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ISO 9000 complaint definition iso

ISO 9000 Share DEFINITION of 'ISO 9000'

A series of international guidelines for quality control. ISO 9000 pertains specifically to the criteria that needs to be met during the manufacturing process. These guidelines do not guarantee product quality, but merely the standards used in the production of goods.


ISO rules and guidelines were established by the International Organization for Standardization. These rules first gained popularity in Europe, then spread to America in the 1990s. The certification process for this standard takes over a year and requires substantial documentation and demonstration.

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read the DMCA complaint We Train Healthcare Professionals support@ My Cart 0 items Sign In | Sign Up +1-800-385-1607 +1-800-385-1607 Toggle navigation Home About Us Webinars Webinar Pack Categories Resource Directory Advanced Search 2-day In-person Seminar Medical Device Complaint Handling By Dan O'Leary
Location: Baltimore, MD   Date: April 28th & 29th, 2016   Time:   9:00 AM to 6:00 PM PST    |     Venue : Hilton Garden Inn - Baltimore Inner Harbor Home Agenda Register Venue Speaker Register for Seminar     For discounts on multiple registrations, contact customer care at +1-800-385-1607     Register Now

Does your Complaint Management system provide value to your company? It does if your company handles complaints efficiently and effectively - taking them through the reporting, classification, investigation, corrective action, and design change phases. Your system is effective if it recognizes the requirements to report to regulatory agencies (such as FDA, the EU, and Health Canada) and ensures you make the reports on time.

An integrated system addresses multiple elements:

Designated individuals and their required skill sets Procedures to define the process and standardize work Records to maintain and their prescribed content Reports to file with regulatory agencies and their timeframe

The workshop covers all of these elements and includes checklists to help you integrate them into your QMS.

To help clarify the issues, the workshop includes FDA Warning Letters. These Warning Letters illustrate problems that other companies have had so you can avoid them. The workshop also includes hands-on exercises for practical applications.

Why should you attend:

In this two-day workshop you will understand all the processes and elements in a Quality Management System (QMS) that come to bear on effective Complaint Management. It starts with the definition of a complaint in FDA's Quality System Regulation (QSR) and ISO 13485:2003. (The complaint definitions are not the same.) In these systems a complaint has a specific technical meaning that is significantly different from the colloquial meaning.

Areas Covered in the Session: Complaints can lead to investigations that lead to corrective action. The workshop explains how to investigate complaints and perform corrective action using the elements of your QMS. It helps establish the interfaces between these systems, designate individuals, assign responsibility, and assure the required skill set. A complaint may represent a serious event reportable to regulatory authorizes. The workshop helps you understand the FDA reporting requirements for Medical Device Reports (MDRs) and the corresponding reports for the EU and Health Canada. Each of these systems has different definitions, thresholds, and time frames. The corrective action may lead to design changes. Does the design control system handle these changes? Do you know how to evaluate the change for an updated 510(k)? How does the change affect the UDI? Documenting the change in a Technical File or Design Dossier is very important in the EU. The corrective action may lead to a field action, potentially requiring a report to FDA. However, there are complex exceptions to the reporting requirements that may create a record, but not a report. The workshop will help you understand the requirements, establish regulatory timelines, and implement a compliant approach. In addition, handling field actions in the EU and Canada involves a different regulatory structure. Complaints are an essential element for the post-production evaluation required by an ISO 14971:2007 (EN ISO 14971:2012) quality management system. You will learn how to update the risk management file and take action to reduce risk. Who Will Benefit: All levels of Management for all departments and those who desire a better understanding QA/QC/Compliance/Regulatory Affairs Marketing & Sales & Customer Service Engineering/Technical Services Consultants Operations and Manufacturing Agenda Day One Lecture 1:

The Regulatory Structure

The development of the QMS (QSR & ISO 13485) The current versions of the QMS (US, EU, & Canada) Records and their content Reports to regulatory agencies (content, trigger, and timing) FDA Inspections and the guiding documents Quality System Inspection Technique Compliance Program 7382.845 Inspection of Medical Device Manufacturers Exercise - FDA Inspection Levels Exercise - QSIT sampling plans for records Lecture 2:

Unique Device Identification

An overview of UDI Recording and Reporting UDI Complaints Servicing MDRs International Implications Lecture 3:


Definition of servicing Relationship to other QMS elements Service Records and Service Reports Service Record analysis (some tools and techniques) Exercise - Analyze a small set of service records using quality tools Lecture 4:


Definition of a complaint QSR vs. ISO 13485 definitions Establishing the complaint files Designating individuals Complaint system interrelationships Complaints & CA&PA Complaints & MDRs Complaints and Risk Management (ISO 14971:2007) Complaint system flowchart Complaint records Exercise - Analyze customer reports to determine if they are a complaint and potentially reportable Lecture 5:

Medical Device Reports (US)

Criteria for reporting Establishing the MDR event files Designating individuals MDR system interrelationships MDRs & Complaints Types of MDRs (30 day & 5 day) Reporting MDRs The eMDR System Records required for the MDR system Exercise - Initiate a Medical Device Report Day Two Lecture 6:

