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ISO Certification in Gujarat

ISO Certification in Gujarat - ISO 9001, 14001, 45001, 27001 And 22000

ISO Certification in Gujarat

Why ISO Required in Gujarat

Gujarat is a leader in industrial sectors such as chemicals, petrochemicals, dairy, drugs and pharmaceuticals, cement and ceramics, gems and jewelry, textiles, and engineering. Major resources produced by the state include cotton, peanuts, dates, sugarcane, and petrol. The state is rich in calcite, gypsum, manganese, lignite, bauxite, limestone, agate, feldspar, and quartz sand, and successful mining of these minerals is done in their specified areas. Ahmedabad, Vadodara, Ankleshwar, and Vapi are the hub of chemical industries in the state, having a number of manufacturing units (private as well as state-owned) manufacturing dyes, specialty chemicals, agricultural chemicals, pesticides, pigments, colors, etc. Rajkot city is the hub of engineering manufacturing and has many companies manufacturing auto components, auto engines, CNC machines, forging & casting parts, etc. Gujarat offers scenic beauty from Great Rann of Kutch to the hills of Saputara.

Refer  ISO Certification schemes for ISO Certification in Gujarat

ISO 9001 (QMS) – Quality Management System

ISO 14001 (EMS) – Environment Management System

ISO 22000 (FSMS) – Food Safety Management System

ISO 27000 (ISMS) – Information Security Management System

ISO 45001 (OHSMS) – Occupational Health and Safety Management System

Other Certifications –

HACCP Certification– This is Hazard Analysis and Critical control points based on food safety. This standard is applicable to those organizations that are engaged in the food chain.

Third-Party Inspection (TPI) – This is a product inspection /certification scheme that can be done at its initial stage i.e. at the time of material receipt, at the time of production, at the time of product inspection, at the time of final inspection and pre-dispatch inspection. Any kind of organization can benefit from this certification scheme.

 

ISO well known as International Organization for Standardization is a worldwide federation of national standards bodies (ISO member bodies). It is the developer of International Standard and provides common standards between nations. ISO standards help organizations to enhance their productivity while minimizing wastages and errors, it also confirms the ISO certified organization those are following standard requirements as laid down by the specified standard are globally well known and practiced for the betterment of the organization and its purpose.

ISO certification of an organization demonstrates its ability to consistently perform as per specified management system standard requirements. ISO certification is the proof of conformity on a specified management system of the organization which is done by the third party accredited certification body

Stages of ISO Certification

  • Implementation the Management System in the organization – that includes Resource provision, Allotment of Team Leader deploying responsibilities for effective specified management system establishment and maintenance, conducting gap analysis, Creating and updating effective documented information
  • Verifying the effectiveness of the established specified management system through Internal Audit
  • Conducting Management Review Meetings
  • Application for specified ISO Certification to accredited Certification Body
  • Document Review / Stage 1 Conducted by an accredited Certification Body (Subject to the closure of identified Major / Minor NC’s)
  • Stage 2 Audit conducted by An accredited Certification Body (Subject to the closure of identified Major / Minor NC’s)
  • Award of ISO Certificate to organization
  • Surveillance audit after 12 and 24 months of certification for ISO certification continuation.

ISO Standard implementation

When the organization plan for ISO Certification to the organization. The Implementation of ISO Standards in the organization is a mandatory requirement before apply for ISO Certification to ISO Certification Body.

For Implementation, the organization can do the following way

  1. Appoint the ISO Consultant, who is competent and has wide experience in the implementation of ISO Standards in the organization.
  2. The organization can do the self-implementation if organization has Team, who have understanding the requirements.

 Steps of Implementation of ISO Standard for Certification are 

  • Understating the requirements
  • Gap Analysis
  • Review of Gap Analysis
  • Developing the Documents
  • Training to Team
  • Implementing the Documents in the organization at different Process/ Function
  • Monitoring the Process
  • Internal Audit
  • Management review meeting

 Requirements of ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 27001 give given below for understanding, along with documentation required for each clause of ISO Standard.

Which can help the organization to understand and implement the ISO Standard in the organization by self, to get ISO Certification in Gujarat?

 ISO 9001 Certification in Gujarat

 Quality Management System – QMS – ISO 9001:2015

QMS is the set of policies, procedures, processes that are required for planning and execution of product / services. The structured way of delivering quality products / services is supported by documented information. This is the basic standard that is applicable to any kind of organization.

Requirements of ISO 9001

Understanding organization and its context – identification of internal and external issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result. External issues considering arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. Internal issues related to values, culture, knowledge and performance of the organization.

Required document – Internal / External issue register

Understanding needs and expectations of the interested parties. The organization shall monitor and review information about interested parties and their relevant requirements.

Required document – Interested parties and their needs and expectations to be mentioned in quality manual

The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system

Required document  – Scope of the organization and its applicability to be mentioned in quality manual.

Quality management system and its processes – Here organization have to determine the process and their interaction, Inputs required and desired outputs, resources needed for the  process and their availability

Required document – Quality manual

Leadership and commitment – Top management has to appoint the team leader to take accountability for the effectiveness of the quality management system.

