What is involved in Quality Management Systems

Find out what the related areas are that Quality Management Systems connects with, associates with, correlates with or affects, and which require thought, deliberation, analysis, review and discussion. This unique checklist stands out in a sense that it is not per-se designed to give answers, but to engage the reader and lay out a Quality Management Systems thinking-frame.

How far is your company on its Quality Management Systems journey?

Take this short survey to gauge your organization’s progress toward Quality Management Systems leadership. Learn your strongest and weakest areas, and what you can do now to create a strategy that delivers results.

To address the criteria in this checklist for your organization, extensive selected resources are provided for sources of further research and information.

Start the Checklist

Below you will find a quick checklist designed to help you think about which Quality Management Systems related domains to cover and 229 essential critical questions to check off in that domain.

The following domains are covered:

Quality Management Systems, Quality management system, 21 CFR 820, Business process, Capability Maturity Model Integration, Cleaner production, Clinical Quality Management System, Code of Federal Regulations, Conformance testing, Continuous improvement, Corrective actions, Corrective and preventive action, Customer satisfaction, Data Management, Deming Prize, Design controls, EFQM Excellence Model, European Foundation for Quality Management, European Quality in Social Services, Good Manufacturing Practice, ISO 13485, ISO 14001, ISO 19011, ISO 9000, ISO 9001, Industrial Revolution, Internal audits, International Organization for Standardization, Manufacturing process management, Measurement systems analysis, Medical device, Medical devices directive, Natural Step, New product development, Organizational structure, Person-centred planning, Preventive actions, Process modeling, Production plans, Quality assurance, Quality control, Quality management, Quality objectives, Quality policy, Social exclusion, Standard operating procedure, Statistical process control, Technical documentation, Total quality management, U.S. Food and Drug Administration, Verification and validation, W. Edwards Deming:

Quality Management Systems Critical Criteria:

Check Quality Management Systems risks and optimize Quality Management Systems leadership as a key to advancement.

– What are the short and long-term Quality Management Systems goals?

– What are the usability implications of Quality Management Systems actions?

– How to Secure Quality Management Systems?

Quality management system Critical Criteria:

Check Quality management system issues and mentor Quality management system customer orientation.

– Where do ideas that reach policy makers and planners as proposals for Quality Management Systems strengthening and reform actually originate?

– Is Quality Management Systems dependent on the successful delivery of a current project?

– How do we manage Quality Management Systems Knowledge Management (KM)?

21 CFR 820 Critical Criteria:

Canvass 21 CFR 820 adoptions and explore and align the progress in 21 CFR 820.

– Why is it important to have senior management support for a Quality Management Systems project?

– What is the source of the strategies for Quality Management Systems strengthening and reform?

Business process Critical Criteria:

Look at Business process outcomes and adopt an insight outlook.

– Have the segments, goals and performance objectives been translated into an actionable and realistic target business and information architecture expressed within business functions, business processes, and information requirements?

– What are the disruptive Quality Management Systems technologies that enable our organization to radically change our business processes?

– Has business process Cybersecurity has been included in continuity of operations plans for areas such as customer data, billing, etc.?

– Do you design data protection and privacy requirements into the development of your business processes and new systems?

– Do the functional areas need business process integration (e.g., order entl. billing, or Customer Service)?

– Do we have detailed information on the business process for refunds and charge backs if they are required?

– If we process purchase orders; what is the desired business process around supporting purchase orders?

– If we accept wire transfers what is the desired business process around supporting wire transfers?

– How do clients contact client services with any questions about business processes?

– If we accept checks what is the desired business process around supporting checks?

– What vendors make products that address the Quality Management Systems needs?

– Will existing staff require re-training, for example, to learn new business processes?

– What would Eligible entity be asked to do to facilitate your normal business process?

– Do changes in business processes fall under the scope of Change Management?

– What business process supports the entry and validation of the data?

– What core business processes drive our industry and channel today?

– On what basis would you decide to redesign a business process?

– What is the business process?

Capability Maturity Model Integration Critical Criteria:

Consult on Capability Maturity Model Integration tactics and point out improvements in Capability Maturity Model Integration.

– Are accountability and ownership for Quality Management Systems clearly defined?

– Does our organization need more Quality Management Systems education?

– How do we Lead with Quality Management Systems in Mind?

Cleaner production Critical Criteria:

Chat re Cleaner production visions and summarize a clear Cleaner production focus.

– What may be the consequences for the performance of an organization if all stakeholders are not consulted regarding Quality Management Systems?

