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Shifa International Hospitals Ltd.

SHIFA QUALITY MANUALDoc #:SIHQM01 Rev:02 Effective date: July 08, 2009 Issue: 01 Page: 1 of 36


SHIFA QUALITY MANUALDoc#:SIHQM01 Rev:02 Effective Date: July 08, 2009 Issue: 01 Page: 2 of 36

Amendment SheetSr. # Nature of change Date Page # Line# New Rev #

01 Addition & Improvement Required in Amendment Sheets

16407 03 01

02 Area of hospital increased & Hospital Telephone # has changed

16407 08 032425

01

03 Quality Policy should be in a separate page with Approval

16407 14 01

04 Quality Objectives should be in a separate page with Approval

16407 16 01

05 Required change in Allied Services Departments & Addition of separate designation Manager Maintenance

16407 19 151627

01

06 Addition of separate designation of Manager Security & transport & required change the frequency of MRM.

16407 20 0931 01

07 Change in Management Structure & responsibilities

8808 01

08 Upgradation of Standard ISO 9001:2008 10709 ALL ALL 02

09 Reference documents need to be identified 7110

102022252628293135

789282128

28293116

1021

03



Table of ContentsSection Contents Page No.

1

1.1 General 7

1.2 Application 7

2 Reference Documents 7

3 Term and Definitions 8

4 Quality Management System 8

4.1 General Requirements 8

4.2 Documentation Requirements 9

4.2.1 General 9

4.2.2 Quality Manual 9

4.2.3 Control of Documents 9

4.2.4 Control of Records 10

5 Management Responsibility 10

5.1 Management Commitment 10

5.2 Customer Focus 11

5.3 Quality Policy 1112

5.4 Planning 13

5.4.1 Quality Objectives 1314

5.4.2 Quality Management System Planning 15

5.5 Responsibility, Authority & Communication 15

5.5.1 Responsibility and Authority 1516

5.5.2 Management Representative 17

5.5.3 Internal Communication 17

5.6 Management Review 17

5.6.1 General 17

5.6.2 Review Input 18

5.6.3 Review Output 18

6 Resource management 19

6.1 Provision of Resources 19

6.2 Human Resources 19

6.2.1 General 19

6.2.2 Competence, Awareness and Training 19

6.3 Infrastructure 20



6.4 Work Environment 20

7 Product (Service) Realization 20

7.1 Planning of Product (Service) Realization 20

7.2 Customer related process 21

7.2.1 Documentation of Requirement Related to Product Service 21

7.2.2 Review of Requirements Related to Product (Service) 21

7.2.3 Customer Communication 21

7.3 Design and Development 21

7.4 Purchasing 22

7.4.1 Purchasing Process 22

7.4.2 Purchasing Information 22

7.4.3 Verification of Purchased Product 22

7.5 Production and Service Provision 23

7.5.1 Control of Production and Service Provision 2325

7.5.2 Validation of processes for Production and Service Provision 2526

7.5.3 Identification and Tractability 27

7.5.4 Customer Property 27

7.5.5 Preservation of Product 2728

7.6 Control of Monitoring and Measuring Devices 29

8 Measurement, Analysis and Improvement 30

8.1 General 30

8.2 Monitoring and Measurement 30

8.2.1 Customer Satisfaction 3031

8.2.2 Internal Audit 31

8.2.3 Monitoring and Measurement of Process 31

8.2.4 Monitoring and Measurement of Product (service) 31

8.3 Control of Non Conformity Product 32

8.4 Analysis Data 32

8.5 Improvement 33

8.5.1 Continual Improvement 33

8.5.2 Corrective Action 33

8.5.3 Preventive Action 34

Appendix “A” Index of Quality System Procedures. Clauses 35

Appendix “B” Term & Definitions 36



Shifa International Hospitals Ltd. Background

Shifa International Hospital was incorporated as a Private Limited Company in 1987, and converted into a public Limited Company in October 1989. The Hospital has a covered area of 500,000 plus square feet, and is headed by a CEO who reports to the Board of Director of the Hospital. COO, Medical Director, Chief Financial Officer assist the CEO.

The Hospital carries experienced group of consultants, paramedical staff and highly trained skills staff/employees providing the following services: Internal Medicine Body Composition Analysis, Paracentesis Diagnostic and

Therapeutic

Cardiology Cardiac Surgery, Cardiac Angiography, Angioplasty, Holter Monitoring, Exercise Tolerance Test , Echocardiography, Carotid Ultrasounds and Doppler , Arterial and Venous Dopplers, Pericardiocentesis Under Echo

ENT ENT Procedures, Tympanometry, Audiological Screening

Nephrology Dialysis , C.V.P(Central Venous Pressure Catheter) and Dialysis Cath insertion

Neurology Neurosurgery, NeurophysiologyEEG(Electro Encephalo Gram), EMG( Electro Mylo Gram), NCS(Nerve Conduction Study), SSEP(Somato Sensory Evoke Potential), BSEP(Brain Stem Evoke Potential) , FVEP(Fresh Visual Evoke Potential), PSEVP(Pattern Shift Visual Evoke Potential)

Oncology Medical Oncology, Radiation Oncology, Chemo Therapy,

Pediatrics Neonatology, Pediatric Infectious Diseases, Pediatric Psychiatry, Pediatric Surgery, Pediatric Nephrology, Pediatric Gastroenterology, Pediatric Endoscopy

Urology Kidney Transplant, Lithotripsy, General Urology

Orthopedic Limb Lengthening Surgery, Arthroscopic Surgery, Joint Replacement Surgery, General Orthopedic Surgery

Ophthalmology Children Eye Care, Cornea Transplant, Intraocular Lens Implant, Diabetic Eye Care, General Ophthalmology

