ISO 13485 Certification

Quality management systems for medical devices and in vitro diagnostics

The ISO 13485 standard serves as the foundation for certifying quality management systems in companies involved in the manufacturing and distribution of medical devices, including those in the supply chain.

Quality management systems for medical devices and in vitro diagnostics (SCC)

A quality management system is essential for a medical device manufacturer as it provides the structure for all activities and tasks. It ensures that both internal and external regulations are reliably considered and followed.

By obtaining appropriate certification, a manufacturer can establish trust in their processes and products and demonstrate their dedication to safety and quality.

What is ISO 13485?

ISO 13485 is a standard that focuses on the quality management systems for manufacturers of medical devices or in vitro diagnostics. It is based on the well-recognized ISO 9000 series of standards. It follows the process-oriented approach of ISO 9001 while also incorporating specific aspects that are particularly relevant for manufacturers of medical devices or in vitro diagnostic medical devices.

Why SACAS?

• More than 15 years of experience in Management Systems certification.
• Audits that provide value-adding insights about your organization.
• Auditors with practical experience and a high level of industry competence.
• Accredited certificates with international acceptance.
• Expertise and approvals for all relevant standards.
• Personal, smooth support from our specialists - regionally, nationally, and internationally.

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ISO 14001 Certification

Environmental management system according to ISO 14001

Companies are increasingly recognizing that environmental protection and sustainability are not just topics of communication but also add value. Consistently following environmental protection guidelines can create real competitive advantages while fulfilling a company's ecological responsibility. The ISO 14001 standard, which is recognized internationally, sets out the specific requirements for an environmental management system.

How does ISO 14001 certification benefit which organizations?

ISO 14001 is a standard that can be implemented by companies of any size and industry sector, including private, non-governmental, and non-profit organizations. An environmental management system based on ISO 14001 can provide numerous benefits to your company. Successfully implementing and becoming certified in this standard can help your company gain a competitive edge in the market.

Important requirements for ISO 14001 certification

To become ISO 14001:2015 certified, your company or organization must fulfil specific requirements. One of these is having an environmental policy created by the company's management. This policy should include a voluntary pledge to protect the environment and improve environmental protection measures within the company.

Revision of ISO 14001

AMENDMENT 1: Climate action changes

4.1

Add the following sentence at the end of the subclause:

The organization shall determine whether climate change is a relevant issue.

4.2

Add the following note at the end of the subclause:

NOTE Relevant interested parties can have requirements related to climate change.

Why SACAS?

• More than 15 years of experience in ISO 14001 certification.
• Audits that provide value-adding insights about your organization.
• Auditors with practical experience and a high level of industry competence.
• Accredited certificates with international acceptance.
• Expertise and approvals for all relevant standards.
• Personal, smooth support from our specialists - regionally, nationally, and internationally.

Request a quote!

We will be happy to provide you with a tailor-made offer for ISO 14001 certification. CLICK HERE

ISO 22000 Certification

Achieve greater food safety with ISO 22000 certification.

The ISO 22000 standard outlines requirements for food safety management systems. Certification demonstrates compliance with high hygiene and safety standards in food manufacturing, distribution, and catering businesses.

The ISO 22000 certificate for safe food

Ensuring food safety is of utmost importance to safeguard consumer health. Any negligence in maintaining hygiene and safety in the food supply chain can pose life-threatening risks. Furthermore, spoiled food leads to massive economic losses every year. To ensure high levels of safety and quality in the production and distribution of both feed and food, the ISO 22000 standard was formulated to guide traders and manufacturers.

The four core areas of the ISO 22000 food safety standard.

ISO 22000 for food safety includes four core areas. These include implementing effective PRPs (Prerequisite Programs), establishing and maintaining the Food Safety Management System (FSMS), organizing internal and external communications, and complying with HACCP requirements.

ISO 22000 for food safety covers the following areas:

1. Implementing effective prerequisite programs.
2. Establishing and maintaining the Food Safety Management System based on ISO 22000 requirements.
3. Organizing internal and external communications.
4. Complying with HACCP requirements.

Why SACAS?

• More than 15 years of experience in Management Systems certification.
• Audits that provide value-adding insights about your organization.
• Auditors with practical experience and a high level of industry competence.
• Accredited certificates with international acceptance.
• Expertise and approvals for all relevant standards.
• Personal, smooth support from our specialists - regionally, nationally, and internationally.

Request a quote!