Required document – Appointment of team leader

Customer focus – understanding customer requirements along with legal requirements, Enhancing customer satisfaction

Required document – Customer satisfaction survey form, delivery compliance

Quality policy – Quality policy as written statement towards customer satisfaction, legal compliance and continual improvement of the organization to be displayed by the organization at prominent places and well understood by the peoples of the organization

Required document – Quality Policy

Organizational roles, responsibilities and authorities – Job description of personnel for effective product / process conformity. Implementation and display of organization chart

Required document – Job description, Organization chart

Action to address Risk and opportunities – referred to internal and external issues as identified by the organization, its action plan towards minimize / control the adverse effect on the organization

Required document – Internal and external issue register and assessment of issues as significant / non-significant and control over it.

Quality objectives and planning to achieve them – Here organization has to determine the quality objectives relevant to the quality management system and implementing an action plan to achieve the same. Here objectives determined by the organization are in measurable form

Required document  – Quality objectives and its monitoring record.

Resources – Here organization has to provided desired resources to achieve its goal, resources comprising, Man, Machine, Money, Material

Required document – List of machines and its preventive / breakdown maintenance plan, Skilled manpower required for desired processes, Availability of utilities

People – Manpower required for process conformity

Required document – List of employees and designation

Infrastructure – List of machines and its preventive / breakdown maintenance plan, Availability of utilities

Required document – List of machines and its preventive / breakdown maintenance plan, Availability of utilities

Environment for the operation of the processes – Here environment is related to human and physical factors such as – appropriate ventilation, humidity, temperature, non-discriminatory, calm, non-confrontational, stress-reducing, burnout prevention, emotionally protective, These factors can differ substantially depending on the products and services provided.

Monitoring and measuring resources – Here organization has to provide appropriate equipments that are required for process / product monitoring and measurements

Required document  – List of Instruments, Calibration plan, Calibration certificate and its traceability to national / international standard.

Organizational knowledge – organization has to determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services

Required documents – Project seminars, Customer feedback, Work instructions, control plans, intellectual property, standards; academia; conferences

Competence – Here organization has to determine necessary competence for the required processes, to ensure person performing the task is competent on the basis of education, training, experience, wherever applicable organization can provide trainings to its peoples to enhance their performance

Required documents – Skill Matrix, Personnel evaluation, Employee records / credentials

Awareness – Organization shall ensure that their employees are aware with the quality policy, objectives and their contribution towards effective quality management system

Required documents – Training plan, Training records and its effectiveness verification

Communication – Here organization have to maintain internal / external communication procedure

Required document – communication procedure

Documented information – Documented information as evidence of conformity to be maintained by the organization for the effectiveness of quality management system

Required document – Master list of documents and records, Policy, procedures, SOPs, Work instructions, Quality manual

Creating and updating – identification of information, its formatting and review and approval for suitability and adequacy

Required document – Revision record sheet, document identification, its retrieval and retention status

Control of documented information – it is all about information access, distribution, retrieval and use. Documented Information that is to be stored and preserved, its retention and disposition

Required document – Master list of records, its revision, retention and disposition

Operational planning and control – here organization have to determine the requirements for product / services, resources needed to achieve product conformity, control plans

Required document – Control plan, Resource planning, Product Monitoring records

Customer communication – Customer communication procedure regarding handling queries, customer complaints, requirement for product / services, handling / controlling customer properties,

Required documents  – Customer queries, Customer complaints, Customer properties, Communication records such as email, purchase order. MOU / MOM

Determining the requirements for products and services – Product requirements as determined through customer purchase order / Work agreement, applicable legal requirements while establishing the product conformity

Required documents – Customer Purchase order / Work Agreement / Scheduling agreement / Work schedule.

Review of requirements for product and services – review and verification of customer requirements for ensuring the ability to meet the requirements

Required document – Contract review / Purchase order verification and acceptance

Changes to requirements for products and services – when the requirements for products and

Services are changed; the organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements

Required document – Amended purchase order / agreement

Design and development of products and services – (if applicable)

Design and development planning – Planning of design that required process stages, design review, verification and validation activities, Design responsibilities and authorities, resource needs, user interface

Required documents – Design plan

Design and development inputs – here organization has to determine the specific type of product / services to be designed, while designing organization have to consider the functional / performance requirement of the product / services to be designed, inputs from similar design, any legal applicable requirements

Required documents – Product specification, technology import, similar design as input, legal requirements.

Design and development controls – This is simply control to be applied to the design phase to achieve desired results / product as per design specification

Required documents – Design output / product specifications, Design review record, Verification / inspection and testing record, Validation records,

Design and development output – This is finished product that meets the design input requirements

Required document – Finished product specification conforming input details,

Design and development changes – This is design revision record specifying upgraded product

Required document – Design revision record sheet

Control of externally provided processes, products and services – This is Control over the entities those are responsible to provide product / raw material / services to the organization to ensure product / process conformity.

Required documents – List of Suppliers / Service providers, Supplier assessment records, Supplier evaluation

Type and extent of control – Here organization shall ensure that the product / process those are externally provided do not have any adverse impact on its product / process. This is nothing but verification of purchased product / inward inspection of product

Required document – Inward Inspection Report, Counter verification of purchased product (Material test certificate, Lab inspection report, etc.)

Information for external providers – This is raw material purchase

Required document – Raw material purchase order, Material delivery challans for external processing

Control of production and service provision – This is about production and production control, production control that includes – availability of resources i.e. man, machine, material, etc. Production Control plans, Production monitoring records, Process validation, prevention of NC product

Required document – Daily production Record, Control plans, Validation record, Work instruction

Identification and traceability – It is about product identification and traceability during throughout production and service provision.

