Certification

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

ISO 13485 established 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 being certified to ISO 13485

• 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 14001:2015 sets out the criteria for an environmental management system and can be certified to. It maps out a framework that a company or organization can follow to set up an effective environmental management system. It can be used by any organization regardless of its activity or sector.

Using ISO 14001:2015 can provide assurance to company management and employees as well as external stakeholders that environmental impact is being measured and improved.

Benefits of Environmental Management System

• Demonstrate compliance with current and future statutory and regulatory requirements
• Increase leadership involvement and engagement of employees
• Improve company reputation and the confidence of stakeholders through strategic communication
• Achieve strategic business aims by incorporating environmental issues into business management
• Provide a competitive and financial advantage through improved efficiencies and reduced costs
• Encourage better environmental performance of suppliers by integrating them into the organization’s business systems.
• A stronger commitment to proactive initiatives that boost environmental performance.
• Achieve strategic business aims by incorporating environmental issues into business management.
• A focus on life-cycle thinking, to consider the environment from development to end-of-life

ISO 22000 is the International Food Safety Management Standard.

It combines and supplements the core elements of ISO 9001 and HACCP to provide an effective framework for the development, implementation and continual improvement of a Food Safety Management System (FSMS).

ISO 22000 aligns with other management systems, such as ISO 9001 and ISO 14001, to enable effective systems integration.

ISO 22000 can be used by any organization directly or indirectly involved in the food chain including:

• Farms, fisheries and dairies
• Processors of meats, fish and feed
• Manufacturers of bread and cereals, beverages, canned and frozen food
• Food service providers such as restaurants, fast food chains, hospitals and hotels and mobile caterers
• Supporting services including food storage and distribution and suppliers of food processing equipment, additives, raw materials, cleaning and sanitizing products, and packaging

In summary, part or all of the ISO 22000 requirements will apply to any products that contacts the food industry or the food chain.

Benefits of ISO 22000 certification

• Customer satisfaction - through delivery of products that consistently meet customer requirements including quality, safety and legality
• Reduced operating costs - through continual improvement of processes and resulting operational efficiencies
• Operational efficiencies - by integrating pre-requisite programs (PRP’s & OPRP’s), HACCP with the Plan-Do-Check-Act philosophies of ISO 9001 to increase the effectiveness of the Food Safety Management System
• Improved stakeholder relationships - including staff, customers and suppliers
• Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers and testing compliance through internal audits and management reviews
• Improved risk management - through greater consistency and traceability of product
• Proven business credentials - through independent verification against recognized standards
• Ability to win more business - particularly where procurement specifications require certification as a condition to supply

The most important asset of any company around the world would be its data. The stakeholders expect and demand for the confidentiality, availability of the data; it would be an absolute disaster if any sensitive information was hacked or stolen. Information security is even more vital for the internet of things era. ISO/IEC 27001:2013 is a Information security standard dealing with the information security for an organization.

Information Security Management Systems (ISMS) is a systematic and structured approach to securely handle company’s sensitive information. ISO/IEC 27001:2013 provide requirements for establishing, implementing, maintaining and continually improving an information security management system.

Benefits

• ISO/IEC 27001:2013 is the only auditable International standard that defines the requirements of information security
• ISO/IEC 27001:2013 Certification helps businesses expand in global markets. It demonstrates credibility when tendering for contracts.
• Protect and enhance organization’s reputation by avoiding costly penalties and financial losses due to data / information breach
• ISMS improves company culture on understanding the infosec risks and integrating the security controls into the organizational processes and thus, lowering the overall risk to the organization.

ISO/IEC 20000 is the international standard specifically aimed at IT Service Management (ITSM). The standard was based on the best practice framework for ITSM, the IT Infrastructure Library (ITIL).

