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ISO90011400145001 IMSManual
ISO90011400145001 IMSManual
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Integrated Management System Manual Based on ISO 9001, 14001 & 45001
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Yousaf Ayub
The Hong Kong Polytechnic University
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ISO 9001, 14001 & 45001 Implementation in Packaging Industry View project
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Manual
Based on ISO 9001, 14001 & 45001
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Signature:
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Doc. # MGT/ISM-01
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Doc. # MGT/ISM-01
Contents
Responsibility Matrix ........................................................................................................................................... 6
1. Introduction & Scope................................................................................................................................... 8
1.1. Introduction ........................................................................................... Error! Bookmark not defined.
1.3. Clauses Exclude.................................................................................................................................... 8
2. Normative references.................................................................................................................................. 8
3. Terms and definitions .................................................................................................................................. 8
4. Context of the organization......................................................................................................................... 9
4.1. Understanding the organization and its context ................................................................................. 9
4.2. Understanding the needs and expectations of interested parties.................................................... 10
4.3. Determining the scope of the Integrated management system ....................................................... 10
4.4. Integrated management system and its processes ........................................................................... 10
5. Leadership ................................................................................................................................................. 10
5.1. Leadership and commitment ............................................................................................................ 10
5.2. Policy.................................................................................................................................................. 11
5.3. Organizational roles, responsibilities and authorities ....................................................................... 11
5.4. Consultation and participation of workers ........................................................................................ 11
6. Planning ..................................................................................................................................................... 12
6.1. Actions to address risks and opportunities ....................................................................................... 12
6.2. IMS objectives and planning to achieve them .................................................................................. 15
6.3. Planning of changes ........................................................................................................................... 16
7. Support ...................................................................................................................................................... 16
7.1. Resources .......................................................................................................................................... 16
7.1.1. General .......................................................................................................................................... 16
7.1.2. People ............................................................................................................................................ 16
7.1.3. Infrastructure................................................................................................................................. 16
7.1.4. Environment for the operation of processes ................................................................................ 17
7.1.5. Monitoring and measuring resources ........................................................................................... 17
7.1.6. Organizational knowledge ............................................................................................................. 17
7.2. Competence ...................................................................................................................................... 18
7.3. Awareness ......................................................................................................................................... 18
7.4. Communication ................................................................................................................................. 20
7.5. Documented information .................................................................................................................. 22
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Responsibility Matrix
Responsible Top Factory Accounts & Sales & Functional
Management Manager Finance Marketing Incharges
Area
(Production)
Understand the Approval of Identify Identify Identify Identify
needs of interest interest parties relevant relevant relevant relevant
party interest party interest party interest party interest parties
Internal and Address the Identify Identify
Identify Identify
external issues issues relevant issues relevant issues
relevant issues relevant issues
identification
Provide
IMS risk and Conduct risk Conduct risk Conduct risk Conduct risk
resources for
opportunity assessment in assessment in assessment in assessment in
risk elimination
identification its area its area its area its area
or reduction
Defining IMS Approval of all Annually define Annually define Annually define Annually define
objectives and its department’s his department his department his department his department
management objectives objectives and objectives and objectives and objectives and
program its program its program its program its program
Authorize for Suggest and Suggest and
Suggest and Suggest and
Changes in IMS changes analyze change analyze change
analyze change analyze change
Approval of
Defining IMS To follow &
policy To Follow it To Follow it To Follow it
policy align objectives
Provide
Training and resources and
Conduct TNA Conduct TNA Conduct TNA Conduct TNA
awareness approval of
Training plan
Approval of new Give input if it is Give input if it Give input if it Developed &
New product
design relevant to him is relevant to is relevant to QA of new
development
him him systems
Approval of Relevant Relevant Relevant Relevant
Document and level 1 document document document document
record control document preparation & preparation & preparation & preparation &
modification modification modification modification
Externally Give approval of Demand raise Demand raise Demand raise Demand raise
provided services purchasing and inspection and inspection and inspection and inspection
and product of items of items of items of items
Non- Provide
conformance, resources for
CPA raise CPA raise CPA raise CPA raise
Corrective & CPA
preventive action
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Scope Statement:
Following Clauses are not applicable to the company’s Integrated Management System:
Clause 8.5.3 is not applicable as the company does not hold any customer property (ISO 9001:2015)
2. Normative references
The following documents, in whole or in part, are normatively referenced in this document.
