We offer customized solutions for certification & consulting in INDIA for ISO 9001:2015 , ISO 14001:2015, OHSAS 18001:2007, ISO 22000:2005, ISO/TS 16949:2009, ISO 27001: 2013, ISO 13485:2003, ISO 50001:2011, ISO 10002:2005 and ISO 20001: 2011 to maximize functionality of processes and add value to client’s business. We offer consultancy & certification solutions to our client companies for the following system & product standards:-
ISO 9001:2015 is designed to respond to the latest trends and be compatible with other management systems such as ISO 14001.
The new version follows a new, higher level structure to make it easier to use in conjunction with other management system standards, with increased importance given to risk ISO 9001:2015 applies to any organization, regardless of size or industry.
Because ISO 9001 specifies the requirements for an effective quality management system, organizations find that using the standard helps them:
All organizations that use ISO 9001:2008 are encouraged to transition to ISO 9001:2015 as soon as possible. This includes not only organizations that are certified to ISO 9001:2008, but also any organizations involved in training or certifying others.
ISO 9001 is based on the plan-do-check-act methodology and provides a process - oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization.
Specific sections of the standard contain information on topics such as:
ISO 9001:2015 specifies requirements for a quality management system when an organization:
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
A newly revised version has just been published, to ensure it remains relevant to the marketplace. ISO 14001:2015 responds to the latest trends, such as an increasing recognition by companies of the need to factor in both external and internal elements that influence their impact, including climate volatility.
Other key improvements in the new version include:
ISO 14001:2015 helps an organization achieve the intended outcomes of its environmental management system, which provide value for the environment, the organization itself and interested parties. Consistent with the organization's environmental policy, the intended outcomes of an environmental management system include:
ISO 14001:2015 can be used in whole or in part to systematically improve environmental management. Claims of conformity to ISO 14001:2015, however, are not acceptable unless all its requirements are incorporated into an organization's environmental management system and fulfilled without exclusion.
ISO 14001:2015 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance.
ISO 14001:2015 is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.
ISO 14001:2015 is applicable to any organization, regardless of size, type and nature, and applies to the environmental aspects of its activities, products and services that the organization determine
The OHSAS 18001 is the international Occupational Health and Safety Management System standard. These standards are applicable to companies of any size, but is especially relevant to companies with a large work force, manual and heavy work tasks, and/or high risk work environments. Targeting the health and safety of employees proves that you are actively working to ensure that your operations are safe both for your employees and the surrounding environment.
The benefits of implementing a systematic and effective OHSAS management system include the following
OHSAS 18001 has been developed to be compatible with ISO 9001 and ISO 14001 to allow for easy integration. Legislative & regulatory commitment and continual improvement are two important aspects of OHSAS 18001.
The elements of OHSAS 18001 include:
ISO 22000 is a Food Safety Management System that can be applied to any organization in the food chain, farm to fork. Becoming certified to ISO 22000 allows a company to show their customers that they have a food safety management system in place. This provides customer confidence in the product. This is becoming more and more important as customers demand safe food and food processors require that ingredients obtained from their suppliers to be safe.
The International Organization for Standardization (ISO) developed the Food Safety Management System Certification: ISO 22000. ISO and its member countries used the Quality Management System approach, and tailored it to apply to Food Safety, incorporating the widely used and proven HACCP principles and Good Manufacturing Principles (addressed by Prerequisite Programs in ISO 22000).
The standard has requirements for Food Safety Management Systems processes and procedures, and requires that the organization implement prerequisite programs and HACCP.
Unlike some of the other Food Safety Management Systems Certification programs (for example FSSC 22000 and SQF) the ISO 22000 does not have specific requirements for prerequisite programs (PRPs), but requires that the organization identifies and implements the appropriate programs. This makes it more flexible, and food organizations of any type can implement and be certified to ISO 22000.
Food processors and manufacturers can use the ISO Technical specification ISO/TS 22002-1 to develop their PRP programs. It outlines the requirements for PRP programs that are applicable to these organizations. The requirements outlined are widely accepted and are equivalent to the requirements in the PAS 220, the publicly available specification used along with ISO 22000 for the FSSC 22000 Certification scheme.
ISO 22000 is not a Global Food Safety Initiative (GFSI) benchmarked standard. This means that if your customer base or market is looking for a GFSI Recognized standard you should look at FSSC 22000, which is the most similar to ISO 22000 or one of the other GFSI recognized certification schemes.
What does iso 22000 require?
ISO 22000 requires that you build a Food Safety Management System. This means that you will have a documented system in place and fully implemented throughout your facility that includes:
The ISO 22000 standard contains the specific requirements to be addressed by the Food Safety Management System. The standard requires food safety management system processes including:
IATF 16949:2016 (replaces ISO/TS 16949:2009) is a standard that establishes the requirements for a Quality Management System (QMS), specifically for the automotive sector. The ISO/TS 16949 was originally created in 1999 to harmonize different assessment and certification schemes worldwide in the supply chain for the automotive sector.
