Checklist of Mandatory Documentation Required by ISO 9001:2015

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Checklist of Mandatory Documentation Required by ISO 9001:2015

Not every single process that is in place in an organisation must be documented to meet the requirements of the ISO 9001 standard.

The 2015 revision of the standard has become more liberal regarding documentation requirements, meaning that there are no longer six mandatory procedures as in the previous 2008 version of the standard.

ISO 9001 also identifies many records that need to be maintained, which are generated by the processes of the Quality Management System.

Below is a list of documents and records are mandatory:

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What Documents and Records are Required?

Mandatory Documents

Scope of the Quality Management System

Quality Policy

Quality Objectives and Plans for Achieving Them

Procedure for Control of Externally Provided Processes, Products and Services (outsourced processes)

ISO 9001:2015 Clause

4.3

5.2

6.2

8.4.1

Mandatory Records

Record of Maintenance & Calibration of Monitoring & Measuring Equipment

Competence Records

Product/Service Requirements Review Record

Record of New Requirements for Product or Service

Design and Development Inputs Record

Record of Design and Development Controls

Design and Development Outputs Record

Record of Design and Development Changes

Record of Evaluation of External Provider (supplier)

Record of Product/Service Characteristics

Record of Changes on Customer’s Property

Record of Changes in Production/Service Provision

Evidence of Product/Service Conformity

Record of Nonconformity

Monitoring Performance Information

Internal Audit Program and Results

Management Review Results

Nonconformities and Corrective Action

ISO 9001:2015 Clause

7.1.5.1

7.2

8.2.3.2

8.2.3.2

8.3.3

8.3.4

8.3.5

8.3.6

8.4.1

8.5.1

8.5.3

8.5.6

8.6

8.7.2, 10.2.2

9.1.1

9.2.2

9.3

10.2.2

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The documents & records that are required to be maintained for the ISO 9001 Quality Management System, but you should also maintain any other records that you have identified as necessary to ensure your management system can function, be maintained, and be improved over time.

While ISO 9001 does not require that you document all of the procedures, there are several processes that are mandatory to be established in order to generate the required records that are outlined above.

These processes and procedures are not required to be documented; however, many companies choose to do so.

One rule of thumb when deciding if you want to document a process is this: if there is a chance that the process won’t be carried out as planned, then you should document it.

In many cases this is the best way to ensure that your Quality Management System is reliably implemented.

What is Apliso?

Apliso is the business portal designed to help in the application of the International Organisation for Standardization (ISO) solutions and standards for companies and organisations. We provide solutions and services to companies and organisations who have either implemented ISO based management systems and standards or are interested in implementing ISO standards and management systems. On the Apliso portal you will find links to tools that ensure compliance to the requirements of the ISO standards or contact with experts who can assist in the development and implementation of your management system according to the requirements of the applicable standard.

How Can Apliso Help Your Business?

Track Non-conformances

A key requirement of ISO Management systems is the logging, tracking, correction and prevention of Non-conformances or Non-compliance. Use the Apliso NC Management system to log all your non-conformances. Allocate resources to complete corrective actions, complete effective root cause analysis and execute effective preventative action.

Customer Complaint Mngt

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Business Improvements

How do you drive business improvement – easy you log any event, incident, or error that occurs. You allocate these events to the appropriate people to correct, and then apply effective root cause analysis and carefully planned preventative action to ensure no future event and drive improvement. Use detail analysis to monitor and measure improvements.

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Occupational health and safety requirements are such that any incident or near miss must be logged, corrected and effectively closed out. Appropriate controls should be put in place to prevent further occurrences of such events. Apliso Incident Management application allows you to comply to the requirements and effectively manage your Health and Safety requirements.

Management System Implementation

You have decided to implement or need more information on an ISO Management system (ISO 9001 Quality or ISO 14001 Environment Management or ISO 27001 Information Security Management plus more). You need assistance or advice on how to go about these requirements, what is involved, how long it will take etc. – Apliso provides this expert consulting service.