Organization Person or group of people that has its own functions with responsibilities,
authorities and relationships to achieve its objectives.
Context of the Combination of internal and external issues that can have an effect on an
Organization organization’s approach to developing and achieving its objectives.
Compliance Legal requirements and other requirements (admitted term) legal requirements
obligations that an organization has to comply with and other requirements that an
organization has to or chooses to comply with.
Customer Person or organization that could or does receive a product or a service that is
intended for or required by this person or organization
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Interested Party
A person or group concerned with or affected by the performance of ABC
Internal Audits
A systematic, independent, and documented process for obtaining audit
evidence and evaluating it objectively to determine the extent to which the
Integrated Management System audit criteria set by ABC are fulfilled
ISO Objective An overall quality goal, consistent with the IMS Policy that ABC has set itself to
achieve
Policy
The overall intentions and direction of ABC related to its ISO performance, as
formally expressed by top management. Our IMS Policy provides a framework for
action and for the setting of ISO objectives and targets
Quality
Conformance to the requirements of interested parties or absence of variation
Risk Assessment A protocol to estimate the magnitude of risk and decide whether or not the risk
is tolerable
4. Context of the organization
• ABC Management has determined the external and internal issues (arising from legal,
technological, competitive, market, cultural, social and economic environments, whether
international, national, regional or local) that are relevant to its purpose and its strategic
direction and that affect its ability to achieve the intended result(s) of its integrated management
system.
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• Management of ABC Packaging monitor and review information about these external and
internal issues. These Issues can include positive and negative factors or conditions for
consideration. Understanding the external and internal context related to values, culture,
knowledge and performance of the ABC are also taken to consider these issues.
• To evaluate the internal and external issues relevant to the context of the organization,
functional heads conduct SWOT Analysis relevant to their own department annually.
• Internal issues to be considered during SWOT analysis include technological concerns, employee
concerns, culture of organization, management concerns, etc. and external concerns which
needs to be considered include the concerns arising from competition, society and culture,
statutory and regulatory issues, supply chain, economic issues, etc.
5. Leadership
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• Customer and applicable statutory and regulatory requirements are determined, understood and
consistently met;
• The risks and opportunities that can affect conformity of services and the ability to enhance
customer satisfaction are determined and addressed;
• The focus on enhancing customer satisfaction is maintained as per Procedure for Customer
Related Process section 8.2.1
5.2. Policy
ABC has developed the Policy (MGT/POL-01) as per the requirements of ISO 9001, 14001 & 45001.
Policy Statement
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6. Planning
Select one area and consider Issues of interest parties to identify the risk related to all routine and non-
routine activities (Maintenance, repairs, generator etc.). Then, identify the issues related with each activity
considering but not limited to following:
a. Activities of all internal and external persons having access in ABC
b. Human behaviors and capabilities
c. Social & human Factors
d. Infrastructure, equipment and materials
e. Design of work areas/facilities
f. Potential Emergency Situations
g. Areas of concern in each area
Other than this environment aspects and impacts related to environment are identified which include
change, planned or new developments, and new or modified activities, products and
services; abnormal conditions and reasonably foreseeable emergency situations
Likelihood Description
Certain (10) Incident is expected to happen most frequently (e.g. may be daily basis or every time
certain activity is performed)
Very Likely (8) Incident is expected to happen frequently (e.g. maybe once a week or historic data
showed that it happened many times in past)
Likely (6) Incident is expected to happen sometimes if proper care is not taken (e.g. maybe once a
month or historic data showed that it happened few times)
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Unlikely (2) No possibility of having an incident in this case (e.g. No past history)
Severity Description
Trivial (2) OHS: Discomfort – first aid not required/ No action required
EMS: Routine disturbance of environment / No environmental Impact
IMS: Routine operational issues without affecting conformance or service
Minor (4) OHS: Minor cuts, bruises, burns, twists etc. – onsite first aid required or
EMS: Environmental contamination but easily reversible or
IMS: Minor operational issues causing minor schedule modification
Medium (6) OHS: Severe cuts, burns, twisted joints etc. – hospitalization required or
EMS: Contamination in a restrained area but effort required to reverse
IMS: Operational issues which cause minor delays or conformance issues
Serious (8) OHS: Fractures, joint dislocation, loss of conscious, 3rd degree burns or
EMS: Irreversible contamination but in a limited area or
IMS: Delays/conformance issues which result in public dissatisfaction.
