Sedex Certification

Empowering Ethical Business Practices with SEDEX SMETA Audit By Shark Certification Pvt. Ltd., Indore In today’s global marketplace, ethical sourcing and transparent business practices have become key differentiators. At Shark Certification Pvt. Ltd., we help organizations align with internationally recognized ethical standards through guidance and support for SEDEX SMETA (Sedex Members Ethical Trade Audit). Understanding SEDEX and SMETA It’s important to clarify that SEDEX (Supplier Ethical Data Exchange) is not a certification body, and there is no official “SEDEX certification.” Instead, SEDEX provides a collaborative platform where businesses can manage and share data related to ethical performance across global supply chains. The SMETA audit methodology, developed by the SEDEX membership, is a recognized audit protocol designed to evaluate ethical business practices in four key areas: Labour Standards Health & Safety Environmental Management Business Ethics SMETA allows companies to undergo a single audit and share the results with multiple customers, reducing the need for repeated assessments and saving time and resources. Benefits of SMETA Audit Participation By conducting a SMETA audit and becoming a member of SEDEX, your organization can: Demonstrate compliance with ethical and social standards Meet legal, regulatory, and contractual obligations Boost supplier credibility and win customer trust Enhance access to global markets and export opportunities Increase productivity through improved working conditions Mitigate risks using SEDEX’s risk assessment tools Reduce audit fatigue by sharing reports with multiple clients Whether your customer is requesting an audit or you're proactively building a more transparent supply chain, SMETA adds measurable value to your business operations. SMETA Audit Types: 2-Pillar vs 4-Pillar There are two types of SMETA audits: 2-Pillar Audit: Covers Labour Standards and Health & Safety 4-Pillar Audit: Includes the 2-pillar components, plus Environmental Practices and Business Ethics The type of audit depends on customer requirements and the nature of your business. SMETA Audit Process with Shark Certification Pvt. Ltd. At Shark Certification Pvt. Ltd. in Indore, we provide comprehensive consulting and audit preparedness services for SMETA audits. Our step-by-step approach ensures a smooth and efficient process: Gap Analysis – Evaluation of current systems against SMETA criteria Documentation Review – Guidance on policies, procedures, and legal compliance Employee Training – Sessions to raise awareness across the workforce Mock Audit – Simulated audit to identify potential non-conformities Remedial Action Plan – Assistance in closing any gaps or findings Audit Coordination – Liaison with SEDEX-approved auditors and platform support Ongoing Compliance Support – Post-audit improvements and re-evaluation assistance Why Choose Shark Certification Pvt. Ltd.? ✅ Located in Indore, serving businesses across India ✅ Experienced consultants well-versed in SEDEX SMETA protocols ✅ Personalized services tailored to your business needs ✅ Transparent and reliable support throughout the audit lifecycle ✅ Cost-effective solutions for both SMEs and large-scale manufacturers ✅ Training and tools to help maintain long-term compliance Get Started with SEDEX SMETA Today If your customers are requesting ethical trade assessments or you're ready to elevate your sustainability credentials, let Shark Certification Pvt. Ltd. guide your journey. We ensure that your business not only meets SEDEX expectations but also stands out as a socially responsible organization in your industry. Contact us today to learn more about SEDEX SMETA audits, and how our expert consultants can support your success.

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QMS & EHS Standards

ISO 9001, ISO 14001, or ISO 45001 certification

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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QMS & EHS Standards

ISO/TS 16949:2009 Certification

The ISO/TS 16949 was jointly developed by the International Automotive Task Force (IATF) members and submitted to the International Organization for Standardization (ISO) for approval and publication. The document is a common automotive quality system requirements catalog based on ISO 9001:2008, and specific requirements from the automotive sector. It’s first edition was published in March 2002 as ISO/TS 16949:2002. This document, coupled with customer-specific requirements defines quality system requirements for use in the automotive supply chain. About 30 percent of the more than 100 existing automobile manufacturers affiliate the requirements of the norm but especially the large Asian manufacturers have differentiated, own requirements for the quality management systems of their corporate group and their suppliers. The requirements are intended to be applied throughout the supply chain. For the first time vehicle assembly plants will be encouraged to seek ISO/TS16949 certification The IATF has developed a common registration scheme for supplier 3rd party registration to the ISO/TS 16949. The registration scheme includes third party auditor qualifications and common rules for consistent global registration. Some of the benefits of the IATF registration scheme include: Improved product and process quality Additional confidence for global sourcing Reassignment of supplier resources to quality improvement Common quality system approach in the supply chain for supplier/subcontractor development and consistency Reduction in multiple 3rd party registrations

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Social Accountability & Sustanibility

