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ISO9001-QUALITY MANAGEMENT SYSTAM


How to achieve ISO 9001 certification - ISO 9001 implementation / Certification steps

Omega SSR. offers a well defined and globally proven implementation methodology for ISO 9001:2015 certification.

  • Gap Analysis 
  • Awareness Training 
  • Process Identification and definition 
  • Documentation Design and finalization 
  • Implementation 
  • Internal Auditor Training and conduct of internal audit 
  • Management Review Meeting 
  • Pre-assessment
  • Stage 1 – certification audit
  • Stage 2 – certification audit
  • Award of ISO 9001 certification

Continual improvement of the system through value added consulting and training services

What are the requirements of ISO 9001 standard
  • Determine the internal and external context that affects the organization
  • Determine the need and expectations of interested parties
  • Determine the scope of quality management system
  • Determine the input required and output expected of these processes
  • Determine interaction of these process
  • Determine the criteria ,methods, including measurement and related performance indicators needed to ensure effective operation and control these processes
  • Determine the resources needed for these processes and ensure their availability
  • Assigning responsibilities and authorities for these processes by adopting a Stakeholder approach to quality management.
  • Determine risks and opportunities in accordance with these process and appropriate actions to address them.
  • Determine the methods to monitor, measure and evaluate the processes
  • Determine opportunities for improvement in processes and quality management system
  • Makes it easier for the Service industry with the word product replaced by goods and services.
  • Determine the amount of documented information on processes.

Documents needed by the organization to ensure the effective planning, operation and control of its processes:
In new standard, wherever you identified a word "maintain" it tells to establish documents and wherever you identify a word "retain" it tells to establish a record and maintain.

There are several requirements of ISO 9001:2015 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:

  • Process maps, process flow charts and/or process descriptions
  • Organization charts
  • Specifications
  • Work and/or test instructions
  • Documents containing internal communications
  • Production schedules
  • Approved supplier lists
  • Test and inspection plans
  • Quality plans

What is ISO 14001-ENVIROMENT MANAGEMENT SYSTEM

The ISO 14000 is a family of internationally recognized standards for environmental management systems that is applicable to any business or organization, regardless of size, location or income. These standards are developed by the International Organization for Standardization (ISO), which has representation from committees all over the world. The ISO 14000 family includes most notably the ISO 14001 standard, which represents the core set of standards used by organizations for designing and implementing an effective environmental management system. Other standards included in this series are ISO 14015, which gives additional guidelines for a good environmental management system, and more specialized standards dealing with specific aspects of environmental management.

The ISO 14000 environmental management standards exist to help organizations minimize how their operations negatively affect the environment. The major objective of the ISO 14000 series of norms is "to promote more effective and efficient environmental management in organizations and to provide useful and usable tools - ones that are cost effective, system-based, flexible and reflect the best organizations and the best organizational practices available for gathering, interpreting and communicating environmentally relevant information".

It offers a source of guidance for introducing and adopting environmental management systems based on the best universal practices, in the same way that the ISO 9000 series on quality management systems, which is now widely applied, represents a tool for technology transfer of the best available quality management practices. In structure the ISO 14000 series is similar to ISO 9000 quality management and both can be implemented side by side.


ISO 14001 is the principal management system standard which specifies the requirements for the formulation and maintenance of an EMS. There are three fundamental commitments required in an environmental policy that meets the requirements of ISO 14001. These include:

  • Prevention of pollution
  • Compliance with legislation
  • Continual improvement of the EMS

These commitments help drive the improvements in overall environmental performance.

ISO 14001 can be used as a tool; it focuses on controlling your environmental aspects or the way that your activities products and services interact with the environment; for example, emissions to air, land or water. Organisations must describe what they intend to do, adhere to their procedures and record their efforts to demonstrate compliance and improvement. You will set objectives, targets and implement a programme to improve your environmental performance which often leads to financial benefits.

Organisations are required to identify applicable legal, statutory and related requirements. It is particularly important to identify how the legislation affects you so that compliance measures can be adopted and periodically evaluated ensuring requirements are understood by employees and implemented effectively.

ISO 14001 is accompanied by ISO 14015, Environmental Management systems - General Guidelines on principles, systems and support techniques. This standard covers issues such as the establishment, implementation, maintenance and improvement of an MS and discusses the principle issues involved.


How to achieve ISO 14001:2015 certification - ISO 14001:2015 implementation / Certification steps

Omega SSR. offers a well defined and globally proven implementation methodology for ISO 14001:2015 certification.

  • Gap Analysis 
  • Awareness Training 
  • Process Identification and definition 
  • Documentation Design and finalization 
  • Implementation 
  • Internal Auditor Training and conduct of internal audit 
  • Management Review Meeting 
  • Review of Implementation
  • Pre-assessment
  • Stage 1 – certification audit
  • Stage 2 – certification audit
  • Award of ISO 9001 certification
  • Continual improvement of the system through value added consulting and training services

What is OHSAS 18001


OHSAS 18001:2007 is the International Occupational Health and Safety Management Standard.

It was published in July 2007, superseding OHSAS 18001:1999, and is intended to address occupational health and safety (OH&S) rather than product safety.

OHSAS 18001 provides a framework to the effective management of OH&S including compliance with the legislation that applies to your activities and identified hazards

The standard is applicable to any organisation that wishes to eliminate or minimize risk to employees and other stakeholders who may be exposed to OH&S risks associated with its activities.

Many organizations will have elements required by OHSAS 18001 already in place which can be supplemented to provide a more cohesive management system to meet the requirements of the standard.

Organisations that implement OHSAS 18001 have a clear management structure with defined authority and responsibility, clear objectives for improvement, with measurable results and a structured approach to risk assessment. This includes the monitoring of health and safety management failures, auditing of performance and review of policies and objectives.

Benefits of OHSAS 18001:2007

In a competitive marketplace, your customers are looking for more than just keen pricing from their suppliers. Companies need to demonstrate that their businesses are managed efficiently and responsibly and that they can provide a reliable service without excessive downtime caused by work-related accidents and incidents.

Certifying your BS OHSAS 18001 management system enables your organization to prove that it conforms to the specification and provides the following benefits:

  • Customer satisfaction - through delivery of products that consistently meet customer requirements whilst safeguarding their health and property
  • Reduced operating costs - by decreasing down-time through incidents and ill health and reducing costs associated with legal fees and compensation
  • Improved stakeholder relationships - by safeguarding the health and property of staff, customers and suppliers
  • Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers
  • Improved risk management - through clear identification of potential incidents and implementation of controls and measures
  • 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

How to achieve OHSAS 18001 certification - OHSAS 18001 implementation / Certification steps

OMEGA SSR. offers a well defined and globally proven implementation methodology for OHSAS 18001-2007 certification.

  • Gap Analysis 
  • Awareness Training 
  • Hazard analysis and risk analysis 
  • Documentation Design and finalization 
  • Implementation 
  • Internal Auditor Training and conduct of internal audit 
  • Management Review Meeting 
  • Review of Implementation
  • Pre-assessment audit
  • Stage 1 – certification audit
  • Stage 2 – certification audit
  • Award of of OHSAS 9001 certification
  • Continual improvement of the system through value added consulting and training services

ISO 22000-FOOD SAFETY MANAGEMENT SYSTAM 

A feed and food safety management system enables companies to provide trust to customers and consumer about the corporate capability to manage the food safety related risks. 

The ISO22000 standard has been developed within ISO by experts from the food industry along with representatives of specialized international organizations and in close cooperation with the Codex Alimentarius commission, the body jointly established by the United Nations` Food and Agriculture Organization (FAO) and World Health Organization (WHO) to develop food standards. 

Food Safety Management system is a risk management tool specifically designed for the food industry in order to assure food safety. It specifies requirements for food safety. Where an organization in the food chain needs to demonstrate its ability to control food  safety, hazards in order to ensure that food is safe at the time of human consumption. 

ISO22000 is designed to allow all types of organization within the food chain to implement a food safety management system. These range from feed producers, primary producers. Food manufacturers, transport and storage operators and subcontractors to retail and food service outlets together with related organization such as producers of equipment, packaging material, cleaning agents,  additives and ingredients. 

Another benefit of ISO22000 is that it extends the successful management system approach of the IOS9001 quality management system with Hazard Analysis process & Critical Control and plans in order to provide safe food. 

Adoption to these standard changes the concerned company’s approach from retroactive quality testing to a preventive work culture. Companies face strong requirements from legislators, customers and consumer to assure consistently safe production processes. A

Commitment to conscious risk management will be one of the main competitive advantages.

HACCP (Hazard Analysis & Critical Control Points)

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).

Increasing consumer demand for safe food has led many companies to develop both food quality and safety management systems, based on the Hazard Analysis and Critical Control Point (HACCP). In 2001, ISO started the development on an auditable standard, which further defines HACCP's role in food safety management systems and culminated in the newly formed ISO 22000. The ISO 22000 standard intends to define the food safety management requirements for companies that need to meet and exceed food safety regulations all over the world. One standard that encompasses all the consumer and market needs. It speeds and simplifies processes without compromising other quality or safety management systems.

