?
• Needs & Expectations
– ?
– ?
– ?
Worksheet 1
Perspective:__________________________________________________________

Identifying Internal Issues
Internal Weaknesses Internal Strengths
Worksheet 2
Perspective:__________________________________________________________

Identifying External Issues
External Threats External Opportunities
Worksheet 2
Perspective:__________________________________________________________

Risk - Perspective
• Strengths & Opportunities = Positive Risks
– Strengths  Must be retained, safeguarded
– Opportunities  Must be tapped through conscious effort
& strategy.
• Threats, Weaknesses = Negative Risks
– Threats  Must Guard Against, build internal defensive
controls.
– Weaknesses  Must overcome ASAP by applying controls.
Internal threats should be taken as internal weakness as they
are internal and thus controllable.

Risk Categorization Policy
• High
– Any thing that can have a strong –ve impact on operations & quality of service
delivery e.g., litigation, fines, restrictions, financial loss, extreme negative
feedback or lost business/customers or operational incapacitation.
• Medium
– Anything that can have a considerable –ve impact on operations & quality of
service delivery e.g., delays, increased costs, poor service delivery, negative
customer feedback.
• Low
– Anything that can have a low –ve impact on operations & quality of service
delivery and loss. Isolated negligence etc.
• Acceptable
– Anything determined to be –ve and must be catched to prevent from
aggravation. We can continue living with this situation but keep it from
growing.
Consider both Existing and Potential Risks
For Safety & Security Risk Assessment Ref. Respective matrices
A dept/div/section may choose to define their own risk definitions

*Controls vs Risk Level
High Medium Low Acceptable
Root Cause Analysis Root Cause Analysis -
System Review System Review Process Review
Policy Review Policy Review Policy Review
Process &
Procedure Review
Procedure Review Procedure Review
Major Training
Across the Board
Limited
Trainings/Awareness
Individual counseling
Set Objective Set Objective Monitoring Mechanism
Track through KPI Track Trough KPI Track Though KPI Track for
growth
Consider New
Technology
Consider New
Technology
Consider New
Technology
To decide, which set of controls to apply, is a very subjective matter

Utility of SWOT Analysis
Issue Risk Level Existing
Controls
Strategy Approv
al
Reason
INTERNAL ISSUES OF XYZ DIVISION
A (weakness) -ve High Nil Apply Controls* yes
B (weakness) -ve Low Not
effective
Improve no Ban on hiring
C (strength) +ve High Nil Apply Controls* yes
D (strength) +ve Med Effective -
EXTERNAL ISSUES OF XYZ DIVISION
E (threat) -ve High Nil Apply Controls* no Cost
Constraints
F (threat) -ve Low Nil Apply Controls* Yes
G (opportunity) +ve High Nil Apply Controls* No Next Year!
H (opportunity) +ve Med Not
Effective
Improve
Effectiveness*
yes
THE CONTEXT | ACTION STRATEGIES | MGMT COMITTMENT
ISO 4.1 ISO 6.1 ISO 5.1
ConsideringNeeds&ExpectationsofCustomers&
InterestedParties&OperationalLimitations
ISO 4.2

GOLDEN TIPS
1. If the issue is controllable from within the organization and the source of
the issue is internal, identify it as an internal issue (can be a weakness or
strength).
2. If the issue is not controllable from within the organization and the
source is outside the organization, identify it as an external issue (can be
a threat or opportunity)
3. Organization can deal with external issues by developing defense or
attack mechanisms corresponding to threats and opportunities.
4. If you feel organization is capable/can/should internally handle an issue
for good, declare it as an internal weakness so that additional controls
can be focused on remove that particular weakness.
5. Any thing which is a violation of state laws, regulations, agreements,
standards, company’s own policy and procedures which can lead to
punitive action, restrictions, fines, or cancellation of existing
certifications, approvals, authorizations should be categorized as high
risk irrespective of the fact that an occurrence has happened or not or
the frequency of the occurrence of such deviation.

