Requirements to the Management System for Organizations - Case Study Example

Complying with ISO 9001 section 8 Name Institution Date Table of Contents Table of Contents 2 Complying with ISO 9001 section 8 3 Introduction 3 Monitoring, Measurement, Analysis and Improvement Processes 3 Customer Satisfaction 3 Internal Audit 5 Measurement and Monitoring Of Products and Processes 6 Control of Monitoring and Measuring Equipment 7 Control of Non Conforming Product 8 Analysis of data 9 Improvement 10 Continual Improvement 10 Corrective Action 12 Preventive Action 13 Conclusion 14 References 15 Complying with ISO 9001 section 8 Introduction ISO 9001 stipulates particular requirements for quality management system for organizations to hold on to. The requirements and procedures are outlined in clause 8 and they are meant to guide an organization towards achieving the desired results. The main concept in this clause is the monitoring, measuring, analysis and improvement activities. The purpose of carrying out these activities is to ensure that the products and services of the company are able to meet the required standards (Arumugam, 2008). This step ensures that the organization is able to meet the requirements of the quality management. The quality management requirements are also outlined in other clauses and it is dependant on the sector that the organization falls under. The steps are applicable for the purpose of continuously improving the quality of the products and services of the organization. Monitoring process is important during the operations of the organization and it ensures that the organization makes improvements on a continuous basis. However, it is imperative to note that an organization has to apply other methods in order to meet the requirements of this clause. These methods may involve the collection of data or using the statistical techniques to monitor the process of the organization. The paper extensively discusses the steps and procedures found in section eight of the ISO 9001 in relation to the accepted quality standards. Monitoring, Measurement, Analysis and Improvement Processes Customer Satisfaction Customer satisfaction is one of the main processes of monitoring, measurement and improvement. ISO 9001 identifies the customer satisfaction as a measure of performance by the organization. This is because it influences the operations of the organization. Good performance by the organization means that the customers are satisfied with the products and services of an organization. However when the performance of an organization is poor, the customers are usually not satisfied with the products and services of the company. In order to monitor and measure the customer satisfaction levels, ISO 9001 recommends that an organization should determine the methods to use during the process. Some of the most common methods used during the process includes; customer complaints, customer communication, customer surveys and return products from the customers (White, 2002). It is therefore important for an organization to determine the most appropriate methods to use while monitoring and measuring the levels of customer satisfaction. This is also important for the organization to make continuous improvements based on the customer feedback. It is for this reason that most of the organizations are developing a feedback mechanism from their customers so as to determine the measures to put in place for customer satisfaction. The organization should consider customer satisfaction as its main objective as compared to making profits. This objective will ensure tat the organization puts in place all the mechanisms that will lead to customer satisfaction. It is also important to note that the success of the organization depends on the rate of customer satisfaction. This is an advantage to the organization apart from it being a requirement for the ISO 9001. On the other hand, it is important to satisfy the customers by ensuring that the products of the organization does not cause any harm when consumed. The ISO 9001 is thus aimed at protecting the customers fro exploitation (Bamford, 2003). Internal Audit The internal audit is important during the monitoring and measurement process. This process is usually mandatory for an organization and must be carried out on a regular basis or s defined by the organization. Since the internal auditors cannot audit their work, it is important to compare the result with those of the external auditor or customer response. The internal audit process must also conform to the requirements of ISO 9001. The process should be effective and the high standards should be maintained during the auditing process. It is also important for the organization to identify the areas that needs to be audited and the results should always be compared wit the previous ones. This is important in terms of determining the progress being made by the organization. Improvements can also be done based on the results of the previous audit reports. The methods and criteria used by the organization during the audit process should also be clearly defined. This is for the purpose of determining the accuracy and the quality of the process. It is also recommended that auditors should be qualified and competent enough for the purpose of obtaining accurate results. Transparency is also important during the process and high ethical standards should be observed. The organization should also take the necessary action to ensure that there is no non conformity with the required rules and regulations. ISO 9001 forbids the organizations fro engaging in unethical practices during the internal audit. This is because some of the auditors may be influenced to work in favor of the organization. It is thus necessary for the organization to be transparent. This requires some mechanisms to be put in