ISO 22000 is an international certification standard that defines the requirements of food safety management systems. It can be used by all organisations, in the supply chain - from farmers to food services, to processing, transportation, storage, retail and packaging.

ISO 22000 creates a harmonised safety standard that's accepted the world over. By integrating multiple principals, methodologies and applications, ISO 22000 is easier to understand, apply and recognise. That makes it more efficient and effective as an entry-to-market tool than previous combinations of national standards.

ISO 22000 specifies the requirements for a food safety management system that combines well-recognized key elements to ensure food safety along the food chain, up to the point of final consumption:

  • Provide interactive communication, internationally and across the supply chain.
  • Compliance with the HACCP principles – Hazard Analysis, Identify Critical Control Points (CCP's), Establish Critical Links, Monitor CCP's, Establish Corrective Action, Record Keeping, Verification.
  • Harmonise the voluntary and prerequisite standards.
  • Create a structure that's aligned with ISO 9001:2000.
  • System management.
  • Process control

Benefits of HACCP – ISO 22000:2005 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

How to achieve HACCP – ISO 22000;2005 certification – HACCP/ISO 22000 implementation / Certification steps

Omega SSR. offers a well defined and globally proven implementation methodology for HACCP / ISO 22000 Food safety management system certification.

  • Gap Analysis 
  • Awareness Training 
  • Hazard analysis and risk analysis 
  • Documentation Design and finalization 
  • Implementation 
  • Internal Auditor Training and conduct of internal audit 
  • Management Review Meeting 
  • Review of Implementation
  • Pre-assessment audit
  • Stage 1 – certification audit
  • Stage 2 – certification audit
  • Award of ISO 22000 / HACCP certification
  • Continual improvement of the system through value added consulting and training services

ISO10002-COMPLAINT MANAGEMENT SYSTEM 

ISO10002 complaints managements system provides guidance on the process of complaints handing related to product within on organization, including planning,

Design, operation, maintenance and improvement. The complaints handing process

Described is suitable for use as one of the processes of on overall quality management system , the international standard provides a framework that the information obtained through the complaints handling process can lead to 

  • Improvement in products and processes
  •  Improve the reputation of organization 

Complaint Management system compliant to ISO10002 is relevant to any organization that wishes to exceed customer expectations, a basic requirement for businesses of all types and sizes, whether they’re in the private, public or voluntary sectors, ISO10002 is not applicable to disputer referred for resolution outside the organization or for employment-related disputes. 

BENEFITS

ISO10002 addresses all aspects of complaints handling with benefits as below: 

  1. Ability to retain the loyalty of customers, 
  2. Implementation and certification ensures a consistent process to handle customers, which enable to identify causes and eliminate the causes of complaint, 
  3. System helps to adopt a customer-focused approach to handle analysis and review complaints, 
  4. It provides a basis for continual improvement, 
  5. Provide complainants with an open, effective and easy to use complaints process etc.  

GMP COMPLIANCE 

Good manufacturing practice (GMP) is a term that is recognized worldwide for the control and management of manufacturing, testing and overall quality control of food and pharmaceutical products. GMP takes quality assurance approach which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and required by the marketing authorization. 

GMP addresses issues including documentation, record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling, Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. 

The quality approach of GMP ensures manufacturing, enabling companies to minimize or elimination, instances of contamination, mix-ups, and errors. This in turn, protects the consumer from purchasing a product, which is not effective or even dangerous. Failure of firms to comply with GMP regulation can result in very serious consequences including recall, seizure, fines, and jail time. 

It is believed that GMP is a good business tool, which will help to refine both compliance and performance of the company; GMP requirements are largely common sense practices, with will help companies better itself as it moves toward a quality approach using continuous improvement. 

GMP is also sometimes refereed to as “cGMP”. The “current,” methodologies  of manufacture, testing, technologies and system, which are up-to-date. System and equipment used to prevent contamination, mix-ups. And errors are adequate by today’s standards.

ISO 27001 - INFORMATION SECURITY MANAGEMENT SYSTEM 

Information is the key to growth and success of an organization, it is an important asset, valuable to an organization and hence needs to be suitably protected, Organizations have realized the importance of security and that it is vital to keep confidential business information secure, sensitive and confidential information need to be protected in management system complaint to international stander demonstrates that information is suitably protected, ISO has developed ISO27001 standard in order to overcome the information security shortcomings in organizations. 

