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QMS & EHS Standards

The International Standards specify requirements for quality management systems where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements and aim to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. The ISO 9001 certification defines good management practices and aims at providing a global standard that spells out quality and trust. A Quality management system can be used by an company in any industry. Since the standard is neither industry- nor product-specific, it may be used by any organization that provides a product or service. The ISO 9001 standard enable company to develop a Quality Management System (QMS) to meet customer quality requirements while progressively improving operational processes. It provides company with a set of principles that ensure a common sense approach to the management of your business activities to consistently achieve customer satisfaction. What is quality management system? It is the much desired framework that is needed to monitor and improve performance in any specialized area of your business. It could improve the way your business operates or it could help you bring down your operating costs. Benefits of quality management system Higher levels of efficiency: With the ISO 9001 Certification, you can be assured of better performances within the company. Your employees would be working towards a common goal and this would increase the performance of each department. Better belief in the company: Employees always want to work with the best quality standards in place. Better brand image: having the right brand image is an important part of every business. Having a QMS implemented would lead to a good brand image within the industry, clientele and your competitors. Why ISO 9001:2015 certification? ISO 9001:2015 is a standard that sets out the requirements for a quality management system. It helps businesses and organizations to be more efficient and improve customer satisfaction. This is generic standard can be deployed across all industries. ISO 9001:2015 now follows the same overall structure as other ISO management system standards (known as the High-Level Structure), making it easier integrate multiple management systems. Another major difference is the focus on risk-based thinking; the new version gives it increased prominence. ISO 9001:2015 brings a number of benefits ISO 9001:2015 puts greater emphasis on leadership engagement Helps address organizational risks and opportunities in a structured manner Uses simplified language and a common structure and terms, which are particularly helpful to organizations using multiple management systems, such as those for the environment, health & safety, or business continuity Addresses supply chain management more effectively Is more user-friendly for service and knowledge-based organizations Advantages: Greater Assurance of meeting objectives as risk based thinking applied all across in the organization. Integration of QMS into business processes, as accountability of QMS lies with top management. Clear strategic direction of an organization as context of the organization is part of QMS. Promotion of leadership across organization. More reliable Product/Services as risk based approach is used for more effective and efficient service/product provision processes Customer satisfaction – through delivery of products that consistently meet customer requirements More Specific Benefits Reduces cost Improves product reliability Better process control and flow Better documentation of the processes Greater employee quality awareness Increased Productivity Certification Procedure The Certification Procedure is a multiple-step process. The certification cycle is described briefly: Applying for Certification (Turnkey Project) Consultancy/ Documentation & System Development as per Standard Pre audit (optional) Certification audit – (Stage 1 + Stage 2) Issue of certificate on successful completion of certification audit Surveillance audits at defined period Recertification audit after 3 years

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Food Safety Standards

FSSC 22000 v6 Certification Food Safety Compliance Made Easy with Shark Certification Pvt. Ltd., Indore In today’s global food market, food safety is not just a requirement—it’s a responsibility. The FSSC 22000 Version 6 Certification is a globally recognized food safety standard that combines ISO-based systems with specific sector requirements to help organizations ensure food safety across the supply chain. At Shark Certification Pvt. Ltd., we provide expert guidance and end-to-end support to help your business in Indore and across India achieve FSSC 22000 v6 Certification smoothly and efficiently. 🌐 What is FSSC 22000 v6? FSSC 22000 (Food Safety System Certification) is a robust, ISO-based food safety management system recognized by the Global Food Safety Initiative (GFSI). Version 6 brings new and enhanced requirements, focusing on risk management, food fraud prevention, and sustainability. It is applicable to organizations across the entire food supply chain, including: Food manufacturers Animal feed producers Packaging material manufacturers Catering and food service providers Retailers and wholesalers Logistics and transportation companies 🔍 What’s New in FSSC 22000 Version 6? Enhanced focus on food safety culture Updated requirements for equipment management Stronger control of allergens Greater emphasis on environmental monitoring and validation Clearer definitions for food fraud and food defense programs Our team stays up to date with every change in the standard so you don’t have to worry about what’s new—we guide you every step of the way. 🛠️ Our FSSC 22000 v6 Certification Services At Shark Certification Pvt. Ltd., we offer complete support for companies seeking FSSC 22000 certification: ✅ Gap Assessment & Readiness Check We begin with a full review of your current systems and identify areas needing improvement to meet FSSC 22000 v6 requirements. ✅ Implementation Support Our team helps design and implement a food safety management system (FSMS) tailored to your business, ensuring compliance with all key clauses of FSSC 22000 v6. ✅ Internal Audit & Pre-Certification Checks We conduct detailed audits to prepare your team for the final certification. This includes food defense, food fraud, traceability, risk control, and GMP reviews. ✅ Training for Staff & Management Customized training programs are provided to improve awareness and ensure team readiness—from floor workers to top management. ✅ Support During Certification Audit We assist in coordinating with certification bodies, handling documentation, and providing on-site support during your audit. 🎯 Why Choose Shark Certification Pvt. Ltd. in Indore? 🏢 Local presence, global reach – Based in Indore, we support clients throughout India 👨‍💼 Experienced consultants & auditors – Deep knowledge of FSSC, ISO, and GFSI frameworks 🧩 Custom solutions – Whether you’re a small processor or a large manufacturer, we tailor our approach to your business 💼 End-to-end service – From documentation to audit closure 💡 Up-to-date with Version 6 – Fully aligned with the latest version of FSSC 22000 standard 📞 Let’s Get Started Today! Become FSSC 22000 v6 certified with confidence and unlock global opportunities in food production and export.

