BIS Certificate For Hospital Planning [Compliance & Certification Guide]

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.