Design Completion Checklist-Non-Electromechanical Devices ISO Template | QP1100-3

Design Completion Checklist-Non-Electromechanical Devices ISO Template

For all non-electromechanical products, a Design Completion Checklist-Non-Electromechanical Devices ISO Template should be completed and evaluated. QP1100-3 DESIGN COMPLETION CHECKLIST FOR NON-ELECTROMECHANICAL DEVICES covers items such as product specification, performance factors, range, linearity, and more. At the completion of each design/development activity, a review of the results should be performed.

Reviews should be objective, unbiased examinations by appropriately trained employees who were not directly involved in that design activity. The design team should keep a record of all such reviews and necessary actions that arise from them. Review results and actions arising from them should be documented in report form and signed by Management employees as complete and accurate.

All changes made as a result of review findings should likewise be documented. Reports should include conclusions and recommended follow-up and should be disseminated in a timely manner to appropriate organizational functions, including management. The Product Development Team should keep all such reports in the Design & Development file.

Design Completion Checklist-Non-Electromechanical Devices ISO Template Details

Pages: 01
Words: 124
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: Quality Assurance Policy Statement and Procedures
Procedure: ISO Design Development Procedure QP1100
Type: Checklist

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Design Development Procedure ISO 9001 2015 | QP1100

ISO Design Development Procedure

The ISO Design Development Procedure delineate planning and controls during the design phase to optimize quality, effectiveness, safety, and customer satisfaction prior to manufacturing in conformance with ISO 9001:2015.

This procedure applies to all new product development, as well as to developing significant changes to existing products. (20 pages, 3226 words)

ISO Design Development Responsibilities

All Employees are responsible for ensuring product and process improvement.

The Engineering Manager is responsible for designing, evaluating, testing, and all technical aspects of product and process development.

The Accounting Manager is responsible for evaluating and reporting on the financial aspects of product/process development.

The Marketing Manager is responsible for coordinating product development with the customer base, supervising field trials, finding new markets for the company’s products/processes, and raising awareness of the company’s offerings.

Top Management is responsible for final review and approval of design and development (D&D) projects.

The Product Development Team is responsible for managing the product design-and-development process; may also be known as “the Project Team”.

ISO Design Development Definitions

Design phase – The most important phase of the product life cycle, because inherent quality, effectiveness, and customer satisfaction of the product are established here. No matter how carefully a product may be manufactured or how perfect a quality control program, inherent qualities cannot be improved except through design enhancement.

It is crucial that adequate planning and controls be established, implemented, and maintained during the design phase to optimize quality, effectiveness, safety, and customer satisfaction prior to manufacturing.

Failure Mode and Effects Analysis (FMEA) – Technique for testing design of products in which failures are assumed to occur. The probability of each failure occurring and the result of failure are analyzed. If possible, hazards and faulty performance are designed out of the device; if not, hazards/substandard performance are compensated, reduced, or prevented (by interlocks, warning signs, explicit instructions, alarms, etc.). Risk of failure cannot always be removed from products but can be understood and controlled to the extent possible with existing technology.

Fault Tree Analysis – Deductive, top-down approach to failure mode analysis, where:

  • System failure or safety hazard is assumed;
  • Basic component failure or an event that could cause the assumed system failure or safety hazard is identified; and
  • Computational techniques are used to analyze basic defects, determine failure probabilities, and establish the severity of failure effects.

Key characteristic – Feature of a material, part, or process, variation of which will significantly influence a product’s fit, performance, service life, or manufacturability. Key characteristics are essential to meeting product goals.

Quality Function Deployment (QFD) – Structured approach to defining customer needs or requirements and translating needs into specific plans to produce products to meet those needs. The “voice of the customer” (the term used to describe stated and unstated customer needs or requirements) is captured in a variety of ways (e.g., direct discussion or interviews, surveys, focus groups, customer specifications, observation, warranty data, field reports) and then summarized in a product planning matrix – a “house of quality”. Houses of quality are used to translate higher-level “whats” – needs – into lower-level “hows”, product requirements or technical characteristics to satisfy these needs.

Requirement – Condition that must be met in order to do something; something wanted or needed; something essential to the existence or occurrence of something else.

