ISO 9001 Management Training

1. ISO 9001 Management Training Nomad Aviation ISO 9001 Training for Management -Rev. A

2. ISO 9001 System Requirements ISO 9001 Training for Management -Rev. A

3. 4.1 General Requirements • Identify the processes needed for the Business / Quality System and their application throughout the Organization. • Determine the interaction of the processes. • Determine the criteria and methods needed for effective operation and control of the processes. • Ensure availability of adequate resources to support the operation of the processes. • Monitor, measure and analyze the processes. • Implement the actions necessary to achieve planned results and continual improvement of the processes. • When any process that affects product conformity is outsourced the Organization shall ensure control over the Supplier's process. ISO 9001 Training for Management -Rev. A

4. ISO 9001 Quality System 4.2      ISO 9001 quality system documentation requirements:    Quality policy and quality objectives A quality manual The procedures specified by ISO9001   Other documents required for effective planning, operation and control    The records specified by ISO9001 There is an urban myth that procedures must spell out everything in minute detail.  This is a hangover from the Defense standards and has NEVER been a requirement of ISO 9001.  To paraphrase 4.2.1 Note 2 –> are we doing simple or complex tasks ? Are we a large or small company ? Do you consider that staff are competent? The answers to these questions will influence the amount of documentation required. The modern way of documenting a quality system is to have lightweight procedures balanced by heavy training records, which demonstrate competence. Also, think about having process map or flow-charts instead of text. You can draw adequate process maps using Word ‘s auto-shapes. ISO 9001 Training for Management -Rev. A

5. ISO 9001 required procedures • Document Control – How do we approve, amend, identify, make available, control external and obsolete documents. • Control of Records – Who maintains and retains them and for how long. • Internal Audits • Control of Nonconforming Product • Corrective Action • Preventive Action Note: Procedures may be in text or process map (flow chart) format. ISO 9001 Training for Management -Rev. A

6. Nomad's Quality Policy • Nomad Aviation, Inc. is committed to exceeding our customer’s requirements and expectations by providing the highest quality products and services in the aviation industry. • Our organization strives to continually improve its processes to provide maximum value for our customers to ensure the highest level of satisfaction. ISO 9001 Training for Management -Rev. A

7. Nomad's Objectives Quality / Business Objectives (2008-2009) 1- Develop an ISO 9001 Quality System to improve the business and secure future contracts. 2- Increase Sales by 50%. 3- Maintain 100% on time delivery. 4- Improve T-44 first time pass yield to 3 or less customer test flights. 5- Meet the 38 day turn around cycle on the T-44 modifications. 6- Complete Navair Installation and Fabrication quality audits without any findings, minor or major. 7- Pass all FAA Repair Station and PMA Quality Audits. ISO 9001 Training for Management -Rev. A

8. Management Responsibility 5.0 • Top Management shall demonstrate commitment to develop and implement a quality (business) management system and continually improve its effectiveness. • Top Management shall communicate to everyone in the Organization the importance of meeting customer as well as statutory and regulatory requirements by establishing the quality policy and quality objectives, conducting management reviews and ensuring the availability of resources. • Top Management shall ensure that the responsibilities and authorities are defined and communicated within the Organization including the appointment of a Management Representative (MR). The MR is responsible for ensuring that the System's processes are established, implemented, maintained and reporting to Top Management about the performance of the System and any need for improvement as well as promoting customer requirements throughout the Organization. • Top Management shall review the Quality Management system periodically and document the required inputs and outputs. ISO 9001 Training for Management -Rev. A

9. ISO 9001 Quality (Business) Objectives 5.4.1 How to Profit from Quality: • ISO 9001 does not specify how quality objectives are documented: they may be documented in business plans, management review output, annual budgets, etc. However, your quality objectives must be defined; they must reflect the quality policy, be coherent, and align with the overall business objectives, including customer expectations. In short, ISO 9001 quality objectives must have a meaningful result. Quality objectives = company objectives. • Example quality objectives: improve on-time delivery by X%, reduce scrap levels by Y%, increase pass-first-time levels by Z%, etc. • ISO 9001 Data Analysis (8.4) requires that performance be analysed; such things as supplier performance, customer satisfaction and internal performance.  Where analysis shows poor performance, this data should be used to set quality objectives, which need to be communicated (6.2.2 and 5.5.3). • Quality objectives are not static and need to be updated in view of the business climate and other continual improvement activities. So don’t be hesitant about revising quality objectives. The achievement (or even partial achievement) of objectives demonstrates continual improvement. Remember - there is a clear link between the dynamic aspect of revising the quality objectives and the commitment of the organization to continual improvement.
  ISO 9001 Training for Management -Rev. A

10. ISO 9001 – Resource Management Training, awareness, competence - 6.2      6.2.1    General ISO 9001:2000 requires that personnel performing work affecting product quality must be competent, based on their education, training, skills and previous experience. Competent = personnel are able to perform their tasks with minimum of supervision. 6.2.2    Competence, awareness & training   a- Decide the necessary skills and competencies   b- Provide training    c- Evaluate the effectiveness of the training. Staff are trained to improve their performance.  Personnel must also be aware of the relevance of their activities to the performance of the system. Comparing existing performance to post-training performance is a simple way of assessing training effectiveness. A common training template is to grade performance in terms of: "Shown" - the person has received instruction, 
 "Competent" - the person performs satisfactorily, 
 "Able" - extremely competent and able to train others. d- Maintain training records ISO 9001 Training for Management -Rev. A

