Key Elements of Effective Quality Management Systems in Compliance with ISO 9001:2015
The development and implementation of quality management systems in compliance with the requirements of ISO 9001 has increased substantially amongst organisations over the years. The reasons for this are plentiful. ISO 9001 is an international standard aimed at helping organisations achieve quality objectives, improved business performance, consistency in quality, and increased customer satisfaction.
Though many organisations already have quality management systems in place, compliance with the requirements of ISO 9001 helps them to ensure that their current systems are on par with international requirements. Compliance furthermore helps to improve their current systems with the benefits of better supply chain management, and higher employee morale, accountability, training, and leadership involvement.
We take a look at some of the core elements of ISO 9001:2015-compliant quality management systems below to give you an indication of how compliance benefits organisations.
Without involvement from the executive management, the quality management system cannot be effective. As such, ISO 9001:2015 places particular emphasis on leadership involvement. The management team must ensure that every department and employee in the organisation have a thorough understanding of the quality goals and the system. The management team must also ensure full understanding of customer expectations, in addition to regulatory requirements, and the expectations of suppliers, partners, and all parties relevant or affected by the organisation’s quality management implementation. For this, the management team must undergo the necessary and relevant training, and must motivate and ensure provision of training for the employees according to their job roles and responsibilities, as relevant to the quality management system.
More Focus on Customer Satisfaction
The organisation’s quality management system must be geared towards meeting and exceeding customer expectations when it comes to the level of quality related to product and service delivery. As such, the organisation continually conducts in-depth research and analyses of the organisation’s needs and makes the necessary changes to ensure that the goals, especially quality goals, are achieved. In order to do so, the organisation must align its objectives with the market trends and ensure that this is communicated at all levels of the organisation. Part of this process entails the implementation of plans for measurement of customer satisfaction and using the information received to improve on the satisfaction levels.
If the employees are unaware of the requirements, do not understand the objectives of quality management systems, and are not involved in the development, implementation, and maintenance of the systems, they will lose interest and the systems will fail. ISO 9001:2015 thus places emphasis on the importance of communication to ensure that employees understand their roles. It also focuses on the importance of employee motivation, feedback, and provision for active employee participation in the quality plans of the organisation.
Decision-Making Based on Analysis and Evidence Evaluation
Decision-making should be based on evidence. As such, management is expected to analyse and evaluate information to guarantee correct decision-making. As part of the quality management system implementation, it is essential to have policies and procedures in place for observation, measurement, and auditing to ensure that quality standards are met.
ISO 9001:2015 requires the organisation to follow a process-based approach related to quality management systems. This includes the creation of documents, a set process for implementation, and documentation of compliance with the requirements of the standard. With this approach, it is necessary to define the organisation’s objectives regarding quality at the various process levels. In addition, all the business processes must be compliant.
Organisations do not operate in isolation. They have suppliers, business partners, and vendors. The organisation must share knowledge and values with the third parties and build relationships with them to ensure that quality standards are met and improvements are made where necessary. It is important to identify and select suppliers based on quality and to develop joint programmes for improvement, which can include training. It is furthermore important to have scorecards and other measurements in place for measurement of supplier performance.
Systematic Risk Management
Risk management forms an integral part of quality management systems. Indeed, it should form part of the organisation’s daily activities to ensure that the business processes deliver on customer satisfaction expectations. With the new standard, risk-based thinking forms an important part of quality management. With this approach, proactive steps can be taken to avoid quality problems and problems with non-compliance. Corrective actions can be taken to prevent repeat incidents of non-compliance.
In order to ensure successful risk management, the risks that will affect the organisation’s ability to reach its quality goals must be identified. It also means that action plans for addressing identified risks must be in place. The management processes must be properly defined and ongoing improvement must be facilitated to ensure that changes in the opportunities or risks can be effectively managed.
Management of Third Party Risks
To be effective, quality management systems should also include an approach for managing quality risks associated with usage of third parties. The organisations must have processes and controls in place for third parties, such as suppliers to facilitate ongoing monitoring of supplier performances in relation to quality. Audits, quality score systems, and inspections form part of the approach to ensure that quality risks in the supply chain are effectively managed.
Compliance with ISO 9001:2015 is not a one-off process. Instead, it is about ongoing improvement of processes to improve business performance and effectiveness. Consistency in quality is essential and as such, it is important to train employees to use the methods and various tools available to facilitate improvement. It is furthermore important to focus on the product, management system, and process improvement. This must be done on individual, business unit, and organisational levels.
How We Help
Transition from the old ISO 9001:2008 to the new version of 2015 can be done with our assistance. Where organisations have yet to comply with the standard, we assist with consultation, training, internal and external auditing, GAP analyses, certification preparation, maintenance after compliance, and integration of the compliant quality management system with the organisation’s existing management systems.