Management System Certification

ISO 13485 – Medical devices

Quality management system certification for organizations working in the design, development, production, installation or sale of medical devices and related services. Quality management system certification for organizations working in the design, development, production, installation or sale of medical devices and related services. The certification of quality management systems for medical devices supports organizations in this sector to achieve regulatory compliance and to meet the needs of their clients, both for companies and for related services.

What Is ISO 13485 Certification?

The ISO 13485 standard shares its structure with that of ISO 9001 and includes important factors such as sterile manufacturing, traceability and risk assessment. This permits the monitoring of the full healthcare-product production process, from design conception to end destination. ISO 13485 compliance enables organizations to meet quality system requirements around the world, including those set by the FDA in the United States, the Canadian authorities and the European Union.

Key Benefits

• Ensures compliance with international regulatory schemes
• Ensures compliance with client requirements
• Enables the full monitoring of products, from design conception to end destination
• Fosters recognition and confidence in the medical device industry
• Provides access to national and global markets
• Increases efficiency
• Enhances the company’s reputation

Why Certify With GITCHIA Certification?

GITCHIA Certification is a prestigious independent body that was established to help organizations achieve their aim of continuous improvement. We assess the specific needs of our clients so that our auditors, who specialize in the sectors in question, can add maximum value while evaluating an organization’s compliance. Our teams of professionals draw up customized certification plans taking into account client structures, processes and areas of activity. Our global presence, extensive product portfolio and wide-ranging accreditations enable us to provide our clients with a comprehensive, expert and tailor-made service.

ISO 14001 – Environmental Management

Certification of environmental management systems; International standard ISO 14001 helps companies to control their environmental impact and achieve sustainable growth. It belongs to the ISO 14000 family of environmental management standards that were drawn up in 1996. Following the United Nations Conference on Environment and Development, also known as the Earth Summit that was held in Rio de Janeiro in 1992 ISO’s Technical Committee 207 set out to work towards achieving sustainable development.

The implementation and certification of an environmental management system demonstrates that a company is complying with current environmental legislation and assessing and minimizing environmental risks. ISO 14001 certification also supports companies in accessing new markets and fostering new client relationships. This standard can apply to any company, regardless of sector or size.

ISO 14001:2015 Update

This standard was initially published in 2004 and was then updated in 2015. Companies were given three years from the date of publication to make the transition. The new version still helps companies to reduce waste, save energy and boost their reputation vis-à-vis clients and suppliers. The key difference is that it is now based on a high-level structure. This new framework facilitates the integration of the ISO 14001 standard with those of other management systems. This enables companies wanting to certify to several ISO standards that share the same structure to make savings in terms of both time and money.

What Are The Benefits Of ISO 14001?

The primary advantage of implementing and certifying to the ISO 14001 standard is the chance for a company to create a robust and efficient environmental management system with which it can demonstrate its commitment to sustainable development. The certification of such a system is of benefit to companies both internally and externally.

At an internal level, ISO 14001:

• Helps a company to detect and address its weak points through a risk assessment of its environmental processes
• Increases productivity by offering greater control over processes
• Significantly reduces quality-related costs by guaranteeing compliance with environmental legislation
• Strengthens the relationships between departments as a result of the leadership and staff involvement required
• Enables improvements in product or service design through the checks carried out at every stage of their life cycle

At an external level, ISO 14001:

• Offers businesses a competitive advantage over market competitors
• Improves a company’s image by publicly demonstrating its environmental commitment
• Increases confidence among clients and end users
• Boosts access to new markets that value corporate environmental responsibility

Who Is This Standard Targeted At?

The ISO 14001 standard is designed to apply to any company, regardless of its size, sector or geographical location. It is a voluntary standard; in other words, an organization can decide for itself if it wishes to implement it. By doing so, the company’s environmental management system will offer added value to the business.

Why Certify With GITCHIA Certification?

