ISO Certification for Pharmaceutical Industry

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Pharmaceutical industries have the responsibility upon themselves for ensuring the wellbeing of a society. As it is significant for our health and life, it is essential to maintain standard quality and efficiency of pharmaceutical products. Every stage of production of these products are required to undergo certain controls that ensure the safety of products. For this purpose, the International Organization of Standardization (ISO) publishes certain standards that help in maintaining the quality, efficiency, and safety of pharmaceutical products. Therefore, the demand for ISO certification Pharmaceutical industry is in constant rise. This also helps the pharmaceutical companies to prove their credibility in the market and move ahead of their competitors.

Which ISO Standards are best Pharmaceutical Industry?

The following are the list of ISO certifications applicable for pharmaceutical industries:

ISO 9001 Standard

ISO 9001:2015 is the most popular ISO certification for implementation of quality management systems in an organization. It can be applied to any industry and for pharmaceutical companies, it holds great importance as it ensures the quality, safety, and efficiency of pharmaceutical products as well as that of the processes through which the products pass.

ISO 14001 Standard

The growing concern over the deteriorating environment has prompted several legislations to check the adverse impact of business activities on the environment. With ISO 14001 certification, the pharmaceutical companies can establish and implement an environmental management system that would improve the organization’s interaction with the environment as well as make it compliant to any environmental laws.

ISO 45001 Standard

It is important to ensure the safety and wellbeing of your workforce in order to increase productivity. An ISO 45001 certification helps in implementing Occupational Health and Safety Management System in an organization that prevents any occupational safety risk.

ISO 50001 Standard

ISO 50001 certification demonstrates the ability of an organization in reducing its carbon footprint. With the help of this certification, the pharmaceutical companies can effectively utilize its energy resources and reduce wastage. By increasing the efficiency and cutting the costs, these organizations can achieve competitive advantage.

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Benefits of ISO certification for Pharmaceutical Industry

The Pharmaceutical Industry is indeed the backbone of any economy. It is also one of the most infamous sectors when it comes to causing irreparable damages to the environment. Thus, with the help of ISO Certification, these industries can maintain the balance between development and environmental sustainability to standardize their system and processes according to internationally recognized and accepted norms.

ISO certification ensures that there has been risk-based decision-making that would result in timely identification of risks, so that they can be prevented or mitigated on time.
It ensures an improved involvement of the leadership for effective implementation of the management system.
ISO certification ensures a smooth supply chain management.
Since ISO certification is a proof of credibility of an organization, it helps the pharmaceutical companies in delivering premium and safe products that meets the customer’s requirements.

ISO Certification process for Pharmaceutical 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 ISO certification Process

ISO certifications have huge significance across a varied range of industries. They not only help in improving the processes within the organization, but also ensure a smooth flow of services throughout the supply chain. Know more about Sis Certifications: Click

FAQs

What are the ISO requirements for the Pharmaceutical Industry?

The most commonly required ISO standards that are applicable for all kinds of Pharmaceutical Industry are as listed below:

ISO 9001 Standard: Quality Management System.
ISO 14001 Standard: Environmental Management System.
ISO 27701 Standard: Privacy Information Management System
ISO 45001 Standard: Occupational Health and Safety Management System.
ISO SOC Standard: System and Organisation Controls
ISO 22000 Standard: Food Safety Management System.
ISO GDPR Standard: General Data Protection Regulation

How do we become ISO Certified for the Pharmaceutical Industry?

Achieving ISO Certification is no big deal in today’s upgraded systems. The basic steps to become ISO Standards For Pharmaceutical Industry 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?

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 Pharmaceutical Industry?

Firstly, select the type of ISO certification you want for your Pharmaceutical 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?

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.

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