What is ISO 9001?

ISO 9001 is the international standard that specifies what is required for a quality management system (QMS). The standard is used by organisations worldwide to create, implement and maintain a system that allows for the consistent providing of products and services that meet customer and regulatory requirements.

The purpose of ISO 9001 and QMS documentation is to provide a clear framework that documents an organisation’s operations. It also allows for the consistency of processes, and provides evidence of the achievement of objectives and goals.

ISO 9001 certification will improve customer experience and satisfaction, whilst simultaneously enhancing the internal workings of the organisation and promoting a continuous quality improvement culture.

What is a quality management system?

A quality management system (QMS) refers to the policies, procedures and other records that guide an organisation in the delivery of its products and services, and is designed to set the standards of practice within an organisation.

An organisation’s QMS will illustrate its systems for the planning and execution of projects, and how these are designed to deliver maximal customer satisfaction. It is effectively an internal quality manual that explains how quality is maintained throughout the organisation in the performance of its operations.

ISO 9001 specifies what is required of an organisation to create and implement an effective QMS.

What are the benefits of ISO 9001?

ISO 9001 certification provides many benefits, both for the consumer and the organisation as a whole:

• Customer satisfaction is a priority for organisations certified against ISO 9001. The standard is designed to help organisations consistently produce products or services of a high quality that meet the needs of the market and their customers.
• It is a mark of quality. Certification against ISO 9001 demonstrates that an organisation has created, implemented and maintained quality standards across the board. Consequently, they can enjoy an enhanced company image and reputation.
• ISO 9001 promotes a culture of continuous quality improvement, and illustrates an emphasis on growth and the professional development of its employees.
• The collation of all QMS documents will lead to a greater integration and streamlining of internal policies and procedures.
• It often provides organisations with greater partnership opportunities. ISO 9001 certification is evidence of meeting international standards of practice, and consequently other organisations often use it as a requirement when assessing companies for potential partnerships.

What documents are required for ISO 9001?

As an internationally recognised and esteemed standard, ISO 9001 does have a specific documentation list. It should be noted that the ISO 9001:2015 Standard brought some significant changes from ISO 9001:2008. The ISO 9001:2015 requirements mean the following four areas must be properly accounted for:

1. scope of the organisation’s QMS
2. quality policy
3. quality objectives, and
4. criteria for the evaluation and selection of suppliers.

The full scope of the organisation’s quality management system must be described in detail, and every requirement of the standard in relation to the organisation must also be explained.

The quality policy involves a brief statement that defines the goals and objectives of the organisation. The organisation should ensure the documented information explains their commitment to meeting these, and how it can be done alongside their quality management system.

The quality objectives refer to the measurable steps planned to achieve the quality policy. Perfection may not always be possible, and consequently an organisation often has to be realistic and define an acceptable tolerance for mistakes/errors.

The criteria for the evaluation and selection of suppliers will detail the quality of the goods or services, the credibility and reliability of delivery, quantities, commitment to prices, and various parameters (such as the willingness to solve quality problems or the ability to train personnel).

ISO 9001 documentation can be a daunting prospect.

To help you along the way towards certification, we’ve come up with the following master list of documents for ISO 9001, which outlines both the mandatory and non-mandatory documents required for ISO 9001:2015.

Key documents for ISO 9001:2015

• Monitoring and measuring equipment calibration records
• Records of training, skills, experience and qualifications
• Product/service requirements review records
• Record about design and development outputs review
• Record 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 measurement results
• Internal audit program
• Results of internal audits
• Results of the management review, and
• Results of corrective actions.

Additional documents to consider for ISO 9001:2015

• Procedure for determining context of the organisation and interested parties
• Procedure for addressing risks and opportunities
• Procedure for competence, training and awareness
• Procedure of 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 non-conformities and corrective actions
• Procedure for monitoring customer satisfaction
• Procedure for internal audit, and
• Procedure for management review.