OHSAS 18001 Certification in Sri Lanka

OHSAS 18001 stands for Occupational health and safety management. OHSAS 18001 gives a structure to perceive, control and diminish the threats associated with health and safety in the working environment. OHSAS 18001 motivates the staff and draws in the client and providers. OHSAS 18001 is made of procedures, frameworks, practices, records, and plans that decide the laws administering how your association deals with occupational health and safety.

Occupational Health and Safety Management – is a universally applied standard for word related wellbeing and security the executive's frameworks. It endures helping a wide range of organizations set up verifiably solid word related health and safety management system. It is a generally perceived and mainstream word related health and safety management of the executive's framework. It decreases "working environment perils and lifts worker confidence". The main goal of this Management System is to reduce operational risks and hazards. OHSAS 18001 assists you to build the best achievable working conditions in your organization – and helps you to meet industry, contractual requirements as well as regulatory and customer requirements.

Also, check ——>> OHSAS 18001 Certification in Sri Lanka

What is the PDCA (Plan Do Check Act) Model in OHSAS?

Plan-Do-Check-Act (likewise called "PDCA") is a cycle that was begun by Walter Shewhart and made mainstream by Edward Deming – two of the dads of present-day quality control. This idea is a cycle for actualizing change which, when pursued and rehashed, would prompt rehashed enhancements in the process it was applied to.
This is a model for development that is supported, as opposed to only a one-time convenient solution, and it is thus that it is applied to the ISO norms. The ISO models have the primary objective that is a nonstop improvement of the Management System.

Benefits of OHSAS 18001 Certification

• Enhances corporate image and probability among regulators, stakeholders, prospective clients, customers, and the public.
• Adoption of universal best manner in relation to risk management.
• Ensures the health and well-being of sub-contractors, public and the workers, sub-contractors and the public.
• Minimization of reliability of employers through the support of proactive rather than reactive controls.
• Reduces accident and conflict rates by decreasing or reducing workplace hazards.
• Improves the disturbance research process.
• Increases employee motivation through the provision of a safer workplace and participation process.
• Encouragement to determine risk associated factors and activities.
• Reduction in defection and employee turnover.
• Increase in awareness concerning risks in the business.
• Active participation and trust from employees.
• Reduced cost of accidents and insurance.
• Established organizational control and risk management.
• Recognized as qualified for International standard adds credibility to the organization.

Requirements of OHSAS 18001 Certification

• Hazard identification, Risk Assessment, and Determining Controls.
• Legal and Other Requirements.
• Objectives and Programs.
• Responsibility, Roles, Resources, Authority, and Accountability.
• Competence, Exercise, and Consciousness.
• Consultation, Communication, and Participation.
• Documentation.
• Control of Documents.
• Operational Control.
• Emergency Preparation and Response.
• Performance Measure and Monitoring.
• Evaluation of Compliance.
• Incident Investigation, Non-conformances, Corrective & Preventive Action.
• Control of Records.
• Internal Audit.
• Management Review.

Also, check ——>> OHSAS 18001 Consultant in Sri Lanka

OHSAS 18001 Certification Process

The OHSAS 18001 certification process involves a two-stage certification process.

• Stage 1 OHSAS 18001 (Document review and to see the preparedness of the organization for Stage-2 Audit)

• Stage 2 OHSAS 18001 (Certification Assessment)
  – Review of Audit Report & Certification decision
  – Award of Certification

OHSAS 18001 certificate validity is for 3 years and a company needs to undergo surveillance visit audits every Year to maintain their OHSAS 18001 certification. Achieving the standard will lead a clear sign to your partners that you watch worker's health and safety as an inclination inside your association.
Now the OHSAS 18001 is replaced by ISO 45001, which was announced on March 2018 by the International Organization for Standardization. The companies/Organization which are certified to OHSAS 18001 should transfer to ISO 45001 by March 2021 if they want to maintain a verified certification.

What is RoHS Certification?

