8006808 Documenting Iso 90012008 Quality Management System

What is ISO 9001? The ISO 9001:2008 is an international standard published by the International Organization for Standardization (ISO). It was first published in 1987 and later revised in 1994 and 200. This year in 2008, it went through another revision in order to accommodate current needs. Hence, it is now referred to as ISO 9001:2008. ISO 9001 is a standard for the implementation of a quality management system (QMS). It provides a benchmarking for organizational performance in terms of product quality. In ISO 9001, the term "product" refers to both tangible and intangible products. It is applicable to all kinds of organization, whether public, private or non-governmental. It contains eight sections or clauses. They are • Clause 1 Scope • Clause 2 Normative reference • Clause 3 Terms and definitions • Clause 4 Quality management system • Clause 5 Management responsibility • Clause 6 Resource management • Clause 7 Product realization • Clause 8 Measurement, analysis and improvement The key to understanding the ISO 9001:2008 International Standard is to get the correct interpretation of the requirements. How do you do this? Firstly, you can attend a short course on understanding the ISO 9001:2008 organized by your local Certification Bodies such Lloyd's RQA, BVQI, SGS, etc. Secondly, you just read the standard many times over until you get the big picture of the ISO 9001 quality management system. A system is a set of inter-related and interacting processes. For example, in Clause 7.4 of ISO 9001:2008, your organization is required to establish, implement, maintain and continually improve the processes of selecting and approving your suppliers or vendors and evaluating their performance over time. The output of these processes shall ensure that all products supplied to your organization meet all quality requirements, which subsequently will have an impact on the end products. As you read the standard, do a mind-track of the other clauses that are interrelated and interacting with clause that you are reading. Another example: If you are reading Clause 8.2.2 on Internal Audit, the process requires that the internal auditors be competent before they can conduct any audits. This competency requirement is related and interacting with Clause 6.2 on Human Resources. This is how you go about understanding the ISO 9001:2008 standard. ISO 9001:2008 Documentation Requirements The ISO 9001 is not focused on documentation. It views documentation as a medium that supports your Quality Management System in terms of providing evidence of implementation and conformity to specified requirements. You must establish the following documents, and if you know and understand their functions you will see why: • documented statements of a quality policy and quality objectives, • a quality manual, • documented procedures required by this International Standard, o o

Control of documents Control of records

o o o o

Control of non-conformances Internal audit Corrective action Preventive action

• documents needed by the organization to ensure the effective planning, operation and control of its processes, and • records required by your quality management system and this International Standard. Manuals, procedures, work instructions and forms or formats are methods to control a process effectively. They promote uniformity and consistency in the way things are done. They also provide a basis for future reference. They can also be used as a training tool in terms bringing new employees up to speed of the organization's operations. Records are generated as a result of the implementation of processes. They may exist throughout the quality management system. Records management is a process of ensuring the proper creation, maintenance, use and disposal of records in order to achieve efficient, transparent and accountable management. A sound records management programme is advantageous because: • a well-organized indexing system enables an organization to find information easily. • the orderly and efficient flow of information enables the organization to perform its functions successfully and efficiently; • authoritative and reliable records are created and maintained in an accessible, intelligent and usable manner to support the business and accountability requirements of the organization; • efficiency and economy are ensured by eliminating unnecessary duplication of records; • a retention and disposal programme ensures that the organization maintains only those records it really needs for functional purposes; and • controls are exercised to ensure that only authorized persons have access to the information, thus preventing information and/or the records themselves from being stolen or damaged. This ensures the protection of privacy and confidentiality, and prevents the inappropriate disclosure of information that could harm the organization or infringe the privacy rights of individuals. Organizations can only be effective and efficient if records management is considered a business process designed to support business objectives, a resource and utilized effectively to achieve business objectives. The organization needs to create and maintain a culture which will promote effective and efficient records management to facilitate efficient and timely decision-making. ISO 9001:2008 Documentation Templates Developing necessary ISO 9001 documentation is a time consuming process in itself, but it is not out of reach for most managers. To do so, you must have a thorough understanding of the ISO 9001:2008 requirements and your organizational processes. Integrate the two and you'll have a good documentation system based on ISO 9001:2008 requirements. Although you may try to develop the documentation yourself, many managers opt to purchase readily-available ISO 9001:2008 Documentation Templates. It is a quicker and smarter way of establishing your documentation. But the biggest advantage of purchasing these ready-