Benefits of ISO/IEC 20000 certification

• Increased customer satisfaction because of increased business-focus as opposed to Technology-focus
• Demonstrates a management commitment to quality.
• Differentiator to win new business as this is increasingly a requirement for many contracts, including government contracts.
• Creates opportunities to improve the efficiency, reliability and consistency of IT services via regular certification audits.
• Reduce costs by increasing efficiencies.
• Achieve international best practice standards of IT service management
• Develop IT services that are driven by and support business objectives
• Integrate people, processes and technology to support business goals
• Put in place controls to measure and maintain consistent levels of service
• ISO/IEC 2000 is compatible with ITIL to support continual improvement

Occupational health and safety is a multidisciplinary field concerned with the safety, health, and welfare of people at work. The goals of occupational safety and health programs include to foster a safe and healthy work environment. The main focus in occupational health is on three different objectives: (i) the maintenance and promotion of workers’ health and working capacity; (ii) the improvement of working environment and work to become conducive to safety and health and (iii) development of work organizations and working cultures in a direction which supports health and safety at work and in doing so also promotes a positive social climate and smooth operation and may enhance productivity of the organization.

• Health and safety in the workplace are the prime concern of most businesses, still deaths and injuries occur. ISO 45001 helps the minimum standard of practice to protect employees.
• The burden of occupational injuries and diseases is significant, both for employers and the wider economy, resulting in losses from early retirements, staff absence and rising insurance premiums.
• ISO 45001, Occupational health and safety management systems – Requirements, will help organizations reduce occupational injuries and ill health by providing a framework to improve employee safety, reduce workplace risks and create better, safer working conditions,
• ISO 45001 is applicable to all organizations, regardless of size, industry or nature of business.
• It is designed to be integrated into an organization’s existing management processes and follows the same high-level structure as other ISO management system standards, such as ISO 9001 (quality management) and ISO 14001 (environmental management).

Benefits

• will help them manage their OH&S risks and improve their OH&S performance by developing and implementing effective policies and objectives. Key potential benefits from use of the standard include:
• Reduction of workplace incidents
• Reduced absenteeism and staff turnover, leading to increased productivity
• Reduced cost of insurance premiums
• Creation of a health and safety culture, whereby employees are encouraged to take an active role in their own OH&S
• Reinforced leadership commitment to proactively improve OH&S performance • Ability to meet legal and regulatory requirements
• Enhanced reputation
• Improved staff morale

ISO 50001 is based on the management system model of continual improvement making it easier for organizations to integrate energy management into their overall efforts to improve quality and environmental management.

Benefits of ISO 50001 Certification

• A significant improvement of the energy performance level from an initial energy baseline.
• Supports the development of an energy policy and contributes to the structure of an energy plan to achieve set targets.
• Uses data to better understand and make decisions concerning energy use and consumption
• Reviews the effectiveness of the energy policy
• Continually improves energy management
• Facilitates engagement (commitment and agreement) of management and has a positive contribution towards the energy targets.
• Creates awareness and a commitment about energy (i.e. consumption, use, efficiency, renewable sources) within the organization.
• Improves the ability of organizations to manage energy risks concerning possible impacts in an efficient and effective way.
• Strengthens the competitiveness of organizations and reduces their vulnerability with respect to energy price fluctuation and availability of energy.
• Allows organizations to gain credible external visibility of energy saving actions.
• Provides a better understanding between predictable energy demand and supply.
• Reduces energy costs and improves profitability.

One of the automotive industry’s most widely used international standards for quality management, ISO/TS 16949, has evolved with the publication of a new global industry standard called as Automotive Quality Management System Standard – IATF 16949. On October 3rd, 2016 IATF 16949:2016 was published by the IATF and supersedes and replaces the current ISO/TS 16949.

This Automotive QMS along with applicable automotive customer – specific requirements, ISO 9001: 2015 requirements, and ISO 9000:2015 defines the fundamental quality management system Requirements for automotive production and relevant service parts organizations.

The Goal of this Automotive QMS Standard is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.

The potential benefits for an organization implementing this Automotive QMS are

• Consistently meeting product, services, customer requirements & meeting applicable statutory and regulatory requirements.
• Improved operational processes and greater efficiency
• Enhancing opportunities for customer satisfaction
• Mitigate risk and improve opportunity management with a greater application of risk-based thinking
• Increase involvement of your leadership team
• Enriching quality and continual improvement to the heart of the organization.