Verification – Evaluating a system or component during or at the end of the development process to determine if it satisfies specified input requirements.

Validation – Evaluating a system or component during or at the end of the development process to determine if it satisfies actual use conditions.

ISO Design Development Activities

  • Design Inputs
  • Design and Development
  • Design and Development Review
  • Design Verification
  • Design Validation and Testing
  • Project Assessment

ISO Design Development References

  • ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sept., 2015 http://www.iso.org.

ISO Design Development Forms

 

Difference Between Verification and Validation

If you’re tasked with preparing a project management plan, one of the elements of that plan is a test plan. Your test plan should include three distinct tests that you’ll need to perform: verification, validation, and acceptance. Do you know the difference between verification and validation, and how they’re related to design development?

VERIFICATION TESTING

This is testing that ensures the expressed user requirements, gathered in the Project Initiation phase, have been met in the Project Execution phase. One way to do this is to produce a user requirements matrix or checklist and indicate how you would test for each requirement. For example, if the product is required to weigh no more than 15 kg. (about 33 lbs.), the test could be, ”Weigh the object ” does it weigh 15 kg. or less?”, and note “yes” or “no” on the matrix or checklist.

VALIDATION TESTING

This ensures that any implied requirement has been met. It usually occurs in the Project Monitoring and Control phase of project management. Using the above product as an example, you ask the customer, “Why must it be ‘no more than 15 kg.’?” One answer is, “It must be easy to lift by hand.” You could validate that requirement by having twenty different people lift the object and asking each one, “Was the object easily to lift?”If 90% of them said it was easy, you could conclude that the object meets the requirement.

We call this an implied requirement because the answer to “Why?” was not stated: the ”easy to lift” requirement was not clearly specified or defined. Another way to validate an implied requirement is to produce some test objects, or prototypes, and have the customer evaluate them in the field.

ACCEPTANCE TESTING

Next comes Acceptance Testing, the official approval of your deliverables by the customer. Your customer may accept your verification and validation test results and accept the object. The customer may also have their own “easy lifting expert” on hand and use them for the acceptance test. Acceptance testing often occurs at the end of the Project Monitoring and Control phase, but it can also take place at the beginning of the Project Review and Close phase.

Design Review Checklist ISO Template | QP1100-1

Design Review Checklist ISO Template

A Design Review Checklist ISO Template that is appropriate to the product should be constructed, using QP1100-1 DESIGN REVIEW CHECKLIST for guidance. The checklist may include, but need not be limited to, the following:

  • Physical characteristics, constraints, and aesthetic specifications;
  • Safety needs of the user, environmental compatibility, and the need for failsafe characteristics;
  • Considerations of unintended uses and misuses;
  • Compliance with regulatory requirements and industry standards;
  • Labeling, including warnings, identification and traceability, operating and maintenance instructions;
  • Packaging, handling, shelf life, storage and stability requirements; and more.

The design review should identify and anticipate problem areas and inadequacies, and initiate corrective actions to ensure that the final design and supporting data meet customer requirements. The Product Development Team should refer to the Design Review Checklist ISO Template when periodic project reviews are conducted.

Design Review Checklist ISO Template Details

Pages: 02
Words: 209
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: Quality Assurance Policy Statement and Procedures
Procedure: ISO Design Development Procedure QP1100
Type: Checklist

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Document Control Log ISO Template | QP1000-2

Document Control Log ISO Template

The Document Controller should log external documents in the Document Control Log ISO Template and distribute to approved/interested parties. QP1000-2 DOCUMENT CONTROL DATABASE should contain, at a minimum, the following information on each document:

  • Document number;
  • Document title;
  • Current revision number/ID;
  • Revision date;
  • Effective date; and
  • Distribution list.

The Document Controller should distribute (or limit distribution of electronic) documents only to locations shown on the database. Any previous versions of documents should be removed from work areas as new revisions are released. In the case of electronic document distribution and control systems, access permission for any previous version must be withdrawn or denied.