Radiology Sonology, Ultrasound, C.T. Scan, X Ray Imaging, MRI, Fluoroscopy, Ultrasound Guided Biopsy, Bone Scan , Thallium Scan,

Rehabilitation Speech Therapy, Physiotherapy, Occupational Therapy



Gastroenterology Proctoscopy Colonoscopy, Sigmoidoscopy, PEG Tube, Endoscopy, ERCP(Endoscopic Retrograte Cholingio Pancretography), Digestive and Liver Disease

Pulmonology Thoracentesis Diagnostic and Therapeutic, Pulmonary Function Test, Bronchoscopy, Pulmonology & Critical Care

Endocrinology Diabetes Clinic, Other

Psychiatry Psychotherapy, Drug Addiction Treatment, Depression,Psychosis

General Surgery Breast Surgery, Laparoscopic Surgery, Bariatric Surgery, Appendectomies , Laprotomies, General Surgery

Obstetrics & Gynecology

Normal Deliveries, CSection, Antenatal care, Postnatal Care, Gynecology

The hospital also provide the following diagnostic and treatment services, i.e. Code Blue Protocol, 24 hours Emergency Services, Operating Rooms, 24 Hours Ambulance, Nutrition Clinic , Critical Care, Plastic Surgery, Dermatology, L and D, Pharmacy, Anesthesiology, Infectious Diseases, Nuclear Medicine, Clinical Laboratories & Blood Band.

Shifa International Hospital Sector: H 8/4, Islamabad PakistanPhone: 4603666Fax: 4863182



1. Scope

1.1 General

Shifa International Hospital Ltd. has based the Quality Management System (QMS) described in this manual to demonstrate our capability to consistently provide products/services that meet customer and applicable regulatory requirements, and to operate with increased effectiveness and efficiency with the overall aim of enhancing customer satisfaction.

Our QMS utilizes the process approach and quality management principles contained in the international standards: ISO 9000:2005, ISO 9001:2008 and ISO 9004:2000 to enhance our ability to continually improve.

1.2 Application

Shifa International Hospital is a serviceoriented organization,(neither concerned to an industry nor a designer or developer). Moreover, the services are not specified requirement of Clause # 7.3(Design & Development) in the SIH process, therefore Clause # 7.3 is not applicable or excluded.

2. Reference Documents.

The following external documents contain provisions which, through reference in this manual, constitute provisions of our QMS:

ISO 9000:2005, Quality management systems – Fundamentals and vocabulary ISO 9001:2008, Quality management systems – RequirementsISO 9004:2000, Quality management systems – Guidelines for performance improvements

Appendix A contains a List of Key QMS documents referenced in this manual and defines the key top level processes for implementing our quality policy. Note: documents are referenced throughout this manual only by document number; see Appendix A for complete titles.



3. Terms and Definitions.

Our QMS uses the same internationally recognized terms, vocabulary and definitions given in ISO 9000:2005. Acronyms, terms, vocabulary and definitions unique to our organization, customers, industry and region and referenced throughout our QMS are contained in Appendix B.

4. Quality Management System

4.1 General requirements

Our QMS is that part of our overall management system which establishes, documents and implements our quality system as a means of ensuring that the hospital provides service conforming to the specified needs and requirements of its patients, and related processes for providing products and services which meet or exceed customer requirements, and satisfies QMS requirements of ISO 9001:2008.

The quality is defined in SIH quality manual, SIH quality procedures and SIH SOPs. The SIH quality manual describes the policy of SIH regarding all applicable aspects to ISO9001:2008 standards, refers to the corresponding quality procedures, and also outlines the structure of the documentation used in the quality system.

We have adopted the process approach advocated by ISO 9000:2005, by defining and managing:

• process inputs, controls, and outputs to ensure desired results are achieved, and

• interfaces between interrelated processes to ensure system effectiveness is achieved.

Appendix A contains a List of Key QMS Documents.

We recognize the significant role that Contractor/Subcontractors play in achieving desired results and also recognize that we must ensure proper control over outsourced QMS processes defined in SIHQSP7.4, and fulfill the statutory and regulatory requirements(where applicable).



4.2 Documentation requirements

4.2.1 General

This manual contains documented statements of our quality policy and quality objectives and references documented procedures required by ISO 9001:2008 and other documents needed to ensure effective planning, operation and control of our key QMS processes.

The level and type of QMS documentation established for our business is continually reviewed to ensure it remains appropriate for the complexity and interaction of our processes and the competence of our employees. QMS documents and data may be in hard copy or electronic media. QMS documentation includes this Quality Manual, Quality System Procedures(QSP), Standard Operating Procedures(SOPs), and other internal and external documents and data needed to manage, perform or verify work affecting product quality. We also issue and control work instructions, job descriptions, and other internal and external documents and data as appropriate and needed to effectively manage our QMS (Section 4.2.3).

4.2.2 Quality manual

This manual is that part of our QMS that defines the scope of our QMS and documents the policy, procedures and processes needed to implement our quality policy and achieve our quality objectives. This manual also documents justifications for exclusions from ISO 9001:2008 requirements (Section 1.2) and defines the overall sequence of and interaction between our key QMS processes.

4.2.3 Control of documents

The Quality Assurance Analyst has overall responsibility for ensuring that all QMS documents, including forms used to create quality records, are controlled per procedures detailed in SIHQSP 4.2.3 and summarized below:

a) approve documents for adequacy prior to issue.b) review, update as necessary and reapprove documents.c) identify the current revision status of documents.d) ensure that relevant versions of applicable documents are available at points of

use.e) ensure that documents remain legible, readily identifiable and retrievable.f) ensure that documents of external origin (including customer engineering

standards/specifications) are identified and their distribution controlled.g) prevent the unintended use of obsolete documents, and to apply suitable

identification to them if they are retained for any purpose.


