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complaint definition iso

Medical Device Complaint Systems Agenda

10:00 a.m. – 10:15a.m.

Introduction to the Virtual Conference

10:15 a.m. – 11:00 a.m.

Servicing Can Lead to Complaints — an In-Depth Look at 21 CFR 820.200 The FDA cites the quality system regulations 21 CFR 820.200 in warning letters that connect service reports to what it considers an unreported complaint. The regulation says that each manufacturer must create and maintain procedures for each time they service a device. This presentation will review statistical techniques that can be used to analyze service reports. Some of these techniques include: scatter plots, check sheets, Pareto charts, and cause-and-effect diagrams.

Attendees will:

Learn how individual service reports can lead to complaints and MDRs Understand the requirement for statistical analysis — learn how it can be used to uncover potential complaints Learn 6 key elements that the FDA requires in a service report and what records must be kept Tatyana Chorny, Customer Complaint Investigator, CT Quality & Regulatory, Philips Healthcare  

11:00 a.m. – 11:15 a.m.

Morning Break

11:15 a.m. – 12:00 p.m.

Two Sides of the Same Coin: Analyzing the Definition of a Complaint in 21 CFR 820.198 and ISO 13485 According to the FDA, a complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution. The International Organization for Standardization (ISO) definition of a complaint in its quality management systems standard — ISO 13485 — is essentially the same, but it lacks a requirement for effectiveness. This presentation will review the definition of a complaint and describe what an effective system

Attendees will:

Learn how to evaluate a complaint to determine if an MDR is required Determine if an investigation is necessary — What are the requirements for designated units and designated investigators? Discuss which records must be kept and how are they linked to MDRs

Susan Reilly, Owner and Principal Consultant, Reilly & Associates, LLC  

12:00 p.m. – 12:45 p.m.

EMDR Update: The FDA’s Current Thinking on eMDRs The FDA has been encouraging the use of eMDRs in recent years and is moving toward making eMDRs the rule and not the exception. The proposed rule, published in August, would require all device manufacturers to submit medical device reports (MDRs) electronically. During this session, Brandi Stuart, acting Chief of the Information Analysis Branch, will discuss where eMDRs are and where they are going.

Brandi Stuart, acting Chief of the Information Analysis Branch, CDRH FDA  

12:45 p.m. – 1:45 p.m.

Lunch Break

1:45 p.m. – 2:30 p.m.

Front Line Employees — Recognizing Customer Interactions as Complaints The FDA expects firms to train their employees to know what a complaint looks like and how they need to react. In two recent warning letters, the FDA cited a company for their failure to train their front line employees. This presentation will define steps companies should take to make sure their sales and service people recognize a potential MDR event and report it correctly.

Attendees will:

Learn how to train the sales force to recognize and report complaints Establish guidelines for customer service representatives to be able to handle complaints What service people should be looking for to identify complaints when they interact with consumers

John Talarico, Sr. VP Quality Systems and Regulatory Affairs, Delcath Systems  

2:30 p.m. – 3:15 p.m.

5-day or 30-day Report?  Understanding MDR Under 21 CFR 803 The FDA has laid out guidelines device firms must follow in 21 CFR Part 803 that detail steps to take when filing a medical device report. Companies have many responsibilities that involve the patient, the user facilities, and their importers. Not only are you required to file medical device reports, but you must also submit any follow-up information on each. This presentation will detail all requirements that must be fulfilled, records that must be maintained, when each step must be taken and who is qualified to be involved in the process.

Attendees will learn:

What key terms, definitions and forms companies are responsible for Learn what the difference between 5-day reports and 30-day reports as well as which one to use and when Who is qualified to make medical judgments under 21 CFR 803.20(c)(2)

Edward Wilson, Partner, Hogan & Hartson  

3:15 p.m. – 3:30 p.m.

Afternoon Break

3:30 p.m. – 4:15 p.m.

CDRH’s Proposed Rule On eMDRs to Be Made Mandatory, Are You Ready? The FDA is urging device manufacturers to voluntarily adopt the agencys electronic medical device reporting (eMDR) process in anticipation of the final guidance. The Comments for the draft rule mandating electronic reporting has recently closed.

Attendees will:

Discover best practices for setting up a streamlined closed-loop process for complaint recording, investigations, root cause analysis, resolution and reporting Analyze the proposed eMDR rule and its impact on manufacturers Understand the implementation strategies for low and high-volume eMDR submissions — including tips for submissions to the EMEA, Canada, Japan and Australia Deborah Kacera, Senior Product Manager, Pilgrim Software  

4:15 p.m. – 5:00 p.m.

