Iso9001healthcare Overview

This Documents is meant for private circulation only and published in the interest of Promotion Of Quality Management System
in Hospitals
ISO 9001:2008 Quality Management System

Awareness On Development & Implementation For Hospital
Contents Sr. No 1. Chapter Introduction Page No 2
Benefits
Scope of ISO 9001 in Hospitals
ISO 9001 Requirements
Approach for Development & Implementation
16
Certification Process
20
Presented by Ajay Deshpande 1
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This Documents is meant for private circulation only and published in the interest of Promotion Of Quality Management System in Hospitals
Chapter 1
INTRODUCTION
FOUNDED in 23 rd Feb 1947, ISO (International Organisation for Standardization) consists of approximately 157 member countries at present and this number is expected to grow. It is based in Geneva, Switzerland.
ISO is responsible for the promotion and development of international standards and related activities, including conformity assessments such as testing, inspection, laboratory accreditation, certification and quality assessments. ISO comprises more than 180 technical committees, covering many industrial sectors and products. These technical committees, as far as possible, try to address the requirements of the member countries while formulating their standards. It aims at harmonization of standards at the international level with a view to minimise trade and technical barriers.
The standard finds its origin in the European Community (EC) July 1985 product liability directives (also known as the single market directives) which state that for certain regulated products, manufacturers exporting to the EC and, eventually, to the European Free Trade Association, would need to have a well documented and implemented Quality Assurance System. The ISO 9000 series standards provide the requirements to which organisations desirous of certification must conform.
ISO-9000:2008 Series
Last revision of ISO-9000 Quality System was done in 1994.On 15th November 2008, ISO released the new version of the ISO-9000 series of the standards. The new standard is based on eight quality management principles and is more a management standard. The title of standard ISO 9001: 1994 was "Quality Systems- Model for quality assurance in design, development, production, installation and servicing".
The title of the ISO 9001:2008 standard is Quality Management System- Requirement." The change in title itself signifies a paradigm shift and evolution of managing quality from inspecting quality to building quality and now to quality product/service through Quality Management Systems. The ISO9000: 2008 is more user friendly. In the new revision of the Standards, there is a "Single Quality
Presented by Ajay Deshpande 2 Of 34
Management" required Standard (ISO-9001) applicable to all organizations, products, services, that replaced ISO-9001; ISO-9002; & ISO-9003 of 1994 Series.
Under ISO-9000: 2008, there are three Primary Standards:
ISO-9000 - Quality Management System - Fundamental & Vocabulary ISO-9001 - Quality Management System Requirements ISO-9004 - Quality Management System - Guidance to Performance Improvement
The focus of the new standard has shifted from building quality to managing quality. Hence there is a very strong emphasis on the management commitment and how the top management is providing leadership to the various processes involved in product realization for the satisfaction of the customer. The focus has also moved more towards the stated and implied requirements of the customer.
Concepts of quality
Quality is defined as fitness for purpose. International Organisation for standardisation, ISO, defines quality as those characteristics of an entity that fulfil its stated and implied needs. It means that measures of quality will vary depending on the type of product belonging to the services that is sought by the customer.
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Evolution of Quality Management
Rework and Salvage Post rejection Exercise
Corrective action SPC Process Compliance
Preventive action Company wide QA Extensive use of QE tools
Continuous improvement Customer Orienta-tion Empowered employees
Inspection
Quality Assurance
Total Quality Control (TQC)
Total Quality Management (TQM)
Quality in Hospital
The hospital quality will have similar attributes. The dimensions of quality in hospital will include:
Patient satisfaction Safety Technical competence Efficient services Accessibility Continuity Interpersonal relationships Amenities including patient & their relatives comfort
It is important to note that first six of the above deal directly with the primary objectives of the patient care and remaining two are connected with logical requirements for any service industry.
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Quality management Management of quality is one of the important functions of any top management that is seriously interested in its business. By definition quality concerns the essential requirements of the service that the organisation provides to its customers. Hospital personnel are particularly concerned at all times whether the activity they are carrying on is achieving tangible results for the patient or not.
ISO 9001:2008 is based on eight quality management principles which reflects best management practices. These eight principles are :-
1. Customer focused organisation 2. Leadership 3. Involvement of people 4. Process approach 5. System approach to management 6. Continual improvement 7. Factual approach to decision making 8. Mutually beneficial supplier relationship
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Chapter 2 Benefits of ISO 9001 Certificate