Fatal (10) OHS: Permanent disability, death, injury among a group of people etc.
EMS: Irreversible contamination in an uncontrolled manner or
IMS: Severe customer complaints/Regulatory issues
Use the following chart to measure the acceptability of the risks.
Severity
Risk Matrix
Trivial (2) Minor (4) Medium (6) Serious (8) Fatal (10)
Unlikely (2) 4 8 12 16 20
Possible (4) 8 12 24 32 40
Likelihood
Likely (6) 12 24 36 48 60
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Substitution Replace the risky item/activity with one with less risk. Depends
Engineering Control Modifying the process or equipment to reduce the risk. 70%-90%
PPE (OHS) Safety goggles, ear plugs, gloves, masks etc. ≤20%
ABC management has documented information of its compliance obligations in the form of NEQs and
PEQs
Review the risk assessment at least once in a year on regular basis in addition to following situations:
Associated Records
• Quality Risk Assessment Sheet
• Environmental Risk Assessment Sheet
• Health & Safety Risk Assessment Sheet
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Note: Objectives and Targets are set in such a way that they must be S.M.A.R.T (Specific, Realistic,
Measurable, Achievable and Time Bound).
To achieve the set objectives and targets, management program is established which translates the goals
into concrete actions
To ensure its effectiveness the management program describes the following;
a. Stepwise actions to be taken
b. Resource requirement for each step/ target
c. Responsible person(s) for each step
d. Target date
e. Status
Progress of objectives and targets is reviewed on a regular basis in management review meetings and it
is reviewed by top management (Director/Manager) at least on quarterly basis
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All changes are carried out after discussion with management and minutes of meeting is recorded. Minor
changes are also brought through CPA after getting approval from Top Management but considering
above a, b &c points.
7. Support
7.1. Resources
7.1.1. General
ABC top management provides the resources needed for the establishment, implementation,
maintenance and continual improvement of the Integrated management system.
Associated Records:
a. Accounts record
7.1.2. People
ABC Management has determined and ensures that sufficient human resource is provided for the
effective implementation of its ISO and for the operation and control of its processes. Recruitment is
performed as per government policies and records are maintained accordingly.
Associated Records:
a. HR Personnel Files
b. Service Rules
7.1.3. Infrastructure
ABC Management maintains the infrastructure necessary for the operation of its processes and to
achieve conformity of services. ABC Manufacturing Plant at Sunder IE is the key contact area that
connects all interest parties of ABC. It is properly secured and maintained. For proper ventilation, ABC
has installed air curtain that helps in maintaining the temperature of production halls.
For IT technology, IT department is looking after it. Account is created in ABC domain for every new
employee hired.
Associated Records:
a. Service Rules
b. Accounts record
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To create a culture of team work & harmony and reduction in psychological pressure; management of
ABC organized trainings and other sport events.
Working methods are developed and maintained to perform the specific activities/ tasks safely and
effectively.
Associated Records:
a. Service Rules
b. Environment Monitoring Form
c. Housekeeping Form
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Admin should intimate each employee before his departure for external training, conference or
seminar that employee should submit the copy of reading material upon his/her return.
Knowledge Retention Admin will maintain a knowledge base for all types of knowledge items he/she
keeps. All types of knowledge when received or collected will be entered in ABC ERP portal
Knowledge Sharing and Access: Employees of ABC can collect his relevant knowledge though online
ABC portal and knowledge relevant to specific product can be taken through principle trainings. For
knowledge regarding ABC technical aspect (manuals, reports, project details etc.) is stored at relevant
section under supervision of its Manager.
