iTech has implemented a quality management system meeting the requirements of ISO 9001:2008. The purpose is to define the standard operating procedures (SOP) for the requirements of the iTech quality management system.
Scope
This document determines about the standard operating procedures for all the processes of iTech’s quality management systems that are inclusive of production and non-production processes. The document presents and determines the interaction and sequences of these processes. It describes the purpose and activity of each process and the corresponding input and output conditions. All the applicable sections of ISO 9001:2008 are identified per each of the processes. Key process indicator (KPI) is identified for each of process. The SOP itself is compliant with ISO 9001:2008 section 4.1, which states that an SOP document must describe the processes for QMS, their sequence, and interactions, determine their criteria and methods and availability of the resources. Monitoring, measuring and analysis of the processes along with the implementation of necessary actions against the planned results must be performed, and the processes must be continually improved.
Reference Documents
The following external documents must be referenced as part of this manual. For each of the document the latest edition must be applied.
Responsibilities
Management responsibility
iTech’s executive management team must ensure the development and implementation of the QMS and continually improved its effectiveness by following the regulatory requirements of iTech, establishing the quality policy, establishing the QMS objectives, conducting reviews on a regular basis and ensuring the availability of resources. The executive management is responsible for ensuring that the customer requirements are met with a customer focus and an aim of customer satisfaction.
Human Resource Responsibility
The personnel working for the human resources must determine and provide an effective environment for education, training and skill development of iTech staff. They must ensure that the required competence for working at iTech is achieved and that the staff can contribute to achieving the QMS objectives. The HR personnel working for iTech must be aware of the quality policy and maintain appropriate records of training, skill development and education.
Resource management
The resource management team of iTech develops required processes that ensure proper product development and a plan for product realization. This team must ensure that quality objectives for the products are met, relevant documents and processes are created and resources specific to the product are provided. It is a responsibility of resource management team to carry forward the product specific activities of monitoring, validating, inspecting, verifying and testing. All of these activities are essential criteria for product acceptance. The necessary records must be created, documented and stored as evidence for the realization of the processes.
The relevant processes are described in section 6.0 of this manual.
Definitions
Processes
Customer related processes
The requirement specified by a customer must be included as part of the requirements for delivery, Requirements that are not specified by the customer but are the necessary part for the use of product must be included as requirements for delivery. All the product requirement must be documented and defined. All the records that have been documented must be reviewed and in the case of nay change of requirements from the original documents the relevant personnel must be aware of the changes. The customer must be communicated and informed about the product information, all contracts, and product related documents including amendments. All the customer feedback including complaints must be effectively acknowledged, documented and acted upon.
Input
Customer requirements, feedback, complaints.
Output
Product or service delivery on time with quality and resolution of all customer highlighted issues.
Design and Development process
iTech as a defined product development roadmap that presents a phased approach for the product development. The various phases include design review, design verification, validation ad changes. For each of the phases, the relevant deliverables and timeframes must be acknowledged and performed. For each of the stages, there would be different groups involved including hardware, software, marketing, and operations. A seamless operation among all of these groups is necessary to ensure effective communication and a smooth product development.
Input
Design requirements including functional, non-functional, client and performance requirements.
Output
Design document with details of functionality and processes against each of the requirements.
Purchasing process
iTech ensures that all the purchased product conforms to specific purchase requirement including supplier details, product type and other relevant product minute details. The selected suppliers are evaluated based on their record and current ability to supply products according to the specifications. The purchase system defines the description of products and services, and that needs to be purchased based on appropriate approvals and defined processes. One of the quality requirements for the product is an ISO 9001 certification and compliance to all regulatory requirements. At the end, each of the products must be inspected and verified.
Input
Product purchase requirements, quality requirements, necessary approvals management and identification of suppliers.
Output
Product purchases instructions with all requirements to the identified suppliers.
Monitoring and measurement processes
iTech implements a monitoring and measurement processes to ensure the quality of the product, conformance and effectiveness of QMS, and customer satisfaction. As the part of the monitoring and measurement processes, an internal audit must be performed on a regular basis. The audit program must take into consideration all the processes and their respective scopes and objectives. The results of the audit must be documented and published. Selection of the auditors must be random, and auditors must not audit their work. The suppliers to iTech must be monitored for their product and service quality, and the evidence of the conformity must be documented and stored. The final product to customers must not proceed until all relevant QMS processes have been properly completed. The product release must be carried out by a relevant authority of iTech and if relevant by the customer.
Input
Product and process detail that needs to be monitored.
Output
Records and documents of the monitoring and measurement result.
Improvement process
iTech ensures a continuous improvement of its QMS, through the use of a quality policy, regular audits, review and analysis of data and relevant preventive and corrective actions. At each time, the focus of all activities is customer satisfaction and improvement of the quality of product and services of iTech. The improvement process establishes a procedure to review nonconformities including customer complaints and their causes. Relevant preventive and corrective action must be taken on the identified non-conformities.
Input
Audit results, analysis data and suggested preventive and corrective actions for the identified nonconformities.
Output
Evaluation of the data, requisite actions on the suggested corrective actions and a report on the actions taken.
Records
Records are the results of each process stage and document in a valid format for review by the concerned team for the process. The records must be maintained at each stage, and a failure to do so must result in a penalty or audit for the concerned team.
Input
Details of result for a particular process, the actions are taken SOP followed and effected changes.
Output
A detailed document on the results, current status, and future required actions.
SEQUENCE AND INTERACTIONS OF PROCESSES
Figure 1 shows a flowchart diagram that shows the process flow of all QMS SOPs and processes.
Figure 1: Flowchart diagram
REVISION HISTORY
