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ISO 9001 2015 certification standard is published in September 2015. Earlier version of ISO 9001 standard was 2008 version. Whole standard is revised on structure as well as intent wise. Many requirements are added in the ISO 9001 2015 version which was not included in the ISO 9001 2008 version. Some of ISO 9001 2015 version requirements are.
- Determining internal and external issues with respect which are key for organization to run its business as per Quality management system requirements.
- Determination of interested parties which are affecting Quality management system. Also determine what are requirements of these interested parties.
- Determine scope of quality management system. Organization may exclude clause of ISO 9001 2015 standard which is not applicable. However a well defined justification is needed to ensure that this exclusion will not affect organization’s ability to consistently provide product/service as per client requirements.
- Identify processes for quality management system. Define input, output, resources, responsibility and authority, risk and opportunities, performance indicators for these processes. Monitor processes for identified performance indicators. Implement corrective actions on non achieved indicators. Review and update performance indicators for better output.
- Top management shall take accountability of effectiveness of quality management system. Top management shall show leadership by following its responsibility as per designation and show an example to others. Top management shall ensure that quality policy, quality objectives, risks, processes are identified and implemented. Top management shall ensure that quality management system is delivering intended results.
- Top management shall ensure that focus on enhancing customer satisfaction is maintained.
- Top management shall ensure that all statutory requirements and customer requirements are determined, understood and are met.
- Quality policy shall be communicated understood, applied and available
- Roles and responsibilities with respect to Quality management system shall be communicated, understood and assigned. Responsibility for ensuring quality management system processes are delivering intended output, requirement of reporting performance of quality management system including opportunity of improvement, change management shall be assigned.
- Identification of Risk & Opportunities with respect to Quality management system. Identify potential non conformities , implement preventive actions and check effectiveness of these preventive actions.
- Define Quality objectives , prepare action plan for same. Monitor and evaluate quality objectives.
- Adopt an effective change management process
- Provide adequate resources for operation of quality management system processes and achievement of product requirements. Resources shall include peoples, infrastructure, environment, knowledge, monitoring and measuring resources.
- Determine competency level of persons doing work affecting QMS performance and effectiveness.. Take action for fulfilling competency gapes. Check effectiveness of these actions taken.
- Make employees aware of importance of their work and consequences if they do not follow their assigned procedure.
- implement effective communication mechanisms for internal and external communication to ensure faster and gape less communication.
- Control documents / Records of quality management system by giving identification, revision status, approval, controlled distribution, control of access, prevention of legibility, prevention of loss.
- Implement effective customer communication processes for getting inquiries, orders, complaints, feedbacks
- implement suitable contingency actions for business continuity
- Determine product requirements and ensure that organization can meet claim of products and services
- Review client requirements before committing supply to ensure that organization can meet client requirements.
- Do design and development planning, Design input review and approval, Design output review and approval, Design verification control, Design validation control, Design change control.
- Implement effective supplier selection, evaluation and reevaluation process for control of bought out material suppliers and service providers
- Implement verification/inspection/testing/auditing etc. activities to have an effective control on suppliers / service providers
- Provide suitable and complete purchasing information to suppliers to avoid any communication gape.
- Implement effective production and service provision activity including suitable equipments, instruments, work instruction, product testing criteria, process monitoring criteria, validation of processes and implementation of processes to reduce human interventions
- Provide identification of products / services through out organization with respect to monitoring and measuring status and traceability of records from customers to suppliers OR dispatched lot to receipt of material from supplier.
- Implement effective methods for handling customer and external providers property
- Implement effective methods for preservation of products including handling, storage, packaging, protection and identification, transportation and contamination control.
- Prepare a Quality plan / product release plan that includes inspection and testing stages , testing parameters, acceptance criteria and approval authority. Implement plan in routine. Take deviation approval when suitable including with customers as required.
- Control non conforming products and services to ensure their suitable disposal and unintended use.
- Identify monitoring and measuring indicators for each process, define method and frequency of monitoring and measurement, implement mechanism of evaluation of results for monitoring and measurement of performance and effectiveness of quality management system.
- Implement methods for getting customer feedback , customer perception, up to which level organization has fulfilled customer requirements.
- Do data analysis of process monitoring indicators and evaluation opportunities for improvements.
- Implement internal audit of quality management system to ensure its effectiveness. Select internal auditors. Prepare and distribute audit plan indicating auditing functions, date, time. Maintain record of internal audit results.
- Implement management review of quality management system to ensure its continuing suitability, adequacy and effectiveness of quality management system. Follow agenda points as per ISO 9001 2015 standard. Identify actions which improves products, processes, objectives, performance indicators of quality management system.
- Take corrective actions on product/process non conformities to prevent their reocurence. Integrate these actions in the quality management system processes.
- Bring continual improvement through data analysis and management review.
Above is an overview of quality management system requirements. This shall be taken as guideline for understanding Quality management system requirements.
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