Did you know hospitals without proper certification risk patient safety, reputational damage, and hefty penalties? Therefore, hospitals must ensure a safe and compliant environment. That’s where the BIS Certificate for Hospital Planning comes into play.
The healthcare industry must meet strict standards to guarantee hospital facilities’ safety, quality, and efficiency. However, navigating these regulations can be overwhelming, especially with compliance protocols that seem to grow more complex each year.
Hence, this guide will break down everything you need to know about obtaining a BIS certification for hospital planning. From understanding what BIS certification involves to why it’s essential and how to get started, we’ll help you make informed, confident steps toward certification. Whether you’re a hospital administrator, healthcare planner, or equipment supplier, this article has the insights to ensure your facility is up to standard and ready to provide safe, reliable care for every patient.
What Is The BIS Certificate For Hospital Planning?
The BIS certificate is a certificate issued by the Bureau of Indian Standards which is crucial for hospital planning in India. BIS regulates standards to ensure the quality, safety, and performance of goods and services across industries. BIS certification helps hospitals establish standardized guidelines for infrastructure, safety measures, and equipment.
With the proper BIS certification, hospitals can assure patients of a secure and efficient healthcare environment. Obtaining a BIS certificate for hospital planning ensures that healthcare institutions comply with government standards. This compliance can also improve patient satisfaction, build trust, and support hospitals in maintaining an excellent reputation.
Why Is BIS Certification Important for Hospital Planning?
BIS certificate is important for Hospital Planning as it enhances safety and helps in maintaining high-quality patient care. With a BIS certificate for Hospital Planning, hospital administrators can confidently operate, knowing their facilities are built to handle patient’s needs safely.
Without BIS certification, hospitals may face penalties, risk reputational damage, and compromise patient safety. Therefore, complying with BIS standards is a smart way to protect the institution’s reputation while fulfilling legal obligations.
Who Needs BIS Certificate For Hospital Planning?
Any institution building, managing, or operating a hospital facility must secure BIS certification. This requirement is especially critical for new healthcare facilities but also applies to hospitals undergoing major renovations or upgrades. Here’s who typically needs BIS certification:
- Hospital Administrators: Those responsible for hospital operations must ensure that the facility complies with BIS regulations to avoid legal issues.
- Healthcare Planners: Architects and planners play a key role in designing facilities that align with BIS standards.
- Equipment Suppliers: Many suppliers must also adhere to BIS standards if their equipment is to be used in certified hospitals.
BIS certification is thus essential for various stakeholders in the healthcare industry to create a safe, effective, and compliant facility.
How To Apply For BIS Certificate For Hospital Planning?
Here we have mentioned the steps to apply for BIS Certification For Hospital Planning:
- Know the BIS Standard: First, find out which BIS standard applies to your hospital planning. For example, IS 12433: 1988 is a common standard for hospital design. Make sure your plans match the guidelines in that standard.
- Submit Your Application Online: Now go to the BIS website https://www.manakonline.in to create an account and start your application. Remember to upload all the required documents, like project designs, compliance details, etc.
- Follow the Certification Process: After submitting the application, share all the required details about your hospital plans. Arrange for any testing that might be required through a BIS-approved lab. BIS officials might also visit your site to check if it meets the standards.
- Receive Your Certification: Once everything is verified, BIS will issue the certification for your hospital project.
By following this process you can apply to get BIS certificate for Hospital Planning. However, if you need help you can hire a consultant who’s experienced with BIS certifications. ELT Corporate is here to help you.
