An ISO9001 certified company seeking quality system certification should focus on two main aspects: first, establish and improve the quality assurance system; second, ensure all tasks directly related to the system certification are well-handled. In establishing the quality assurance system, one should start with the allocation of quality functions, draft the quality assurance manual and procedure documents, implement the manual and procedures, and ensure comprehensive quality records.
The output of the management review should include relevant decisions:
Continual suitability, adequacy, and effectiveness of the occupational health and safety management system in achieving expected results; opportunities for continuous improvement; any requirements for changes to the occupational health and safety management system; required resources; necessary measures; opportunities to integrate the occupational health and safety management system with other business processes; any conclusions related to the organization's strategic direction.
The role of ISO9001 procedure documents.
Maintain control over quality activities. Establish specifications for all activities affecting quality; - Define the methods and criteria for evaluating these activities to ensure they are under control.
Define the responsibilities, authorities, and interrelations of personnel related to quality activities: duties, powers, and relationships.
As the basis for executing, verifying, and evaluating quality activities. The provisions of the procedures are to be implemented in actual operations; evidence of the execution should be retained; and the actual operations should be reviewed against the requirements based on the procedures.
Quality is controlled by people, and people are bound to make mistakes of one kind or another. How to prevent or minimize mistakes, or to give you as few opportunities to make mistakes as possible, is the essence of the ISO 9000 series standards. Preventive measures are an important improvement activity, and they are spontaneous and proactive. It can be said that the ability of an organization to take preventive measures is a reflection of its management strength. Some organizations, after five or ten years of audits, have no records of preventive measures.
Of course, the ISO9000 series standards are customer-centric, as customers expect companies to have the ability to prevent issues from occurring. Therefore, this is a consideration factor for customers when selecting suppliers.
The standard requires organizations to establish a documented procedure for preventive measures. Many organizations combine this procedure with the corrective action procedure, especially small and medium-sized enterprises. This does not violate the standard requirements.
In the practice of ISO9001 certification audits, it's often found that many clients can self-disclose issues such as internal audits, assessments, inspections, returns and exchanges, and complaints. They have also taken some measures, but many of these are merely formalities, addressing the issue at hand and merely correcting the non-conformities. Subsequently, there are often recurring instances. For example, the surface oil污 issue with injection molded parts. Clause 8.5.2 of the ISO9001 standard clearly stipulates requirements for corrective actions. When problems are identified, not only should they be improved, but they should also be improved effectively. If resources are invested to solve a problem, it should be resolved thoroughly. To effectively resolve issues, it lies in eliminating the root causes of the problems.
Purpose of ISO 9001 Certification
As a criterion for evaluating the supplier's quality system prior to contract (in cases of second-party certification or registration). Before the contract is signed, customers often need to assess the supplier's quality system to determine their ability to meet the technical requirements of the ordered products. Prior to the evaluation, both parties should agree on which quality assurance standard to use, as well as any supplementary requirements necessary for the assessment (or certification).




