The primary focus of the IATF 16949 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 standard, combined with applicable Customer-Specific Requirements (CSR’s), define the QMS requirements for automotive production, service and/or accessory parts. IATF 16949:2016 is an independent QMS standard that is fully aligned with the structure and requirements of ISO 9001:2015. Therefore, the IATF 16949 cannot be implemented alone as a stand-alone document, but must be implemented as a supplement and in conjunction with ISO 9001:2015. After October 01, 2017, audits cannot be conducted to ISO/TS 16949 and organizations must transition to the new IATF 16949 in line with their current audit cycle, according to the allowable timing requirements. Failure to conduct the audit within the allowable timing requirements requires the organization to start over with an initial certification audit. The transition audit shall be the duration of a recertification audit plus additional time for a documentation review. All supporting functions on site or at a remote location shall be included in the transition process.
A Quality Management System based on IATF 16949:
The IATF 16949 standard provides guidance and tools for companies and organizations who want to ensure that their products consistently meet customer requirements and that quality and customer satisfaction are consistently improved. Requirements for certification to IATF 16949 are defined in the 2016 Revision 5 of the rules for achieving and maintaining IATF recognition.
The IATF 16949 standard is a supplemental standard and is used in conjunction with the ISO standards:
IATF 16949 defines the criteria for an automotive-based QMS with the goal to become 3rd party registered. It can be used by any supplier, large or small, and should be applied throughout the automotive supply chain. In fact, there over 65,000 suppliers worldwide which are currently certified to ISO/TS 16949. All requirements of IATF 16949 are applicable unless suppliers do not provide product design related functions. Requirements are generic and are intended to be applicable to any supplier providing design and development, production and, when relevant, assembly, installation and services of automotive related products, including products with embedded software. The IATF 16949 standard is applicable to sites of the organization where manufacturing of customer-specified production parts, service parts, and/or accessory parts occur.
The standard is based on seven Quality Management Principles, including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These Quality Management Principles are defined as follows:
Implementing IATF 16949 ensures that customers receive consistent, good quality products and services, which in turn may bring many business benefits. IATF 16949 specifies requirements for a Quality Management System when an organization wants to:
Compliance to the IATF 16949 standard can be done at any time but is typically used when:
Organizations’ deciding to develop and implement any new or improved QMS is a strategic decision. All efforts should be focused on the identification and minimization of risk while meeting and exceeding customer and organizational goal and objective requirements.
Organizations should make a commitment to:
IATF 16949 Compliance can be achieved through Quality-One’s Seven Phase Approach:
What is ISO 27001?
ISO/IEC 27001:2013 (ISO 27001) is the international standard that describes best practice for an ISMS (information security management system). Achieving accredited certification to ISO 27001 demonstrates that your company is following information security best practice, and provides an independent, expert verification that information security is managed in line with international best practice and business objectives. ISO 27001 is supported by its code of practice for information security management, ISO/IEC 27002:2013.
For advice and guidance on ISO 27001 or to find out more about the solutions we offer, get in touch with one our experts today.
What is an ISMS?
An ISMS is a system of processes, documents, technology and people that helps to manage, monitor, audit and improve your organisation’s information security. It helps you manage all your security practices in one place, consistently and cost-effectively.
At the heart of an ISO 27001-compliant ISMS is business-driven risk assessments, which means you will be able to identify and treat security threats according to your organisation’s risk appetite and tolerance.
Why achieve ISO 27001 certification?
How to implement an ISMS
Implementing an ISO 27001-compliant ISMS will include the following key elements:
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ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.
If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.
Using energy efficiently helps organizations save money as well as helping to conserve resources and tackle climate change. ISO 50001 supports organizations in all sectors to use energy more efficiently, through the development of an energy management system (EnMS).
ISO 50001 is based on the management system model of continual improvement also used for other well-known standards such as ISO 9001 or ISO 14001. This makes it easier for organizations to integrate energy management into their overall efforts to improve quality and environmental management.
ISO 50001:2018 provides a framework of requirements for organizations to:
Like other ISO management system standards, certification to ISO 50001 is possible but not obligatory. Some organizations decide to implement the standard solely for the benefits it
provides. Others decide to get certified to it, to show external parties they have implemented an energy management system. ISO does not perform certification
ISO 10002:2014 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance, and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system.
ISO 10002:2014 is not applicable to disputes referred for resolution outside the organization or for employment-related disputes.
It is also intended for use by organizations of all sizes and in all sectors. Annex A provides guidance specifically for small businesses.
ISO 10002:2014 addresses the following aspects of complaints handling:
ISO/IEC 20000-1:2011 is a service management system (SMS) standard. It specifies requirements for the service provider to plan, establish, implement, operate, monitor, review, maintain and improve an SMS. The requirements include the design, transition, delivery and improvement of services to fulfil agreed service requirements.
ISO/IEC 20000-1:2011 can be used by: