ISO Certification for Healthcare Industry | ISO 13485 , 15189 , 9001, 14001, 45001, 27001 ,22301 ,10002 ,26000 ,20000 ,GMP ,HACCP | Accredify Global
The Healthcare industry involves all the institutions that ensure the health and safety of people. It includes drug manufacturers, hospitals, pharmacies, medical devices industries, and so on. The quality of products and services and efficiency of processes are extremely important in this industry. For this purpose, the International Organization for Standardization (ISO) publishes a certain set of ISO Certification for Healthcare Industry that can help the organizations belonging to the healthcare sector in demonstrating their credibility in the market.
How is ISO Certification helpful for the Healthcare industry?
ISO certification is beneficial for the healthcare industry by promoting a culture of quality and continuous improvement, leading to enhanced patient safety, operational efficiency, and overall patient satisfaction through standardized practices, regular audits, and a focus on identifying areas for improvement, ultimately building trust with patients and stakeholders.
Why do ISO certification for Healthcare Industry?
ISO certification in the healthcare industry is important because it demonstrates a commitment to quality, patient safety, and operational efficiency by adhering to internationally recognized standards, which ultimately builds trust with patients, improves service delivery, and can lead to better overall patient outcomes by identifying areas for improvement and promoting continuous quality improvement within the organization; essentially, it signifies a healthcare provider is taking proactive steps to ensure high-quality care is consistently delivered.
- The ISO Certification helps you to build a bridge to get hold of international attention in the world economy.
- Helps you to show your commitment to satisfying the customers.
- The ISO certification helps with offering significantly more capability in how the consignments are systematized.
Which ISO Standards are best Healthcare Industry?
The following ISO Certification for hospitals/healthcare industry are applicable to the organizations belonging to the healthcare sector.
ISO 13485:2016 Standard
Ensures quality, safety, and regulatory compliance in medical device manufacturing. Reduces product defects by up to 40%.Essential for manufacturers, suppliers, and distributors of medical devices.
ISO 9001:2015 Standard
ISO 9001 certification is an internationally accredited standard for quality management systems (QMS). This standard helps in the accomplishment and maintenance of quality management systems (QMS) in your organization so that the quality of your products, as well as processes, are top-notch.
ISO 14001:2015 Standard
ISO 14001 Certification is the general standard for Environment Management Systems. ISO 14001 standard helps in the execution of Environmental Management Systems (EMS) in your organization to make sure that your products and services are not causing environmental damage. It also helps your organization to minimize the harmful impacts of your processes in the environment.
ISO 45001:2018 Standard
ISO 45001 Certification is an internationally required standard which is probably the most important one for your organization, as it ensures the safety and wellbeing of your manpower, contractors as well as the nearby population. This standard helps in the implementation of Occupational Health and Safety Management Systems (OHSMS) in your organization.
ISO 27001:2022 Standard
ISO 27001 Certification is a globally recognized standard that helps in implementing Information Safety Management Systems (ISMS) in your organization that would protect the data stored within your premises from any breach or loss.
ISO 22301:2019 Standard
Ensures operations remain functional during crises. Reduces downtime by 60%, enhancing resilience. Minimizes downtime and financial losses.
ISO 10002:2014 Standard
Improves customer feedback management. Enhances brand reputation and consumer trust. Reduces customer complaints by up to 30%.
ISO 26000:2010 Standard
Encourages ethical sourcing and fair trade practices. Supports sustainable agriculture and food production. Builds consumer trust in ethical food brands.
ISO 20000-1:2018 Standard
Ensures efficient IT management in hospitals and medical institutions.Reduces system downtime and improves patient data security. Enhances interoperability between healthcare IT systems.
GMP : Good Manufacturing Practices Certification
Ensures safe and hygienic food production.Prevents contamination, cross-contamination, and foodborne risks.Essential for food processing units, bakeries, and packaging plants.