ISO27001 is an information security management system (ISMS) standard published in October 2005 by the international organization for standardization and the international electro technical commission, 

An information security management system identifies and reduces critical security risks of organization` information assets and makes a platform to protect that asset. It sets standard for handling the confidentiality, integrity and availability of information asset,  

SRM - SOCIALLY RESPONSIBLE MANAGEMENT  

It is commonly understood that the welfare of the employees in industrial organizations is to be considered and enhanced effectively. The conscience of these Organizations has been picked either voluntarily or by outside pressure, and consequently, it became applied to the manufacturers in ensuring the workers are not being exploited. 

Such guidance has been developed in the form of SA 8000, a` standard` for specifying minimum criteria to meet` socially accreditation` levels. This standard is not subject to accreditation by any of National Accreditation Bodies e.g. UKAS, therefore it was felt more appropriate for OMEGA to develop its own scheme to match or exceed the requirements of SA8000. 

The benefits of adopting this standard are manifold: 

  • Public awareness of company `s commitment of assuring humane working conditions,
  • Drives company values into action, 
  • Enhances company and brand reputation, 
  • Supports better supply chain management and performance, 
  • Provides clear and credible assurance for ethical business, 
  • Identifies ethically made products and companies committed to ethical sourcing, 
  • Differentiates from the competition,

CE Marking - Product Certifications  

The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European directives. The letter `CE` are an abbreviation of Conformity Europeenne, French word for European conformity. The CE mark must be affixed to a product if it falls under the scope of ` New Approach Directives of European union.

Without the CE marking, and thus without complying with the provisions of the Directives, the product may not be placed in the market or put into service in the fifteen member states of the European Union and Norway, Iceland and Liechtenstein. However, if the product meets the provisions of the applicable European Directives and the CE mark is affixed to a product, these countries may not prohibit, restrict or impede the placing in the market or putting into service of the product.

The CE mark is compulsory within the context of the application of EC new approach directives. Thus, CE marking can, be regarded as the product’s trade passport for Europe.

Notified bodies are recognized organizations within member states, which can certify conformity assessment on the basis of the new approach directives.

ISO 50001 EnMS - Energy Management System

ISO 50001 Standard
specifies requirements for an Energy Management System to enable organization to develop and implement a policy, controls for identified significant areas of energy consumption and energy reductions. It resets the best practices in energy management upon existing national standards and initiatives.

ISO 50001 Certification
requires organizations to promote energy savings initiatives and establishes for the reduction of energy intensiveness of a company's operation. OMEGA offers certification against 

ISO 50001 EnMS Standard
is applicable to all types of organizations irrespective of size, nature or geography such as Hospital, Health Care, Construction and Buildings, Shopping Malls, Commercial Building, Manufacturing, Service Companies, Software Companies, Medical Device in india

Benefits of ISO 50001 EnMS Certification are:
» A structured approach to identify, measure and manage energy consumption
» Enable Organizations to reduce GHG emissions
» Improve organization's image with customers, partners, and the public
» omply with statutory and regulatory requirements
» Increase awareness for the energy management policy

IMS (Integrated Management System)

When organization chooses more than one standards for implementation together is known as Integrated Management. In which organization integrate two or three or more management system standards together for implementation in the organization. During the implementation of integrated management system organization shall have one Quality Manual integrated with two or three or more standards together. The common business practice for integrated management system implementation or certification is ISO 9001 & ISO 14001 or ISO 9001, ISO 14001 & OHSAS 18001 or ISO 9001 & ISO 22000 or ISO 9001 & ISO 27001. The Audit and certification of integrated management system is known as integrated management system certification.

The summarized requirement details of Integrated Management System Certification are given below :

Benefits of Integrated Management System Certification

  • One quality Manual.
  • Common Internal Audit – with integration of requirements of all standards.
  • Common Management Review Meeting.
  • Less time for development of documentation and implementation.
  • Cost effective.
  • Less Audit time as compare to individual management system certification.
  • Common audit report.
  • Duplication effort reduced during implementation.

Applicant organization shall ensure the followings prior to Integrated Management System Certification

  • Implementation of Integrated Management System in the organization. Established the
  • Integrated System Manual, relevant procedures and SOP's.
  • Conducted one complete cycle of Integrated Management System Internal Audit.
  • Conducted at Least One Management Review Meeting on Integrated Management System.
  • grated management system have been identified and compliance has been established.

Integrated Management System Certification Process

  • Application review and contract Sign up between OSS and applicant organization.
  • Stage-1 Audit.
  • Stage-2 Audit.
  • Certification decision.
  • Issue of certificate.
  • Surveillance audit (annually or Half yearly as finalized during application review process and agreed by client).