Actions taken to address risks and opportunities shall be proportionate to
the potential impact on the conformity of products and services.
• NOTE 1 Options to address risks can include avoiding risk, taking risk in
order to pursue an opportunity, eliminating the risk source, changing the
likelihood or consequences, sharing the risk, or retaining risk by informed
decision.
• NOTE 2 Opportunities can lead to the adoption of new practices,
launching new products, opening new markets, addressing new
customers, building partnerships, using new technology and other
desirable and viable possibilities to address the organization’s or its
customers’ needs.
• NOTE 2 Statutory and regulatory requirements can be expressed as legal
requirements.
ISO9001:2015 Section 6.1.2
GOLDEN TIPS
ISO9001:2015 Section 1

NOTE 1 Issues can include positive and negative factors or conditions for
consideration.
NOTE 2 Understanding the external context can be facilitated by considering
issues arising from legal,
technological, competitive, market, cultural, social and economic
environments, whether international, national, regional or local.
NOTE 3 Understanding the internal context can be facilitated by considering
issues related to values, culture, knowledge and performance of the
organization.
GOLDEN TIPS

Statements are Important
Example of Issue Type Root Cause Additional Control
Lack of regular
refresher job
related trainings.
Weakness
(Medium
Risk)
Nominated
employees are not
released from
operational duties
due to lack of
alternate
arrangements.
Plan refresher trainings during
low operational activity period
OR
Send trainer to conduct
refresher trainings at site. OR
Introduce online refresher
training modules which
employees can attend at their
convenience.
Frequent lapses in
completing
mandatory safety
training refreshers
before expiry date.
Weakness
(High
Risk)
Same as above. Initiate training request 90days
prior to expiry OR
Proactive planning to arrange
backup to release the employee
for mandatory refresher
trainings.
Perspective : PHS Training Section

Statements are important
Example of Issue Type Root Cause Additional Defensive Controls
Repeated
offloading of cargo
pallets/ULDs by PIA
Safety Inspector
causing delays.
Weakness
(high risk)
Absence of internal
cargo QC
inspections before
releasing shipment
for loading. Lack of
awareness. Lack of
resources.
[Policy]All resources required in
context of ensuring safety of
operations to be given TOP
PRIORITY by the management.
And
[Training]The employees involved
in cargo buildup to be made
aware of the safety
requirements. And
[Oversight/Cross Check] An
additional monitoring by
departmental QC inspectors
before sending the shipment for
loading on aircraft.
Perspective : Cargo Terminal (Cargo Buildup)

Example of Issue Type Root Cause Additional Defensive Controls
Restrictions to
operate into EU due
to SAFA Index
Threat
(high risk)
Absence of solid
management
action/response
over increasing
findings from
internal SAFA
inspections in the
last 6 months.
Re-define Safety Responsibilities,
Authorities and Accountabilities
of management, non-
management and operational
personnel. Increased internal
monitoring.
Tap Australian
Market. Direct
flights.
Opportuni
ty (High)
Lack of aircrafts to
start operations to
Australia.
Plan for AUS operations to start
from the induction 4 new A320s
w.e.f. June 2019. Prepare
checklist for proactive
management of this change
Perspective : Corporate
Perspective : Market Planning

Example of Issue Type Risk Additional Controls
Highly skilled and
experienced route
specialist FOOs
Strength
(high)
Low salary, high
risk of attrition
jeopardizing the
operations.
Introduce market competitive
pay packages for employees
critical for maintaining
operational standards.
Perspective : Dispatch Operations (flt ops)

Inter-relationships : The Big Picture
1. Understand & Identify the perspective
(scope)
2. Identify the context by identifying the
internal and external issues (SWOT analysis)
3. Identify Risks Associated with Internal &
External Issues
4. Identify control strategies to address these
–ve and +ve risks
5. Brief and take management decision over
the proposed strategies.

Inter-relationships : The Big Picture
6. Identify the capabilities and capacities for service delivery
to customers & interested parties.
7. Make sure the offered services clearly communicate the
limitations to keep the customer /interested party’s
expectations within the capacity of the organization.
8. Identify the customer requirement & requirements of the
internal and external interested parties. If already known go
to step 6 to match capability with requirements.
9. Make sure that the organization has mechanisms to
deliver in accordance with the above requirements.
10. If it is found that the organization is not capable of
delivering as per capacity and capability – identify it as a
weakness and go to step 2

Quality Objectives & KPIs
• After doing the above exercise an organization is
better able to identify
– Requirements of its customers & interested parties
and organizational capabilities and limitations.
– What elements of performance should be measured
through KPIs
– On what aspects of functions to set Quality Objectives
on
– How well you are able to deliver and function
productively in the progress of the organization as a
whole.

Golden TIPS
• Set Key Performance Indicators KPI’s on
– Key elements of service delivery parameters which
the organization MUST deliver upon to ensure a
set standard is maintained. Set a reference
minimum acceptable bar for each parameter.
– Measurement parameters on which quality
objectives or quality targets are set.
– On a weakness to monitor improvement.
– On high risk issues to prevent occurrence.

