ISO 9001 Certification is widely recognized standard to specify requirements for Quality Management System in all industries.
ISO 9001 Standard provides effective Risk Assurance based Quality Management System focusing QMS principles enhancement in Customer Satisfaction, Leadership, Engagement of People, Process Approach, Improvement, Evidence based Decision Making and Relationship Management.
ISO 9001:2015 enables Risk based thinking while implementing QMS, this means to identify Risks and Opportunities in processes to establish an effective ISO 9001:2015 Quality Management system with a strong customer focus, the motivation and implication of Top Management, the process approach and continual improvement.
ISO 9001 Standard enables Business improvements by assessing Risks and Opportunities, strengthen process approach to implement quality management system which ensure products and services consistently meet customer requirements along with consistent improvement in quality.
QMS auditing to ISO 9001 certification verifies Quality is extent of suitability for compliance and fulfillment of requirements stated by customer, inherent characteristics and regulatory requirements of product and service as per Quality Management System requirements.

ISO 9001 Quality Management System certification by HAND CORP. indicates organization’s adherence to QMS – Quality Management System requirements and practices and as a truly QMS Auditing Firm to ISO 9001 Certification, offers Value Auditing Services in QMS Auditing because, no matter the type of organization, the Auditing Services of HAND Corp are designed to meet Global Standards that deliver Credibility in QMS ISO 9001 Certification.
To achieve QMS objective, professionally trained auditors are deputed to identify ‘Opportunities for Improvements’ in QMS ISO 9001 Certification.

ISO 9001 QMS Standard is widely adopted standard specify requirements for Quality management system in all industries, specially the types of organizations such as QMS in Hospitals & Health Care and also QMS in Medical Devices in India.

HAND CORP is The ISO 9001 Consultancy and are associated to Certification body. The ISO 9001 Certification are issued by the Certificate body. We are associated with Accredited Certification Agency for ISO 9001.

HIGHLIGHTS OF ISO 9001:2015 STANDARD INCLUDE

Quality Management System requirement documentation as per ISO 9001:2015 Standard means activity or process to document that contains sufficient information for effective implementation of processes and be retained to provide evidence that activities were performed.
The new ISO 9001:2015 standard includes three basic core concepts:

a.) process approach
b.) plan-do-check-act methodology, and
c.) which is new in the 2015 version is risk based thinking

New structure of ISO 9001:2015 standard has aligned with the common 10-clause to ensure greater harmonization among its many different management system standards, which is built around the Plan-Do-Check-Act sequence. This will help organizations to integrate the requirements of more than one ISO Management System Standard.

ISO 9001:2015 version further require that organization ‘determines’ processes needed for quality management system and identify all the processes that include Actions to Address Risks and Opportunities.
Risk Based Thinking is a new and welcome addition to ISO 9001:2015 standard requirement

A structured approach to risk assessment for a quality management system requirement can describe a process, an actual or potential threats and decision on whether to accept, mitigate, eliminate or transfer the risk, and identify the controls needed to ensure the effectiveness of the processes. By including ‘potential’ threats, organization can put in place preventive actions.

Quality objective as per ISO 9001:2015 Certification are seen as those that have a direct impact on customer requirements, have a direct impact of the efficiency of the client’s business, which means an improvement in the quality system processes.
ISO 9001:2015 standard requires quality objectives to be measurable which means that targets have to be set.
The requirements around the ISO 9001:2015 objectives have also been made more detailed. They are to be consistent with the ISO 9001:2015 quality policy, measurable (if practicable), monitored, communicated, and updated as appropriate. They have to be established at relevant functions and levels. Now planning how to achieve its quality objectives is introduced in the new version of ISO 9001:2015 standard.

ISO 14001 Certification is designed to establish an internationally accepted framework for environmental evaluation, risk assessment, environmental performance measurement, to protect environment and to respond to changing environmental situations for socio economic needs. This standards is also used for auditing and Certification to ensure the extent of effectiveness of Environmental Management System of an organization.

ISO 14001 requirements are to prove that the businesses are taking effective steps to full fill social & environmental responsibilities by establishing Environmental Objectives and Program. An effective “Environmental Management System” helps organizations to control and successfully manage the most significant environmental aspects of organizations created by processes, e.g. emissions, waste-handling, utilize natural resources and energy-efficiency together with compliance to environmental regulations.

ISO 14001 Standard – EMS is applicable to organizations irrespective of their size or nature such as Hospitals, Medical Devices, and Health Care in India.

HAND Corp is Associated with Certification Body to offer ISO 14001 Certification worldwide.

Auditing Services for Organization’s EMS are designed to meet global acceptable standards that offer credibility in EMS Auditing.

ISO 14001 Certification by HAND CORP. Certification Body indicates the organization’s adherence to Environmental Aspects and offers Value Added Auditing Services in EMS Auditing.

The ISO 14001 certification provides following Benefits:

• Helps reduce negative impacts on the environment
• Saves costs on fees and fines
• Aids compliance with legal requirements related to the environment
• Helps maintain and improve market position
• Increases your customers trust in you as a safe supplier of products and services.
• Steps towards Sustainable Business.

Information is valuable asset for the business organization operations and hence, required to be suitably protected, controlled and management. Compliant to ISO 27001 – ISMS requirements ensures that the information are suitably protected and managed in business.