Benefits to the hospital Realistic third-party assessment of the status of Hospital Improvements can be achieved with much greater ease and can be properly directed at tangible goals The employees of ISO 9001 Hospital have greater opportunities of learning and contributing which helps them to satisfy their esteem needs bringing positive and enjoying work culture in the organisation Following of proper quality system will reduce chances of mishap/mortality. Clearly laid down criteria for job requirements will make selection of the personnel easier. Possible reduction in medico-legal claims. Sharing & direction towards common goals and objectives to every employee. Clarity in definition of authorities and responsibilities. Enhanced corporate image and market positioning. Better records and documentation in case of litigation Use of recognized mark (of certifying agency) on stationary and advertisement Better traceability to root causes of health problems Improvement in House keeping, safety and cleanliness Analysis of defects / errors and necessary corrective / preventive action results in reduction possibilities of its occurrence There is less of fire fighting and employees are encouraged to be pro-active Enhanced patient satisfaction Reduction in wastage results in better profitability
Benefits to the patient Predictability in provided services, health education and training Transparency in charging and care. Reduction in inherent risk in disease management.
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Chapter 3 Scope of ISO 9001 in Hospital

ISO 9001:2008 promotes process approach when developing, implementing and improving the effectiveness of Quality Management System, to enhance customer satisfaction by meeting customer requirements.
For a Hospital; to function effectively, it has to identify and manage numerous linked activities and their application throughout the organisation. This section will look at some of the activities and the associated aspects, which shall constitute scope of QMS. These are discussed for the purpose of illustration. A hospital shall have to define the scope based on their own charter of services.
3.1
Out Patient Department (OPD)
3.1.1 Planning
i)
Physical facilities for diagnosis, curative, preventive and rehabilitative. Emergency or casualty department to provide immediate treatment to patient on arrivals.
ii)
Expected work load with regard to number of patients, availability of other health care facility
iii)
Adequate manpower, equipment, laboratory etc.
3.1.2 Oraganisation structure Well defined organisational structure including responsibility, authority and job description for medical/paramedical personnel.
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3.1.3 Functional Management i) ii) iii) iv) v) vi) Timing of OPD, IPD etc Entrance and Ambulance Zone Enquiry & Registration Medical records Clinics for various medical disciplines Pharmacy (Dispensary)
3.2
Wards, Nursing services and Operation theater:
3.2.1 Ward i) ii) iii) iv) v) vi) vii) viii) ix) Arrival of patient, Enquiry and registration Allocation of bed Bed preparation Nursing records/case sheets Initiation of treatment Medical / Nursing care Investigation Day to Day Management Discharge, follow up
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3.2.2 Operation theater i) ii) iii) iv) v) vi) vii) viii) 3.3 Reception Pre-anaesthetic medication Pre-operative check up Anaesthisation Operation theater check list Operative procedure Recovery and post operative care Wards discharge
Hospital support services Hospital supply system i) ii) Medical and surgical store General store
3.3.1
3.3.2
Laundry i) ii) iii) iv) v) vi) vii) Patient care linen Bed linen Body linen Operation theater linen Staff linen Contaminated infected linen Soiled linen
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3.3.3 Hospital Dietary Services i) ii) iii) iv) v) Organisational structure Functional activities Menu Procurement Storage / safety / hygienic
3.3.4
House keeping and maintenance i) ii) iii) iv) v) Waste Management Hospital hygiene maintenance Infection control / pest control Environment control Sanitation
3.4
Hospital Equipment Management i) Breakdown maintenance ii) Preventive and predictive maintenance iii) Critical spares management iv) Annual maintenance/service contract
3.4.1
Planning i) ii) iii) Medical and diagnostic equipment Supportive equipment(kitchen, laundry) Trained manpower
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3.4.2 Power supply i) ii) iii) iv) Availability of standby power/UPS Automatic switch over Voltage regulation Earthing
3.4.3
Safety i) ii) iii) Chemical safety Electrical and Mechanical safety Radiation safety
3.4.4
Regulatory aspects i) ii) Radiation protection Ultra violate radiation Magnetic Resonance Imaging
iii)
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Chapter 4
ISO 9001:2008 Requirements
Requirements of ISO 9001:2008 are grouped in five major clauses.
1) QMS ; calls for establishing and maintaining of QMS
2) Management responsibility; calls for management commitment through quality policy, quality objectives and patient focus.
3) Resource management; this requires organisation to provide resources i.e. infrastructure, work environment and above all competent personnel.
