ISO Standards clause Name
Context of
Oraganization
9001-2015
Context of
9001-2015 Oraganization
Context of
9001-2015 Oraganization
9001:2015
9001-2015
Leadership
9001-2015
Leadership
9001-2015
Leadership
9001-2015
Planing
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
Support
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
Operation
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
9001-2015
Standard Requirement
4.1 Understanding the organization and its context
The organization shall determine external and internal issues that are relevant to its purpose and its strategic d
4.2 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
a) the interested parties that are relevant to the quality management system;
4.3 Determining
b) the the of
requirements scope of interested
these the qualityparties
management
that aresystem
relevant to the quality management system.
Theorganization
The organizationshall
shallmonitor
determineandthe boundaries
review and applicability
information about these of the quality
interested management
parties and theirsystem torequirem
relevant establi
a) the external and internal issues referred to in 4.1
b) the requirements of relevant interested parties.
c) the products and services of the organization.(4.3c - it is identified in a generic way to be noted as 'The produ
clause 4.4.1 "... The organization shall determine the processes needed for the quality management system an
5.2.2 Communicating the quality policy The quality policy shall:
a) be available and be maintained as documented information;
b) be communicated, understood and applied within the organization;
5.3 Organizational roles, responsibilities and authorities Top management shall ensure that the responsibilities a
a) ensuring that the quality management system conforms to the requirements of this International Standard;
b) ensuring that the processes are delivering their intended outputs;
c)
N/Areporting on the performance of the quality management system and on opportunities for improvement , in p
6.1 Actions to address risks and opportunities
6.1.1 When planning for the quality management system, the organization shall consider the issues referred to
a) give assurance that the quality management system can achieve its intended result(s); b) enhance desirable
c) prevent,
6.1.2 or reduce, undesired
The organization shall plan:effects;
d) achieve improvement.
a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality management system processes
N/A
; 2) evaluate the effectiveness of these actions. Actions taken to address risks and opportunities shall be propor
N/A
N/A
6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes needed for th
a) be consistent with the quality policy;
b) be measurable;
c)
6.3take into account
Planning of changesapplicable
When therequirements
organization determines the need for changes to the quality management sy
d) be relevant to conformity of products and services
a) the purpose of the changes and their potential and to enhancement of customer satisfaction;
consequences;
e) be monitored; f) be communicated;
b) the integrity of the quality management system;
g)
c) be
theupdated as appropriate.
availability of resources; The organization shall maintain documented information on the quality objectives
7.1 Resources
d) theGeneral
7.1.1 allocation
The ororganization
reallocation shall
of responsibilities
determine and and authorities
provide the resources needed for the establishment, implem
7.1.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure necessary for the operation of its proc
a) buildings and associated utilities
; b) equipment, including hardware and software;
c) transportation resources;
d) information
7.1.4 Environment and
forcommunication technology.
the operation of processes
The organization shall determine, provide and maintain the environment necessary for the operation of its proce
a) social (e.g. non-discriminatory, calm, non-confrontational);
b) Competence
7.2 psychologicalThe
(e.g. stress-reducing,
organization shall: burnout prevention, emotionally protective); c) physical (e.g. tempera
a) determine the necessary competence of person(s) doing work under its control that affects the performance
b) ensure that these persons are competent on the basis of appropriate education, training, or experience;
c) where
7.4 applicable, take
Communication actions to acquire
The organization the necessary
shall determine competence,
the internal and evaluate
and external the effectiveness
communications of to
relevant thethe
ac
d) retain appropriate documented
a) on what it will communicate; information as evidence of competence.
b) when to communicate;
c)
7.5with whom to communicate;
Documented information
d) how to communicate
7.5.1 General The organization’s quality management system shall include:
a) documented information required by this International Standard;
b) documented
8.1 information
Operational planning anddetermined
control Theby the organization
organization as being
shall plan, necessary
implement andfor the effectiveness
control the processesofneeded
the quat
services, and to implement the actions determined in Clause 6, by
a) determining the requirements for the products and services;
b) establishing criteria for:
N/A
8.2.1 Customer communication Communication with customers shall include:
a) providing information relating to products and services;
b) handling enquiries, contracts or orders, including changes;
c) obtaining
8.2.2 customer
Determining the feedback relating
requirements to products
for products andand services,
services Whenincluding customer
determining complaints; for the produ
the requirements
d) handling or controlling customer property;
shall ensure that: a) the requirements for the products and services are defined, including:
e)any
1) establishing specific
applicable requirements
statutory for contingency
and regulatory actions, when relevant.