place by the organization in order to proof that the information of the internal auditors is correct. This is thus an important consideration for the organizations during the internal audit process. Any violation is unacceptable and may disqualify the organization (Biazzo, 2003). Measurement and Monitoring Of Products and Processes Monitoring and measurement of processes is also an important step towards achieving the customer satisfaction. ISO 9001 requires that an organization should be in a position of measuring and monitoring its processes. This should be done on a regular basis to ensue that the customers are satisfied. Incase the organization discovers that there is a problem in the process; it is advisable for it to make the necessary improvements immediately. The improvements should be in accordance with requirements. Monitoring of the process is also important as it ensures that the organization conforms to the required standards. It is also important to ensure that the guidelines are followed strictly during the monitoring process. The personnel involved with the monitoring process should also be well trained and competent enough. This is for the benefits of the organization as well as the customers. On the other hand, it is always important to keep records during the process. This may act as a guide for making future improvements in the company. This process should also be continuous and should not be stopped even if the requirements have been met. This is because it the desired results have to be maintained once it has been achieved and this requires monitoring and measurement. The measurement process is also important for the company as it gives the position of the company regarding the process. Various methods can be used for the purpose of measuring the performance of the organization. It is thus important to obtain accurate results during the measuring process as it determines the outcome of the whole process. Recommendations to the company should always be made after the measuring process has been concluded. The organizations that measure the performance of their products in the market are always innovative. This is because it enables the organization to modify its products for the purpose of customer satisfaction (Barreto, 2007). Control of Monitoring and Measuring Equipment The control of monitoring and measuring equipment is an important requirement for the ISO 9001. This process is for the purpose of ensuring that the monitoring and measuring process is not biased. Accurate results about the product can only be obtained by controlling the measurement and monitoring equipment. This means that the organization has to measure and monitor the products to ensure that they have met the required specification. The planning of the product realization is important during this process as it strives to ensure that the products meet the required standards. This process requires that the development of the product should be done in stages so as to ensure that it meets the required standards. The stages are important during the production and it enhances the process of monitoring. This process is quite critical for the organization as the product should meet all the specifications before being released to the market. It is important to ensure that any error is corrected before the products are sold in the market. It is also required that records must be kept concerning the products and its inspection. All the results of the monitoring process should be recorded for the purpose of determining the quality of the products. It is also important to ensure that the personnel who were responsible for the release of the products sign in the form. This is for the purpose of determining the measures to take against them if the products of poor quality are sold to the customers. The products that do not meet the standards specific in the planning product realization should not be released to the customers. This is for the purpose of ensuring that the customers receive only the good quality products. However, the product can only be released to the customers if they have been informed about the quality of the product. Their approval is required incase the product has to be released when it has not met the required standards (Gingele, 2003). Control of Non Conforming Product During the production process, some of the goods may fail to meet the required standards due to unintentional reasons. This may include errors by the machine or any other causes that may interfere with the quality of the products. According to ISO 9001, it is mandatory for the organization to identify the products that do not conform to the required standards. This is for the purpose of ensuring that the product does not end up in the market as it may cause arm to the customers. This may also result to legal implications which might affect the reputation of the organization. It is also required that the organization should establish a mechanism of dealing with non conforming products. The methods of identifying and dealing with the non conforming products should be established by the organization and strictly followed. Records should also be kept concerning the non conforming products. This is important for the purpose of making future improvements to the products. The records can also be used for the purpose of identifying the reasons for non conformity and hence establishing a solution to the problem. Some of the main methods that can be used during the process of identifying the non conforming products include; scraping the non conforming products. This ensures that the product is identified and should not be released to the market. The organization must also establish the necessary action that should be taken against the non conforming products. This may include re-working on the product or upgrading the