– Do those selected for the Quality Management Systems team have a good general understanding of what Quality Management Systems is all about?

– How is the value delivered by Quality Management Systems being measured?

Clinical Quality Management System Critical Criteria:

Map Clinical Quality Management System leadership and assess and formulate effective operational and Clinical Quality Management System strategies.

– Who will be responsible for documenting the Quality Management Systems requirements in detail?

– Can we do Quality Management Systems without complex (expensive) analysis?

– Are there Quality Management Systems problems defined?

Code of Federal Regulations Critical Criteria:

Communicate about Code of Federal Regulations outcomes and triple focus on important concepts of Code of Federal Regulations relationship management.

– What role does communication play in the success or failure of a Quality Management Systems project?

– What potential environmental factors impact the Quality Management Systems effort?

– What are the long-term Quality Management Systems goals?

Conformance testing Critical Criteria:

Add value to Conformance testing tasks and probe the present value of growth of Conformance testing.

– Think about the people you identified for your Quality Management Systems project and the project responsibilities you would assign to them. what kind of training do you think they would need to perform these responsibilities effectively?

– When a Quality Management Systems manager recognizes a problem, what options are available?

Continuous improvement Critical Criteria:

Meet over Continuous improvement outcomes and work towards be a leading Continuous improvement expert.

– Which customers cant participate in our Quality Management Systems domain because they lack skills, wealth, or convenient access to existing solutions?

– So, how do you avoid getting wrapped up in the complexities and use systems thinking to guide change and continuous improvement?

– Is there a Quality Management Systems Communication plan covering who needs to get what information when?

– Has organization developed a plan for continuous improvement?

– How will you measure your Quality Management Systems effectiveness?

– How do we place an emphasis on continuous improvement?

Corrective actions Critical Criteria:

Chart Corrective actions goals and get out your magnifying glass.

– Has management taken appropriate corrective actions related to reports from external sources for their implications for enterprise Risk Management?

– Do we review the EFFECTIVENESS of corrective actions -were the actions taken successful in eliminating the cause(s) of nonconformities?

– How likely is the current Quality Management Systems plan to come in on schedule or on budget?

– What is the frequency of product failures and adequacy of corrective actions?

– How to deal with Quality Management Systems Changes?

Corrective and preventive action Critical Criteria:

Explore Corrective and preventive action management and shift your focus.

– Record-keeping requirements flow from the records needed as inputs, outputs, controls and for transformation of a Quality Management Systems process. ask yourself: are the records needed as inputs to the Quality Management Systems process available?

– How do you determine the key elements that affect Quality Management Systems workforce satisfaction? how are these elements determined for different workforce groups and segments?

– Are appropriate corrective and preventive actions taken?

Customer satisfaction Critical Criteria:

Read up on Customer satisfaction visions and work towards be a leading Customer satisfaction expert.

– Do we Make sure to ask about our vendors customer satisfaction rating and references in our particular industry. If the vendor does not know its own rating, it may be a red flag that youre dealing with a company that does not put Customer Service at the forefront. How would a company know what to improve if it had no idea what areas customers felt were lacking?

– What is the difference, if any, in customer satisfaction between the use and results of agile-driven software development methods and the use and results of plan-driven software development software development methods?

– Are there any easy-to-implement alternatives to Quality Management Systems? Sometimes other solutions are available that do not require the cost implications of a full-blown project?

– How important are hard measurements that show return on investment compared to soft measurements that demonstrate customer satisfaction and public perception?

– Performance Standard: What should be the standards for completeness, reliability, accuracy, timeliness, customer satisfaction, quality and/or cost?

– Has it re-engineered or redesigned processes, and leveraged technologies to improve responsiveness, Customer Service and customer satisfaction?

– How does the company manage the design and delivery of products and services that promise a high level of customer satisfaction?

– Is the Customer Satisfaction Process something which you think can be automated via an IVR?

– How will we insure seamless interoperability of Quality Management Systems moving forward?

– How does the firm measure and monitor client service and customer satisfaction?

– What employee characteristics drive customer satisfaction?

– How can skill-level changes improve Quality Management Systems?

Data Management Critical Criteria:

Apply Data Management management and perfect Data Management conflict management.

– What are the data access requirements for standard file, message, and data management?

– How will the repository monitor access to ensure that restrictions are being enforced?

– Assignment completeness are all parameters assigned and are all elements considered?

– If your data is being stored elsewhere, do they have a backup policy in place?