requirements;
2) those
8.2.3 considered
Review necessary byfor
of the requirements theproducts
organization
and services
[Link] The organization shall ensure that it has the ability to meet the requirements for products and services t
a) requirements specified by the customer, including the requirements for delivery and postdelivery activities;
b)
8.4requirements not stated by theprocesses,products
Control ofexternallyprovided customer, but necessary for the specified or intended use, when known;
and services
c) requirements specified by the organization;
8.4.1 General The organization shall ensure that externally provided processes, products and services conform t
d)
b) statutory and services
products and regulatory
arerequirements applicable
provided directly to theto the products
customer(s) by and services
external providers on behalf of the organiza
c)
N/Aa process, or part of a process, is provided by an external provider as a result of a decision by the organizatio
8.4.2 Type and extent of control The organization shall ensure that externally provided processes, products and
a) ensure that externally provided processes remain within the control of its quality management system
;b) define both the controls that it intends to apply to an external provider and those it intends to apply to the re
;c)
8.5.1take into consideration:
Control of production and service provision The organization shall implement production and service provi
a) the availabilityimpact
1) the potential of the externally
of documented provided
information processes, products and services on the organization’s ability
that defines:
2) the effectiveness of the controls applied by the external
1) the characteristics of the products to be produced, the services provider;to be provided, or the activities to be perform
d)
2) determine the verification,
the dentificationand
results to be achieved or other activities, necessary to ensure that the externally provided process , prod
8.5.2I traceability
;b)
Thethe availabilityshall
organization and use
use suitable
of suitable monitoring
means andoutputs
to identify measuring
whenresources;
it is necessary to ensure the conformity of pr
c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for
d) the use of suitable infrastructure and environment for the operation of processes;
8.5.4
e) thePreservation
appointment of competent persons, including any required qualification
The organization
;f) the validation, shall preserverevalidation,
and periodic the outputs of
during production
the ability and service
to achieve plannedprovision,
results oftothe
theprocesse
extent necessary to
8.5.5 Post-delivery activities
The organization shall meet requirements for post-delivery activities associated with the products and services.
b) the potential undesired consequences associated with its products and services;
c) theControl
8.5.6 nature,ofuse and intended
changes lifetime of shall
:The organization its products and control
review and services;
changes for production or service provision,
d) customer requirements
8.6 Release of products and services The organization shall implement planned arrangements, at appropriate st
8.7 Control of nonconforming outputs
8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identified and co
a) correction
b)
9.1segregation, containment, return
Monitoring, measurement, or suspension
analysis of provision of products and services;
and evaluation
c) informing the customer;
9.1.1 General The organization shall determine:
d)what
a) obtaining
needsauthorization for acceptance
to be monitored under concession. Conformity to the requirements shall be verified wh
and measured;
8.7.2 The organization shall retain documented
b) the methods for monitoring, measurement, analysis information
and that:
evaluation needed to ensure valid results;
a)
c) describes
when the the nonconformity;
monitoring and measuring shall be performed;
9.1.2.
b) customer
describes the satisfaction
actions taken;
d)
The when the results
organization from
shall monitoring
monitor and measurement
customers’ perceptions shall
thebe analysed and evaluated. The
andorganization shall
c) describes any concessions obtained; d) identifies theofauthority
degree to which
deciding the their needs
action expectations
in respect have
of the nonconfor
9.1.3 Analysis and evaluation The organization shall analyse and evaluate appropriate data and information aris
a) conformity of products and services;
b) the degree of customer satisfaction;
c) the
9.2 performance
Internal audit and effectiveness of the quality management system;
d) if planning has been implemented
9.2.1 The organization shall effectively;
conduct internal e) at
audits the effectiveness
planned of to
intervals actions taken
provide to address
information onrisks and the
whether oppoq
a) conforms to:
1) the organization’s
Management review own requirements for its quality management system;
2) the requirements of this International
9.3.1 General Top management Standard;b)
shall review is effectively
the organization’s implemented
quality managementand system,
maintained.
