What is ISO 9001: 2015?
ISO 9001:2015 specifies requirements for a QMS (Quality Management System) where an organization needs to demonstrate its ability to consistently provide products and services that meet customer satisfaction and comply with statutory and regulatory requirements.
All requirements of ISO 9001:2015 are generic and are applicable to any organization regardless of its type, size, products and services. This could be applied to industries such as engineering, construction, technology, manufacturing, hospitality and others.
What is ISO 14001: 2015?
ISO 14001:2015 offers a framework for organizations to establish an Environmental Management System (EMS). Companies implementing ISO 14001 aim to identify and manage their environmental impact, enhance environmental performance, comply with legal requirements, and promote sustainable practices.
What is ISO 45001: 2018?
ISO 45001: 2018 is an international standard that specifies requirements for an occupational health and safety management system (OHSMS). It provides a framework for organizations to establish, implement, maintain, and continually improve their occupational health and safety management systems.
ISO 15189: 2022 - Medical laboratories is a standard that specifies the requirements for quality and competence in medical lab enviroments. Essentially, it is a standard that requires labs to develop a robust, reliable Quality Management System (QMS).
What is ISO MS 17025: 2017?
ISO/IEC 17025: 2017 - General requirements for for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent.
What is ISO 13485: 2016?
ISO 13485:2016 - Medical devices — Requirements for regulatory purposes is the internationally recognized standard for quality management systems (QMS) specific to the medical device industry. It ensures organizations can consistently meet customer and regulatory requirements for medical devices and related services.
What is ISO 22301: 2019?
ISO 22301:2019 - Security and resilience — Requirements for business continuity management (BCM). It helps organizations prepare for, respond to, and recover from disruptive incidents, ensuring continuity of operations.
What is ISO 37001: 2016?
ISO 37001:2016 - Anti-bribery management systems — Requirements with guidance for use is the global standard for implementing an anti-bribery management system. It helps organizations prevent, detect, and respond to bribery risks and maintain ethical business practices.
What is ISO/IEC 27001: 2022?
ISO/IEC 27001:2022 - Information security management systems — Requirements is the leading standard for information security management systems (ISMS). It helps organizations protect sensitive data through risk management, security controls, and continuous monitoring.
What is IATF 16949: 2016?
IATF 16949:2016 - Quality management system requirements for automotive production in the automotive industry. It focuses on defect prevention, continuous improvement, and reducing variation in the supply chain.
What is AS 9100: 2016?
AS 9100:2016 - Requirements for Aviation, Space, and Defense Organizations in the aerospace industry’s quality management standard. It ensures safety, reliability, and regulatory compliance in aerospace manufacturing and services.
Consultancy / Auditing services:
1) Provide necessary trainings on various ISO topics to ensure your company is competent in the relevant standards and requirements.
2) Assist to set up and also to review the necessary processes and develop alongside the company its ISO relevant standard operating procedures and forms.
3) Guide and train your company's internal auditors to conduct planned internal QMS audits and assist with MRM (Management Review Meeting's).
4) Prepare your company for certification (pre-audit certification) and assist during external audit by certification body.
Frequently Asked Questions (FAQs):
These various systems aim to help organisations meet the needs of their customers and other stakeholders more effectively. This is achieved by building a framework to ensure consistent quality in the provision of goods and services. Other benefits include well managed business risks and opportunities and a strong organisational quality culture.
By getting certified, your company shows its commitment in providing a high level of customer satisfaction through continuous improvement.
What industries can apply for these certifications?
ISO 9001 - all industries or companies, such as a manufacturer, government entity, construction firm, engineering firm, technology provider, healthcare provider and many more.
ISO 14001 - manufacturing, construction, energy, services, healthcare, hospitality, transportation, agriculture, technology, and government sectors.
ISO 45001 - manufacturing, construction, oil and gas, healthcare, transportation, chemical and pharmaceutical, and aerospace, and the construction industry.
ISO 15189 and ISO 17025 - medical laboratories and any laboratory.
ISO 13485 - Healthcare, medical device manufacturing, regulatory bodies.
ISO 22301 -All industries, particularly finance, healthcare, IT, government, and critical infrastructure.
ISO 37001 -All industries, especially corporate governance, finance, government, and multinational businesses.
ISO 27001 - IT, finance, healthcare, telecommunications, and data-sensitive industries.
IATF 16949 - Automotive manufacturing, suppliers, and logistics in the automotive industry.
AS 9100 - Aerospace, aviation, defense, and space industry organizations.
How much will it cost my company?
The costing will depend on various factors such as size of company, manpower and the number of subsidiaries. It can be sub divided into:
1. Consultancy costs (training, developing documents such as SOPs and forms, auditing) and;
2. Certification costs to be paid directly to Certification Bodies.
How long will it take for my company to be certified?
There is no fixed time for your company to be certified. It depends on the readiness of your company to ensure that all requirements are met before the certification audit.