ISO 9001 Mandatory documents and records :
To be compliant with the standard, you will need to produce the following:
- Scope of the QMS (clause 4.3)
- Quality policy
- Quality objectives
- Criteria for the evaluation and selection of suppliers
Mandatory Records:
Monitoring and measuring equipment calibration records:
- Records of training, skills, experience and qualifications and proof.
- Product/service requirements review records.
- Record about design and development outputs review
- Records about design and development inputs
- Records of design and development controls
- Records of design and development outputs
- Design and development changes records
- Characteristics of product to be produced and service to be provided
- Records about customer property
- Production/service provision change control records
- Record of conformity of product/service with acceptance criteria
- Record of nonconforming outputs
- Monitoring and measurement results
- Internal audit program
- Results of internal audits
- Results of the management review
- Results of corrective actions
*Records marked with* are not mandatory when the relevant clause is excluded.
Non-mandatory documents:
The following Non-mandatory documents (procedures) can be used for ISO 9001 implementation and are sometimes regarded as necessary. You might find that an auditor request to see the documented information concerning these clauses. It also demonstrates that you do understand and apply the standard requirements in the specific sections.
The ISO 9001:2008 standard required six procedures, but ISO 9001:2015 does not have any required procedures. Every organization needs to determine which procedures are needed to implement the QMS scope successfully in order to avoid nonconformity in the processes.
Although ISO 9001:2015 cites no mandatory procedures in the requirements; however, organizations may need to include them to ensure that processes occur as planned, in which case the following comes in very handy:
- Procedure for determining context of the organization and interested parties clauses 4.1 and 4.2
- Procedure for addressing risks and opportunities
- Procedure for competence, training and awareness
- Procedure for equipment maintenance and measuring equipment
- Procedure for document and record control
- Sales procedure
- Procedure for design and development
- Procedure for production and service provision
- Warehousing procedure
- Procedure for management of nonconformities and corrective actions
- Procedure for monitoring customer satisfaction
- Procedure for internal audit
- Procedure for management review
Do you need a quality manual?
While a quality manual is not required by ISO 9001:2015, it is just so much easier to give your auditor a summary in short of what happens within the organization and how the Quality Management System is integrated and implemented within the processes of the organization.
Sometimes it is necessary to create a manual in response to a customer requirement, or the manual can serve to showcase the mandatory documents of the QMS – scope, quality policy, quality objectives, and supplier selection criteria – into one document, also containing explanations of how clauses of the standard is applied within the processes of the business.
Our document kit makes it very easy to establish and implement a DIY Quality Management System with our help.