4) Product realisation ; this section comprehensively require organisation to plan, implement and achieve patient care and treatment from patient admission to discharge/departure
5) Measurement , analysis and improvement; this clause deals with monitoring and improvement related aspects for patient treatment & care.
These clauses are described in details in subsequent paragraph. 1.0 Quality Management System
1.1 General requirements The Hospital shall establish, document and implement Quality Management System which shall cover organisational structures, responsibilities and authorities, procedures, the resources that
ensures the quality of patient care services. Depending upon the nature of services, typical hospital/health care unit may establish QMS for following activities: a. Patient needs assessment b. Health care service design
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Chapter 4
ISO 9001:2008 Requirements
c. Delivery of health care services d. Function of Patient wards , Operation theatre , Clinical laboratories, Storage of medical items e. Waste management f. Infection Control
1.2 QMS Documentation shall include
a. Documented statements of a quality policy and quality objectives b. Quality manual defining scope of activities of Hospital c. Procedure required by ISO 9001:2008 d. Procedures needed by the Hospital to ensure the effective planning, operation and control of its activities e. Records required by ISO 9001:2008 as evidence that system is effectively functioning as described vide Quality Policy, Quality Objectives, Quality Manual and Procedures
All documents shall be controlled. Procedure shall be established to identify following
a) Approval of documents before release b) Review, up-date and re approval c) Ensuring that pertinent version of documents are available with personnel identified in distribution list
Quality records, likewise shall be maintained. Procedure shall be developed covering means of identification, indexing, storage, retention time and disposition of quality records.
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2.0 Management responsibility
Top management of the Hospital shall provide evidence of its commitment to the development and implementation of the Quality Management System which will be capable of meeting patients need (Stated & Implied) and continually improving its effectiveness.
CEO of unit shall define the Quality policy consistent with the units goals and patients requirements.
Hospital shall plan the activities to establish the objectives and requirements of Quality of Services and application of QMS elements.
The quality planning shall be based on
a. Patients requirement b. Performance criteria of health care services c. Quality objectives
The responsibility and authority of all paramedical, laboratory and administrative staff who provide patient care services shall be defined and communicated within the unit. One of the member of management shall be nominated as Management Representative (MR) who shall ensure that QMS meets all the requirements of standard. He shall also communicate the performance of QMS to the top management for Management reviews.
3.0
Resources Management
The Hospital shall identify and provide resources to implement QMS aimed at meeting patients requirement on continuous basis.
The Hospital / Healthcare unit shall identify necessary competence needed for medical professional, paramedical and laboratory staff. The training needs shall also be identified for personnel related to
safety, security, handling chemicals and drugs, bio-medical equipment, utility services, infection control, waste management and other support services.
The infrastructure related to buildings (patient arrival lounge, OPD, IPD, operation theater, pathology/radiology labs) shall be provided based on the established/identified norms. Support services shall be provided. The work environment within Hospital/Healthcare unit needs special attention with respect to safety, ergonomics, social interaction, hygiene, pollution and environmental parameters i.e. heat, dust, humidity, ventilation, illumination, water etc.
4.0 Product realisation
3.1
Planning
The Hospital/Healthcare unit shall plan:-
a. Responsibility and authority for delivering of Quality healthcare services to the patients. b. The qualification criteria/skill/competence of medical/paramedical/ administrative staff, involved in the process of delivery of health care services. c. Quality plan identifying the sequence of activities from the arrival of the patient, delivery of services till discharge of patient, post discharge services along with responsibility and authority of medical / paramedical administrative staff and reference to documented procedures where required. d. Resource requirements in terms of infrastructure, equipment, compliance to regulatory requirements etc.
3.2
Customer related processes:-
The Hospital/Healthcare unit shall establish procedure covering all the activities of interface between patient and Hospital/Healthcare unit.
