Although ISO 9001 standard is known to have several procedures, not all of them are mandatory. The latest version of ISO 9001 only provides four mandatory documents, compared to the six mandatory procedures needed in the 2008 standard.
The latest version, revised in 2015, is much more flexible in terms of documentation requirements. Below, we’ll discuss the mandatory procedures for ISO 9001:2015, which your organisation must comply with to become certified. These procedures can be classified into two groups:
- Mandatory documents cover quality policies or objectives you develop that can be modified later.
- Mandatory records keep evidence of the results obtained. Records are not subject to revision since they are proof of a result or outcome of an activity.
ISO 9001 CERTIFICATION FROM BEST PRACTICE
Mandatory Documents for ISO 9001:2015
Mandatory documents are written procedures that enable an organisation to gather, organise, and store important information for a smooth business assessment. This information should be as diverse and simplified as possible to allow for easy use by all departments and external parties. These documents include:
- Scope of Quality Management System (QMS)
- Quality objectives
- Quality policy
- Procedure for the management of outsourced processes
Mandatory Records for ISO 9001:2015
Mandatory records are used to monitor and assess administrative documents and processes that have been developed or received by a company. The procedure involves protection, storage, identification, retrieval, and retention.
Control records help determine the efficiency of a QMS and its functions. These records must be accessible and are usually subject to regular review and audit. These mandatory records include:
- Records for design and development of inputs
- Records for design and development outputs
- Records of monitoring and measuring equipment
- Staff competency records
- Records of design and development control
- Procedure for evaluation and selection of supplies
- Customer property records
- Control of nonconforming outputs
- Design and development changes records
- Internal audit results
- Release of products and services
- Monitoring and measuring outcomes
- Identification and traceability records
- Results of the management review records
Internal Audit Procedures
Internal audit procedures are used to ensure that your organisation meets the requirements of the ISO standard. It helps obtain evidence and evaluate your company objectively to determine the extent to which the QMS conforms to the requirements and guidelines of the standard.
ISO 9001 internal audits provide an opportunity to identify non-conformities and areas of improvement to verify the efficacy of the preventive and corrective actions taken. In addition, these audits can help ensure your organisation meets its internal objectives and customer requirements.
Control of Nonconforming Outputs
As part of complying with ISO 9001 requirements, all nonconforming outputs should be recognised and amended. Nonconformity generally occurs when outputs fail to meet the standard’s quality requirements. This problem can be controlled by identifying the defect, documenting it, and recommending proper action to amend it.
Prevention And Corrective Actions
Prevention actions are activities taken to reduce or eliminate the risk of non-conformity. It suggests the most appropriate actions for a specific business risk, reducing the chances of occurring. Corrective action, on the other hand, is the process of establishing a remedy to ensure that any identified hazards are addressed promptly and effectively.
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These are some of the mandatory requirements you must observe to become ISO 9001 certified. At Best Practice Certification, we are equipped to help you get your ISO certification so you can conform to international standards. Get in touch with us today to get started.