Medical device reports in the EU and Canada

Criteria for reporting The regulatory structure in the EU (MDD and MedDev) The regulatory structure in Canada Role of the Notified Body Role of the MDD Authorized Representative Exercise - Analyze an adverse event to determine when to report and when Lecture 7:

Corrective and Preventive Action (CA&PA)

Definitions QSR definitions ISO 9000:2005 definitions The difference between corrective action (CA) and preventive action (PA) CA&PA Interrelationships The CA&PA flowchart CA&PA verification and validation CA&PA effectiveness review CA&PA records Complaint analysis (some tools and techniques) Exercise - Analyze complaints as quality data to identify quality problems Lecture 8:

Design Changes

Understand the role of change in the design control system Design Change interrelationships The Design Change flow chart Design change records Linking design changes to process changes Design change records Exercise - Classify a changes as a design change or a production process change Lecture 9:

510(k) Changes

When a design change requires a pre-market notification change 510(k) change process Interrelationships Design change Risk Management Process 510(k) change records and reports The FDA guidance document Exercise - Analyze design changes to determine if they require a 510(k) Lecture 10:

Risk Management

The definition of risk Determining acceptable risk Establishing the Risk Management File Collecting production and post-production information Evaluating and acting on information Linking risk evaluation to design changes Exercise - Evaluate post-production information for changes to risk Lecture 11:

Corrections and Removals (C&R)

Defining the terms C&R Interrelationships CA&PA Design changes Enhancements C&R records and reports Linkage to recalls Exercise - Evaluate proposed field actions to determine if they are a correction or a removal
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In case you wish to register by using check, please make a check to NetZealous LLC DBA and mail it to the below address. NetZealous LLC, DBA MentorHealth, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: +1-800-385-1607 Seminar Pricing Includes (With stay) Google Nexus 7 Tablet 2 Days' Stay Pick-up and Drop Facility (Nearest Airport) Breakfast and Lunch High Tea Pack of 3 Past Webinars on similar subject Group participations Get fabulous discounts by participating in groups of two or more. Send two attendees: Get a discount of 10%! Send three to six attendees: Get a grand discount of 20%! Send seven to 10 attendees: Get a great discount of 25%! Send more than 10 attendees: Get a whopping discount of 30%! To avail the above group discounts, all the participants should register by making a single payment Call our representative TODAY on +1-800-385-1607 to have your seats confirmed! Quick Contact Toll free: +1-800-385-1607 Email: support@ Want to register by Wire Transfer? Please call any of our representatives on +1-800-385-1607 to help you completed the transfer. Venue Location: Baltimore, MD Hotel: Hilton Garden Inn - Baltimore Inner Harbor   625 South President Street Baltimore MD 21202
Speaker Dan O'Leary President, Ombu Enterprises p>Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

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ISO 9001 Resources 5 Steps to ISO 9001 Tips ISO 9001:2015 Training More 5 Steps to ISO 9001 Certification Step 1: Preparation Step 2: Quality Manual, Quality Policy and Procedures Step 3: Implementation, Training and Work Instructions Step 4: Internal Audits Step 5: Certification ISO 9001 Tips The following tips are designed to help employees at small and midsize businesses comply with ISO 9001 requirements. You may find these ISO 9001 tips useful during the ISO 9001 implementation phase or even later on as refreshing reminders.

What is Document Control? Document control means that the right persons have the current version of the documents they need, while unauthorized persons are prevented from use.

We all handle many documents every day. These documents include forms that we fill out, instructions that we follow, invoices that we enter into the computer system, holiday schedules that we check for the next day off, rate sheets that we use to bill our customers, and many more.

An error on any of these documents could lead to problems. Using an outdated version could lead to problems. Not knowing if we have the latest version or not could lead to problems. Just imagine us setting up a production line to outdated specifications or making strategic decisions based on a wrong financial statement.

ISO 9001 gives us tools (also referred to as "requirements") that show us how to control our documents. Take a look into the ISO 9001 Quality and Procedures Manual for more information and simple instructions.

ISO 9001 Documents There are no “ISO 9001 documents” that need to be controlled, and “non ISO 9001 documents” that don't need control. The ISO 9001 system affects our entire company, and all business-related documents must be controlled. Only documents that don't have an impact on our products, services or company don't need to be controlled - all others need control. This means, basically, that any business-related document must be controlled, and our ISO 9001 manual explains how to do it.

However, how much control you apply really depends on the document.

The extent of your approval record , for example, may vary with the importance of the document (remember, documents are approved before they are published for use).

The Quality Policy, an important corporate policy document, shows the signatures of all executives.

Work instructions often just show a note in the footer indicating approval by the department manager.

Some documents don't even need any approval record: if the person who prepared a document is also responsible for its content (e.g., the Quality Manager prepares instructions for his auditors), a separate approval is superfluous.

On the other hand, identifying a document with a revision date, source and title is basic. It really should be done as a good habit for any document we create.

Please note that documents could be in any format: hardcopy or electronic. This means that, for example, the pages on the corporate internet need to be controlled.

Responsibility for Document Control Document control is the responsibility of all employees. It is important that all employees understand the purpose of document control and how to control our documents in accordance with ISO 9001.

