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The ISO (International Standard Organization) certification is an important certification of the company which indicates the abilities and trust of the company and designates a company entirely meeting their customer requirements. ISO 9001 belongs to the family of ISO 9000. In the World, the ISO 9001 Standard is a widely used management system. Benchmark Consultant is Providing a best effective ISO certification service consultancy in Ahmedabad and Surat.
Quality Management System
ISO 9001:2015 Quality Management System (QMS) is internationally recognized as the world’s leading quality management standard and has been implemented by over one million organizations in over 170 countries globally. ISO 9001 implemented, to its full potential, becomes an invaluable asset to your organization.
The purpose of the standard is to assist companies in meeting statutory and regulatory requirements relating to their product while achieving excellence in their customer service and delivery. The standard can be used throughout an organization to improve the performance or within a particular site, plant or department.
ISO 9001 contains eight key principles of quality management which is not auditable but do form the fundamental characteristics of quality management:
- Customer focus and customer satisfaction
- Involvement of people
- Process approach
- Systematic approach to management
- Continual improvement
- Factual approach to decision making
- Mutually beneficial supplier relationship
Benefits of ISO 9001:2015
- Become more cost efficient
- Increased credibility and competitiveness
- Lower costs and shorter cycle times through effective use of resources
- Enhanced customer satisfaction and improved customer loyalty leading to repeat business
- Increased revenue and market share obtained through flexible and fast responses to market opportunities
- Integration and alignment of internal processes which will lead to increased productivity and results
- Consistency in the delivery of your product or service
- Improved communication, planning and administration processes
ISO 14001 Environmental Management System (EMS) is a systematic framework to manage the immediate and long term environmental impacts of an organization’s products, services and processes. By completing ISO 14001 certification your organization can assure stakeholders that your environmental management system meets international industry specific environmental standards
ISO 14001 environmental certification provides a framework for environmental management best practice to help organizations:
- Minimize their environmental footprint
- Diminish the risk of pollution incidents
- Provide operational improvements
- Ensure compliance with relevant environmental legislation
- Develop their business in a sustainable manner.
Occupational Health and Safety Management System
OHSAS 1800:2007 Occupational Health and Safety Management Certification is an international standard which provides a framework to identify, control and decrease the risks associated with health and safety within the workplace. Implementing the standard will send a clear signal to your stakeholders that you view employee’s health and safety as a priority within your organization.
An increasing number of organizations are completing OHSAS 18001 certification as employers are under increasing pressure to ensure that a rigorous health and safety policy is in place which protects employees against possible occupational risks and reduces the likelihood of accidents in the workplace. By planning ahead an organization can also identify health and safety risks and conform to health and safety legislation.
Benefits of OHSAS 18001:2007
- Improves corporate image and credibility among stakeholders, regulators, customers, prospective clients and the public.
- Adoption of international best practice in relation to risk management Ensures health and well-being of employees, sub-contractors and the public.
- Minimization of liability of employers through adoption of proactive rather than reactive controls.
- Ensures legislative awareness and compliance.
- Reduces accident and incident rates by reducing or eliminating workplace hazards.
- Improves the incident investigation process.
- Increases employee motivation through the provision of a safer workplace and participation process.
Quality Management System – Medical Devices
ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
Benefits of ISO 13485:2016
Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.
- Increase access to more markets worldwide with certification.
- Outline how to review and improve processes across your organization.
- Increase efficiency, cut costs and monitor supply chain performance.
- Demonstrate that you produce safer and more effective medical devices.
- Meet regulatory requirements and customer expectations.
ISO 22000:2005 / 22000:2018
(Food Safety Management Systems)
ISO 22000: 2005 / 22000:2018stands for food safety management system. It is a prevention-based food safety system that identifies and prevents microbial, chemical and other hazards in the food based industry.
It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products. The means of meeting any requirements of this International Standard can be accomplished through the use of internal and/or external resources.