PDCA Cycle
Plan: establish the objectives of the system and its processes, and
the resources needed to deliver results in accordance with
customers’ requirements and the organization’s policies, and
identify and address risks and opportunities;
Do: implement what was planned;
Check: monitor and (where applicable) measure processes and the
resulting products and services against policies, objectives,
requirements and planned activities, and report the results;
Act: take actions to improve performance, as necessary.

Plan
• Plan Meetings to Identify Internal & External
Issues.
• Carry out the risk assessment.
• Identify action strategies.
• Present the outcome to the management for
approval.
• Document and Implement decisions

THANK YOU
(AN EXAMPLE EXERCISE IS SHARED IN THE APPENDED SLIDES)
From Corporate Quality Assurance

EXAMPLE
Just for Guideline

Identifying the Context
• Perspective: Medical Division (Head Office Karachi)
• Customers:
– Employees & Their Dependents at Head Office & Dom & Intl. Network Stations
– Operational Departments (Flight Ops, PHS, TGS, Cabin Operations, Engg & Maint, S&QA, Cargo Division,
Dispatch Operations) for medical fitness of operational personnel.
• Cockpit & Cabin Crew
• Equipment Operators
• Food Handlers
• Safety Officers
• Baggage Staff
• Customer Requirements: (max wish list)
– medical coverage
• OPD
• Hospitalization
• Ambulance & Surgical Services
• Emergency Care Centres
• Nursing Care
– Dental Care
– Cosmetic Surgery
– Availability of Medicines
– Wait Time 30minutes
– Reliable Lab Tests
– Medical Expense reimbursements
– Shuttle Service from main roads to head office medical centre.

Medical Facilities Legal Requirement*
Limitation of Services That
Can be Offered.
Operational
Employees**
Other
Employees
Dependents***
OPD
Hospitalization
Ambulance Surgical
Services
Emergency Care
Nursing Care
Dental Care
Cosmetic Surgery
Availability of
Medicines
Less Wait Time
Reliable Lab Tests
Multivitamins
Fitness Regular Tests
YES
YES
YES
YES
YES
YES
YES
No
YES
YES
YES
No
Yes
YES
YES
YES
YES
YES
YES
YES
No
YES
YES
YES
No
No
YES
YES
YES
YES
YES
YES
YES
No
YES
YES
YES
No
No
*Legal requirement = Regulatory, Statutory, Standard, Contractual, Company Policy
**Regular Tests as per company policy.
***upto the age of 24, unmarried daughters….. (ref. P&P Manual)

Identifying Internal Issues
Internal Weaknesses
1. 1 Doctor per 2000 customers
2. 1 Lady Doctor per 5000 female
customers
3. Average Wait Time 3hrs
4. Non- availability of the required
medicines.
5. Weak system of verifications of
medical expense reimbursements.
6. No shuttle service for pensioners
visiting medical centre at head office.
7. No system of knowing doctor’s rating.
8. No system of knowing employee
health profile/history.
Internal Strengths
9. Contracts with hospitals of best repute
(Agha Khan, Liaquat National, NMC,
Jinnah, South City).
10. Contracts with Laboratories of best
repute (Essa, Agha Khan, Karachi Lab).
Context of Medical Services at Head Office
Perspective A*:Medical Division (Head Office)
*Since Head Office, Domestic Stations and International Station arrangements and context is
different therefore, it is appropriate to identify their context separately e.g.,
Perspective B: Medical Services at Domestic Stations
Perspective C: Medical Services at International Stations

Identifying External Issues
External Threats
11. Terrorism attempt at Medical
Facilities.
12. Stealing equipment.
13. Stealing confidential records.
External Opportunities
14. Automation tools and applications
available for improving service
delivery.
Context of Medical Services at Head Office
Perspective A*:Medical Division (Head Office)

Risk Assessment – Policy Framework
• High
– Any act, behavior, situation or condition that can lead to incapacitation
of the medical division to deliver services, or a situation in which there
is life risk or legal violation; extensive financial loss; fine, penalty;
Extreme delays; Misuse of resources. Inability to provide the
prescribed medicine on the same day. Aggregate Weekly Customer
Feedback on KPI’s less than 2.5 (on a scale of 1-5).
• Medium
– Time delays in provisioning of medical services and medicines not
leading to any life risk situation. Aggregate Weekly Customer Feedback
on KPI’s between 2.5 and 3.5 (on a scale of 1-5)
• Low
– Aggregate Weekly Customer Feedback on KPI’s less than 3.5 & 4.5 (on
a scale of 1-5).

