Quality Management System Understanding the Requirements into Plain English
Syed Noor Mustafa Shah
Understanding the Requirements of EN ISO 9001:2008 Following is general guidance which is attempted to translate the basics of EN ISO 9001:2008 into Plain English.
1 - Scope 1.1 General 1.2 Application
2 - Normative References 3 - Terms and Definitions 4 - Quality Management System 4.1 General Requirements Establish and document your Quality Management System Implement your Quality Management System Maintain and improve your Quality Management System 4.2 Documentation Requirements Develop Quality Management System documents including your Quality Policy and measurable Quality Objectives Prepare your Quality Manual, Procedures and Work Instructions to reflect what you do and how you do it Control your Quality management System documents Maintain Quality Management System records
5 - Management Responsibility 5.1 Management Commitment Demonstrate your commitment to quality Promote the importance of quality within your organisation Support the development of your Quality Management System Support the implementation of your Quality Management System Support the continual improvement of your Quality Management System
5.2 Customer Focus Enhance customer satisfaction by ensuring that you identify customer requirements Enhance customer satisfaction by ensuring that customer requirements are being met 5.3 Quality Policy Ensure that your organisation's Quality Policy serves its overall purpose. Ensure that your Quality Policy makes it clear that requirements must be met. Ensure that your Quality Policy makes a commitment to continually improve the effectiveness of your Quality Management System. Ensure that your Quality Policy supports your organisation's Quality Objectives. Ensure that your Quality Policy is communicated and discussed throughout your organisation. Ensure that your Quality Policy is periodically reviewed to make sure that it is still relevant to your organisation. 5.4 Planning 5.4.1 Establish and periodically review measurable Quality Objectives 5.4.2 Plan the establishment, documentation and implementation of your Quality Management System. Plan to ensure that you maintain and continually improve your Quality Management System 5.5 Responsibility, Authority and Communication 5.5.1 Define and communicate your organisation’s responsibilities and authorities 5.5.2 Appoint a Management Representative from the organisation’s management 5.5.3 Ensure that appropriate internal communications are established throughout your organisation 5.6 Management Review 5.6.1 Review the organisation’s Quality Management System at planned intervals 5.6.2 Examine management review inputs including records and data 5.6.3 Generate management review outputs including decisions, actions and improvements.
6 - Resource Management 6.1 Provision of Resources Identify and provide resources required to implement, maintain and continually improve your Quality Management System
Identify and provide resources required to enhance customer satisfaction by meeting customer requirements. 6.2 Human Resources 6.2.1 Employ and use competent personnel. 6.2.2 Regularly review employee competence. Provide and evaluate training and keep records of education, training, skills and experience. Promote employee awareness of quality within the organisation. 6.3 Infrastructure Identify, provide and maintain infrastructure needs such as buildings, work areas, equipment and transport. Infrastructure includes hardware, software, information systems and communications equipment. 6.4 Work Environment Identify and manage the work environment required to carry out your activities satisfactorily. Examples of conditions under which work is performed could include safety, hygiene, noise, vibration, temperature, humidity, light, air quality, weather, etc.
7 - Product Realisation 7.1 Planning of Product Realisation Plan, develop and record product realisation processes 7.2 Customer-related Processes 7.2.1 Identify customers' product requirements including delivery and post-delivery activities. Verify product statutory and regulatory requirements and any other additional requirements. Requirements could include warranties, maintenance, recycling, final disposal, etc. 7.2.2 Review your customers' product requirements, maintain records of product requirement reviews and control changes in customers’ product requirements. 7.2.3 Communicate with your customers. 7.3 Design and Development 7.3.1. Plan the design and development of your products. Control the design and development of your products. Update your planning outputs whenever product design and development progress makes this necessary. 7.3.2 Identify product design and development inputs. Maintain a record of design and development inputs. Review your product design and development inputs. 7.3.3 Produce product design and development outputs. Approve product design and development outputs before they are formally released. Verify that product design and development outputs meet design and development input requirements. 7.3.4 Perform systematic design and development reviews throughout the design and development process. Maintain a record of design and development reviews.