This shall include the identification of needs of patients through initial assessment. The process of treatment on the basis of initial assessment shall be informed to the patient. The cost involved and risk factors associated with treatment should also be communicated. The review activity in it is an on-going process and should include things like consent forms from patients. The changes in the patient condition or on the basis of on-going diagnosis, it may call in for further review of medical service requirements. The communication channel with the patients and their associates needs to be worked out and recorded. The review records should establish the clarity about the medical services provided and conditions including risk factors.
3.3
Design & Development of Product
Requirement of design & development in Hospital / Healthcare units refers to new processes of treatment / patient care services. Competent medical professionals and administrators are needed for planning and providing such services.
Input needed in such cases shall include following:-
a. Analysis of patient history & needs b. Review details at the time of initial assessment c. Applicable regulatory requirements i.e. WHO guidelines etc
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Design output report shall be prepared containing following:-
a. Competence of personnel required to provide service b. Resource requirement such as external experts, diagnosis services, emergency kits etc c. Process control & evaluation parameters
Medical service designed are to be reviewed and verified. These may include following:-
a. Review of output vis--vis input b. Comments of patients c. Comments of external expert d. Comparing the designed treatment with similar cases provided else where e. Reviewing all clinical guidelines, manuals, patient reviews prior to providing actual treatment/service
Such designs also need to be validated. Design validation in a healthcare service is an on-going process. The quality of new service is ascertained by tests carried out under normal living conditions. If required the patients, on which new services are applied are monitored during treatment and during post-discharge period, as per validation plan.
3.4
Purchasing
The healthcare unit shall make arrangements to ensure that the purchased products (drugs, food stuff, medical aids etc) and services(disposal of bio-medical waste, infection control, house keeping, electrical maintenance etc) conform to specified requirements. The hospital staff selection criteria shall be established in a manner so that the competence requirements for providing healthcare services are met.
The procedure should also address about hiring of medical experts/ paramedical staff and other medical services like blood blank, diagnostic services, ambulance etc. The criteria for evaluation of suppliers of materials or providing of services(medicines, X Ray films, surgical instruments) should be clearly established. The legal & regulatory requirements as applied needs to be compiled in all purchases. The hospital rules should clearly brings out the patients rights for verification of services provided including those by its suppliers.
3.5
Production and service provision
It calls for compliance with specified requirements to satisfy patients and interested parties. The processes to provide medical services are to be established with respect to 7Ms. Men : Qualified and competent medical professionals. Most of the processes in Hospitals/ Healthcare are special processes where deficiency become apparent only in post discharge period. Hence only qualified and competent personnel needs to be detained Method : Various procedures and work instructions for clinical / surgical / service functions and may also be established for associated functions such as collection of samples in a pathological lab, cleaning / sterlisation of bio-medical equipment, waste disposal , linen and laundry etc Machine : The bio-medical equipment used in IPD, operation theater, laboratory, and other functions need to be selected on the basis of specified requirements. They should be installed and maintained as per established schedule incorporating safety considerations
Material : Appropriate supply of materials i.e. Drugs, chemicals, spares etc Milieu : The work environment incorporating safety regulations and aspects like temp, humidity, illumination, noise, electromagnetic radiation etc needs to be defined and established Money : This calls for provision of resources to establish QMS inline with International standard ISO 9001:2008 and needs patients and other interested parties
Hospital/ Healthcare unit is also required to establish tracking of patients treatment including critical drugs administered during the treatment. The identification of treatment can be maintained in form of;
a. Patient registration number b. Patient treatment records c. Ward (OPD/IPD) records d. Consent forms e. Discharge certificate
Hospital/Healthcare unit shall take care of patient supplied items i.e. Medicines, blood, injections, reports of earlier treatments; organs etc besides others i.e. advance payments, valuables etc.
The storage, handling, packaging, preservation and delivery aspects in patient care need to be identified and established. For example handling refers to;
a. Handling of samples b. Patient care and counseling c. Handling of waste d. Handling of radiological materials e. Handling of surgical tools
