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'quality management system'

Items tagged with 'quality management system'

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Food Safety Standards

Ensure Transparency and Trust with Non-GMO Certification Offered by Shark Certification Pvt. Ltd., Indore As global consumers grow increasingly conscious about the origins of their food and feed, demonstrating that your products are free from genetically modified organisms (GMOs) has never been more important. At Shark Certification Pvt. Ltd., we help businesses build consumer confidence through Non-GMO Supply Chain Certification that verifies every step of production meets stringent non-GMO standards. What is Non-GMO Certification? Our Non-GMO Supply Chain Standard ensures that your product—whether it's a single ingredient or a fully processed food item—is traceable and compliant from seed to shelf. Certification is based on key EU regulations, including Directive 2001/18/EC, and Regulations 1829/2003 & 1830/2003, providing a robust foundation for global market access. This certification applies to: Seed Providers and Farmers Traders and Processors Storage and Transport Providers Sampling and Testing Laboratories We conduct independent audits of your quality management systems, focusing on GMO traceability, legal compliance, and proper labelling practices throughout the entire supply chain. Certified organizations are subject to annual surveillance audits to maintain ongoing compliance and market credibility. Key Areas Covered Under the Standard Seed selection and GMO-free verification Crop cultivation, harvest, and post-harvest handling Transportation and warehousing procedures Processing and packaging operations Sampling, testing, and analytical methods Final product labelling and legal compliance This certification is ideal for companies aiming to demonstrate full transparency, reduce risk, and meet consumer expectations in the non-GMO food and feed markets. Protect Ecosystems with Non-Biome Supply Chain Certification In response to increasing concern over deforestation and biodiversity loss—particularly in sensitive regions like the Brazilian Amazon Biome—Shark Certification Pvt. Ltd. also offers Non-Biome Supply Chain Certification for organizations sourcing soybeans from Brazil. Since 2006, a collective agreement has prevented the trade of soybeans grown in the Amazon Biome, helping curb illegal land conversion and environmental degradation. Our certification verifies that your soy products are sourced exclusively from areas outside the protected biome, in line with this long-standing agreement. Benefits of Non-Biome Certification Ensure soy sourcing aligns with global sustainability efforts Reduce environmental impact associated with deforestation Strengthen your brand’s environmental responsibility Maintain traceability and accountability in sourcing Meet buyer and stakeholder demands for eco-conscious sourcing Like our other services, this certification does not replace compliance with national or international regulations, but it does enhance your market reputation by demonstrating responsible sourcing practices. Why Choose Shark Certification Pvt. Ltd.? Located in the heart of Indore, Shark Certification Pvt. Ltd. is a trusted partner for businesses seeking credible, third-party verification in the areas of sustainable agriculture, food safety, and supply chain integrity. Our team of experienced auditors and compliance experts are here to guide you through every step of the Non-GMO or Non-Biome certification process, ensuring a smooth, efficient, and transparent experience. Certify Non-GMO Products with Confidence If you're ready to showcase your commitment to safe, traceable, and environmentally responsible products, Shark Certification Pvt. Ltd. is here to help. Whether you're a farmer, food processor, trader, or logistics provider—we provide end-to-end certification solutions tailored to your role in the supply chain. Contact us today to begin your certification journey and strengthen your position in the sustainable and non-GMO marketplace.

