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ISO 9001:2015 | ISO 14001:2015 | ISO 45001:2005 |
ISO 22000:2018 | ISO 27001:2013 | ISO 13485:2016 |
ISO 50001:2011 | ISO 55001:2013 | ISO 37001:2016 | ISO 20000-1:2011 | ISO 22301:2012 | ISO 21001:2018 |
ISO 41001:2018 | ISO 29990:2010 | ISO 10002:2019 |
ISO 15858:2016 | ISO 16604:2004 | ISO 22612:2015 |
SA 8000:2014 | IATF 16949:2016 | ISO 17025:2005 |
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ANSI | NIOSH | EN 166:2002 |
FDA | US FDA | AIOTA |
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CGMP | CLSI | FAMI QS |
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Requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
It specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. ISO 14001:2015 is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.
The purpose of an OH&S management system is to provide a framework for managing OH&S risks and opportunities. The aim and intended outcomes of the OH&S management system are to prevent work-related injury and ill health to workers and to provide safe and healthy workplaces; consequently, it is critically important for the organization to eliminate hazards and minimize OH&S risks by taking effective preventive and protective measures.
It specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption. It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products.
It specifies the requirements for establishing, implementing, maintaining and continually improving an information security management system within the context of the organization. It also includes requirements for the assessment and treatment of information security risks tailored to the needs of the organization.
It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities
Quality Manual : A quality manual outlines the organization's quality management system (QMS) and provides an overview of how the organization meets the requirements of the ISO standard.
Quality Policy : A quality policy is a statement of the organization's commitment to quality and customer satisfaction. It should be endorsed by top management and communicated throughout the organization.
Documented Procedures : These are documented instructions that outline how various processes within the organization are carried out. Examples include procedures for document control, internal audits, corrective and preventive actions, and control of non-conforming products/services.
Records of Training and Competence : Documentation of employee training and competence to ensure that personnel are adequately qualified to perform their assigned tasks.
Internal Audit Reports : Reports from internal audits conducted to assess the effectiveness of the organization's quality management system and identify areas for improvement.
Management Review Records : Records of management reviews conducted to evaluate the performance of the quality management system, set objectives for improvement, and allocate resources as needed.
Corrective and Preventive Action Records : Documentation of corrective and preventive actions taken to address non-conformities and prevent their recurrence.
Monitoring and Measurement Records : Records of monitoring and measurement activities conducted to ensure that products, processes, and the quality management system itself meet the requirements of the ISO standard.
Customer Feedback and Complaints Records : Documentation of customer feedback and complaints, along with records of actions taken to address any issues raised.
Supplier Evaluation and Monitoring Records : Documentation of processes for evaluating and monitoring suppliers to ensure they meet the organization's quality requirements.
Evidence of Compliance with Legal and Regulatory Requirements : Documentation demonstrating that the organization complies with relevant legal and regulatory requirements applicable to its products, services, and operations.
Risk Assessment and Management Records : Documentation of processes for identifying, assessing, and managing risks to the organization's ability to meet its quality objectives.
ISO Certification is a seal of approval from a 3rd party body that a company runs to one of the internationally recognised ISO management systems. The certification can be used to tender for business as a proof of a company’s credibility but also to install confidence in the potential client that you will
keep your promises.
ISO Certification costs vary dependent on the size of an organization and the level to which the company is already run with regards to processes and procedures. If you decide to implement more than one standard at the same time, there are some preferential fees available. We are a fixed fee organization, which means once we have met you to discuss your requirements and sent you a formal quotation, this fee is then set. We will not charge you any extra then what is specified, so that you know from the outset your costs and the payment method.
Due to our proposals being bespoke and the number of variables that can affect the cost of implementation, we do like to meet our potential clients so as to get to know them a little better before providing them with costing
An ISO certification only certifies standards , it has got nothing to do with permits and licenses. Even though you might have an ISO certification, you still need government and authority permission, permits and licenses to work your business.
One of the main reasons is credibility. ISO offers great credibility in the market and enhances the reputation of your business. The government has now made it mandatory for all companies filing tenders for government work to have an ISO certification.
ISO 9001 and ISO 14001 are common management system standards that can be applicable to any organization.