When your business is “ISO 9001 Certified,” it means that your business has met the requirements in ISO 9001, which defines an ISO 9001 Quality Management System.
ISO 9001 evaluates whether your Quality Management System is appropriate and effective, while ensuring that you identify and implement improvements.
What is ISO 9001:2015?
Looking to find the latest ISO 9001 requirements? Well, they have changed considerably since the last version of ISO 9001. Creating, implementing and maintaining your Quality Management Systems (QMS) is an important documentary requirement for any company. It formalizes the procedures and policies that promote the quality of products and services that a company provides.
One way to do this is to follow the ISO standard and gain ISO 9001:2015 certification.
The international standard that is known as the ISO 9001:2015 gives a list of requirements for a system that determines that a company is able to provide international-quality products and services consistently.
It also aims to improve the internal system of a company so that it is able to produce quality services and products while promoting a culture that is aimed towards growth and continuous improvement.
What is a Quality Management System (QMS)?
A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization (i.e., areas that can impact the organization’s ability to meet customer requirements). ISO 9001 is an example of a Quality Management System.
What are the ISO 9001 Requirements?
The requirements of ISO 9001 are provided in QMS Standard in clause no 4 to Clause no 10. The key objective of ISO 9001 requirements is
- Enhancement of Customer Satisfaction by consistent supply of products and services which meets the customer requirement and applicable legal /regulatory requirement (if any).
- Continual improvement
- Enhancement of Process and products performance
- Adopting the Risk-Based Thinning
- Apply the QMS principles
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 — as such mandatory document’s requirement wording are not used in ISO 9001:2015 Standards.
The Classification on Mandatory or Non- Mandatory documents of ISO 9001:2015 can be depends on the activities of the organization and it applicability.
But as a general business organization, the some of documents given below are the minimum requirements for QMS are given below as reference.
- Quality Policy and objective
- Procedures of different process / function/ SOP
- Details of process, Functions, interactions of process
- Product process Characteristic
- Monitoring and Measurement Criteria of product / Process
- Risk Analysis record
- 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 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
- 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
To conclude, the ISO 9001 outlines a set of quality standards that must be actively followed and maintained by any certified organization in order to ensure that everything coming in and out of the business is in tip-top shape for distribution.
While becoming certified with ISO 9001 is not a legal requirement in order to run a company, it is highly recommended for the best possible business practices and results.