– Are there any data with privacy concerns to sharing (e.g., human subjects)?

– What metrics could assist with reappraising data for long-term retention?

– Which indices and catalogs should reference the availability of the data?

– Will you be using a standard naming format and version control?

– How are operational information/Data Management decisions made?

– Will any permission restrictions need to be placed on the data?

– Which file formats will you use for your data, and why?

– How will the dataset be licensed if rights exist?

– What is data management and why is it important?

– What aggregate data would you want to capture?

– How frequently do we need to access the data?

– What is your backup plan for the data?

– How will you manage data security?

– Who will have access to the data?

– Who decides which data to keep?

– How will data be collected?

Deming Prize Critical Criteria:

Judge Deming Prize risks and work towards be a leading Deming Prize expert.

– To what extent does management recognize Quality Management Systems as a tool to increase the results?

– Are there Quality Management Systems Models?

Design controls Critical Criteria:

Contribute to Design controls tasks and devote time assessing Design controls and its risk.

– Consider your own Quality Management Systems project. what types of organizational problems do you think might be causing or affecting your problem, based on the work done so far?

– How can we incorporate support to ensure safe and effective use of Quality Management Systems into the services that we provide?

EFQM Excellence Model Critical Criteria:

Reorganize EFQM Excellence Model failures and use obstacles to break out of ruts.

– Think about the functions involved in your Quality Management Systems project. what processes flow from these functions?

– Do the Quality Management Systems decisions we make today help people and the planet tomorrow?

– What are the Key enablers to make this Quality Management Systems move?

European Foundation for Quality Management Critical Criteria:

Win new insights about European Foundation for Quality Management tasks and innovate what needs to be done with European Foundation for Quality Management.

– Will Quality Management Systems deliverables need to be tested and, if so, by whom?

– Why is Quality Management Systems important for you now?

European Quality in Social Services Critical Criteria:

Use past European Quality in Social Services engagements and display thorough understanding of the European Quality in Social Services process.

– What will be the consequences to the business (financial, reputation etc) if Quality Management Systems does not go ahead or fails to deliver the objectives?

– What are all of our Quality Management Systems domains and what do they do?

Good Manufacturing Practice Critical Criteria:

X-ray Good Manufacturing Practice tasks and report on setting up Good Manufacturing Practice without losing ground.

– What other jobs or tasks affect the performance of the steps in the Quality Management Systems process?

ISO 13485 Critical Criteria:

Examine ISO 13485 quality and give examples utilizing a core of simple ISO 13485 skills.

– Do Quality Management Systems rules make a reasonable demand on a users capabilities?

ISO 14001 Critical Criteria:

Boost ISO 14001 projects and get out your magnifying glass.

– Is Supporting Quality Management Systems documentation required?

ISO 19011 Critical Criteria:

Mine ISO 19011 risks and gather ISO 19011 models .

– Is maximizing Quality Management Systems protection the same as minimizing Quality Management Systems loss?

ISO 9000 Critical Criteria:

Pay attention to ISO 9000 decisions and ask what if.

– What process management and improvement tools are we using PDSA/PDCA, ISO 9000, Lean, Balanced Scorecard, Six Sigma, something else?

– Does Quality Management Systems systematically track and analyze outcomes for accountability and quality improvement?

– Do not ISO 9000 and CMM certifications loose their meaning when applied to the software industry?

– Does Quality Management Systems analysis isolate the fundamental causes of problems?

ISO 9001 Critical Criteria:

Study ISO 9001 failures and get out your magnifying glass.

– Does a supplier having an ISO 9001 or AS9100 certification automatically satisfy this requirement?

– What sources do you use to gather information for a Quality Management Systems study?

– Do we have past Quality Management Systems Successes?

Industrial Revolution Critical Criteria:

Refer to Industrial Revolution management and pioneer acquisition of Industrial Revolution systems.

Internal audits Critical Criteria:

Think about Internal audits goals and correct Internal audits management by competencies.

– Do you monitor the effectiveness of your Quality Management Systems activities?

– Are assumptions made in Quality Management Systems stated explicitly?

International Organization for Standardization Critical Criteria:

Closely inspect International Organization for Standardization visions and use obstacles to break out of ruts.

– Among the Quality Management Systems product and service cost to be estimated, which is considered hardest to estimate?

Manufacturing process management Critical Criteria:

Steer Manufacturing process management issues and gather Manufacturing process management models .

– What other organizational variables, such as reward systems or communication systems, affect the performance of this Quality Management Systems process?