Please be aware that if you copy a document or print one out from the Intranet and then distribute it, you are responsible for controlling its distribution! The original author won't know that you distributed copies of his documents, so the original author can't control your distribution.

Dating Documents ISO 9001 requires us to show on every document when it was created or last updated. Many of us may have thought to use our word processor's automatic date function for this, but... should we use the automatic date field on documents?

Generally not. If you enter the automatic date field into a document, the field will automatically be updated to always show the current date, no matter when you actually created or updated the document.

Example : For example, if you use the automatic date field in a fax and you save the fax on your computer for future reference, you won't be able to tell when you wrote the fax: when you open the fax on your computer, it will always show today's date.

Another Example : Another example is entering the automatic date field in the footer of a document that you frequently change and then print. You may have used the automatic date field as an easy way to see on your printouts when they were printed; your idea here probably was that the document with the latest date is the most current printout. However, you may make one printout today and another tomorrow without having made any changes to the document. Though both printouts are identical, they now show different dates. This will inevitably lead to confusion.

Document control requires us to show on any document when it was created or last updated. The automatic date field is not suitable for this. Therefore, as a general rule, don't use the automatic date field to identify revision status .

Controlling Forms Yes, forms must be controlled as long as the form has an impact on our products, services or our company.

Blank forms are similar to work instructions as they guide the user to provide certain information. If the form is outdated or incomplete, the user will not be prompted to supply all the necessary information. It is, therefore, important to control blank forms like any other document. Refer to our quality procedures manual on how to meet this ISO 9001 requirement.

Once a form is filled out , however, it has become a record. At this point, we need to be concerned with filing, storage, archiving and eventually destruction. Our Record Retention Guide specifies how long records must be kept and how we can get rid of them (for example, do we need to shred them or is the recycle bin okay?).

Complete ISO 9001 Documentation Some auditors like to ask this question, so it is best to know that our ISO 9001 quality management system is documented through:

the Quality Procedures Manual, which also includes corporate policies and procedures affecting the entire company

Work instructions, which explain in detail how to perform a work process

Records, which serve as evidence of how we meet ISO 9001 requirements

Policies and Procedures Our ISO 9001 Quality Management Manual includes the corporate Quality Policy and all ISO 9001 Procedures! While most procedures affect only managers, every employee must be familiar with the Quality Policy and with the Document Control procedure. The Quality Policy contains the corporate strategy related to quality and customer satisfaction; all other ISO 9001 documents must follow this policy. The Document Control procedure shows how to issue documents, as well as how to use documents.

Process Identification Management at each business unit or individual location needs to identify all key processes (or activities). The number of processes depends on how detailed you want to be. For the purpose of meeting ISO 9001:2015 requirements, about 10 key processes or less should be sufficient to describe the activities of the entire department, office or facility.

Once the key processes are identified, management needs to describe how the processes interact with each other. How to do this? A flowchart is ideal when identifying processes and their interaction.

Flowcharts Flowcharts are great ways to describe the interaction of processes. Flowcharts are often used to show how the key processes (also referred to as "activities") in an office or at a production facility work together; flowcharts are also often used to explain how to perform work, for example in work instructions and as part of procedures.

The following explains how to create and read flowcharts. Though there exist numerous flowchart shapes, the following shapes are sufficient for most flowcharts. Note the arrows which are used to connect the different shapes in the correct order.

This is the shape used to describe a process (or activity). In this example, the process is called “Check invoice”.

This is the shape used to describe a decision. A decision in a flowchart has usually two possible outcomes. In this example, the decision is “Is the invoice correct?” and the two possible outputs are “yes” and “no”.

Some decisions have several possible outcomes: the decision “From which supplier is the invoice?” could have either of the outcomes “Supplier A”, “Supplier B”, or “Supplier C”.

This shape describes a document. In this example, the document is called “Invoice”. See example below on how this shape is used.

Example on how to use all three shapes:

Microsoft Visio is an excellent program to create flowcharts; also Microsoft Word and PowerPoint can be used for some basic flowcharting.

Whichever tool you use, please keep it simple for the user. Some sophisticated shapes might make much sense to you, but most users will be confused as they won't understand the subtle differences.

Audit Preparation ISO 9001 audits are typically more challenging for management than for workers. ISO 9001 is a quality MANAGEMENT system and provides many requirements on activities of managers and executives; in many cases, ISO 9001 directly affects how the company is managed.

All audits may cover any or all sections of the ISO 9001 quality management manual. As a general rule, almost all audits cover objectives, customer feedback, management reviews, internal audits (especially to verify if nonconformities from prior audits have been properly corrected), and corrective action. An extensive list of insider audit preparation tips is included with 9001Simplified's ISO 9001 Complete Package.

Continuous Improvement Implementing ISO 9001 is not a one-time benefit to our company. While we are utilizing our procedures and work instructions in daily business activities, we are not only benefiting from better quality and increased efficiency but we are also continually improving. In fact, the ISO 9001 requirements are designed to make us continually improve. This is a very important aspect because companies that don't continue to improve are soon overtaken by the competition.