RoHS stands for Restriction of Hazardous Substances. RoHS comes into effect on 1 July 2006. RoHS is a product certification which comes in restrictions of the hazardous substance in electrical and medical equipment to support security to the environment and health in the EU (European Union). The hazardous substance in the gear could be disposed of during waste administration process which could block numerous human and natural dangers. By following the rules laid by RoHS, hardware assembling firms confirm the wellbeing of their items additionally picking up buyer trust. RoHS additionally highlights measures to keep the unsafe substance from entering the items sometime down the road.

RoHS is stretching out its limitations to the new classification of gear emerging in the EU. It had made a reasonable commitment to an expanding piece of the pie of the European Union and giving a chance to reasonable exchange. A wide range of organizations, with the exception of merchants, should keep applicable consistency documentation for at least 10 years. RoHS certification can be applied by any of the metal industry for any purpose metal plating, chromating, anodizing or other finishes on EEE components, connectors or heatsinks. The RoHS mandate was received to confine the number of hazardous materials in the assembling gear. The purpose is to reduce the number of heavy metal poisoning incidents, and maybe even e-waste.

After July 1, 2006, all appropriate products required RoHS compliance in the EU market.

Also, check ——>> RoHS Certification in SriLanka

RoHS restricts the use of the following materials:

1. Lead (Pb)
2. Mercury (Hg)
3. Cadmium (Cd)
4. Hexavalent chromium (Cr⁶⁺)
5. Polybrominated biphenyls (PBB)
6. Polybrominated diphenyl ether (PBDE)
7. Bis(2-Ethylhexyl) phthalate (DEHP)
8. Butyl benzyl phthalate (BBP)
9. Dibutyl phthalate (DBP)
10. Diisobutyl phthalate (DIBP)

DEHP, BBP, DBP, and DIBP were added as part of DIRECTIVE (EU) 2015/863 which was published on 31 March 2015.
PBB and PBDE are flame retardants used in several plastics. Hexavalent chromium is used in chrome plating, chromate coatings, and primers, and in chromic acid.

The directive applies to equipment as characterized by a segment of the WEEE directive. The following numeric categories apply:

1. Large household appliances
2. Small household appliances
3. IT & telecommunications equipment (although infrastructure equipment is exempt in some countries)
4. Consumer equipment
5. Lighting equipment – including light bulbs
6. Electronic and electrical tools
7. Toys, leisure, and sports equipment
8. Medical devices (exemption removed in July 2011)
9. Monitoring and control instruments (exemption removed in July 2011)
10. Automatic dispensers
11. Semiconductor devices

Benefits of RoHS Certification

• Consumer safety
• Consumer satisfaction
• Prevention and elimination of hazardous substance
• Prevents wastage of resources
• Saves cost
• The better market opportunity in the EU
• The benefit of International stature to your product.

As more associations and nations are embracing the mandate, there will be less landfill sullying and harming cases. Overall, the advantages of RoHS compliance has not only affected the electronics industry but also produced solutions to electronic customers the world over.

Requirements of RoHS Certification

• Conduct product testing
• Monitor conformity compliance
• Carry out inspections
• Verify product safety
• Take enforcement actions
• Eliminate hazardous substance during the time of manufacturing
• Internal auditing
• On-site testing

Also, check ——>> RoHS Consultant in SriLanka

How to Get RoHS Certification

To make the RoHS Certification process simple. You should hire a consultant when a consultant received your application they will guide you and your business through the following steps.

1. Testing
2. Process Audit
3. Documentation Review

The Technical File must contain the following:

• General product description and design structure information
• Risk assessment of materials, parts, and subassemblies
• Conformity information on materials, parts, and subassemblies
• Manufacturing documentation and records
• Harmonized standards, specifications, and conformity procedures

    4. Certification Statement

ISO 9001 Certification and Its Benefits

ISO 9001 focuses on Quality Management System. A quality management system is a set of policies, processes, and procedures required for planning and fulfilling (production /development/ service) in the focus business sector of an organization (the areas that can affect the organization’s capacity to meet customer demands). ISO 9001 can be applied by any of the organization whether it's large or small; ISO 9001:2015 is certified by over one million companies and organization in 170 countries.