Knowledge Usage: When addressing changing needs and trends, ABC Management consider its current
knowledge and determine how to acquire or access any necessary additional knowledge and required
updates.
7.2. Competence
Management staff, non-management staff is competent on the basis of appropriate education, training,
skills and experience. The section 7.3 for Competence, Training & Awareness defines these activities in
detail to provide the competent work force.
Competency criteria required for any job is mention in Job Description/Competency Policy and on the
basis of this criteria new hiring is done.
Associated Records
a. Personnel files
b. Job Description
7.3. Awareness
ABC Management run a training program to increase competency of its employees for this purpose
following procedure is followed:
7.3.1. Identification of IMS Training Needs
At the start of each year, Admin in consultation with the head of departments reviews the current IMS
performance levels and identifies the IMS training and awareness needs of the personnel. Following
factors are taken into account while identifying the training needs;
a. Changes in the IMS System, such as new or revised procedures, or changes in the IMS policy;
b. Changes in processes, or operations;
c. Changes in applicable laws, regulations, and other requirements;
d. New significant IMS issues, objectives, or targets;
e. New management programs;
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Manager provides orientation training to all new and existing employees. It presents basic concepts,
principles, and requirements of the Integrated Management System, discusses the IMS policy, the
company’s significant IMS issues, objectives, and targets. Participation in the general orientation training
is recorded. The records are maintained by Admin department.
General Awareness on IMS is also communicated through banners/postings, IMS awareness
programs/events, etc.
7.3.2.2. Training on IMS (ISO 9001, 14001 & 45001)
Training sessions of management and section in charges are carried out on the understanding and
implementation of IMS Requirements (Policy, objectives, CPAs, MRM etc.). The records of training are
maintained by Admin department.
7.3.2.3. Training on Emergency Preparedness and Response
Personnel assigned with specific responsibilities in implementing emergency response procedures are
trained in how to carry out the tasks and activities assigned to them. This training may include operating
emergency equipment (Fire Extinguisher) coordinating evacuation, notifying external emergency services,
and so forth. Section Incharges ensure that all personnel designated for specific emergency response
activities are adequately trained.
7.3.2.4. Competence and Skill Training
Departmental Heads and Admin are responsible for ensuring that personnel whose work can have effect
on the quality of service are sufficiently competent and skilled in performing their work.
Personnel who have proven experience in operating relevant processes and equipment are also required
to undergo any refresher training program to update their skill level. Competence acquired through
experience may be identified and recorded in the form of experience certificates or bio-data, which are
maintained by HR department.
7.3.2.5. External Training
The company also directs employees to participate in approved seminars, conferences, and other forms
of external training. Departmental Heads recommend employees for external IMS training, which is
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7.4. Communication
Organization has determined the internal and external communications relevant to the integrated
management system,
Section Incharges are responsible for communicating IMS Procedures and related policy (and any
changes to the procedures), with staff working under them. Factory Manager will facilitate all
Incharges accordingly being custodian of IMS Master folder
7.4.2. External Communication
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Inquiries and other communication (received by mail, fax, telephone, social media or in person) from
external parties concerning company’s quality, health, safety or environment performance may be
received by a number of company’s representatives. All such communication and replies before reply
shall be copied to Section Incharges and Director.
On an as-needed basis the company may solicit the views of the interested parties on its Integrated
Management System, and other related matters.
As a part of the management review process the team member nominated to conduct the review shall
evaluate the effectiveness and the efforts made in the formal/ informal meetings.
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“DEPT/AAA-NN”
Where,
DEPT Department
AAA Represents the code for type of document (such as Policy, Procedure, Manual etc.)
NN Represents the serial number of documents starting from 01, 02 and so on. The serial number
is reinitialized if the document type changes.
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“DEPT/FRM-PP. NN”
DEPT Department
FRM Represents the form
PP. NN PP Represents the serial number of relevant procedure/Manual Section and NN form starting
from 01, 02 and so on. The serial number is reinitialized if the document type changes
Codes:
Following codes are used for different types of documents.
