GMP vs. ISO 9001: Understanding the Key Differences for Your Business!

Know the difference between GMP vs ISO 9001 certification. How do these help your business grow and boost success? And these are the main certifications for any business that are needed.

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Founder does many things for their business, especially those companies that are part of the food and pharma industries. These certification mainly works better for these industries, because these sectors are known to be very sensitive in terms of health and well-being. GMP vs ISO 9001 are both certifications used to ensure quality in a manufacturing unit.

GMP certification ensures the safety and quality of a manufacturing unit, mainly for the food and pharma industries. While the ISO 9001 certification is a voluntary standard for quality management systems, it is important for any industry focusing on customer satisfaction and continuous business improvement. Basically, GMP certification in India focuses on providing legal compliance for product safety, and it requires documentation and hygiene in your facility. The ISO 9001 certification focuses on the company’s overall management system and processes. 

1. Key Contrast Points on Both GMP vs ISO 9001 Certifications

Now, look at the key differences between these two certifications, that how these standards are used in your industry, their focus, scope, requirements, and goals, etc. Details are given below:

The GMP certification services in India are mandatory, while ISO 9001 is voluntary for any business or manufacturer globally. GMP mainly targets specific manufacturers related to food and pharma in terms of their product safety. The ISO 9001 certification targets the overall business quality management system of all manufacturers. Quality standards comparison ensures that the product is not harmful, and ISO ensures overall business quality and customer satisfaction.   

2. For Whom are These GMP & ISO 9001 Certifications Important?

Some companies need these certifications separately. But in the list, there are some businesses for which both certifications are crucial in terms of their growth. This includes those industries those safety becomes very crucial these are such as pharmaceuticals, medical devices, cosmetics, and food.

ISO 9001 is important for a general framework for overall quality management, which shows the commitment of different manufacturers towards consistency and customer satisfaction. And why do some companies need both certifications? Details are given below:

1. Mandatoriness – GMP certificate registration in India is a mandatory thing, whether you have ISO 9001 certification or not. For some specific industries that are sensitive. And it protects consumers by ensuring consistency in quality for products that are produced and controlled.
2. Due to quality systems – ISO 9001 certification is considered an international standard for a Quality Management System (QMS). This is universal because every manufacturer that manufactures products for some specific industries ensures they meet customer and regulatory requirements.

And there are some complementary benefits that are also included if a manufacturer has both certifications. Holding both these certifications sparks a company’s commitment to quality and safety to customers, partners, and regulatory bodies.  The strict production controls of the GMP certificate apply online can be improved by a strong QMS (ISO 9001), which can also decrease inefficiencies and improve processes. That’s why both certifications are important for some manufacturers. 

3. Process of Getting Both these Standards

The process of getting both certifications is kinda similar, for both GMP and ISO 9001 certification companies. Need to perform a gap analysis in their production unit and conduct quality management systems (QMS). Train their staff under the standards of both certifications, then conduct real audits with the help of an authorized body. And correct any non-conformities found.

Some detailed steps that are common for both GMP vs ISO certification in India

1. Gap analysis of your unit – Check your current process and systems against the GMP guidelines for identifying any non-compliance.
2. Documentation & Development – Creates and prepares the Quality Management System (QMS) and Standard Operating Procedures (SOPs) with all the necessary documents of your company.
3. Training – Ensures that your staff and employees are trained under the GMP and ISO guidelines to ensure widespread understanding and compliance.
4. Implementation – Then starts with processing your documents and systems into practice with the help of an organization.
5. Conducts internal audits – Then go for internal audits to verify that the implemented systems are functioning effectively in terms of meeting GMP and ISO requirements.
6. External Audit & Certification – After the internal, go for an external audit in which an authorized body will conduct a formal inspection. An audit of your facility processes and documentation to check that your unit is adhering to regulations.
7. Corrections – After the audits and inspections, if any non-compliance or issue is found in your manufacturing unit, address them with corrective actions.
8. Issuance – When all audits and procedures are completed, your certification will be issued for your company. 

4. Some Facts About GMP and ISO 9001 Certification

1. Did you know: ISO 9001 certification is a universal certification if you are a manufacturer, even if you don’t want it. It’s compulsory for you.
2. Did you know: The GMP certificate registration online is mandatory for some industries only, which include food, pharma, and cosmetic-related industries.
3. Did you know: The process of getting both certifications is kind of similar to the steps that are included for getting both are the same for businesses.
4. Did you know: The ISO 9001 certification uses the Quality Management System (QMS) standard for ensuring quality and safety in any product.
5. Did you know: A GMP certification even controls your manufacturing process of your unit, while the ISO 9001 doesn’t control anything; it just ensures quality management. 

5. LegalRaasta’s Role in Getting GMP & ISO 9001 Certification

We are a verified company in terms of providing different services for business founders and manufacturers. The GMP certification and ISO 9001 service are available on our website. Get the GMP vs ISO 9001 easily with our help. ISO 9001 certification for startups and scaling companies is also available at LegalRaasta for any business owner and sellers. A trusted company that helps you in your growth and success, and works to provide legal services without any hurdles. ISO 9001 certification service providers are fewer in the market. And we are one of them for getting these services easily. We also provide many services like virtual CFO, company registration, LLP registration, NBFC registration, etc. By which you can easily get what you want from our website. Financial leadership in uncertain markets.