1.

Implementation steps:

Implementation of a QMS is a multi-faceted challenge. Here is a rough plan for

getting a QMS implemented:

1. General templates for all Controlled Documents that the company plans to

use should be drawn up before QMS documents are written. Templates

should have consistent styles and formats thus making them easy to read and

navigate. All template procedures and instructions should have purpose,

scope and responsibilities sections. Templates must also meet controlled

document requirements e.g. unique identifier etc. It is optional for a company

logo to be included in a document header.

2. Many companies will have written procedures already in place; however,

these current procedures may not be up to scratch in terms of being out of

date or incomplete etc. There may be some areas of the business, such as

finance, that are not seen to fall under the scope of the QMS and existing
procedures may be seen as the best option to achieve compliance.

Companies need to ensure these areas do not impact on overall quality

management.   

3. Companies should undertake a flowchart-style mapping of quality framework

management processes. This helps to include all stakeholders in the process,

highlights areas of non-compliance and missing documents, and is a great

method of identifying areas where change is needed.

 
 4. It is useful to map your QMS documents and structure according to hierarchy

using process/document maps and organisation charts.

5. Documents should be drafted according to the specifications in the document

maps; be aware of your audience and use appropriate language accordingly.

A large international company with bilingual staff may need to publish

documentation in several languages.

6. Electronic drafts should be managed appropriately. They should be

documented and filed so that they can easily be identified, retrieved,

reviewed, tracked and managed. The process used in the document control

mechanism should be consistent to that used in the drafting process.

7. It is important for all documents to be reviewed by Subject Matter Experts

from all areas affected by the document scope. Failure to review documents

may result in a reduction of compliance, increase the risk of deviation from the

QMS and create friction between staff/departments.

8. It is important to obtain the appropriate approval level for an issued document

which will be dictated by the compliance standard. Once issued and

approved, a hard copy of the document must be filed at a secure location.

Once documents are published staff can be trained to use them.

2.clinical documentation:
Clinical documentation (CD) is the creation of a digital or analog record
detailing a medical treatment, medical trial or clinical test.
Clinical documents must be accurate, timely and reflect specific services
provided to a patient. Paper or digital documentation is often accompanied
by supporting electronic files such as magnetic resonance imaging (MRIs)
scans, X-rays, electrocardiograms (EKGs) and monitoring records.

A document management system reduces the risk of non-compliance

with automated features such as recording retention schedules.
Having this system in place makes it easier to classify and store your
documents.

Purpose of Medical Documentation

The primary purpose of documentation in the hospital is to ensure that patients get
the care they need by providing medical professionals the information necessary to
make good care decisions, notes the Journal of AHIMA. While receiving medical
care, a patient is likely to deal with a variety of medical professionals, which may
include multiple doctors and nurses. Patients may also see providers at other
facilities for ongoing or follow-up care. Medical documentation also includes lab
test results and imaging from technicians that the patient may not even directly
speak to.

The patient's file should include a diagnosis and treatment plan as well as the
treatments that have already been administered. Clear and accurate medical
documentation ensures that any doctor or nurse just coming on shift will correctly
treat the patient. It also helps to prevent incorrect administration of medications.
The treatment plan helps to make sure the patient receives the follow-up care
needed to fully recover or manage an ongoing condition.

Finally, good medical documentation is critical in emergency situations. Doctors

need to know about a patient's diagnosis and underlying conditions to ensure the
treatments offered in an emergency don't cause harm.

3. ENVIRONMENTAL MANAGEMENT SYSTEM:

An efficient environmental management system helps you to control the

environmental footprint related to all these activities. ISO 14001 provides
a systematic approach to planning, implementing and managing your
environmental management system. Implementation allows your
organisation to control its environmental impact and ensure it meets legal
requirements, both national and international.

How ISO 14001 certification supports your

organisation
 The potential benefits of ISO 14001 are numerous, but the most
significant and tangible ones are that the standard enables your
organisation to: 

 Identify, understand and monitor the environmental impacts of your

activities and the risks involved.
 Be aware of the organisation’s direct environmental impact, as well as
indirect impact through you suppliers.
 Implement necessary controls in order to manage all factors impacting
the environment.
 Establish an environmental policy and objectives
 Comply with applicable legal requirements and meet stakeholder
demands.
 Continually improve your management system.
 Improve your resource management, including use of energy, which also
may imply a reduction in the cost of running your operations.
 Facilitate reductions in pollution, waste generation, chemical handling
and unintended discharges to the environment.
 Enhance your environmental performance over time.
One of the most important aspects of the standard is the inherent
commitment to continual improvement. When you are certified to ISO
14001 you will not only confirm that your environmental management
system meets the standard’s basic requirements and all applicable
legislation. You also commit to a continuous process of improvement to
ensure minimal environmental impact from your activities.