GITCHIA Certification is the GITCHIA management-system certification unit. It is founded on the principles of independence and impartiality. Our end goal is to:

• Help our clients achieve and demonstrate their commitment to ongoing improvement
• Ensure that our clients’ products gain access to international markets
• Certify our clients’ compliance with the most exacting of standards by way of second-party and third-party audits.

Iso 22000 – Food Safety Management System

Food safety management systems certification. The food industry supply chain is increasingly complex and global, requiring the adoption of common food quality and safety standards, which allow increasing the fluidity of relationships and ensure some common criteria for all the parties in the chain.

What Is ISO 22000?

The ISO 22000 certification in food and agriculture sector companies helps ensure food safety throughout the food chain to the end consumer or sales outlet. This international standard applies to organizations involved in primary production, food producers, retailers, catering companies, and service companies related to the field of food safety (cleaning and disinfection, transportation, storage and distribution, etc.).

Who compiled ISO 22000 ?

ISO 22000 is an international standard originating from ISO, the International Organization for Standardization. It is the result of collaborative and collective work by all stakeholders across the world. 35 countries participated in the latest update, which was finalized in June 2018. France is very much involved in the development of ISO 22000, via GITCHIA’s “traceability and food safety – management and hygiene” Standardization Commission which brings together professionals in the field from around thirty organizations: representatives of the State, industrialists, consumers, certification bodies, as well as universities, schools and institutes. Participation is open to all. It is essential for ISO 22000 and all international standards to meet the expectations of professionals in France. The standardization of management methods, product specifications and analysis methods has increased over the years. Almost 140 countries participate in the ISO Technical Committee for the agri-food industry, with more than 840 documents already published and kept up to date.

Why use ISO 22000 ?

Setting up a food safety quality management system leads to the deployment of resources to ensure the safety of products and services. This is an approved prevention and continuous improvement tool. The PDCA (Plan, Do, Check, Act) cycle is deployed at two levels: the first of these applies to the management system, the second to the HACCP principles. Like any international standard, ISO 22000 facilitates dialogue and saves time: by applying it, you are using a recognized, globally shared method. ISO 22000 builds trust with your suppliers, customers and interested parties in the food chain. It promotes effective communication with them by identifying potential hazards and by defining the measures to be implemented to control these hazards when they occur. However, ISO 22000 certification does not attest to the safety of a product, or of its fitness for use.

Benefits Of ISO 22000 Certification

Manage and control food safety risks in all the supply chain’s parties:

• Help compliance with the food legislation applicable to each organization
• Provide effective communication with the parties involved in food safety and an increase in clients’ and consumers’ trust
• Integrate the food safety management system with the company’s quality management system (ISO 9001)
• Achieve an industry-recognized certification
• Increase your organization’s competitiveness

Why With GITCHIA Certification?

GITCHIA Certification is an independent and renowned entity that aims to help organizations achieve their commitment to continuous improvement. We analyze the clients’ needs so that our auditors, who are specialists in each field, perform a service that provides the maximum value evaluating your organization’s compliance. Our teams develop specific certification plans according to our clients’ structure, processes and activities. Our international presence, extensive product portfolio, and accreditations allow us to offer global and expert service, tailored to your organization’s needs.

ISO 45001 – Occupational health and safety

The new, international ISO 45001 standard supersedes the British OHSAS 18001 standard. Both share the same objective: helping businesses to prevent accidents and manage health and safety in the workplace. In 2015, ISO (International Organization for Standardization) began work on ISO 45001 with a view to developing a truly international standard that could bridge the divide created by OHSAS 18001. The main aim of this new standard is to protect all workers around the world with a single version of the standard. The final draft of ISO 45001 was approved in January 2018 and the standard was published in March. Companies have 3 years to make the transition to the new standard before OHSAS 18001 is repealed.

What Are The Benefits Of Iso 45001?