Document Control Log ISO Template Details

Pages: 01
Words: 38
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: Quality Assurance Policy Statement and Procedures
Procedure: ISO Document Control Procedure QP1000
Type: Log

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Document Request ISO Template | QP1000-1

Document Request ISO Template

To submit a change, the requestor should obtain a current copy of the document and “red-line” requested changes on the copy. Then they should fill out a Document Request ISO Template, attach the new/changed document, and submit this to his/her Department Manager for review. After reviewing the request, the Department Manager should submit QP1000-1 DOCUMENT REQUEST and any attachments to Quality Management, who should review the request to ensure the document conforms to the QMS.

If Quality finds the requested document (change) does not conform to the QMS, Quality should return the Document Request form and attachments to the Department manager with an explanation. If the requested document is determined to conform to the QMS, Quality should determine who else needs to review the new/changed document and submit the form, with attachments, to those individuals for their review and approval. Upon receiving the necessary approvals, Quality should forward the original QP1000-1 DOCUMENT REQUEST and attachments to Document Control. Flow diagrams, engineering drawings, and other documents generated outside the company (e.g., supplier blueprints, industry standards) are to be submitted to The Document Controller with a Document Request form.

Document Request ISO Template Details

Pages: 01
Words: 151
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: Quality Assurance Policy Statement and Procedures
Procedure: ISO Document Control Procedure QP1000
Type: Form

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Documented Information Control Procedure ISO 9001 2015 | QP1000

Documented Information Control Procedure

The Documented Information Control Procedure defines the methods and responsibilities for controlling documents used to provide work direction or set policy and defines methods for document revision, approval, and distribution.

This procedure applies to all documents required by the ISO 9001 :2015 and your QMS. Documents of internal or external origin are included. (12 pages, 2304 words)

Documented Information Control Responsibilities:

Document Control is responsible for controlling the Quality Management System documents, records, procedures and work instructions related to the QMS, and all internal and external documents required by the QMS.

Department Managers and Supervisors are responsible for ensuring that the latest versions of relevant documents are available at the point(s) of use, that these documents are legible, and that they are understood and followed. They are also responsible for reviewing and responding to document change requests in a timely manner.

The Engineering Manager is responsible for control of external and internal drawings (e.g., blueprints, schematics, and technical drawings), bills of material (BOM), and customer specifications and requirements documentation.

Quality Management is responsible for ensuring that documents conform to applicable standards.

Top Management is responsible for reviewing requests and giving final approvals to the Quality Manual and QMS-related procedures.

Documented Information Control Definitions:

Controlled Document – Document that provides information or direction for performance of work within the scope of the QMS. Characteristics of control include such things as revision number (letter), signatures indicating review and approval, and controlled distribution.

Document – Information and its supporting medium. The medium may be paper, magnetic, electronic, optical, photograph, or sample product.

Documented Information – Information determined to be necessary for the effectiveness of the QMS. This may include procedures, work instructions, or evidence (record) that an event (e.g., physical or electronic document, photograph, or product sample) has occurred and, in the aggregate, can be analyzed and conclusions drawn regarding QMS effectiveness.

External Document – Document originating outside the company (e.g., customer drawings, industry and/or international standards, suppliers’ equipment maintenance manuals, or references) that provides information or direction for performing activities within the scope of the QMS.

Form – Printed, typed, or electronic document with blank spaces for insertion of required or requested information (e.g., tax form, order form).

Internal Document – Document of internal origin (developed entirely by or completed by the company) that provides information or direction for the performance of activities within the scope of the Quality Management System. Examples include, but are not limited to, the procedures contained in the company’s QMS manual.

Procedure – Process description or series of acts involved in a particular form of work; detailed elements of a process used to produce a specified result.

Quality Management System (QMS) – Ordered, well-documented system of policies, processes, procedures and records, designed to assure product quality, effectiveness, customer satisfaction and promote continual improvement of products and processes.

Quality Manual – Formal, authorized document setting out the quality policies, systems, procedures, and practices of an organization.

Uncontrolled Document – Document that is not a part of the controlled document system.  Uncontrolled documents may not be used to provide work direction or information necessary for the performance of work.

Work Instruction – Detailed description of how to perform a process in steps to allow an inexperienced person to perform the work.

Documented Information Control Activities

  • Document Format
  • Documented Information
  • Document Approval
  • Temporary Document Changes
  • Document Revisions
  • External Documents
  • Document Distribution

Documented Information Control References

  • ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sept., 2015 http://www.iso.org.