at planned interva
9.2.2 The organization shall:
9.3.2 Management review inputs The management review shall be planned and carried out taking into consider
a)
a) plan, establish,
the status implement
of actions and maintain
from previous an audit reviews;
management programme(s) including the frequency, methods, responsib
b) define the audit criteria and scope for each audit
b) changes in external and internal issues that are relevant to the quality management system;
c)
c)select auditors
information on and
the conduct audits
performance andto effectiveness
ensure objectivity
of theand the impartiality
quality management of the auditincluding
system, process;d) ensure
trends in: tha
1)
2) the extent to which quality objectives have been met;
3) process performance and conformity of products and services;
4) nonconformities and corrective actions;
5) monitoring and measurement results;
6) audit results;
7) the performance of external providers;d) the adequacy of resources;e) the effectiveness of actions taken to a
9.3.3 Management review outputs The outputs of the management review shall include decisions and actions re
a) opportunities for improvement;
b) any need for changes to the quality management system
O45001:2018 , ISO14001:2015 )
Department Responsible
TOP Management
TOP Management
TOP Management
All Departments
All Departments
All Departments
RQHSE
All Departments
All Departments
RQHSE
Human Resources
IT department ,
Insurance Department , Accounts Receivable,
Accounts Payable , Personnel Department ,
Maintenance Department
Adminstration Department , Insurance
Department And Maintenance Department
Human Resources
Personnel Department
RQHSE
OPERATIONS
Customer service Department and Marketing
Department
commercial Adminstration department and
logistics Department
Logistics Department and Production
Department
contracts
RQHSE
All Departments
RQHSE
RQHSE
RQHSE
Procurement and supply chain Department
RQHSE
All Departments
Marketing Department
All Departments
RQHSE
RQHSE
015 )
What to check
1-Esnure That SWOT Analysis covers all points realted to Internal and External Issues
to Environmental , Health and Safety.
2- Ensure that the SWOT Analysis Form is updated with valid Revision Number and
Revision Date.
3- Ensure that the SWOT Analysis Form is communicated
4- IMS Manual Update to include all Standards
1-Esnure that list of Interested Parties include all parties related to HSE,
Environemntal
2- Ensure that the Interested Parties Form is updated with valid Revision Number and
Revision
1- EnsureDate.
that Scope is idenrified for all ISO standards related departments
2- Ensure that the scope is idenified in the Manual
Esnure that all Departments are running within written ( Procedure ) written and
reviewed and approved and communicated
1- Ensure that the IMS Policy is created .
2- Ensure that the IMS policy Includes points related to HSEand EnMS.
3- Ensure that the policy is communicated through company to All levels of the
company .
4- Ensure that the Policy is communicated to External parties as contractors and sub
contractors .
1- Ensure that job Descriptions are Updated , includes updated Revision Number and
updated Dates and signature from top management of each department .
2- Ensure that Job descriptions Include real life tasks and it should reflect each
employee Responsiblities .
1- Ensure that Risk Assessment Form is updated
2- Ensure that Risk Matrix is Updated and cover all Risks Likley hood and Severity
3- Ensure that all Risks are valid and action plans are planned out to decrease the
likley hood of happening
1-Ensure that All Risks have action plan and this action plan is measured and
monitored to mitigate the risk
2-Ensure that effectivness of action plans taken are being Evaluated in the time
frame discussed in the procedures
1-Ensure that top management establish Objectives for all departmens
2- Ensure that all objectives are measureable , have time frame , easily monitored ,
goes with company policy and communicated
3- Ensure achievement is measured every year
1- Ensure that all Departments carries out change in any thing related to IMS within
planned manner
Ensure that man power plan is being planned every year signed by top management
including time frame for Achievement
Ensure that all Equipments and Hardware and software are performing to Achieve
conformities of the management System
1- Ensure that Insurance covers all the assets related to the company
2- Ensure that insurance Certificates are valid
1- Ensure that training plan is planned for all Employees
2- Ensure that trainings planned for employees are based of their yearly performance
upraisal
3- Ensure that training plan will be planned within the time frame put
Ensure that all communication internally are comunicated to all Employees within
time frame Mentioned in the communication Procedures
1- Ensure that all documentation Required by the IMS are updated
2- Ensure that document review phase is being carried out before internal Audit
3- Ensure that all documents are controlled with list of Documents updated
1-Ensure that operations plan covers all the requirements of the standards .