SHIFA QUALITY MANUALDoc#:SIHQM01 Rev:03 Effective Date: January 07, 2010 Issue: 01 Page: 10 of 36

4.2.4 Control of records

The Quality Assurance Analyst has overall responsibility for ensuring that all records required for the QMS (including customerspecified records) are controlled and maintained to provide evidence of conformance to requirements and effective operation of the QMS. Records are retained for a period defined by the customer, applicable regulatory requirements and/or SIH management, as applicable, and then disposed of in accordance with applicable requirements. Records may be in the form of hard copy or electronic media.(SIHQSP 4.2.4)

5. Management Responsibility

5.1 Management commitment

Top Management provides evidence of its commitment to the development, implementation and improvement of our QMS in very tangible ways:

Our quality policy statement (Section 5.3) documents and communicates the importance of meeting or exceeding all applicable requirements (including customer, regulatory and legal requirements) through continual improvement of our processes, products, and services.

We ensure that our quality policy is understood, implemented, and maintained at all levels of the organization through widespread printed distribution of our quality policy statement, and through periodic management review of the quality policy statement and corporate level improvement objectives (Section 5.6). In addition, our quality policy and objectives are communicated and deployed throughout the organization through individual performance objectives established and reviewed during employee performance reviews (Section 6.2.2).

All HODs demonstrate their commitment to the development and improvement of the QMS through the provision of necessary resources (Section 6.1), through their involvement in the internal audit process (Section 8.2.2), and through their proactive involvement in our continual improvement activities (Section 8.5.1) – where emphasis is placed on improving both effectiveness and efficiency of our key QMS processes.



5.2 Customer focus

Top management ensures that a proper Customer/Patient focus is established and maintained through the following activities:

Customer/Patient complaints and other customer input/feedback are continually monitored and measured to identify opportunities for improvement (Section 8.2.1).

We continually look for other ways to interact directly with individual customers /Patients to ensure a proper focus to their unique needs/expectations is established and maintained.

In addition, we have established an interactive website: www.shifa.com.pk to provide customers with quick access to information and points of contact within our organization (Section 7.2.3).

5.3 Quality policy

Our quality policy statement indicates our commitment and focuses on what is important to us as an organization: achieving customer/patient satisfaction; and it prescribes the method by which we accomplish this: by continually improving processes, products, and services to ensure they consistently meet or exceed requirements. Moreover, our quality policy statement acts as a compass in providing the direction and a framework for establishing key corporate level performance measures and related improvement objectives (Section 5.4.1).

We ensure that our quality policy is communicated and understood at all levels of the organization through documented training, regular communication, and reinforcement during annual employee performance reviews (Section 6.2.2.).

Our quality policy statement is controlled by inclusion in this manual, and along with all policies contained in this manual, is reviewed for continuing suitability during management review meetings (Section 5.6.2).



5.4 Planning

SIH established and maintains documented procedures for review of patient needs and expectations and ensuring that it has the capability to meet them. The SIH's management ensures that:

• It is understood and where appropriately defined and documented before reaching to the agreement/ understanding before provide them a specific service.

• Shifa International Hospital has the professional holding capabilities and the instrumental resources to meet any requirements related to the service proposed to the patient.

• Any other concerns of the patient, like legal operational activity and the requirements/ obligations/ risk involved in proposed services are addressed, explained and clarified prior to the specific service.

5.4.0.1. Changes in Treatment or Service

SIH keeps its patients (or their relatives) informed of any major changes that may be required in their treatment, as a result of subsequent tests and assessment. The concerned functions inside SIH are simultaneously kept abreast, so as to provide a well coordinated and efficient service.

5.4.1 Quality objective

Our overall quality goal is to achieve our quality policy, and maintain the integrity of and continually improve a QMS compliant with ISO 9001:2008. Further, we establish both corporate level and operational level improvement objectives that are measurable and achievable within a defined time period. Corporate level improvement objectives are documented, and reviewed for achievement during management reviews (Section 5.6.2). All HODs of key QMS processes monitor and measure performance of processes within their area(s) of responsibility and, where appropriate, establish measurable operational level improvement objectives consistent with our quality policy and corporate level improvement objectives. Operational level improvement objectives are documented, and deployed to individuals or individual work areas and monitored for achievement through employee performance reviews (Section 6.2.2).



5.4.2 Quality management system planning

The QMS planning process involves the establishment and communication of our quality policy (Section 5.3) and objectives (Section 5.4.1) through issuance of this manual and its associated procedures, and through the provision of resources needed for its effective implementation (Section 6.1). Accordingly, this manual constitutes our overall plan for establishing, maintaining and improving an effective QMS. Our management review process (Section 5.6) and internal audit process (Section 8.2.2) ensure the integrity of our QMS is maintained when significant changes are planned and implemented that affect our key QMS processes.

The Quality Assurance Analyst also develops appropriate quality planning documents for specific products/services, projects or contracts whenever customer requirements exceed the capability or intent of the product/service realization and support processes described in our QMS (Section 7.1).

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

The Chief Executive Officer (CEO) sets direction and ensures the success of our business through the clear definition and communication of QMS responsibilities and authorities. Other members of Top Management include: The Medical Director, the Chief Operating Officer (COO), the Chief Financial Officer (CFO), Administrator, GM Operations, GM Medical Support Services, GM Credit & Collection, GM Technical & Chief of Nursing . The interrelationship of Top Management and other key personnel is depicted our Organization Chart. Responsibility and interaction for QMS processes are depicted in procedures.

