ISO 9001:2015, Quality Management System

ISO 9001:2015 is the quality management system standard which addresses the basic requirements for a quality system. It is equally applicable to manufacturing, servicing, inspection/testing and other sectors.

The latest version is ISO 9001:2015.: The theme of the standard is

  • Say what you do;
  • Do what you have said;
  • Write down, what you say and you do;
  • Prove it, improve it;

Cost of ISO 9001:2015, Quality Management System

Organizations are recognizing that an effective Quality Management System leads to reduced costs and greater operating margins. A well designed and implemented Quality Management System based on ISO 9001 has been shown to provide Organizations with the reduced costs, obtained through:

  • Improved all reliability
  • Better process control and flow
  • Better documentation of processes
  • Greater employee quality awareness
  • Reductions in all error and mistakes

ISO 9001:2015, Requirements of Quality Management System

The requirements can be divided into two areas:

  • General requirements (related to Organization)
  • Generic requirements (related to the Standard)

Mandatory documents and records required by ISO 9001:2015

Here are the documents you need to produce if you want to be compliant with ISO 9001:2015. (Please note that some of the documents will not be mandatory if the company does not perform relevant processes)

  • Scope of the QMS (clause 4.3)
  • Quality policy (clause 5.2)
  • Quality objectives (clause 6.2)
  • Process Flows Charts
  • Job Descriptions
  • Criteria for evaluation and selection of suppliers (clause 8.4.1)

And, here are the mandatory records (note that records marked with * are only mandatory in cases when the relevant clause is not excluded):

  • Monitoring and measuring equipment calibration records* (clause
  • Records of training, skills, experience and qualifications (clause 7.2)
  • Product/service requirements review records (clause
  • 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 10.1)