Managing Corrections and Removals – Living Up To 21 CFR 806 During a standard FDA inspection of a manufacturing plant, the auditor will likely ask whether a recall or field correction and removal has been initiated and, if so, to review the related files. The FDA will then assess whether the manufacturer fulfilled its reporting responsibilities under 21 CFR Part 806. This presentation will identify key essentials companies need to be concerned with to avoid a mandatory recall and be ready for an inspection.

Attendees will learn:

How to distinguish between a correction and a removal and define terms such as “market withdrawal,” “routine servicing,” and “stock recoveries” When a report is required for a correction or removal as well as what documents a company needs to keep if it files a report When to report the same event as an MDR and a correction or removal

Dan O'Leary, President, Ombu Enterprises  

  How does this virtual conference work?

The Medical Device Complaint Systems Virtual Conference takes all the best elements of the best live conference you’ve at mnacpkac. complaint letter to landlordtended and avoids all the negatives. It delivers valuable clinical trial development intelligence using the internet for visual components and your speakerphone for the accompanying audio.

All you do is go to the specified website on the day of the event and dial the specified toll-free telephone number, both provided in your registration confirmation. That’s all there is to attending.

Then, relax at your desk or in your conference room, enjoying summit sessions featuring PowerPoint slide presentations, helpful handouts and Q&A opportunities where specific attendee questions will find direct answers from leading supply chain professionals.

What are the top benefits of a virtual conference ?

Highly effective communication: This event uses internet and audioconferencing to create a seamless interface and deliver vital compliance and management advice using technology found in every workplace.

Great value: Select as many of your colleagues to attend as you wish and educate everyone for one low price, with no travel, lodging or per diem expenses.

Stress-free: No hotel or airport nightmares because you never have to leave your building. You’ll feel like you’re off-site at a top-flight conference, until you realize how easy it is to get things done during breaks.

Efficient: You can assign your staff to different sessions.  Staffers can go to the sessions that most pertain to their responsibilities.

Content-rich: This virtual conference addresses your most challenging, complex and frustrating supplier quality problems.

Interactive: No one-way street, you’ll have plenty of opportunities to ask questions and get involved.

Up to the minute: This program will be up to the minute with the latest changes initiated by the FDA and international regulatory bodies incorporated into the event.

Comprehensive: You’ll hear from six industry experts all in the course of one day.


complaint definition iso

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moncler womens ski jackets sale Major v's Minor Nonconformance Started by Markcra , Jul 25 2011 10:33 AM You cannot start a new topic Please log in to reply 11 replies to this topic #1 Markcra Markcra Grade - Active

IFSQN Associate 23 posts 5 thanks 0 Neutral Australia Gender: Male Posted 25 July 2011 - 10:33 AM

I am an experienced 3rd party auditor in both HACCP and ISO 9001. Recently I have started to audit against ISO22000, but only have one client under this standard. Last week I failed my witness audit (the overseeing accreditation body for the certification body that I work for) due to wrongly classifying a non-conformance (I raised 9 audit findings - 1 major and 8 minor). I would appreciate some opinions regarding how the following scenario could be rated eg minor or major non-conformance.

The client that I audited processes flexible packaging (printing, adding pinholes, shirring and laminating). The end product is used for casing cured meats and vacuum sealing. That is the product is food contact.

In a particular process, a machine (shirring) with a rotating knife blade is used on the plastic film. This process is identified as a CCP as there is a hazard of the knife blade breaking and becoming lodged on the film which is rolled up.

The CCP is monitored by an operator by regular visually checking for a damaged blade and there is a metal detector on the line, in the event that a broken blade enters the product. At the beginning of each shift the operator as part of the standard operating procedure checks the operation of the metal detector with a test piece.

During the audit I interviewed the operator and asked him how he monitored the CCP. He showed me how the machine is visually checked to determine if there had been any damage to the blade and how the metal detector worked when he put the test piece through. The metal detector sounded an audible alarm and the line stopped, so that the product could be isolated. I also checked with his Supervisor who verified that this check was done at the start of each shift.

The HACCP plan required the operator to record the start up operational check on a form. This was not being done. During the morning I was shown a critical incident report, where several months ago a blade did happen to break and the product was isolated and discarded. Customer complaint records show that there has never been a problem with a broken blade ending up in the finished film/product.

