Sample iso 2008 quality manual




















Normally companies charge for various types of quality manuals for small industry or medium to large corporate but this one set has two quality manual sets.

This helps you choose the way you want your quality manual to be. Click Buy Now for various product options. Check bank account information here - Write to us at mail isohelpline. Contents Kit containts following: 2 sets quality manual 6 mandatory procedures 30 other procedures and work instructions 35 forms samples Sample set of quality manual, procedures, work instructions and forms. Revised to edition. The kit contains following documents in a structured manner: Documentation structure A three tier documentation is best approach to document quality management system.

The three tiers of a quality management system can be defined as: 1. Forms Formats for making records Quality Manual Documentation Kit contains two Quality Manual samples and one sample set of procedures, work instructions and forms.

One advantage of electronic documents is that links to other documents, of any type, can be embedded in the document. In the example QM, links are represented by blue underlined text, but they are simulated. In your real document, each link would actually point to a real document on your file server.

This ability makes control of documents easier. Therefore, whenever someone clicks on the link, they will always — and only — see the current version of the referenced document. The older version can be saved under a different name; the easiest way to do that is to simply add the revision date, in ISO format 2 , to the file name.

For example, assume that procedure QP with the revision date of November 10, is being replaced with a new version revised today. No links have to be changed, and the date added to the old version file name uniquely identifies it.

Sharp readers will also note that a version of ISO date format appears in a number of places in the example QM. The date is always written with the biggest time unit year on the left and the smallest time unit day of month for dates on the right.

One advantage is that the format is unambiguous and culture-independent. Another is that a date in this format as part of the file name is always sorted in correct order by a computer.

The most common permissible exclusion is clause 7. However, it is generally not a good idea to simply omit the excluded parts from the QM. It is much better to include reference to them, specifically state that they are excluded and why, and what the plans are if the current situation ever changes. Section 7. In some cases, such as the case of the example QM, the scope of the QMS is so tightly defined that functions normally part of the QMS are actually performed by organizational departments that are outside the defined QMS.

In the case of Mythical True Value Metrology, purchasing is an example of that. The metrology organization only has limited authority for small purchases; all others must go through the corporate purchasing department, which is not part of the QMS. In cases like this, the organization should do two things. First, the QM should describe what they can do, including the limits on it. The QM should also state that other parts of the parent organization — the parts outside the boundary of the defined QMS — are treated as suppliers or customers, as appropriate.

This is shown in section 7. In a situation like this, it is also important that the parent organization be on the approved supplier list! In the example system, Mythical True Value Metrology has to be sure Mythical Airlines is on the approved supplier list for relevant services and products. As used in 7. In many industries, such as aviation, this is important to prevent the introduction of inferior counterfeit parts into the manufacturing or maintenance operations.

As used by metrology calibration organizations and in section 7. These are similar concepts, but in the first case traceability refers to the origins of a physical item, and in the second case it refers to the documented uncertainty of a measurement result — a number. The example QM is for an organization that is hypothetically registered to ISO and also operates in a regulated industry.

This means that there are cases where regulatory requirements may need to be addressed in the QM. A specific regulatory requirement has been added to the QM in a logical place. The same can be done for other requirements — add them to the QM in a location where it makes sense in the organization of the manual.

For example, if Sarbanes-Oxley compliance is a requirement, the logical place to add it might be the Management Responsibility section of your QM. The example quality manual for Mythical True Value Metrology, a service-providing organization, is presented as an example and training aid.

It demonstrates several issues of a quality management system, especially issues that may arise in a regulated industry or in a small department that is registered separately from the rest of the parent organization.

While this is written to demonstrate how the organization meets the requirements of ISO , the concept can be extended to any conformance or compliance requirement, or simply as a recognized best business practice. Service requirements are defined. Contract requirements differing from those previously expressed are resolved, if any.

The Hospital has the ability to meet the defined service requirements. The results of the review and subsequent follow-up actions are recorded in the customer file. Where the customer does not provide any documented statement of requirements, the customer requirements are consociated before acceptance, wherever required.

It is ensured that, wherever service requirements are changed, the relevant documents are amended and the concerned persons are made aware of the changed requirements. Note: Such awareness is relevant in the case of service information catalogues, brochures, advertisements etc. The Hospital identifies and implements effective arrangements for communicating with the customer relating to following:.

Service information. Through information catalogues, brochures, advertisements etc. Enquiries, contracts including amendments.

Customer feedback including Customer complaints. Criteria for selection, evaluation and periodical re-evaluation of suppliers are established. The results of evaluations and necessary follow up actions are recorded and maintained. R eference:. Quality management system requirements.

The Hospital ensures the adequacy of specified purchase requirements contained in the purchasing documents, prior to their communication to the supplier.