List Of Indian Standards Of BIS For Hospital Planning
Here we have listed down products covered under BIS certificate For Hospital Planning:
SI. No. | IS No. | TITLE |
---|---|---|
1 | IS 10905: Part 1: 1984 | Recommendations for basic requirements of general hospital buildings: Part 1 Administrative and hospital services department buildings |
2 | IS 10905: Part 2: 1984 | Recommendations for basic requirements of general hospital buildings: Part 2 medical services department buildings |
3 | IS 10905: Part 3: 1984 | Recommendations for basic requirements of general hospital buildings: Part 3 Engineering services department buildings |
4 | IS 12377: 2016 | Classification and matrix for various categories of hospitals (First Revision) |
5 | IS 12433: Part 1: 1988 | Basic requirements for hospital planning: Part 1 up to 30 bedded hospital |
6 | IS 12433: Part 2: 2001 | Basic requirements for hospital planning: Part 2 up to 100 bedded hospital |
7 | IS 13808: Part 1: 1993 | Quality management procedures for – Patient department (OPD) and emergency services – Guidelines: Part 1 up to 30 bedded hospitals |
8 | IS 13808: Part 2: 1993 | Quality management procedures for diagnostic and blood transfusion services – Guidelines: Part 1 up to 30 – Bedded hospitals |
9 | IS 13808: Part 3: 1995 | Quality management for hospital services (Upto 30 – Bedded Hospitals) – Guidelines: Part 3 wards, nursing services and operation theatre |
10 | IS 13808: Part 4: 1996 | Quality management for hospital services (For 30 – Bedded Hospital) – Guidelines: Part 4 hospital support services |
11 | IS 13808: Part 5: 1996 | Quality management for hospital services (For 30 – Bedded Hospital) – Guidelines: Part 5 hospital equipment management |
12 | IS 15195: 2002 | Performance guidelines for quality assurance in hospital services up to 30 – Bedded hospitals |
13 | IS 15461: 2004 | Performance guidelines for quality assurance in hospital services up to 100 – Bedded hospitals |
14 | IS 15551: 2003 | Quality management systems – Guidelines for process improvements in health service organizations |
15 | IS 15784: 2007 | Healthcare facilities – Particular requirements |
16 | IS 15902: 2011 | Guidelines For Nursing Home |
17 | IS 15903: 2010 | Guidelines For Maternity Nursing Home |
18 | IS 15904: 2011 | Guidelines For Single Doctor Clinic–Including Dental Clinic |
19 | IS 17722: 2021/ISO/TS 22583:2019 | Guidance for supervisors and operators of point-of-care testing POCT devices |
20 | IS 17723: 2021/ISO 22870:2016 | Point-of-care testing POCT Requirements for quality and competence |
21 | IS 23485: 2019 | Medical devices – Quality management system requirements and essential principles of safety and performance for medical devices |
22 | IS/IEC 62366 : Part 1 : 2015/IEC 62366-1:2015 | Medical Devices Part 1 Application of Usability Engineering to Medical Devices |
23 | IS/IEC 80369 : Part 5 : 2016/IEC 80369-5:2016 | Small-bore connectors for liquids and gases in healthcare applications Part 5 Connectors for limb cuff inflation applications |
24 | IS/IEC 80369: Part 6: 2016/ISO 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications Part 6 Connectors for neuraxial applications |
25 | IS/IEC/TR 62366: Part 2 :2016/IEC/TR 62366-2:2016 | Medical Devices Part 2 Guidance on the Application of Usability Engineering to Medical Devices |
26 | IS/ISO 13485: 2016/ISO 13485:2016 | Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision ) |
27 | IS/ISO 14971: 2019/ISO 14971 :2019 | Medical devices – Application of risk management to medical devices First Revision |
28 | IS/ISO 15189: 2012/ISO 15189 :2012 | Medical laboratories – Requirements for quality and competence (Second Revision) |
29 | IS/ISO 15190: 2003/ISO 15190:2003 | Medical Laboratories — Requirements for Safety |
30 | IS/ISO 15195: 2018/ISO 15195:2018 | Laboratory Medicine — Requirements for the Competence of Calibration Laboratories Using Reference Measurement Procedures |
31 | IS/ISO 15197: 2013/ISO 15197 :2013 | In vitro Diagnostic Test Systems —Requirements for Blood-GlucoseMonitoring System for Self-Testing Managing Diabetes Mellitus |
32 | IS/ISO 15198: 2004/ISO 15198:2004 | Clinical Laboratory Medicine — In vitro Diagnostic Medical Devices — Validation of User Quality Control Procedures by the Manufacturer |
33 | IS/ISO 15223: Part 1: 2016 | Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( Second Revision ) |
34 | IS/ISO 15223: Part 2: 2010/ISO 15223-2: 2010 | Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied: Part 2 symbol development, selection, and validation |
35 | IS/ISO 16142: Part 1: 2016/ISO 16142-1: 2016 | Medical Devices — Recognized Essential Principles of Safety and Performance of Medical Devices Part 1 General Essential Principles and Additional Specific Essential Principles for all Non-IVD Medical Devices and Guidance on the Selection of Standards |