What is CE Marking?
The letters 'CE' on a product are the manufacturer's claim that the product meets the requirements of all relevant European Directives. CE marking on a product:

• Indicates to governments that the product can be legally sold within the European Union (EU) and the European Free Trade Area (EFTA)
• Ensures the product can move freely throughout the European Single Market
• Indicates to customers that the product meets designated minimum safety standards and therefore a minimum level of quality
• Promotes public health and safety
• Enhances product credibility
• Leads to improved sales and greater customer satisfaction

CE marking is mandated by New Approach Directives. Many products are covered by these directives. To be placed on the market in the EU, it's a legal requirement that some must bear CE marking. CE marking is the manufacturer's claim that the product meets the essential requirements of all relevant European Directives.

STEP 1
Identify the conformity assessment procedure that must be taken. This could be self-declaration, involve testing, inspection or quality system assessment from a Notified Body or a combination of these. The conformity assessment procedure will differ depending on your product and the Directive in respect of which you will be CE marking.

STEP 2
Identify the Directive(s) that are applicable to your product. You can download these directives free of charge from the European Union website

STEP 3
Determine the dates by which you must take action. This will be the date that the Directive comes into force. The majority of directives are already in force. In these cases, it is an offence to place a product on the market without CE marking because it indicates a presumption of conformity with all relevant Legislation.

STEP 4
Identify if there are any Harmonised European Standards applicable to your product. These are not always mandatory for manufacturers although there is a presumption that conformity to these standards will give conformity with the relevant part of the Directive. Whenever possible or appropriate, manufacturers should follow harmonised standards.

STEP 5
Ensure the product complies with all the essential requirements of the Directive(s). Take appropriate measures to comply or identify existing data and test reports.

STEP 6
Identify whether independent assessment of your conformity to the Directive, or some aspects of it, is required from a Notified Body. This will be stated in the directive and is dependent upon the product you are CE marking. You must not affix CE marking to your product until all necessary certifications have been obtained from the Notified Body.

STEP 7
Maintain Technical Documentation required by the Directive(s). Your technical documentation should support your compliance with the requirements of the Directive. It is essential to retain this documentation.

STEP 8
Prepare the Declaration of Conformity and the required supporting evidence. The Declaration of Conformity along with the Technical Documentation should be available to Competent Authorities (EU Members) upon request.

STEP 9
Check that no other purely national requirements exist in the countries where the product will be sold. These may include national standards, labelling or packaging requirements.

STEP 10
Affix CE marking on your product and/or its packaging and accompanying literature as stated in the directive.

GMP refers for the goods manufacturing practices.GMP Certification is mainly developed for the natural and pharmaceutical product manufactures. It is a set of guidelines that gives you the assurance that your product is safe and correct. It is mainly dedicated for the food manufactures and medication manufactures and GMP provides assurance for produce safe and quality products according to the Quality standard. GMP is responsible for the safety, efficiency and quality of pharmaceutical products and medical devices.

Benefits of GMP Certification

• Improves brand value or image in the market
• Provide guideline on how to produce safe and quality products.
• Develops customer satisfaction by deliver the safe and quality product and services.
• Develops motivation and team work between the employees of the organization.

Good Distribution Practices (GDP) Certification for Pharmaceuticals demonstrates your dedication to good distributive practices and quality in every aspect of your service.

Good Distribution Practices (GDP) is a quality system for warehouse and distribution centers dedicated for medicines. Internationally accepted pharmaceutical GDP regulations stipulate that distributors of pharmaceutical products must align their operations with the standards. The scheme ensures that consistent quality management systems are in place throughout your entire supply chain, from the early delivery of raw materials to the manufacturing plants, to the final shipment of finished drugs to the end user. An independent assessment of compliance against international GDP requirements is the most effective way to establish that your quality management system aligns with GDP guidance.

