To attain ISO 9001 certification, seven ISO 9001 Clauses require a company or organization to submit documents and records reporting its internal processes, procedures and standards (or Quality Management System).
Contents
- What are the ISO 9001 Requirements?
- Mandatory Requirements — Documents and Records
- Non-Mandatory Requirements — But Often Included
- ISO Quality Management Systems (QMS)
- ISO 9001 Clauses
Seven Clauses Define The Requirements
All the ISO 9001 requirements are set out by ISO inseven clauses.
Mandatory requirements need to be complied with, while non-mandatory requirements may be submitted for documentation purposes.To be certified compliant with ISO 9001:2015, the following documents must be submitted.
ISO 9001 Mandatory Requirements — Documents and Records
- 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
- Results of corrective actions
Non-Mandatory Requirements — But Often Included
- Procedure for determining the context of the organization 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 nonconformities and corrective actions
- Procedure for monitoring customer satisfaction
- Procedure for internal audit
- Procedure for management review
What Are the Aims of ISO 9001?
ISO 9001:2015 aims to improve customer experience and satisfaction.
It also aims to improve a company's internal system to produce quality services and products while promoting a culture of growth and continuous improvement.
The ISO stipulates quality management principles, which, when complied with by certified companies, reassure clients that the company has established a tried and tested Quality Management System.
Simply put, ISO certification shows that your company can be trusted.
Who Is Responsible For Quality?
As stated in the ISO 9001 requirements, top management is responsible for the quality management system, while all employees are responsible for delivering quality to their aspects of work. Depending on the company culture, top management usually delegates tasks by appointing quality professionals to upper-level management teams.
A Quality Manager is often responsible for analyzing quality management system data and performance evaluation, monitoring and measuring the achievement of quality objectives and policies, undertaking internal audits and improving the quality of products and services.