EUDR Certification

EU Deforestation Regulation (EUDR) Consulting Services By Shark Certification Pvt. Ltd., Indore – Guiding You Toward Responsible Sourcing and Regulatory Compliance The European Union Deforestation Regulation (EUDR) is a game-changing directive that affects a wide range of industries sourcing commodities linked to deforestation. At Shark Certification Pvt. Ltd., we offer expert consulting services to help businesses across India and beyond understand, comply with, and implement EUDR requirements effectively. 🌍 What is the EUDR? The EUDR aims to eliminate deforestation from supply chains by requiring businesses to ensure that their imported or exported products are not linked to illegal deforestation or forest degradation. This regulation applies to commodities like soy, cocoa, palm oil, coffee, cattle, timber, and rubber—and extends to derived products such as leather, paper, and furniture. If your company trades with the EU or supplies to EU-based partners, EUDR compliance is not optional—it's essential. 🛠️ Our EUDR Consulting Services Shark Certification Pvt. Ltd. offers complete support for businesses affected by the EUDR. Our services are built around clarity, compliance, and sustainable growth: ✅ 1. EUDR Impact & Compliance Assessment We analyze your supply chain and business processes to evaluate how EUDR applies to your operations. Our assessment covers: Product origins and sourcing practices Supply chain traceability gaps Legal and compliance risks Documentation readiness ✅ 2. Strategy & Implementation Support We guide your organization in aligning with the EUDR through tailored implementation plans, including: Building traceability and tracking systems Revising procurement and supplier policies Supplier onboarding and risk evaluation ✅ 3. Due Diligence & Risk Mitigation The EUDR mandates strong due diligence mechanisms. We help you: Conduct risk assessments for high-risk supply chains Develop mitigation strategies Monitor ongoing compliance ✅ 4. Staff Training & Capacity Building Our specialized training modules help teams across departments understand: EUDR regulatory expectations Risk identification and documentation Day-to-day roles in maintaining compliance ✅ 5. Reporting & Documentation Support We assist in organizing and managing documentation needed to demonstrate compliance, including: Due diligence statements Supplier declarations Verification records for product origins and legality 🤝 Why Partner with Shark Certification Pvt. Ltd.? ✔️ Expertise in Global Sustainability Regulations ✔️ India-based, globally aligned consulting ✔️ Customized solutions for SMEs and large enterprises ✔️ Efficient implementation and audit readiness ✔️ Ongoing compliance support We work closely with manufacturers, exporters, importers, and suppliers to help them meet the requirements of the EUDR and remain competitive in environmentally conscious markets.

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Product Certification

CE Certification

CE Marking Certification in Indore At Shark Certification Pvt. Ltd., we assist manufacturers, exporters, and importers in obtaining CE Marking, which is a critical requirement for products entering the European Economic Area (EEA). CE Marking signifies that a product complies with harmonized European standards and meets essential requirements related to health, safety, and environmental protection. What is CE Marking? CE stands for Conformité Européenne, meaning European Conformity. It is not a quality label, but a mandatory declaration of conformity indicating that a product adheres to applicable EU directives and regulations. By affixing the CE Mark, the manufacturer takes full responsibility for the product’s compliance with relevant EU legislation—allowing free movement and market access across all EU member states, including Iceland, Liechtenstein, and Norway. Why is CE Marking Important? ✔ Market Access to the EU – Acts as a trade passport for seamless entry into the European market ✔ Compliance with Unified Standards – Ensures that the product complies with standardized EU regulations instead of varying national rules ✔ Increased Buyer Confidence – Demonstrates product safety, regulatory compliance, and adherence to environmental standards ✔ Avoids Legal Barriers – Eliminates the need for re-certification across multiple EU countries ✔ Mandatory for Certain Products – Essential for machinery, electrical devices, toys, medical equipment, construction materials, and more Applicable EU Directives Include: Machinery Directive (2006/42/EC) – For safety in design and operation of machinery Low Voltage Directive (2014/35/EU) – Applies to electrical equipment operating between 50–1000V AC and 75–1500V DC EMC Directive (2014/30/EU) – Ensures electromagnetic compatibility of electrical and electronic devices Medical Device Directive, Toy Safety Directive, RoHS, and more – Based on product category Steps to Obtain CE Marking Identify Relevant Directives & Standards Determine which EU legislation applies to your product, including applicable harmonized standards. Product Evaluation Assess whether the product meets essential health, safety, and environmental protection requirements. Product Testing Conduct in-house or third-party testing based on specific directive requirements. Compile Technical Documentation Create a technical file including: Product specifications and risk assessment Test reports and certifications Declaration of conformity User manuals, safety data sheets, etc. Affix CE Marking Once conformity is ensured, apply the CE logo to your product and issue the formal EU Declaration of Conformity. Documents Required for CE Marking Product Specifications and Description Relevant Test Reports Risk Assessment Report Manufacturer’s Declaration Proof of Conformity with EU Regulations Technical Construction File Why Choose Shark Certification Pvt. Ltd. for CE Marking? At Shark Certification Pvt. Ltd., we bring deep regulatory expertise and a client-centric approach to guide you through the entire CE Marking process. Whether you're a domestic manufacturer or an international exporter, we support you in: ✅ Identifying applicable EU directives and standards ✅ Conducting gap analysis and risk assessments ✅ Coordinating required product testing ✅ Preparing all technical and regulatory documentation ✅ Liaising with notified bodies, where needed ✅ Achieving full CE compliance and affixing the CE logo Confidently Enter the EU Market with Shark Certification With a team of qualified experts and in-depth knowledge of EU compliance pathways, Shark Certification Pvt. Ltd. ensures that your product meets all legal obligations under CE Marking. Let us help you navigate regulatory complexity and unlock new global market opportunities. 📞 Contact us today for expert CE Certification support tailored to your industry and product type. Shark Certification Pvt. Ltd. provides reliable and expert CE Certification services in Indore, guiding businesses through the process of ensuring their products meet European Union standards. CE Certification is essential for verifying that products meet the safety, health, and environmental requirements set by the EU before being sold within its market. With years of experience in certification, Shark Certification Pvt. Ltd. offers professional advice and support, ensuring that your products comply with all necessary regulations. Their process is straightforward, covering everything from initial product assessment to testing and final certification, with customized solutions tailored to your specific needs. The company prioritizes efficiency, ensuring a swift certification process to help you bring your products to market quickly. Achieving CE Certification not only guarantees compliance but also enhances your product's global credibility. Shark Certification Pvt. Ltd. serves multiple industries such as electronics, machinery, medical devices, and toys, offering continuous assistance to ensure your products remain in compliance. For businesses in Indore looking for dependable CE Certification services, Shark Certification Pvt. Ltd. is the trusted partner to help you meet EU regulations and expand your market reach.