• Top Management – Members of Top Management are ultimately responsible for the quality of SIH’s products and services since they control the systems and processes by which work is accomplished. Top Management is responsible for Business Planning, development and communication of our quality policy (Section 5.3), QMS Planning (Section 5.4.2) including the establishment and deployment of objectives (Section 5.4.1), the provision of resources needed to implement and improve the QMS (Section 6.1) and management reviews (Section 5.6).

• Management – All Divisional Heads are responsible for execution of the Business Plan and implementation of the policy, processes and systems described in this manual. All Divisional Heads are responsible for planning and controlling QMS processes within their area(s) of responsibility, including the establishment and deployment of operational level objectives (Section 5.4.1), and the provision of resources needed to implement and improve these processes (Section 6.1). Managers also conduct employee performance reviews (Section 6.2.2.4). Management with responsibility



and authority for corrective action are notified promptly of nonconformities (Section 8.5.2). Management ensures that processes across all shifts are staffed with personnel in charge of, or delegated responsibility for product quality (Section 7.5.1.1).

• Employees All employees are responsible for the quality of their work and implementation of the policy and procedures applicable to processes they perform (Section 8.2.3). Employees are motivated and empowered (Section 6.2.2.4) to identify and report any known or potential problems and recommend related solutions through internal audits (Section 8.2.2) and/or the continual improvement and corrective/preventive action processes (Section 8.5).

Detailed responsibilities and authorities for QMS implementation and improvement are contained in lower level documents referenced throughout this manual and other QMS documents including procedures, flow charts, job descriptions, work instructions, etc.



5.5.2 Management representative

CEO has appointed the COO as the Management Representative (MR) for SIH's quality management system. The MR, irrespective of any other assignment,is responsible and has the authority to:

● Ensure that a quality system is established, implemented and maintained in accordance with ISO 9001:2008.

● Report on the performance of the quality system of the SIH in the Management Review meetings.

● Liaise with external/ internal parties on matters relating to the quality system.

5.5.3 Internal communication

The management of hospital maintains its interdepartmental communication through holding different meeting on weekly basis, and holds some meeting as per the required scenario. It keeps continued communication through writing memos in order to stream line the departments routing work. SIH applies certain devices like overhead paging system etc., which is effective and enhances the work efficiency.

All HODs and supervisors are responsible for establishing internal communications as needed to convey to their employees the relevance and importance of their activities. Communications regarding how employees contribute to the achievement of objectives is also conveyed and reinforced during employee performance reviews (Section 6.2.2).

5.6 Management review

5.6.1 General

Top Management conducts a management review meeting on semiannually basis to ensure the continuing suitability, adequacy, and effectiveness of our QMS in accordance with procedures detailed in SIHQSP5.6. The primary inputs reviewed include data that measures the conformance and performance of our QMS and recommendations based on analysis of such data. Conformance is primarily assured through internal audits (Section 8.2.2) and demonstrated through a review of internal audit results and our demonstrated ability to correct/prevent problems. Performance is primarily assured through the deployment of corporate/operational level objectives (Section 5.4.1) and demonstrated through a review of our demonstrated ability to achieve desired results. The primary outputs of management review meetings are management actions taken (Section 8.5) to make changes or improvements to our QMS and the provision of resources needed to implement these actions.



5.6.2 Review input

The management review meeting includes a review of our quality policy (Section 5.3), all applicable requirements of the QMS, related performance trends and opportunities for improvement, followup actions from earlier management reviews, results of self assessments (Section 8.4), and strategic or operational changes that could affect the QMS.

At a minimum, corporate level improvement objectives (Section 5.4.1) documented in prior management reviews are reviewed for status and continuing suitability:

5.6.3 Review output

At a minimum, outputs from management review meetings include new/revised corporate level improvement objectives and any related actions required for improvement of the QMS and its processes, improvement of product related to customer requirements, and provision of resource needs. Results of management review meetings are recorded and maintained by the Quality Assurance Analyst.



6. Resource Management

6.1 Provision of resources

SIH determines its resources requirements through planning & budgeting and allocates human, technical and financial reasons to its departments to implement and maintain quality management system for meeting the customer requirements.

6.2 Human resources

6.2.1 General

SIH maintains documents to identify the training needs of all personnel performing activities affecting quality and provide the required training. Personnel assigned to perform specific tasks are qualified on the basis of appropriate education, training or experience. Records of personnel qualification and training are maintained. SIH continuously strives to provide refresher and new training skills to all employees.

6.2.2 Competence, training, and awareness

The competency of people assigned responsibilities defined in the QMS is determined on the basis of documented criteria for appropriate education, training, skills, and experience for each required competency or work assignment. The HR Manager has overall responsibility for administering SIH ’s Human Resource Management programs in accordance with procedures.

6.2.2.0 Training Plans and Their Execution

SIH prepares training plans, which also describes the nature and frequency of training. In service training classes, onthejob training, continuing education courses, and access to scientific journals and audiovisual equipment are some of the methods used by SIH for providing updates and continuing education.

6.2.2.1. Orientation Training and Quality System Training

Orientation training is provided to all new employees, while quality system awareness training is providing to all personnel whose job effects quality, and their records are maintained.

6.2.2.2. Records

Records of training are maintained by SIH.