This International Standard ISO 22000 certification specifies requirements to enable an organization to plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer.
Benefits of ISO 22000:2005 / 22000:2018
- An auditable standard with clear requirements which provides a framework for third-party certification.
- The structure aligns with the management system clauses of ISO 9001 and ISO 14001.
- Enables communication about hazards with partners in the supply chain
- System approach, rather than product approach.
- Applicable to all organizations in the global food supply chain.
- Systematic management of prerequisite programs.
- Increased due diligence.
- Provides potential for harmonization of national standards.
- Covers the majority of the requirements of the current retailer food safety standards.
- Complies with the Codex HACCP principles.
- Provides communication of HACCP concepts internationally.
Food Safety System Certification
FSSC 22000 is a Food Safety Management System (FSMS) Certification Scheme
The FSSC 22000 System was designed to provide companies in the food industry with an ISO-based food safety management system certification that is recognized by the Global Food Safety Initiative (GFSI).
Recognition by GFSI provides worldwide recognition and acceptance by food manufacturers and retailers. FSSC 22000 defines requirements for integrated processes that work together to control and minimize food safety hazards.
Benefits of FSSC 22000
FSSC 22000 Is an ISO based Food Safety Management System and it integrates nicely with other ISO based management systems including ISO 9001, ISO 14000 and others.
First and foremost, building an FSSC System will provide your company with effective management of food safety hazards by creating an environment capable of producing safe product and a management system to continually manage, monitor, validate and improve the system.
Maintain current customers
Statistics show that approximately 1 out of 4 certified companies are asking their suppliers to achieve certification. Chances are that if you have not been asked yet, you will be asked in the near future. Starting on your certification can help you stay competitive and qualified to work with your current customers.
Increase your market reach
Large retailers and multinational manufacturers or processors are also demanding certification of their suppliers. Having FSSC Certification means you are qualified to supply these organizations or their suppliers, opening up a large market for your products.
Prepare for upcoming regulatory changes
Countries across the globe are making changes to food safety regulations, including the United States and its Food Safety Modernization Act (FSMA). FSSC prepares your organization to meet many or most of the FSMA requirements.
Becoming certified to FSSC can increase your market opportunities, increase your customer’s confidence in your food safety practices and improve your internal processes to ensure safe product.
Information Security Management System
ISO 27001 is the international standard which is recognised globally for managing risks to the security of information you hold. Certification to ISO 27001 allows you to prove to your clients and other stakeholders that you are managing the security of your information. ISO 27001:2013 (the current version of ISO 27001) provides a set of standardised requirements for an Information Security Management System (ISMS). The standard adopts a process based approach for establishing, implementing, operating, monitoring, maintaining, and improving your ISMS.
Benefits of ISO 27001:2013
Protecting your organization’s information is critical for the successful management and smooth operation of your organization. Achieving ISO 27001 will aid your organization in managing and protecting your valuable data and information assets.
By achieving certification to ISO 27001 your organization will be able to reap numerous and consistent benefits including:
- Keeps confidential information secure.
- Provides customers and stakeholders with confidence in how you manage risk.
- Allows for secure exchange of information.
- Helps you to comply with other regulations (e.g. SOX).
- Provide you with a competitive advantage.
- Enhanced customer satisfaction that improves client retention.
- Consistency in the delivery of your service or product.
- Manages and minimizes risk exposure.
- Builds a culture of security.
- Protects the company, assets, shareholders and directors.
IT Service Management System
SO 20000-1 is the international standard for quality management specifically focused on IT Service Management. ISO 20000-1:2011 (the latest version of ISO 20000-1) provides a set of standardized requirements for an IT service management system (SMS). Given how vital IT is to organizations, it is essential that both your internal and external IT services are aligned with the needs of your business and customers.
Benefits of ISO 20000-1:2011
By achieving certification to ISO 20000-1 IT Services Certification, your organization will be able to reap numerous benefits such as:
- Reduction in incidents and improved incident management.
