Quality Management Systems (QMS) are today extensively a part of an organization. If the TM (top management) is committed, it uses the ISO 9001 based management system to meet customer requirements, ensure customer focus and provide desired outputs. Where the TM/ leadership is immature, they often may implement a quality management system to get the ISO 9001 certification. This decision to have a QMS certification without effective implementation is a waste of money and resources. It is not worth the paper the certificate is on. Or perhaps it is, because having that ISO 9001 certificate may be the passport to win a contract or run a business.
Failed management systems (MS) invariably have a lack of management commitment or worse a leadership who do not understand the cost of not having quality. Such quality management systems are aligned to ISO 9001, but for easy auditing written to the clause structure of the standard. Such systems are written for auditors, who then audit it effortlessly as they can see the system written to the clause structure of the ISO 9001. Leaders forget that MSs should be designed for implementation by their employees.
Organizations do not work to clauses of the ISO 9001. They use the clauses to design a better MS. The organizational structure of any organization takes its direction from the policy (clause 5.2 of the ISO 9001). The policy leads the organization and its functional departments to convert the policy into measurable objectives (clause 6.2 of ISO 9001). These functional division of the organization work to achieve their objectives by functioning per their key and support processes. A quality management system based on ISO 9001 requires the system to work using a process-based management system approach. The idea is to be systematic about working so that customer requirements and expectations are analyzed before being accepted. Once accepted, the organization with the efficient interaction of its processes produces the desired outputs meeting the requirements and specifications as the case may be, and also ensures, where applicable that the statutory directions are met.
ISO 9001:2015 emphasizes customer focus not only in clause 5.1.2 but throughout the standard to ensure that the Quality Management System based on ISO 9001 appreciates the risks in the context of the organization and consistently produces confirming products and services. It is important that customer focus is maintained throughout, integrity of the quality management system always maintained and if for any reason a non-conforming product is produced then such non-conforming product or service is handled in a manner that the customer is never sent such a product.
For this reason QMSs based on ISO 9001 or for that matter any ISO standard, or an industry specific standard like AS 9100 or say a MS based on ISM Code (for maritime safety) and so on, should work using the accepted PDCA (Plan Do Check Act) cycle. Processes are designed, documented or undocumented to ensure that a good preparation is made at the Plan Stage. Any good QMS interprets the clauses of ISO 9001 for its QMS using clauses 4, 5, 6 & 7 to appreciate the risk and make a good plan before going to the do stage. The implementation of executing the inputs to convert them into desired outputs is done using ISO 9001 clauses under 8.
Any quality management system based on ISO 9001 has to sustain its processes delivering the final product or service by designing them well, resourcing them and monitoring them. Therefore, a strong objective check stage is required to conduct internal audits and to analyze data so that the information provides inputs for better resourcing. Clauses 9 and 10 of ISO 9001 address the check and act phases synonymous with monitoring and decision making by leadership before the next cycle of the PDCA cycle is implemented. The act stage is a vital stage associated with the leadership wherein a management review of the performance of the quality management system is conducted.
For the quality management system to deliver what ISO 9001 is designed around, is only possible if the leadership is genuinely committed to not just have a QMS based on ISO 9001, but uses it to make decisions. The business system and the QMS should be married in a strong unbreakable bond.