1 Release C.1 Control of Customer- Supplied Documents and Data The organization shall establish and maintain a documented procedure(s) to control all customer-supplied documents and data (e.g., network architecture, topology, capacity, installation termination assignments, drawings, and database) if these documents and data influence the realization and/or support of the product. Added drawings and simplified wording from design, verification, validation, inspection and testing, or servicing to realization and/or support of the product C.1 Customer Relationship Development NO CHANGE No C.2 Customer Communication Procedures Customer Communication Methods The organization shall establish and maintain methods for communicating with selected customers to share expectations, to solicit and consider customer input for quality planning activities, and to ensure product quality improvement. The outcome of customer communication should generate actions for resolving identified issues and provide opportunities for improving customer satisfaction.  d title. Deleted Procedure(s) and added Methods. Requirement was reworded to incorporate intent of former bulleted items into body of text. Deleted procedure requirement C.2 NOTE C.2-NOTE It is recognized that it is not possible for an organization to provide the same level of communication with all its customers. The level provided may depend on the amount of business with the customer, the history of problems, customer expectations, and other factors (see the Appendix, Guidance for Communication with Customers. ) Deleted 1 in Note number. Deleted F after Appendix in parenthesis. All Appendices are now located on the TL 9000 website C.1 Quality Objectives NO CHANGE No C.1 Long- and Short- Term Quality Planning The organization s quality planning activities shall include long- and short-term plans with goals for improving quality and customer satisfaction. The plans shall address business factors relevant to the organization and its customers, including performance objectives established jointly with selected customers. Performance to these goals shall be monitored and reported. Added The plans shall address business factors relevant to the organization and its customers, including performance objectives established jointly with selected customers. Deleted bullets a)-f) and incorporated into NOTE 1. (see C.1 NOTE 1) C.1 NOTE 1 See C.1-NOTE 2 Placement now follows C.1 NOTE C.1 NOTE C.1-NOTE 1 Example factors which might be considered for planning are a) cycle time, b) customer service, c) training, d) cost, e) delivery commitments, and f) product reliability. Note. d bullets a)-f) from requirements to examples C.1-NOTE 2 Top Management should demonstrate their active involvement in long- and short-term quality planning. only, from C.1- NOTE 1 to C.1-NOTE 2. No change to text.
2 Release C.2 Customer Input NO CHANGE No C.3 Supplier Input NO CHANGE No C.1 Organization NO CHANGE No Performance Feedback C-NOTE Education and training needs may vary greatly depending on the nature of the organization s activities, individual responsibilities, and the stage of organizational and personal development. Methods of delivery may include onthe-job training, cross-training, job rotation, classroom experience, computerbased training, distance learning, or other methods. Training may take place within the organization or be provided externally, and should be reinforced on the job. Note C.1 Internal Course Development Where the organization is responsible for developing internal training courses, the organization shall establish and maintain methods to ensure consistency in course planning, development, and delivery. to clarify intent. Replaced process with methods for consistency C.2 Quality Improvement Concepts Quality and Process Improvement Concepts Those employees that have a direct impact on the quality of the product, including top management, shall be trained in and apply the fundamental concepts of continual improvement, problem solving, and customer satisfaction.  Added and Process to title. Added and apply to better convey intent of requirement C.3 Training Requirements and Awareness Product Quality Training Opportunity Awareness Where training that affects product quality is required, the organization shall implement methods to ensure employees are enabled to participate. Methods should address a) communication of training opportunities, and b) availability of training. d title. to clarify intent. Added bullets to requirement and requirement for availability of training C.4 ESD Training Electrostatic Discharge (ESD) Training All employees with functions that involve handling, storage, packaging, preservation, or delivery of ESD-sensitive products shall receive training in ESD protection prior to performing their jobs. Moved definition of ESD acronym from body of text to title. Deleted any in body of text C.5 Advanced Quality NO CHANGE No Training C.6 Training Content Hazardous Conditions Training Content Where the potential for hazardous conditions exists, training content shall include a) task execution, b) personal safety and appropriate protective equipment, c) awareness of hazardous environment, and d) equipment protection. d title. Added Hazardous Conditions to title to better reflect intent. d should to shall and added and appropriate protective equipment to bullet b).