External Documents are identified by their code if provided by the originator. In case the document does
not bear any code; it is then identified by nomenclature. Following documents used in the company are
of external origin and maintained in logged in Master List of files/folders
• Legislation and Regulations
• Product Standards/Specifications
• Material Safety Data Sheets
• Equipment Manuals
• Any Document Provided by Customer or Supplier
7.5.3. Document Format
• All documents are generated with following standard header and footer in the order of
occurrence.
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Name:
Prepared by: Designation:
Signature:
Name:
Reviewed by: Designation:
Signature:
Name:
Approved by: Designation:
Signature:
CONTROLLED
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Copy No.
• A document bearing no stamp will be considered “UNCONTROLLED”. Distribution and use
of uncontrolled documents shall be considered nonconformity.
• For distribution of documents in electronic/soft form FM upload relevant document at “ISO
folder” on Company Internal Server. Company employees has access at this folder. All
folders share at server in non-editable form (PDF or any other) with “CONTROLLED” mention
at the footer of document. As new document is uploaded on Server FM inform to ABC
employees through email.
7.5.6. Document Change Process
• Any person can initiate a request to introduce new revision of the existing document /
format by raising Document Change Request (DCR) Form. The DCR after being raised by the
initiator is submitted to;
a. Director through Factory Manager for IMS documents / formats
b. Concerned Incharge in case of departmental documents / formats
• Director / concerned Incharge will accept or reject the request after proper analysis in
consultation with related authorities.
• If Director / concerned Incharge after review, accepts the document change request then
documents will be reviewed and approved by defined authorities.
• Hand written amendments are not allowed.
• The details of the changes are entered into the “Amendment History Record” table.
• All changes made will be highlighted as; “UNDERLINED” for addition and “STRIKETHROUGH”
for deletion in the column headed “Amendment Text” of “Amendment History Record”
table.
• After final approval has been made, the original Master Document and its controlled copies
will be recalled. The original Master Document is stamped OBSOLETE in “Red Color” and
placed in the obsolete documents file till the arrival of next revision. All the retrieved back
copies are shredded as per instructions provided in section 4.7
OBSOLETE
• The updated documents will be distributed again according to the defined methodology in
this procedure.
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<Department Name>
<Name of Department>
<File Name>
<File Name> Code < Code >
NOTE: All registers and note books have page number to ensure traceability. Page numbering can
either be done manually or by pasting stickers with numbers imprinted or through printing (in
case company has the option to print registers via printer).
7.5.9. Associated Records
• Master List of Documents
• Master List of files and folders
• Document Change Request Form
8. Operation
8.1. Operational planning and control
ABC Management has planned, implemented and controls the processes needed to meet the requirements
for the provision of services, and to implement the actions as per Standards (Quality Plans) and routine
Procedures through Meetings.
8.1.1. Housekeeping
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Admin is responsible through janitorial staff for housekeeping of halls, corridors and offices. Daily basis
cleaning activities are recorded on housekeeping and lavatory inspection sheets that are pasted at the
gate of relevant area.
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a. Fixed Assets
Assets that cannot move outside from its specified area like AC, Extruders, Generator etc.
b. Mobile Assets
Assets that are allotted to the ABC staff for its use like Laptops, USB, office vehicle etc.
All assets that are purchased in ABC; Manager Accounts is responsible for its coding. Coding
Scheme is done as per following format and sticker is attached on it:
Asset Type/ NN
Asset Type Abbreviation
Chair CHR
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Asset. Code
Name:
Due:
By:
Asset Code: Asset Code defined based on Type/NN like for printer PRT/01
Date: Name of Equipment/ Asset
Due: Date of Next Calibration/Maintenance
By: Calibrated on/Maintenance done on
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8.1.22. Trainings
Trainings of the employees are conducted on planed basis related to each type of emergency situation.
Trainings provided include but not limited to the following;
a. Firefighting training will be given to all factory personnel as a part of the regular training
program. Firefighting training and qualification will be given to all operating and maintenance
staff. Selected personnel will be required to attend advanced firefighting courses.
b. First Aid training is provided to the members of Emergency Response Team related to the
medical emergencies and personal injuries like electric shock, cuts, unconsciousness etc.
c. Spill control training is also provided to the personnel where there is a chance of oil, chemical
or dye spill.
d. Waste Management training is also provided to the personnel to provide them awareness on
how to handle each type of waste.
