Eight common challenges companies face when implementing ISO9001 – don’t say you’ve never encountered them!

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Quality system management has become essential and fashionable in various industries, but few are able to actually utilize it to generate benefits and improve corporate management levels. Whether quality system management holds a prominent position within a company determines the fate of its survival and development. The article outlines some common issues in the quality system management process along with solutions, to be shared with all those working in quality management. In the comments section at the bottom of the article, let’s discuss matters related to quality systems together. For every employee working in a manufacturing company, the ISO9001 (GB/T19001) quality system is not unfamiliar, but there is still much that can be done in terms of quality system management. Whether quality system management holds a prominent position within a company determines the attitude the company adopts toward product quality, as well as the philosophy guiding its operations. Products of poor quality bring endless troubles, decline, and even bankruptcy to a company. Quality system management has become essential and fashionable in various industries, but few are able to actually utilize it to generate benefits and improve corporate management levels. Puzzles in implementing and maintaining the operation of the ISO9001 quality management system: 1. Among companies that possess a quality management system certification, 80% of their top management is only concerned with obtaining such certification; they show no interest in, understanding of, or commitment to improving the efficiency and effectiveness of the quality management system. In some cases, the quality management function is treated as a secondary department, which leads to resistance among leaders and employees toward following the standards set by the quality management system, resulting in people continuing to work as they see fit. Such long-term development inevitably leads to a situation of disconnection in corporate management, where the systems established do not match actual operations. Quality system management is carried out merely to obtain certifications and improve the company’s appearance, while the actual factory management remains on a \"despotic\" level – the management team simply does not give proper importance to quality control. 2. The quality system procedure documents, which are merely tools for self-protection within a company, represent a summary of quality management in the course of business operations and serve as regulatory guidance documents. However, such procedure documents cannot cover everything; it is only through proper quality awareness and mindset, along with an understanding of the causal relationships underlying various phenomena, that quality issues can be addressed during the management of production and operations. Through continuous summarization and refinement, procedure documents that can guide future actions can be developed. In many companies, the quality management system documents have essentially become weapons for various departments to use for self-protection within the company’s operational structure. The departments involved in discussing issues each hold their own views, relying on these documents as a basis for their arguments in order to shirk responsibility; this leads to severe internal conflicts, with decisions often difficult to reach and even harder to implement once made. In daily management, one first discusses the conditions before taking action, and bargaining takes place. They rush to do the things that are profitable and are reluctant to do those that aren’t, always able to use official regulations as an excuse to justify their actions. For matters that truly cannot be pushed through, one emphasizes objective factors, uses \"procedures\" as a buffer, or agrees to certain conditions before accepting. 3. The belief that the quality system can solve everything. Quality system documents outline basic procedural requirements; it is within this framework that we should use the eight management principles of the quality system to address product-related issues in a company’s operations, rather than using quality system management to blame everything that goes wrong in business operations. In fact, in the process of enterprise management, there is quality system management, human resources system management, financial system management, business decision-making management, and so on. Quality system management is merely the management of aspects related to product quality within the production and operation process. 4. The quality management system documents are used in a negative or even incorrect manner, treating quality system management merely as a means for supervisors to enforce orders through various audits such as centralized audits, special audits, monthly inspections, quarterly inspections, etc., which leaves all departments exhausted and deeply annoyed. The decline in quality management after certification is always linked to leaders’ one-sided understanding of quality. The company’s top management must pay close attention to understanding the quality system documents. Implementing ISO9001 requires mobilizing a large amount of resources from the enterprise, as well as new intangible resources. It is far too difficult to promote ISO9001 relying solely on the efforts at the grassroots level, as there is a lack of management authority and control over corporate resources. 5. Treating quality system management as a mere formality – the position of quality system manager is essentially vacant; tasks are only undertaken when leaders need to deal with quality incidents. Quality system management is viewed one-sidedly as the role of an incident investigator, or as a role focused solely on handling various detailed tasks. It fails to play any role in guiding the standardization of operations, as there is insufficient authority and adequate compensation for relevant positions; as a result, such systems do not receive due attention among employees. The measures and methods established for quality system management are not implemented, and employees continue to act according to the orders of their supervisors. 