Required document – Product identification record such as product specification, batch number, product code / tagging

Property belonging to customers or external providers – This is about property preservation, retention and due care during the production and service provision

Required document – Customer product specifications, Work agreement, List of Assets provided by external provider such as customer / user / Supplier, List of drawings, Tools and tackles, Fixtures,

Preservation – This is about product handling, packaging, storage, transportation and identification of product

Required document – Product preservation criteria, Packing list, Handling procedure,

Control of changes – This is about any changes in results of the review, person authorizing change throughout the production and service provision

Required document – Revision record sheet, review record

Release of products and services – This is final / pre-dispatch inspection of the product as desired by the customer

Required document  – Final Inspection Report, Pre-Dispatch Inspection report, Work completion record / certificate with appropriate authority to release the product.

Control of nonconforming outputs – This is internal rejection of the organization occurred during production and service provision phase, which can be controlled by the organization through rework, or else segregated or obtaining concession from customer

Required document – Rejection record, Rework register, Tolerance record / CAPA record

 

Customer satisfaction – This is customers perception monitoring related to their needs and expectations

Required document – Customer Survey, Customer feedback, Customer claims

Analysis and evaluation – This is data analysis arising from monitoring and measurement activities of the management system

Required document – Objective analysis record

Internal audit – This internal assessment of an effective quality management system that conforms to organizations own requirements for its quality management system, the requirement of this international standard, and it is been effectively implemented and maintained.

Required document – Internal audit plan, schedule, Assessment record, NC record, CAPA record of identified NC’s

Management review – It is to ensure organizations continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization

Required document – MRM agenda, Management review record, Output of the Management review

Nonconformity and corrective action – This is non conforming product including arising from complaints and organizations correction and corrective action

Required document  – Non conforming record, Correction of NC product and corrective action record.

Continual improvement – The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system.

Required document – Business plans,

For effective implementation, the organization needs to

  • Provide training within organization to improve the skills of employees along with ISO awareness
  • Implementation of documented information and verification of its effectiveness and control
  • Complying applicable legal requirements that organization access
  • Conducting internal audit and management reviews and fulfilling/minimizing non-compliances that are observed

Benefits of ISO 9001

  • Suitable for all kind of organization
  • The globally known practice adopted by the organization
  • Legal compliance
  • Product compliance
  • Minimized customer complaints
  • Risk-based thinking
  • Peoples involvement
  • Increased productivity
  • Systematic approach
  • Happy customer / increased customer satisfaction

 ISO 14001 Certification in Gujarat

 Environmental Management System -ISO 14001:2015  

 EMS is Environment Management System standard that focuses on organizational activities, Product / Process / Services that have an adverse impact on the environment, resource depletion and prevention & control on it, and organizations contribute to the environmental sustainability and its responsibility towards environment protection and cure.

The requirements of this standard are applicable to any organization regardless of size, location, and maturity level.

Requirements of this standard ISO 14001

Understanding the organization and its context – identification of internal and external issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result.

Required document – Internal / External issue register

Understanding the needs and expectations of the interested parties. The organization shall monitor and review information about interested parties and their relevant requirements.

Required document – Interested parties and their needs and expectations to be mentioned in the quality manual

The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered,

Required document  – Scope of the organization and its applicability to be mentioned in EMS manual.

Environment management system and its processes – Here organization have to determine the process and their interaction, Inputs required and desired outputs, resources needed for thede process and their availability

Required document – Quality manual

Leadership and commitment – Top management has to appoint the team leader to take accountability for the effectiveness of the quality management system.

Required document – Appointment of team leader

Environmental policy – EMS policy as a written statement towards nature, scale and

Environmental impacts of its activities, products, and services, legal compliance, protection of the environment, including prevention of pollution and other specific commitment and continual improvement of the organization to be displayed by the organization at prominent places and well understood by the peoples of the organization

Required document – Environmental Policy

Organizational roles, responsibilities, and authorities – Job description of personnel for effective product/process conformity. Implementation and display of organization chart

Required document – Job description, Organization chart

Action to address Risk and opportunities – referred to internal and external issues as identified by the organization, its action plan towards minimizing/control the adverse effect on the organization

Required document – Internal and external issue register and assessment of issues as significant / non-significant and control over it.

Environmental Aspects – This is the determination of environmental aspects of its activities, products, and services that it can control and those that it can influence, and their associated environmental impacts, considering a life cycle perspective.

Required document – Environmental Aspects and Impact register, Criteria for assessing significant aspects and significant environmental aspects.

Compliance obligation – This is the determination of compliance obligation related to organizations environmental aspects, determination of compliance obligation application

Required document – Legal register

Planning action – Organization to address its significant aspects, compliance obligations, risk, and opportunities identified and evaluate the effectiveness of these actions

Required document – Environmental aspects and impact register, Internal and external issue register, and assessment of issues as significant / non-significant and control over it.

Environmental objectives and planning to achieve them – Here organization has to determine the quality objectives relevant to the quality management system and implementing an action plan to achieve the same. Here objectives determined by the organization are in measurable form

Required document  – Environmental objectives and its monitoring record.

 

Resources – Here organization has to provide desired resources to achieve its goal, resources comprising, Man, Machine, Money, Material

Required document – List of machines and its preventive / breakdown maintenance plan, Skilled manpower required for desired processes, Availability of utilities

 

People – Manpower required for process conformity

Required document – List of employees and designation

 

Infrastructure – List of machines and its preventive / breakdown maintenance plan, Availability of utilities

Required document – List of machines and its preventive / breakdown maintenance plan, Availability of utilities

 

Environment for the operation of the processes – Here environment is related to human and physical factors such as – appropriate ventilation, humidity, temperature, non-discriminatory, calm, non-confrontational, stress-reducing, burnout prevention, emotionally protective, These factors can differ substantially depending on the products and services provided.

