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ISO 45001 Occupational Health & Safety Quality Management

Medical Devices

Occupational Health & Safety Management System ISO 45001

With the effect from March 2018 OHSAS 18001 is replaced by ISO 45001:2018. Scope and applicability of the ISO 45001 standard remains the same as previous standard that has been specifically dedicated to Occupational Health and Safety (OH &S). The focus of the ISO 45001 standard is to specify 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.

A competent ISO 45001 consultant or ISO 45001 consulting companies use(s) a disciplined approach for ISO 45001 certification process to meet all the requirements of ISO 45001:2018 through providing ISO 45001 training to all interested parties to ensure dissemination of Asset Policy, Asset Objectives & Targets, Asset compliance obligations, determination of significant Asset costs and consumption.  Any organization planning for ISO 45001:2018 certification, requires ISO 45001 training for all employees related to internal and external issues of interested parties and mitigation of Asset usage/consumption risks in Asset conservation and protection of natural resources. All interested parties to understand implications of not adhering to ISO 45001:2018 requirements, and continual improvements through risk considerations. Total ISO 45001 certification cost cannot be fully determined since ISO 45001 certification is a never-ending process and a race with no finish line.

The ISO 45001 standard is applicable to any organization that wishes to establish, 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.

  • A clear-cut management system and organizational structure with clearly defined systems of authority and ultimate responsibility.
  • Occupational Health and Safety Management Systems objectives towards ISO 45001 certification will be realistic and measurable, but also structured towards the organizations.
  • Policy of occupational health and safety policy.
  • Requires the development of an effective risk assessment system to identify potential exposure of hazards to the company’s employees.
  • There is also a requirement by the ISO 45001:2018 for organizations to develop effective monitoring of occupational health and safety policies while conducting independent audits on the effectiveness of the policy framework.

Any facility offering Products or Services and is desirous of having a globally acceptable Occupational Health and Safety assurance system needs to get certified to ISO 45001:2015.

Any facility desirous of assuring customers about their Occupational Health and Safety systems should get ISO 45001 certification.

Any facility desirous of having interests of all stake holders covered in their system and has adequate provisions for mitigating risks in their processes must get ISO 45001 Certification

Any facility desirous of having a strong marketing tool to showcase their Occupational Health and Safety capabilities must get ISO certification

Any facility desirous of having a complete system which covers all aspects of operations in one single system for management review must have ISO certification

Any facility whose management desires to have one single system through which management can build teamwork, review progress, measure, monitor, make corrections and give impetus for continual improvement must get ISO 45001 Certification