3 Release HV.1 Operator Qualification Qualification of Personnel The organization shall establish personnel qualification and requalification requirements for all applicable processes. Qualification requirements shall address employee education, experience, training, and demonstration of skills.  d title. Replaced Operator with Personnel in title and body of text. Deleted The organization shall communicate this information to all affected employees HV.1-NOTE Examples of processes which may require personnel qualification and re-qualification include wire wrapping, soldering, welding, and fiber-optic fusion splicing C.1 Infrastructure The organization shall identify critical areas of the infrastructure and provide for the security needed to protect these areas. Security restoration plans shall be developed and periodically assessed C.1 Work Areas Areas used for handling, storage, and packaging of products shall be clean, safe, and organized to ensure that they do not adversely affect product quality or personnel performance.  C.1 Life Cycle Model The organization shall establish and maintain an integrated set of method(s) that covers the life cycle of its products. The method(s) shall contain, as appropriate, the processes, activities, and tasks involved in the concept, definition, development, introduction, production, operation, maintenance, and (if required) disposal of products, spanning the life of the products.  Note Requirement Added the word product. Replaced guidelines and framework with method(s) for consistency and added the word introduction. Reference  is now  C.2 Product Introduction C.2 NOTE C.1-NOTE The new product introduction methods should include provisions for such programs as quality and reliability prediction studies, pilot production, demand and capacity studies, sales and service personnel training, customer documentation and training, and new product post-introduction evaluations. DELETED REQUIREMENT Deleted Covered elsewhere Note to map to 7.1.C.1. Added customer documentation and training and changed program to methods for clarification and consistency C.3 Disaster Recovery 7.1.C.2 Disaster Recovery The organization shall establish and maintain documented plans for disaster recovery to ensure the organization s ability to recreate and service the product throughout its life cycle.  C.2-NOTE Types of recovery capabilities should include a series of action statements related to disaster recovery. Examples include: who is notified, under what circumstances are they notified, who has authority to act, and who will coordinate the steps outlined in the plan. from 7.1.C.3 to 7.1.C.2. Methods changed to documented plans. Reference  is now . Note
4 Release C.4 End of Life Planning 7.1.C.3 End of Life Planning The organization shall establish and maintain a documented procedure(s) for the discontinuance of manufacturing and/or support of a product. The documented procedure(s) should include a) cessation of full or partial support after a certain period of time, b) archiving product documentation and software, c) responsibility for any future residual support issues, d) transition to the new product, if applicable, and e) accessibility of archive copies of data.  from 7.1.C.4 to 7.1.C.3. Deleted by the operation and service organizations. Reference  is now  C.4 Tools Management The organization shall ensure that internally developed software and/or tools used in the product life cycle are subject to the appropriate quality method(s).  from 7.1.S.3 to 7.1.C.4. Expanded scope to common from software only. d title from Support Software and Tools Management to Tools Management. Examples previously in text were split out to a separate Note (see 7.1.C.4- NOTE). Reference  is now  C.4-NOTE Examples of tools to be considered include: design and development, testing, configuration management, documentation, and diagnostic tools, including scripts and customizations, as well as software used to build and test product HS.1 Configuration Management Plan NO CHANGE to text or title HS.1 NOTE HS.1-NOTE Work instructions defining general configuration management tasks and responsibilities need not be replicated as part of a specific documented configuration management plan. The Configuration Management Plan need not be contained in a single document. Reference Only Note Reference is now  not . Deleted 1 in Note number. Deleted the word General and added The Configuration Management Plan need not be contained in a single document S.1 Estimation See S.2 Moved from 7.1 to S.1 NOTE 1 See S.2-NOTE Moved from 7.1 to S.2 Computer Resources See S.3 Moved from 7.1 to S.3 Support Software and Tools Management See 7.1.C V.1 Service Delivery Plan Organizations that are responsible for the delivery or implementation of a service, and are not responsible for the design and development of that service, shall comply with the Project Plan requirements of C.1. Expanded Scope Placement now follows 7.1.C.3. d Suppliers to Organizations.