6. A leadership management philosophy that focuses only on results and not on the process is contrary to the basic principles of a quality management system; the \"process approach\" is violated as a result, leading to an unintentional failure to keep quality management records or follow relevant procedures when implementing the quality management system documents, and to the inclusion of fake data in order to provide evidence. As long as results are not seen immediately, the level of corporate management will inevitably decline over time. Given the long-term nature and continuity of quality management, factories must have a 5-year or 10-year plan that starts with fundamental tasks; through policy guidance and appropriate methods, quality concepts are implemented in the organization’s day-to-day operations, and regular inspections are carried out to ensure that employees adhere to the established behavioral standards. 7. Focusing only on the number of non-conformities in quality audits does not meet the increasing requirements of quality system certification. Non-conformities identified during audits should be viewed properly; it cannot be assumed that a high number of non-conformities or common issues indicate poor quality management. As a leader, I need to carefully consider what resources I have made available for quality management, and how to use the non-conformities identified during audits to continuously improve the management of the quality system. 8. Ineffective communication during audits: Whether it is second-party or third-party audits, it is common for the auditing agencies to be unable to communicate effectively during the audit process. Some of these agencies even act like \"emperors,\" believing that the factories being audited must comply fully with their \"unequal terms\" and are not allowed to raise any objections ； The managers of the factories under audit also approach the requirements for system management with the aim of not offending the auditors. In fact, the purpose of the audit is to identify what the problems and shortcomings in the factory are. Only through communication between both parties and a thorough understanding of these issues can true improvement be achieved. How to achieve effectiveness in quality system management: 1. Write down what is required, do what has been written, and record what has been done. ”The purpose of formulating quality system documents (quality manual, procedure documents) in accordance with these principles is to standardize employees’ work. Whether employees carry out their tasks in compliance with the requirements outlined in the procedure documents is one of the quantitative indicators used to assess effectiveness. Many certified companies share the same feeling: it’s easy to prepare the documents, but difficult to implement them. In fact, emphasize systematicness and practicality: “Write what is needed, do what is written, and record what has been done.” ”Using tables to manage quality records will yield excellent results. 2. Self-correction through rolling quality internal audits: Conducting quality internal audits thoroughly is an important aspect of quality system management. It is necessary to ensure that these audits cover every area and level within the company, thereby enabling self-correction. Practice has shown that even if a company obtains quality system certification, various problems still arise in the actual operation of that quality system. Without a mechanism for continuously identifying problems, solving them, and making improvements, various issues will arise that affect the operation of the quality system, gradually making it difficult for the system to function, eventually leading to its virtual disappearance. In general, internal audits, based on internal hierarchical structures, usually do not audit management levels, which is actually incorrect. Because the management’s attitude toward quality directly affects employees’ attitude toward quality work. 3. Pay attention to quality costs to satisfy customers. Quality costs are one of the quantitative indicators used to assess the level of quality management; one can imagine what the quality standards are like in companies that fail to achieve efficiency. A company’s quality efforts reflect the principles of quality management—the eight fundamental principles. With the philosophy of \"the customer is king,\" it is necessary to pay attention not only to the quality of the products provided to customers but also to maintaining good relationships with them. Customer satisfaction actually involves a great deal of communication and understanding. In the course of business operations, quality management should be based on the actual conditions of the company; it is not possible to fulfill all of the requirements put forward by customers. For those requirements that exceed the company’s capacity to meet them, solutions should be found through communication. 4. A tracking system is implemented for standardized workflow procedures. The quality of products and services is ensured through such standardized procedures; any defective items have their causes identified, and it is possible to pinpoint the responsible persons. Even without imposing penalties, merely exposing such issues can help raise awareness of quality. Recurring defects require focused follow-up and closure, with employees being educated based on facts through quality case studies and quality analysis meetings. 5. Management must always demonstrate a high level of wisdom regarding quality. Some employees, even those at the grassroots level, find it difficult to understand why simple tasks need to be broken down into so many steps, or why work instructions are necessary. Do we really not able to produce high-quality products without such things? Many people also often complain that if everything had to be done this way, we wouldn’t need to do anything at all. Once conflicts arise between the quality control department and the production department, business managers (the leadership) prefer that the products be of acceptable quality, focusing instead on production and sales. So, in many cases, a company’s quality system management is out of necessity. The story of Zhang Ruimin breaking the refrigerator reflects the great wisdom behind him, which helped turn Haier into an international corporation. But when it comes to product quality in reality, there are few cases of products causing problems; thus, it’s not hard to understand the situation faced by numerous companies. In summary, quality system management, as an important part of management in the manufacturing industry and across all organizations, requires continuous attention and authorization from senior management, ongoing improvement efforts on the part of quality professionals, and the involvement of the entire organization in the PDCA cyclical quality process. Only in this way can the quality work within an organization be truly improved, and its quality standards raised. Source: Internet