Occupational accidents and illnesses not only affect worker health and safety, but also have a major impact on organizations as a whole. ISO 45001 certification offers companies a variety of advantages, including:

• Improved management of incidents and a subsequent reduction in lost time
• Reduced insurance premiums and general cost savings related to health and safety incidents
• Reduced absenteeism and turnover rates
• Simplified communication with overseas suppliers, clients and partners
• Enhanced company image through a demonstration of social responsibility
• Improved competitive advantage

Who Is This Standard Targeted At?

Any organization can implement and certify a management system under ISO 45001, regardless of its size or sector. The standard is particularly aimed at companies wanting to:

• Minimize risks to staff and other stakeholders through the implementation of an internationally recognized health and safety management system
• Maintain and constantly improve on performance levels in the area of health and safety
• Adjust all operations to comply with the health and safety policies set out in this international standard

Transition From OHSAS 18001 To ISO 45001

The new standard was published on 12th March 2018 and there is a transition period in force for all companies wishing to remain certified. As of 11th March 2021, occupational health and safety management systems will need to be certified under ISO 45001. Understanding the principal aspects of the new standard is vital to ensuring a successful transition. GITCHIA Certification runs training courses to help clients understand how the changes will affect them and to explain the benefits of certifying to ISO 45001 standard. Our highly experienced team of auditors can also offer clients a professional audit of their management systems and certify their compliance with the new requirements.

How Does The New Standard Differ From OHSAS 18001?

The new ISO 45001 standard differs from OHSAS 18001 in a number of key respects, principally in terms of structure and content. The following are some of the new features to be found in ISO 45001:

• Terms and definitions. ISO 45001 provides more definitions, including new concepts such as “Performance evaluation”, “Context of the organization”, “Support”, “Leadership”, “Operation”, “Improvement”, “Planning” and “Worker participation”.
• Context of the organization. To implement ISO 45001, a company’s internal characteristics –its structure, objectives, policies and strategies, amongst other things – must first be taken into account. It is also a prerequisite to consider any external context that may impact on the management system – the cultural, social and economic climates, for example – as well as to assess competencies.
• Leadership and worker participation. While OHSAS 18001 refers only to leadership, clause 5 of the ISO 45001 standard brings in worker participation and consultation. It also places greater emphasis on the responsibility of management throughout the process.
• Planning. The new standard more clearly defines the requirement to identify hazards by assessing risks and opportunities. This facilitates the prediction and mitigation of undesired effects on processes.
• Support. Here, the primary difference between the new standard and OHSAS 18001 is that in ISO 45001, resources are listed under “Documented information” and not “Documents and records”.
• Operation. ISO 45001 incorporates controls on all processes and includes the identification of potential emergency scenarios so that an appropriate response can be planned.
• Performance evaluation. The new standard also covers the management system’s monitoring and measurement. The aim is to make it easier to meet the compliance obligations. This assessment is also fundamental as it feeds into both the internal audit and the management review.
• Improvement. This section is divided into two parts. The first refers to incidents, nonconformity and corrective action. The second details continual improvement, with objectives defined and the process of achieving them explained.

Why With GITCHIA Certification?

• GITCHIA Certification is an independent and renowned entity that aims to help organizations achieve their commitment to continuous improvement.
• We analyze the clients’ needs so that our auditors, who are specialists in each field, perform a service that provides the maximum value evaluating your organization’s compliance.
• Our teams develop specific certification plans according to our clients’ structure, processes and activities.
• Our international presence, extensive product portfolio, and accreditations allow us to offer global and expert service, tailored to your organization’s needs.

PS:3733-2022

Halal Certification is becoming mainstream in the food industry. As the worldwide Muslim population has crossed 1.6 billion, the demand for producing and packaging foods processed according to Islamic dietary laws using chicken, mutton, beef, and other ingredients is growing day & night.

Halal Certification is a third-party verification that products, processes, or systems in the supply chain meet accepted Halal Standards. Halal Certification provides a “Systematic Approach” that ensures the products’ features and quality according to the rules established by the Islamic Council that allow the mark Halal.

