
Nike Quality Control Manual Template
Guidance on Writing a Quality Assurance Manual Excerpt from, ^Requirements for ASME NQA-1 Certification , Issue No.: 3, Date, February 10, 2014: 3.1 The Quality Assurance Manual shall not be a reiteration of the NQA-1 Standard, but rather, a detailed written document which clearly describes the controls for each element of the Nuclear. I even created an ISO 13485 Quality Manual Example so you can see how short it can be. This Quality manual template is provided to you for free so don’t hesitate to download it. I made it like if Easy Medical Device is a company manufacturing medical device products. But don’t stick to the full content as everything is a fiction.
Quality Templates and Excel Tools
Box and whisker plot (Excel) This graphical plotting tool goes beyond the traditional histogram by providing you with easy-to-read displays of variation data from multiple sources, for more effective decision making.
Check sheet (Excel) Use this simple, flexible tool to collect data and analyze it with histogram and Pareto charts.
Control chart (Excel) See how a control chart tracks process change over time, and create your own.
Design of experiments (DOE) (Excel) This powerful tool helps you see the effect multiple input factors can have on a desired output (response), exposing important interactions that may be missed when experimenting with one factor at a time.
Failure Mode and Effects Analysis (FMEA) (Excel) Use this template to evaluate the potential failure of a product or process and its effects, and then identify actions that could eliminate or reduce the occurrence of the potential failure.
Fishbone (cause-and-effect) diagram (Excel) Analyze process dispersion with this simple, visual tool. The resulting diagram illustrates the main causes and subcauses leading to an effect (symptom).
Flowchart (Excel) Create a graphical representation of the steps in a process to better understand it and reveal opportunities for improvement.
Gantt chart (Excel) This tool can be used in process planning and control to display planned tasks and finished work in relation to time.
Histogram (Excel) Analyze the frequency distribution of up to 200 data points using this simple—but powerful—histogram generating tool.
Pareto chart(Excel) Use this quick and very basic tool to capture and analyze problem occurrences.
Relations diagram checklist, template, and template instructions (DOCs and PDF) Mainly used to identify logical relationships in a complex and confusing problem situation, the strength of an interrelationship diagram is its ability to visualize such relationships. The process of creating an interrelationship diagram can help groups analyze the natural links between different aspects of a complex situation.
Scatter diagram(Excel) This tool shows the relationship between an input, X, and the output, Y. If a relationship exists, the input is correlated to the output.
Stratification diagram (Excel) Analyze data collected from various sources to reveal patterns or relationships often missed by other data analysis techniques. By using unique symbols for each source, you can view data sets independently or in correlation to other data sets.
Quality Tools in Healthcare
Case Studies and Articles
The following examples show how these quality tools and templates can be used in a healthcare setting.
What's the Plan? (Quality Progress) When ER-One of Livonia, Michigan, needed to transition the management of newly acquired hospital emergency departments to its organization, it turned to advanced implementation quality planning (AIQP).
Development and Implementation of a New Process for Handling Add-On Lab Orders at Duluth Clinic–Ashland (PDF)Read a case study that includes a control plan created at SMDC Health System’s Duluth Clinic—Ashland Laboratory as part of a successful project to improve the handling of add-on laboratory test orders.
Tip of the Iceberg (Quality Progress) Heartland Health’s iceberg is a pyramid that depicts the vision of the organization, a Baldrige Award recipient, and illustrates its bottom-up, holistic approach to healthcare.Taking Process Improvement Beyond the Quality Department(PDF) Team improvement projects are key to process improvement at Genesis Health System (GHS), who shares its road map for bringing together key stakeholders and process owners in kaizen blitz teams.
Lean Nursing (PDF, Quality Engineering) A case study demonstrates the use of lean Six Sigma to reduce length of stay for patients with total hip replacements while at the same time reducing costs.
Jersey Score (Quality Progress) Baldrige recipient AtlantiCare's 5Bs framework aims to make the organization the best in five areas: quality, customer service, people and workplace, growth, and financial performance.
