iso 9001 2015 quality objectives and definitions

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. Information Example 1 Three different examples of data were given to you earlier. Let's have a look at how that data can be turned into information. Example 1: Data We started off with the raw data which was 51, 77, 58, 82, 64, 70. At this stage, those numbers could have been anything from street numbers to chart positions of certain records. Context The raw data is given a context. We are told that the numbers are test scores which were achieved by a group of students. At last they start to make some sense. However even with a context, the data still needs to be processed in order to turn it into information. Processing The processing in this case might be to calculate the average from the set of scores. The average is 67 so we can now tell that student

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Page 1: iso 9001 2015 quality objectives and definitions

. Information Example 1Three different examples of data were given to you earlier. Let's have a look at how that data can be turned into information.

Example 1:

Data

We started off with the raw data which was 51, 77, 58, 82, 64, 70.

At this stage, those numbers could have been anything from street numbers to chart positions of certain records.

Context

The raw data is given a context. We are told that the numbers are test scores which were achieved by a group of students. At last they start to make some sense.

However even with a context, the data still needs to be processed in order to turn it into information.

Processing

The processing in this case might be to calculate the average from the set of scores. The average is 67 so we can now tell that student 1 did particularly badly in the test because they were so far below the average mark.

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 Information Example 2

Data

In this example we started off with a list of things which could have been many different things from flavours of milk shake to paint colours for a wall. So at this stage, the list is definitely data.

Context

We then find out that the data is in fact different tubs of ice-cream which was sold yesterday. We can safely assume from that context that the data is in fact the flavours of the tubs sold.

The data still needs to be processed to become information.

Processing

Because we have different instances of the same thing i.e. many tubs of chocolate ice-cream being sold and many tubs of vanilla ice-cream being sold, it would be useful to find out which was the most popular flavour sold yesterday.

The processing could take the form of creating a bar chart. This would instantly tell us which flavour sold the most yesterday.

The processing could even include charting yesterday's sales against the sales for the previous week or month.

Information Example 3

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Data

We are given a list of numbers but have no idea what they mean

Context

We are told that the numbers are dates when a holiday cottage has been booked. They now have some meaning. With date data, it is also vital to know the format. For example they could be UK format: dd-mm-yy or they could be in American format: mm-dd-yy or perhaps they could even be in a text sort-friendly format: yy-mm-dd.

Processing

The dates are muddled. After sorting them into ascending order it would be easy to see when the first booking was due and when subsequent bookings would happen. It would also be possible to see when the cottage had not been booked.

 

Challenge see if you can find out one extra fact on this topic that we haven't already told you

Click on this link: Data, Information and Knowledge

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8. Knowledge examplesExample 2

Data

chocolate, strawberry, vanilla, strawberry, vanilla, vanilla, strawberry, vanilla, vanilla

Information - this is a list of flavour of ice cream sales yesterday.

The data now has some context and so make sense. A bit of analysis is useful to glean more information.

For example, the most popular flavour of ice cream sold yesterday is vanilla.

Knowledge

The shop manager can see that vanilla is the most popular ice-cream flavour. Next time he places an order, he will ask for five times as much vanilla ice-cream than chocolate ice-cream.

 

Example 3

Data

14-05-08, 09-10-08, 21-11-08, 09-09-08, 31-07-08

Information - these are a list of dates in dd/mm/yy format. They are booked dates for a holiday cottage.

Now that the format of the data is known, it can be processed further. For example, they could be sorted into time order

The dates are sorted into order:

14th May 2008 31st July 2008 9th September 2008 9th October 2008 21st November 2008

Knowledge

The owner of the holiday cottage can see that it has hardly been rented over the summer period. She might decide to lower her rental price in order to get extra bookings.

 

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Within an EnMS, it is important for organizations to identify and address both existing and potential nonconformities. An existing nonconformity is a situation where a requirement is not met. A potential nonconformity is a situation where, if action is not taken, a nonconformity will potentially occur in the future. You want to eliminate a potential nonconformity before it occurs.

A nonconformity is a situation where a requirement is not met.An example of an existing nonconformity is: EnMS Procedure #3 states that the energy review shall consider all major energy sources. The 2011 energy review did not include consideration of the facility propane use, and propane is a major energy source included in the facility scope.

An example of a potential nonconformity is: The organization has an EnMS objective to reduce the amount of energy used by the compressed air system by 5% by the end of 3rd quarter of the year. It is the middle of the 2nd quarter and measuring and monitoring data show that there has been no decrease in the amount of energy used by the compressed air system. It appears that if no action is taken, the objective will not be met and therefore a potential nonconformity exists.