5 Release C NOTE 1 DELETED NOTE Deleted C-NOTE 1 text became new requirement, see C.2 Contract Review C-NOTE The product acceptance plan should include, as appropriate, a) acceptance review process, b) acceptance criteria, c) documented test procedure(s), d) test environment, e) test cases, f) test data, g) test responsibilities, h) resources involved, i) method(s) for problem tracking and resolution, and j) required acceptance test reports.  Note from C NOTE 2 to C-NOTE. Added new bullet item, g) test responsibilities C NOTE 2 See C-NOTE C.1 Closure Tracking All actions resulting from requirements reviews shall be tracked to closure C.2 Contract Review The organization shall establish and maintain a contract review process that should include a) product acceptance criteria and criteria review process, b) method(s) for handling problems detected after product acceptance, including customer complaints, c) plan(s) for removal and/or correction of nonconformities after applicable warranty period or during product maintenance contract period, d) identification of risks and possible contingencies, e) adequate protection of proprietary information, f) definition of the organization's responsibility with regard to outsourced work, g) activities carried out by customer, including the customer's role in requirements, specifications and acceptance, h) facilities, tools, and software items to be provided by the customer, and i) all referenced standards and procedures.  Requirement Requirement. This new requirement contains much of the same text in C-NOTE 1 from Release 3.0. Bulleted items d) i) are new C.1 Notification About Problems NO CHANGE No
6 Release C.2 Problem Severity Except for those products specifically excluded from severity level reporting, the organization shall assign severity levels to customer-reported problems based on the impact to the customer in accordance with the definitions of critical, major, and minor problem reports contained in the TL 9000 Measurements Handbook. The severity level shall be used in determining the timeliness of the organization s response.  Added except for those products specifically excluded from severity level reporting and changed contained in the glossary of this handbook to contained in the TL 9000 Measurements Handbook to text. Reference  is now  C.2 NOTE C.2-NOTE NO CHANGE to text or title. Deleted 1 from Note number C.3 Problem Escalation NO CHANGE to text or title. Reference Only C.4 Customer Feedback The organization shall provide the customer with feedback on their problem reports in a timely and systematic manner H.1 Organization s Recall Process HS.1 NO CHANGE to text or title HS.2 Design and Development Process Quality Measurements Data Reporting On request by the customer, communications shall include reporting and evaluation of a jointly agreed set of design and development process measurements. Expanded Scope Reference  is now . Deleted procedure requirement and added and systematic to text. from H.1 to HS.1. Expanded scope of requirement to include software. Requirement C.1 Project Plan The organization's project planning activities shall be based on the defined product life cycle model (see 7.1.C.1). The project plan should include a) project organizational structure, b) roles, responsibilities, and accountabilities of the project team, c) roles, responsibilities, and accountabilities of related teams or individuals, within and outside the organization, and interfaces between them and the project team, d) means for scheduling, tracking, issue resolution, and management reporting, e) budgets, staffing, and schedules associated with project activities, f) identification of method(s), standards, documented procedure(s), and tools to be used (If such items are clearly defined as part of the product life cycle model, a reference to that life cycle model is sufficient.), g) references to related plans (e.g., development, testing, configuration management, and quality), h) project-specific development or service delivery environment and physical resource considerations (e.g., resources to address development, user documentation, testing, operation, required development tools, secure computing environment, lab space, workstations, etc.), i) customer, user, and supplier involvement during the product life cycle (e.g., joint reviews, informal meetings, and approvals), j) management of project quality, k) risk management and contingency plans (e.g., risks of rework, poor field reliability and defects, resource and schedule variance), l) project-specific training requirements, for clarification. Deleted bullet l) performance, safety, security, and other critical requirements from. Added reference to Life Cycle Model 7.1.C.1. Reference  is now .
7 Release 4.0 m) required certifications (e.g., product certifications or employee technical certifications), n) proprietary, usage, ownership, warranty, licensing rights, and o) post-project analysis.  C.1 NOTE 1 NO CHANGE No C.1 NOTE 2 Work instructions defining tasks and responsibilities common to all development projects need not be replicated as part of a project plan C.2 Requirements Traceability NO CHANGE to text or title. Reference Only Deleted the word General in text. Reference  is now  C.2 NOTE 1 NO CHANGE to text or title. Deleted 1 from Note number C.3 Test Planning Test plans shall be documented and should include a) scope of testing (e.g., unit, feature, integration, system, acceptance, field, migration and regression), b) types of tests to be performed (e.g., functional, boundary, usability, performance, regression, interoperability, stress), c) traceability to requirements, d) test environment (e.g., relevancy to customer environment, operational use), e) test coverage (degree to which a test verifies a product s functions, sometimes expressed as a percent of functions tested), f) expected results, g) data definition and database requirements, h) set of tests, repeatable test cases (inputs, outputs, test criteria), and documented test procedure(s), i) use of external testing, j) method of reporting and resolving defects, and k) customer test requirements.  The results of testing and subsequent action taken shall be recorded (see 4.2.4). Added bullet k) customer test requirements and expanded bullet a) to include field, migration and regression testing. Deleted results recorded but added reference to Control of Records. Reference  is now  C.3 NOTE 1 DELETED NOTE Deleted Covered elsewhere in standard.