 

Competence – Here organization has to determine necessary competence for the required processes, to ensure person performing the task is competent on the basis of education, training, experience, wherever applicable organization can provide training to its peoples to enhance their performance

Required documents – Skill Matrix, Personnel evaluation, Employee records / credentials

Awareness – Organization shall ensure that their employees are aware of the quality policy, objectives and their contribution towards an effective quality management system

Required documents – Training plan, Training records, and its effectiveness verification

Communication – Here organization have to maintain internal/external communication procedure

Required document – communication procedure

Documented information – Documented information as evidence of conformity to be maintained by the organization for the effectiveness of the quality management system

Required document – Master list of documents and records, Policy, procedures, SOPs, Work instructions, Quality manual

Creating and updating – identification of information, its formatting and review and approval for suitability and adequacy

Required document – Revision record sheet, document identification, its retrieval and retention status

Control of documented information – it is all about information access, distribution, retrieval, and use. Documented Information that is to be stored and preserved, its retention and disposition

Required document – Master list of records, its revision, retention and disposition

Operational planning and control – here organization have to determine the requirements for product / services, resources needed to achieve environmental goals, control plans

Required document – Control plan, Resource planning, Product Monitoring records

Emergency preparedness and response – organization have to maintain the processes needed to prepare for responding to the potential emergency situation

Required documents  – Emergency preparedness plan, Mock drill record

Monitoring, Measurement, Analysis, and evaluation – This is data analysis arising from monitoring and measurement activities of the management system

Required document – Objective analysis record, Environmental testing record

Evaluation of compliance – This is the fulfillment of compliance obligations

Required document – Legal register

Internal audit – This internal assessment of an effective quality management system that conforms to organizations own requirements for its quality management system, the requirement of this international standard, and it is been effectively implemented and maintained.

Required document – Internal audit plan, schedule, Assessment record, NC record, CAPA record of identified NC’s

Management review – It is to ensure organizations continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization

Required document – MRM agenda, Management review record, Output of the Management review

Nonconformity and corrective action – This is a non-conforming product including arising from complaints and organizations correction and corrective action

Required document  – Non conforming record, Correction of NC product, and corrective action record.

Continual improvement – The organization shall continually improve the suitability, adequacy, and effectiveness of the environmental management system.

Required document – Business plans,

Benefits of ISO 14001 certification

  • Minimized environmental pollution level within organization
  • Well established control over Environmental aspect that has an adverse impact on the environment due to organizational activities
  • Legal compliance
  • Resource optimization
  • Increased relationship between interested parties

ISO 45001 Certification in Gujarat

Occupational Health and Safety Management System -ISO 45001:2018  

OH&SMS is the Management System standard of Occupational Health and Safety Management System that provide a framework for managing OH&S risks. The intended outcomes of the OH&S management system are to prevent work-related injury and ill health to workers and to provide safe and healthy workplaces to workers.

ISO 45001 is newly published standard on occupational health and safety management system that will replace OHSAS 18001 standard, Organizations already certified to OHSAS 18001 will have three years to comply with the new ISO 45001 standard.

Requirements of this standard ISO 45001

Understanding organization and its context –  identification of internal and external issues (related to health and safety) that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result.

Required document – Internal / External issue register

 

Understanding needs and expectations of the interested parties. The organization shall monitor and review information about interested parties and their relevant requirements including workers related to health safety.

Required document – Interested parties and their needs and expectations to be mentioned in manual document

 

The scope of the organization’s OH&S management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered,

Required document  – Scope of the organization to be mentioned in manual document.

 

OH&S management system – Here organization have to determine the process and their interaction, Inputs required and desired outputs, resources needed for these process and their availability

Required document – manual document, Process interaction / Flow chart, Inputs required and desired output from these processes

 

Leadership and commitment – Top management have to appoint the team leader to take accountability for the effectiveness of the OH&S management system for prevention of work-related injuries and ill-health issues.

Required document – Appointment of team leader

OH&S policy – OH&S policy as a written statement towards the commitment to provide safe and healthy working conditions for the prevention of work-related injury and ill health, legal compliance and continual improvement of the organization and includes a commitment to consultation and participation of workers, and, where they exist, workers’ representatives to be displayed by the organization at prominent places and well understood by the peoples of the organization

Required document – OH&S Policy / Health & Safety Policy

Organizational roles, responsibilities and authorities – Job description of personnel for effective product / process conformity. Implementation and display of organization chart

Required document – Job description, Organization chart

Consultation and participation of worker – It is involvement of workers at all level including hazard assessment, identification, applying controls, evaluating OH&S management system

Required document – Manual document, OH&S Policy, OH&S objectives, other control documents

 

Action to address Risk and opportunities – referred to internal and external issues as identified by the organization, its action plan towards minimize / control the adverse effect on the organization

Required document – Internal and external issue register and assessment of issues as significant / non-significant and control over it.

