Iso 9000 documentation


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Iso 9000 documentation

  1. 1. Iso 9000 documentationSuccessfully implementing an ISO 9001 Quality Management System depends ondeveloping a clear understanding of seven aspects of the program, including:1. The purpose of a quality management systemThe principles of quality management are:Quality is achieved through conformance to defined specifications in terms ofperformance, price, and delivery and is not just limited to how a product or service looksor performs.Customer satisfaction is achieved by understanding the customer requirements and usingmethods to ensure that these requirements are consistently met.Controlling and improving processes are achieved through the use of documentedpolicies, procedures, and continual improvement activities.The ISO 9001 Quality Management System is a business system designed to make iteasier for companies to comply with these principles.The system establishes both the rules for identifying the customer requirements and thepolicies and procedures for providing organizations with the means for deliveringproducts and services that comply with these requirements. It also creates a means forensuring consistency, stability, and the continual improvement of the processes used inrunning a business. Its based on documentation and demands effective informationmanagement, operational discipline, and accountability.The ISO 9001 Quality Management System was developed and is managed by aninternationally recognized organization. The system was originally implemented in 1987,subsequently revised in 2000, and is currently used in over 130 different countries byover 350,000 companies.2. The benefits of a systemAn ISO9001 Quality Management System has the potential of providing severalsignificant benefits, including:Improved Profitability - Profit improvement results from more productive employees,better organization, better suppliers, better infrastructure, and systematic continualimprovement programs.
  2. 2. Employees are more productive because the system establishes standards for hiring andtraining, requires employee involvement, and demands accountability.Documented procedures create better organization, which promotes consistency andreduces the number of mistakes.Qualification criteria, auditing procedures, and the use of performance measurementsimproves supplier performance.Controls and policies placed on the management of the infrastructure including thebuildings, machinery, tooling, software and hardware, and the general working conditionsresult in more reliable and better working conditions.Corrective and preventive action programs and other continual improvement processesprovide a mechanism for preventing problems from reoccurring, finding and fixingproblems before they occur, and developing new and better ways of doing things.If effectively implemented a quality management system can eliminate duplication andprocess variability, lower cycle times and inventories, and reduce both in-house and fieldfailures.Improved Customer Satisfaction - Customers benefit because:Policies and procedures for managing process information, measuring instruments, andthe verification and validation requirements result in better products.Procedural changes and improvements in supplier performance result in better deliveries.Changes in the way customer communication and product development are managedresult in better customer relations.Increased Sales - ISO 9001 certification is an internationally recognized accomplishment.Its a bragging right but more importantly its a promotional opportunity. It opens doors toprospects that treat certification as a tipping point or a supplier requirement, and its ameans of letting your customers know that you comply with a set of internationallyrecognized management standards.Improved Job Satisfaction - Job satisfaction improves because:The system includes change processes that provide all employees with an opportunity tomake a difference in how a company is managed.Theres comfort in knowing what youre responsible for doing, andTheres security in knowing that the system creates a more competitive position.
  3. 3. The instructions bridge interrelated responsibilities, which eliminates confusion andreduces conflict.The key word to remember is "potential." The benefits dont come automatically andwont happen without a genuine commitment starting at the top, a system that is wellcomposed and managed, and a long-term commitment.3. The components of the implementation processThe three components of the implementation process are: 1) documentation, 2)information management, and 3) operational changes.Documentation - On the surface it may seem that developing the ISO 9000documentation shouldnt be that difficult. You must have a manual that includes a policy,objectives, scope, and the interaction of the processes; and you must have writteninstructions for:1. Managing the quality system documents2. Managing the quality system records3. Conducting internal audits4. Controlling nonconforming product5. Implementing corrective action6. Implementing preventive actionThe standard also hints at the need for additional instructions, e. g. referring to the workinstructions, section 7.1 states "shall determine the following, as appropriate," buttechnically, aside from the manual and these six instructions, anything more is optional.The reality, however, is that in order to get the most out of a quality management systema great deal of additional documentation is required. A primary function of the system isto establish consistency and eliminate misunderstandings, which is best facilitated withclear and unambiguous written instructions. Policies, which are a pervasive part of anysystem, have absolutely no value if theyre not in writing, and enforcing accountability isextremely difficult if the responsibilities are not spelled out.Information Management - Extensive information management is another integral part ofthe implementation process. Just keeping track of all of the records associated with thequality system is in itself a daunting challenge. Then there are training records, records ofall of the customer complaints, warranty claims, and past due shipments. Theres alsosales and purchasing records, traceability documentation, product development records,