8 Release HS.1 Migration Planning The organization shall develop and document a migration plan when a system, hardware or software product is planned to be migrated from an old to a new operational environment. If the old environment will no longer be supported, users shall be given notification of migration plans and activities which shall include a description of the new environment with its date of availability, and a description of other support options available, if any, once support for the old environment has been removed. The migration plan should also include a) requirements analysis and definition of migration, b) development of migration tools, c) conversion of product and data, d) migration execution, e) migration verification, and f) support for the old environment in the future.  Expanded Scope from S.2 to HS.1. Expanded scope to include hardware. Reference  is now  HS.1-NOTE 1 The operational environment is made up of hardware, software or systems on which the product depends, that the customer purchases and installs separately, from either the organization or other suppliers. Examples of changes from old to new software operational environments include upgrades to the operating system, database, or communications protocol stack. Examples of changes from old to new hardware operational environments include using existing circuit packs in new racks or with new controllers, or upgrading computer hardware. Both hardware and software platform migration could affect either hardware or software components or systems so migration plans should cover all possibilities. Note HS.1-NOTE 2 If the old environment will no longer be supported, consideration should be given to arrangements for access to data that was used by, or associated with, the old operational environment, for data protection and audit purposes, in accordance with regulatory and contract requirements. Note HS.2 Design and Development Process Quality Measurement Planning and Implementation During the design and development planning phase, the organization shall establish and maintain a method(s) for selecting and reporting appropriate design and development process quality measures for the project. As recommended during this phase, this measurement system shall be implemented appropriately to the project. Requirement
9 Release HS.2-NOTE See the Appendix Set Up and Operation of a Design Process Measurement System for guidelines to aid in selecting and establishing appropriate design and development process measurements for the project. Note. All Appendices are now located on the TL 9000 website S.1 Integration Planning NO CHANGE to text or title. Reference Reference  is now . Only S.2 Migration Planning See HS.1 Expanded Scope S.2 Estimation The organization shall establish and maintain a method for estimating and tracking project factors during project planning, execution, and change management.  S.2-NOTE Project factors should include product size, complexity, requirements changes, effort, staffing, schedules, cost, quality, reliability, and productivity S.3 Computer Resources The organization shall establish and maintain methods for estimating and tracking critical computer resources for the target computer, the computer on which the software is intended to operate.  from 7.1.S.1 to S.2. No change to title or text. Reference  is now . from 7.1.S.1-NOTE 1 to S.2-NOTE. No change to text. from 7.1.S.2 to S.3. No change to text or title. Reference  is now  S.3-NOTE Examples of these resources are utilization of memory, throughput, real-time performance, and I/O channels. Firmware examples include utilization of processor, memory, I/O channels, etc S.4 Regression Test Planning If regression testing is to be performed, test plans shall specify which tests are regression and what features and functions are covered by these regression tests. Note Requirement C.1 Customer and Supplier Input C.2 Design and Development Requirements NO CHANGE No Design and development requirements shall be defined and documented, and should include a) quality and reliability requirements, b) functions and capabilities of the product, c) business, organizational, and user requirements, d) safety, environmental, and security requirements, e) installability, usability, and maintainability requirements, f) design constraints, g) testing requirements, and h) computer resources for the target computer.  Added new bullet h) computer resources for the target computer. Reference  is now .
10 Release C.3 Requirements Allocation The organization shall document the allocation of the product requirements to the product architecture.  C.3-Note Examples of requirements which should be allocated are response time for software, heat dissipation for hardware and service response time for services. Expanded Scope from S.2 to C.3. Expanded scope to common from software only. No change to text or title. Reference  is now . Note H.1 Content of Requirements S.1 Identification of Software Requirements S.2 Requirements Allocation S.1 Software Design and Development Output NO CHANGE No NO CHANGE to text or title. See C HS.1 Design and Development Output Design and development outputs should include, but are not limited to a) system architecture, b) system detailed design, c) source code, and d) user documentation.  Reference Only Expanded Scope Expanded Scope Reference  is now . No change to text or title. from S.1 to HS.1. Expanded scope to include hardware. Deleted Software from title and text V.1 Services Design and Development Output NO CHANGE to text or title C.1 Verification of Documentation The organization shall verify the customer and/or user documentation prior to product delivery HS.1 Stress Testing The organization shall test the product under stress conditions, including, but not limited to, out-of-boundary and invalid input conditions, high volume and peak load simulations, and operational errors.  HS.2 Abnormal Conditions The organization shall test the product under abnormal conditions, which shall include, as appropriate a) hardware errors, b) software errors, c) operations, administration, maintenance and provisioning (OAM&P) errors, d) overload traffic, e) invalid user input, and f) system recovery from an outage Reference Only Reference  is now . Requirement Requirement Requirement Requirement S.1 System Testing Each software release shall be subjected to a system test in accordance with a documented system test plan.  C NOTE 1 NO CHANGE to text or title. Deleted 1 from Note number.
