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Why Have Procedures? What are the Mandatory Procedures for ISO 9001:2015?

02 Feb

Why have procedures? Some would answer this question by providing very long lists of reasons why, these lists are sometimes not useful. They are too long to remember and absorb them, and there is too much overlap and redundancy. There are four very basic reasons that demonstrate why we should develop procedures to document important process.

  • Compliance
  • Operational Needs (i.e. consistency)
  • Manage Risks
  • Continuous Improvement

What to cover in Mandatory ISO 9001:2015 Procedures?

These mandatory ISO 9001:2015 procedures are specified by ISO 9001 and are included in quality manual template. There are the six procedures that are mandatory to be documented. Organization need to ISO 9001:2015 document these six procedures. This doesn’t mean simply will go away with just these six, the ISO 9001:2015 procedures you wish can abundantly rely upon the scale and complexness of your organization, these six but are those that you simply should have.

Six Mandatory ISO 9001:2015 Procedures

ISO 9001:2015 Mandatory Procedures

1. Control of Documents:

In this ISO 9001:2015 procedure, a written procedure to control the approval and re- approval of procedures and ensuring that the current revision status is displayed. It is the process to ensure that the obsolete documents are controlled and legible and that documents are intended for the external parties such as their clients or the process owner. The documents must be approved by senior management

2. Control of Records:

This is the procedure for checking the archiving of identification, protection, storage and deletion of records by the owner of the process and also keeping records in a specific location. The established records will be checked to provide confirmation of compliance with the requests and the effective functioning of the quality management system.

3. Internal Audit:

The purpose of the ISO 9001 internal audit is to assess the effectiveness of the quality management system and the organization’s overall performance. Your internal audits demonstrate compliance with planned arrangements, e.g. QMS manual, procedures or process maps and that the planned arrangements are implemented and maintained.

4. Control of Non-Conforming Product:

As regards the ISO 9001 standard, the documents are necessary and the records of the non-conformity problem are kept in order to identify them and act in this way. This is a procedure that ensures that the testimonial of the useless product and no action is performed and documented procedure is established to define the controls and the related responsibilities and authorities to deal with non-compliant products.

5. Corrective Action:

A corrective action should be considered as a reactive response to a problem since it is taken when a non-conformance is detected or upon receipt of a customer complaint or other event. Your organization should first contain the problem and then determine its root cause in order to take appropriate corrective action to prevent the problem’s recurrence.

6. Preventive Action:

The Preventive actions are pro-active – something could go wrong and these are actions taken to prevent it from happening, or to prevent it from becoming too severe. If something has already gone wrong, it is a non-compliance that is addressed with corrective actions. ISO 9001: 2015 requires documenting the preventive action procedure. Furthermore, it is necessary to keep a record of the identified preventive actions and actions taken.

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