We will be happy to provide you with a tailor-made offer for ISO 22000 certification. CLICK HERE

ISO 45001 Certification

Occupational health and safety

Are you looking for a way to protect your employees from accidents and health risks? One way to achieve this is by implementing a certified management system by the ISO 45001 standard. This international standard emphasizes the importance of occupational health and safety as a strategic management issue. By implementing this system, you can minimize and potentially avoid risks to your employees' safety and health.

What is ISO 45001?

ISO 45001 is a globally accepted standard for implementing an efficient occupational health and safety (OHS) management system. This standard enables companies to recognize potential work-related hazards that may threaten their employees' health, cause accidents, or lead to injuries. By implementing preventive measures, companies can avert such risks. Companies can obtain ISO 45001 certification to demonstrate their compliance with this standard.

Revision of ISO 45001

AMENDMENT 1: Climate action changes

4.1

Add the following sentence at the end of the subclause:

The organization shall determine whether climate change is a relevant issue.

4.2

Add the following note at the end of the subclause:

NOTE Relevant interested parties can have requirements related to climate change.

Why SACAS?

• More than 15 years of experience in Management Systems certification.
• Audits that provide value-adding insights about your organization.
• Auditors with practical experience and a high level of industry competence.
• Accredited certificates with international acceptance.
• Expertise and approvals for all relevant standards.
• Personal, smooth support from our specialists - regionally, nationally, and internationally.

Request a quote!

We will be happy to provide you with a tailor-made offer for ISO 45001 certification. CLICK HERE

ISO/IEC 27001 Certification

Information security with a system

As companies move towards digital transformation, the need for "Information Security" is becoming increasingly important. Insufficient security measures can result in data loss and theft by hackers and business disruptions due to web attacks or data misuse. Companies can adopt an Information Security Management System (ISMS) to establish a structured approach that complies with the ISO/IEC 27001 standards.

What is ISO/IEC 27001?

ISO/IEC 27001 is the primary international standard for implementing a comprehensive management system for information security. Its primary focus is on identifying, assessing, and managing risks related to handling information processes. The standard emphasizes securing confidential information as a critical strategic element.

What makes the ISO/IEC 27001 standard useful for my company?

Introducing an Information Security Management System (ISMS) according to ISO/IEC 27001 is a crucial and strategic decision for any company. Implementing the standard's deliberately general requirements must reflect the company's specific needs, goals, security requirements, organizational processes, and size and structure. In other words, the implementation of ISO/IEC 27001 in your company should be customized to fit your unique situation.

Revision of ISO/IEC 27001.

In the summer of 2022, the standard was prepared by the Joint Technical Committee ISO/IEC JTC 1, Information Technology, Subcommittee SC 27, Information security, cybersecurity, and privacy protection.

Why SACAS?

• More than 15 years of experience in Management Systems certification.
• Audits that provide value-adding insights about your organization.
• Auditors with practical experience and a high level of industry competence.
• Accredited certificates with international acceptance.
• Expertise and approvals for all relevant standards.
• Personal, smooth support from our specialists - regionally, nationally, and internationally.

Request a quote!

We will be happy to provide you with a tailor-made offer for ISO/IEC 27001 certification. CLICK HERE

HACCP (SANS 10330) Certification

Important certification standard for food manufacturers and distributors.

Companies can obtain HACCP certification to ensure food safety throughout the production and supply chain.

HACCP - An important concept for ensuring food safety.

The HACCP (Hazard Analysis Critical Control Points) standard is a set of guidelines that aims to improve food safety and ensure consumer health. This concept involves all supply chain stages, from food production to sale. The main objective of HACCP is to prevent harmful or toxic substances and bacteria from contaminating food products. By implementing HACCP, the food industry can better identify and control potential hazards at every stage, thus minimizing the risk of foodborne illnesses.

Important components of HACCP certification

The HACCP concept is built on the foundation of standard hygiene systems that already comply with legally binding food hygiene requirements. The three crucial components of the HACCP system are:

• Analyzing and assessing potential hazards.
• Identifying "Critical Control Points" and taking measures to control them.
• Verifying and documenting the HACCP system.

Why should companies get HACCP certified?

• All-important audits for product safety and quality certification from one source.
• Many years of industry experience and competence of our auditors.
• Personal contact people at more than 80 locations worldwide.
• High service quality also beyond the audit itself.

Why SACAS?

• More than 15 years of experience in Management Systems certification.
• Audits that provide value-adding insights about your organization.
• Auditors with practical experience and a high level of industry competence.
• Accredited certificates with international acceptance.
• Expertise and approvals for all relevant standards.
• Personal, smooth support from our specialists - regionally, nationally, and internationally.

Request a quote!

We will be happy to provide you with a tailor-made offer for HACCP certification. CLICK HERE