Documented Information for ISO 9001
ISO 9001: (2008):
Document requirements for the ISO9001:2015 version of this standardincludes not only mandatory documents, but also the most frequently used documents for the implementation of the Quality Management System. Some of the documents might not be mandatory if relevant processes are not performed by your company).
ISO 9001 mandatory documents
The four documents and 18 records listed below are the ISO 9001 mandatory documents required by the standard; however, each can be removed from the list if that clause is not included in the QMS scope of your company.
Exclusions normally occur when Design and Development is not a process integrated in the business day to day routine or, for instance when Validation of processes for Production and Service Provision clause (Clause 8.5.1f) are required by the standard, but validation automatically takes place through.
Collating all Management Systems documents
Collating all Management Systems documents and certified as conforming by an ISO certification body, is done with the purpose to streamline the company’s processes and procedures with continual improvement as a definite objective.
Compliance
To be compliant with the standard, you will need to produce the following:
ISO Mandatory documents:
- Scope of the QMS (clause 4.3)
- Quality policy (clause 5.2)
- Quality objectives (clause 6.2)
- Criteria for the evaluation and selection of suppliers (clause 8.4.1)
Mandatory Records:
- Monitoring and measuring equipment calibration records* clause 7.1.5.1
- Records of training, skills, experience and qualifications and proof clause 7.2
- Product/service requirements review records clause 8.2.3.2
- Record about design and development outputs review* clause 8.3.2
- Records about design and development inputs* clause 8.3.3
- Records of design and development controls* clause 8.3.4
- Records of design and development outputs* clause 8.3.5
- Design and development changes records* clause 8.3.6
- Characteristics of product to be produced and service to be provided clause 8.5.1
- Records about customer property clause 8.5.3
- Production/service provision change control records clause 8.5.6
- Record of conformity of product/service with acceptance criteria clause 8.6
- Record of nonconforming outputs clause 8.7.2
- Monitoring and measurement results clause 9.1.1
- Internal audit program clause 9.2
- Results of internal audits clause 9.2
- Results of the management review clause 9.3
- Results of corrective actions clause 10.2
Suggested Procedures:
- Procedure for determining context of the organization and interested parties clauses 4.1 and 4.2
- Procedure for addressing risks and opportunities clause 6.1
- Procedure for competence, training and awareness clauses 7.1.2, 7.2 and 7.3
- Procedure for equipment maintenance and measuring equipment clause 7.1.5
- Procedure for document and record control clause 7.5
- Sales procedure clause 8.2
- Procedure for design and development clause 8.3
- Procedure for production and service provision clause 8.5
- Warehousing procedure clause 8.5.4
- Procedure for management of nonconformities and corrective actions clauses 8.7 and 10.2
- Procedure for monitoring customer satisfaction clause 9.1.2
- Procedure for internal audit clause 9.2
- Procedure for management review clause 9.3
Non-mandatory documents
ISO 9001: (2008):
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:.
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 Systemis 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.