Hazard identification – It is hazard identification from organizations routine and non-routine activities, product, services, infrastructure, equipments that may have adverse impact on human health / well being

Required document – HIRA register

Assessment of OH&S risks and other risks to the OH&S management system – This is hazard assessment in terms of significant and non-significant hazard and determining controls taking into account the effectiveness of existing controls

Required document – HIRA register

Assessment of OH&S opportunities and other opportunities to the OH&S management system – It is identification of OH&S opportunities to enhance OH&S performance

Required document – HIRA register comprising existing controls and opportunity to improve

Determination of legal requirements and other requirements – Here organization have to determine the legal requirements that are applicable to its hazard identified and have access to the requirements keeping updated compliance

Required document – Legal register

Planning Action – Here organization have to plan its action to address risks and opportunities, legal requirements and preparation to emergency response

Required document – HIRA register, Emergency procedure, Legal register

OH&S objectives and planning to achieve them – Here organization has to determine the quality objectives relevant to the OH&S management system and implementing action plan to achieve the same. Here objectives determined by the organization are in measurable form

Required document  – OH&S objectives and its monitoring record.

Resources – Here organization has to provide desired resources to achieve its goal, resources comprising, Man, Machine, Money, Material

Required document – List of machines and its preventive / breakdown maintenance plan, Skilled manpower required for desired processes, Availability of utilities

Competence – Here organization has to determine necessary competence for the required processes, to ensure person performing the task is competent on the basis of education, training, experience, wherever applicable organization can provide trainings to its peoples to enhance their performance

Required documents – Skill Matrix, Personnel evaluation, Employee records / credentials

Awareness – Organization shall ensure that their employees are aware with the quality policy, objectives and their contribution towards effective quality management system

Required documents – Training plan, Training records, and its effectiveness verification

Communication – Here organization have to maintain internal/external communication procedure

Required document – communication procedure

Documented information – Documented information as evidence of conformity to be maintained by the organization for the effectiveness of quality management system

Required document – Master list of documents and records, Policy, procedures, SOPs, Work instructions, Quality manual

Creating and updating – identification of information, its formatting and review and approval for suitability and adequacy

Required document – Revision record sheet, document identification, its retrieval and retention status

Control of documented information – it is all about information access, distribution, retrieval and use. Documented Information that is to be stored and preserved, its retention and disposition

Required document – Master list of records, its revision, retention, and disposition

 

Operational planning and control – here organization have to determine the requirements for product/services, resources needed to achieve product conformity, control plans

Required document – Control plan, Resource planning, Product Monitoring records

Eliminating hazards and reducing OH&S risk – Here organization have to eliminate the identified significant hazard by applying control over it, controls may be the reorganization of work, engineering control, admin control and use of personal protective equipment

Required document – HIRA register

Management of change – it is action against temporary or permanent changes within the organization that include a new product, services and processes/developments in knowledge and technology

Required document – HIRA register, Legal register, Internal/external issue register

 ProcurementThis is control over the procurement of product / services that does not have adverse impact on organizations health and safety activities

Required document – Control Plan, Purchase procedure, OH&S assessment of procured product/services (Supplier evaluation)

Contractor / Outsourcing – This is hazard assessment of contractors / Outsourced service providers associated with their activities related to the organization

Required document – HIRA register, Contractor evaluation

Emergency preparedness and response – organization have to maintain the processes needed to prepare for respond to potential emergency situation

Required documents  – Emergency preparedness plan, Mock drill record

Monitoring, Measurement, Analysis and evaluation – This is data analysis arising from monitoring and measurement activities of the management system

Required document – Objective analysis record, Environmental testing record

Evaluation of compliance – This is fulfillment of compliance obligations

Required document – Legal register

Internal audit – This internal assessment of an effective quality management system that conforms to organizations own requirements for its quality management system, the requirement of this international standard, and it is been effectively implemented and maintained.

Required document – Internal audit plan, schedule, Assessment record, NC record, CAPA record of identified NC’s

Management review – It is to ensure organizations continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization

Required document – MRM agenda, Management review record, Output of the Management review

Incident, nonconformity and corrective action – This is action to deal with the consequences, incident response and reporting and reviewing existing controls and opportunity to improve further

Required document – Incident Investigation Record, HIRA register updating, Non conforming record

Continual improvement – The organization shall continually improve the suitability, adequacy and effectiveness of the environmental management system.

Required document – Business plans,

Benefits of ISO 45001 Certification

Increased acceptance by regulators, the public, and interested parties. Accepted as being proactive about Health and Safety and continual improvement.

Provides a platform for attracting lower insurance premiums and proves due diligence to the marketplace.

Allows better identification of hazards and risk.

Minimized accidents, injuries and health issues

Prompt resource utilization

ISO 22000 Certification in Gujarat

Food Safety Management System -ISO 22000:2018  

ISO 22000 that can be applied to any organization in the food chain. FSMS is a system that focuses and ensures on food that does not have adverse effect on human health. It provides a framework, that an organization needs to do to demonstrate its ability to control food safety hazards in order to ensure that food is safe. ISO 22000 can be used by any organization regardless of its size or position in the food chain.

Requirements of this standard ISO 22000

Understanding organization and its context – identification of internal and external issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result. External issues considering arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. Internal issues related to values, culture, knowledge and performance of the organization.

Required document – Internal / External issue register

Understanding needs and expectations of the interested parties. The organization shall monitor and review information about interested parties and their relevant requirements.

Required document – Interested parties and their needs and expectations to be mentioned in FSMS manual document

The scope of the organization’s food safety management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system

Required document  – Scope of the organization and its applicability to be mentioned in FSMS manual.