Documented Information Control Forms

 

Employee Competence Matrix ISO Template | QP1070-1

Employee Competence Matrix ISO Template

The Human Resources Manager should screen applications and resumes to select candidates with the appropriate competencies for positions to be filled, using QP1070-1 EMPLOYEE COMPETENCE MATRIX (SAMPLE) as a guide. The Employee Competence Matrix ISO Template organizes position requirements based on education, experience, knowledge, and skills. Hiring supervisors and managers interview candidates to identify and select candidates who possess the minimum competencies required for the position.

  • The Human Resources Manager may verify application or resume information of the final candidates by checking references or previous employers.
  • If the best candidate does not have the minimum competence required, the hiring manager may arrange for training or other actions, as appropriate, to satisfy the requirements for the position.
  • Until the employee demonstrates the required competencies, employment is considered probationary. Probationary employees require supervision adequate to ensure their performance does not have a negative impact on product or process quality.

The hiring supervisor or manager should evaluate the effectiveness of training or other action taken with respect to the appropriate Job Description.

Employee Competence Matrix ISO Template Details

Pages: 01
Words: 218
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: Quality Assurance Policy Statement and Procedures
Procedure: ISO Competence Training Awareness Procedure QP1070
Type: Guide

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Employee Development Plan ISO Template | QP1070-2

Employee Development Plan ISO Template

The Human Resources Manager, in conjunction with the supervisor/manager and the employee in question, should develop and maintain a training plan for each employee, using QP1070-2 EMPLOYEE DEVELOPMENT PLAN as a guide. The Human Resources Manager should then periodically compare every employee’s actual training record with his or her Employee Development Plan ISO Template to ensure that the employee is making suitable progress toward their individual competence and training goals.

The Employee Development Plan covers information regarding training and other development actions, such as dates and competency. A clear understanding – and documentation – of the degree to which company objectives for providing training and development have been achieved is crucial.

The Human Resources Manager should ensure that the company training and development program produces the desired result -a highly skilled, competent workforce – thereby meeting the stated objectives. The Human Resources Manager should measure employee knowledge, skills, and the effectiveness of their training and development program.

Employee Development Plan ISO Template Details

Pages: 02
Words: 38
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: Quality Assurance Policy Statement and Procedures
Procedure: ISO Competence Training Awareness Procedure QP1070
Type: Form

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Employee Group Training Record ISO Template | QP1070-3

Employee Group Training Record ISO Template

The Employee Group Training Record ISO Template keeps track of employee names, employee IDs, and instructor initials. Managers should ensure training is provided to their employees as changes in products/services, business requirements, statutes/regulations, and technologies dictate. The Human Resources Manager should maintain a record of each employee’s job-related training, such as QP1070-3 EMPLOYEE GROUP TRAINING RECORD.

Company employees whose work affects the quality of company products should be evaluated periodically (this should be done annually, at a minimum) with regard to QMS competence and training. Records of such evaluations should be kept in the employee’s file. The Human Resources Manager should then periodically compare every employee’s actual training record with his or her plan to ensure that the employee is making suitable progress toward their individual competence and training goals.

Employee Group Training Record ISO Template Details

Pages: 01
Words: 17
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: ISO 9001
Procedure: ISO Competence Training Awareness Procedure QP1070
Type: Log

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Engineering Change Notice ISO Template | QP1110-1

Engineering Change Notice ISO Template

For minor product/process changes or for changes to documentation only, Engineering may elect to implement the change by issuing an Engineering Change Notice ISO Template. QP1110-1 ENGINEERING CHANGE NOTICE covers the model or part number, description of change, assemblies affected, reason for change, and more. On reviewing design changes, Design Engineers should issue an Engineering Change Notice.

Engineering should complete Part I of the Engineering Change Notice ISO Template, obtain the appropriate authorization(s), enter the change in the Product Development file/database, and assign a change number for tracking, logging, and filing purposes. The Design Change team should record verification and validation information in Part II of QP1110-1 ENGINEERING CHANGE NOTICE.

Design Engineers should complete Part III after verification and validation are complete, to ensure that product-related documentation affected by the change is appropriately updated in a timely manner. Design Engineers should have overall responsibility for coordinating, scheduling, and executing documentation changes with Document Control. All design changes should be adequately communicated and documented and implemented within the specified time frame.