HACCP stands for Hazard Analysis and Critical Control Point and it is mainly designed to identify and minimize hazards in food production. In other words, HACCP is a process in which food safety is addressed by the analysis and control of biological and physical hazards. It is a global recognized standard for food safety and provides high credibility to the potential clients.

HACCP define for the prevention of hazards not for the finished product inspection it helps to provide guideline to the organization on how to analysis the hazards and how to reduce or control them for human consumption. The main objective of HACCP is process and makes the product safe. The Preventive approach of HACCP is helps to improve the food management system as well as improve the quality management system.

Benefits of HAACP Certification

• Improve food quality and food safety management system.
• Improve the market value of the organization.
• Reduce risk in food production system.
• Develop team work among the employees.
• Time saving and cost saving process.
• It helps to ensure that you are compliant with the law.
• Commitment to produce safe and quality food for human consumption.

What is halal?
Halal simply means permitted or lawful. So when we are talking about halal foods it means any foods that are allowed to be eaten according to Islamic Sharia law.

This means that for any food to be considered halal it must comply with the religious ritual and observance of Sharia law.

What is halal certification?
This means that food has been subjected to approved certification systems which guarantee to consumers that nothing in the food has any forbidden components. Halal certificates are issued, for a fee, by a certifying body.

What are the Benefits of Halal Certification?

• Opportunities to tap a global Halal food market of about 2 billion people (Middle east , Asia Pacific ,EU,USA,LATAM,Central Asia)
• Halal logo is an authoritative, independent and reliable testimony to support Halal food claims
• 200% profit of greater market share: No loss of non-Muslim markets/clients
• Enhance marketability of products in Muslim countries/markets
• Small cost investment relative to multiple growth in revenues
• Image boosts in meeting varied customer needs.
• Improve the food preparation hygienic system
• Improve the food quality into global standards

Supplier audits
Second-party audits can help you confirm your suppliers operate according to your requirements or protocols

Internal audits
Let us review your organizational governance against industry-specific requirements, protocols and standards

We can provide a range of internal audits across different governance protocols, requirements and standards. Typical audits include a combination of:

• Client specific protocol or governance criteria
• Management systems related requirements – Ex: Quality management system based on ISO 9001
• Process evaluation related requirements
• Customized requirements, including a combination of the above

What is halal?
ISO 26000 is an international standard on social responsibility. It provides an organization with an outline of the principles and core subjects that it should be managing to ensure it identifies and manages a number of societal risks and impacts.

The standard covers a number of core subject areas including:

• Organizational Governance
• Human Rights
• Labor Practices
• Environment
• Fair Operating Practices
• Consumer issues
• Community involvement and development

Who is ISO 26000 applicable to?
Every organization is encouraged to become more socially responsible by using this standard.

It is intended to be useful to all types of organizations:

• In the private, public and non-profit sectors,
• Whether large or small,
• Whether operating in developed or developing countries,
• For those beginning to address Social Responsibility (SR), as well as those more experienced with its implementation.

What are the benefits of ISO 26000?
ISO 26000 can help an organization identify strengths and weaknesses in how it manages a number of social responsibility areas. This can help significantly with compliance in a number of areas, including human rights and employment legislation and guidance, as well as the more commonly understood areas of environment and health and safety.

ROHS refers for the Restriction of Hazards Substances. It is designed for the restriction of the use of hazardous substances in electrical and electronic equipment (EEE)". Its objective is to restrict the use of six hazardous substances within electrical and electronic equipment Such as Lead, Mercury, Cadmium, Hexavalent Chromium (Cr-VI), Polybrominated Biphenyl (PBB), Polybrominated Biphenyl ether (PBDE) All applicable products in the EU market must pass the ROHS compliance after July 1, 2006. The mandatory requirement of ROHS directive is applicable for the European Union and the impact of

Benefits of ROHS Certification

• Mandatory requirement for the European Union
• Improve reliability and efficiency of the product
• Improve brand value and market value in the international market
• It helps to the organization to produce safe products
• Develops the better relationship between the client and the organization