ISO 9001 is established on quality management principles which include motivation, powerful customer focus, and engagement of top management, the process method, and constant improvement. These principles are described in more detail in the pdf Quality Management Principles. Using ISO 9001 helps to assure that consumers get constant, good quality products and services, which in change brings numerous business advantages. ISO 9001 is an example of a Quality Management System. ISO 9001 will help your organization to improve the quality process and performance of your product & services. ISO 9001 gives you the capacity to stand out with your competitor's and immediate extension in Profitable margin. An ISO 9001 certification can improve an organization’s reliability as it shows customers that the organization’s products and services meet quality expectations. There are some situations where an ISO 9001 certification is needed or lawfully mandated for businesses/Companies in some industries.

Also, check ——>> ISO 9001 certification in Sri Lanka

By Achieving ISO 9001:2015 certification determines that an organization has described the following:

• Follows the guidelines of the ISO 9001 standard
• Fulfills its own requirements
• Meets consumer requirements and legal and managerial requirements
• Maintains documentation

By implementing ISO 9001 it can improve the credibility of the organization by showing consumers that it’s Product and services satisfy the expectations. In some industries or some situations, certification is required or lawfully mandated.

Basic principles of ISO 9001

1. Customer focus
2. The Process approach
3. Leadership Importance of top management
4. Improvement
5. Relationship Management
6. Engagement of People
7. Evidence-based decision making

Benefits of ISO 9001

• Continually improve their processes
• Save costs
• Helps to reduce your costs.
• Product and services meet the International Standard of Quality.
• Improves your quality and services.
• Create satisfied customers, management, and employees
• Certification joins the reliability of international stature, against other organizations that do not describe such third-party approvals.
• Increases marketing opportunities.
• Enhance your product & service quality to approach increased customer satisfaction.
• Mandates continuous monitoring & measurement of the processes that prevent unintended derailments.
• Customers and shareholders have confidence & trust in you.
• Increases your efficiency and revenue.
• Makes a strong relationship with your supplier.
• Creates an image as an authority on the quality management process.
• Increases income and financial performance.
• Helps to build relevant systems to control manpower orderly and monitor their performances.

Documents and requirements for ISO 9001

The certification process involves fulfilling the requirements of ISO 9001 and then developing a successful registrar’s audit verifying the organization meets those requirements.

• Monitoring and measuring equipment calibration records
• Records of training, skills, experience, and qualifications
• Product/service requirements review records
• Record about design and development outputs review
• Record about design and development inputs
• Records of design and development controls
• Records of design and development outputs
• Design and development changes records
• Characteristics of the product to be produced and service to be provided
• Records about customer property
• Production/service provision change control records
• Record of conformity of product/service with acceptance criteria
• Record of nonconforming outputs
• Monitoring measurement results
• Internal audit program
• Results of internal audits
• Results of the management review
• Results of corrective actions

Also, check ——>> ISO 9001 consultant in Sri Lanka

How to get ISO 9001 certified

To make the ISO 9001 Certification process simple. You should hire a consultant when a consultant received your application they will guide you and your business through the following steps.

• Gap analysis 
• Formal assessment 
• Training
• Documentation
• Internal Audit
• External Audit
• ISO 9001 Certification Plan & how to get Certified
• Certification and beyond 

ISO 27001 Best Practices

The ISO 27001 focuses on Information security management system (ISMS). The last version of ISO 27001 was published in 2013 by the International Organization for standardization and International Electronic Commission (ISE). ISO 27001:2013 based on how to manage information safety in a company, it provides security to your organization’s assets such as financial information, commercial information, IT systems, classified data of people, projects and much more should be secured by implementing risk management process in the organization.