6.3 Infrastructure

SIH provides and maintain the infrastructure needed to deliver quality care. The information includes building, equipment, information system and for each maintenance system is in place. The COO has overall responsibility for planning, providing and maintaining the resources needed to achieve product conformance, including buildings, workspace and associated utilities; process equipment (hardware and software); and supporting services (such as internal transportation and material handling systems and communications systems).(SOPBIO001) (MTCWI001004)(SOPMTC001) (SOPMIS001014)(SOPCOM001008)

6.4 Work environment

SIH strive for a professional work environment, maintained through strict adherence to standard operating procedures, which is essential for assured quality care. We provide employee benefits, job and schedule flexibility, interesting work, and involvement of our employees in an empowered environment of continual improvement. We engender total participation by involving employees in internal audit (Section 8.2.2) and improvement (Section 8.5) activities. The HR Manager has overall responsibility for identifying, implementing and maintaining effective employee benefit and workforce involvement programs. The Safety & Security Manager has overall responsibility for identifying, implementing and maintaining safety and environmental management systems, processes and controls needed to ensure product conformance and meet customer, statutory or regulatory requirements. We monitor and improve workplace safety, health, and ergonomics through adherence to good manufacturing practices, and through safety team meetings and training (Section 6.2.2)(PLASEC001).

7. Product Realization

7.1 Planning of product realization

SIH has defined and documented quality plans for all main services i.e. Offered by SIH. Quality plans give consideration how the requirement of quality is met in providing, monitoring and ensuring the health care service at SIH.

SIH, examines, inspects and tests all incoming purchased products to verify their suitability. All patient are examined at the time of entry in the hospital determine their current status their stay in the hospital, and at the time discharge from the hospital. Records of inspections are established and maintained.



7.2. Customer Related Process

7.2.1. Determination of Requirement Related to the Product (service)

SIH establishes and maintains documented procedures for review of patient's needs and expectations and ensuring that it has the capability to meet them.

7.2.2. Review of Requirements Related to the Product (service)

Prior to providing service SIH assess and review the patient needs and requirements to ensure that:

• They are clearly understood, and where appropriate define and documented before reaching an agreement/ understanding to provide them a specific service.

• Any concern of the patient and the requirements/ obligations/ risks involved in proposed services are addressed, explained and clarified.

• General public awareness program

The hospital has the professional capability and the resources to meet the requirements of the proposed services.

7.2.3. Customer Communication

SIH establishes, determines and implement the effective arrangements for appropriate Customer communications through a variety of channels:

• We pay particular attention to customer feedback, including customer complaints and customer satisfaction. Customer satisfaction is evaluated on an ongoing basis see Section 8.2.1.

• Our HOD of MIS maintains a user/customer friendly web site, www.shifa.com.pk which contains extensive product information, a list of contacts of use to both customers and suppliers, and an electronic customer feedback form.

7.3 Design and development.

7.3.1. General

The specific clause is excluded.



7.4 Purchasing

7.4.1 Purchasing process

SIH has established a purchasing system to ensure that all purchased products/ services that effect quality offered by SIH conform to specified requirements. SIH assesses and continuously monitors its Contractors/Subcontractors/ Vendors for quality. The purchased products include medicine, medical supplies and equipment, food item, and all other items / services that are used in patient care and treatment.

SIH evaluates and selects Contractors/Subcontractors/ Vendors on the basis of their ability to meet subcontract requirements, including meeting quality system and quality assurance requirements.

SIH maintains and periodically reviews its approved Contractors/Subcontractors/ Vendors.

7.4.2 Purchasing information

The HOD of Purchase Department ensures the adequacy of specified purchase requirements prior to communication to the supplier per procedures defined in the Purchase Procedures.

Purchasing information communicated to our suppliers contains the appropriate data needed to clearly and fully describe requirements for purchased materials and services; including, where appropriate, requirements for approval/qualification of product, procedures, processes/systems, equipment; qualification of personnel; and quality management system requirements.

7.4.3 Verification of purchased product

All purchased products/ equipment are checked and verified before acceptance. The purchase documents specify, if the verification by SIH is done at the subcontract's premises. Customer / patients may verify SIH's services at SIH premises prior to making a contractor for SIH services.

7.4.3.1 Reference Document/Clause

Clause 7.4 is supported SIHQSP7.4



7.5 Production and service provision

7.5.1 Control of production and service provision

SIH carries out all its health care services in a planned manner and under controlled conditions.

7.5.1.1. Process Control and Monitoring

SIH core healthcare services are divided into following categories:

The Procedures applies to all healthcare service Units of SIH namely:

i. Clinical Laboratory/ Blood Bankii. Pharmacyiii. Radiologyiv. Emergency Room (ER)v. Operating Room (OR)vi. Cath Lab vii. CSSDviii.Labour & Deliveryix. Physical Therapyx. Dialysisxi. Radiation Therapy/ Medical Physicsxii. Lithotripsyxiii.Endoscopyxiv.IPD Floors/ Wardsxv. Intensive Care Unit (ICU) and NICUxvi.Food and Nutrition Service Department xvii.OPD Clinics

i. Medical Clinicsii. Internal Medicineiii. Digestive and Liver Diseasesiv. Infectious Diseasesv. Cardiologyvi. Dermatologyvii. Neurologyviii.Endocrinologyix. Psychiatryx. Pulmonologyxi. Nutritionxii. Pediatricsxiii.Pediatrics Psychiatry



xiv.Neonatologyxv. Speech Language Therapyxvi.Oncologyxvii.Surgical Clinicsxviii.General Surgeryxix.ENTxx. Cardiac Surgeryxxi.Rehabilitationxxii.Surgery Paediatricsxxiii.Neurosurgeryxxiv.Urology and Kidney Transplantxxv.Orthopaedic xxvi.Plastic Surgeryxxvii.Dentistryxxviii.Rheumatologyxxix.Ophthalmologyxxx.Obstetrics and Gynaecology

The above service are performed and verified using quality plans/procedures/policies.