documents is that they provide the ISO 9001 understanding in terms of implementation. The ISO 9001 standard tells you what to do, but the ISO 9001 templates tells you how it should be done. For example, within Clause 4 of the ISO 9001, the standard tells you that you all documents within the quality management system must be identified. This means you have to establish a unique numbering system for all your quality documents. Now, the ISO 9001 template on the Control of Documents readily defines this numbering process. See how it helps you in your ISO 9001:2008 project? Here, we have already prepared a set of ISO 9001:2008 Documentation Templates for you. You only need to customer certain sections of the templates. Customization should be a breeze as the documents have been designed to be universal in nature. Go through them and see if you need to make any minor modifications. But remember, these documents will help you understand how to implement the ISO 9001:2008 quality management system in your organization. Grab these documents templates for a low price of USD299.00 now! Credit card payments only, processed by PAYPAL, the premiere internet payment processor in the world. You will download these documents immediately after making the payment. PAYPAL will redirect you the download page. You will just need to right-click on the documents and save it to your local computer. Bonus: Free e-mail support for all purchases. Just send your e-mail to [email protected] and get prompt responses...guaranteed. Why you should purchase these documents? • They are probably the most cost-effective kind in the entire web • They are well-written in perfect English • They are complete and unambiguous in terms of its content • They are implementation-ready • They were made for you in mind • These documents are universal in nature and applicable to any nature of organizational operations • If you seek knowledge of ISO 9001, these documents will educate you by presenting to you a quality management system that is operable and actionable • These documents can be a source of reference for you to upgrade your QMS to the ISO 9001:2008 version • If you are a consultant, you can use these documents to assist you in your projects • If you are an educator, you can use these documents as your teaching materials This is the list of documents that you will get to download: Quality Policy Quality Management System Manual Six mandatory procedures * Control of documents * Control of records * Internal audit * Control of nonconforming product * Corrective action * Preventive action plus these forms and formats Quality Objectives Register Quality Objective Monitoring Form Document Control Form Document Distribution Form

Document Control Form Log Book Registry of Documents Registry of Records Employee Competency Record Training Request Form Training Programs Planner Product Quality Plan Supplier Selection Form Approved Suppliers Register Supplier Performance Evaluation Internal Audit Programme Audit Plan Audit Checklist Auditor’s Notes Audit Findings Report Corrective Action Request Registry of Nonconformities Nonconforming Product Form Data Analysis Register Meeting Minutes Work Instruction What you should do after you purchase the document? If you are planning to establish a quality management system, this is what you should do: • Read and thoroughly understand the QMS manual and related procedures and formats. • Brief top management on the requirements and benefits of the quality management system • Appoint your Management Representative • Appoint your Quality Representatives • Establish the QMS Committee • Define your Organization Chart • Include your employees' Job Descriptions into the QMS records to support the Organization Chart and fill out Employee Competency Record • Finalize the Quality Policy • Establish measurable quality objectives to every quality process in the quality management system • Implement the Control of Documents procedure • Implement the Control of Records procedure • Include your enterprise resource planning records into the QMS • Include your infrastructure planning and maintenance records into the QMS • Complete the Product Quality Plan • Finalize the Control of Nonconforming Product procedure as per your product requirements • Include your product realization records into the QMS • Complete the supplier-related formats • Fill out the Data Analysis Register • Conduct your QMS awareness programs for all employees • Conduct internal quality auditing training for your internal auditors • When you think you are ready, implement the QMS as per the QMS Manual specifications • After 3-6 months, implement the Internal Audit procedure • Implement the Corrective Action procedure • Implement the Preventive Action procedure

• Get the QMS Committee and the Quality Improvement Teams to conduct the Analysis of Data process and come up with improvement plans, if any • Conduct the management review of the QMS • Ensure the QMS Committee and the Quality Improvement Teams are actively participating in the QMS process and keep all meeting records.