11 Release S.1 Release Management S.1 Release Management The organization shall establish and maintain method(s) to ensure that the release and delivery of software products and related documentation are carried out under controlled conditions. Method(s) should provide for the delivery to the customer of a) release planning information in advance of the release, b) product introduction and release schedules, c) detailed descriptions of product features delivered, including any changes incorporated in new software products or releases, and d) advisories regarding current or planned changes to contractual terms (see C.2).  Deleted procedure requirement. for clarification of intent. Added reference to C.2. Reference  is now  C.1 Management Process The organization shall establish and maintain a documented procedure to ensure that all requirements and design changes, which may arise at any time during the product life cycle, are managed and tracked in a systematic and timely manner appropriate to the life cycle stage. The organization shall ensure that changes which adversely affect mutually agreed conditions for quality, reliability and functional intent are reviewed with the customer prior to approval. Management of changes should include a) impact analysis, including impact on resources and schedule, b) planning, c) implementation, d) testing, e) documentation, f) communication, and g) review and approval.  Added documented procedure requirement. to clarify intent. Expanded bullet a) to add including impact on resources and schedule. Added NOTE to this requirement C.1-NOTE While a change management process is required throughout the life cycle, controls within that process may depend on the life cycle stage. For example, during design, the organization should be able to react to rapidly changing customer requirements, and take advantage of emerging technologies with an encompassing, responsive change management process. After General Availability the change management process scope should consider how the change on the operation and maintenance of the product and its installed base impacts the community of customers and stakeholders. The consideration should include quality, reliability, and functional intent. Note C.2 Informing Customers NO CHANGE No change
12 Release HS.1 Problem Resolution Configuration Management C.3 Problem Resolution Configuration Management The organization shall ensure that its configuration management system tracks fixes to problems and incorporates those fixes in future revisions.  Expanded Scope from HS.1 to C.3. Expanded scope to common from hardware and software only. to clarify intent. Reference  is now  H.1 Component s NO CHANGE No C.1 Purchasing Procedure(s) The organization shall establish and maintain a documented purchasing procedure(s) to ensure a) product requirements are clearly defined, b) risks are understood and managed, c) qualification criteria are established, d) acceptance criteria are established, e) contracts are defined, f) proprietary, usage, ownership, warranty, and licensing rights are satisfied, g) future support for the product is planned, h) ongoing supply-base management and monitoring is in place, i) supplier selection criteria are defined, j) suppliers are re-evaluated based on defined criteria, and k) feedback is provided to key suppliers based on data analysis of supplier performance.  to clarify intent. Added new bullet d) acceptance criteria are established. Corrected typo in bullet list by adding bullet j). Reference  is now  C.1 NOTE 1 NO CHANGE to text or title. Deleted 1 from Note number C.1 Organization s DELETED REQUIREMENT Deleted Covered elsewhere in standard. Support Program C.2 Service Resources C.1 Service Resources The organization shall provide customer contact employees with appropriate tools, training, and resources necessary to provide effective and timely customer service.  from C.2 to C.1. No change to text or title C.2 Product Delivery The organization shall establish and maintain method(s) to minimize interference with the customer s normal site operation and service during product delivery and installation.  Requirement HS.1 Emergency Service The organization shall ensure that services and resources are available to support recovery from emergency failures of product in the field throughout its expected life. The organization shall identify potential situations that may have an impact on its ability to provide the emergency service and shall have response plans to address these situations. These plans shall be based on risk and periodically assessed.  Kept original text. Added The organization shall identify potential situations that may have an impact on its ability to provide the emergency service and shall have response plans to address these situations. These plans shall be based on risk and periodically assessed.
13 Release HS.2 Installation Plan The organization shall establish and maintain a documented installation plan. The installation plan shall identify the resources, the information required, the sequence of events and any necessary records.  HV.1 Operational s Each time a significant change is made in the established operation (e.g., a new operator, new machine, or new technique), a critical examination shall be made of the first unit(s)/service(s) processed after the change.  to clarify intent. Reference  is now . requirement from HV.1 to HV.1. No change to text or title S.1 Patching Procedure(s) The organization shall establish and maintain a documented patching procedure(s) that a) guides the decision to solve problems by patching, b) addresses patch development procedures, propagation (forward and backward), and resolution, c) is consistent with customer needs or contractual requirements for maintenance support, and d) ensures that the organization provides the customer with a statement of impact on the customer's operation for each patch.  requirement to clarify intent. Reference  is now  S.2 Patch Documentation NO CHANGE to text or title. Reference Only S.3 Replication The organization shall establish and maintain a documented procedure(s) for replication, which should include a) identification of master copy, b) identification of replicate copies for delivery, c) quantity of replicates to deliver, d) type of media, e) labeling, f) identification of required documentation such as user guides, g) packaging of documentation, and h) control of environment to ensure repeatable replication.  Reference  is now . Deleted the words the following: for consistency. Reference  is now  V.1 Software Used in Service Delivery The organization shall establish and maintain a documented procedure(s) for the maintenance and control of software used in service delivery to ensure continued process capability and integrity V.2 Tool s The organization shall establish and maintain a documented procedure(s) to ensure that substitutions or changes to tools used in performing the service do not adversely affect the quality of the service HV.1 Operational s HS.1 Product Identification H.1 Traceability for Recall for clarification and consistency. Deleted the words, and implement processes. for consistency. See HV.1. No change to text or title. REORDERED Reordered Reordered. Placement now follows H.2. NO CHANGE No