• Medical Services• Nursing Services• Administrative and support services• Engineering and Maintenance Services• BioMedical Engineering• Management Information Services• Telecommunication• Admission & Discharge / Registration• Medical Records• Patient Service Department• Patient Coordination Services• House keeping• Linen Room• Laundry

The above service are provided using quality plans/procedures/policies.



7.5.1.2. Controlled Conditions

All SIH's service are carried out under controlled conditions that include:

● Quality Plans/ SOPs are available for carrying out each step of the above service.

● Appropriately qualified consultants and paramedical staff are available to provide the services.

● Suitable medical equipment is used to carry out tests, examination of patients.

● SIH maintains clean, hygienic and appropriate environment in each of its departments, to enable best care to the patients and also for performance of examination, inspection and tests.

● Quality plans clearly show the requirements of quality are met in providing a particular health care services.

● Patient are continuously monitored throughout the treatment process

7.5.1.3. Special Process

Because of the importance to human life and the requirement of monitoring during the health care process, all SIH's health care (medical) service are considered special process. They are thus continuously monitored, operated under written SOPs by qualified doctors/ nurses using approved equipment, and their records maintained.

7.5.1.4. Maintenance of equipment

SIH conducts planning and breakdown maintenance for all its civil, electrical, airconditioning, mechanical and biomedical equipment, so that the medical services do not hamper or deteriorate over a period of time.(SOPMTC001)(SOPBIO001)

7.5.2. Validation Of Processes For Production & Service Provision

7.5.2.1. Inspection and Testing

● All patients are examined at the time of entry in the hospital to determine their current status and identify the treatment required. Patients are continuously monitored and examined during their undertreatment stay in the hospital, and the time of discharge from the hospital. Records of examination and testing are established and maintained.

● SIH examines, inspects and tests all incoming purchased products to verify their suitability. Records of inspection and testing are established and maintained.



7.5.2.2 Receiving Inspection, Inprocess Inspections and Final Inspections

Purchased products are not used or processed further, unless they have been inspected or verified. Health Care (Medical) service are operated under quality plans which define the milestones for checks/ examinations/tests/ parameters checked, responsibilities, SOPs, equipment used and records maintained. The Health care services are operated under the Quality plans.

Patients are released from hospital only after the consultant's evaluation and advice, which takes into account the complete report of all tests and treatment carried out and the final condition of the patient. If ever an incoming product is released for urgent use, without verification, it is positively identified and recorded.

7.5.2.3. Laboratory and Diagnostic Radiology

Laboratory and Diagnostic Radiology support the above processes by performing testing and diagnostics in the areas of biochemistry, haematology, microbiology, pathology, radiography,Fluoroscopy , computerized Tomography, Ultra sound, Mammography, X ray and Carms. The laboratory and Radiology have established procedures to receive test requested, patient identification data, source, time and date of specimen collection, methods of carrying out tests and analysis procedures, and verification of test results.The Laboratory ensures trained technicians, records of reagents, control specimens, patients and analysis data. The laboratory records all nonconforming conditions related to specimens that are improperly collected, labelled or transported to the laboratory. Quality control measure are used to ascertain the confidence level for the specific analytic result obtained.

7.5.2.4. Inspection and Records

● SIH maintains complete medical records for all OPD/IPD patients. ● SIH maintains complete record of all inspections carried out on products when

received.

7.5.2.5. Reference Documents/Clause

Clause 7.5.2,(SOPMTC001)(SOPBIO001)(SOPMRD001)



7.5.3 Identification and traceability

SIH has a documented system that provides identification and traceability (where and to the extent required) for all SIH patients, treatments, services, samples, lab tests, medicine/drugs and meals through physical identification tags/labels and electronic records.Each patient is issued a unique number to himself, his documents, and his samples, for the purpose of identification and traceability. This Registration number is the key for traceability of patient, his records/ samples.

7.5.4 Customer property

SIH does not receive any customersupplied products that it incorporates into its services. However SIH has a system for looking after any valuable/ belongings of patients, if a patient is unconscious or anesthetized.

7.5.5 Preservation of product/Service

7.5.5.1 Handling Storage, Packing, Preservation and Delivery

SIH documents and maintains control features for handling of patients and products, hygiene, storage, packing, preservation and delivery of products and services to prevent them from harm, damage, decay or deterioration.

7.5.5.2 Handling

SIH considers patients handling from arrival to final discharge from hospital as a vital issue of its service. Therefore, besides the handling of medical products and supplies, it has also provided suitable methods, means and instruction to handle patients from their arrival to discharge from hospital. The handling methods ensure well being of patients, safety, efficiency and prevent damage to their belongings. SIH staff is trained to handle patients in a manner so as to avoid any further discomfort or deterioration in their condition. The instructions are extended to handling of patient when carried from one place to another in SIH ambulance. Medical equipment, including medicines are handled according to their specific individual requirements.Collection and handling of specimen for testing in the laboratories are handled according to welldefined instructions. All specimens are handled as though they contain a hazardous agent or pathogen. Specimens are collected and stored in the laboratory in a safe, timely and efficient manner. Food is handled with all food and hygiene related precautions.



7.5.5.3. Hygienic Conditions and Control

SIH operates all its medical service under strict environment and hygienic control. The Housekeeping & Infection Control Department is responsible for cleanliness, fumigation, microbiological monitoring and effective disposal of hospital wastes. An incinerator burns infectious materials like microbiological Media, disposable syringes and needles, gauzes, bandages etc.

7.5.5.4. Storage

Designated storage areas and stock rooms for medicines, medical supplies, laboratory supplies and food items are used to prevent any damage and deterioration. Only these products that have been properly identified and products that have passes the mandatory inspections are authorized to enter and leave the stockrooms . Storage conditions are maintained to;

1. Ensure that product or material do not deteriorate due to ageing, life expiry or environmental conditions.

2. Periodically, the stockrooms are cleaned up and inspection to assess the condition of stock, in order to detect deterioration.