  4. 4. verification and validation records, incoming inspection records, and internal and externalnon-conformance records.All of this involves gathering, managing, and analyzing information, which is anunavoidable requirement of the ISO 9001 standard.Operational Changes - The final component of the implementation process is theoperational changes, which are the changes needed in order to meet the proceduralrequirements of your system. These include such things as training, instrumentcalibration, housekeeping, product traceability, product preservation, managingnonconforming materials, auditing, and the implementation of the corrective andpreventive action activities. Its not good enough to say what youre going to do, youactually have to do it.System documentation and information management are the paperwork part of thesystem. The operational changes are the action part and represent the part of theimplementation process that makes the system work.4. The system contentAn ISO 9001 quality management system is not limited to just the processes andprocedures required by the ISO 9001 Standard.Section 0.3 in the Introduction of the International Standard states:ISO 9004 is recommended as a guide for organizations whose top management wish tomove beyond the requirements of ISO 9001, in pursuit of continual improvement ofperformance.Section 0.4 states:This International Standard does not include guidance specific to other managementsystems, such as those particular to environmental management, occupational health andsafety management, financial management, or risk management. However, thisInternational Standard enables an organization to align or integrate its own qualitymanagement system(s) in order to establish a quality management system that follows theguidelines of this International Standard.The implications are: 1) youre encouraged to use the ideas in the 9004 standard andtherefore not limited to building your quality management system exclusively around therequirements in the ISO 9001 standard, and 2) youre free to combine processes andinstructions from other systems.What makes this significant is the fact that the ISO 9001 requirements are far frominclusive. Theres nothing, for instance, in the standard to address inventory control, yetthis is a major concern for most companies and a logical addition to a qualitymanagement system. The same can be said for product costing. Its difficult to develop
  5. 5. the cost of quality if youre not costing your products. Nor is there anything in thestandard to regulate environmental, safety, business planning, or financial concerns, all ofwhich have a significant impact on the way most people run their business.The objective is to create a system that effectively manages the important activities ofyour business, which means that if something is not included in the standard butnevertheless important to your operation, not only can it be included it should beincluded.5. The system structureThe authors of the standard have also made it clear that the outline of the standard is notmeant as an outline for the quality system documentation.Section 0.1 of the Introduction states:It is not the intent of this International Standard to imply uniformity in the structure ofquality management systems or uniformity of documentation.It is also noted that every system is:[i]nfluenced by varying needs, particular objectives, the products provided, the processesemployed, and the size and structure of the organization.The message is that youre responsible for structuring your own system. There is noprocess list and no procedure list anywhere to be found in the standard, and nowhere inthe standard is it suggested that you should use the outline of the standard as a basis foridentifying your processes or developing your procedures.To the contrary, a persuasive argument can be made that to do so is a mistake. It limitsthe scope of the system because it removes the need for thinking about the processes thatare unique to your operation, and it bogs down the implementation process because itcauses you to design procedures around requirements rather than developing proceduresto meet your needs, which can be like pushing a square peg into a round hole.6. The "process approach"While the "process approach" is one of the eight quality management principles listed insection 4.3 of the ISO 9004 standards, and the use of the "process approach" isrecommended as a means for structuring your ISO 9001 system (refer to section 0.2 ofthe standard), neither standard provides a clear explanation of what a process approach is.The ISO 9004 standard defines the process approach principle as:A desired result is achieved more efficiently when activities and related resources aremanaged as a process.
  6. 6. The ISO 9001 standard defines a process as:An activity using resources, and managed in order to enable the transformation of inputsinto outputs.Our way of interpreting the meaning of a "process" is to group related activities based ondefining inputs and outputs. For example, the inputs and outputs of the human resourceprocess may be defined as:Input = Rules for making sure employees are informed and capable of performing theassigned responsibilitiesOutput = Capable, competent, trusted, and motivated employeesA process that defines the management of the infrastructure of an organization may bedescribed by:Input = Rules and policies for managing the tangible assets used to support the businessOutput =Fewer disruptions, a better working environment resulting in fewer mistakes,better efficiency, better throughput, and more satisfied customersPolicies and procedures that affect such things as hiring, training, and performancemanagement would be part of the human resource process. Housekeeping, machinerymaintenance, network maintenance, and the maintenance of measuring devices would bepart of the infrastructure process.The authors of the 9001 standard explain the "process approach" as:The application of a system of processes within an organization, together with theidentification and interactions of these processes, and their management.Our way of interpreting the meaning of "process approach" is to think in terms of acommon objective for a set of different processes. An objective might be the continualimprovement of the management system, which is what is used in the illustration shownin the standard; or an objective might be the growth and profitability of the organization,which is what we use in our 9000 Advisers system model. Its the objective that binds theprocesses together and determines how the processes interact. It is also an explanationthat fits the model illustrated in the ISO 9001 Standard.Structuring systems based on this interpretation of the "process approach" result insystems that are more personal, flexible, and easier to develop. Youre not handcuffed bythe outline of the ISOStandard, and youre not limited by the requirements of the standard. You establishprocesses that represent the particular needs of your operation and develop the policiesand procedures that bring about the desired output of these processes. Then you make
  7. 7. sure these policies and procedures accommodate all of the requirements of the ISO 9001Standard.7. The basic compliance requirementsUnder certain circumstances it is possible to request an "exclusion" if for some reasonyou find it impossible to comply with certain requirements within the standard. Therequirement must be part of clause 7 of the standard, you must provide an explanationand the justification for the request in the Quality System Manual, and your alternativesolution must not affect the ability "to provide product that meets customer andapplicable regulatory requirements." (Refer to sections 1.2 and 4.2.2 of the standard.)Procedures that are added to your system as a result of ideas taken from the ISO 9004Standard, or from other systems, or simply because they are an important part of the wayyou run your business are not subject to the compliance audit for ISO 9001 certification.Only the requirements specified in the ISO 9001 standard are audited, but unless youhave been granted an exclusion you must comply with all of these requirements.If you want to download over free 50 ebook for iso 9001 standard, you can visit:http://iso9001ebooks.infoBest regards