According to its documentation, ISO 27001 was formed to produce a guide for implementing, monitoring, establishing, operating, reviewing, managing and upgrading an information security management system. ISO 27001 can be implemented by any of the organization, whether it's small or large, private or state-owned, profit or non-profit. It's essential to note that ISO 27001 does not work individually. Instead, it requires input by management to consider the security risks present and take suitable actions based on the threats and vulnerabilities present. Management will have to create and execute their own security controls or other forms of risk management, i.e. risk avoidance or risk transfer, to address the problems present.

Also, check ——>> ISO 27001 certification in Sri Lanka

What's the need for ISO 27001?

The standard was set to bring businesses with a certain degree of information security protection. ISO 27001 sets out different controls that need to be in place to measure up to the certification requirements such as:

• Identifying potential information security risks.
• Providing a secure framework for the ideal implementation and management of controls.
• Properly manage compliance with laws and regulations.
• Outlining the objectives of information security management.
• Underlining the information security policies, standards and processes to be followed by businesses.

Benefits Of ISO 27001

• Security of the classified data of a company.
• The trust of consumer and stakeholders in risk management of your company.
• Preserves assets of your company.
• Divine risks in the company.
• Catalogs manage and reduce risks.
• Increased business resilience.
• Preserves the goodwill and reliability of your company.
• A contentious advantage over other companies.
• Improved customer and business partner confidence.
• A lower expense due to risk evaluation.
• Provides secure exchange of the data.
• Built maintenance and handle programs in the company.

ISO 27001 Controls

ISO 27001 although does not directly make any information security control an imperative, it does have a controls-checklist which should be carried into account when abiding with code of practices (ISO 27002). The main sections include:

• Risk Management.
• Security Policy.
• Information Security.
• Asset Management.
• Human Resource Security.
• Environment Security.
• Communications and Operations Management.
• Access Control.
• Information System Acquisition.
• Information Security Incident Management.
• Business Continuity Management.
• Compliance.

How does ISO 27001 work?

ISO 27001 works on a top-down, technology-neutral, risk-based approach. The specification defines a six-part plan process:

1. Establish security management.
2. Manage the range of the (ISMS) information security management system.
3. Convoy a risk assessment.
4. Control identified risks.
5. Select-control goals and controls to be performed.
6. Develop a statement of applicability.

ISO 27001 draws coordination among all sections of an organization and improves management accountability, assures constant improvement, handles internal audits and undertakes corrective and defensive actions.

How To Obtain ISO 27001

To implement ISO 27001 in your organization, you have to follow these 10 steps:

1. Plan.
2. Get top management support.
3. Organize a management structure.
4. Conduct a risk assessment.
5. Perform the risk assessment and risk treatment.
6. Conduct training.
7. Review and update the required documentation.
8. Measure, monitor, and review.
9. Conduct an internal audit.
10. Registration/certification audits.

Also, check ——>> ISO 27001 consultant in Sri Lanka

To make the ISO 27001 Certification process simple. You should hire a consultant when a consultant received your application they will guide you and your business through the following steps.

• Gap analysis 
• Formal assessment 
• Training
• Documentation
• Internal Audit
• External Audit
• ISO 27001 Plan & how to get Certified
• Certification and beyond 

CE marking for medical devices

As we all know CE Marking stands for CE stands for Conformité Européenne (French), which means European conformity. CE Marking focuses on Health and Safety & Environmental protection standard. The CE mark is compulsory conformity marking for specific products traded in the European Economic Area (EEA) since 1985. The CE Marking gives you intelligence to sell your product in the EU, Norway, Iceland, and Liechtenstein. The CE marking wipes out your need for interest in many competing jurisdictional laws covering your products. CE marking converts another level of safety for customers and other end-users, which lower damage claims and insurance premiums.