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What are the aims and objectives of NABL…? National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act. NABL has been established with the objective to provide government, industry and society in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories. Government of India has authorized NABL as the sole accreditation body for testing and calibration laboratories. In order to achieve this objective, NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with NABL criteria based on internationally accepted standard for laboratory accreditation ISO/IEC 17025. These services are offered in a non-discriminatory manner and are accessible to all testing and calibration laboratories in India and abroad, regardless of their ownership, legal status, size and degree of independence. What Is Laboratory Accreditation? The concept of Laboratory Accreditation was developed to provide a means for third-party certification of the competence of laboratories to perform specific type(s) of testing and calibration. Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands. Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories. The globalization of Indian economy and the liberalization policies initiated by the government in reducing trade barriers and providing greater thrust to exports that makes it imperative for accredited laboratories to be at international level of competence. What Are Benefits Of Accreditation? Potential increase in business due to enhanced customer confidence and satisfaction. Savings in terms of time and money due to reduction or elimination of the need for re-testing of products. Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent. Increase of confidence in Testing / Calibration data and personnel performing work. Customers can search and identify the laboratories accredited by NABL for their specific requirements from the directory of accredited laboratories. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories. What types of laboratories can seek accreditation…? The laboratories should be legally identifiable & appropriately registered. They can be a part of a big organization or an independent entity. NABL can provide accreditation to: Laboratories undertaking any sort of testing or calibration in the specified fields, private or government laboratories, small operations to large multi-field laboratories, site facilities, temporary field operations and mobile laboratories.

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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

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

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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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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Social Accountability & Sustanibility

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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Food Safety Standards

Boost Your Business with BRCGS Food Safety Certification Partner with Shark Certification Pvt. Ltd., Indore – Your Gateway to Global Food Safety Standards Looking to elevate your brand in the competitive food industry? Achieve BRCGS Food Safety Certification with Shark Certification Pvt. Ltd., and take a powerful step toward global recognition, customer trust, and sustained business growth. Why BRCGS Food Safety Certification? Enhance Food Safety Systems Demonstrate that your products are manufactured under the highest standards of food hygiene, safety, and quality. Achieve Global Compliance Align your operations with international food safety regulations, giving you easier access to domestic and international markets. Gain a Competitive Advantage Stand apart from competitors by showcasing your commitment to certified food safety practices. Build Trust with Customers and Retailers Consumers and major retailers trust BRCGS-certified companies—enhancing your reputation and increasing opportunities for partnerships. How Shark Certification Pvt. Ltd. Supports You At Shark Certification Pvt. Ltd. in Indore, we offer comprehensive consulting and audit support to help your organization achieve BRCGS certification with ease: Gap analysis and documentation preparation On-site implementation and employee training Internal audits and pre-assessments Final certification guidance and audit support Whether you’re a food processor, manufacturer, packer, or distributor—our expert team ensures a smooth, hassle-free certification journey.

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