‘Halal Certified’ refers to products that have been endorsed as Halal by a credible Islamic body (Third-party certification).

Frequently, Halal Certification involves a series of steps, including ingredient verification, inspection/audit, and approval by a committee. Cosmetics and pharmaceuticals are also Halal Certified. Frequently, these products contain animal by-products.
Alcohol is present in perfumes.
Pig-fat is present in lipsticks and lip balms.
Makeup products actively contain the by-Products of animals like cows, goats, pigs, chickens, turkeys, etc.

FSSC 22000 v5.1

We are providing Food Safety System Certification 22000 (FSSC 22000) through our sister company EAC. Food Safety System Certification 22000 (FSSC 22000) is a robust, ISO-based, internationally accepted certification scheme for auditing and certification of food safety within the food and beverage manufacturing sector.
FSSC 22000 is a Food Safety Management Certification Scheme, managed by Foundation FSSC 22000 and governed by an independent Board of Stakeholders which consists of representatives from several sectors in the food industry. FSSC 22000 is used to control food safety risks.
The Food Safety Certification requirements provide a rigorous system to manage food safety risks and provide safe products for use by companies in the food industry.
FSSC 22000 is a GFSI recognized food safety certification. This allows your customers to have confidence in your food safety program and know that you have a rigorous food safety system in place.

ISO 27001 – Information Security Management

Certification of information security management systems Information is one of the most important of any company’s assets. Organizations handle and store a vast amount of confidential or sensitive data in their systems, which must remain accessible as well as secure at all times.An information security management system (ISMS) allows organizations systematically and efficiently to understand, manage and minimize information-security risks. The appropriate implementation and certification of such a system provides an assurance of the confidentiality, integrity and availability of stored data.

 Certified information security management systems foster confidence among clients and improve company efficiency. ISO 27001:2013 is currently the most widely recognized standard for managing information security. This international standard was drawn up by ISO (International Organization for Standardization) in 2005 in order to safeguard the security of company-held information. It was revised in 2013 in response to needs that had become apparent during the eight years the standard had been in use. One change made was the standard’s alignment with Annex SL, bringing it into line with a high-level structure. This new structure permits organizations to enhance their health and safety and environmental performance and also facilitates the standard’s integration with other management systems.

What Are The Objectives Of An ISO 27001:-Certified ISMS?

• To protect data and guarantee its security
• To identify risks resulting from data storage
• To facilitate understanding of the standard and its integration with other management systems

What Are The Benefits Of ISO 27001?

• Reduced information-security risks (data loss, theft, corruption, etc.)
• Legal compliance
• Reduced costs and improved functioning of processes
• Enhanced client confidence that data entrusted to the organization will be handled appropriately
• An improved competitive advantage
• Increased staff awareness of the importance of information security
• Improved organizational efficiency
• Simpler integration with other management-system standards such as ISO 9001, ISO 14001 and ISO 45001

Who Is This Standard Targeted At?

Any organization can certify its ISMS under ISO 27001, regardless of its size or sector. At the moment, this standard is implemented most frequently by IT, insurance, retail and transport companies, as well as public sector bodies.

Why Certify With GIGC Certification?

GIGC Certification is a prestigious independent body that was established to help organizations achieve their aim of continual improvement. We assess the individual needs of our clients so that our auditors, who specialize in the sectors in question, can add maximum value while assessing an organization’s compliance.

Our team of professionals draw up customized certification plans taking into account the client’s structure, processes and area of activity. Our global presence, extensive product portfolio and wide-ranging accreditation enable us to provide our clients with a comprehensive, expert and tailor-made service.

