ISO CERTIFICATION FOR HAND SANITIZER

The Hand Sanitizer Market is expected to grow exponentially worldwide in response to the high demand for Personal Hygiene Products after the outbreak of the COVID-19 Pandemic. As the demand for hand sanitizers skyrocket, the number of companies diving into the manufacturing and marketing of these products also increases. This heated competition is forcing companies to be more professional, organized, and efficient in their process by implementing quality management systems like ISO 9001 and GMP (Good Manufacturing Practice).  The following are some of the reasons why seeking ISO certification for hand sanitizer is no more a choice, but a necessity.

• To maintain a competitive advantage over their competitors.                                          
• In response to a regulatory or statutory requirement.                                       
• Competitors have obtained the certification and they have no choice but to get certified. 
• Certification is demanded by their customers or vendors.   

QUALITY MANAGEMENT SYSTEMS FOR HAND SANITIZER 

There are different types of quality management systems adopted by manufacturers of the hand sanitizer industry. For example, ISO 9001 Certification is the most widely used management tool and it is the most popular quality management system in the world.  GMP is the mandatory quality management system enforced and mandated by the US Food and Drug Administration (FDA) for producers of pharmaceuticals, medical devices, foods, beverages, dietary supplements, and cosmetics. In the United States, GMP regulations for Good Manufacturing Practices are outlined in Title 21 CFR.

ISO 9001 AND GMP FOR HAND SANITIZER

It is convenient and cost-effective for the hand sanitizers to integrate GMP and ISO 9001 Quality Management Systems. Both ISO 9001 and GMP cover a lot of areas, such as requirements in terms of documentation of a firm’s processes into standard operating procedures, staff training, traceability, manufacturing area requirements, risk management, etc. 

Implementing and integrating multiple quality management systems like GMP and ISO 9001 has many advantages. It can enhance and credibility of your company, helps you avoid developing and maintaining multiple lists of quality management system documents, and helps you increase your market share by expanding your market reach to other countries outside of the United States.

IMPLEMENTATION OF ISO 9001 FOR HAND SANITIZER

ISO 9001 starts with a GAP Analysis of your existing quality management system compared to the desired Quality Management System. Our ISO 9001 implementation process for Hand Sanitizer can save you money, time, and other valuable resources. 

At LMG New York, we understand that each company is set up unique to its own way of operation.  Our unique and step by step process can be tailored to your unique needs and can be implemented without disrupting the day to day operations of your business. Our highly specialized and flexible consultants can fast-track the implementation of the ISO Quality Management System for Hand Sanitizers cost-effectively and within your required time frame.

ISO 9001 CERTIFICATION PROCESS FOR HAND SANITIZER

ISO Certification for Hand Sanitizer process includes:

• GAP analysis of your existing Quality Management System related to ISO 9001 requirements.
• Developing documents such as quality manual, procedures, forms, templates.
• ISO awareness training
• Review of your Standard Operating Procedures (SOP)
• Implementing a well-documented Quality Management System throughout your organization.
• Internal Audit identifying non-conformities related to ISO 9001 requirements.
• Management Review Meetings
• Corrective and preventive actions /Root cause analysis addressing non-conformities.
• Certification body (Registrar) selection
• Certification body (Registrar) audit support
• Closing of any non-conformities found by the certification body
• Issuance of ISO 9001 Certification

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