- Improving corporate image and credibility .
- Adoption of an integrated process to the delivery of IT services .
- Reduction in response times and interruptions to IT service.
- Improved management of costs, leading to financial savings .
- A culture of continuous improvement.
- Greater understanding of roles and business objectives.
- Ensuring legislative awareness and compliance.
- Protecting the company, assets, shareholders and directors.
- Increased customer satisfaction from internal and/or external customers .
- Provides you with a competitive advantage.
- Enhanced customer satisfaction that improves client retention.
- Consistency in the delivery of your service or product.
Hazard Analysis and Critical Control Points
Hazard Analysis and Critical Control Points(HACCP) is a management system used in the food industry and this chapter describes basic HACCP principles along with a few details from the more recent Hazard Analysis and Risk-Based Preventive Controls system variation. The US Food and Drug dministration created four food-specific websites describing important details for diary, juice, retail/food service, and seafood HACCP programs. These programs and efforts to teach how to control food risks will be discussed, including alleged violations of HACCP regulations, which are illustrated in food-related Warning Letters and publications citing needs for improved HACCP execution. Topics include information on hazards associated with juice and seafood, pest control, and drug residues in dairy products
Benefits of HACCP
Although the main goal of HACCP is food protection, there are other benefits acquired through HACCP implementation, such as:
- Increase customer and consumer confidence
- Provides market protection
- Reduce costs through reduction of product losses and rework
- Reduce risks of recalls and product withdrawals thus reducing costs associated with insurance and business liability protection
- Increase focus and ownership of food safety
- Simplify inspections primarily because of record keeping and documentation
- Provide consistent quality product
- Demonstrates conformance to the product requirements and regulations
Good Manufacturing Practices
Good manufacturing practice (GMP) is a concept that ensures products are consistently produced and controlled according to quality standards.It is designed to minimise the risks to the patient involved in any pharmaceutical production.
GMP constitutes the license to operate in pharmaceutical manufacturing, and is a core condition worldwide. However, rules and interpretations differ from country to country and change frequently. Therefore, having fully trained experts at hand to help with the implementation of these rules is very important.
Benefits of GMP
- Costs reduced and resources saved.
- Evidence of safe and efficient food handling.
- Compliance with legal requirements and builds customer trust.
- Ability to trade internationally.
- Food culture within your company.
Good Distribution Practices
Good distribution practices ensure maintaining product safety and quality during distribution across the supply chain and this practice is of significant importance for the pharmaceutical industry. Good Distribution Practices (GDP) Compliance report for Pharmaceutical Industry demonstrates Quality commitment & sound practices in the entire pharmaceutical distribution supply chain.
Managing quality of medicines during distribution is a challenging operation. The challenges of the pharmaceutical products supply chain is and due to its specified shelf life and storage conditions. The various dosage forms (eg tablets, syrups, injectables etc.) are to be transported and stored at different environmental conditions hence all medicines cannot be handled with a general rule. viz the requirement of handling tablets, syrups and injectables shall widely vary.
Benefits of GDP
- Ensures principles of GDP are applied throughout the supply chain.
- Maintains product integrity and patient safety.
- Helps achieve consistency.
- Reduces the risk of falsified medicines entering the supply chain.
- Reduces distribution complaints.
- Improves customer confidence.
- Reduces expensive mistakes.
Road Traffic Safety(RTS) Management Systems
ISO 39001:2012 specifies requirements for a road traffic safety (RTS) management system to enable an organization that interacts with the road traffic system to reduce death and serious injuries related to road traffic crashes which it can influence.
The requirements in ISO 39001:2012 include development and implementation of an appropriate RTS policy, development of RTS objectives and action plans, which take into account legal and other requirements to which the organization subscribes, and information about elements and criteria related to RTS that the organization identifies as those which it can control and those which it can influence.