Given that the client had demonstrated that the monitoring process was effective in controlling the CCP, what rating would you apply to the audit finding that there were no records of the metal detector being checked at the start of each shift.

Regards

Mark

0 Back to top Thanked by 1 Member: #2 Madam A. D-tor Madam A. D-tor Grade - PIFSQN

IFSQN Principal 524 posts 155 thanks 18 Good Netherlands Gender: Female Interests: meat, meat products, ready to eat, food safety, QMS, audits, hazard analyses, IFS, BRC, SQF, HACCP, ISO 9001, ISO 22000 Posted 25 July 2011 - 12:26 PM

Dear Mark,

I would raise a major on 7.6.4. NC-description would be:

From records it is not demonstrable that the CCP is under control.
There are no records of measurements or observations.

All non-conformities relating to CCPs should be a major. Even if these are only theoretical. For HACCP-certification, ISO 22000 and FSSC 22000 the CCPs are the most important subject of the standard. If these do no comply with standard requirements there should be a major. If the organisation failed to show you the other evidence (interview, demonstration, critical incident report) it should have been a critical non conformity.

All above of course to my opinion.

0 Kind Regards, Madam A. D-tor Back to top Thanked by 1 Member: Markcra #3 Charles.C Charles.C Grade - FIFSQN

IFSQN Moderator 12,117 posts 3130 thanks 333 Excellent Earth Gender: Male Interests: SF TV Movies Posted 25 July 2011 - 12:31 PM

Dear Markcra,

No documentation = it was never checked = negative detection results hv no meaning. + failure of verification system + training system ++++

I am predicting you classified it as minor.

I'm not a professional auditor but I would hv thought the assessment might also depend on things like - did the form actually exist but simply not filled in ?, other CCPs handled correctly ?, audit history, eg first deviation from a well documented correct scenario, how long the discrepancy had existed, explanation (if any) ?

In the sense of the whole HACCP system relies on documented monitoring of the CCPs, it seems like a rather non-minor thing to me but .....

Rgds / Charles.C

0

Kind Regards,

 

Charles.C

Back to top Thanked by 1 Member: Markcra #4 mind over matter mind over matter Grade - SIFSQN

IFSQN Senior 369 posts 43 thanks 2 Neutral Philippines Posted 25 July 2011 - 01:40 PM

Hi Markcra,

What's the reason why you want to know the rating to the audit finding? If you do use major or minor, what do you expect client to do different when they address them? I am predicting it's the timetable by which they are resolved, but I'm curious and interested to hear the reason from you.

0 Back to top Thanked by 1 Member: Markcra #5 Madam A. D-tor Madam A. D-tor Grade - PIFSQN

IFSQN Principal 524 posts 155 thanks 18 Good Netherlands Gender: Female Interests: meat, meat products, ready to eat, food safety, QMS, audits, hazard analyses, IFS, BRC, SQF, HACCP, ISO 9001, ISO 22000 Posted 25 July 2011 - 02:53 PM

Dear Mind over Matter,

If an auditor raise a major for an initial certification audit, the organisation will not be certified, until it is proofed that the major is solved (re visit).

If there are too many majors and minors, a total new initial audit will be needed.

A major raised during a surveillance audit, needs to be followed up with an follow up audit. Minors are usually only verified during the next surveillance audit.

Above is applied for the standards ISO 9001, HACCP, ISO 22000, FSSC 22000, ISO 14001, etc.

Edited by Madam A. D-tor, 25 July 2011 - 02:53 PM.

0 Kind Regards, Madam A. D-tor Back to top Thanked by 1 Member: #6 Markcra Markcra Grade - Active

IFSQN Associate 23 posts 5 thanks 0 Neutral Australia Gender: Male Posted 26 July 2011 - 12:02 AM

Hi Markcra,

What's the reason why you want to know the rating to the audit finding? If you do use major or minor, what do you expect client to do different when they address them? I am predicting it's the timetable by which they are resolved, but I'm curious and interested to hear the reason from you.


I needed some other opinions, as I don't audit many clients for ISO 22000. This is my first certified food safety standard and my experience is with ISO 9001 where majors are not common. So I need to re calibrate my judgement as it seems that in the certified food safety standards majors are more common in every day audits.

The minor would be followed up at the next visit in 6 months time, but the major would need to be checked in 3 months. It is a good client and from past experience they would act immediately to restore the recording of the checks. 0 Back to top Thanked by 1 Member: #7 mind over matter mind over matter Grade - SIFSQN

IFSQN Senior 369 posts 43 thanks 2 Neutral Philippines Posted 26 July 2011 - 01:04 AM

Dear Mind over Matter,

If an auditor raise a major for an initial certification audit, the organisation will not be certified, until it is proofed that the major is solved (re visit).