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Medical / Pharma Standards

USFDA Certification

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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CE Marking Certification

Europe is a competitive but prize market, easier to access than ever before. Too many Indian exporters, especially small and medium sized enterprises, avoid it because the technical requirements for entry seem too complicated, too difficult, or too expensive. Indian manufacturers who have successfully accessed the European market know that the time to understand the European system is well worth the effort. The European Union alone is filled with affluent consumers, approximately 450 million of them. The European market is a large area that comprises more than 25 countries. For the exporter, therefore, Europe as a whole has become a market whose technical requirements have been greatly simplified. Before the creation of the European Union, each country imposed its own technical requirements. Different standards and conformity assessment procedures forced exporters to target one or two countries only, or to forego exporting to Europe altogether. The unification of these European countries into a European Union, and the consequent harmonization of laws, standards, and conformity assessment procedures, changed all that. Perhaps more importantly, ISO 9001 Certification is used extensively in Europe as a condition of acceptance of a manufacturer’s product or as a means of recognition of the manufacturer’s credibility. It is important to note that a manufacturer with a quality system in place (such as ISO 9001 QMS) should not automatically assume that his or her products are CE compliant because of the quality system alone. The appropriate New Approach Directive(s) will prescribe the correct and full route to conformity assessment. The CE Mark, which is affixed to a product or its packaging, is considered a proof that the product has met the requirements of the harmonized European standard, or directives; refers to Communauté European. Translated from the French, this literally means European Community. The European Commission, which administers the program, describes the CE Mark as a passport for goods to be sold freely within the internal European market. It is required by law if the product falls under one of the New Approach Directives. It is not a quality mark, nor is it a mark for consumers. Intended for Member State authorities, it is the visible sign to those authorities that your product is in compliance with the New Approach Directives. All manufacturers are required to affix the CE mark to products that are governed by New Approach Directives. CE marking on a product indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product. The first step to compliance is determining which directives apply to the product. A product may be regulated by more than one directive. The CE mark does not disclose which directive(s) or standards apply to the product, nor will it indicate the method of conformity assessment used to bring the product into compliance. This information is provided by other accompanying documents, such as the Declaration of Conformity. The Manufacturer or the Authorized Representative affixes the CE marking to the product. It is not affixed by a Notified Body.

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Food Safety Standards

Ayush Certification

VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS Introduction The Ayush products are regulated under the Drugs and Cosmetics Act, 1940 by the Drugs Controller General of India through the State Governments. The Department of AYUSH has been exploring the possibility of introducing a voluntary product certification scheme for selected AYUSH products to enhance consumer confidence. The matter was discussed in a series of meetings taken by the Secretary (AYUSH) beginning 24 Dec 2008 and the Quality Council of India (QCI) offered to develop a concept paper on the subject. On approval of the concept, the Department of AYUSH signed an agreement with the QCI on 27 July 2009 to design the Scheme with Department of AYUSH being the Scheme owner and QCI being responsible for managing the Scheme. The draft Scheme was given to the Department of AYUSH on 3 Aug 2009 and Simultaneously placed on the websites of Department of AYUSH and QCI for public consultation. The Scheme will be overseen by a Multi stakeholder Steering Committee (MSC) chaired by the Secretary (AYUSH) with secretariat in QCI. The MSC will be supported by a Technical Committee and a Certification Committee constituted by QCI. The Scheme is based on a criteria for certification. It has two levels: Ayush Standard Mark which is based on compliance to the domestic regulatory requirements Ayush Premium Mark which is based on GMP requirements based on WHO Guidelines and product requirements with flexibility to certify against any overseas regulation provided these are stricter than the former criteria. Under this scheme, each manufacturing unit would obtain a certification from a approved certification body (CB) which is accredited to appropriate international standards by the National Accreditation Board For Certification Bodies (NABCB) and will be under regular surveillance of the certification body.

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Food Safety Standards

GMP+ Feed 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.