Food Safety management system and its processes – Here organization have to determine the process and their interaction, Inputs required and desired outputs, resources needed for thede process and their availability

Required document – FSMS manual

Leadership and commitment – Top management have to appoint the team leader to take accountability for the effectiveness of the food safety management system.

Required document – Appointment of team leader

Establishing the food safety policy – food safety policy as a written statement towards food safety requirements, legal compliance and continual improvement of the organization to be displayed by the organization at prominent places and well understood by the peoples of the organization

Required document – Food Safety Policy

Organizational roles, responsibilities and authorities – Job description of personnel for effective product / process conformity. Implementation and display of organization chart

Required document – Job description, Organization chart, Food Safety Team, and Team Leader

Action to address Risk and opportunities – referred to internal and external issues as identified by the organization, its action plan towards minimizing/control the adverse effect on the organization

Required document – Internal and external issue register and assessment of issues as significant / non-significant and control over it.

FSMS objectives and planning to achieve them – Here organization has to determine the quality objectives relevant to the quality management system and implementing an action plan to achieve the same. Here objectives determined by the organization are in measurable form

Required document  – FSMS objectives and its monitoring record.

Planning of changes – This is the action plan against the changes when organization determines the need for changes in existing FSMS

Required document – Control Plan for changes, Job Description

Resources – Here organization has to provide desired resources to achieve its goal, resources comprising, Man, Machine, Money, Material

Required document – List of machines and its preventive / breakdown maintenance plan, Skilled manpower required for desired processes, Availability of utilities

People – Manpower required for process conformity

Required document – List of employees and designation

Infrastructure – List of machines and its preventive / breakdown maintenance plan, Availability of utilities

Required document – List of machines and its preventive / breakdown maintenance plan, Availability of utilities

Environment for the operation of the processes – Here environment is related to human and physical factors such as – appropriate ventilation, humidity, temperature, non-discriminatory, calm, non-confrontational, stress-reducing, burnout prevention, emotionally protective, These factors can differ substantially depending on the products and services provided.

Required document – Plant layout with associated utilities and safety concerns

Externally developed elements of the food safety management system – This is control over externally developed elements of FSMS including Pre-requisite programs, Food safety hazard, and control plan that to have conformance of the organization’s food safety management system.

Required document – PRP, OPRP, HACCP record

Control of externally provided processes, products, or services – This is Control over the entities that are responsible to provide product / raw material/services to the organization to ensure product/process conformity.

Required documents – List of Suppliers / Service providers, Supplier assessment records, Supplier evaluation

Competence – Here organization has to determine necessary competence for the required processes, to ensure person performing the task is competent on the basis of education, training, experience, wherever applicable organization can provide trainings to its peoples to enhance their performance

Required documents – Skill Matrix, Personnel evaluation, Employee records / credentials

Awareness – Organization shall ensure that their employees are aware of the quality policy, objectives and their contribution towards an effective quality management system

Required documents – Training plan, Training records and its effectiveness verification

Communication – Here organization have to maintain internal / external communication procedure

Required document – communication procedure

Documented information – Documented information as evidence of conformity to be maintained by the organization for the effectiveness of the quality management system

Required document – Master list of documents and records, Policy, procedures, SOPs, Work instructions, Quality manual

Creating and updating – identification of information, its formatting and review and approval for suitability and adequacy

Required document – Revision record sheet, document identification, its retrieval and retention status

Control of documented information – it is all about information access, distribution, retrieval, and use. Documented Information that is to be stored and preserved, its retention and disposition

Required document – Master list of records, its revision, retention and disposition

Operational planning and control – here organization have to determine the requirements for product / services, resources needed to achieve product conformity, control plans

Required document – Control plan, Resource planning, Product Monitoring records

Prerequisite programs (PRPs) – This is action prior to processing of food / product to prevent food hazards or reduction of contaminants within food processing

Required document – PRP, Plant layout, Pest control record, Cleaning record, Waste disposal record.

Traceability system – This is the identification of raw material to finished product at the first stage of the distribution route

Required document – Record of identification – batch no., Bar code, Tags, etc.

Emergency preparedness and response – organization have to maintain the processes needed to prepare for responding to potential emergency situation related to food safety

Required documents  – Emergency preparedness plan, Mock drill record

Preliminary steps to enable hazard analysis – This is hazard analysis including legal requirements, product / process / equipment

Required document – Hazard analysis

Characteristics of raw materials, ingredients and product contact materials – This is the identification of biological, chemical and physical characteristics of raw materials, ingredients, and food contact materials including applicable legal food safety requirements

Required document – Process flow chart, Raw material, ingredient, product contact material composition/formulation, Raw material acceptance criteria (including product packaging, shelf life, storage condition)

Characteristics of end products – This includes finished food product/end product and its characteristics needed to conduct the hazard analysis

Required documents – Process flow chart, Food composition / formulation, Food acceptance criteria (including product packaging, shelf life, storage condition)

Intended use – This is as expected handling of the end product, identification of an appropriate group of consumers / users especially vulnerable to specific food safety hazards shall be

identified.

Required document – User instructions / Handling procedure

Preparation of the flow diagrams – This is a graphic representation of the process and its interaction which shall be used at the time of hazard analysis for evaluating possible occurrence, increase, decrease of food safety hazards.

Required document – Process flow diagrams and its interaction including outsourced processes, Rework/recycle and end products, intermediate products, by-products, and waste are released or removed.

