1 of 11 ISO 9001 2008 Requirements ISO 9000 Checklist

1 Of 11 Iso 9001 2008 Requirements Iso 9000 Checklist-PDF Download

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ISO 9001 2008 List of all requirement clauses Numbered clauses are links in the actual document Scroll to next page. Contents page for ALL personnel Shaded clauses contain requirements that should be known by all personnel. You may need to know additional requirements depending on the type of work that you do Summary statements below may not. contain all requirements of the clause, 4 Quality management system title only This page has a summary statement of the content of each clause. 4 1 General requirements identify processes their sequence and interaction resources needed how processes are controlled and. monitor measure analyze and improve processes,4 2 Documentation requirements title only. 4 2 1 General defines what should be included in quality management system documentation. 4 2 2 Quality manual defines requirements for the Quality Manual and what should be included. 4 2 3 Control of documents requirements for documents documents must be kept current and how to request a document change. 4 2 4 Control of records requirements for identification storage protection retrieval retention time and disposal of records. 5 Management responsibility title only, 5 1 Management commitment evidence mgt committed to quality system customer legal requirements and continual improvement. 5 2 Customer focus Top management must ensure that customer requirements are determined and are met. 5 3 Quality policy requirements for the quality policy must commit to meet requirements and continually improve QMS. 5 4 Planning title only, 5 4 1 Quality objectives Top mgt must ensure measurable quality objectives are established at relevant levels in the organization. 5 4 2 Quality management system planning use 4 1 requirements to plan processes quality objectives plan system changes. 5 5 Responsibility authority and communication title only. 5 5 1 Responsibility and authority who is responsible for activities and who has authority to take what action must be known. 5 5 2 Management representative a member of mgt is Mgt Rep respon for QMS reports to Top Mgt on performance needs of QMS. 5 5 3 Internal communication Top Mgt ensures communication processes of the QMS are established and effective. 5 6 Management review title only, 5 6 1 General Top mgt must review quality system to determine if changes are needed to improve system effectiveness.
5 6 2 Review input review must include audit results customer feedback conformance of product and processes status of actions etc. 5 6 3 Review output determine actions needed to achieve objectives improve product and processes allocate resources for actions. 6 Resource management title only, 6 1 Provision of resources processes must have the resources required to perform the work. 6 2 Human resources title only, 6 2 1 General people must be competent to do work based on education training skills and experience. 6 2 2 Competence training and awareness determining competency requirements providing and evaluating training people must know. the importance of their work and how they contribute to meeting quality objectives. 6 3 Infrastructure identify supply and maintain buildings work areas and services needed to meet conformity to requirements. 6 4 Work environment manage work environment so conditions allow workers to meet product requirements. 7 Product realization title only, 7 1 Planning of product realization what must be included when planning for a specific project contract or order. 7 2 Customer related processes title only, 7 2 1 Determination of requirements related to the product determine all customer requirements related to the order or contract. 7 2 2 Review of requirements related to the product review requirements clarify differences confirm requirements when no document. 7 2 3 Customer communication establish effective communication with customers about product amendments feedback and complaints. 7 3 Design and development title only, 7 3 1 Design and development planning plan stages reviews verification validation responsibilities authorities info flows updates.
7 3 2 Design and development inputs what should be considered when defining design requirements for a product or service. 7 3 3 Design and development outputs must meet input req provide info for purchasing prod and servicing acceptance criteria etc. 7 3 4 Design and development review hold design reviews to ensure requirements met and to i d problems incl reps from all functions. 7 3 5 Design and development verification verify outputs meet input requirements keep records of verif results and necessary actions. 7 3 6 Design and development validation validate product meets use requirements before product delivered keep validation records. 7 3 7 Control of design and development changes review of design changes must include effect on other parts and delivered product. 7 4 Purchasing title only, 7 4 1 Purchasing process purchased items must meet requirements requirements for selection evaluation and re evaluation of suppliers. 7 4 2 Purchasing information requirements for submitting a request for purchased products or services. 7 4 3 Verification of purchased product ensure purchased product meets specified purchase requirements. 7 5 Production and service provision title only, 7 5 1 Control of production and service provision work performed under controlled conditions work instructions avail where needed. 7 5 2 Validation of processes for production and service provision establish your requirements for validating special processes. 7 5 3 Identification and traceability product must be identifiable throughout product realization and inspection and test status known. 7 5 4 Customer property identify verify protect and safeguard customer property report any unsuitable lost or damaged property. 7 5 5 Preservation of product preserve product considerations for identification handling packaging storage and protection. 7 6 Control of monitoring and measuring equipment determine measurements required calibrate and verify measuring equipment. 8 Measurement analysis and improvement title only, 8 1 General identify monitoring meas analysis and improvement processes needed to meet requirements control improve the QMS. 8 2 Monitoring and measurement title only, 8 2 1 Customer satisfaction monitor information related to customer satisfaction. 8 2 2 Internal audit audit product service plans and the organization s documentation take corrective action on nonconformities. 8 2 3 Monitoring and measurement of processes monitor and where appropriate measure processes take action and corrective. action when planned results are not achieved, 8 2 4 Monitoring and measurement of product monitor and measure product at appropriate stages to verify requirements are met.