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Medical / Pharma Standards

Apply For USFDA Certification In Indore Looking for comprehensive certification solutions? Shark Certification offers a wide range of services, including FSSC, BRC, HALAL, KOSHER, NGMO, GMP, USFDA, and ORGANIC. Let us guide you through the process. About the U.S. FDA The U.S. Food and Drug Administration (FDA) is a key federal agency under the United States Department of Health and Human Services. As part of the federal executive structure, the FDA plays a vital role in safeguarding public health by regulating a wide range of products including pharmaceuticals, food items, cosmetics, and medical devices. The FDA is responsible for the approval and oversight of: New pharmaceutical products, including biologics Food and feed additives for humans and animals Color additives used in consumables and cosmetics Select categories of medical equipment and devices To ensure that products entering the U.S. market meet stringent quality and safety standards, the FDA also conducts inspections in manufacturing units located outside the U.S., including facilities in India that export drugs and food items to the American market. These inspections are based on Current Good Manufacturing Practices (CGMP) standards set by the agency. Compliance and FDA Inspections During inspections, FDA officials assess the level of compliance with CGMP guidelines. If any deviations or concerns are observed, they are documented in Form 483. This form outlines specific areas of non-compliance and is discussed directly with the management team of the manufacturing facility. Alongside the Form 483, the agency provides an Establishment Inspection Report (EIR), indicating whether any further action is necessary. Companies are expected to respond to the Form 483 within 15 working days. While the response is not legally required, submitting a detailed reply outlining corrective actions is highly recommended to avoid escalation. If the response is inadequate or if violations are severe, the FDA may issue a Warning Letter. In critical cases, enforcement actions such as import alerts, product approval delays, or even revocation of manufacturing licenses can follow. The FDA Approval Process For a drug or high-risk medical device to receive FDA approval, the manufacturer must demonstrate that it is both safe and effective for its intended use. While the FDA itself does not conduct testing, it rigorously reviews the data and clinical trial results submitted by manufacturers. Approval is granted only after a thorough review by a multidisciplinary team of FDA experts—including statisticians, biologists, chemists, and clinicians. Why FDA Compliance Matters for Indian Manufacturers The U.S. remains one of the largest and most lucrative markets for pharmaceutical products. Over the past few decades, Indian pharmaceutical firms have gained a significant presence in the U.S. generics space. To maintain and grow this market share, ongoing compliance with FDA regulations is crucial. Shark Certification Pvt. Ltd. – Your FDA Compliance Partner At Shark Certification Pvt. Ltd., we specialize in helping pharmaceutical and medical device companies navigate the complex regulatory landscape of the U.S. FDA. Our goal is to provide tailored, efficient, and value-driven solutions that reduce compliance risks and enhance operational excellence. Our team comprises seasoned professionals with deep experience in FDA regulations, global quality standards, and risk-based auditing approaches. We support clients from audit readiness to submission preparation—ensuring both compliance and business continuity. Our Core Services CGMP and Pre-Inspection Audits Pre-Approval Inspection (PAI) Preparation Quality Assurance and Control System Development 21 CFR Part 11 & GAMP 5 Compliance & Audit Support IT System Validation and Audit Services Quality Risk Management System Development Process Analytical Technology (PAT) & Quality by Design (QbD) Process Validation and Documentation USFDA Audit Readiness Training Regulatory Submission Support: 510(k), PMA, NDA, ANDA, IND, IDE, DMF, PAS Specialized Expertise Areas End-to-end Quality System Implementation & Gap Analysis Data Integrity & Compliance Audits Vendor and Third-Party Audits Good Clinical Practice (GCP) Audits Risk Assessments and Due Diligence Reviews FDA Form 483 and Warning Letter Responses GMP Compliance for Pharmaceuticals and Medical Devices Partner with Shark Certification Pvt. Ltd. With an unwavering focus on regulatory excellence and global health standards, Shark Certification Pvt. Ltd. is your trusted partner for U.S. FDA compliance. Whether you're preparing for your first inspection or responding to regulatory observations, we provide the guidance, expertise, and support needed to achieve and sustain compliance.