14 Release H.2 Traceability of Design s The organization shall define and implement methods necessary to provide traceability of design changes to identifiable manufacturing dates, lots, or serial numbers HS.1 Product Identification The organization shall establish and maintain a process for the identification of each product and the level of required control. For each product and its versions, the following shall be identified where they exist: a) product documentation, b) development or production tools essential to repeat product creation, c) interfaces to other products, and d) software and hardware environment.  Reordered Deleted procedure requirement. Reordered. Added NOTE to this requirement. No change to text or title. Reference  is now  HS.1-NOTE Examples of product identification include barcode, tag, label, electronic ID, etc., containing information such as production lot numbers and dates, and serial numbers. technologies for data retrieving such as RFID may also be considered C.1 Anti-Static Protection Electrostatic Discharge Sensitive (ESDS) Protection Where applicable, antistatic protection shall be employed for components and products susceptible to electrostatic discharge (ESD) damage C.1-NOTE 1 Types of components and products which should be protected include electronic parts, integrated circuits, printed wiring board assemblies, magnetic tapes and disks, and other media used for software or data storage.  Note d title from Anti-Static Protection' to Electrostatic Discharge Sensitive (ESDS) Protection. Added NOTE 1 and 2 to this requirement. Note C.1-NOTE 2 Certification to ANSI/ESD S20.20 published by the ESD Association should be taken as indication that the certified facilities meet TL 9000 requirements C.4 and C.1 concerning ESD protection. Please check the TL 9000 website (visit tl9000.org) for the acceptability of any later editions of the ANSI standard. Note HS.1 Packaging and Labeling Audit HS.1 Packaging and Labeling Verification The organization shall establish and maintain methods to ensure that the packaging and labeling of products and components conform to specified requirements. d title. Deleted Audit and added Verification to title. requirement to clarify intent. Deleted examples from requirement and incorporated them into a new NOTE HS.1 NOTE HS.1-NOTE Packaging and labeling verification is normally performed on products ready to ship and may include, for example, marking, labeling, kitting, documentation, addressing, customer-specific marks, and verification of quantities to be shipped. Deleted 1 from Note number. Deleted This audit is normally done on products ready to ship.
15 Release H.1 Deterioration HV.1 Deterioration Where the possibility of deterioration exists, the organization shall establish and maintain methods to determine when materials that may impact product quality have deteriorated or exceeded their expiration dates, and assess any required subsequent action.  S.1 Software Virus Protection NO CHANGE to text or title H.1 Identified Equipment 7.6.C.1 Equipment Identification Monitoring and measuring devices that are either inactive or unsuitable for use shall be visibly identified and not used. All monitoring and measuring devices that do not require calibration shall be identified.  C.1 Customer Satisfaction Data The organization shall establish and maintain a method to collect data directly from customers concerning their satisfaction with provided products. The organization shall also collect customer data on how well the organization meets commitments and its responsiveness to customer feedback and needs. This data shall be analyzed and trended.  Expanded Scope Reference Only Expanded Scope from H.1 to HV.1. Expanded scope to include services from hardware only. to clarify intent. Reference  is now . from 7.6.H.1 to 7.6.C.1. Expanded scope to common from hardware only. d title to Equipment Identification from Identified Equipment. No change to text. Deleted the words collected and and the sentence, Trends of the data shall be kept. Added the words and trended C.1 Process Measurement Process measurements shall be identified, documented, and monitored at appropriate points to ensure continued suitability and promote increased effectiveness of processes. This includes the establishment of appropriate design process measurements. Key process measurements that impact product quality should have specific performance targets or control limits established.  Deleted developed, added identified, and text This includes the establishment of appropriate design process measurements. Key process measurements that impact product quality should have specific performance targets or control limits established. Reference  is now  HV.1 Inspection and Test REORDERED Reordered Placement now follows H.4. Documentation HV. 2 Inspection and REORDERED Reordered Placement now precedes S.1. Test Records H.1 Periodic Retesting The organization shall establish and maintain a documented procedure(s) that ensures products are periodically retested to assess the product's ability to continue to meet design requirements. When determining the depth of the retest, the organization should consider the conditions in H.3  Added reference to H H.2 Content of Testing NO CHANGE No H.2-NOTE H.2-NOTE Product specifications may include environmental, vibration, flammability, operational stress type testing, and intrusion/penetration testing. Added and intrusion/penetration testing. Deleted 1 from Note number.
16 Release H.3 Frequency of Testing The organization shall establish and document the frequency for test and periodic retest. When determining the test frequency, the organization shall include a) product complexity and service criticality, b) number of design, engineering and/or manufacturing changes made to the product and whether the change(s) affect form, fit, and/or function, c) changes to the manufacturing process, d) manufacturing variations, (e.g., tooling wear), e) material and/or component substitutions and failure rates, and f) the field performance record of the product.  Deleted the following: for consistency. No change to bulleted items H.4 Testing of Repair NO CHANGE No and Return Products HV.1 Inspection and Test Documentation Each inspection or testing activity shall have detailed documentation. Details should include, but are not limited to a) parameters to be checked with acceptable tolerances, b) the use of statistical techniques, control charts, etc., c) sampling plan, including frequency, sample size, and acceptance criteria, d) handling of nonconformities, e) data to be recorded (see 4.2.4), f) defect classification scheme, g) method for designating an inspection item or lot, and h) electrical, functional, and feature testing.  Reordered Reordered. Deleted the following and added but are not limited to for bulleted list. Added reference to 4.2.4, Control of Records for bullet e) HV.2 Inspection and Test Records Inspection or test records shall include a) product identification, b) quantity of product, c) documented procedure(s) followed, d) person performing the test or inspection, e) calibrated equipment used (see 7.6), f) date performed, and g) number, type, and severity of defects found.  Reordered Reordered. Added bullet e) calibrated equipment used (see 7.6). Added reference to 7.6, Control of Monitoring and Measuring Devices S.1 Test Documentation Software tests shall be conducted per the test plan according to a documented procedure(s). Records of testing shall include a) test results, b) analysis of test results, c) conformity to expected results, and d) problem reporting for nonconforming items.  for clarity and consistency. Reference  is now .