8 3 Control of nonconforming product identify segregate and determine what will be done with nonconforming product. 8 4 Analysis of data collect and analyze data and information to demonstrate system effectiveness and where to improve system. 8 5 Improvement title only, 8 5 1 Continual improvement identify where improvements can be made to the quality management system. 8 5 2 Corrective action review evaluate nonconformities determine if action needed plan action implement record results on CPAR form. 8 5 3 Preventive action determine action to eliminate potential nonconformities actions must be appropriate to effects of potential problems. Directory ISO 9001 Explained ISO 9001 2008 Auditor Training Course and Forms 2009 ISO 9000 Checklist. file iso 9001 2008 explained rev 2 20 09 pdf,Return to top. Best viewed at 87,5 6 Management review,5 6 1 General. Top management must review the quality management system at planned intervals to ensure it. remains suitable adequate and effective The review must include evaluating opportunities for. improvement and whether changes are needed to the quality management system the quality. policy and quality objectives, Records from management reviews must be kept as described in clause 4 2 4. 5 6 2 Review input, The input to management review must include the following material.
a results of audits,b feedback from customers, c information on conformity of product to requirements and process performance. d status of preventative action and corrective action efforts. e follow up report on actions from any prior management reviews. f changes that could have an affect on the quality management system and. g recommendations for improvement,5 6 3 Review output. The output from the management review must include written records of any decisions and actions. related to, a improvement of the effectiveness of the quality management system and the processes that. make up the system, b improvement of the product and service related to customer requirements and. c resource needs, Text of ANSI ISO ASQ Q9001 2008 paraphrased with permission of the American Society for Quality Next clause.
Documents related to this clause, Click on blue text to view illustration documents Other documents forms and methods may be used. Links to sample documents are not active here You may view these samples from the product web page. Action Number Form This form is used to list items that are identified for possible action during the management review. This chart is located in Directory Mgt review forms file action number form doc. Management Review Result Chart All potential actions are listed on this Excel chart as they are discussed during. management review A priority is assigned to each item Items selected for action become improvement objectives for the. organization, This chart is located in Directory Mgt review forms file mgt review result chart xls. Opportunities Log Items not selected for action are placed in the Opportunities Log for future consideration when resources can. be made available, The Opportunities Log is located in Directory Opportunities Log file 1 opportunities log xls. Instructions for the Opportunities Log are located in Directory Opportunities Log file 1 opportunities log instructions xls. Directory ISO 9001 Explained ISO 9001 2008 Auditor Training Course and Forms 2009 ISO 9000 Checklist. file iso 9001 2008 explained rev 2 20 09 pdf,5 6 Management review. 5 6 1 General,The standard requires that, top management review the quality management system at planned intervals to ensure it remains suitable.
adequate and effective, It is the ongoing responsibility of top management to review the quality management system to ensure the system. continues to be suitable adequate and effective, The definitions on the following chart indicate the basis for evaluating the performance of the management system. The system is, Suitable when results are achieved in the best way using the best. methods and most efficient use of resources, Adequate when output meets requirements standards and regulations. Effective when planned results are achieved, Basis for evaluating management system performance.
Planned intervals, The quality management system must be reviewed at planned intervals Planned intervals means that the time. period between management reviews should be determined in advance This allows performance to be measured on. a regular basis and enables comparisons to be made A written statement in the quality manual or a procedure will. meet this requirement For example The ISO Management Representative schedules the management review. meeting at least annually during the last quarter of the year. At a minimum the review should be held once a year An interval of every 6 months is more common as. organizations find they must remain responsive to customers changes in the marketplace and changes within the. organization itself Reviews can be held more frequently if circumstances indicate that an entire system review is. needed more frequently, Organizations that want to focus on rapid performance improvement identify all items that require improvement. assign a priority to each of these items and improvement projects are implemented sometimes several at one time. until the system is established as effective A program of rapid performance improvement is often carried out when. the system is first implemented, Improvement projects can take longer than a month to complete The status of improvement projects can be. monitored during monthly management meetings or at a defined interval An improvement project status review is. not considered Management Review which is intended to be a high level review of the entire system A report on. the status of improvement projects and the results of completed projects is included in the minutes the record of the. next scheduled Management Review meeting, A management review does not have to be conducted in a single meeting Several meetings can be held each. covering a part of the quality management system or a part of the organization As the goal of management review. is to obtain an overall view of the system these meetings should be held within a several day to several week. A management review must be held prior to the organization s initial registration audit Records from this meeting. provide evidence that management review is an established and implemented process. Directory ISO 9001 Explained ISO 9001 2008 Auditor Training Course and Forms 2009 ISO 9000 Checklist. file iso 9001 2008 explained rev 2 20 09 pdf,How the review process works.
The review process measures the current performance of the product and the processes used to make the product. Where to obtain the ISO 9000 2005 and ISO 9001 2008 Standards Document Key Introduction to Standard and Clauses 1 2 and 3 2008 List of all requirement clauses Numbered clauses are active links in actual document 4 Quali t ymanagemen s stem title onl 4 1 General requirements Documentation requirements title only General Quality manual written Quality Manual required 4 2 3 Control

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