A Dose of DMAIC (Quality Progress) Hospital pharmacy's use of process capability studies as part of a Six Sigma and lean effort to improve wait times, efficiency, and patient flow.
Get the Whole Picture (Quality Progress) Two healthcare programs used systems thinking, which helps you analyze how multiple processes fit together and work in tandem, to improve service to patients, save money, and cut waste.
Additional Tools and Templates
The following include a template and additional methods to use in a healthcare setting.
Employee instruction sheet (XLS) Use this employee instruction sheet, submitted by Matthew Bommarito, to capture the components of process documentation on one comprehensive worksheet. The downloadable spreadsheet includes separate tabs with instructions, a template, and an example from Heartland Regional Medical Center, St. Joseph, MO.
Force field analysisForce field analysis is based on the assumption that any situation is the result of forces for and against the current state being in equilibrium. Countering the opposing forces and/or increasing the favorable forces will help induce a change.
Impact effort matrixThe impact effort matrix provides answers to the question of which solutions seem easiest to achieve with the most effects.
Problem concentration diagramA problem concentration diagram helps you connect events to physical locations, thus perhaps revealing patterns of occurrence.
Purpose and applications of interrelationship diagrams Relations diagrams can help you identify relationships in a complex or confusing problem situation.
SIPOC+CM diagramA suppliers, inputs, processes, outputs, customers (SIPOC) diagram offers a high-level view of the 'as is' state of a process under investigation. The +C stands for constraints facing the system and the +M for the measures to be used.
Job Aid: How to Create a SIPOC Diagram (PDF) Use this job aid when you conduct team sessions to develop a suppliers, inputs, process, outputs, customers (SIPOC) diagram.
SMART matrixA SMART (specific, measurable, attainable, resources, time) matrix is a communication and planning tool used to identify the specifics of actions or tasks.
Success and effect diagram: Quality improvement Is not just for problemsUnderstanding successful processes can give you insight on how to improve other processes and continually improve efficiency and effectiveness—this tool can help you analyze successful processes and is a hybrid of the popular cause and effect diagram.
ISO 9001 Quality Manual Template - contains the quality manual, quality policy, scope, objectives, procedures, forms, reports, process maps, audit checklists - whether this is your very first ISO 9001 implementation or you are transitioning from 9001:2008 to 9001:2015, our fully-editable, comprehensive quality manual template contains all the documents you need to achieve certification.
Simply put, our Quality Manual Template includes everything you need to get certified.
Some companies don’t mind shelling out thousands of dollars for consultants to write their documentation. Others, like yours, want to bootstrap the process as much as possible by using a quality manual template.
Everything You Need
ISO Certification made Clear and Simple
Sure, you could spend hours scouring the web to piece together different free documents like a jigsaw puzzle — manuals, procedures, forms, audit checklists, gap analysis, quality policy, objectives etc. you need for your ISO 9001 implementation — but they will all be in different formats, using different references and numbering, different tone of voice and terminology. Gamefowl breeding method.
Or worse, you could try to create your ISO 9001 documentation all from scratch.
But what if instead, you decided to work smarter not harder by using the same all-inclusive quality manual template that small businesses and large corporations have been using since 2002 to get the job done right.
First Time Implementation with Guidance | |
ISO 9001:2015 quality manual with quality policy, quality objectives, including all clauses of the standard and every requirement documented. All procedures, forms, reports, process maps, audit checklists and a Non-Conforming & Corrective Action Tracker. $279 |
For more details and PDF download samples, please see the table further down the page.