Actions to Address Internal &
External Issues
SWOT
Ref.
Issue Risk Additional Control Mgmt Decision
Target Dt/Resp
W-1 1 Doctor per 2000
customers
High To induct/contract ##
Doctors.
W-2 1 Lady Doctor per 5000
female customers
High To induct/contract ## Lady
Doctors.
W-3 Average Wait Time 3hrs Med Introduce Que-matic
Monitoring System
W-4 Non- availability of the
required medicines.
High IT /ERP to Link purchase
requisitions with medicines
that were not available.
W-5 Weak system of
verifications of medical
expense
reimbursements.
Med Increase sample size for
internal audit verification
of claims vz amount of
claim.
Each additional control is only briefly mentioned here but actually a complete action Implementation plan
with all necessary details should be developed and presented for Management decision. Specific
responsibilities for ensuring implementation within a given target date must be ensured. This working
should be reviewed regularly.

SWOT
Ref
Issue Risk
Level
Additional
Control/Defense
W-6 No shuttle service for pensioners
visiting medical centre at head
office.
Low Introduce shuttle service
every hour from 3 entry
points-wait areas.
W-7 No system of knowing doctor’s
rating.
Med Establish specific KPIs to
identify ratings
W-8 No system of knowing employee
health profile/history.
High Linked with automation
project.
S-1 Contracts with hospitals of best
repute (Agha Khan, Liaquat
National, NMC, Jinnah, South
City).
High Priority – within 60 days.
Payments of Bills
presented by these
hospitals.S-2 Contracts with Laboratories of
best repute (Essa, Agha Khan,
Karachi Lab).
High
External Issues

SWOT
Ref
Issue Risk
Level
Additional
Control/Defense
Management
Decision
T-1 Terrorism attempt at
Medical Facilities.
High Introduce 3 levels of
security controls.
T-2 Stealing equipment. High Allow authorized
access to restricted
areas, increase CCTV
surveillance.
T-3 Stealing confidential
records.
High Disk Mirroring and
Regular Archiving.
Application access
limitations.
O-1 Automation tools and
applications available for
improving service delivery.
High Phase wise
implementation of
automation initiatives
External Issues

KPIs & Quality Objectives
• Keeping the identified context the following KPIs will help
in actively monitoring the system.
– Number of Doctors per Customer Ratio
– Number of Lady Doctors per Female Customers Ratio
– Average waiting time per category of doctor.
– % of new medicines that were not available in stock per week.
– % of routine medicines that were not available in stock per
week.
– Fitness Profile of Operational Employees
– Doctor’s Rating Profile
– Medical Emergency Response Time in minutes, for Operational
Personnel based on drills/actual emergency.
– Number of employees reported injuries at workplace.
– Patient Feedback Profile

KPI to Identify Doctor’s Rating
• Service Line Assignment Scoring Criteria
• Medical Record Collection Scoring Criteria
• Expert/Case Matching Scoring Criteria
• Clinical Integration Scoring Criteria
• Intake Scoring Criteria
• BDR Scoring Criteria
• Diagnostic Impact Scoring Criteria
• Therapeutic Impact Scoring Criteria
• Impact Rating Examples
• Clinical Summary Scoring Criteria
• BDRS Scoring Criteria
• Report Delivery/Documentation Scoring Criteria
• Case Analysis Scoring Criteria

Quality Objectives
1. To reduce wait time by at least 25% (from 3hrs to
1.5hrs) by 31st December 2019.
2. To reduce the invoice processing time (from 125 days
to 60days) for contacted hospitals. Prepare monthly
deviation report for management action.
3. To ensure feedback is received from at least 50%
employees visiting medical centers, on key aspects of
medical services and weekly report is prepared.
4. To ensure 100% operational personnel undergo
routine tests once every year as per company policy.

Remember
The system should be concurrent, make sense,
improvement oriented and serve to the interest
of the organization and its stakeholders.
It is an opportunity to make your positive contribution in
the progress of the organization therefore, undergo this
exercise with a positive and open mind and avoid doing it
for documentation just for the sake of documentation.
Certifications reflect the organizational capability. To get
the best out of the QMS framework is upto us.
[Seema Zaman]

Understanding the Context - ISO9001:2015

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