What is Auditing?
Auditing is nothing more than a verification of compliance with the status of the Quality System implemented.
Some people use an analogy of auditing as inspection or checking of a certain process, but, in brief, it is one of the quality tools for checking the compliance status that the company is in.
What are the benefits of Auditing?
Auditing offers several benefits, but the main two are: The first benefit is an indication of non-conformities. That is, a survey of what is not in accordance with rules to be followed by the company, regulatory agency or certification organism. The Audit shows where the Quality System non-conformities are. The Audit is able to show non-conformities in documentary, physical, operational, etc.
The second major benefit is its corrective and preventive actions, which is the ability to bring a clear view of the process and help with necessary corrections. The Audit not only shows problems and / or failures, but in the course of the process it is able to assist in their resolution and create solutions to prevent the problem and / or failure.
What is the connection between Quality System and Audit?
Auditing is a tool that assists in verifying the effectiveness of the Quality System. It is the careful checking of the entire systemic implantation, if it is functional, what are the errors and failures, how to solve them and other indication about the quality standards.
It can be applied in any company, regardless of size, aiming at continuous improvements and, consequently, organized growth in the company.
How can Stone Okamont help in this process?
Stone Okamont has specialized professionals to carry out audits in companies. The Audit is carried out in a preparatory manner, that is, if the company wants or needs the Certification of Good Manufacturing Practices, Stone Okamont performs an audit to verify and correct the implementation of the Quality System, so that, when the auditors of National Health Surveillance Agency (ANVISA) inspect the company or carry out the certification audit, the company has no problems or reservations with the regulatory agency.
Stone Okamont also offers other types of Audit, such as Auditing for Licensing purposes, to obtain the Operating License. Stone Okamont checks and evaluates the implanted system to know if it will be in accordance with the requirements necessary to acquire the license.
How does an International Audit work?
A company can request International Audit services in order to check the Status of its Quality System.
This Audit can have several functionalities, such as checking the status of the Quality System implanted with an international view of a differentiated auditor, or having its focus on your product, to know the observations of non-conformity or applicable vulnerabilities, another option is to harmonize the system, for a common or specific certification (ANVISA, ISSO, etc.) with another country, according on its activity.
In the case of a Harmonization, Stone Okamont is requested by the company to carry out a systemic assessment, in order to understand where are and what are the breaking points and adjustments between the country of origin and the destination. The Audit is carried out to show what is critical or not, how the regulatory system of the country of origin is and what its specifications are. Then, Stone Okamont performs the same process of checking the regulatory system of that activity in Brazil (or another destination country) and its requirements, to harmonize the systems according to the application of the legislation of each country.
What is System Harmonization in an International Audit?
As we have seen, a company that intends to export must be in compliance with the legislation of the country of origin and the country of destination. But this is not a simple process, since many laws and regulations are different in their application according to each country. That is, if something in Germany is allowed, in Brazil it may be prohibited, or a differentiated verification is necessary.
Stone Okamont understands this process and specializes in harmonizing foreign legislation with a focus on the Brazilian market.
This means that Stone Okamont can harmonize systems, so that the product / service reaches Brazil and it is applied according to the standards of the certifying agencies. This process is complex, as it requires a thorough knowledge of national and other countries' legislation. The Stone Okamont team, with years of experience, can be the great differential to find the solution in an agile, simplified way and without unnecessary expenses, since it offers specialized technicians, with knowledge in several languages and who perform international audits, guaranteeing functional processes and transparent.
Solving your problems ...
Stone Okamont is prepared to solve your problems and present you the best ways to carry out all the necessary audits. Whether for licensing, certification, product or even international purposes, Stone Okamont has a specialized team that will bring quick, simple solutions, with no extra costs and with zero bureaucracy!