11. ISO 9001 Product Realization Planning 7.1 
    
The product and service provision planning process defines the following controls, as appropriate to the product. This plan is sometimes called a quality plan.   • The quality objectives and regulations    • The necessary processes, documents and resources •     The required checks and criteria for product acceptance •     The records needed • The resulting plan may be project-specific or more general documentation. • Planning also leads into the following areas of product realization (doing the job)    • Customer related processes    • Design  • Purchasing • Process control • Calibration • Some exclusions are permitted but the exclusions are limited to the Product Realization requirements (ISO 9001:2000 Section 7). Exclusions are only permitted where an element of Section 7 is genuinely not relevant to the company. ISO 9001 Training for Management -Rev. A

12. ISO 9001 Customer Related Process 7.2 
    The objective of an ISO 9001 QMS is to keep the customer happy. These requirements apply at all stages of the sales process, eg. inquiry & quotation, order receipt, order processing, order amendment. At each stage, the key questions are, "Do we really understand what the customer wants ? Are we able to do the job on time and in full? Has the customer changed their requirements ?" Such key questions should be the basic sales objectives in any business. We publish our quality objectives as part of our sales and customer feedback system. Customer related processes also link to Design, Purchasing, and Process Control. ISO 9001 Training for Management -Rev. A

13. ISO 9001 Design & Development 7.3 •  7.3.1    Planning. Who is going to do it ? How and when will they communicate with each other ?    • 7.3.2    Input. At the start of the design process we have some design brief or outline specification. Customer requirements - In addition to the technical aspects of the product supplied by the customer the Organization uses its quality/business objectives to complete the design input. • 7.3.3   Output - The final drawing or specification should meet the input requirements.  The output would normally be used as basis for Purchasing and Process control.   • 7.3.4    Review - At key stages of the design relevant people should review the design to ensure that the inputs are met and to identify and resolve any technical problems.  •   7.3.5   Verification - Basic concept "Does it work on paper ?”.   • 7.3.6    Validation - Basic concept "Does it work in reality ?” •   7.3.7   Changes. Consider the impact of proposed changes, especially in terms of "backwards compatibility."  ISO 9001 Training for Management -Rev. A

14. Purchasing and Supplier Management 7.4 • The Organization (Nomad) shall evaluate and select its Suppliers based on their ability to supply product in accordance with the Organization's and its customer's requirements. • The purchasing information must include; Requirements for product approval, procedures, processes, equipment, personnel qualification and Quality management system. • Purchased product must be inspected upon receipt to ensure its conformance to the purchase order requirements. ISO 9001 Training for Management -Rev. A

15. Production and Service Provision 7.5Control of monitoring and measuring devices 7.6 • The Organization plans and controls its processes through product specifications, work instructions, suitable equipment, monitoring / measuring and product release, delivery and post delivery activities. • Special processes that can't be verified by subsequent measurement are validated by review and approval prior to acceptance of the process. • The product status shall be identified throughout the production process. • Where traceability is required unique identification and records are retained. • Customer property (including intellectual property) is identified, verified, protected from damage and safeguarded from tampering. • Damage or loss must be reported to the customer. • Product must be preserved to prevent deterioration. • Calibrated equipment must be identified, safeguarded from readjustment and recalibrated as necessary. When any calibrated equipment is found to be nonconforming the validity of previous product measured with it is assessed. • Calibration records must be maintained. ISO 9001 Training for Management -Rev. A

16. ISO 9001 Measurement, Analysis and Improvement 8.0Customer Satisfaction 8.2.1 The Organization plans and implements monitoring, measurement, analysis and improvement processes to demonstrate conformity of the product and the quality management system and to improve it effectiveness. The effectiveness of the QMS must be communicated to all employees (internal customers/suppliers). Example messages: Are we achieving Quality objectives 5.4.1? What's happening with external Customer satisfaction? Example methods;    team-briefing;    notice-board;    intranet;    company newsletter;   employee surveys; suggestion schemes    ISO 9001:2000 requires that external customer satisfaction is monitored but does not specify methods. Consider using measures like these; Do we deliver on time ? Do we deliver in full ? What feedback do we get from sales reps and service engineers ? Are the key accounts growing ? Customer audits or monitoring ? If favorable, use them as evidence but direct feedback from the customer is always best. If things are "on the slide" the offenders should become Quality objectives 5.4.1 ISO 9001 Training for Management -Rev. A

17. Training verification • Please complete the following test to evaluate the effectiveness of this ISO 9001 overview. Include your name and title on the last page. Print the 3 test pages and return to Edgar Rodriguez . Save a copy of this course to your computer's desktop for reference. Thanks for your cooperation! ISO 9001 Training for Management -Rev. A