ISO 9000:2008 or ISO 9000:2015

• The organization should be aware of its mission and vision and should know its strengths and weaknesses, internal and external, which have influence on achieving its vision (objectives).
• The external issues could be related to technology, competition, market, social and economic environment, and legal restrictions.
• The organization shall continually improve the QMS to improve its suitability, adequacy, and effectiveness using the results of analysis and evaluation from internal audits, process performance measures, customer satisfaction measures, and other similar measures of performance.
• The organization shall retain record on the nature of the nonconformities, actions taken, and the results of the corrective action.
• The internal issues could be related to capacity and capabilities of the processes in the organization.
• The term “interested parties” includes the customers, supplies, investors, employees, the community where the organization is located, and the whole society where the organization’s products are used.
• The organization should learn what the requirements of the stakeholders are, requirements that are expected to be delivered by the quality system.
• The organization should determine the scope of the QMS and make it a part of the record defining the products covered and the boundaries and applicability of this International Standard.
• The scope should be determined, taking into account the requirements of the interested parties, the external and internal issues mentioned above relating to the organization, and the products the organization is capable of delivering.
• The organization shall apply all the requirements of the International Standard if they are applicable within the scope envisaged.
• In case any of the requirements of the standard is determined not applicable, such determination should be made part of the record.
• Such exclusions are admissible only if they do not affect the organization’s ability or responsibility to deliver to the customer products that conform to their requirements and enhance their satisfaction.
• A requirement where the standard stipulates that the organization shall establish, implement, maintain, and continually improve a QMS in accordance with this International Standard.
• The standard goes into details of how to establish the system, such as determining the processes needed for the system, providing inputs, determining the sequence and interaction of the processes, assigning responsibilities, ensuring their effectiveness by measuring their performance using proper measurements, and monitoring and controlling them.
• The organization should continuously monitor the performance of the processes and implement changes where needed.
• The organization should maintain recorded data to support operation of these processes as well as to record that the processes performed as planned.
• The top management shall demonstrate leadership and commitment to the QMS by taking accountability for effective performance of the system, formulating quality policy and objectives compatible within the context of the organization and its vision, and integrating the quality management requirements into the organization’s business processes.
• While planning a QMS taking into account the needs of its interested parties and its own strengths and weaknesses, the organization shall consider the risks and opportunities that need to be addressed to assure that the QMS achieves its intended results, enhance desired effects, prevent or minimize undesired effects, and achieve improvement.
• If there is need to make changes to the QMS, it shall be done in a planned manner considering the purpose of the changes and their potential consequences and availability of resources, so that the integrity of the QMS remains intact and responsibilities and authorities are properly reallocated.
• The organization shall make sure that the people working in the organization are aware of the quality policy, relevant quality objectives, the individual’s contribution to the effectiveness of the system, and the possible results arising out of non-conformance to the system requirements.
• The top management shall ensure that responsibilities and authorities for the relevant roles in the QMS are assigned, communicated, and understood within the organization, for making sure that the QMS conforms to the International Standard, for ensuring that the processes are delivering intended results, for measuring and reporting performance of the QMS to top management including opportunities for improvement, and for ensuring integrity of the system during the times when changes to the system are planned and implemented.
• The organization shall establish quality objectives at relevant functions, levels, and processes as needed for the QMS.
• The top leadership shall ensure that risk opportunities that can affect conformity to meeting customer needs are recognized and addressed.
• The top management shall establish, implement, and maintain the quality policy in accordance with their needs.
• The quality policy shall be maintained as a record and be communicated, understood, and applied.
• The planning for quality objectives shall include information on what will be done, using what resources, by whom, when and how the objectives will be evaluated.
• The persons should have appropriate education, training, or experience to have acquired the competencies.
• Records should be kept as evidence of the persons having the competencies.
• The top leadership shall demonstrate leadership and commitment with respect to customer focus by ensuring that customer and relevant statutory and regulatory requirements are understood and met consistently.
• The organization shall determine competence of persons operating the system and make sure they have the necessary competencies to manage the system perform effectively.
• These objectives shall be monitored, communicated, and updated as appropriate.
• The objectives will be measurable, relevant to meeting customer requirements, and to enhance customer satisfaction.
• The focus on enhancing customer satisfaction shall be maintained by the top leadership.
• The organization shall have arrangements at appropriate stages to verify that the product meets the requirements.
• The top management should promote process approach and risk-based thinking, ensure resources are available, emphasize the importance of adhering to QMS requirements, and make sure the QMS achieves its intended results.
• Organization shall use suitable means to identify outputs when traceability is needed, shall identify status of outputs with respect to measurement requirements throughout the production process, shall control the unique identification of the outputs, and shall retain record to enable traceability.
• Organization shall evaluate the performance and effectiveness of the QMS and keep appropriate documentation of the outcomes.
• The organization shall Identify and select opportunities for improvement and make changes to meet customer requirements and enhance customer satisfaction.
• The organization shall retain record of the release of products, which will include evidence of conformity to accepted criteria and traceability to persons authorizing the release.
• The organization shall meet the requirements of post-delivery activities associated with the products including statutory and regulatory requirements, potential undesired consequences associated with the product, and customer needs.