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Food Safety Standards

GMP+ Certification for Feed Industry Ensuring Feed Safety and Quality Across the Supply Chain At Shark Certification Pvt. Ltd., we provide GMP+ certification services for feed manufacturers and supply chain partners. The GMP+ standard is a globally recognized certification system that ensures the safety and quality of animal feed, while helping businesses demonstrate compliance, build customer trust, and access international markets—especially within the European Union. What is GMP+ Certification? GMP+ (pronounced "GMP Plus") is an independent certification standard tailored specifically for the feed industry. Built on the foundation of ISO 9001 and incorporating Hazard Analysis and Critical Control Points (HACCP) principles, GMP+ sets comprehensive requirements for the entire feed production and distribution process. It ensures that all steps—from raw material procurement to final product delivery—are performed under strict quality and safety guidelines. Benefits of GMP+ Certification ✅ Proven Product Safety and Quality ✅ Minimized Risk of Contamination and Non-Conformance ✅ Improved Market Access, Especially in the EU ✅ Stronger Customer Confidence and Brand Image ✅ Competitive Edge in the Global Feed Industry Who Should Get GMP+ Certified? GMP+ certification is suitable for all participants in the feed supply chain, including: Feed and feed additive manufacturers Storage and warehousing providers Feed transport and logistics companies Traders and distributors of feed and raw materials Whether you operate a small-scale plant or a large multinational operation, GMP+ can be adapted to your business size and needs. What Does the GMP+ Standard Include? The GMP+ framework integrates: ISO 9001-based quality management principles HACCP-based risk assessment and control measures Additional sector-specific requirements for feed safety A structure tailored to specific operational roles within the feed chain Certification is divided into several modules, addressing production, transport, storage, trading, and laboratory services in the feed sector. The Certification Process with Shark Certification Pvt. Ltd. Initial Consultation & Quotation – We assess your readiness and provide a tailored proposal Implementation Support – Guidance on aligning processes and documentation with GMP+ requirements Audit & Certification – Formal audit conducted by our experienced assessors Certification Award – Issuance of GMP+ certificate and certification mark Surveillance Audits – Periodic checks to ensure ongoing compliance Recertification – A full review to renew your certification after the cycle ends Cost of GMP+ Certification Certification costs vary depending on your company's size, the scope of certification, and process complexity. We offer customized, no-obligation quotes based on your specific requirements. Reach out to our team for a personalized estimate. Why Choose Shark Certification Pvt. Ltd. for GMP+? ✔ Deep knowledge of global feed and agri-supply chain regulations ✔ Extensive experience conducting feed-related audits ✔ Seamless integration with other quality certifications like ISO 9001 ✔ End-to-end support—from gap analysis to audit readiness ✔ Personal, responsive service with a global reach Ready to Strengthen Your Feed Safety Credentials? Contact Shark Certification Pvt. Ltd. today to explore GMP+ certification for your business. Our team will guide you through every step, helping you meet international feed safety standards and unlock new market opportunities.

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Food Safety Standards

The BRC Global Standard is for Food Safety. This certification many times becomes necessary for doing business with UK and many European retailers and other global retailers. This food quality standard focuses on HACCP ( Hazard analysis critical control point), food safety management system, competence of personnel performing various processes that has effect on food quality and various controls on processes, raw materials, infrastructure and work environment, This standard is most applicable to manufacturers of food contact packaging for retailers labeled products and branded products as well. Manufacturers have an obligation to put appropriate systems and controls in place to ensure the suitability of their packaging for safe food use. The BRC and IOP (Institute of Packaging) have developed this standard to assist retailers and food manufacturers in the fulfillment of their legal obligations. This Standard will help in the protection of the consumer by providing a common basis for the audit of companies supplying packaging for food products to retailers. We provide BRC certification for food, consumer products, packaging and storage & distribution suppliers. The standard has been adopted by food manufacturers throughout the world, especially by those organizations supplying British retailers. Third-party certification to the standard helps manufacturers, brand owners and retailers fulfill their legal obligations and safeguard consumers. The standard covers a comprehensive scope of product safety areas, as well as the legal and due diligence responsibilities of both the supplier and the retailer. Benefits Of BRC Registration Customers, employees, stockholders and competitors develop sustainable respect for an organization which demonstrates its commitment to food safety and/or packaging regulations Operating costs drop as rework reduces, efficiencies increase and non-compliance penalties reduce Improved credentials to supply retailers An enhanced food safety and food safety management system A demonstrable commitment to producing safe food. Increased customer confidence in your product’s safety and quality.

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QMS & EHS Standards

Testing & Calibration Laboratories Quality Management System Consultancy ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification. ISO/IEC 17025 : 2005 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025 : 2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply. ISO/IEC 17025 : 2005 is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025 : 2005 is not intended to be used as the basis for certification of laboratories. Compliance with regulatory and safety requirements on the operation of laboratories is not covered by ISO/IEC 17025 : 2005.