On-site confirmation of flow diagrams – This accuracy verification of flow diagram on ground level / related source

Required document – On-site assessment record

Description of processes and process environment – This is about defining process layout, process equipment, PRPs, external requirements to conduct hazard analysis

Required document – Process flow diagrams and its interaction including outsourced processes, Rework/recycle and end products, intermediate products, by-products, and waste are released or removed.

Hazard analysis / Hazard identification and determination of acceptable levels – It is food safety hazard identification from organizations routine and non-routine activities, product, services, infrastructure, equipment that may have adverse impact Its  assessment in terms of significant and non-significant hazard and determining controls taking into account the effectiveness of existing controls

Required document – Hazard identification and risk assessment record

Selection and categorization of control measure – This is controls applied on identified food hazard to prevent or reduce and categorization of controls as OPRP or at CCP

Required document – OPRP (Operational prerequisite programme), CCP (Critical Care Point) record

Validation of control measure(s) and combinations of control measures – This is a validation of control measures for achieving the intended control of significant food safety hazards. This shall be done prior implementation of control measures and to be included in hazard control plan

Required document – Validation record, Hazard control plan

Hazard control plan (HACCP/OPRP plan) – Here organization has to maintain hazard control plan that including control measures at each CCP or OPRP

Required document – Hazard control plan

Determination of critical limits and action criteria – This is the identification of critical limits at CCP and action criteria for OPRP shall be specified. Here organization has to ensure that an acceptable level is not exceeded.

Required document – CCP and OPRP record

Monitoring systems at CCPs and for OPRPs – This is monitoring of CCP and OPRP to detect any failure to remain within prescribed limits and documentation of monitoring system

Required document – CCP and OPRP record, Evaluation of monitoring records, Instructions (in case of visual monitoring)

Actions when critical limits or action criteria are not met – This is implementation of corrections and corrective actions when CCP exceed the desired limits

Required document  – Correction and corrective action record, identification of the potential unsafe product.

Implementation of the hazard control plan – This is the implementation of hazard control plan as evidence of documented information

Required document  – Hazard control plan

Updating the information specifying the PRPs and the hazard control plan – This is about updating information on raw material characteristics, ingredients and product contact material, end product characteristics and intended use of end product, flow diagrams and description of processes and process environment (processing conditions of product)

Required document – Revision records of PRPs and hazard control plan, process flow diagrams, raw material information

Control of monitoring and measuring – This is about Monitoring result conformity i.e. calibration of monitoring and measuring equipment

Required document – List of equipment, calibration records of equipment along with its traceability to national/international standard, Software validation (in case of software monitoring of FSMS)

Verification – This is about verification activities of PRP, OPRP, Hazard control plan and its frequency of verification along with stating roles and responsibility of verification which should not be done by the person responsible for monitoring the same activities

Required document – Records of verification of PRP, OPRP, Hazard control plan

Analysis of results of verification activities – This is about analysis of the results of verification

Required document – Analysis records of verification

Control of product and process nonconformities – This is about evaluation of PRP, OPRP by competent personnel who has the authority to initiate corrections and corrective action

Required document – Correction and corrective action record

Corrections – This is about controlling obtained results to achieve defined CCP level and identification and control of product with regard to their use and release

Required document – Correction and corrective action record

Corrective actions – This is an action against when critical limits at CCP or action criteria for OPRP are not met

Required document – Correction and corrective action record

Handling of potentially unsafe products – This is an action against preventing the potential unsafe product from entering into the food chain

Required document – Correction and corrective action record, Records of verification of PRP, OPRP, Hazard control plan

Evaluation for release – This is about the release of affected product conforming action criterion of OPRP

Required document – Correction and corrective action record, Records of verification of PRP, OPRP, Hazard control plan, Monitoring and measuring records

Disposition of non-conforming products – This is about handling, reduction and or disposition of failure product

Required document – Product handling procedure of failure product, Recycling / rework record, Disposition record

Withdrawal/recall – This is about timely withdrawal/recall of lots of end products that have

been identified as potentially unsafe

Required document – Withdrawal procedure / Recall records / Mock recall procedure for product identification and effectiveness verification of FSMS

Monitoring, measurement, analysis, and evaluation – This is data analysis arising from monitoring and measurement activities of the management system

Required document – Objective analysis record

Internal audit – This internal assessment of an effective food safety management system that conforms to organizations own requirements for its quality management system, the requirement of this international standard, and it is been effectively implemented and maintained.

Required document – Internal audit plan, schedule, Assessment record, NC record, CAPA record of identified NC’s

Management review – It is to ensure organizations continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization

Required document – MRM agenda, Management review record, Output of the Management review

Nonconformity and corrective action – This is a non-conforming product including arising from complaints and organizations correction and corrective action

Required document  – Non conforming record, Correction of NC product and corrective action record.

Continual improvement – The organization shall continually improve the suitability, adequacy, and effectiveness of the quality management system.

Required document – Business plans,

Benefits of ISO 22000 Certification

Enhance Food Safety performance of supply chain

Embeds food safety culture into the organizational culture

Minimizes the likelihood of contracting food borne diseases

Ensure compliance to Food Safety legislation

ISO 27001 Certification in Gujarat

Information Security Management System -ISO 27001:2013

 The information security management system preserves the confidentiality, integrity, and availability of information by applying a risk management process and gives confidence to interested parties that risks are adequately managed. This International Standard specifies the requirements for establishing, implementing, maintaining and continually improving an information security management system within the context of the organization. ISO 27001 provides a proven framework that helps organizations protect their information through effective technology, auditing and testing practices, organizational processes, and staff awareness programmes.