You must obtain CE marking on your medical devices which will give you the right to sell your medical devices in European countries (EU), CE marking determines that your medical device fulfills with the appropriate EU organizations and allows the commercialization of your products in 32 European countries. As a legal medical device manufacturer, you are responsible for managing regulatory assent and guarding CE Marking for your product, although of whether you outsource any or all components of your manufacturing operation. A manufacturer is described as a person who is able to design and manufacturing a product with the intention of placing it in on the market under their personal name or brand. Even a person really manufactures, designs, packs, assembles, labels or processes a product themselves, or they authorize out any or all of certain duties, does not imply in concerns to CE marking. The manufacturer has the responsibility to assure that the product and design are made in agreement with the relevant act. They must also pick up the expected professional documentation and assure those relevant assessment methods are carried out.

CE Marking logo affixed on the medical device shows the device fulfills the quality specifications and coordinated standards. Medical Device Regulation EU MDR Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 are the two new regulations on the medical device.

Also, check ——>> CE marking certification in Sri Lanka

How to obtain CE marking for your medical device

CE is not a quality mark, but an understanding with EU Directives needs you to meet the appropriate standards of performance, quality, safety, and efficacy for your product type. However, the basic process follows these steps:

1. Determine which EU Directive applies to your device: Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive (98/79/EC) or Active Implantable Medical Devices Directive (90/385/EEC).
2. Determine the classification of your device. See our chart.
3. Classify all the EU directives and standard for the product applicant of CE marking.
4. Implement a Quality Management System, if applicable to your device. Most companies use ISO 13485 to meet the requirements.
5. Prepare a CE Marking Technical File or a Design Dossier.
6. Perform the conformity assessment according to relevant EU requirements of the directives.
7. Prepare a Clinical Evaluation Report (CER) according to MEDDEV 2.7/1 rev4 and MDD (or MDR).
8. Take necessary measures to make corrections of any divergence in the marking process.
9. Select and appoint a European Authorized Representative to act on your behalf within the EU if you have no physical location in Europe.
10. Attest the CE marking of the product.
11. Have your QMS and Technical File/Design Dossier audited by a Notified Body unless your device is Class I, is not sterile and has no measuring function.
12. Obtain CE Marking and ISO 13485 certificates from your Notified Body.
13. Arrange all the required documents and certificates.
14. Prepare and sign the EU declaration of Conformity.
15. Prepare a Declaration of Conformity (DoC), which states that your device complies with the appropriate Directive.

Also, check ——>> CE marking consultant in Sri Lanka

To make the CE Marking certification process more simple. You should hire a consultant when a consultant received your application they appoint a client manager who will guide you and your business through the following steps.

• Gap analysis 
• Formal assessment 
• Certification and beyond 
• CE Marking & how to get Certified

NOTE: The process of the medical device will be changed when Europe’s new Medical Device Regulation (MDR 2017/745) comes into force in May 2020.

Top 5 Most Important ISO Standards

ISO is everywhere, ISO is an independent non-governmental organization and the world's largest developer of international standards. International standards make things work. They give world-class specifications for your system, services, and products to ensure quality, safety, and efficiency. They are helpful in promoting international trade. There are many more different ISO standards and sometimes it's difficult to understand which one is the most important and suitable standard for your organization or business. Some standards are universal and can be applied by to any organization whether it's small or big. ISO can be applied by any Companies of all sizes big-small and in all industries such as enterprises, retailers, manufacturers, suppliers, packagers, processors, growers, transporters, planning, production, supply, distribution, storage, installation, controlling, monitoring, maintain and even retailers and restaurants.

If you are not ISO certified in any standard and If you looking for ISO Certification, Here are the top 5 most Important ISO standards currently in place:

1. ISO 9001

ISO 9001 is the most important and popular standard. ISO 9001 Is based on the Quality Management System (QMS) ISO 9001:2015 comes with Constant improvement that ensures your consumers benefit by receiving products/services that meet their requirement, and that you deliver consistent performance. ISO 9001 will help your organization to improve the quality process and performance of your product & services. ISO 9001 gives you the capability to stand out with your competitors & immediate growth in Profitable margin.

Benefits Of Being ISO 9001 Certified

• Reduce Waste and Improve Efficiency
• Helps to reduce your costs.
• Improves your quality and services.
• makes a strong relationship with your supplier.
• Increases income and financial performance.
• Boost staff performance and overall productivity.