Agriculture And Food HACCP Certification

Enhance your food safety management and product quality with an HACCP (Hazard Analysis and Critical Control Points) certification from GIGC. HACCP certification instantly demonstrates to customers your commitment to producing or trading in safe food. This evidence-based approach can be particularly beneficial when you are subject to inspection by regulatory authorities or stakeholders. Demonstrating a real commitment to food safety through HACCP compliance can also transform your brand and act as an effective entry-to-market tool, opening up new business opportunities around the world. Our global network of food experts carries out HACCP audits and helps you focus on the hazards that affect food safety and hygiene. It is then possible to systematically identify where the hazards are by setting up control limits at critical points during the food production process.

HACCP certification is an international standard defining the requirements for effective control of food safety. It is built around seven principles:

• Conduct Hazard Analysis of biological, chemical or physical food hazards
• Determine critical control points
• Establish critical control limits, for example, minimum cooking temperature and time
• Establish a system to monitor control of Critical Control Points
• Establish corrective actions
• Establish procedure for verification to confirm that the HACCP system is working effectively
• Establish documentation and record keeping

Benefits of HACCP

The primary purpose of a HACCP system is to protect people from food borne illness, but the benefits of the system also extend to the company.

• Increased confidence in your products
• Ability to reach markets and customers that require a HACCP based system
• Reduced Liability
• Effective process management
• Improved quality and consistency

Why Certify With GIGC Certification?

GIGC Certification is the GIGC management-system certification unit. It is founded on the principles of independence and impartiality. Our end goal is to:

• Help our clients achieve and demonstrate their commitment to ongoing improvement
• Certify our client’s compliance with the most exacting of standards by way of second-party and third-party audits
• Ensure that our clients’ products gain access to international markets.

Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any production that cannot be eliminated through testing the final product.

Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a food or drug product is safe for human consumption. Many countries have legislated that food, pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.

All guidelines follow a few basic principles:

• Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.
• Controlled environmental conditions in order to prevent cross contamination of food or drug product from adulterants that may render the product unsafe for human consumption.
• Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
• Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
• Instructions and procedures are written in clear and unambiguous
• Operators are trained to carry out and document procedures.
• Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations are investigated and documented.
• Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
• The distribution of the food or drugs minimizes any risk to their quality.
• A system is available for recalling any batch from sale or supply.
• Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.

The key benefits to GMP certification:

• Prove organization’s management capabilities in product quality, safety assurance
• Enable employees to develop good production / operations habits
• Reduce safety risk in product quality and safety
• Timely detect production and management problems, reduce cost
• Better understand and comply with the relevant laws and regulations
• Enhance the international credibility and public image
• Increase customer’s long-term confidence in the enterprise

Why Certify With GIGC Certification?

GIGC Certification is the GIGC management-system certification unit. It is founded on the principles of independence and impartiality. Our end goal is to:

• Help our clients achieve and demonstrate their commitment to ongoing improvement
• Certify our client’s compliance with the most exacting of standards by way of second-party and third-party audits
• Ensure that our clients’ products gain access to international markets.

Vegan Certification

Vegan certification highlights the importance your cosmetic brand places on animal well-being and allows you to share a wider message with your consumers regarding your brand’s ethics and values.

Among other elements, a vegan-certified cosmetic product is defined as containing no animal ingredients or by-products, using no animal ingredients or by-products in the manufacturing process and no testing on animals by any company or independent contractor.

As a reminder, European Cosmetics Regulation EC No 1223/2009 banned animal testing on cosmetic products in 2004 and on cosmetic ingredients in 2009 and 2013 (Article 18). Since the Common Criteria in EU No 655/2013 prohibit any marketing communications that would “convey the idea that a product has a specific benefit when this benefit is mere compliance with minimum legal requirements” (Legal Compliance criterion, §3), claiming that a product is “cruelty-free” is therefore illegal in the EU. As of today, there are not many ways of providing such information to the consumer without raising compliance issues. However, the claim “vegan” is an option since its definition encompasses non-animal testing, among other requirements. 