Measurement systems analysis Critical Criteria:

Survey Measurement systems analysis results and forecast involvement of future Measurement systems analysis projects in development.

– Will new equipment/products be required to facilitate Quality Management Systems delivery for example is new software needed?

Medical device Critical Criteria:

Model after Medical device issues and define what our big hairy audacious Medical device goal is.

– What are the key elements of your Quality Management Systems performance improvement system, including your evaluation, organizational learning, and innovation processes?

– What are your most important goals for the strategic Quality Management Systems objectives?

Medical devices directive Critical Criteria:

Communicate about Medical devices directive decisions and tour deciding if Medical devices directive progress is made.

– Do we all define Quality Management Systems in the same way?

– What are current Quality Management Systems Paradigms?

– How do we keep improving Quality Management Systems?

Natural Step Critical Criteria:

Mix Natural Step visions and maintain Natural Step for success.

– Will Quality Management Systems have an impact on current business continuity, disaster recovery processes and/or infrastructure?

– Which individuals, teams or departments will be involved in Quality Management Systems?

New product development Critical Criteria:

Coach on New product development planning and find out what it really means.

– A dramatic step toward becoming a learning organization is to appoint a chief training officer (CTO) or a chief learning officer (CLO). Many organizations claim to value Human Resources, but how many have a Human Resources representative involved in discussions about research and development commercialization, new product development, the strategic vision of the company, or increasing shareholder value?

– Project type: what percent of resources should go to new product developments?

– Which step in new product development you think is the most important?

– Does Quality Management Systems appropriately measure and monitor risk?

– What are the steps in the new product development process?

– How can new product development be sped up?

Organizational structure Critical Criteria:

Troubleshoot Organizational structure tactics and probe the present value of growth of Organizational structure.

– Do we cover the five essential competencies-Communication, Collaboration,Innovation, Adaptability, and Leadership that improve an organizations ability to leverage the new Quality Management Systems in a volatile global economy?

– Another critical success factor is that appropriate governance needs to be in place. That is, is an appropriate organizational structure in place to manage the organization facing the cloud computing solution?

– Do you have a clearly defined organizational structure at organization level in order to sustain the risk management process?

– How will the existing culture and organizational structure be impacted by agile project management?

– How to manage workflows and projects, that are inherently distributed outside the organizational structure?

– What does a typical data warehouse and business intelligence organizational structure look like?

– Organizational structure for international business?

– What Organizational Structure is Required?

– How can we improve Quality Management Systems?

Person-centred planning Critical Criteria:

Troubleshoot Person-centred planning results and check on ways to get started with Person-centred planning.

– Why should we adopt a Quality Management Systems framework?

Preventive actions Critical Criteria:

Prioritize Preventive actions projects and shift your focus.

– Are preventive actions taken appropriate to the impact of the potential problems?

– What are the Essentials of Internal Quality Management Systems Management?

Process modeling Critical Criteria:

Value Process modeling goals and give examples utilizing a core of simple Process modeling skills.

– In the case of a Quality Management Systems project, the criteria for the audit derive from implementation objectives. an audit of a Quality Management Systems project involves assessing whether the recommendations outlined for implementation have been met. in other words, can we track that any Quality Management Systems project is implemented as planned, and is it working?

– How do we go about Comparing Quality Management Systems approaches/solutions?

Production plans Critical Criteria:

Probe Production plans projects and mentor Production plans customer orientation.

– Does the Quality Management Systems task fit the clients priorities?

Quality assurance Critical Criteria:

Face Quality assurance risks and improve Quality assurance service perception.

– Is the Quality Assurance function recognized to be different from implicit and continuous quality control during fabrication, in that it is discrete, explicit following production, and ignores the sequence or nature of the fabrication steps or processes?

– Does a quality plan exist for significant it functions (e.g., system development and deployment) and does it provide a consistent approach to address both general and project-specific Quality Assurance activities?

– How do employee selection and development practices, as well as staff performance management, well-being, motivation, satisfaction, and compensation, contribute to the growth of the organization?

– What is your Quality Assurance process to ensure that the large volumes of data gathered in the monitoring process are handled efficiently?

– Does the software Quality Assurance function have a management reporting channel separate from the software development project management?

– Is software Quality Assurance done by an independently reporting agency representing the interests of the eventual user?

– How do company leaders guide the organization toward a common purpose of quality based on shared values and priorities?

– How does the company create high performance relationships with its independent trade partners?

– Is there sufficient technical information for maintaining the component properly?