Engineering Change Notice ISO Template Details

Pages: 03
Words: 268
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: ISO 9001
Procedure: ISO Design Change Procedure QP1110
Type: Form

External Property Procedure ISO 9001 2015 | QP1160

External Property Procedure

The External Property Procedure defines the methods to be used to identify, verify, protect, and safeguard customer property while it is in your company’s control in conformance with ISO 9001:2015.

This procedure applies to any items supplied by customers, including components and materials supplied for inclusion in products, tooling and fixtures used in manufacturing and inspection processes, and intellectual property. (6 pages, 690 words)

External Property Responsibilities:

Customer Service is responsible for notifying Production and Purchasing of the customer’s intent to supply materials during the quotation and contract review processes and coordinating delivery of customer supplied materials.

Inventory Control is responsible for identifying items as coming from or belonging to the customer, keeping those items segregated from other production materials/tools, and maintaining control of customer inventory.

Production or Engineering is responsible for managing customer supplied tooling and fixtures.

Engineering is responsible for managing and safeguarding customer’s intellectual property.

External Property Definitions:

Intellectual property – Creation(s) of property having commercial value, including copyrighted (e.g., literary or artistic), ideational property (e.g., patents, appellations of origin, business methods/processes), or real value (e.g. credit card numbers, bank account, electronic banking).

External Property Activities

  • Receipt, Inspection, and Stocking of Customer Supplied Items
  • Intellectual Property
  • Unsuitable or Missing Items
  • Ongoing Control

External Property References

  • ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sept., 2015 http://www.iso.org.

External Property Forms

 

 

 

External Provider Evaluation Procedure ISO 9001 2015 | QP1120

External Provider Evaluation Procedure

The External Provider Evaluation Procedure defines the criteria and methods for selecting and evaluating vendors for addition to or disqualification from your company’s approved vendor list.

This procedure applies to all vendors of products, materials, and services that directly affect the quality of your company’s products/services. (18 pages, 2381 words)

External Provider Evaluation Responsibilities:

The Procurement Manager is responsible for initial vendor identification and for collection of business information related to the potential vendor. The Procurement Manager is also responsible for maintaining vendor performance data for ongoing evaluation.

The Accounting Manager is responsible for evaluation of potential vendors’ financial information.

The Quality Assurance Manager is responsible for evaluating vendors’ quality systems as appropriate and for reporting vendor quality performance.

External Provider Evaluation Definitions:

Critical external provider – an organization that produces processes, products, and services that must conform to requirements. Contrast that with a non-critical external provider of commodities (e.g., office supplies) where quality is not as critical, tolerances can be fairly wide, and there are commonly available alternatives.

Certificate of Conformance – Is issued by an external provider certifying the item was made in accordance with required specifications. It may include test results or process specifications.

ISO-certified external provider – an organization that has demonstrated (or can demonstrate) that its processes conform to ISO 9001 and has implemented a system of continual improvement.

Provisional approval – Partial approval, usually granted by a customer to an external provider, pending correction of specified deficiencies.

Qualification approval – Approval given a part, component, or material that has been evaluated against a standard and approved.

External provider – an organization that provides processes, products, or services that are intended for incorporation into the organization’s own products and services, provided directly to the customer on behalf of the organization, or a process or part of a process is provided as a result of a decision by the organization

External Provider Evaluation Procedure Activities

  • External Provider Files
  • External Provider Screening
  • External Provider Purchase Orders
  • External Provider Evaluation
  • External Provider Notice
  • External Provider Removal

External Provider Evaluation Procedure References

  • ISO 9001:2015, “Quality Management System Requirements”, International Organization for Standardization (ISO), Sep., 2015.
  • Regulation/Legislation

External Provider Evaluation Procedure Forms

Great Supplier Relationships

Great supplier relationships are built on more than price, they are built on delivering to the customer what the customer wants. How do you build your supplier relationships?

In a May Issue of a local restaurant and cooking magazine, the featured article was about the important relationships some of our city’s best chefs have with local farmers and growers.

In the half-dozen great supplier relationships profiled, rarely does the topic touch on price (and when price is mentioned, it focuses on the great value). The emphasis is on other features: freshness, taste, quality, variety, shared attitudes.