The purchasing order can be verbally, telephonic or through purchase order. Making available, information that describes the characteristics of the service. Availability of work instructions, as necessary. Using and maintaining suitable support services. Availability and use of the monitoring and measuring devices, where applicable. Implementing of monitoring and measurement activities, where applicable. The implementation of release and post-service activities.

The Hospital identifies, the service provided by suitable means throughout the process of service realization. The Hospital does identify the status of the service with respect to monitoring and measurement requirements. The Hospital does control and record the unique identification of the all the patients to whom the service has been provided. The Hospital takes care of the customer property like medical documents etc.

The Hospital identifies, verifies, protects and safeguards the property of customer. The Hospital duly informs the customer if any of the customer property is lost damaged or is otherwise found to be unsuitable for use. This covers identification, handling, storage and protection. The Hospital ensures that medicines, equipment, documents, patient items used in the Hospital are maintained and delivered in a manner that prevents damage, deterioration and loss.

Instructions have been given to staff for handling, storage, preservation and timely delivery of services to patients so as to achieve the highest level of customer satisfaction. The diagnostic records etc. The Hospital ensures that the services provided match the treatment plan evolved during the initial visit of the patient and in the time frame as decided during the initial consultation.

On completion of the treatment, the patient is given detail record. When the results of calibration are found to be unsatisfactory or the instrument goes out of order , the equipment is immediately discontinued from use and the service agency is informed. The equipment is put back in use only after the defect is satisfactorily rectified. In addition the Hospital assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements.

When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed. This is undertaken prior to initial use and reconfirmed as necessary. The Hospital does define, plan and implement the monitoring, measurement, analysis and improvement processes needed:. To demonstrate conformity of the service. To ensure conformity of Quality Management System. To continually improve the effectiveness. The Hospital does monitor information relating to customer satisfaction as one of the measurements of performance of the quality management system.

The Hospital also monitors information relating to customer perception for fulfillment of customer requirement. The methodologies for obtaining and using this information are determined. The Hospital conducts periodic planned internal audits at least once in nine month to determine whether the quality management system:.

Conforms to planned arrangement of the requirements of the International Standard and to the Quality Management System established by the Hospital. That the internal audit system is effectively implemented and maintained. The Hospital plans the audit program taking into consideration, the status and importance of the processes and areas to be audited, as well as the results of the previous audits.

The audit criteria, scope, frequency and methods are defined. Selection of auditors is done in a manner, which brings about objectivity and impartiality of the audit process. In case the audit is conducted departmentally then it is ensured that no person conducts audit in respect of his own area of activity.

A documented procedure QP 8. Management takes timely corrective actions on deficiencies found and eliminates non-conformities and the causes detected during the audit without undue delay. Follow up activities includes the verification of the implementation of corrective actions, and reporting of verification results. These methods do demonstrate their ability to achieve planned results.

The Hospital monitors and measures the characteristic of the service, to verify that requirements for the service are fulfilled. This is carried out at appropriate stage of the service realization process according to planned arrangement. Evidence of conformity with the acceptance criteria is documented in the patient file. Records do indicate the person authorizing for release of service. Discharge of patient does not proceed until all the planned arrangements have been satisfactorily completed, unless otherwise approved by the relevant authority and where applicable by the customer.

The Hospital ensures that the service, which does not confirm to the requirements, is identified and controlled to prevent unintended use, delivery and treatment. The control and related responsibilities and authorities for dealing with non-conformance service are defined in a documented procedure QP 8. The Hospital collects and analyzes appropriate data to determine the suitability and effectiveness of the Quality Management System and to evaluate where continual improvements of the Quality Management System can be made.

The Hospital analyses this data, to provide information on:. Customer satisfaction. Conformance to service requirements. Characteristics and trends of processes and service including opportunities for preventive action.

The Hospital plans and manages the processes necessary for the continual improvement of the effectiveness of Quality Management System and facilitates the continual improvement of Quality Management System through the use of Quality Policy, Quality Objectives, Audit results, Analysis of data, Corrective and Preventive actions and Management Review. The Hospital takes actions to eliminate the cause of non-conformity in order to prevent recurrence. Corrective actions are appropriate to the effect of non-conformities encountered.

The documented procedure QP 8. Reviewing Non-conformities including customer complaints. Determining the causes of non-conformities. Evaluating the need for actions to ensure that non-conformities do not recur. Determining and implementing the action needed.

Recording results of action taken. Reviewing of corrective action taken. The Hospital determines action to eliminate the causes of potential non-conformities in order to prevent their occurrence. Preventive action s taken are appropriate to the effect of the potential problems.

Determining potential non-conformities and their causes. Evaluating the need for action, to prevent occurrence of non-conformities. Determining and implementing preventive action needed. Reviewing of preventive action taken. Patient Relation. To give the patients immediate and right treatment. Counseling of the relatives while admission by CMO Billing. Reporting of the investigation to consultant RMO. Administering the deliverance of inpatient care on time with accuracy and zero error.