  • Process of ISO certification starts with preparation of an Occupational Health and Safety Management System (OHMS)
  • ISO Consultants assist in developing a comprehensive, OHMS to meet all requirements of ISO 45001 and Third-Party Certification Body stage 1 audit requirements. The stage 1 audit from Certification Bodies vary depending on the selected Certification Bodies which verifies the documented system meeting all ISO 45001 certification requirements or not
  • An ISO 45001 consulting firm provides the techniques for implementation, and trains organization’s internal auditors to become competent to perform internal audits or provides ISO Internal Auditing Services to audit all processes, all ISO 45001 Standard requirements and effective implementation of ISO 45001 Standard
  • Facilities need to initiate corrective actions and continual improvement is realized through control of nonconforming products/services.
  • Facilities need to implement the prepared OHMS for a minimum of 3 months and gather adequate data and record to show as evidence
  • Managements of the facilities need to conduct one full scale review of the entire OHMS and ensure its adequacy for their organization. Management Team needs to identify Action items to make corrections to any ISO 45001 certification requirement not being fulfilled
  • Once OHMS is ready, Internal audit is performed and one full set of Management review takes place, the facility needs to contact a certification Body for certification audit
  • Reputed consultants qualified to conduct audit on ISO 45001:2018 will perform audit for compliance
  • Once the Facility passes ISO 45001 compliance audit successfully the auditing agency will issue a compliance certificate
  • Compliance certificate to ISO 45001 may avoid OHSAS audit from Government agencies.
  • QSE Consulting is the practice of assisting small, medium and large organizations in developing, training, implementing, and maintaining a documented Occupational Health and Safety Management System (OHMS) for achieving ISO 45001 certification
  • QSE Consultants can prepare your facilities to have an Occupational Health and Safety Management System (OHMS) and associated documents/records to show as evidence of having implemented the system
  • QSE always follows a tried and tested 10 step disciplined path in preparing facilities for ISO 45001 certification, which is insensitive to failure
  • QSE Consultants assist facilities to prepare a comprehensive simplified documentation system to show as evidence of having a streamlined process that ensures Occupational Health and Safety product or service every time without fail
  • QSE consultants help in identifying issues and concerns of all stake holders and take them in to account in preparing OHMS for ISO 45001 certification
  • QSE assist facilities in matching competence of personnel assigned to tasks, methods to select providers who supply Occupational Health and Safety Services
  • QSE Consultants assist to build a robust system which compels task performers to have defined roles, responsibilities and controls to ensure Occupational Health and Safety
  • QSE Consultants assist organizations to identify all manufacturing and nonmanufacturing processes and facilitate in establishing process performance metrics or process performance indicators (Key Process Indicators = KPIs) to effectively monitor and measure organizations intended Goals and Objectives
  • QSE Consulting services are required to assist organizations in building comprehensive OHMS to identify risks at every process and have steps to mitigate risk
  • Internal Occupational Health and Safety Audits conducted by QSE consultants, help the facilities to find all deficiencies in their implementation which are not normally found during organizations first party audits
  • QSE Consultants assist in meeting “Annex SL, a section of the ISO/IEC Directives part 1 that prescribes how ISO Management System Standard (MSS) standards should be written.” which in turn meets ISO 45001 requirements
  • QSE Consultants provide training to top management in promoting Risk-Based Thinking, Process Approach, and Continual Improvement
  • QSE consultants assist organizations to effectively control document information (Documents and Records) related to changes, conducting ISO management review meetings covering all management review inputs (as per ISO 45001 requirements)
    Including the trends to be monitored, internal audit results are fully addressed, risk related activities identified/assessed/mitigated, root-cause, identified and analysis is fully applied
  • QSE consultants will ensure that certification is achieved with no or minimum nonconformities first time around
  • QSE has over 27 Years of standing in the field of ISO 45001 Consulting, Auditing and Training for any ISO Standard, Sector Specific Standard, AISC standard or Food Safety Standard
  • QSE’s ISO 450001 Consultants has helped over 700 facilities to earn their ISO certifications and other certifications
  • All QSE customers passed ISO 45001 certification audits with no or minimum nonconformities
  • Over 98 % of QSE customers passed ISO 45001 certification audits with nil nonconformity first time around. QSE has a 100 % success rate in obtaining certifications for its customers
  • Unlike our competitors, QSE provides a unique, comprehensive, evidence based, simplified single level, documentation system for ISO 45001 compliance which is easy to implement and provides evidence for implementation to earn ISO 45001 certification
  • QSE Consultants through ISO45001 Internal Auditing provide an effective management tool to run any business considering from “Quote to Cash” processes for enhancing customer satisfaction and Bottom-Line Improvement. ISO 45001 Audit checklists are used ot accomplish error free ISO 45001 Audits
  • QSE’s designed ISO 45001 templates are tried and tested for accuracy and correctness and provide objective evidence during internal audits and ISO certification audits
  • QSE’s ISO 45001 simplified system is evidence based, and it is easy to implement, easy to use and easy to audit
  • QSE ‘s ISO 45001 evidence based system with proven lists, forms and tables results in ISO certification with minimum or no nonconformities
  • QSE engages all competent ISO 45001 auditors to conduct internal audits or supplier audits
  • President QSE, Baskar Kotte is an original and an active member of ISO/US TAG/TC 176, the Technical Committee that originally developed the ISO 9000 family of standards, ISO/US TAG/TC 207 which developed the ISO 14000 family of standards, ISO/US TAG/ TC 301 (TC 242) which developed ISO 45001 and   ISO 19011 the Guiding standards for Auditing. Mr. Kotte also participated and provided input to the development of the current ISO 45001:2015, ISO 140001:2015, ISO 45001:2018 family of Standards and ISO 19011:2018 revised standards. of certified OHSMS
  • The certification is renewable every three years

 

The benefits of developing an occupational health and safety policy under the ISO 45001:2018 certification program, are diverse and include:

  • ISO 45001 Provides an effective way of guaranteeing the safety and health of your staff while allowing your company to attract the best skilled professionals in your area of operations.
  • ISO 45001 charter that helps to develop the necessary risk mitigation measures that prevent potential disasters in the future.
  • Through comprehensive risk assessment criteria, the ISO 45001:2018 presents an opportunity for organizations to identify weaknesses in their production systems that may expose their staff to potential risk.
  • Obtaining compliance to ISO 45001:2018 is an automatic compliance to all OSHAS requirements
  • ISO 45001:2018 has been critical in promoting the development of an inclusive risk protection and occupational health and safety policy for organizations in the world.
  • Through a good risk assessment on the organization processes, there has been considerable development of cost-effective production by implementing ISO 45001
  • Continual improvement of OH & S performance through ISO 45001
  • ISO 45001 helps in Fulfillment of legal requirements
  • ISO 45001 helps in Achievement of OH & S objectives.

ISO 45001:2018 is not necessarily a certifiable standard but compliance certificate is essential to show as evidence for having implements all requirements for ISO 45001:2018

Reputed consulting companies proficient in ISO 45001 or independent agencies qualified to certify may accord compliance certificates after a compliance audit.

Typically, it takes anywhere between 5 to 6 months for certification when you start from scratch. QSE has well developed systems and ISO 45001 templates which are easily understood for implementation. Therefore, it is possible to get compliance certification within about 3 months through QSE.

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