ISO 27001 is an Information Security Management System – ISMS published by the International Organization for Standardization and International Electro technical Commission.

An Information Security Management System – ISMS reduces critical security risks of organizations’ informational assets, ISO 27001 Controls and Objectives and makes a framework to protect those assets. It sets standard for handling of Confidentiality, Integrity and Availability of Informational Assets which safeguard, controls and manages ISMS ISO 27001 Objectives through effective ISMS Audit.

ISMS ISO 27001 Standard is applicable to all types of organizations irrespective of size, nature or geography.

ISO 27001 Certification duly ISMS Audit indicates the organization’s adherence to Informational Security Aspects and offers Value Addition Auditing Services in ISMS Auditing.

The ISO 27001 Certification provides following Benefits:

• Ensure information within the Organization secure and effective
• Ensures information is available on time
• Prevents loss, abuse and unauthorized modification of information
• Ensures information is only accessible to authorized persons
• Assists compliance with legal requirements and data protection

National Accreditation Board for Hospitals and Healthcare Providers

National Accreditation Board for Hospitals and Healthcare Providers known as NABH is committed to support improvement of quality of healthcare service in our country for all strata of the population through various methodologies and tools to supplement the efforts of the providers of healthcare service and the requirements of the system at various levels.

NABH, therefore, intends to be a robust, accessible, and competent organization to complement the healthcare system to improve its efficiency and the predictability of healthcare outcomes.

National Accreditation Board for Hospitals & Healthcare Providers (NABH) is a constituent board of Quality Council of India, set up to establish and operate accreditation program for healthcare organizations. The board is structured to cater to much-desired needs of the consumers and to set benchmarks for the progress of the health industry. The board while being supported by all stakeholders including industry, consumers, government, have full functional autonomy in its operation

Values

 Credibility: Provide credibly and value addition services

• Responsiveness: Willingness to listen and continuously improving service
• Transparency: Openness in communication and freedom of information to its stakeholders
• Innovation: Incorporating change, creativity, continuous learning and new ideas to improve the services being provided

National Accreditation Board for Testing and Calibration laboratories
NABL is an accreditation body, with its accreditation system established in accordance with ISO/ IEC 17011. ‘Conformity Assessment –Requirements for Accreditation bodies accrediting conformity assessment bodies. NABL provides voluntary accreditation services to:
• Testing laboratories in accordance with ISO/ IEC 17025 ‘General Requirements for the Competence of Testing and Calibration Laboratories’
• Calibration laboratories in accordance with ISO/ IEC 17025 ‘General Requirements for the Competence of Testing and Calibration Laboratories’
• Medical testing laboratories in accordance with ISO 15189 ‘Medical laboratories -Requirements for quality and competence’
• Proficiency Testing Providers (PTP) in accordance with ISO/IEC 17043 “Conformity assessment — General requirements for proficiency testing” and
• Reference material producers (RMP) in accordance with ISO 17034 “General requirements for the competence of reference material producers”.
NABL is Mutual Recognition Arrangements (MRA) signatory to ILAC as well as APAC for the accreditation of Testing and Calibration Laboratories (ISO/IEC 17025), Medical Testing Laboratories (ISO 15189) and Proficiency Testing Providers (PTP) (ISO/IEC 17043). NABL is also signatory to APAC MRA for accreditation of Reference materials producers (RMP).
Such MRA reduces technical barrier to trade and facilitates acceptance of test/ calibration results between countries which MRA partners represent.
NABL has been established with the objective of providing Government, Industry Associations and Industry in general with a scheme of Conformity Assessment Body’s accreditation which involves third-party assessment of the technical competence of testing including medical and calibration laboratories, proficiency testing providers and reference material producers. Accreditation process details are provided in NABL 100 “General information Brochure”.
NABL offers accreditation services in a non-discriminatory manner. These services are accessible to all testing including medical and calibration laboratories, proficiency testing providers and reference material producers in India and other countries in the region, regardless of the size

Scope of Accreditation

NABL Accreditation is currently given in the following fields and disciplines.

• Clinical Biochemistry
• Clinical Pathology
• Haematology
• Microbiology & Infectious disease serology
• Histopathology
• Cytopathology
• Flow Cytometry
• Cytogenetics
• Molecular Testing

The mission of Joint Commission International (JCI) is to improve the safety and quality of care in the international community through the provision of education, publications, consultation, and evaluation services. Joint Commission Resources educational programs and publications support, but are separate from, the accreditation activities of Joint Commission International.

Joint Commission International (JCI) works to improve patient safety and quality of health care in the international community by offering education, publications, advisory services, and international accreditation and certification. In more than 100 countries, JCI partners with hospitals, clinics, and academic medical centers, health systems and agencies, government ministries, academia, and international advocates to promote rigorous standards of care and to provide solutions for achieving peak performance.

To maintain best practices, JCI turns to its Standards Advisory Panel, comprised of experienced physicians, nurses, administrators, and public-policy experts. The panel guides the development and revision process of the JCI accreditation standards. Panel members are from five major world regions: Latin America and the Caribbean, Asia and the Pacific Rim, the Middle East, Europe, and the United States. The panel’s recommendations are refined based on an international field review of the standards and input from experts and others with unique content knowledge.