– Are previous revisions of documents marked to indicate that they are superseded?

– Is there sufficient technical information for operating the component properly?

– How do you assure that repairs andor preventative maintenance were completed?

– How does improper/incomplete documentation affect disciplinary actions?

– Were adequate human factors considered in the design of the equipment?

– Who closes the loop with the person that submitted a complaint?

– How does the qa plan cover all aspects of the organization?

– An evaluation: how does it really work in practice?

– How will you measure your qa plan effectiveness?

– How often are the protocols reviewed?

– Quality Assurance for whom?

Quality control Critical Criteria:

Debate over Quality control strategies and sort Quality control activities.

– Do we conduct regular data quality audits to ensure that our strategies for enforcing quality control are up-to-date and that any corrective measures undertaken in the past have been successful in improving Data Quality?

– Have we established unit(s) whose primary responsibility is internal audit, Quality Assurance, internal control or quality control?

– What policies do we need to develop or enhance to ensure the quality control of data gathered?

– How do we know that any Quality Management Systems analysis is complete and comprehensive?

– What quality control measures will be used to ensure the program progresses as planned?

– How important is Quality Management Systems to the user organizations mission?

– Do we regularly review and update its Data Quality control procedures?

– Are regulatory inspections considered part of quality control?

– What is your quality control system?

– What about quality control? Defects?

– What about quality control?

Quality management Critical Criteria:

Categorize Quality management governance and forecast involvement of future Quality management projects in development.

– At what point will vulnerability assessments be performed once Quality Management Systems is put into production (e.g., ongoing Risk Management after implementation)?

– How can you negotiate Quality Management Systems successfully with a stubborn boss, an irate client, or a deceitful coworker?

– What is the future of Data Quality management?

– Quality management -are clients satisfied?

Quality objectives Critical Criteria:

Look at Quality objectives goals and explain and analyze the challenges of Quality objectives.

– Why are Quality Management Systems skills important?

– Have Data Quality objectives been met?

Quality policy Critical Criteria:

Match Quality policy tactics and devise Quality policy key steps.

– What tools do you use once you have decided on a Quality Management Systems strategy and more importantly how do you choose?

– Does Quality Management Systems analysis show the relationships among important Quality Management Systems factors?

Social exclusion Critical Criteria:

Brainstorm over Social exclusion tasks and summarize a clear Social exclusion focus.

– Have all basic functions of Quality Management Systems been defined?

– How do we go about Securing Quality Management Systems?

Standard operating procedure Critical Criteria:

Depict Standard operating procedure quality and give examples utilizing a core of simple Standard operating procedure skills.

– How do you incorporate cycle time, productivity, cost control, and other efficiency and effectiveness factors into these Quality Management Systems processes?

– Who is responsible for ensuring appropriate resources (time, people and money) are allocated to Quality Management Systems?

– Who are the people involved in developing and implementing Quality Management Systems?

Statistical process control Critical Criteria:

Meet over Statistical process control visions and forecast involvement of future Statistical process control projects in development.

– Are Acceptance Sampling and Statistical Process Control Complementary or Incompatible?

– Who will provide the final approval of Quality Management Systems deliverables?

– Is the scope of Quality Management Systems defined?

– What are our Quality Management Systems Processes?

Technical documentation Critical Criteria:

Devise Technical documentation outcomes and forecast involvement of future Technical documentation projects in development.

– In what ways are Quality Management Systems vendors and us interacting to ensure safe and effective use?

– What is our formula for success in Quality Management Systems ?

Total quality management Critical Criteria:

Chat re Total quality management results and create a map for yourself.

– Are we making progress? and are we making progress as Quality Management Systems leaders?

– What threat is Quality Management Systems addressing?

U.S. Food and Drug Administration Critical Criteria:

Frame U.S. Food and Drug Administration leadership and test out new things.

– What are the barriers to increased Quality Management Systems production?

Verification and validation Critical Criteria:

Confer re Verification and validation decisions and point out Verification and validation tensions in leadership.

– Who will be responsible for making the decisions to include or exclude requested changes once Quality Management Systems is underway?

– What prevents me from making the changes I know will make me a more effective Quality Management Systems leader?

– Is a Quality Management Systems Team Work effort in place?

W. Edwards Deming Critical Criteria:

Extrapolate W. Edwards Deming issues and slay a dragon.

– How do we Identify specific Quality Management Systems investment and emerging trends?

– Are there recognized Quality Management Systems problems?