2- Ensure That the Operation plans is desgined with last year performance
3- Ensure that operations plan goes in same direction of company objectives
Done
Ensure That All services and products provided are being controlled through supplier
evaluation with explained criteria
Ensure that all external provider and services follow our policy and standards and
legal requirements
Ensure All the Above
Ensure that Calibration of tools and Equipments are done within stated time frame
Ensure that All services offered are meeeting customer satisfaction
Ensure that all documents are being updated and controlled through the
organizations
Ensure that all complaints are being studied and analayzed with Root cause analysis
and given correction and corrective action
Ensure that in case of Nonconformity of product , root cuase analysis and correction
and corrective action are being conducted to know the cause of the problem and
elimintaing it
1- Ensure That all Departments have KPIs
2- Ensure that those KPIs are being monitored and measured
3- Ensure that these KPIs results are being analysed and data are collected from it for
next years targets .
1- Ensure Marketing Department is conducting customer satisfaction surveys
2- Ensure that customer satisfaction surveys results are being communicated to
process owners with +ve and _ve feedback
3- Ensure that actions are being planned for -Ve points for Improvement of service
gap
1- Ensure that Internal Audit is carried withing the planned Interval as mentioned in
the Audit Programme
2- Ensure that Audit Plan was sent to all process owner at least two weeks before the
Audit
1- Ensure that Management Review being carried out within the planned interval
2- Ensure that management review covers all the inputs and outputs required by the
standards
3- Ensure that management review results being commincated within the Top
managment
Current status
1- No swot Analysis
2- No needs and expectations of Interested parties Identified responsible
3- Interested parties are not identified
Scope needs to be identified in the IMS Manual with respect to ISO9001:2015, ISO45001:2018& ISO
14001:2015
Done with Gaps
Many procedure are either not approved or not finished or contain forms that don’t exist
IMS Policy Needs to be created with Respect to all the Standards
Job descriptions are not Impleneted Effectively as no communication with employees with their
Job description
1-Project on going to create Risk Register for all departments
2- No Opportunites are identified
3- Hazarard log is finished ( need tbe finished , need to check again
4- Environmental impacts needs to be more assessed
1- Need to have company objectives
2- Departmental Objectives need to be casscaded from Company objectives
3- departmental objectives need to be measurable
Done , we have procedure for change management
is not approved yet
HR Need to have annual Manpower plan , Identified and communicated with top management and
be measurable for its Achivement
GAP
1- Assets Identifcation
2- Insurance for Assets
3- IT Processes
1-Need to Have TNA ( Training needs appraisal ) for all employees working
2- Annual Training plan ( Include soft skills , tehcnical , language if needed )
3- need to Measure Achivement for Trainings done in time frame stated in procedure
Done
Done With Gaps
1- Need to have retention period stated for all documents stated by ( Both Quality Manager and
department Manager and make sure we don’t break any law or regulation .
Done
Not clear ( Need to have meeting with operation department to see their responsibilities and check
its reflection on the sop )
Done
Done
RATP Polices shall be communicated to external providers through our procurement department
Done with Gaps
Done with Gaps
Needs to approve the Procedure for callibration , Need to have the Callibration log filled with all
Tools and equipments used by Maintenance and HSE Departments
Done through Myster shopper and customer satisfaction survey
Done with Gaps , Many documents in the master document list are not approved while its
supposed to be used by departments
Done
done with gaps
No root cause analysis is being implemented in any findings correction and corrective action
gap
on going project is done for having departmental KPIs
done
Need to see Actions taken
Gap
Gap
clause
10
Action needed
1-Swot Analsyis
2-Interested Parties Identificaiton
3-needs and Expectation of Interested Parties
4-Departments Procedures
1-Top Mangement Commitment ( management Review ) and 2-Internal Audit
3-Organizational Charts for all company to be updated and communicated
4-Jop Descriptions to be updated and communicated
5-IMS policy Creation
1-Risk Register for all Departments
2-action plan to achieve risks
3-opportunity register for company
4-Quality Objectives for Company
5-Departmental Objectives for all departments
6-Hazard Identification
7-Impacts Identification
1-Asset Management
2-Insurance on our Assets
3-TNA ( Training need analsysi and Employee performance review )
4-Training plan
5-Annual Man power plan
1-Maintenance procedure ( include all data of preventive maintenance provided by supplier
2- Maintenance check lists
3- callibration for tools used and equipments
4- Tracability records for callibration
5- drill plan include ( safety and enviornmental objectives )
6- operation procedure
7- customer feed back and complaints logs action plan
1-Measurment and Analysis for KPIs
2-Audit programme
3-Audit Plan
4-Audit report
5-Mangement review
6-MR inputs
7-MR outputs
continual Improvement plan