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.
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.
What is ISO MS 15189: 2022?
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.
Consultancy / Auditing services:
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):
ISO 9001, ISO 14001, ISO 45001, ISO 15189, and ISO 17025 aims 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 standards are important to obtain these certifications?
The requirements will be based on compliance to the latest standards in ISO 9001: 2015, ISO 14001: 2015, ISO 45001: 2018, ISO MS 15189: 2022 and ISO MS 17025: 2017. It outlines the requirements an organization must monitor and maintain in their quality system.
What industries can apply for these certifications?
ISO 9001 is applicable to all industries or companies, such as a manufacturer, government entity, construction firm, engineering firm, technology provider, healthcare provider and many more.
ISO 14001 is applicable to manufacturing, construction, energy, services, healthcare, hospitality, transportation, agriculture, technology, and government sectors.
ISO 45001 is applicable to manufacturing, construction, oil and gas, healthcare, transportation, chemical and pharmaceutical, and aerospace, and the construction industry.
ISO 15189 and ISO 17025 is applicable to medical laboratories and any laboratory.
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.