Advantages of Being OHSAS 18001 Certified

OHSAS 18001 is an occupational health and safety management systems implemented worldwide. It comprises the policies, plans and practices of any company for handling occupational health and safety matters. The system is adaptable to any company's needs and requirements, considering that each company has unique occupation health and safety hazards. Being certified proves that the company meets all legal requirements and has a safe environment to do business. And there are many other advantages of being OHSAS 18001 certified.

• Creating a work environment with low risk of accidents and/or professional diseases. Companies who adopt this standard strive for zero work related accidents and professional diseases. The standard provides a framework for identifying occupational health and safety hazards and minimizing the associated risks. OHSAS 18001 provides the tools for identifying the dangers and improve employee risk awareness.
• Implementing the standard will greatly reduce accident rates. Furthermore, it will improve accident reporting and post-accident processes, including monitoring, accident investigation and damage control. These translate into a significant decrease of accident and insurance costs. 
• Demonstrates that the company is committed to have an effective health and safety policy. The company shows that health and safety are a priority for the top management team and it has the right means for protecting all employees. 
• Improves reputation and investor satisfaction. Having safety policies compliant to this standard improves corporate image and credibility among clients, potential business partners, regulators and the general public. A major accident caused by inadequate safety practices can be disastrous for the company. 
• Allows the company to gain a major advantage on the market. Ensuring legislative awareness and compliance proves that the company has efficient safety management practices, which is highly appreciated on the market. 
• By displaying results of audits, inspections, risk assessments, the company will be regarded as a very transparent one, again, gaining good reputation amongst all business partners and potential clients. 
• Better work results from company's employees. Providing a safe working environment will increase productivity and efficiency. Workers who know that they are protected against will perform better. 
• Implementing OHSAS 18001 is an efficient way to tackle absenteeism. Absenteeism is a major problem for any company. When it is caused by improper conditions which lead to occupational health problems, urgent measures must be taken. Improving work environments will lead to higher employee morale and greater involvement and commitment. Overall, the absenteeism problem will be reduced and easier to manage and the productivity of the company will increase.

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The Importance of ISO 13485 Standard

Being ISO 13485 certified helps consolidating business and employees' trust, an essential requirement in the medical device manufacturing industry. ISO 13485 has become the worldwide accepted standard in medical manufacturing industry and certifies the conformity to regulatory requirements. Organizations in the industry are expected to provide proof for quality management system implementation throughout the entire production cycle. This is why getting ISO 13485 certified is so important.

ISO 13485 certification guarantees the conformity to international standards throughout all phases of medical devices' life cycle: design, manufacturing, installing, technical assistance and sales. This QMS standard also covers other post production aspects like storage, distribution, provision of associated services. Furthermore, disposal and decommission of used/damaged medical devices is regulated by this ISO.

This standard is based on the ISO 9001 QMS standard, adapted for the medical device manufacturing environment. Being certified for both standards ensures competitiveness, transparency, effectiveness and will only bring more trust to potential business partners.

For manufactures, the certification means expanded market access. Being able to work with a worldwide network of potential customers and business partners is one of the top reasons why any company should require certification. National and international regulatory authorities prefer manufactures with a third-party audited and certified quality management system in. Investing in such a system speeds access into those countries that require it. Expanding production or sales operation to a new country with this QMS is difficult and in some cases, impossible.

Investing into implementation and recognition of ISO 13485 has the potential of saving a lot of money. First of all, by providing proofs for meeting high quality standards, finding potential customers takes significantly less time. All major companies which buy medical equipment require credibility and commitment to qualify for all business partners.

Although this standard does not emphasize the need for continual improvement, pointing strictly to meeting the quality requirements and achieving customer satisfaction, implementing it the company will get process control which will allow it further development and improvement. Contact our experts!

The latest version of this ISO highlights more the need for effective risk management and risk-decision management. Risk management of any medical device must be fully documented and applied during the entire life-cycle of any product. Proving that the risk was fully understood and documented will help companies get not only ISO 13485, but also ISO 14971, which is the ISO standard for the application of risk management to medical devices.

If you need further understanding and counseling for ISO 13485 standard our experts will be more than happy to help! Head to ISO Consulting, ISO Certification, ISO Training | GlenView Group for more details.