Quality Management System ISO 9001:2015


ISO 9001 is international standard for a Quality Management System (QMS). The requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, business, regardless of size & industry type.

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. ISO 9001:2015 helps businesses and organizations be more efficient and improve customer satisfaction by meeting expectations of Customers & legal compliance requirements.


Benefits of ISO 9001:2015 to the Organization

  • Improves Product or Service Quality
  • Improves Organizations Credibility in the market
  • Improves Customer Satisfaction
  • Process becomes streamlined & integrated
  • Reduce Waste
  • Helps to continual improvement
  • Achieve International Quality Recognition
  • Communicates a positive message to staff and customers

Quality Management System – Medical Devices
ISO 13485:2016

ISO 13485:2016 specifies the requirements for Quality Management System where an organization needs to demonstrate its ability to provide medical devices and related services that are consistently meet customer and applicable regulatory requirements for the design and manufacture of Medical Devices.

ISO 13845:2016 is beneficial for many organisations and can be used by suppliers and external parties that are involved with providing medical device products. The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organisation are the responsibility of the organization and are accounted for in the organisation’s quality management system by monitoring, maintaining, and controlling the processes.


Benefits of ISO 13485:2016

  • Improves Risk Management and gives assurance to the Quality of product
  • Meets customer expectations and improves ability to respond to customer requirements
  • Meets the applicable regulatory requirements to avoid penalties
  • Increases overall efficiency and cost savings
  • Helps to maintain the quality of the supply chain

Environmental Management System ISO 14001:2015

ISO 14001 is the international standard that specifies requirements for an effective Environmental Management System (EMS). ISO defines an environmental management system as a “part of the management system used to manage environmental aspects, fulfil compliance obligations, and address risks and opportunities to minimize how their processes, negatively affect the environment.”

EMS includes the organizational structure, planning and resources for developing, implementing and maintaining policy for environmental protection. Based on their own positive experiences, many companies with ISO 14001 certification have asked their suppliers to demonstrate their commitment to conserving resources and decreasing their impact on the environment.


Benefits of ISO 14001:2015

  • Improves operational environmental protection
  • Reduce waste & environmental risks
  • Improves environmental performance includes the environmental quality of products and services
  • Increase new business opportunities
  • Enhance Organization’s social image and competitive ability to the society
  • Manage environmental obligations with consistency
  • Promoting a positive image with stakeholders, customers and employees

Food Safety Management System ISO 22000:2018

ISO 22000 is an international standard that defines the requirements of a Food Safety Management System. It maps out what an organization needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe. It can be used by any organization regardless of its size or position in the food chain. ISO 22000 Certification services provide clients a systematic method for analyzing food processes, determining the possible hazards, and designating the critical control points.

ISO 22000 incorporates HACCP principles and is compatible with ISO 9001 Quality Management System, making it the ideal basis for implementing a comprehensive, cost effective food safety management system. ISO 22000 certification demonstrates your on-going commitment to food safety, proves your integrity to the market, and enhances consumer confidence in your brand.



Benefits of ISO 22000:2018

  • Introduce to internationally recognized processes to your business.
  • Give suppliers and stakeholder’s confidence in your hazard controls.
  • Introduce transparency around accountability and responsibilities.
  • Continually improve and update your systems so it stays effective on Food Safety Aspects.
  • Recognized by the Global Food Safety Initiative (GFSI)
  • Reduces food safety hazards
  • Promotes legal compliance

Occupational Health Safety Management System
ISO 45001:2018


ISO 45001 specifies requirements for an Occupational Health and Safety (OH&S) Management System, and gives guidance for its use, to enable organizations to provide safe and healthy workplaces by preventing work-related injury and ill health, as well as by proactively improving its OH&S performance.

ISO 45001:2018 implement and maintain an OH&S management system to improve occupational health and safety, eliminate hazards and minimize OH&S risks (including system deficiencies), take advantage of OH&S opportunities, and address OH&S management system nonconformities associated with its activities.

By successful implementation of an effective OH&S management system can gain an organization the recognition and reputation of being a safe place to work. ISO 45001:2018 helps an organization to achieve the intended outcomes of its OH&S management system.

Benefits of ISO 45001:2018

  • Increase awareness of health and safety risk associated with their business.
  • Development of OH&S policies and processes including setting OH&S objectives.
  • Reduction in accidents by way of systematization of all activities relevant to occupational health and safety
  • Improved employee identification and motivation due to management involvement in OH&S processes
  • Improved image and competitive ability based on documented and sustained OHSAS performance
  • Improves the safety of all persons affected by the company’s activities.

Energy Management System ISO 50001:2018


ISO 50001 Energy Management System (EnMS) certification provides a framework for establishing energy management best practices to help the organizations to improve their energy efficiency. The standard enables organizations to establish the systems and processes necessary to improve energy performance, including energy efficiency, use and energy consumption.

An Energy Management System (EnMS) establishes the structure and discipline to implement technical and management strategies that significantly cut energy costs and greenhouse gas emissions - and sustain those savings over time. Savings can come from no- to low-cost operational improvements. Manufacturers, corporations, utilities, energy service companies, and other organizations are using ISO 50001:2018 to reduce costs and carbon emissions. As of 2017, almost 23,000 sites worldwide achieved ISO 50001 certification.

Benefits of ISO 50001:2018

  • Increase assist organisations in making better use of energy-consuming assets
  • Facilitate transparency / communication on management of energy resources
  • Promote best practices for energy management
  • Assist facilities in evaluating and prioritising the implementation of new energy-efficient technologies
  • Provide framework for energy efficiency throughout the supply chain
  • Facilitate energy management improvements for GHG emissions reduction projects

Integrated Management System (IMS)


An integrated management system (IMS) integrates all organization’s systems & processes, combine all related components of a business into one system for easier management and operations organization to work as a single unit with unified objectives. Quality, Environmental and Safety management systems are often combined and managed as an IMS.

Organizations often focus on management systems individually, often in silos and sometimes even in conflict. A quality team is concerned with the QMS, often an EHS manager handles both Environmental and Health and Safety issues, or a QHSE Manager handles Safety, Health, Environment and Quality, etc.

The three management systems share many common requirements and the continual improvement goal. They differ in their approach and degree of prescription, but the ISO 9001, ISO 14001 and ISO 45001 standards are compatible in content, terminology & many of the requirements. It is often more efficient to combine the three systems (QMS, EMS and OHSMS) into one and sharing the common clauses and procedures.

Benefits of Integrated Management System

  • Consistent objectives, planning, and document management
  • Implementation and Operation of the system cost less.
  • Easier internal audits
  • No Redundancies, reducing the chance of conflict.
  • Cost reduction due to integrated audits and assessments, as well as optimize processes and resources.
  • Optimize Processes and Resource

Trainings

Quality Management System ISO 9001:2015

Environmental Management System ISO 14001:2015

Occupational Health Safety Management System ISO 45001:2018

Internal Auditor

Quality Improvement Techniques

Quality Management System – Requirements for Medical Devices ISO 13485:2016

Risk Analysis

Total Quality Management

5S at Workplace

Kaizen

Lean Management

Failure Mode & Effects Analysis

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