4. What Is NABH?
NABH -National Accreditation Board for Hospitals and Healthcare Providers is
 A part of the Quality Council of India which was established to offer
accreditation to healthcare providers and hospitals based on their adherence to
quality guidelines.
 An institutional member of the ISQua-International Society for Quality in
Healthcare. ISQua’s approval authenticates that NABH’s standards conform to
the global benchmarks set by it.
What Does NABH Accreditation Mean To Hospitals?
NABH accreditation is
 o The proof that the hospital provides quality healthcare as per global standards.
o The testimony that hospital wishes to increase the patient’s experience
positively.
o A mark of international recognition for any hospital.
o Valuable to the hospital for medical tourism.
Only 173 hospitals in India have NABH accreditation and 521 are working
towards it. 49 blood banks and only 2 dental hospitals have gained this
recognition

NABH Standards For Hospitals

Access, Assessment And Continuity Of Healthcare
The hospital should
o Define and display the services it provides.
o Have a well-defined registration and admission process along with a transfer and
referral system for inter-hospital transfer
o Educate patient and his family before taking decisions
o Offer initial assessment before patient care.
o Provide laboratory and imaging services as per the patient’s requirement.
o Provide established quality assurance and safety programs for laboratory and
imaging.
o Offer multi-disciplinary and continuous patient-care
o Document the discharge of patients

5. NABL
National Accreditation Board for Testing & Calibration Laboratories (NABL),
similar to the NABH, is also an autonomous body, under the Quality Council of
India. The primary objective being to maintain an accreditation system for
laboratories suitable for India, developed in accordance with relevant national
and international standards and guides. The NABL Accreditation is a formal
recognition of the technical competence of a laboratory based on third party
assessment and following international guidelines. Trained Assessors taken
from institutions all over India, with established credentials in testing and
calibration activities carry out the assessment.

Benifits of NABL for healthcare providers

 Superior competence in the process of calibration
 Potential increase in business due to customer confidence and satisfaction
 Recognition and greater reach of products in domestic & international markets
 Saving of time and money from  reduced retesting of products
 Better control of laboratory operations and feedback
Benefits of NABL for the people
 Assurance of genuine reports from accurately calibrated testing
 Confidence in personnel performing tests
 Elimination of the need for re-testing thereby saving money & time
  Satisfaction from the services provided.

NABL establishes trust and quality for labs where competence is concerned.

6. Security service in a hospital is a service responsible for ensuring the

security and safety of the hospital plant, personnel, patients and public as well
as regulating the traffic within the hospital premises.

 safety and security is the responsibility of every staff member, the technical staff,
being busy in patient care, have neither the time nor training in these matters.
Patients, by and large, are incapable of protecting themselves or their belongings.

Therefore, the hospitals have a separate and specialized department called security
service which is entrusted with the responsibility of watching over the entire hospital
organization and preventing anything untoward (of nonmedical, nontechnical nature)
from happening.

The role of security services is to prevent and handle any disturbance or breach in
security, so that the hospital functioning can go on smoothly and without any
disturbance.

Their core duties include the protection of hospital, its staff and property, the
patients/public and their property, control the traffic and also run a lost and found
service.

 There should be a security office and a control room conveniently located on

the ground floor and equipped with CCTV monitors and a good
communication system
 The Security service must be headed by an experienced security officer fully
trained in security techniques and procedures.
 Hospital should have a documented security manual for the hospital security
service including policies and procedure covering every aspect of the security
of patients, staff and the hospital property against any physical harm.
  The scope of their duty is to detect and prevent the commission of crime or
any harm to hospital, its property, patient’s staff or public.
  The security staff must have the telephone numbers of the nearest police station for
need in an emergency situation.
  Smoking and drinking should be strictly prohibited while on duty in the hospital
premises.

Because of the increasing incidence of safety and security violations in the hospitals, the
importance of an efficient security service is being increasingly realized. It is being realized
that a good security system, like a good lock, is a good investment and not expenditure.

7. Fire alarms;
Hospitals or other healthcare and critical facilities such as nursing homes are
important buildings in the community. Thus, it’s essential to make sure it’s
rightfully protected and secure from any type of damage or catastrophe. Due
to it’s large and complex construction type, the installation of fire alarm
systems for healthcare facilities may pose a challenge.

Because of this, it’s essential to have fire alarm systems that are efficient and
effective in detecting issues and responding appropriately to fire emergencies.

According to the NFPA 101 Life Safety Code:

“All healthcare facilities shall be designed, constructed, maintained, and operated

to minimize the possibility of a fire emergency requiring the evacuation of
occupants. Because the safety of healthcare occupants cannot be ensured
adequately by dependence on the evacuation of the building, their protection from
fire must be provided by appropriate arrangement of facilities, adequate staffing,
and development of operating and maintenance procedures."