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QMS & EHS Standards

With the rising need to save energy, most companies today are putting their maximum efforts to promote better energy consumption. Having the best energy efficiency credentials are a must for your business and also for the promotion of your business too. Having an ISO 50001 certification would mean better savings and also better commitment towards the environment. Because you would be using an energy management system with a quality standard you would be able to reduce wastage within your organization. When you look at this event on a long term basis, you would be saving a lot of money and thus protecting the environment too. We at SHARK make sure that the entire certification process is simple and easy. We understand your existing set up first and figure out the drawbacks when compared to ISO 50001 requirements. This will help your organization understand business areas where you need to focus on more to receive your certification. These changes could be processes and procedures that need to be added to your existing setup for better productivity. This would help you understand the areas to be worked upon before a formal assessment, thus saving you valuable time and money. Once the conduct the formal assessment for ISO 50001 certification, we will share details of our study that will show the areas to develop. If all the requirements are in place, we will assess the different implementations and proceed with the energy management system quality certification. Having such a quality standard for your EMS would mean that your business is managing energy efficiently. It would mean that your greenhouse gas emissions are within the permissible limits and that EMS is working towards meeting environmental targets. Such a certification would prove that your business is a responsible one and keeps energy management as its most important target. With the rising need to save energy, most companies today are putting their maximum efforts to promote better energy consumption. Having the best energy efficiency credentials are a must for your business and also for the promotion of your business too. What is ISO 50001 Certification? It is a quality system model that aims at continuous improvement that is focused towards the energy management of a company. With standards like this, you can be assured to integrate energy management as the top priorities of the company. Once the conduct the formal assessment for ISO 50001 certification, we will share details of our study that will show the areas to develop. If all the requirements are in place, we will assess the different implementations and proceed with the energy management system quality certification. Benefits of ISO 50001 Certification Having such a quality standard for your EMS would mean that your business is managing energy efficiently. It would mean that your greenhouse gas emissions are within the permissible limits and that EMS is working towards meeting environmental standards. Such a certification would prove that your business is a responsible one and keeps energy management as its most important target.

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QMS & EHS Standards

Learning services for non-formal education and training – Basic requirements for service providers The objective of this International Standard is to provide a generic model for quality professional practice and performance, and a common reference for learning service providers (LSPs) and their clients in the design, development and delivery of non-formal education, training and development. This International Standard uses the term “learning services” rather than “training” in order to encourage a focus on the learner and the results of the process, and to emphasize the full range of options available for delivering learning services. This International Standard focuses on the competency of LSPs. It is intended to assist organizations and individuals to select an LSP who will meet the organization’s needs and expectations for competency and capability development and can be used to certify LSPs. ISO 29990:2010 is an International Standard for providers of training and further training. It offers a certifiable and state of the art Standard according to ISO requirements for Management Systems. The Standard addresses – for the first time with international validity – all types of educational institutions. This includes single trainers, private seminar providers, organizations providing further training with courses, curricula and internal training as well as further training up to higher educational institutions and universities. The Standard has some congruent features with other management systems, above all with ISO 9001 .ISO 29990 is basically subdivided into two areas: learning services (for example, these services include designing, providing and monitoring of learning services) and management at the learning service provider for example business planning, financial management, risk management as well as human resources management. This Standard is the first Standard for learning providers that is valid and applied on an international scale. The advantages for learning providers are transparency of their own services, international comparability and defined processes for quality assurance. BENEFITS of ISO 29990:2010 Advantages for Learning Service Providers:- Outstanding performance during tendering work from official bodies. Globally marketability. Enhancement in internal quality potential. Transparently defined & documented processes. Enthusiastic and active trained experts participation in the development. Work on (PDCA) Cycle. Advantages for Learner:- Adequate resources, including trainers with suitable competence, infrastructure and learning environment. Evaluating criteria for Education. Advanced & Authentic processes. Transparency/comparability of services. Assuring quality, transparency and comparability in educational institutions. Benefits for Global Cooperation Base of development for international cooperation in the area of education and training Globally comparable benchmarks for existence of quality. No deformation of the globally competitive market. Common unified standards/common understanding of quality