The storage should address medicines, chemicals, bio-medical equipment, vaccine, patient samples, etc. The environmental conditions required for preservation and shelf life of items should also be defined.
5.0 Control of monitoring and measuring devices :-
The monitoring and measuring devices shall cover all critical equipment i.e. diagnostic and radiological equipment, pathological analysers, test equipment, bed side monitors, ECG Machines, blood pressure measuring equipment, incubators, sample storing refrigerators etc. All such devices needs to be calibrated having traceability to national standards. Where national standards do not exist, the method of verification using first principle or using reference samples, should be established. The interval of calibration is to be decided by the Hospital/Healthcare unit (Please refer NABL 112 Standard). Suitable identification methods to indicate calibration/verification shall be defined and put to use.
3.6
Measurement, analysis and improvement
The management of Hospital/Healthcare unit shall plan & implement the monitoring, analysis, and improvement processes needed to demonstrate that the service rendered are as per the specified requirements and to continually improve the effectiveness of QMS.
The management shall monitor information relating to patient perception about the medical service rendered by the unit. Determining the causes of patient dissatisfaction is an on-going and critical aspect of the improvement process. This could be done by obtaining written feedback and / or interviews with the patients and their associates.
Hospital / Healthcare unit shall establish and maintain documented procedures for planning and carrying out internal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine effectiveness of QMS.
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The nature & satisfaction level of services rendered to patients should be evaluated. Some of the examples in this are;
a. Patient satisfaction index b. Infection control data c. Clinical laboratory data d. Effective utilisation of hospital facilities e. Treatment / service process success rate f. After effect of treatment / drugs
In case non conformity in providing treatment / service has occurred, it shall be identified and disposed off. Some examples are:-
a. Providing supplementary treatment/services b. Repeat of diagnosis c. Repeat of treatment / operation d. Providing compensation to the patient / patients associate
Revision in treatment plans if required should be communicated to patient or patients associate. Management of Hospital/Healthcare unit shall plan and review the QMS at defined intervals. This among others should include following:-
a. Results/Trends in patient care services including support services b. Patient satisfaction Index c. Achievement with respect to Quality policy / Objectives d. Results of internal audit
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The Hospital/Healthcare unit shall establish and maintain documented procedure for implementing corrective and preventive actions. The corrective actions on the basis of patients complaint or feedback shall be recorded, analysed and based on this appropriate corrective action shall be taken. Some of the examples of corrective actions could be:-
a. Revision / Modification of treatment plan for particular ailment b. Training of Doctors/paramedical staff to enhance their competence c. Changes in documented procedure d. Up-gradation of facilities and work environment
Preventive actions on the other hand are to be taken based on the data available on patients complaints, non conformances observed and other performance indices. Hospital/Healthcare unit can also set up quality teams comprising of Medical Doctors, Paramedical staff and Administrators to visualise potential causes of non conformances likely to occur and based on that take action to prevent their occurrence.
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Chapter 5 Approach for Development & Implementation
Milestones for ISO 9001: 2008
Quality Policy & Objectives. Selection of M.R. and core team for implementation
Development of Documentation i.e. Quality Manual, Procedures, Formats etc
Implementation Of documents as Per ISO 9001 Requirements
ISO 9001:2008 Certificate Awarded to The Hospital
Above milestones are mainly classified into QMS Implementation Steps.
6.4.1 Obtain top management commitment:-
Quality is a management function. Quality Policy, Quality objectives and commitment to quality originate from top management. It is therefore necessary that top management should understand implication of adapting ISO 9001:2008 and take conscious decision on this. Top management is responsible for identifying all the necessary resources and provide leadership in effective implementation of QMS.
6.4.2
Company Wide Awareness Training
Implementing and working to requirements of ISO 9001:2008 would require extensive awareness among all the employees of the organisation. Everyone in the organisation should know, what is in it for the employees, and what is their role in its implementation. Timely communication is key to effective implementation of ISO 9001.
6.4.3
Appointment of MR and constituting core group/implementation teams
Management representative is a key player in establishing, implementing and in