7.5.5.5. Packaging, Preservation

SIH controls preservation of its medicine, medical supplies, laboratory supplies and food items from deterioration or life expiry by strict control of life dates and ensuring suitable storage conditions. Life expiry information is clearly marked on all medicine/ items that have a limitation on life.

7.5.5.6. Delivery of Services

SIH delivers its service within SIH premises. SIH provides suitable ambulance service, when it is required to transfer patients from one location to another. The patient is transferred under the care of trained staff to ensure that patient can receive the necessary attention during transit.

7.5.5.7. Reference Clause/Documents

(POLND001),(SOPFNSD001),(SOPBIO001),(SIHICM001),(LABPRO0106),(HKDPRO001007),(SIHOPD001)(SIHPHR001)



7.6. Control of Monitoring & Measuring Devices

7.6.1. Control of Inspection, Measuring and Test Equipment

SIH has established and documented control features to control, calibrate, and maintain inspection, examination, measuring and test equipment (including equipment used in laboratories). SIH selects appropriate equipment for remaining the patients and for use in laboratories for inspection and testing.

7.6.2. Control Features

SIH has established following control features for its measuring and test equipment.

• Selecting suitable measurement equipment.• Calibrating all inspection and test equipment at defined intervals, against certified

equipment, traceable to national standard. Where no such standards exist, the basis of such calibration is documented.

• Documenting control features for calibration of all measuring and test equipment, including type, identification number, location, frequency of check, check method, acceptance criteria, and actions taken when results are unsatisfactory.

• Identifying measuring and test equipment with a suitable indication system to show the calibration status.

• Maintaining calibration records.• Assessing and documenting the validity of previous tests, when measuring

equipment is found to be out of calibration.• Providing suitable environment conditions for calibration as well as testing and

measurements.• Ensuring handling, storage and preservation conditions that maintain the accuracy

and fitness for use of the measuring and test equipment.• Ensuring that measuring and test equipment is not tempered or adjusted in an

unauthorized manner that may invalidate the calibration setting.• Where the availability of technical data pertaining to inspection equipment is a

specified requirement, such data shall be made available, when required to the customer of his representative.

7.6.3. Reference Clause/Document

(SOPBIO001)



8. Measurement, Analysis and Improvement

8.1 General

SIH establishes and maintains documented control procedures for implementing corrective and preventive actions. Causes of nonconforming conditions arising out of healthcare services processes, morbidity and mortality audits, internal quality audits or complaints by patients or their relatives are investigated and corrective actions are implemented. Controls are applied to ensure that corrective and preventive actions are effective.

8.1.1. Review of corrective & Preventive Actions

SIH management reviews all corrective and preventive actions taken and their effectiveness and trends during Management Review Meetings. Any changes to be documented procedures resulting from corrective and preventive actions are recorded.

8.2. Monitoring and Measurement.

8.2.1. Customer Satisfaction

SIH has defined the procedure to receive, handle and investigate customer and feedback. Customer and their corrective actions forms inputs for management review . SIH management takes the corrective / preventive against the patients complaints /observations.

8.2.2 Internal audit

8.2.2.1. General

Quality Assurance Analyst is responsible to conducts comprehensive, planned and documented quality system audit to determine conformity to ISO 9001:2008. Audits are scheduled on the basis of the status and importance of the activity. Personnel independent of those have direct responsibility for audited activity conduct the audits. Identified nonconforming conditions are brought to the attention of the concerned Department Heads, a corrective actions are requested and followup audit are conducted.



8.2.2.2. The Audit Function Includes

Scheduling and documenting the audit plans;Staffing and training auditors to ensure personnel are qualified.Conducting of audits and their reporting;Followup;Recording the results of internal quality audits;Reporting the results of audit to Executive ManagementOnly personnel independent of the audit activities are assigned to conduct the internal audits.

The Quality Assurance Analyst is maintains all internal audit records, including internal auditor training records, results of internal audits and related followups; periodically reviews internal audit results as well as progress towards achievement of corporate level objectives aimed at improving overall QMS effectiveness (Section 5.4.1); and provides related recommendations for review by Top Management; (Section 5.6)

8.2.2.3 Reference Clause/Document

(SIHQSP8.2.2)

8.2.3 Monitoring and measurement of processes

8.2.3.1 Statistical Techniques

SIH identifies and uses statistical techniques to control its services. Written procedures implement and control the application of statistical techniques in SIH.

8.2.3.2. Reference Procedure

Governs the application of statistical techniques to the key characteristics of SIH service for measuring performance and keeping a control of process.

8.2.4. Monitoring and Measurement of Product (service)

8.2.4.1 Servicing

Servicing is not only a specified requirement of SIH processes. The required followup / post treatment service are carried out within the SIH premises, and are covered by the same procedures as applicable to the original services.



8.3. Control of Nonconforming Product (service)

8.3.1. General

SIH has established and maintains documented procedures to identify, evaluate and prevent non conforming product (medical supplies, medicines, food) from being used or deliver inadvertently. The controls include identification, documentation, segregation, (where practical), evaluation and disposition of nonconforming product and for notification to the concerned authority.

8.3.2. Review and Disposition of Nonconforming Product

The responsibility for review and authority for disposition of non conforming product is clearly defined. The non conforming product are rejected or scrapped and not used under any circumstances.

8.3.3. Reference Clause

This policy is supported by clause SIHQSP8.3. Control of Non Conforming Product/ Service.

8.4. Analysis of Data

8.4.1. Statistical Techniques

SIH identifies and uses statistical techniques to control its services. Written procedures implement and control the application of statistical techniques in SIH.