He shall be the head of the medical department, responsible for supervision of the doctors and making policies for them. He shall hold meetings with the RMO incharge weekly. He sees the establishment and administers the proper treatment and medicines to the patient by RMO.

He shall be answerable for all the medico legal cases. He shall be the head medical records and responsible for making policies for medical records. Communicating with the consultant in case if there is any problem. He shall examine every patient on admission and make proper entries thereof and take care that such medicines as he may think proper for their certain and speedy cure be duly administered. He shall see every patient once a day and oftener, if requested.

He shall order and be responsible for the drugs, surgical instruments and books belonging to the asylum and he shall report the case of every patient fit for discharge to one or more of the Committee of Visitors. At each monthly meeting he shall state the number of patients received and discharged, the number of deaths, the manner of employment, the weekly cost of maintenance with such matters as may appear as desirable.

He shall be responsible for the management and condition of the establishment of the medical, surgical and moral treatment of the patients and of all general arrangements within the institute, and in case of emergency shall have the power of calling on the assistance of any physician or surgeon.

He shall also in all cases of fatal or dangerous accident or other emergency immediately communicate to the Director. He shall regulate the duties of the Doctors and and prepare from time to time a manual there of for their guidance. He shall review all the discharge summaries before giving it to the patients. He will make sure that all the medical policies are adhered by the RMOs. Helping Director or Medical superintendent in drafting policies and implementing them. Address RMO inter-personal issues.

He shall lead the team of RMOs and motivate the time to time. He shall handle all the medico legal issues. He should take round everyday ,speak to the patient relative and ask for feedback. At each monthly meeting he shall state the number of patients received and discharged the number of deaths, DAMA, any mismanagement at our end. He shall be responsible for the management and condition of the establishment of the medical, surgical treatment of the patients and of all general arrangements within the institute, and in case of emergency shall have the protocol of calling on the assistance of any physician or surgeon.

He shall also in all cases of fatal or dangerous accident or other emergency immediately communicate to the medical superintendent. Resident Medical Officer R. As such no moment the Hospital can be left uncovered by R.

Even at the end of his shift, he will not leave the post till the other RMO takes over. Though a patient as always admitted being on the spot under a consultant, but he on the spot, will be responsible for either first-aid if consultant has not seen the case or for carrying out the orders of that consultant.

He will ensure that all advised tests and procedures are carried out without any delay. He should also make sure that uncommon abbreviations are not used in the case sheet.

He will sign the case sheet with his comments during all his rounds. He will also consult the specialists at time of requirements. He will also accompany the consultants, when they come on round and will ensure that all his orders are carried out. The Nursing department assists all the patients for bedside nursing care,mediaction and administrative functions in the ward.

To give the patients comprehensive nursing care which will help the patients in the recovery. The Matron will be responsible to the MS for the administrative and technological aspects of nursing in the hospital. Her charter of duties will include the following:.

Standard is maintained all the time. Punctuality of staff working under her. Availability of material consumable and non-consumable items. Availability of life-saving drugs. Availability and functioning of the saving equipment. To check and ensure the judicious use of telephone. Administrative duties of her will include the following:. General: A nurse by the very nature of her duties is in closer touch with the patients and therefore is in a better position to win his confidence.

It is the duty of every nurse to uphold the noble traditions of her profession and dedicate herself to the care of patient in her charge. She should pay particular attention to her turnout and conduct.

While maintaining the dignity and decorum of her profession, she must at all times be cheerful, kind and courteous and sympathetic towards her patients and their anxious relatives.

These qualities along with professional skill will win her respect and cooperation of her patients. She must remember as good nursing is as important part of efficient patient care as good doctoring.

These duties will be as follows:. Technical nursing care comprises those tasks and activities concerned with the treatment and management of the particular illness of which the patient is suffering. These will be as follows:. Main points in nursing duties and responsibilities Clinical :. Admission and Discharge of patients.

Getting discharge summery prepared by RMO. Informing the reception about the room no. Informing all transfers to the reception. Assistance and instructions to the patients and their relatives. Personal hygiene of the patient, viz. Serving and removing hot water bottles, bedpans and urinals.

Feeding of patients who can not eat themselves. Ward rounds with Nursing Superintendent, M. Assisting doctors in carrying out certain procedures whenever required.

Assisting or actually carrying out technical procedures, sterilization preparation of injections, indenting of medicines, giving enemas, oxygen therapy etc. Collecting samples for investigation whenever required. Getting all tests done, which the treating doctor ordered.

Taking and recording of vital signs like Pulse, Temperature and Respiration. Escorting patients to and from departments. OT, either herself or with the help of ward boy. At each change of over, the outgoing nurse will go with the incoming to each patient from bed to bed, room to room and thus hand over to the patient.



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