maintenance of QMS. He/She is generally member of Management, who in addition to his/her primary responsibilities, takes on this task.
Appointment (Nomination) of MR, is generally announced by CEO, after top Management briefly session. Alternatively it could be made after detailed awareness training of senior management is completed. This helps in choosing an appropriate and willing person to take on this vital task. Generally speaking, any member of management level could be appointed as MR. However the person enjoying excellent rapport among senior managers (good communicator and charismatic) should be given this mettle. During initial days, MR used to be mostly nominated among QA managers.
These days, there are instances, where managers from HR, marketing or even finance are appointed as MR. Depending on size on organisation, implementation structure could be Suggested . Generally following type of structure is recommended for large scale company. Steering committee -
Comprising of CEO as chairman and heads of function (HODs) as members. MR acts as member secretary. Core Group -
This is headed by MR and has one manager from each function, as members.
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Implementation teams -
These are departmental groups, comprising of Manager(s) supervisors and workmen.
Composition of core group and implementation teams is made after awareness phase of training is complete. Like in case of MR, this helps in choosing people with right attributes.
In a medium size of company, only 2-tier structure is suggested, while in SSI, single tier steering committee or core group take on all the implementation related activities.
6.4.4
System appraisal
This means looking at existing system. The system appraisal is like taking inventory of QMS within the organisation, using Process-based approach. A summary report on system appraisal, among others, will contain whether organisation has in practice the following: Quality policy and quality objectives Defined responsibility and authorities of key personal Appropriate work environment Trained man-power Quality planning Customer communication from acceptance of work through product realisation to delivery of product Control on vendors/suppliers
Measurement of products and processes Management reviews on assessment of effectiveness of QMS
This is what a basic QMS should cover. The practices are then compared with the requirements listed in ISO 9001:2008. This will also reveal how much time and effort, will be required. This would help top management to take conscious decision on implementing QMS, based on international standard ISO 9001-2008.
6.4.5
Training Workshop:-
This phase is devoted on specific training. This could fall in following categories:-
(i)
Evolving Quality Policy and Quality Objectives
(ii)
Documentation Workshop
(iii)
Training for Internal Auditors
6.4.6
Preparation of QMS Document
The training workshop on documentation, if organised in a planned way, can lead to the preparation of QMS documents by the same members who have attended the workshop. The contents of quality manual procedures and other documents are guided by following considerations.: What requirements must be incorporated into the manual documentation to satisfy the needs and interests of the organisation
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Requirements of ISO 9001 standard to which the manual and documentation must comply Records specially required by standard
The QMS documents should be designed to enhance the companys operational effectiveness as well as satisfy ISO 9001 requirements. It should be a mirror image of company operations. The company may choose one of the many ways for accomplishing the manual/ documentation drafting task.
(a) Quality Manual is an apex level document and should be written under the ownership of the steering committee. The MR obviously should take lead and get the manual written by the CEO and HODs for their respective functions.
(b) The Procedures, which are applicable company wide, i.e., Training procedure, Document control procedure etc., could be written by CORE GROUP.
(c) The procedures specific to the functions, i.e., calibration procedure, purchase procedure etc. should be written by implementation team. They also should develop the work-instructions for their areas, with the active involvement and participation of supervisory and workmen level of personnel (process owners).
(d) The Management may contract an outside consultant for assisting in development of manual and other documents.
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6.4.7
Action Plan
To summarise, following are step by step actions to implement QMS into realism of operations in the organisation:-
(1) Implementation should be led by CEO. (2) It should be planned based on consensus by top management. (3) Organise awareness training for everyone. (4) Appoint MR, constitute steering committee, core group and implementation teams. (5) Carry out status appraisal of existing system and identify gap areas vis--vis requirements of ISO 9001:2008, and permissible exclusions from the scope. (6) Organise specific training workshops on quality policy, quality Objectives and documentation requirements. (7) Development of documents i.e. quality-manual, procedures, forms, formats etc. (For guidance refer chapter.5) (8) Implement documents (9) Training for internal auditors (10) Carry out internal audits and implement corrective actions (For guidelines refer chapter.8). (11) Conduct management review. (12) Invite certification body for pre-assessment. (13) Implement corrective actions, based on pre-assessment audit. (14) Invite certification body for assessment. (15) Obtain registration/certification. (16) Evaluate and measure results on a continuous basis.
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Chapter 6 Certification Process Pre-Certification Requirement Organisations interested in obtaining the Certificate of Registration should have established a Quality Management System complying with the requirements of ISO 9001 standard for certification. The QMS documentation may include documents such as quality manual, quality plan, executive procedures, work instruction etc., as required by the standard.
Stage 1 : Preliminary information.
Upon enquiry the organisation is provided with a form for Preliminary information about the organisation seeking registration. This form is intended to gauge the status of organisations Quality Management System.
Stage 2 : Application
Organisation should submit the application for registration of their Quality Management System in the prescribed profarma to the Certification Body along with the required application fee. Each application is accompanied by relevant Quality Management System documentation i.e. Quality Manual.
All applications are screened for completeness before acceptance and the Certification Body may seek or provide more information when necessary.
Stage 3 : Pre-Assessment Process