If there are too many majors and minors, a total new initial audit will be needed.

A major raised during a surveillance audit, needs to be followed up with an follow up audit. Minors are usually only verified during the next surveillance audit.

Above is applied for the standards ISO 9001, HACCP, ISO 22000, FSSC 22000, ISO 14001, etc.

I completely understand your view point, and I was only refering to the process of treating both minors and majors as requiring corrective actions.
If there is a ruling, under the third party registration scheme, on categorizing nonconformities, it surely has something to do with the difference in grading of the nonconformities. But....

I would appreciate if someone could cite any references to grading nonconformities. Edited by mind over matter, 26 July 2011 - 01:05 AM.

0 Back to top Thanked by 1 Member: #8 Philips Philips Grade - AIFSQN

IFSQN Associate 43 posts 11 thanks 0 Neutral Kenya Gender: Male Location: Nairobi Interests: Reading, sharing with other professionals,driving and a humble drinker Posted 09 August 2011 - 01:54 PM

Well, I have a bit of experience in auditing food safety management system . One, you may have failed in your test if you could not be able to demonstrate the facts on the ground, however, your judgement was correct, this is a major non conformity. The issue here is, if an occurence would happen due to the failure of operator monitoring the CCP, Would it cause a negative impact to the consumer, and the answer is yes, thus a major; this is not when a document is not signed, but whe a ccp is not monitore, and the evidence of monitoring is the record maitained, your classification is okay, major with no mercy.

0 Back to top Thanked by 1 Member: Markcra #9 Yuri Yuri Grade - Active

IFSQN Active 5 posts 4 thanks 0 Neutral Belgium Posted 10 August 2011 - 10:31 PM

I completely understand your view point, and I was only refering to the process of treating both minors and majors as requiring corrective actions.
If there is a ruling, under the third party registration scheme, on categorizing nonconformities, it surely has something to do with the difference in grading of the nonconformities. But....

I would appreciate if someone could cite any references to grading nonconformities.


Maybe this can help - source: http://C*#!!.com/Forums/showthread.php?t=31370

Major nonconformity
Is one or more of the following:
• The absence or total breakdown of a system to meet a requirement. A number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity.
• Any noncompliance that would result in the probable shipment of nonconforming product. A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose.
• A noncompliance that judgement and experience indicate is likely either to result in the failure of the quality management system or to materially reduce its ability to ensure control of processes and products.

Minor nonconformity
Is a failure to comply with the standard which based on judgment and experience is not likely to result in the failure of the quality management system or reduce its ability to ensure controlled processes or products. It may be one of the following:
• A failure in some part of the client's quality management system relative to the standard
• A single observed lapse in following one item of a company's quality management system. 0 Back to top Thanked by 1 Member: PremixBelle #10 Yuri Yuri Grade - Active

IFSQN Active 5 posts 4 thanks 0 Neutral Belgium Posted 10 August 2011 - 10:33 PM

As for the original question: this would be a major non-conformity for me: no proof of monitoring.

0 Back to top Thanked by 1 Member: #11 mind over matter mind over matter Grade - SIFSQN

IFSQN Senior 369 posts 43 thanks 2 Neutral Philippines Posted 13 August 2011 - 04:22 PM

Maybe this can help - source: http://C*#!!.com/For...ead.php?t=31370

Major nonconformity
Is one or more of the following:
• The absence or total breakdown of a system to meet a requirement. A number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity.
• Any noncompliance that would result in the probable shipment of nonconforming product. A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose.
• A noncompliance that judgement and experience indicate is likely either to result in the failure of the quality management system or to materially reduce its ability to ensure control of processes and products.

Minor nonconformity
Is a failure to comply with the standard which based on judgment and experience is not likely to result in the failure of the quality management system or reduce its ability to ensure controlled processes or products. It may be one of the following:
• A failure in some part of the client's quality management system relative to the standard
• A single observed lapse in following one item of a company's quality management system.

Now, can you cite a reference to grading nonconformities from ISO 22000? 0 Back to top Thanked by 1 Member: #12 Dr Ajay Shah Dr Ajay Shah Grade - SIFSQN

IFSQN Senior 318 posts 105 thanks 4 Neutral Australia Gender: Male Location: Melbourne Posted 15 August 2011 - 12:45 PM

If the HACCP plan indicates that the start up should be monitored and recorded and it is not then from a due diligence perspective it is not meeting the requirements and so should be classed as a Major Non conformance.

