ISO9001 - ISO9001:2015(E) Kwaliteitsmanagementsystemen - Vereisten

Overzicht

The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to an organization of implementing a quality management system based on this International Standard are: a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities associated with its context and objectives; d) the ability to demonstrate conformity to specified quality management system requirements. This International Standard can be used by internal and external parties.

Wie moet voldoen

Organizations of any size or sector seeking to demonstrate consistent quality management, on a voluntary basis.
Suppliers required by customers or tenders to hold ISO 9001 certification.
Not a legal requirement; adoption and certification are optional.

Belangrijkste verplichtingen

Context and leadership

Hoog

Determine the internal and external issues, interested parties and scope relevant to the quality management system, and demonstrate top management commitment and a customer focus.

Risk-based planning

Hoog

Identify risks and opportunities that can affect the conformity of products and services, set measurable quality objectives, and plan actions to address them.

Operational control

Kritiek

Plan and control the processes for providing products and services, including requirements review, design, control of external providers, and management of nonconforming outputs.

Support and resources

Gemiddeld

Provide the people, infrastructure, competence, awareness and documented information the system needs to function.

Performance evaluation and improvement

Tijdlijn

1987
First edition of ISO 9001 published.
2015-09
Third (current) edition ISO 9001:2015 published, introducing the high-level structure and risk-based thinking.
2024-02
Amendment 1 added, addressing climate change considerations.

Hoe Anove helpt

✓Controls koppelen — breng uw controls één keer in kaart en hergebruik het bewijs voor elk overlappend kader dat op u van toepassing is.
✓Gapanalyse — zie precies waar u staat ten opzichte van elke vereiste, met een geprioriteerde lijst van wat u eerst moet aanpakken.
✓Deadlinebewaking — volg uw gereedheid ten opzichte van belangrijke data en wijs eigenaren toe zodat er niets tussenuit valt.
✓Continue monitoring — word gewaarschuwd zodra een tool, leverancier of control niet langer compliant is.

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Data

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ISO9001:2015(E) Kwaliteitsmanagementsystemen - Vereisten