Before the actual assessment, a detailed examination of the applications QMS documentation is undertaken for ensuring compliance with applicable requirements of QMS standard. The organisation will have to carry out all necessary correction /amendments prior to assessment exercise, since this documentation will form the basis during assessment. A preliminary visit may be made to the supplier to assess to resources needed for assessment.
After a satisfactory verification of the organisations QMS documentation, the organisation will be Request for convenient dates for assessment. Intimated about the composition of the assessment team.
Stage 4: Assessment Process
An assessment team will visit the organisations premises (identified in the application) for assessing compliance with the procedures and requirements described in their QMS documentation and ISO 9001 standard. Assessment Process is as follows.
(a) Introductory/Opening Meeting
The purpose of this meeting is to introduce the assessors to the organisations representatives (including Chief Executive and other Senior Executives),. The scope of the assesment programs are reviewed and confirmed. The lead Assessor will conduct the meeting and described the process of assessment and methods of discrepancy reporting. Logistic arrangements will also be finalised during this meeting.
(b) Brief Tour
The assessment team will have a very short tour of premises to have an idea of the scale and layout of operation.
(c) Assessment Execution
The assessors in the team usually act as individuals split up to assess different areas of the company. Each assessor is to be accompanied by a guide who facilitate movement around the works. The assessor will record, the non-conformances observed, in factual terms along with objective evidences and seek the consent of the organisations representative.
(d) Closing Meeting and Report
During this meeting the assessors meet the organisations management and present them with the results of assessment. It is preferable that all members present during the opening meeting be present in the closing meeting also. The time frame for requisite corrective actions by the organisation will also be finalised.
Stage 5 : Post Assessment Process
(a) Corrective Action
Minor non-compliance not closed during assessment can be cleared through written confirmation of corrective actions. Major non-compliance will have to be cleared/closed generally after physical verification of corrective action at the premises thus might warrant another assessment.
(b) Certification
Once the discrepancies raised during assessment are cleared, the organisation is recommended for Certification. After Certification, the organisation is authorised to made use of the Certificate of Registration in marketing activities.
During assessment the organization is expected to:
ensure the presence of Chief Executive and other Senior Executives during opening and closing meeting
ensure availability of all concerned personnel, relevant documents, records, etc.
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provide place for assessors for their meeting and discussion
provide a guide during assessment for each assessor.
Surveillance Audits :
Grant of Certificate of Registration will be followed by surveillance visits (generally once in 6 months), to verify the maintenance of QMS and continued compliance with ISO 9001 requirements.
Modification to the Scope of Certification :
An organisation holding a valid Certificate of Registration may apply for the modification to the scope of certification. The Certification body can at its discretion, decide either in favour of reassessment or fresh application as applicable.
Renewal of Certification of Registration :
The certificate of Registration is generally valid for a period of three years. For the purpose of renewal the organisation is required to apply for renewal three months before the expiry of the current validity period. The renewal application should be accompanied by the original copy of the Certificate Registration and applicable charges. The Certification Body may, at its discretion, decide for renewal of Certificate of Registration based on surveillance reports of the current validity period and re-assessment.
Suspension of Registration
Registration may be suspended for limited period of the discretion of the Certification Body under the following circumstances: If surveillance indicates minor non-conformance to the QMS requirements and the same is not cleared even after lapse of initial time period given for corrective actions
If the surveillance indicates major non-conformance to the QMS requirements If there has been any other contravention of the applicable requirements
Upon fulfillment of indicated conditions in the suspension notice within specified period, the suspension will be revoked.
Withdrawal / Cancellation of Registration:
Withdrawal of Certification of Registration and authorisation for the use of Logo and cancellation of registration will be resorted to under the following circumstances If the organisation under suspension fails to rectify non-conformance within specified period If the organisation cannot ensure conformance to changed rules of procedure If the organisation ceases to supply the product, process or services covered under the scope Failure to meet the financial obligations to Certification Body At the formal request of organisation Any other serious contravention of applicable requirements
Appeals:
There is a provision (or the applicant to appeal against any decision related to grant/suspension/cancellation/withdrawal of Certificate of Registration.
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Obligations of Organisation:
An organisation holding a valid certificate of registration shall:
(a) comply in all respects with the requirements of ISO 9001. (b) Not claim or imply that his product, process or service has been assessed, certified or approved. (c) Submit to the Certification Body for prior approval, the form in which he proposes to use the Certificate of Registration. (d) Not use the Certificate of Registration in any manner which implies or lead to interpretation as certification of his product process or service. (e) Not make any change to the QMS which formed the basis for grant or continuation of registration and which prevents compliance to the QMS standard. (f) Documents all changes made to the QMS and make available records of such changes to the Certification body (g) Notify the Certification Body of any change of key personnel in relation to quality assurance, technological functions or senior management. (h) Give access to the assessment team appointed by Certification Body for the purposes of assessment or surveillance. (i) Keep records of all customer complaints in respect of products, process or service and corresponding remedial measures. (j) Upon suspension or cancellation or withdrawal of Certificate of Registration, discontinue the use of Certificate of Registration and logo in all advertising material and other matter which contains any reference thereto. (k) Pay all financial dues to the Certification Body as prescribed.
Bibliography: Book on ISO 9001 implementation by Mr. Giridhar Gyani.
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ISO 9001:2008 Quality Management System

