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14 Steps for Customer Complaint Management System based on ISO 10002
by Certification Consultancy
Posted: Jul 16, 2022
Posted: Jul 16, 2022
If an organization wants to obtain an ISO 10002 Certification based on Complaint Management System (CMS) requirements, it might not know where to begin and find it difficult. Here is a summary of the actions that must be implemented to achieve that nothing is missed during installation and certification preparations:Begin ISO 10002 Certification Project, Project plan, and resources – Finding the products or services that fall under the scope of ISO 10002 certification is the first step in the certification process. Includes the resources and development plan as well. Conduct ISO 10002 Awareness Training - It is important to have a fundamental understanding of ISO 10002. The ISO 10002 training covers every important element of the standard. Additionally, evidence of training records must be kept for exhibit during the ISO 10002 certification audit. Also, establish the ISO 10002 system implementation team and provide ISO 10002 system implementation training. Define context, scope, and Policy – Defining the context, scope, and policy of the CMS will help to confirm the limits of what needs to be done. Define RA & RT, Objectives, processes, and procedures – Risk assessment and risk treatment the support of ISO 10002 implementation. ISO 10002 Documents will include the mandatory actions defined by the ISO 10002 standard, but also any extra processes and procedures required by the company to ensure consistent and adequate results concerning CMS. Implement ISO 10002 processes and procedures – The processes will already be in place at the organization and will just require to be effectively documented to ensure consistent results. Conduct ISO 10002 Internal Auditor training – ISO 10002 standard requires the organization to train a team of internal auditors who would perform the audits regularly. Conduct ISO 10002 internal audits – Before the Lead Auditor for the certification visit sits to audit the system, ISO 10002 mandates that the organization audit each process internally. It will give the organization a chance to make sure that the processes are doing according to plan. Closure activities and Corrective Action reports – at this step where the organization finds the root cause of any problems found during the measurements, internal audits and management review, deviations from the established processes, and customer concerns and takes action to correct the root cause. Conduct ISO 10002 management reviews – Just as it is important that management supports the implementation of ISO 10002, it is also important that they are fully involved in the maintenance of the CMS. Pre-assessment / ISO 10002 Gap Analysis - This should be done by a Specialist Industry expert, the ISO 10002 Consultant also helps the organization in gap analysis, so that gaps identified during pre-assessment/ gap analysis are plugged before the organization Proceeds for Certification Audit. Choose a certification body – The certification body is the company that will ultimately come in to audit your CMS and decide if it is compliant with ISO 10002 requirements, as well as whether it is effective and improving. Operate & measure the CMS – This is when you will collect the records that will be required in audits to show that your processes meet the requirements set out for them, that they are effective, and that improvements are being made in your CMS as needed. ISO 10002 Certification audit- Stage 1 – Here, review your documentation by the certification body auditors to verify that, on paper, the organization has addressed all the requirements of the ISO 10002 standard. The auditors will issue a report outlining where it complies and where there are problems and have a chance to implement any corrective actions to address the problems. ISO 10002 Certification audit- Stage 2 – The certification body auditors will examine the documents gathered by using the CMS processes throughout this primary audit, including the records of internal audits, management reviews, and corrective actions. Also, they will publish a report outlining their findings and whether they considered the CMS to be efficient and in conformity with the ISO 10002 requirements after this assessment, which will take a few days. If everything goes well, the organization gets certification.
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Iso 13485:2016 Medical Devices Quality Management System
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