GREAT LOCAL SUPPLIERS

These chefs know their customers. The chefs understand that people come to their restaurant because they want a great dining experience, not because they want to save a dollar or two on a meal. The chefs know the importance of having great local suppliers in order to deliver that great dining experience.

SUPPLIER CHOICE IMPACTS CUSTOMERS

Any business that uses suppliers can take a lesson from this. Too often a business focuses heavily on unit price from their suppliers, and they forget to focus on total cost, relationships, and even more importantly, how choosing competitive suppliers impacts their customers.

SUPPLIER TOTAL COST OF OWNERSHIP

Are you really saving money if you select a supplier based on unit cost, but shipments are late, parts are defective, or they require constant hand-holding to understand specifications or other criteria?

The union shop across town may not be able to compete with a third-world supplier on a unit price basis, but it you account for the total cost of ownership of foreign suppliers (i.e. of testing and dealing with defective materials, extra inventory or production delays because shipments are traveling halfway around the world, the personal relationship and convenience of dealing with a local supplier), you may be saving money in the long run if the local supplier consistently delivers quality parts on time with little or no oversight.

Plus, if supplier problems causes you to lose a customer, how much have you really saved?

Great supplier relationships are built on delivering to the customer what the customer wants based on quality, timely delivery, and value. How valuable are your suppliers to your customers?

First Article Inspection Report ISO FAI Template | QP1210-2

First Article Inspection Report ISO FAI Template

A First Article Inspection Report ISO FAI Template may be required on some items (e.g., new parts, part revisions). If the company requires an First Article Inspection report of the vendor, the Quality Assurance Manager should verify that it addresses the company’s requirements, using QP1210-2 FIRST ARTICLE INSPECTION REPORT for guidance. If multiple part numbers are included in a shipment, each part will be segregated and handled (e.g., inspected, put into stock) according to applicable requirements.

A First Article Inspection is defined as the process monitoring of key characteristics to ensure that parts can be manufactured continually, inexpensively, in compliance with specifications, and with minimum variation. The Quality Assurance Manager should periodically pull samples of incoming parts, components, materials, etc., to verify that the items conform to requirements and validate vendors’ test reports and certifications. The Quality Assurance Manager should report to Top Management on Receiving-Inspection activity on an as-needed basis and/or at Management Review meetings.

First Article Inspection Report ISO FAI Template Details

Pages: 01
Words: 123
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: Quality Assurance Policy Statement and Procedures
Procedure: ISO Receiving Inspection Procedure QP1210
Type: Report

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Identification Traceability Procedure ISO 9001 2015 | QP1150

ISO Identification Traceability Procedure

The ISO Identification Traceability Procedure outlines the content and format requirements for identification and caution labels attached to products in conformance with ISO 9001:2015.

This procedure applies to all products manufactured, distributed, or sold by your company. (6 pages, 1249 words)

ISO Identification Traceability Responsibilities

Receiving is responsible for identifying raw materials, parts, components, etc., as they are delivered to the company, confirming completeness and initial acceptability of incoming orders, and moving inspected items to appropriate areas.

Manufacturing (Processing) is responsible for maintaining parts, components, materials, and finished product identification through final processing and packaging.

Quality is responsible for maintenance of identification and traceability records, where required.

ISO Identification Traceability Definitions

Finished product – Product that will undergo no further processing or transformation within the company.

Material – Elements, constituents, or substances of which something is composed or can be made (including, but not limited to: raw and processed material: parts: components; assemblies: fuels: and other items which may be worked into a more finished form in performance of a contract).

Traceability – Ability to trace path, history, application, or location of something (document, work product, part, subassembly, etc.) by means of recorded information.

ISO Identification Traceability Procedure Activities

  • Identification and Traceability – General
  • Identification /Traceability System Development
  • Identifying / Tracing Items
  • Identification/Traceability Review

ISO Identification Traceability Procedure References

Individual Training Record ISO Template | QP1070-4

Individual Training Record ISO Template

The Individual Training Record ISO Template keeps track of the date, subject, and trainer. Managers should ensure training is provided to their employees as changes in products/services, business requirements, statutes/regulations, and technologies dictate. The Human Resources Manager should maintain a record of each employee’s job-related training, such as QP1070-4 INDIVIDUAL TRAINING RECORD.