Scope of ISO 9001 in Hospitals

ISO 9001 Requirements

Approach for Development & Implementation

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Under ISO-9000: 2008, there are three Primary Standards:

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Evolution of Quality Management

Rework and Salvage Post rejection Exercise

Corrective action SPC Process Compliance

Preventive action Company wide QA Extensive use of QE tools

Continuous improvement Customer Orienta-tion Empowered employees

Total Quality Control (TQC)

Total Quality Management (TQM)

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Chapter 2 Benefits of ISO 9001 Certificate

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Chapter 3 Scope of ISO 9001 in Hospital

Out Patient Department (OPD)

Adequate manpower, equipment, laboratory etc.

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Chapter 3 Scope of ISO 9001 in Hospital

Wards, Nursing services and Operation theater:

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Chapter 3 Scope of ISO 9001 in Hospital

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Chapter 3 Scope of ISO 9001 in Hospital

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Chapter 3 Scope of ISO 9001 in Hospital

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ISO 9001:2008 Requirements

Requirements of ISO 9001:2008 are grouped in five major clauses.

1) QMS ; calls for establishing and maintaining of QMS

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ISO 9001:2008 Requirements

1.2 QMS Documentation shall include

All documents shall be controlled. Procedure shall be established to identify following

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2.0 Management responsibility

The quality planning shall be based on

a. Patients requirement b. Performance criteria of health care services c. Quality objectives

4.0 Product realisation

The Hospital/Healthcare unit shall plan:-

Customer related processes:-

Design & Development of Product

Input needed in such cases shall include following:-

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Design output report shall be prepared containing following:-

Production and service provision

5.0 Control of monitoring and measuring devices :-

Measurement, analysis and improvement

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Chapter 5 Approach for Development & Implementation

Milestones for ISO 9001: 2008

Development of Documentation i.e. Quality Manual, Procedures, Formats etc

Implementation Of documents as Per ISO 9001 Requirements

ISO 9001:2008 Certificate Awarded to The Hospital

Above milestones are mainly classified into QMS Implementation Steps.

6.4.1 Obtain top management commitment:-