7.3.5 Carry out design and development verifications. Maintain a record of design and development verifications. 7.3.6 Perform design and development validations. Maintain a record of design and development validations. 7.3.7 Control design and development changes: a) b) c) d) e) f)
Identify changes in design and development. Record changes in design and development. Review changes in design and development. Verify changes in design and development. Validate changes in design and development. Approve changes in design and development before you implement these changes.
7.4 Purchasing 7.4.1 Establish criteria that you can use to control suppliers. Evaluate your suppliers' ability to supply products that meet your organisation's requirements. Select suppliers that are capable of supplying products that meet your organisation's specified requirements. Make sure that purchased products meet specified purchase requirements. 7.4.2 Describe your purchasing requirements. Ensure that purchasing requirements are adequately specified before you discuss them with suppliers. 7.4.3 Establish product verification or inspection methods in order to ensure that purchased products meet purchase requirements. Implement product verification or inspection methods in order to ensure that purchased products meet purchase requirements. 7.5 Production and Service Provision 7.5.1 Carry out production and/or service provision under controlled conditions. 7.5.2 Validate production and service provision processes whenever process outputs cannot be measured, monitored, or verified until after the product is in use or the service has been delivered (such a process is often referred to as a special process). Establish arrangements to control special processes. 7.5.3 Establish the unique identity of your organisation's products (if appropriate). Identify the monitoring and measurement status of your organisation's products. 7.5.4 Identify property supplied to you by customers. Verify property supplied to you by customers. Protect property supplied to you by customers. Safeguard property supplied to you by customers. This includes work carried out on sites on behalf of customers. 7.5.5 Make sure that your products and components continue to conform to requirements while they are being processed internally. Make sure that your products and components continue to conform to requirements while they are being delivered to the intended destination. 7.6 Control of Monitoring and Measuring Equipment Identify your organisation's monitoring and measuring needs and requirements. Select equipment that can meet your organisation's monitoring and measuring needs and requirements. Establish monitoring and measuring processes. Calibrate your monitoring and measuring equipment whenever necessary to ensure that results are
valid. Protect your monitoring and measuring equipment. Confirm that monitoring and measuring software is capable of doing the job you want it to do. Evaluate the validity of previous measurements whenever you discover that your measuring or monitoring equipment is out-of-calibration. Maintain calibration records.
8 - Measurement, Analysis and Improvement 8.1 General Identify the monitoring, measurement, and analytical processes that your organisation needs to have in order to be able to demonstrate conformity and make improvements. Plan how monitoring, measurement, and analytical processes will be used to demonstrate conformity and make improvements. Implement your organisation's monitoring, measurement, and analytical processes. 8.2 Monitoring and Measurement 8.2.1 Establish methods that you can use to monitor and measure customer satisfaction (perceptions). Monitor and measure customer satisfaction. 8.2.2 Establish an internal audit procedure. Carry out internal audits of your Quality Management System. Take action to address audit results. 8.2.3 Select suitable methods to monitor and measure the processes that make up your organisation's Quality Management System. Take appropriate action whenever your Quality Management System processes fail to achieve planned results. 8.2.4 Monitor your organisation's product characteristics. Measure your organisation's product characteristics. 8.3 Control of Nonconforming Product Establish and document a procedure to identify and control nonconforming products. Identify and control your nonconforming products. Re-verify nonconforming products that were corrected. Control nonconforming products after delivery or use. Maintain records of nonconforming products. 8.4 Analysis of Data Define quality management information needs. Collect Quality Management System performance data. Provide information to management by analysing data. Utilise findings to develop measurable Quality Objectives. 8.5 Improvement 8.5.1 Continually improve the effectiveness of your Quality Management System. Use information and data to improve the effectiveness of your Quality Management System. 8.5.2 Establish a corrective action procedure. Document your corrective action procedure. Implement your corrective action procedure. Maintain your corrective action procedure. 8.5.3 Establish a preventive action procedure. Document your preventive action procedure. Implement your preventive action procedure. Maintain your preventive action procedure.