The training needs of individual employees should be assessed within the context of the organization’s strategic goals and should assure employees’ ongoing competence and development. Department Managers should periodically conduct a performance assessment of every departmental employee. The Human Resources Manager should then periodically compare every employee’s actual training record with his or her plan to ensure that the employee is making suitable progress toward their individual competence and training goals.

Individual Training Record ISO Template Details

Pages: 01
Words: 09
Format: Microsoft Word 2013 (.docx)
Language: English
Manual: ISO 9001
Procedure: ISO Competence Training Awareness Procedure QP1070
Type: Log

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Infrastructure Control ISO 9001 2015 | QP0700

ISO Infrastructure Control Procedure

The ISO Infrastructure Control Procedure (20 pages, 2100 words) describes the actions taken for proper acquisition, installation, handling, tracking, and disposal of infrastructure and environment, in conformance ISO 9001:2015, to meet defined requirements for:

  • buildings and associated utilities;
  • equipment including hardware and software;
  • transportation resources;
  • information and communication technology; and
  • human and physical factors (social, psychological, physical).

ISO Infrastructure Control Responsibilities

The Infrastructure Asset Manager is responsible for tracking infrastructure assets through their acquisition, distribution, use, and disposal and for ensuring that all infrastructure assets conform to standards.

Top Management is responsible for approving acquisition or disposal of infrastructure assets, reviewing plans with the infrastructure Asset Manager on a regular basis to ensure its continued conformance.

The Tech Support Manager is responsible for logging, testing, accepting, installing, maintaining, and preparing for disposal of infrastructure assets. Tech Support is responsible for ordering and receiving software. Tech Support is also responsible for updating the infrastructure Asset Inventory when any changes to infrastructure assets have been made.

Department Managers are responsible and accountable for furniture, equipment, machinery, and other capital assets in their departments and will maintain control over capital assets.

The Accounting Manager will assist and evaluate any department’s capital asset control procedures.

The Purchasing Manager is responsible for ordering physical infrastructure assets.

Shipping/Receiving is responsible for receiving, distribution, and final disposal of infrastructure assets.

Financial Management is responsible for approving acquisition or disposal of infrastructure assets when their value is $5000 or greater. Finance is also responsible for ensuring corresponding updates to the appropriate financial documents.

ISO Infrastructure Control Definitions

Infrastructure Asset – Any computer, hardware, software, Technology-based Company information, related documentation, licenses, contracts or other agreements, etc. In this context, “asset” and “ infrastructure asset” are understood to be the same.

Nonconforming infrastructure asset – Any infrastructure asset that does not conform to Company requirements; infrastructure assets that don’t work at all or don’t work as expected are “nonconforming.”

ISO Infrastructure Control Activities

  • Infrastructure Planning
  • Infrastructure Acquisition
  • Infrastructure Inspection, Acceptance, & Distribution
  • Infrastructure Disposal
  • Infrastructure Maintenance

ISO Infrastructure Control References

  • ISO 9001:2015, “Quality Management Systems – Requirements”, International Organization for Standardization (ISO), Sept., 2015 http://www.iso.org.
  • Statutory and Regulatory Requirements
    • Laws & Regulations: Certain businesses (e.g., food processors, medical, chemical and pharmaceutical manufacturers) are required to identify, evaluate, and manage risks (a) to comply with laws and regulations and (b) because their products or processes have the potential to adversely affect worker or consumer health and safety. These organizations are strongly urged to seek the help of qualified and competent legal counsel, as well as certified and experienced health and safety experts.
    • RESOURCE CONSERVATION & RECOVERY ACT (RCRA)
    • CODE OF FEDERAL REGULATIONS, TITLE 40 – PROTECTION OF ENVIRONMENT, Rev July 1 2000 (40 CFR 260-299)

ISO Infrastructure Control Forms

  • QP0700-1 Asset Requisition/Disposal Form
  • QP0700-2 Asset Acquisition List
  • QP0700-3 Tech Support Receiving Log
  • QP0700-4 Nonconforming Asset Form
  • QP0700-5 Asset Inventory Database
  • QP0700-6 Network Map