product. This should be done so as to ensure that the products meet the specification. The products should be tested again after the modification has been done to ensure that it has met the correct specification. It is thus important for the organization to establish the best measures of dealing with the non conforming products (Hoyle, 2012). Analysis of data The analysis of the data is an important procedure in terms of determining the quality of the products and services of the company. The ISO 9001 requires the organizations to collect data on a regular basis for the purpose of testing the effectiveness and efficiency of the quality management system of the organization. This process should be carried out by qualified personnel and the results should be a true reflection of the quality of the products and services. Some of the main areas of data collection and analysis include the customer satisfaction. This data should be collected sing the most appropriate method of data collection. This is due to the availability of different methods which depends on the type of information required. The analysis of the data can also be done using different methods and techniques. It may involve the use of statistics or computer software. However, it is important to ensure that the results are accurate regardless of the analysis method used. Data of the conformity of the products should also be collected and analyzed. This data is different from the customer satisfaction data due to the nature of the requirements. However, the analysis methods are similar and it can be manual or the computers may be used. The characteristics of the products and their trends are also important during the process of analysis. This is useful in determining the trends of the products in the market and how it affects the customer satisfaction. It is also important to note that an organization cannot operate without supplies and it therefore requires the services of a supplier. Data concerning the suppliers should also be analyzed by the organization. This is important in determining the efficiency of the suppliers in terms of fulfilling their mandate. It is important to note that the quality of the services offered by a supplier has a direct impact on the operations of the company (Hinrichs, 2001). Improvement Continual Improvement Improvement is one of the most important considerations for an organization. Thos is for the purpose of ensuring that the quality of the goods and services are maintained after the desired objectives have been achieved. It is also important for the organization to continuously improve its quality management system for the benefits of the customers. To achieve this, various methods can be used by the organization. An organization should develop a quality policy that is important when guiding the organization towards the continual improvement of the products and services. The policies developed should be in line with the requirements of ISO 9001. This should be done based on the performance of the organization and the report about the customer satisfaction in relations to the products and services of the organization. It is also important for an organization to set out the quality objectives that will guide the organization during the process (Wu, et al, 2006). The quality objectives should act as a guide for the organization during the production process. Other objectives should also be put in place to ensure that the services of the company meet the required standards. Preventive and corrective actions should also be put in place by the organization for the purpose of ensuring that the processes of the company are improved. The continual improvement process is thus mandatory for the organization regardless of the achievements. This process is also beneficial to an organization as it ensures that only products that meet the required standards are produced. This process also determines the success of the customer satisfaction with regard to the goods and services of the company. Records should also be kept during this process for the purpose of future reference. During the continual improvements, it is important to compare the results so as to determine the success of the process. The improvements should be done depending on the rate of non conformity and the performance of the products of the organization (Jeong, 2003). Corrective Action ISO 9001 is very specific on the corrective measures and it requires the organizations to take action in order to correct the any non conformity of the products. The corrective measures are mandatory for an organization and should be carried out whenever there is a non conformity. It is thus important for the organization to use the most appropriate means for the purpose of correcting the non conformity. The individual customer complaints can be used as a basis for determining the corrective action. It is thus important for the organization to develop a mechanism to handle the complaints of the customers. A feedback mechanism from the customers should be developed by the organization. This will help the organization to determine the response of the customers regarding its products and services. It is also important for the organization to establish a customer care department that handles the complaints of the customers (Tricker, 2012). The information can then be used for the purpose of developing corrective measures. All the causes of non conformity should also be established for the purpose of making the corrections. The causes of non conformity of the products may vary with some being unintentional. The failure to establish the causes of the non conformity will lead to the problem being repeated from time to time. Establishing the cause is thus important as the corrective measure will enable the organization to solve the problem completely. In