QUALITY MANAGEMENT SYSTEM CERTIFICATION
A detailed description of the activities of the PROCEDO certification body is described in the Informative Guide.
Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organisations 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 (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide the product, including quality management system-related services to such organisations.
Requirements of ISO 13485:2016 apply to organisations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organisation.
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Quality management systems — Requirements
This International Standard, ISO 9001, specifies requirements for a quality management system when an organisation:
- 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
All the requirements of this International Standard are generic and are intended to be applied to any organisation, regardless of its type or size, or the products and services it provides.
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Environmental Management Systems
ISO 14001:2015 sets out the criteria for an environmental management system and can be certified to.
Using ISO 14001:2015 can assure company management and employees as well as external stakeholders that environmental impact is being measured and improved.
An effective ISO 14001 EMS implementation into the quality system helps:
- reduced business costs through reducing resource consumption and waste production
- improve environmental performance
- reduce environmental impact and control the environmental risk
- achieve environmental commitments and environmental policy requirements
- meeting their environmental legal requirements
- promote a positive image with stakeholders, customers and employees
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Occupational Health and Safety Management Systems
ISO 45001:2018 specifies requirements for an occupational health and safety (OH&S) management system, and gives guidance for its use, to enable organizations to provide safe and healthy workplaces by preventing work-related injury and ill health, as well as by proactively improving its OH&S performance.
ISO 45001:2018 is applicable to any organization that wishes to establish, implement and maintain an OH&S management system to improve occupational health and safety, eliminate hazards and minimize OH&S risks (including system deficiencies), take advantage of OH&S opportunities, and address OH&S management system nonconformities associated with its activities.
ISO 45001:2018 helps an organization to achieve the intended outcomes of its OH&S management system. Consistent with the organization's OH&S policy, the intended outcomes of an OH&S management system include:
- continual improvement of OH&S performance
- fulfilment of legal requirements and other requirements
- achievement of OH&S objectives
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Food Safety Management Systems - Requirements For Any Organization In The Food Chain
ISO 22000:2018, Food safety management systems – Requirements for any organisation in the food chain, sets out the requirements for a food safety management system. It defines what an organisation must do to demonstrate its ability to control food safety hazards and ensure that food is safe for consumption.
ISO 22000 enables organisations to put in place a food safety management system that helps them improve their overall performance when it comes to food safety.
Potential benefits of using the standard include:
- the ability to consistently provide food-related products and services that are safe and meet regulatory requirements
- improved management of risks in food safety processes
- demonstrating strong links to the United Nations’ Codex Alimentarius, which develops food safety guidelines for governments
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Educational Organizations — Management Systems For Educational Organizations
ISO 21001:2018 specifies requirements for a management system for educational organizations (EOMS) when such an organization:
- needs to demonstrate its ability to support the acquisition and development of competence through teaching, learning or research
- aims to enhance satisfaction of learners, other beneficiaries and staff through the effective application of its EOMS, including processes for improvement of the system and assurance of conformity to the requirements of learners and other beneficiaries
All requirements of ISO 21001:2018 are generic and intended to be applicable to any organization that uses a curriculum to support the development of competence through teaching, learning or research, regardless of the type, size or method of delivery.
ISO 21001:2018 can be applied to educational organizations within larger organizations whose core business is not education, such as professional training departments.
ISO 21001:2018 does not apply to organizations that only produce or manufacture educational products.
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Energy Management Systems
ISO 50001 specifies requirements for establishing, implementing, maintaining and improving an energy management system (EnMS). The intended outcome is to enable an organisation to follow a systematic approach in achieving continual improvement of energy performance and the EnMS.
ISO 50001:
- is applicable to any organisation regardless of its type, size, complexity, geographical location, organisational culture or the products and services it provides
- is applicable to activities affecting energy performance that are managed and controlled by the organisation
- is applicable irrespective of the quantity, use, or types of energy consumed
- requires demonstration of continual energy performance improvement, but does not define levels of energy performance improvement to be achieved
- can be used independently, or be aligned or integrated with other management systems
Annex A of the standard ISO 50001 – guides how to use this document.
Annex B of the standard ISO 50001 provides a comparison between this edition (ISO 50001:2018) and the previous edition (ISO 50001:2011).
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Anti-Bribery Management Systems
ISO 37001:2016 specifies requirements and provides guidance for establishing, implementing, maintaining, reviewing and improving an anti-bribery management system. The system can be stand-alone or can be integrated into an overall management system. ISO 37001:2016 addresses the following in relation to the organization's activities:
- bribery in the public, private and not-for-profit sectors
- bribery by the organization
- bribery by the organization's personnel acting on the organization's behalf or for its benefit
- bribery by the organization's business associates acting on the organization's behalf or for its benefit
- bribery of the organization
- bribery of the organization's personnel in relation to the organization's activities
- bribery of the organization's business associates in relation to the organization's activities
- direct and indirect bribery (e.g. a bribe offered or accepted through or by a third party)
ISO 37001:2016 is applicable only to bribery. It sets out requirements and provides guidance for a management system designed to help an organization to prevent, detect and respond to bribery and comply with anti-bribery laws and voluntary commitments applicable to its activities.
ISO 37001:2016 does not specifically address fraud, cartels and other anti-trust/competition offences, money-laundering or other activities related to corrupt practices, although an organization can choose to extend the scope of the management system to include such activities.
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