Transition from ISO 9001:2008 with Guidance | ||||
Everything you need to migrate your documentation from the previous standard. Includes all templates from the 'First Time Implementation' package above; with the following extras: Gap Analysis Checklist, Implementation Checklist, Transition Plan and Transitioning Planning Guidance. $339 | ||||
First Time Implementation | Transition from 9001:2008 | |||
$209 | $279 With guidance & interpretation | $259 | $339
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| Who is this for? | Companies who wish to gain ISO 9001 certification for the first time | Companies already ISO 9001:2008 certified who wish to make the transition to ISO 9001:2015 | ||
| Good knowledge ofISO 9001:2015 | New to ISO 9001:2015 | Good knowledge of ISO 9001:2015 | New to ISO 9001:2015 | |
Quality Manual Template | ||||
Documented Procedures |
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Reports & Forms |
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Process Maps |
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Audit Checklists |
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Internal Audit, Non-Conforming & Corrective Action Tracker | ||||
| Gap Analysis Checklist - view sample Gap Analysis | ||||
Implementation Checklist | ||||
| Transition Plan | ||||
Transitioning Planning Guidance | ||||
ISO 9001-2015 Internal Audit Guidance Documented Information Guidance Clause-by-clause Interpretation ISO 9001-2015 v 2008 Correlation Matrix | ||||
Addresses all the requirements of ISO 9001:2015 Easy to edit and customise, using MS Word & Excel styles throughout Same format and numbering as the standard - why? Each Procedure and Form is a separate document - why? | ||||
12-months free support 12-months free updates Unlimited users within company | ||||
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- Supplied as fully-editable MS Word, Excel and PDF files
- All the templates use styles – making reformatting and rebranding a breeze
- Immediate download
Pay by Credit Card, Debit Card, PayPal or Apple Pay.
PDF samples from the Quality Manual Templates
Who Is This For?
Bought by Small Businesses and Large Corporations our templates have been sold online and CD since 2002.
Used by:
- Small Businesses – dentists, accountants, engineers
- Large Organizations – hospitals, power plants, aircraft manufacturers
The Templates are used by first timers following our step-by-step, clause-by-clause guidance documents; and experienced Quality Managers wishing to streamline and improve their existing documentation.
The application of our templates is scalable and generic; regardless of the size and type of organization. The elements that form the quality management system are the same.
Why Develop A Quality Management System?
Your organization will utilise ISO 9001 as a framework to document and improve your operational practices to help your business run more effectively.

This will help you better satisfy the needs and expectations of your workers, customers, stakeholders and interested parties.
Help Your Business Improve and Grow
The primary goal of the operating manual and our quality manual templates is to achieve a set of consistent processes that:
- provide a route for enhancing customer satisfaction
- mitigate uncertainty; and
- provide meaningful data for quality control, docusments control and continuous improvement activity
The templates are designed to be implemented within current business practices and serve as an effective tool to help your business grow and improve.
The Quality Manual Template includes policies and procedures - all necessary standard operating procedures. Document management of the quality system is based on ISO standards. Includes practical examples of quality objectives. Implementing ISO and gaining ISO certification will be simple and straightforward using our six sigma process approach to continual improvement using a control plan or quality program.
Why Reinvent The Wheel? Bought by small businesses, big brands and individuals |
How Many Procedures Should You Document?
ISO 9000:2015 (3.4.5) defines a procedure as a specified way to carry out an activity or a process. With this in mind, businesses often risk becoming overburdened with too many procedures that document each business activity. This cumbersome methodology detracts from the 'process approach' that is a central theme in ISO 9001:2015.
We recommend documenting the mandatory processes
Document management - no matter how large or small your organisation, by documenting the mandatory QMS processes, our documented procedures provide what you need to generate the records needed to ensure the effective operation and control of your organisation's QMS and its processes. Our templates fulfull all the requirements of ISO 9001:2015.
Why would you document more procedures?
Some consultants and professionals recommend documenting many more, some even over 40 procedures!
We do not agree with this. It is not necessary to document all your business processes to acheieve ISO 9001.
- How much more work do you want to give Certification Auditors? More procedures take more time and effort, and costs more to review. Why give auditors more information and more opportunities to find non-conformities?
- How many of your Clients want to wade through dozens of procedures to find the sections or elements that matter most to them? Keep it simple, for their benefit and yours!
- How much training can you do? As part of each procedure's implementation, employees require regular training, familiarisation and monitoring. Lots of procedures will take more time away from the coal face!
Do not do it! You are going to be creating much more work for yourself and everybody. It is going to take much more time and is going to cost more money.
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