• Fire
• Medical Emergency
• Personal Injury
• Chemical Spill
• Oil & Gas Spill
• Air Emissions
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• Earthquake
• The person who sees the fire is required to shout “fire, fire, fire” loudly or sound the alarm.
• Fire alarm is raised by the person working near to alarm so that alarm is raised in minimum
possible time.
• Put off main switch of the premises
• Inform the Emergency Team and Security Office
• Use the fire extinguisher and fire buckets to put off the fire if it is in a smaller area
• If the fire is out of control then immediately call Rescue Service
• Move to assembly point
• Shift the injured / burned persons to safe place
• Provide first aid to injured / burned person(s)
• Reassure and monitor. Remain with the person until medical services arrive
• Ask another staff member in the immediate area to contact the relevant emergency personnel.
This could be the Emergency Services (Rescue 1122 etc) if an ambulance is necessary, Security
or Medical Officer
If you are not a trained First Aid Officer;
d. Personal Injury
In the event of personal injury,
• If you are hurt and require first aid seek help from the Emergency Response Team Member of
your area
• If you require medical attention, do so straight away by contacting the Dispensary/Medical
Room
• Notify your immediate supervisor or manager as soon as possible
• If you have had a work related injury/accident/incident/near-miss you are required to report
the incident
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• The Factory Manager will contact the supervisor and have them investigate the
accident/incident
e. Chemical Spill
In case of spilling of acidic chemicals, immediately wash the affected area with a dilute solution of
Soda Ash or any other basic solution to neutralize the effects of acidic chemical otherwise wash the
area with diluted oxalic acid in case of basic chemical. The affected area is thoroughly flushed with
tap water.
In case of eye contact, wash the affected eye immediately with clean lukewarm for at least 20
minutes and hold the affected eye(s) open. Wash your hands with soap and water afterwards. Seek
medical attention if there are any burns caused by chemical.
In case of swallowing, rinse the mouth with cold water. If the victim is conscious, have them drink
lots of water to dilute the acid followed by a glass of milk or milk of magnesia in case of acid. Induce
vomiting any other common chemical is swallowed. Call 1122 for immediate medical assistance.
g. Air Emissions
In case of any excessive emissions which are hazardous to health, safety or environment, the related
process is immediately shutdown to avoid the impacts of emissions. The emergency response team
of the area reviews the situation and decides whether to continue the process or not. If the situation
is severe the process is kept halted and immediately reported to Factory Manager, who takes further
appropriate actions to resolve the issue.
h. Earthquake
If inside the building, get under a desk or table or stand in a doorway or corner. Stay clear of
windows, file cabinets, mirrors, and fireplaces. If possible, extinguish open flames/ignition sources.
If outside the building, stay in an open area away from trees, buildings, walls, and power lines. If
driving, pull over and stop. Avoid overpasses and power lines. Stay inside the vehicle until shaking
stops. If the earthquake was severe, do not attempt to cross damaged walls or buildings.
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• After thorough analysis of complaint corrective action(s) is/are taken on complaint. If the action
taken is effective, efficient and satisfactorily completed or if further follow-up action is needed. If
follow-up action is needed, a follow-up date is determined and documented.
• Customer is then reported to mitigate his dissatisfaction. Customer complaints data and customer
complaint log is maintained by marketing department.
• Customer complaints data is statistically compiled and analyzed quarterly basis by the P&D
department. This analysis is submitted to Director for review. Based on this analysis, Director initiates
corrective actions or recommend preventive actions for improvement using the CPAR.
8.2.7. Customer Surveys / Feedback
• Customer feedback other than complaints may be considered “continuous improvement”
suggestions. Customer feedback may include but is not limited to:
a. Suggestions for process changes that will improve efficiency or quality
b. Ideas for new products
c. Comments on recognition of high-quality work products or services
• Activities associated with Customer Feedback should be documented on the Customer Feedback
form; Director monitors the progress of the customer feedback.