0 Dr Ajay Shah., BSc (Hons), MSc, PhD, PGCE(FE) Managing Director & Principal Consultant AAS Food Technology Pty Ltd www.aasfood.com Back to top Thanked by 1 Member: Back to ISO 22000 0 user(s) are reading this topic 0 members, 0 guests, 0 anonymous users

Reply to quoted posts       Clear     International Food Safety and Quality Network → Global Food Safety Standards → ISO 22000

ISO 9000:2005 Terms and Definitions CUSTOMER One important aspect of ISO 9000:2005 aims defining the important terms used in quality management. Some of them are presented below.   If you need my interpretation regarding other terms used in quality management, please access the section Get Free Answers...   The beneficiary of a product or service supplied by the company. Beneficiary can be an organization or a person.   Based on this definition, companies may be seen each time as suppliers and customers, depending on the side they are. This concept   may be extended for instance to employees. An employee receives something from someone else, playing in this case the role of a   customer, and this employee is supplying something to someone else, playing in this case the role of a supplier.   PROCESS Transformation of inputs into outputs under correlated activities.   Understanding previous definition and linking it to the current one, we may reach the conclusion that processes may be seen as   supplier processes and customer processes. Extending this concept, we can understand that an overall process is an assembly of   smaller processes.   According to Note 3 in the standard, a special process is that one where conformance of the product or service to specified   requirements cannot be easily or economically verified.   PRODUCT Is the output of a process.   Usually, the term product is used for tangible things like a car, furniture, pen, etc. However, ISO 9000:2005 standard identifies four   classes of products such as services (communication services, transportation, consulting), software (computer program or a dictionary,   knowledge database), hardware (car, furniture, pen), and processed materials (paint thinner). By understanding these classes, it's   easy to find out that many products incorporates into them some of these classes.   QUALITY MANAGEMENT SYSTEM A management system in which an organization is oriented and controlled regarding quality.   Quality management system is part of the overall management system of the company, along with other management systems, like   human resource management system, supplier management system, environmental management system, health and safety   management system, etc.   In every single company such system exists, even if they are not recognized as such. As an example, every company has some sort   of prevention methods for safety of employees, also is concerned for reducing the consumptions. A certain level of product quality is   achieved most of the time, either if is lower or higher. This is an example of co-existence of three management systems in a company.   REQUIREMENT The need or expectation, which is explicitly declared or implied, to be achieved.   Most of the time requirements are mandatory. When a customer says that wants a metal bar with a certain metal specification, having   certain dimensions, we understand what an explicitly requirement is. It's unlikely that the customer with accept a metal with other   specification or with other dimensions. In this example is possible however that alternate materials or dimensions to be accepted by   the client, but the goal of the client is to get something that is useful for further use.   An implied requirement would be that the metal bar not to present rust or corrosion. Even if the customer didn't explicitly said that, is   expected that the organization to comply, so that to prevent deterioration of customer satisfaction.   QUALITY ASSURANCE Is part of the quality management system concerned with the supply of full confidence that requirements related to quality will be   achieved.   As an example, the quality control intention is to determine either if a product is within specification limits or not.   CONFORMITY Is the fulfillment of a requirement.   Returning to that example of metal bar, if the client will be provided by the company with the exact specification of material and   requested dimensions, is obviously that the company achieved the conformity in supplying that product, in accordance with initially   stated requirements.   Sometimes, the term is replaced by conformance, but the standard don't prefer it.   NON-CONFORMITY Non fulfillment of a requirement.   Once again, let's go back to the example given in the requirement definition. If the company accepted the customer order initially and   will fail to deliver the metal bar with those specifications and dimensions, there is a non-conformity. The client is provided with a   product that is for no further use.   Please note that non-conformity is a wide term, which refer to product especially (non-fulfillment of a requirement). But for instance,   when an objective was set for a process, like x% rejection rate and that percentage is exceeded, there is a non-conformity related to   that initial objective. Another example of non-conformity may be encountered when a process is operating without complying with the   documentation set for it. In this case, the requirement is: the process must follow the applicable documentation.   CORRECTIVE ACTION Is the action taken to eliminate the cause  of the non-conformity.   Every problem has a cause that lead to emergence of the problem. Identifying the primary cause is the aim of analyze, for fully solving   a problem. It's not enough just to rework the product for instance; is needed also a method for preventing the recurrence of the   problem.   