HACCP: Hazard Analysis and Critical Control Points
Identifies and controls food safety hazards. Ensures hygienic food production and distribution.Reduces risk of contamination and recalls by up to 50%.
ISO Certification process for Healthcare Industry
- Application & contract
- Audit team Assignment
- Document view
- Certification Audit Independent review
- Notification of Certification
- Surveillance audit
- Re-Assessment
The certification process goes further. click here to view the next steps to the ISO certification Process
ISO certifications have huge significance across a varied range of industries. They not only help to improve the processes within the organization but also ensure a smooth flow of services throughout the supply chain.
Services
Benefits of ISO Certifications for healthcare industries
- Assures the customers about the quality and safety of products
- Gives a boost to the reputation of the organization and helps them in winning tenders
- Makes the organizations compliant to the related laws.
- Helps in cost savings due to reduced premium.
- Helps in meeting customer’s requirements by continually improving the system.
Why Choose Accredify Global for ISO Certification?
Accredify Global is a leading ISO certification body, operating in 95+ countries, offering:
- Certified auditors with expertise in the education industry.
- 30% faster certification process than competitors.
- Tailored compliance solutions.
- 24/7 support for audits, quality management & compliance.
- Affordable pricing & flexible certification plans.
FAQs
What are the ISO requirements for healthcare industries
Answer: The most commonly required ISO Certification healthcare industry that are applicable for all kinds of healthcare sector are as listed below:
- âś… ISO 13485:2016 - Medical Devices Quality Management System (MDQMS)
- âś… ISO 9001:2015 - Quality Management System.
- âś… ISO 14001:2015 - Environmental Management System.
- ✅ ISO 45001:2018 – Occupational Health & Safety (OHS)
- âś… ISO 27001:2022 - Information Security Management System (ISMS)
- âś… ISO 22301:2019 - Business Continuity Management (BCMS)
- ✅ ISO 10002:2014 – Customer Satisfaction & Complaints Handling
- âś… ISO 26000:2010 - Social Responsibility
- âś… ISO 20000-1:2018 - IT Service Management for Healthcare
- âś… GMP : Good Manufacturing Practices Certification
- âś… HACCP: Hazard Analysis and Critical Control Points
How do we become ISO Certified for the healthcare industries?
Answer: Achieving ISO Certification is no big deal in today’s upgraded systems. The basic steps to become ISO Certificate for healthcare industries are as follows: > Firstly, you need to prepare all the relevant information about your company in a systematized way (It is always best and safe to hire a legal consultant.) > Secondly, you need to document all the relevant information about your business. > Thirdly, you have to implement all the documented information in your organization. > Fourthly, get ready for the internal audits which are performed first during the certification process and then periodically after. > Lastly, if the certifying body approves your management system then you will be awarded the required ISO standard.
How long is an ISO certificate valid for?
Answer: An ISO Certificate is valid for 3 years. And during this time period of 3 years, a surveillance audit is conducted on an annual basis to ensure that ISO quality standards are being maintained by the organization.
How can I apply for ISO Certification for the healthcare industry?
Answer:
Firstly, select the type of ISO certification you want for your healthcare industry.
Secondly, selecting a recognized and credible ISO certification body (ISO Registrar)
Thirdly, make an application in the prescribed form which should include liability issues, confidentiality, and access rights.
Fourthly, the ISO certification body will review all the documents related to various policies and procedures being followed in the organization. If there are any existing gaps, the applicant has to prepare an action plan to eliminate these gaps.
Then, the ISO registrar will conduct a physical onsite inspection to audit the changes made in the organization.
As soon as the certifying body approves your management system, you will be awarded the required ISO standard.
How much does it cost for ISO certification?
Answer: Basically, when you approach a certifying body for ISO Certification and they approve your management systems and all your processes, they will then quote an amount for the certificate. Moreover, the cost for achieving ISO certification depends mostly on your organization, such as the no. of employees in your organization, No. of branches your organization has, and many more.