17 Release C.1 Trend Analysis of Nonconforming Product H.1 Field Performance Data V.1 Service Performance Data C.1 Quality Improvement Program NO CHANGE No 8.4.HS.1 Field Performance Data The quality management system shall include the collection and analysis of field performance data which can be used to help identify the cause and frequency of product failure. In addition, no trouble found (NTF) data shall also be maintained. This information shall be provided to the appropriate organizations to foster continual improvement.  Expanded Scope NO CHANGE No C.1 Continual Improvement Program(s) The organization shall establish and maintain a continual improvement program(s) that includes a focus to improve a) customer satisfaction, b) quality and reliability of the product, and c) other processes/products/services used within the organization.  from 8.4.H.1 to 8.4.HS.1. Expanded scope to include software from hardware only. Deleted equipment and added product to text. d title from Quality Improvement Program to Continual Improvement Program(s). Deleted documented requirement C NOTE C.1-NOTE Inputs to the continual improvement process may include lessons learned from past experience, lessons learned from previous projects, analysis of measurements and post-project reviews, and comparisons with industry best practices. Corrected Note number, from C- NOTE 2 to C.1-NOTE for consistency. No change to text C.2 Employee NO CHANGE No Participation C NOTE 1 DELETED NOTE Deleted Covered elsewhere in standard C NOTE C-NOTE 1 Review of corrective action is intended to ensure that the action taken was effective. Review activities may include ensuring that root cause was properly identified and addressed, appropriate containment action was taken, and corrective actions have not introduced additional problems. from C NOTE 2 to C-NOTE 1. NO CHANGE to text C NOTE C-NOTE 2 Consideration should be given to include training as part of implementing corrective and preventive actions S.1 Problem Resolution NO CHANGE to text or title. Reference Only from C NOTE 3 to C-NOTE 2. NO CHANGE to text. Reference  is now .
18 Cross Reference for TL 9000 to 4.0 TL 9000 TL 9000 Release C.1 Control of Customer-Supplied Documents and Data C.1 Control of Customer-Supplied Documents and Data 5.2.C.1 Customer Relationship Development 5.2.C.1 Customer Relationship Development No 5.2.C.2 Customer Communication Procedures 5.2.C.2 Customer Communication Methods 5.2.C.2 NOTE C.2 NOTE C.1 Quality Objectives C.1 Quality Objectives No C.1 Long- and Short-Term Quality Planning C.1 Long- and Short-Term Quality Planning C.1 NOTE C.1 NOTE C.1 NOTE C.2 Customer Input C.2 Customer Input No C.3 Supplier Input C.3 Supplier Input No C.1 Organization Performance Feedback C.1 Organization Performance Feedback No C NOTE C.1 Internal Course Development C.1 Internal Course Development C.2 Quality Improvement Concepts C.2 Quality and Process Improvement Concepts C.3 Training Requirements and Awareness C.3 Product Quality Training Opportunity Awareness C.4 ESD Training C.4 Electrostatic Discharge (ESD) Training C.5 Advanced Quality Training C.5 Advanced Quality Training No C.6 Training Content C.6 Hazardous Conditions Training Content HV.1 Operator Qualification HV.1 Qualification of Personnel HV.1 NOTE 6.3.C.1 Infrastructure 6.4.C.1 Work Areas 6.4.C.1 Work Areas 7.1.C.1 Life Cycle Model 7.1.C.1 Life Cycle Model 7.1.C.1 NOTE 7.1.C.2 Product Introduction Deleted 7.1.C.2 NOTE 1 Deleted 7.1.C.3 Disaster Recovery 7.1.C.4 End of Life Planning 7.1.C.2 Disaster Recovery 7.1.C.2 NOTE 7.1.C.3 End of Life Planning 7.1.HS.1 Configuration Management Plan 7.1.HS.1 Configuration Management Plan Reference Only