Requirements of this standard

Understanding the organization and its context – identification of internal and external issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result. External issues considering arising from the legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local. Internal issues related to values, culture, knowledge, and performance of the organization.

Required document – Internal / External issue register

Understanding needs and expectations of the interested parties. The organization shall monitor and review information about interested parties and their relevant requirements.

Required document – Interested parties and their needs and expectations to be mentioned in ISMS manual document

The scope of the organization’s information security management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system

Required document  – Scope of the organization and its applicability to be mentioned in ISMS manual.

Information Security management system and its processes – Here organization have to determine the process and their interaction, Inputs required and desired outputs, resources needed for these process and their availability

Required document – ISMS manual

Leadership and commitment – Top management has to appoint the team leader to take accountability for the effectiveness of the food safety management system.

Required document – Appointment of team leader

Policy – Information Security policy as a written statement towards food safety requirements, legal compliance and continual improvement of the organization to be displayed by the organization at prominent places and well understood by the peoples of the organization

Required document – Information Security Policy

Organizational roles, responsibilities, and authorities – Job description of personnel for effective product/process conformity. Implementation and display of organization chart

Required document – Job description, Organization chart, Food Safety Team, and Team Leader

Action to address Risk and opportunities – referred to internal and external issues as identified by the organization, its action plan towards minimize/control the adverse effect on the organization

Required document – Internal and external issue register and assessment of issues as significant / non-significant and control over it.

Information security risk assessment – This is an assessment of information security risk, establishing and maintaining risk acceptance criteria, criteria for risk assessment, identify, analyze and evaluate the information security risk.

Required document – Risk assessment and evaluation record

Information security risk treatment – This is about selecting appropriate risk and determining controls and comparing it with Annex A as provided in standard to verify whether no necessary controls have been omitted. Producing statement of applicability and formulating a risk treatment plan

Required document – Statement of applicability, Risk treatment record, risk treatment process

Information security objectives and planning to achieve them – Here organization has to determine the quality objectives relevant to the quality management system and implementing an action plan to achieve the same. Here objectives determined by the organization are in measurable form

Required document  – ISMS objectives and its monitoring record.

Resources – Here organization has to provide desired resources to achieve its goal, resources comprising, Man, Machine, Money, Material

Required document – List of machines and its preventive / breakdown maintenance plan, Skilled manpower required for desired processes, Availability of utilities

 

Competence – Here organization has to determine necessary competence for the required processes, to ensure person performing the task is competent on the basis of education, training, experience, wherever applicable organization can provide trainings to its peoples to enhance their performance

Required documents – Skill Matrix, Personnel evaluation, Employee records/credentials

 

Awareness – Organization shall ensure that their employees are aware with the quality policy, objectives and their contribution towards effective quality management system

Required documents – Training plan, Training records and its effectiveness verification

 

Communication – Here organization have to maintain internal / external communication procedure

Required document – communication procedure

Documented information – Documented information as evidence of conformity to be maintained by the organization for the effectiveness of Information Security  management system

Required document – Master list of documents and records, Policy, procedures, SOPs, Work instructions, ISMS manual

 

Creating and updating – identification of information, its formatting and review and approval for suitability and adequacy

Required document – Revision record sheet, document identification, its retrieval and retention status

Control of documented information – it is all about information access, distribution, retrieval and use. Documented Information that is to be stored and preserved, its retention and disposition

Required document – Master list of records, its revision, retention and disposition

Operational planning and control – here organization have to determine the requirements for product / services, resources needed to achieve information security

Required document – Control plan including outsourced process, Resource planning, Mitigation plan

Monitoring, Measurement, Analysis and evaluation – This is data analysis arising from monitoring and measurement activities of the management system

Required document – Objective analysis record, Environmental testing record

Internal audit – This internal assessment of effective quality management system that conforms organizations own requirements for its quality management system, requirement of this international standard and its is been effectively implemented and maintained.

Required document – Internal audit plan, schedule, Assessment record, NC record, CAPA record of identified NC’s

Management review – It is to ensure organizations continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization

Required document – MRM agenda, Management review record, Output of the Management review

Continual improvement – The organization shall continually improve the suitability, adequacy and effectiveness of the environmental management system.

Required document – Business plans,

Annex A for normative reference to determine applicable controls for an effective information security management system.

Benefits of ISO 27001Certification

 

Protects confidential information

Appropriate risk management

Gives confidence to interested parties that risks are adequately managed

It allows for the secure exchange of information.

Stabilized and smooth operations allow employees to work more peacefully and calmly since they understand protocols and procedures.

 

Common requirements of ISO 9001, ISO 14001, ISO 22000, ISO 27001 & ISO 45001 standard if the organization wants to go for IMS Certification in the organization

Understanding the organization and its context

Understanding the needs and expectations of the interested parties

The scope of the organization’s quality management system

Specified management system and its processes

Leadership and commitment

Establishing the policy

Organizational roles, responsibilities, and authorities

Action to address Risk and opportunities

Specified objectives and planning to achieve them

Resources

Competence

Awareness

Communication

Documented information

Creating and updating

Control of documented information

Operational planning and control

Emergency Preparedness and Response

Monitoring, Measurement, Analysis, and evaluation

Internal audit

Management review

Continual improvement