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Clause 4 procedure and department Quality objective

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Guest Created:   May 11, 2021 Last commented:   May 11, 2021

Clause 4 procedure and department Quality objective

1. Is clause 4. is in need of documentation or a procedure? Especially the internal and external issues? Do I need to create a procedure for this? 

2. Is each department is in need to create their department Quality objective or not? are they require to create their department quality objective?

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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Carlos Pereira da Cruz May 11, 2021

1. Is the clause 4. is in need of documentation or a procedure? specially the internal and external issues? Do I need to create a procedure for this?

Answer:

ISO 9001:2015 has no mandatory requirements concerning procedures for clause 4. Please check this article - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/it/knowledgebase/le-cinque-fasi-principali-della-verifica-interna-iso-9001/ist-of-mandatory-documents-required-by-iso-90012015/ . You will find that the only mandatory document is the scope statement. However, consider clause 4.4.2 about documents and records that organizations decide to use even if not mandatory according to the standard.

2. Is each department is in need to create their department Quality objective or not? are they require to create their department quality objective?

Answer:

Quick answer, no!

ISO 9001: 2015 does not refer to departments. ISO 9001: 2015 works with the process approach. According to clause 4.4, each process must have at least one indicator. Hence it is possible to create at least one objective per process based on each indicator.

Some organizations make the objectives of the processes also the objectives of the QMS. Personally, I don't share that approach. I prefer to look at the objectives of the QMS as umbrella objectives, objectives that require the contribution of the organization as a whole.

The following material will provide you more information:

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May 11, 2021

May 11, 2021

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