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Food Safety Standards

“License to operate in the International Feeds Sector.” FEED SAFETY CHALLENGE Feed Safety and Quality are key issues for all companies handling feedstuffs and can have serious consequences when control is lost. A systematic approach is imperative for reducing risk and improving quality. Companies seeking to internationalize their business in Europe must be certified to a standard recognized by the GMP+ International (former PDV) organization. The GMP+ certification is also recognized by other feed certification schemes. Knowledge of GMP+ is spreading and the certificate is requested at a continuously greater extent throughout the world. The GMP+ regulations are in a process of continuous development and improvement and changes are relevant to all organizations in the international supply chain. WHAT ARE GMP+ STANDARDS BASED ON? The GMP+ standards have been developed to harmonize requirements for feed in order to ensure quality and safety throughout the entire feed chain. It is based on widely recognized principles of quality assurance, Hazard Analysis Critical Control Point (HACCP). Choosing which standard (B1, B2, etc.) and certification scope (production of feed materials, trade, etc.) depends on the organization’s role in the feed chain. GMP+ B1 is mandatory for the production of compound feed, but can also be used for the production of feed materials and transport. B2 can be used for the production of feed materials and feed additives, while B3 is intended for trade and transshipment. Each of these standards is intended for different means of feed transport (e.g. B4.1 is intended for truck transport). All steps in the supply chain are thus covered by the given requirements. Advantages of GMP+ certification Companies benefit from GMP+ certification, because it: is focused on quality management (ISO 9001) and risk management (HACCP); provides access to supporting information and services, such as risk assessments, fact sheets, storing and sharing your monitoring data, newsletters, Early Warning messages etc); Offers new sales opportunities and to a great degree, ensures the retention of current customers; Guarantees the continuity of business operations, because the corporate structure is set up more efficiently and the costs and financial risks are limited; Helps improve the company image and the reliability; Makes your company part of a globally operating feed safety system (the GMP+ certificate is accepted internationally by about 12000 companies in 66 countries); Is accepted by other (inter)national schemes; Can easily be combined with multiple certifications (feed safety and sustainability); Contributes to uniformity in the feed chain.

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QMS & EHS Standards

Get ISO Certified with Shark Certification Pvt. Ltd. – Indore’s Trusted ISO Consultants Shark Certification Pvt. Ltd. is a leading ISO consultancy firm based in Indore, offering end-to-end support to organizations looking to implement internationally recognized management systems and obtain ISO certifications. With an expert team and a client-focused approach, we simplify the certification journey for businesses of all sizes. We specialize in providing consultancy services for the following key ISO standards: ✅ ISO 9001:2015 – Quality Management System (QMS) ISO 9001 is the world’s most recognized quality management system standard. It provides a framework for businesses to ensure consistent product and service quality, enhance customer satisfaction, and continuously improve operations. Benefits of ISO 9001 Certification: Improved customer satisfaction and loyalty Streamlined operations and enhanced internal processes Increased marketability and credibility Better decision-making based on data and performance insights Stronger focus on risk management and continual improvement Our Services Include: Gap analysis and QMS implementation support Internal audits and training Preparation for third-party audits Complete documentation and process alignment Assistance in maintaining and renewing certification ✅ ISO 14001:2015 – Environmental Management System (EMS) ISO 14001 helps organizations manage their environmental responsibilities efficiently. It enables companies to reduce environmental impact, comply with regulations, and demonstrate a commitment to sustainability. Benefits of ISO 14001 Certification: Reduction in waste and resource consumption Compliance with environmental laws and regulations Enhanced environmental performance and reputation Improved stakeholder and public trust Identification of environmental risks and opportunities Our Services Include: Environmental impact assessment and EMS setup Compliance analysis and legal requirement mapping Documentation and procedural implementation Internal audits and corrective action guidance Audit preparation and certification support ✅ ISO 45001:2018 – Occupational Health & Safety Management System (OHSMS) ISO 45001 is an international standard that focuses on reducing occupational injuries and diseases. It helps businesses create a safe and healthy workplace for employees, contractors, and visitors. Benefits of ISO 45001 Certification: Enhanced employee safety and workplace morale Reduction in accidents, incidents, and legal liabilities Compliance with national and international safety regulations Cost savings through fewer disruptions and improved productivity A proactive approach to risk prevention and hazard control Our Services Include: Health & Safety risk assessments OHSMS framework development and policy creation Staff training and safety awareness programs Internal safety audits and compliance reviews Support through the certification and surveillance process Why Choose Shark Certification Pvt. Ltd. in Indore? Expert ISO Consultants with industry-specific knowledge Tailored solutions based on your organization’s size and operations Transparent process with end-to-end documentation support Affordable pricing and fast-track certification Ongoing support for audit preparation, renewals, and training Trusted by 1000+ organizations across sectors Let’s Get Started! If you're ready to elevate your business through ISO 9001, ISO 14001, or ISO 45001 certification, partner with Shark Certification Pvt. Ltd. – Indore’s trusted name in ISO consultancy.

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