Conclusion:

This quick readiness checklist is a selected resource to help you move forward. Learn more about how to achieve comprehensive insights with the Quality Management Systems Self Assessment:

store.theartofservice.com/Quality-Management-Systems-The-Cookbook/

Author: Gerard Blokdijk

CEO at The Art of Service | theartofservice.com

[email protected]

www.linkedin.com/in/gerardblokdijk

Gerard is the CEO at The Art of Service. He has been providing information technology insights, talks, tools and products to organizations in a wide range of industries for over 25 years. Gerard is a widely recognized and respected information expert. Gerard founded The Art of Service consulting business in 2000. Gerard has authored numerous published books to date.

External links:

To address the criteria in this checklist, these selected resources are provided for sources of further research and information:

Quality Management Systems External links:

Erie Community College :: Quality Management Systems
www.ecc.edu/quality-management

Quality Management Systems | Quality Molding | EVCO …
www.evcoplastics.com/quality

Systematic Quality Management Systems
www.systematicqms.com

Quality management system External links:

Quality Management System – Blue Island, Illinois
www.modernforge.com/quality.html

Quality Management System – NTTA Home
www.ntta.org/roadsprojects/Pages/QMS.aspx

abaqis® | Quality Management System
www.abaqis.com

21 CFR 820 External links:

[PDF]Quality System Regulation 21 CFR 820 Basic …
www.fda.gov/downloads/Training/CDRHLearn/UCM400795.pdf

Business process External links:

Business Process Analyst Jobs, Employment | Indeed.com
www.indeed.com/q-Business-Process-Analyst-jobs.html

What is business process? – Definition from WhatIs.com
searchcio.techtarget.com/definition/business-process

Business Process Improvement Jobs – Monster.com
www.monster.com/jobs/q-business-process-improvement-jobs.aspx

Capability Maturity Model Integration External links:

[PDF]Capability Maturity Model Integration (CMMI) Overview
www.uccs.edu/Documents/tboult/cmmi-overview05.pdf

Cleaner production External links:

Cleaner Production – Seismické vlny – YouTube
www.youtube.com/watch?v=6BIHgMAeLaI

Journal of Cleaner Production – ScienceDirect.com
www.sciencedirect.com/science/journal/09596526

Nicaragua Cleaner Production – YouTube
www.youtube.com/watch?v=p-CIeYfGIiw

Code of Federal Regulations External links:

Code of Federal Regulations – ssa.gov
www.ssa.gov/OP_Home/cfr20/cfrdoc.htm

NRC: Regulations Title 10, Code of Federal Regulations
www.nrc.gov/reading-rm/doc-collections/cfr

Conformance testing External links:

Gazelle | INTEROPERABILITY & CONFORMANCE TESTING FOR …
gazelle.ihe.net

Conformance testing for the spatial data transfer standard
pubs.er.usgs.gov/publication/70017574

Continuous improvement External links:

Title I / Continuous Improvement Plans
www.fusd1.org/Page/6188

Newman Tech – Equality, Innovation, Continuous Improvement
www.newmantech.com

Continuous Improvement Jobs, Employment | Indeed.com
www.indeed.com/q-Continuous-Improvement-jobs.html

Corrective actions External links:

Corrective Actions Software (CAPA Software) – Harrington
hgint.com/hqms-enterprise-quality-management/corrective-action

Corrective and preventive action External links:

CORRECTIVE AND PREVENTIVE ACTION – Learn and …
www.youtube.com/watch?v=CuZp-dpxOXc

Corrective and Preventive Action | Sparta Systems
www.spartasystems.com/solutions/capa-management

[PDF]Corrective and Preventive Action Basics
www.fda.gov/downloads/Training/CDRHLearn/UCM421767.pdf

Customer satisfaction External links:

Wawa Customer Satisfaction Survey – Welcome
www.mywawavisit.com

Big Lots! Customer Satisfaction Survey
biglots.survey.marketforce.com

Chevrolet Customer Satisfaction
www.chevroletdealershipsurvey.com

Data Management External links:

Spirion – Sensitive Data Management
www.spirion.com

Meter Data Management System (MDMS)
mdms.army.mil

Fountas & Pinnell Literacy Online Data Management System
fpdms.heinemann.com

Deming Prize External links:

[PDF]THE DEMING PRIZE WINNERS – juse.or.jp
www.juse.or.jp/upload/files/Deming_prize_EN/list/LIST_Deming_Prize.pdf