• Customer Feedback Survey is conducted on bi-annual basis to monitor the customer satisfaction and
identify customer needs and expectations. It is done by using the following methods:
a. Designing surveys forms/questionnaires and circulating these forms to customers
b. Collecting feedback through phone calls and personal visits
c. Collecting feedback through participating in different events and exhibitions
Feedback from customers is statistically compiled and reported quarterly basis by the P&D
department. These survey results are presented as input in the management review and analyzed by
top management. Based on these analyses, corrective actions or preventive actions are initiated for
improvement in quality of products
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ABC has retained all documented information on design and development inputs
ABC Management has applied controls to the design and development process to ensure that:
a. the results to be achieved are defined; (Recipes)
b. reviews are conducted to evaluate the ability of the results of design and development to
meet requirements; (Director Meetings)
c. verification activities are conducted to ensure that the design and development outputs
meet the input requirements; (Test report on new batch)
d. validation activities are conducted to ensure that the resulting products and services meet
the requirements for the specified application or intended use; (QC Reports)
e. any necessary actions are taken on problems determined during the reviews, or verification
and validation activities; (Wastage record)
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ABC Packaging Industries (Pvt) Ltd evaluates its existing Suppliers minimum once in a year. Managers are
responsible for evaluation of the suppliers as per the defined criteria in Supplier Evaluation Form. The
minimum passing criteria is 6.
For the selection of a new Supplier, Supplier’s reputation/goodwill is accounted as well. Only Director has
the authority for the approval of a new Supplier.
Functional Incharge(s) raises demand, in form of a demand Note and forwards it to store. If the item is
available in store then it is issued to Functional Incharge. In case of unavailability of item, Store Keeper
informs Functional Manager of the unavailability of item.
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In-case of a new Supplier, quotations are requested from the potential suppliers and these suppliers are
evaluated as per the procedure in described in section 4.1.
8.4.4. Storage
Items received after successful inspection are sent to Store. Store Keeper updates his inventory list and
issues them accordingly.
This is achieved through effective development, implementation and monitoring the planned activities.
ABC has developed a comprehensive system for the monitoring of control measures throughout the
processing and in the events of nonconformities.
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All such documents that has information related to changes are maintained. Approval of all such changes,
are authorized by Director.
9. Performance evaluation
9.1. Monitoring, measurement, analysis and evaluation
9.1.1. General
ABC uses the management system to improve its processes, products and services. Such
improvements aim to address the needs and expectations of customers as well as other interested
parties, to the extent possible.
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After the completion of audit, auditors compile all these findings and prepare Audit Report. It includes
the summary of the audit and audit non-conformities and observations observed. Audit report
normally contains the following information;
a. Report title, number and the relevant information
b. Particulars and compositions of the audit team
c. Background information, such as the auditor’s objective, scope, dates and
procedures used
d. Brief description of the activities and departments audited
e. Summary of findings and observations
9.2.5. Corrective Action and Follow up
Factory Manager initiates the Corrective / Preventive Action Requests (CPARs) on the non-
conformities observed in the audit and gives it to the concerned departmental / section heads.
The concerned departmental / section head investigates the cause of the problem, proposes a
corrective action to be taken and indicates the date by which the corrective action will be fully
implemented.
9.2.6. Input to Management Review Meetings
Results of internal audit are submitted in Management Review Meeting by Factory Manager as input.
9.2.7. Associated Records
a. Annual Audit Program
b. Internal Audit Plan
c. Audit Checklist
d. Internal Audit Report
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9.3.2. Attendance
The Management Review Meeting is chaired by the Director or his deputed representative (in case of
absence) and attended by the following members;
a. Director (Chairs the MRM)
b. Factory Manager (FM)
c. All HODs
d. Other members of Emergency Response Team -ERT (Optional)
10.Improvement
10.1. Nonconformity and corrective action
ABC has established a Procedure to identify non-conformance and corrective action that specify
appropriate actions to identify and eliminate the cause of detected nonconformities, to prevent
recurrence, and to bring the process or system back into control after nonconformity is encountered.
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Any nonconformance occurs in the system must be identified, controlled and appropriate actions
should be taken to eliminate the impact of nonconformance. Any nonconformance identified in the
system must be reported on CPA form and processed as defined in this procedure.
End of Manual
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