36 | IS/ISO 16142: Part 2 :2017/IS/ISO 16142-2: 2017 | Medical devices – Recognized essential principles of safety and performance of medical devices: Part 2 General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
37 | IS/ISO 17511: 2020/ISO 17511:2020 | In Vitro Diagnostic Medical Devices – Requirements for Establishing Metrological Traceability of Values Assigned to Calibrators, Trueness Control Materials, and Human Samples |
38 | IS/ISO 17822: Part 1: 2014/ISO 17822-1: 2014 | In vitro diagnostic test systems – Qualitative nucleic acid – Based in vitro examination procedures for detection and identification of microbial pathogens: Part 1 general requirements, terms and definitions |
39 | IS/ISO 18250: Part 1: 2018/ISO 18250-1:2018 | Medical devices – Connectors for reservoir delivery systems for healthcare applications – Part 1 General requirements and common test methods |
40 | IS/ISO 18250: Part 3: 2018/ISO 18250-3:2018 | Medical devices – Connectors for reservoir delivery systems for healthcare applications – Part 3 Enteral Applications |
41 | IS/ISO 18250: Part 6: 2019/ISO 18250-6:2019 | Medical devices – Connectors for reservoir delivery systems for healthcare applications – Part 6 Neural Applications |
42 | IS/ISO 18250: Part 7: 2018/ISO 18250-7:2018 | Medical devices – Connectors for reservoir delivery systems for healthcare applications – Part 7 Connectors for intravascular infusion |
43 | IS/ISO 18250: Part 8: 2018/ISO 18250-8:2018 | Medical devices – Connectors for reservoir delivery systems for healthcare applications – Part 8 Citrate-based anticoagulant solution for apheresis applications |
44 | IS/ISO 20776: Part 1: 2019/ISO 20776-1:2019 | Susceptibility Testing of Infectious Agents and Evaluation of Performance of Antimicrobial Susceptibility Test Devices Part 1 Broth Micro-Dilution Reference Method for Testing the In vitro Activity of Antimicrobial Agents Against Rapidly Growing Aerobic Bacteria Involved in Infectious Diseases |
45 | IS/ISO 20776: Part 2: 2007/ISO 20776-2:2007 | Clinical Laboratory Testing and In-vitro Diagnostic Test Systems — Susceptibility Testing of Infectious Agents and Evaluation of Performance of Antimicrobial Susceptibility Test Devices Part 2 Evaluation of Performance of Antimicrobial Susceptibility Test Devices |
46 | IS/ISO 23640: 2011/ISO 23640 :2011 | In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents |
47 | IS/ISO 35001: 2019/ISO 35001:2019 | Biorisk management for laboratories and other related organizations |
48 | IS/ISO 62304: 2015/ISO 62304 :2015 | Medical device software – Software life cycle processes |
49 | IS/ISO 80369: Part 1: 2018/ISO 80369-1:2018 | Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 1 General Requirements |
50 | IS/ISO/TR 24971: 2013/ISO/TR 24971: 2013 | Medical devices – Guidance on the application of ISO 14971 |
51 | IS/ISO/TR 80002: Part 2 :2017/ISO/TR 80002-2:2017 | Medical Device Software Part 2 Validation of Software for Medical Device Quality Systems |
52 | IS/ISO/TS 20658: 2017/ISO/TS 20658:2017 | Medical Laboratories – Requirements for Collection, Transport, Receipt, and Handling of Samples |
53 | IS/ISO/TS 22367: 2008/ISO/TS 22367:2008 | Medical Laboratories – Reduction of Error through Risk Management and Continual Improvement |
When Should You Start The BIS Certification Process?
The BIS certification process can be time-consuming, so starting early is essential. Certification should be initiated for new hospitals during the design and planning phase to avoid costly adjustments later. The earlier you integrate BIS standards into your planning, the smoother the application process.
What Are The Key Challenges In Obtaining BIS Certificate For Hospital Planning?
Obtaining a BIS certificate for hospital planning involves several challenges. Here are a few common issues:
- Complex Documentation: The documentation requirements can be extensive and may need input from various departments, such as engineering, safety, and architecture.
- Strict Compliance Standards: BIS standards are stringent, and minor oversights can delay certification. Facilities must be designed and built with close attention to detail to meet all BIS requirements.
- Ongoing Maintenance: Even after certification, hospitals must maintain compliance through regular audits and updates to equipment or safety protocols as required by BIS standards.
Though these challenges seem daunting, hospitals can overcome them with thorough preparation and support from compliance specialists.
What Is The Purpose Of BIS Certificate For Hospital Planning?
BIS certification ensures that Hospital Planning meets specific safety and quality standards, providing a reliable environment for patient care.
Can BIS Certification Help Reduce Hospital Operational Risks?
Yes, BIS certification establishes a framework for safety and quality, reducing risks associated with facility operation and management.