Also, check ——>> ISO Consultant in Sri Lanka

2. ISO 22000

The ISO 22000 was announced in 2005 by the International Organization for Standardization. ISO 22000:2018 focuses on Food Safety Management System (FSMS). It can apply to any organization of a food chain system.
By obtaining an ISO 22000 certificate you can show your customer that your company has a food safety management system certified. Your food is harmless for health, your food ingredients, and food packaging which supply from a supplier are protected. ISO 22000 has been compared with ISO 9001 in order to enhance the unity of the two standards. The ISO 22000 Certificate instructs correctly what is important to be in a Food Safety Management System. That makes assured the food is stored protected in the entire course food supply chain, right up until when the food is eaten.

Benefits Of Being ISO 22000 Certified

• Gives the capability to enhance your food chain process.
• Engage customers and make a successful organization.
• Protect food safety from hazardous.
• Legally upgrade your documentation.
• Keeps food safety in well mannered during an emergency.
• Makes a better relationship between shareholders and customers.
• Promotes international trade.
• Promote your documentation legally.
• Boost possible economic growth and development.
• Enhance your business globally and increase profit.
• Improved business opportunities.

3. ISO 14001

ISO 14001 was first announced in 1996 by the International Organization for Standardization. ISO 14001:2015 based on the Environmental Management System (EMS). An environmental management system helps organizations manage, control, recognize, and monitor,  their environmental problems in a “comprehensive” manner. ISO 14001 helps to regulate, monitor and develop environmental management. ISO 14001:2015 describes the criteria as the environmental management system. Any company can apply this certificate.

Benefits Of Being ISO 14001 Certified

• Manages environmental risks.
• Saves your cost in waste by recycling and consumption.
• Expands employee involvement while working on an ECO-friendly organization.
• Stakeholder’s confidence is gained.
• increase leadership engagement and involvement of employees.
• Environmental performance of suppliers is improved.
• Decreases waste.

4. ISO 27001

The ISO 27001 was announced in 1995 by BSI Group, ISO 27001 relates to Information Security Management System (ISMS). Applying this family standard will help you to enhance security and protect the assets, the organization maintains the safety of assets such as intellectual property, commercial information, employee details or information entrusted to you by third parties.

Benefits Of Being ISO 14001 Certified

• Preserves assets of your company.
• Protects the goodwill and security of your company.
• A contentious benefit protecting other companies.
• Catalogs maintain and decrease the risks.
• A lower expense due to risk evaluation.
• Divine risks in the company.
• Provides secure exchange of the data.
• Built maintenance and handle programs in the company.

5. ISO 50001

The ISO 50001 focuses on Energy Management System (EnMS). It was published in June 2011 by the International Organization for Standardization, ISO 50001 Certification defines the requirements for maintaining, establishing, implementing and improving the energy management system, whose goal is to helps the organization in energy performance, energy security, energy efficiency, and energy consumption. ISO 50001 Standard also focus to reduce the energy use, energy cost and their greenhouse gas emissions of the organization.

Benefits Of Being ISO 50001 Certified

• Reduce energy usage cost.
• Allows the organizations to maintain their energy consumption, which reduces energy bills by increasing company savings.
• Helps in controlling greenhouse gases.
• Continually improve in energy management.
• Avoid energy hazards.
• Allows every employee to be aware of their role in Energy Management.
• Improves operational performance and cost reductions in all section.
• The presence of a healthy and safe environment.

Also, check ——>> ISO Certification in Sri Lanka

How To Get ISO Certified

To make the ISO Certification process simple. You should hire a consultant when a consultant received your application they appoint a client manager who will guide you and your business through the following steps.

• Gap analysis 
• Formal assessment 
• Certification and beyond 
• ISO 13485 Plan & how to get Certified

It’s also important to keep an eye out for updates because the standards are constantly being changed in order to account for government laws and regulations, social attitudes, and technology.