Deming Prize – TQM by Ngo Jo on Prezi
prezi.com/dxkq1y9hbfyg/deming-prize-tqm

Deming prize – SlideShare
www.slideshare.net/YoshikiKurata/deming-prize-9225776

EFQM Excellence Model External links:

EFQM Excellence Model – YouTube
www.youtube.com/watch?v=U4K2_QEMP2s

EFQM Excellence Model Flashcards | Quizlet
quizlet.com/31498276/efqm-excellence-model-flash-cards

European Foundation for Quality Management External links:

EFQM – European Foundation for Quality Management
zfits.net/?page_id=141

European Quality in Social Services External links:

European Quality in Social Services. Training …
slideplayer.com/slide/9811437

[PDF]EUROPEAN QUALITY IN SOCIAL SERVICES – …
www.equass.ee/public/Tallinn_15_dec_2011_GuusvanBeek.pdf

European Quality in Social Services – topics.revolvy.com
topics.revolvy.com/topic/European Quality in Social Services

Good Manufacturing Practice External links:

Current Good Manufacturing Practice (CGMP)
www.ce-certification.us/gmp.html

Good Manufacturing Practice | EFfCI
effci.com/good-manufacturing-practice-gmp

ISO 13485 External links:

ISO 13485 Audit Preparation – The University of Akron
www.uakron.edu/uabs/uas/iso-13485-.dot

Stendard, cloud-based software for ISO 13485 regulations
www.stendard.io

Quality Standards – ISO 9001 & ISO 13485 | Polyzen, Inc.
www.polyzen.com/quality

ISO 14001 External links:

ISO 9001/ISO 14001/ISO 27001 Online Training | Advisera
training.advisera.com

Whittington & Associates: ISO 9001, ISO 14001, AS9100, …
www.whittingtonassociates.com

ISO 19011 External links:

ISO 19011 :2011 – Techstreet
www.techstreet.com/standards/iso-19011-2011?product_id=1819788

ISO 19011 2011 Auditing Definitions – praxiom.com
praxiom.com/iso-19011-definitions.htm

ISO 19011: Guidelines for Auditing Management Systems | ASQ
asq.org/learn-about-quality/iso-19011

ISO 9000 External links:

What is ISO 9000? – Definition from WhatIs.com
searchdatacenter.techtarget.com/definition/ISO-9000

ISO 9000 – MasterControl, Inc.
www.mastercontrol.com/iso9000

ISO 9001 External links:

ISO 9001:2015 Training | Online & DVD Courses | 9001Courses
www.9001courses.com

Wald LLC – ISO 9001:2008 Registered
www.waldllc.com

Home – ISO 9001 certified custom sheet extruder — Pacur
www.pacur.com

Industrial Revolution External links:

Industrial Revolution – Facts & Summary – HISTORY.com
www.history.com/topics/industrial-revolution

Industrial Revolution Timeline – softschools.com
www.softschools.com/timelines/industrial_revolution_timeline/40

Smart Factory Expo | Fourth Industrial Revolution 4IR
www.tmsmartfactoryexpo.com

Internal audits External links:

[PDF]Internal Audits – Association of Corporate Counsel
www.acc.com/chapters/houst/upload/Session4Shook.pdf

Office of Internal Audits – University of Minnesota
audit.umn.edu/staff.html

International Organization for Standardization External links:

MDMC – International Organization for Standardization …
www.logcom.marines.mil/Units/Marine-Depot-Maint-Cmd/ISO

ISO – International Organization for Standardization
www.iso.org

ISO – International Organization for Standardization
www.techstreet.com/publishers/102

Measurement systems analysis External links:

Measurement Systems Analysis (MSA) – Document Center
www.document-center.com/standards/show/MSA/history/2ND EDITION

Measurement Systems Analysis | NC State Industry …
www.ies.ncsu.edu/courses/measurement-systems-analysis-msa

Medical device External links:

MEDSec: A Medical Device Cybersecurity Conference
medsecmeeting.org

Dechoker – Choking First-Aid FDA Class I Medical Device
www.dechoker.com

Medical Device Recalls – Food and Drug Administration
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

Medical devices directive External links:

Medical Devices Directive 93/42/EEC – cemarking.net
cemarking.net/medical-devices-directive

MDD – Medical Devices Directive
www.601help.com/Regulatory/mdd.html

Medical Devices Directive – Emergo
www.emergogroup.com/tags/medical-devices-directive

Natural Step External links:

Gen7Pets Natural Step Pet Ramp | Hayneedle
www.hayneedle.com/product/gen7pets-natural-step-pet-ramp.cfm