19 TL 9000 TL 9000 Release HS.1 NOTE HS.1 NOTE 7.1.S.1 Estimation S.2 Estimation 7.1.S.1 NOTE S.2 NOTE 7.1.S.2 Computer Resources S.3 Computer Resources 7.1.S.3 Support Software and Tools Management 7.1.C.4 Tools Management Expanded Scope 7.1.C.4 NOTE 7.1.V.1 Service Delivery Plan 7.1.V.1 Service Delivery Plan C NOTE 1 Deleted C NOTE C NOTE C.1 Closure Tracking C.2 Contract Review C.1 Notification About Problems C.1 Notification About Problems No C.2 Problem Severity C.2 Problem Severity C.2 NOTE C.2 NOTE C.3 Problem Escalation C.3 Problem Escalation Reference Only C.4 Customer Feedback C.4 Customer Feedback H.1 Organization s Recall Process HS.1 Organization s Recall Process Expanded Scope HS.2 Design and Development Process Quality Measurements Data Reporting C.1 Project Plan C.1 Project Plan C.1 NOTE C.1 NOTE 1 No C.1 NOTE C.1 NOTE C.2 Requirements Traceability C.2 Requirements Traceability Reference Only C.2 NOTE C.2 NOTE C.3 Test Planning C.3 Test Planning C.3 NOTE 1 Deleted S.1 Integration Planning S.1 Integration Planning Reference Only S.2 Migration Planning HS.1 Migration Planning Expanded Scope HS.1 NOTE HS.1 NOTE HS.2 Design and Development Process Quality Measurement Planning and Implementation
20 TL 9000 TL 9000 Release HS.2 NOTE S.3 NOTE S.4 Regression Test Planning C.1 Customer and Supplier Input C.1 Customer and Supplier Input No C.2 Design and Development Requirements C.2 Design and Development Requirements H.1 Content of Requirements H.1 Content of Requirements No S.1 Identification of Software Requirements S.1 Identification of Software Requirements Reference Only S.2 Requirements Allocation C.3 Requirements Allocation Expanded Scope C.3 NOTE S.1 Software Design and Development Output HS.1 Design and Development Output Expanded Scope V.1 Services Design and Development Output V.1 Services Design and Development Output Reference Only C.1 Verification of Documentation HS.1 Stress Testing HS.2 Abnormal Conditions S.1 System Testing C NOTE C NOTE S.1 Release Management S.1 Release Management C.1 Management Process C.1 Management Process C.1 NOTE C.2 Informing Customers C.2 Informing Customers No change HS.1 Problem Resolution Configuration Management C.3 Problem Resolution Configuration Management Expanded Scope H.1 Component s H.1 Component s No C.1 Purchasing Procedure(s) C.1 Purchasing Procedure(s) C.1 NOTE C.1 NOTE C.1 Organization s Support Program Deleted C.2 Service Resources C.1 Service Resources C.2 Product Delivery HS.1 Emergency Service HS.1 Emergency Service HS.2 Installation Plan HS.2 Installation Plan S.1 Patching Procedure(s) S.1 Patching Procedure(s) S.2 Patch Documentation S.2 Patch Documentation Reference Only S.3 Replication S.3 Replication V.1 Software Used in Service Delivery V.1 Software Used in Service Delivery
21 TL 9000 TL 9000 Release V.2 Tool s V.2 Tool s HV.1 Operational s HV.1 Operational s HS.1 Product Identification HS.1 Product Identification Reordered HS.1 NOTE H.1 Traceability for Recall H.1 Traceability for Recall No H.2 Traceability of Design s H.2 Traceability of Design s C.1 Anti-Static Protection C.1 Electrostatic Discharge Sensitive (ESDS) Protection C.1 NOTE C.1 NOTE HS.1 Packaging and Labeling Audit HS.1 Packaging and Labeling Verification HS.1 NOTE HS.1 NOTE H.1 Deterioration HV.1 Deterioration Expanded Scope S.1 Software Virus Protection S.1 Software Virus Protection Reference Only 7.6.H.1 Identified Equipment 7.6.C.1 Equipment Identification Expanded Scope C.1 Customer Satisfaction Data C.1 Customer Satisfaction Data C.1 Process Measurement C.1 Process Measurement HV.1 Inspection and Test Documentation HV.1 Inspection and Test Documentation Reordered HV. 2 Inspection and Test Records HV. 2 Inspection and Test Records Reordered H.1 Periodic Retesting H.1 Periodic Retesting H.2 Content of Testing H.2 Content of Testing No H.2 NOTE H.2-NOTE H.3 Frequency of Testing H.3 Frequency of Testing H.4 Testing of Repair and Return Products H.4 Testing of Repair and Return Products No S.1 Test Documentation S.1 Test Documentation 8.4.C.1 Trend Analysis of Nonconforming Product 8.4.C.1 Trend Analysis of Nonconforming Product No 8.4.H.1 Field Performance Data 8.4.HS.1 Field Performance Data Expanded Scope 8.4.V.1 Service Performance Data 8.4.V.1 Service Performance Data No C.1 Quality Improvement Program C.1 Continual Improvement Program(s) C NOTE C.1 NOTE C.2 Employee Participation C.2 Employee Participation No C NOTE 1 Deleted
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