order to ensure that the on conformity does not occur again, it is important to ensure that the corrective actions taken by the organization are reviewed in order to determine their efficiencies. This is because some of the corrective measures may not yield full results and hence the persistence of the non conformity. Records of non conformity should also be kept so as to avoid future mistakes (Karapetrovic, et al, 2005). Preventive Action Preventive actions should also be taken by the organization to avoid non conformity. This is important during the improvement of the processes of the organization. The preventive action is mainly for the purpose of eliminating the potential cases of the non conformity. It is thus important for an organization to determine the causes of the potential non conformity for the purpose of preventing the future occurrence. The necessary action should then be taken for the purpose of eliminating the problem and hence improvement of the process. This requires proper planning and the use of the past records when dealing with the problem. The effectiveness of the past action taken is also important for the purpose of determining the actions that should be taken to prevent the potential problem. The past preventive actions are important to the organization for the purpose of developing the preventive actions that are not bound to fail (Tsim, 2002). The records of the results of past actions taken are also important should be kept at all times. Preventing the potential non conformity is important for an organization in terms of improving the quality as well as saving on costs. Preventing the non conformity is much better as opposed to dealing with the non conformity itself after it has occurred. An organization should thus present a record showing that it has put in place preventive actions within the organization. It is also important to ensure that the preventive action is tested before being put in place. This is for the purpose of avoiding failures that may compromise the whole process. The effectiveness of the preventive action is important in terms of determining the success of the organization. Incase a preventive action fails to produce the desired results, it is then important to ensure that it is changed (Schlickman, 2003). Conclusion In conclusion, it is evident that ISO 9001 concepts are for the purpose of ensuring that the customers receive good quality products and services. Customer satisfaction is also important for an organization and this forms the basis of ISO 9001. The effectiveness of the operations of the company and the quality of the products and services also requires auditing. It is evident that the internal auditing process plays an important role on determining the levels of conformity to the quality standards. However it is also important for the organization to maintain the transparency during the process. The measurement and monitoring of the processes and product of the organization is also important for the company. This determines the levels of conformity of the organization towards the laid out procedures and policies. Improvements should also be made on a continuous basis depending on the outcome pf the monitoring process. It is also evident that ISO 9001 requires organizations to develop a mechanism of dealing with non conforming products. This is important for the organization in terms of ensuring that the customers do not consume sub standard products. It is also evident that the analysis of the data is important in terms of establishing the position of the organization in terms of customer satisfaction. The preventive and corrective measures are also important for the purpose of improving the quality of the products and services of the organization. References Arumugam, V, 2008, TQM practices and quality management performance: An investigation of their relationship using data from ISO 9001: 2000 firms in Malaysia, The TQM Journal, 20(6), 636-650. Bamford, R, 2003, ISO 9001: 2000 for Software and Systems Providers: An Engineering Approach, CRC-Press. Biazzo, S, 2003, Process management practices and quality systems standards: risks and opportunities of the new ISO 9001 certification, Business Process Management Journal, 9(2), 149-169. Barreto, A, 2007, Applying ISO 9001: 2000, MPS. BR and CMMI to achieve software process maturity: BL informatica's pathway, In Software Engineering, 2007, ICSE 2007. 29th International Conference on (pp. 642-651). IEEE. Gingele, J, 2003, Incorporating links to ISO 9001 into manufacturing process models using IDEF 9000, International journal of production research, 41(13), 3091-3118. Hoyle, D, 2012, ISO 9000 Quality Systems Handbook-updated for the ISO 9001: 2008 standard, Routledge. Hinrichs, H, 2001, An ISO 9001: 2000 compliant quality management system for data integration in data warehouse systems, In International Workshop on Design and Management of Data Warehouses. Jeong, C, 2003, A high-quality-supplier selection model for supply chain management and ISO 9001 system, Production Planning & Control, 14(3), 225-232. Karapetrovic, S, et al, 2005, An empirical study of the benefits and costs of ISO 9001: 2000 compared to ISO 9001/2/3: 1994, Total Quality Management & Business Excellence, 16(1), 105-120. Schlickman, J, 2003, ISO 9001: 2000 Quality management system design, Artech House Publishers. Tsim, Y, 2002, An adaptation to ISO 9001:2000 for certified organisations, Managerial Auditing Journal 17 (5): 245. Tricker, R, 2012, ISO 9001: 2000 for small businesses, Routledge. Wu, C et al, 2006, A unified model for the implementation of both ISO 9001: 2000 and CMMI by ISO-certified organizations, Journal of Systems and Software, 79 (7), 954-961. White, B, 2002, The impact of ISO 15189 and ISO 9001 quality management systems on reducing errors, Vox sanguinis, 83, 17-20. . Read More