Fire Alarm Systems in Hospitals: Important Considerations

Zoning

Proper zoning of fire alarm systems in any healthcare establishment is vital. It

helps determine where in the building, a potential fire emergency is taking place. It
also aids the fire department in locating the origin of the fire. When it comes to the
zoning of fire alarm systems in hospitals and patient-care facilities, the best
approach is to integrate the fire alarm zones with the smoke compartments.
Alerts and Notification

Fire alarm system notifications devices have improved over the years. Older
systems only used chimes or electronic bells. And older hospital buildings had
coded signals to distinguish the zone where the alarm was triggered.

Modern fire alarm systems in hospitals, on the other hand, come with powerful
speaker units that can both provide essential emergency communications and live
messaging functions.

Hospital Fire Alarm Systems: Proper Training and Procedures

NFPA 101 dictates emergency planning, training requirements, and fire drill are
required in every establishment. 

8. What is quality auditing?

Quality auditing is the systematic examination of an organization’s quality management
system (QMS). A quality audit is typically carried out by an internal or external quality
auditor or audit team. It is a key component of the ISO 9001 quality system standard.

Audits are usually conducted at agreed time intervals, ensuring that an organization has
a clearly defined system for quality monitoring. They can also help determine whether an
organization is compliant with the requirements of a specific quality system.

Why are audits important?

As well as being an integral part of compliance and regulatory requirements, audits are
essential for assessing the success of processes, products and systems—whether
existing or newly-implemented. They are also a vital tool for verifying objective evidence
of processes, and providing evidence for the reduction and elimination of any problem
areas.

The three types of quality audit

Process audit

A process audit determines whether an organization’s processes are working within

established limits. It measures conformance to any predetermined or industry standards,
as well as the effectiveness of any instructions.

Product audit

This type of audit examines whether a particular product or services conforms to the
necessary requirement—whether that’s specifications, customer requirements, or
performance standards.
System audit

A system audit verifies that all elements of a management system are effective and
appropriate, and have been developed, documented, and implemented in accordance
with the specified requirements.

First-party audit

A first-party audit is an internal audit designed to measure an organization’s strengths

and weaknesses against its own methods or procedures and/or against external
standards voluntarily adopted by–or imposed upon–the organization. The audit is
conducted by auditors who are employed by the organization being audited but who
don’t have a vested interest in the audit results.

Second-party audit

This is an external audit performed on a supplier by a customer or contracted

organization on the customer’s behalf. Second-party audits are typically more formal
than a first-party audit because the audit results could influence the purchasing
decisions of the customer.

Third-party audit

A third-party audit is performed by an independent organization with no conflict of

interest. This independence is a key part of a third-party audit, as it may result in
certification, recognition, license approval, a fine, or a penalty being issued by the third-
party organization or another interested party.

9. Safety Measures in the Hospital

Bed controls and safety
Ask your nurse how to use the bed controls. Never try to lower the bed's side rails or
climb over them. Keep your top two side rails up at all times. Ask for help to get out of
bed and wear slippers or shoes with non-skid soles. Never use a bedside table or over
bed stand for support; they may move. Be very careful in the bathroom; move slowly and
use the grab bar. Don't hesitate to call for help. Falls are the most common source of
patient injuries, especially falls from or near the bed. Your physician will order activity
based on your condition. Please check with your nurse before getting out of bed or
sitting. Use your nurse call button to get help. 

Dentures and eyeglasses

Dentures and eyeglasses should be stored in the drawer of your bedside table. You are
responsible for any personal items you bring to the hospital. 
Fire drills
Don't become overly concerned when you hear the sound of a fire drill alarm. Stay
where you are unless instructed otherwise by hospital personnel. Fire drills are routinely
conducted on all three shifts. 

Smoking
Mon Health Medical Center is a non-smoking facility. Visitors and patients are not
permitted to smoke or use tobacco products within the hospital or on hospital grounds. 

Personal electronic appliances

Hospital safety regulations prohibit the use of your own television or video games in the
hospital. Hospital personnel must perform electrical safety tests on any appliances you
bring from home before you use them at Mon Health Medical Center. Please ask your
nurse to call Facilities Management to check your personal appliances.  

Prescription drugs and herbal supplements

If you were taking prescription drugs before your hospitalization and brought them with
you, please show them to your nurse so he/she can record the information, and tell the
doctor about your current prescriptions. Send your medications home with your family or
friends after the nurse has reviewed them with you. Your physician will order the
medications you need in the hospital, and our staff will give them to you. 

If you have been taking any herbal products or dietary supplements, they may interact
with medications your doctor may prescribe while you are in the hospital and when you
go home. Let your physician and nurse know of any products you were taking at home.