8.5 Improvement

8.5.1 Continual improvement

SIH identifies resources requirements for providing health care services and provides adequate resources, including training and competent personnel for management, performance of work and verification including internal audits to maintain its quality.The Chief Operating Officer has overall responsibility for establishing and implementing an effective continual improvement system, which includes improvement actions.

8.5.2 Corrective action

SIH maintains control features for identifying, investigating and documented the result of investigation relating to non conformance when found through any of the following methods:

• Customer Complaints• Identified by hospital staff while performing any of the Hospital's

services/processes.• Internal Quality Audit.

When a nonconformance is identified, it is investigated, root cause is found, recorded and corrective action taken. Evidence of nonconforming product, customer dissatisfaction, or ineffective processes is used to drive our corrective action system because a problem exists requiring immediate correction and possible additional action aimed at eliminating or reducing the likelihood of its recurrence. Management with responsibility and authority for corrective action are notified promptly of product or process nonconformities. Investigating and eliminating the root cause of these failures is a critical part of our continual improvement process.

Followups are conducted (through the internal audit process; (Section 8.2.2) to ensure that effective corrective action is taken appropriate to the impact of the problem encountered. In addition, the Quality Assurance Analyst summarizes and analyzes corrective action data to identify trends needed to assess overall effectiveness of the corrective action system and to develop related recommendations for improvement. The corrective action system is considered effective if specific problems are corrected and data indicates that the same or similar problems have not recurred. Results of this analysis and related recommendations are presented to Top Management for review and action during management reviews; (Section 5.6)



8.5.3 Preventive action

The Quality Assurance Analyst has overall responsibility for managing our preventive action process defined in SIHQSP8.5 and summarized below:

Data from internal audits, customer feedback, employee suggestions, and other appropriate data is collected and analyzed (Section 8.4) to identify the actions needed to eliminate the causes of potential problems and thereby prevent their occurrence. Investigating and eliminating the root cause of potential failures is a critical part of our continual improvement process. We review and initiate preventive actions through our preventive action process defined in SIHQSP8.5.

We apply controls and followup to ensure that effective preventive action is taken appropriate to the risk and impact of potential problems and losses. In addition, the Quality Assurance Analyst summarizes and analyzes preventive action data to identify trends needed to assess overall effectiveness of the preventive action system and to develop related recommendations for improvement. The preventive action system is considered effective if potential losses were avoided. Results of this analysis and related recommendations are presented to Top Management for review and action during management reviews; Section 5.6.



Appendix A

Index of Quality Procedures

Document No. Title

SIHQSP5.6 Quality System Procedure For Management Review

SIHQSP4.2.3&4 Quality System Procedure For Control of Documents and Records

SIHQSP7.4 Quality System Procedure For Purchasing

SIHQSP8.2.2 Quality System Procedure For Internal Quality Audit

SIHQSP8.3 Quality System Procedure for Control of non Conforming product /services

SIHQSP8.5 Quality System Procedure For Continual Improvement

POLND001 Nursing Manual

SOPFNSD001 Departmental Food & Nutrition Services Policies & Procedures

SOPBIO001 Departmental Biomedical Procedures

SIHICM001 Shifa Infection Control Manual

LABPRO0106 Departmental Laboratory Procedures

HKDPRO001 Departmental Housekeeping Procedures

SIHOPD001 Shifa Outpatient(OPD) Services Manual

SIHPHR001 Shifa Pharmacy Services Manual

MTCWI001004 Departmental Maintenance Work Instructions

SOPMTC001 Departmental Maintenance Procedure

SOPMIS001014 Departmental Management Information System Procedures

SOPCOM001008 Departmental Communication Procedures



Appendix BTERMS AND DEFINATION/ ABBREVIATIONS

Acceptance Criteria

Defined limits placed on characteristics of materials, products and services

HR Human Resources

Audit(Internal)

Selfexamination by an organization of its own processes to ensure that the Quality System is operating as defined in its documentation and is effective in meeting stated objectives (1st party audit)

HRD Human Resources Development

Auditor A Person who has the qualifications to perform Quality Audit

ICU Intensive Care Unit

BOD Board of Directors IPD Inpatient Department

Calibration Comparison and adjustment to standard of know accuracy

MM Material Management

C & C Credit & Collection Department Management Review

A formal evaluation by senior management of the status and adequacy of the Quality System

CEO Chief Executive Officer MD Medical Director

COO Chief Operating Officer MIS Management Information Services Department

CS Company Secretary MR Management Representative of SIH

MASS Manager of Administration & Support Services MR NO. Unique Medical Record Number of a Patient

GMF General Manager Finance Non conformance or non conforming

The nonfulfilling of specified requirements

CMR Confidential Medical Record OPD Out Patient Department

PSD Patient Service Department OR Operating Room

CON Chief of Nursing Procedure A Document defining the purpose and scope of a process and outlining the what, when, where and by whom the process shall be carried out,

EMC Executive Management Committee QAM Quality Assurance Manager

FNSD Food & Nutrition Services Department QAA Quality Assurance Analyst

QP Quality Plan Quality The totality of features and characteristics of an entity that bear on its ability to satisfy stated or implied needs.

Quality System The organization structure, responsibilities , procedures, processes and resources for implementing the quality management.

HFC Hospital Finance Committee

Sop Standard Operating Procedure usually giving detailed work instruction for a quality plan or procedure.

Quality System Review

A formal evaluation by senior management of the status and adequacy of the quality system in relation to quality policy and new objectives resulting from changing circumstances.

Organization Shifa International Hospital SIH Shifa International Hospital

HOD Head of Department NES Nursing Education Services