Usually, the Analyze of Multiple Caus e method should be used in order to determine the primary cause of a problem. It's useless to   apply a corrective action to an apparent cause. The main cause still exists, and will generate the same problem again. Resources   were provided without a good result. Valuable companies understands the true value of the corrective action and spends quite lage   amounts of time to identify the primary cause of problems.   PREVENTIVE ACTION It is similar in concept with the corrective action  but in this case is applied to potential non-conformity .   The first major difference comes from the apparition or not of the non-conformance. Corrective action is strictly applied to non-   conformities already identified, while preventive action is applied to problems that might appear,  in order to prevent them.   As an example, many preventive actions appear in the design and development phase of a product, when are analyzed the   characteristics of the product and is made an analyze regarding what might go wrong. Another difference in my opinion regarding   corrective and preventive action comes up usually from the amount of information needed to establish adequate actions. While,   usually for a corrective action is needed a smaller amount of information, for a good preventive action is needed a lot of information.   CORRECTION Action needed to eliminate the effect  of a non-conformity.   Based on this definition, the following example will clarify this term. When a product is found as non-conforming, let's say the length of   a metal bar is exceeding given specification, the correction needed for that is to cut the bar to specified length. Correction is the action   needed to comply with stated requirement. In some situations, a correction may by applied, in other cases it cannot.   DOCUMENT Is the information along with its support, which may be a paper or electronic format.   Various documents are used daily. Examples of documents are: a standard, a drawing, a written procedure, etc.   RECORD A document that states the achieved results.   By correlating this definition with definition of a document, results that a record may be on paper or in electronic format. A good quality   management system contains enough amounts of records which prove the conformance with stated requirements. This should not   lead to an extended bureaucracy, however.   EFFECTIVENESS It's simply the level of achievement of established objectives.   The level of achievements regarding planned activities and planned results is what is called effectiveness. It's important to avoid the   confusion between effectiveness and efficiency. The second term considers financial issues.   EFFICIENCY Is the level of resources used to achieve established objectives.   Having this and previous definitions, it's clear that in good quality management systems, these two terms have to be used in   conjunction. Obviously, it's important to discuss about achievement of objectives; a company that achieved planned objectives is   happy, but it has to take also into consideration how much resources were used for that. Achieving a small objective with high amounts   of resources can't lead the company to good performance (most of the time when such situations occur, there are only few steps until   bankruptcy).   Valuable companies achieve important objectives by managing needed resources in an intelligent manner. After all, every company   has a goal of maximizing the profit, by cutting down the costs and to be better compared to previous moments.   QUALITY POLICY Is the orientation of the company regarding the quality.   Quality policy is decided by the top management of the company, in accordance with its vision and mission.   QUALITY OBJECTIVES More precise, the identification of what is to be achieved within quality policy.   These two definitions shouldn't be used separately. Valuable companies have very good visions for the future and decide adequate   missions. As part of the vision and mission, quality policy usually set the long term orientation of the company regarding quality.   Setting the path (needed steps) to fulfill the policy is made using quality objectives.   As an example, a company decides to achieve an increased solidity of the quality of the products, within next 3 years, so that to beat   the competition. This is a quality policy. To achieve that, the company will constantly monitor competitor's performance regarding   quality and will set, from time to time, new quality objectives: in the first year, the maximum number of defective products returned to   them will be that amount, in the second year will be that amount, and so on. These are quality objectives.   The above example is a very simple one. Just think to quality of a product: it is influenced by many, many factors, like supplier   performance, adequacy of processes inside the company, the quality of human resource, the quality of managers, the infrastructure   used to make the product, etc. For each of these elements, quality objectives may be set, which will be in accordance with the quality   policy. New example for quality objective: periodical training of workers so that the capability of product to increase from actual 1.21 to   minimum 1.44. As you can see, the quality policy is more general, setting a main target for quality. The quality objectives set to   approach the policy are focused on more detailed items and are quantified, so that to allow comparison of results with established   objectives.   Quick jump:   Go top   Go top   Go top   Go top   Go top   Go top   Go top   Go top   Go top   Go top   Go top   Go top   Go top   Go top   Go top   Go top   Go top   Current location: Home | Management Standards | ISO 9000:2005 Last updated: 07 Jan 2010 Contact   |  Site map   |  Disclaimer   |  Terms and conditions   |  Privacy policy   |  © 2010 SagiPrest Consulting SRL