Natural Step “N” Stones – Home | Facebook
www.facebook.com/NaturalStepandStones

New product development External links:

New Product Development Jobs, Employment | Indeed.com
www.indeed.com/q-New-Product-Development-jobs.html

New product development (Book, 1986) [WorldCat.org]
www.worldcat.org/title/new-product-development/oclc/18859481

[PDF]New Product Development Proposal
files.asme.org/Committees/K&C/TCOB/30812.pdf

Organizational structure External links:

Organizational Structure | North Dakota ITD
www.nd.gov/itd/about-us/organizational-structure

Organizational Structure Opportunities – CA State Parks
www.parks.ca.gov/?page_id=29225

Social Security Organizational Structure
www.ssa.gov/org

Preventive actions External links:

Corrective and Preventive Actions (CAPA) – Food and …
www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170612.htm

Process modeling External links:

Process modeling (eBook, 1986) [WorldCat.org]
www.worldcat.org/title/process-modeling/oclc/742486675

Process Modeling Using BPMN – MAX Technical Training
maxtrain.com/product/process-modeling-using-bpmn

Quality assurance External links:

Textechno – Your partner in quality assurance
www.textechno.com

LabLink xL™ Quality Assurance Software
www.maslablink.com

Quality Assurance System (QAS) – fanniemae.com
www.fanniemae.com/singlefamily/quality-assurance-system

Quality control External links:

Quality Control Products | Call (504) 392-9464
qcp-llc.com

SPC Software | Quality Control Software | InfinityQS
www.infinityqs.com

Ardent Services, Inc. | Quality Control Evaluation Services
ardentservices.com

Quality management External links:

ASI DATAMYTE – The Global Leaders in Quality Management
www.asidatamyte.com

abaqis® | Quality Management System
www.abaqis.com

Quality Management Training Solutions from BSI
bsi.learncentral.com

Quality objectives External links:

Data Quality Objectives (DQO) – PNNL: Visual Sample Plan …
vsp.pnnl.gov/dqo

[PDF]3.0 Data Quality Objectives
www3.epa.gov/ttnamti1/files/ambient/pm25/qa/vol2sec03.pdf

ERIC – Saving Educational Dollars through Quality Objectives.
eric.ed.gov/?id=ED115584

Quality policy External links:

Quality Policy – MMR Group
www.mmrgrp.com/About/Quality

Quality Policy – Religare Health Insurance
www.religarehealthinsurance.com/quality_policy

Agilent | Quality Policy & Resources
www.agilent.com/quality

Standard operating procedure External links:

Standard Operating Procedure (2008) – IMDb
www.imdb.com/title/tt0896866

How to Write a Standard Operating Procedure: 15 Steps
www.wikihow.com/Write-a-Standard-Operating-Procedure

Statistical process control External links:

SPC (statistical process control) – Gartner IT Glossary
www.gartner.com/it-glossary/spc-statistical-process-control

Statistical process control (SPC) is a method of quality control which uses statistical methods. SPC is applied in order to monitor and control a process. Monitoring and controlling the process ensures that it operates at its full potential.
Reference: en.wikipedia.org/wiki/Statistical_process_control

Technical documentation External links:

Technical Documentation Download for System Center …
www.microsoft.com/en-us/download/details.aspx?id=29256

Service and Technical Documentation | SureShade
www.sureshade.com/service-and-technical-documentation

Technical Documentation Services | Sonovision Canada
sonovisioncanada.com

Total quality management External links:

[PDF]CHAPTER Total Quality Management – Wiley: Home
www.wiley.com/college/sc/reid/chap5.pdf

Total Quality Management Flashcards | Quizlet
quizlet.com/2071564/total-quality-management-flash-cards

Florida ISO 9000 Total Quality Management Consulting
www.isoqualityconsulting.com

U.S. Food and Drug Administration External links:

U.S. Food and Drug Administration – Home | Facebook
www.facebook.com/FDA

Verification and validation External links:

About Verification and Validation | VA Mobile
mobile.va.gov/content/about-verification-and-validation

W. Edwards Deming External links:

W. Edwards Deming: The 14 Points – YouTube
www.youtube.com/watch?v=tsF-8u-V4j4

W. Edwards Deming – Part 1 – YouTube
www.youtube.com/watch?v=GHvnIm9UEoQ

Out of the Crisis: W. Edwards Deming – Blue Cottage Consulting
bluecottage.com/?readinglist=crisis-w-edwards-deming