Benefits of ISO 39001:2012
- Improves company image
- Reduces traffic accidents
- Improves productivity and Improves working environment which leads to higher employee satisfaction
- Cost reduction on vehicles
- Competitive advantage toward your competitors
- Competitive advantage in tenders
- Less administrative procedures with insurance companies
- Commitment to Corporate Social Responsibility
- Safe and effective transportation
- Reduced service complaints
- Ensures quality, safety and reliability
- Alignment regulatory laws
(Packaging Management Systems)
ISO 21898:2004 specifies materials, construction and design requirements, type test, certification and marking requirements for flexible intermediate bulk containers (FIBCs) intended to contain nondangerous solid materials in powder, granular or paste form, and designed to be lifted from above by integral or detachable devices.
(Cloud Security Management Systems)
ISO/IEC 27018:2014 establishes commonly accepted control objectives, controls and guidelines for implementing measures to protect Personally Identifiable Information (PII) in accordance with the privacy principles in ISO/IEC 29100 for the public cloud computing environment.
In particular, ISO/IEC 27018:2014 specifies guidelines based on ISO/IEC 27002, taking into consideration the regulatory requirements for the protection of PII which might be applicable within the context of the information security risk environment(s) of a provider of public cloud services.
ISO/IEC 27018:2014 is applicable to all types and sizes of organizations, including public and private companies, government entities, and not-for-profit organizations, which provide information processing services as PII processors via cloud computing under contract to other organizations.
The guidelines in ISO/IEC 27018:2014 might also be relevant to organizations acting as PII controllers; however, PII controllers can be subject to additional PII protection legislation, regulations and obligations, not applying to PII processors. ISO/IEC 27018:2014 is not intended to cover such additional obligations.
Benefits of ISO 27018
- Greater stakeholder confidence. Compliance to ISO 27018 enables CSP’s to demonstrate they have implemented security controls to protect stakeholder confidential information in the cloud.
- Faster enablement of global operations. Because ISO 27018 provides common guidelines across different countries, it enables CSP’s to do business globally.
- Supply chain requirement. ISO 27018 certification, provides CSP’s with evidence demonstrating they have implemented procedures to protect PII, reducing the time taken negotiating for new business and providing a competitive edge.
- Greater legal protection. Certification to ISO 27018 guarantees a systematic approach to data protection helping CSP’s to address their data security risks and operate within the law.
(Brand Valuation Management Systems)
ISO 10668:2010 specifies requirements for procedures and methods of monetary brand value measurement.
ISO 10668:2010 specifies a framework for brand valuation, including objectives, bases of valuation, approaches to valuation, methods of valuation and sourcing of quality data and assumptions. It also specifies methods for reporting the results of such valuation.
(Educational organizations Management Systems)
ISO 21001:2018 specifies requirements for a management system for educational organizations (EOMS) when such an organization:
- Needs to demonstrate its ability to support the acquisition and development of competence through teaching, learning or research
- Aims to enhance satisfaction of learners, other beneficiaries and staff through the effective application of its EOMS, including processes for improvement of the system and assurance of conformity to the requirements of learners and other beneficiaries.
All requirements of ISO 21001:2018 are generic and intended to be applicable to any organization that uses a curriculum to support the development of competence through teaching, learning or research, regardless of the type, size or method of delivery.
ISO 21001:2018 can be applied to educational organizations within larger organizations whose core business is not education, such as professional training departments.
ISO 21001:2018 does not apply to organizations that only produce or manufacture educational products.
Benefits of ISO 21001:2018
ISO 21001:2018 identifies numerous key benefits of enacting an EOMS. Some highlights include the better alignment of objectives and activities with policy, more personalized learning, increased credibility of the organization, widened participation of interested parties, harmonization of a plethora of standards within an international framework, and stimulation of excellence and innovation. Much like any good education, the results of ISO 21001:2018 may not be felt instantly. However, over time-once educational providers have successfully aligned their activities with their mission and vision under its guidance-learners, the education sector, and the economy as a whole can benefit immensely.