NON-GMO Certification Program

A GMO, or genetically modified organism, is a plant, animal, microorganism or other organism whose genetic makeup has been modified in a laboratory using genetic engineering or transgenic technology. This creates combinations of plant, animal, bacterial and virus genes that do not occur in nature or through traditional crossbreeding methods.

Genetic modification affects many of the products we consume on a daily basis. As the number of GMOs available for commercial use grows every year, the Non-GMO Project works diligently to provide the most accurate, up-to-date standards for non-GMO verification.

FDA Certification

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

FDA also plays a significant role in the Nation’s counter terrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats. GIGC support their customers for the registration of following products

• Medical Devices.
• Vaccines, Blood, & Biologics.
• Tobacco Products.
• Animal & Veterinary.
• Radiation-Emitting Products.
• Food
• Drugs
• Cosmetics

Gluten-Free Certification Program

The Gluten-Free Certification Program (GFCP) is designed for retailers, manufacturers, food service providers and farmers obliged to conform to various government regulations and/or the Codex Alimentarius gluten-free science based guidelines. Delivered by third-party ISO/IEC 17021-1 IDA accredited certifying bodies, GFCP is a non-prescriptive HACCP-based standard that is endorsed by the leading North American celiac organizations and administered by the Allergen Control Group.

Gluten-Free Certification Organization

The Gluten-Free Certification Organization (GFCO) certifies many thousands of products. It is a voluntary program developed in 2005 by the Gluten Intolerance Group (GIG) of North America, a non-profit association funded by private donations. Targeting retailers, manufacturers and farmers, GFCO uses quality assessment and control measures to assure consumers that their food is safe. Certification involves risk assessments, plant audits and equipment and product testing, at the plant and at the point of consumer purchase. Finished products bearing the GFCO logo must contain 10 ppm or less of gluten.

Benefits of Certification

Our gluten-free program provides credible, verified and science-based gluten-free certification with a label consumers can trust. The program demonstrates compliance to FDA gluten-free labeling guidelines and provides additional assurance to consumers through facility inspection and testing.

Why Gluten-Free Certification for Your Organization

Gluten-free certification is a process designed to protect consumers with celiac disease and other gluten-related disorders by confirming that a food, drink or supplement meets strict standards for gluten-free safety. It assures consumers that there is third-party oversight confirming the legitimacy of the manufacturer’s gluten-free processes and claims. There are several certifying owners that offer gluten-free certification, and each has its own criteria to ensure safety for consumers.

In the grocery store, certification seals hopefully make it easier to identify safe and trusted products. Products that have been certified gluten-free will typically bear a symbol on the label, so customers with celiac disease and other gluten-related disorders can quickly and easily recognize the symbol and know that the product has earned approval.

GITCHIA Endorses Gluten-Free Certification Program

GITCHIA endorses the Gluten-Free Certification Program ,a food safety-based gluten management system for manufacturers, which was created by the Allergen Control Group. GITCHIA has brought this system to the UK. As the food industry becomes increasingly globalized, GITCHIA believes that international certifications such as this Gluten-Free Certification will play a critical role in ensuring that our gluten-free food supply is truly safe and trusted.

The GFCP is a management system and facility-based certification. This means that the program does not rely solely on product testing to ensure safety, but examines the entire practices and production process of the facility – from ingredient sourcing to employee training, cleaning practices, cross-contact controls, operational management and, finally, an effective end-to-end testing plan.

The GFCP approves only those facilities that continually meet strict, good manufacturing practices for gluten-free production. Certification audits are conducted annually by trained and approved, independent International Standard for Organization (ISO) and third-party accredited auditing companies. Products manufactured in facilities that have earned GFCP certification may bear a clear and easy-to-recognize certification trademark from the GFCP and endorsed by GITCHIA, on their packaging.

By having qualified third-party professionals involved in each major step of the certification process, the GFCP supports a system of checks and balances eliminating any potential for conflict of interest between the manufacturer’s relationship with and the program, its certifying bodies and/or GITCHIA.