CSN 01 0391:2013
(Corporate Social Responsibility Management System)
This standard sets out the requirements for the Corporate Social Responsibility Management System and is applicable to organizations of all sizes and types (both business and public) regardless of their geographic location. The standard includes requirements for the management system, requirements for the individual pillars of CSR (economic pillar, environmental pillar and social pillar) and requirements for improvement (in line with the PDCA cycle).
(Customer satisfaction Quality Management System)
This document gives guidelines for defining and implementing processes to monitor and measure customer satisfaction.
This document is intended for use by any organization regardless of its type or size, or the products and services it provides. The focus of this document is on customers external to the organization.
NOTE Throughout this document, the terms “product” and “service” refer to the outputs of an organization that are intended for, or required by, a customer.
Benefits of 10004:2018
- Obtain information on new expectation .
- Resolving complaints to the satisfaction of the complainant and the organization.
- Identify trends and therewith eliminate causes of complaints .
- Customer-focused approach to resolving complaints .
- Encourage personnel to improve their skills in working with customers.
- Identify customer expectations.
GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES
Distribution is an important activity in the integrated supply-chain of medical device.Various people and entities are generally responsible for the product sourcing, procurement, transportation, delivery, storage, device tracking, installation, commissioning, service and maintenance, calibration, need to be appropriately managed and controlled to ensure the safety and performance of medical devices at the point of use. In some cases, however, a person or entity is only involved in and responsible for certain elements of the distribution process. The level of risks associated with these activities may be of similar degree as those in the manufacturing environment and the lack of control over these activities may affect safety and performance of the devices. The Good Distribution Practice for Medical Devices (GDPMD) is developed to elucidate the requirements for an appropriate management and control of these activities. GDPMD specifies the requirements for a quality management system to be established, implemented and maintained by an establishment in carrying out activities in medical device supply-chain to comply with Malaysian medical device regulatory requirements as stipulated in Medical Device Act 2012 (Act 737). GDPMD requires an establishment to demonstrate its ability to maintain quality, safety and performance of medical devices in compliance with the Malaysian medical device regulatory requirement throughout the supply-chain. It shall be used by both the internal and external parties to determine the ability of an establishment to meet the requirements specified within.
The certification to GDPMD is to be conducted by the registered conformity assessment body. The design and implementation of GDPMD by an establishment is dependent on the types and categories and classification of medical device, size and structure of the establishment, the processes employed it deals with. It is not the intent of the GDPMD to imply uniformity in the structure of the quality management systems or uniformity of documentation. Certification to GDPMD does not imply compliance to any written laws. It is the responsibility of the establishment to ensure that they are in compliance with all applicable laws in Malaysia. In the event of any contradiction between the requirements of GDPMD and any written law, the latter shall take precedence.
Benefits of GDPMD
GDPMD drives best practice and helps organizations:-
- Savings in cost from reduction of defects and rejects.
- Meet regulatory requirements and customer expectations.
- Consistency to proper storage, handling, distribution and traceability.
- Demonstrate ability to produce safer and more effective medical devices.
Automotive Industry -Quality Management System
TS 16949 is an internationally recognized Quality Management System specification for the automotive industry. TS 16949: 2009 is the current version (last updated in the year 2009) of the standard that was developed for the Automotive Industry. It contains all of the requirements of ISO 9001 plus several additional requirements specifically for the Automotive Industry.
Benefits of ISO/TS 16949:2009
- Implementation and enhancement of documentation .
- Systematization of management activities and processes .
- Full customer-orientation .
- Enhancement of processes .
- Improvement of products quality .
- Improvement of the customers’ opinions on the quality of products or services .
- Marketing tool .
- Better access to domestic and foreign markets .
- Increase of customer satisfaction .
- Improvement of customer relations .