A nonconformity generally means that:

the organization is not doing what it said it would do, what is being done is not working, requirements are not being met, or the intended energy performance improvement is not being obtained.

Initially, most energy management system nonconformities are identified by internal auditors or during monitoring and measurement activities. As the system matures, nonconformities may be identified by the people doing the work. This should be encouraged. People doing the work are often in the best position to see problems and suggest solutions.

When a nonconformity is detected, the first step is to take appropriate action to resolve the immediate situation. For example, in the case where an oven is operating at a temperature lower than the correct temperature because the weather is cooler today, the immediate action taken is to increase the natural gas flow to the oven. This is called correction.

The next step is to determine the magnitude of the nonconformity and its impact on energy performance. Based on this information, a decision is made as to whether action should be taken to ensure the situation is prevented from recurring or occurring in the future. If so, the nonconformity is entered into the organization's corrective action system.

Once entered into the corrective and preventive action system, the nonconformity is reviewed to determine its cause and determine if action is indeed necessary. The organization then decides on and implements an appropriate course of action to eliminate the cause of the actual or potential nonconformity.

Example:

Suppose a plant has a compressed air system which is a large user of energy. The plant has a procedure that states that the system operating pressure set point shall be 105 psig. The plant was found operating their compressor plant at 115 psig.

Correction -> Change operating pressure back to 105 psig if no negative effect on production can be determined.

Evaluate magnitude and impact of nonconformity -> Enter into corrective action system if appropriate.

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Cause -> Determine why the operating pressure was changed.

Corrective Action -> Take action to eliminate the cause.

Sometimes the corrective or preventive actions that are taken to eliminate problems result in the need to make other adjustments or changes to the EnMs. For example, if existing operational controls were modified as part of implementing a corrective action, then there may be a need to modify the associated EnMS documentation. It is important that the actions taken be appropriate to the extent of the problem and its impact on energy performance.

After the appropriate action is taken, a review is performed to determine if the action taken was effective. In other words, did the action taken eliminate the cause and result in the nonconformity not occurring or recurring?In summary:

Correct current situation Determine magnitude and impact of the nonconformity Determine cause of the nonconformity Determine if action is needed Determine appropriate action to be taken Take action Review effectiveness of action taken Maintain records of actions taken

A Corrective Action/Preventive Action Request (CAR/PAR) Form, along with a CAR/PAR Tracking Log are commonly used to record and track the status of corrective and preventive actions. An Example CAR/PAR Tracking Logillustrates how a log sheet may be used to track actions to completion. If you have implemented another management system, such a quality or environmental management system, you may be able to use that same process.

5.3

The Critical Role of Auditingin Continuous Improvement

 By Dr. John Robert Dew

(Originally published in the National Productivity Review, Summer/1994.)

            There is a legitimate role for quality audits in todayÕs workplace. The success of the audit depends on managementÕs guidance of the audit, selection

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and training of auditors, and willingness to involve people in achieving the opportunities for improvement identified by the audit. To be effective, the audit process must be properly managed. A successful audit process is part of an overall plan for continuous improvement and can become a vehicle for recognizing excellence in an organization.

            In an age when organizations are empowering workers, building quality into products, and using statistical control limits to control quality, some might argue that the quality audit is no longer necessary.  It is true that many organizations suffer from over-control and that poorly conducted audits contribute to this problem.  Poorly managed audits instill fear in the organizations and can mislead management with inaccurate information.  But if managers know why they are auditing and if they know how to manage the audit process, well-managed audits can provide a process to foster learning, communication, and internal improvements vital to an organizationÕs ultimate success.

 

Audit Basics 

            Organizations have a legitimate need for an independent, unbiased assessment of activities.  In spite of the best intentions, deviations from expected procedures may occur in almost any work setting. Line managers may filter their problems from the next level of management so issues that need upper management attention may go unresolved.

Audits also provide management with confirmation of excellent performance that can be internally benchmarked by the rest of the organization.

            W. Edwards Deming argued that over 85 percent of the problems in a workplace can be improved only by management improving the work systems.  The audit can be a positive tool for finding the opportunities for continuous improvement.  The area to be audited should be defined by management, based on what management wants to learn.  Working like a photographer, the auditor enters the work area to take ÒsnapshotsÓ of how work processes are being conducted to see whether actual performance matches 

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expectations.  The auditor seeks out accurate images of improvement opportunities and examples of excellence in the organization.

            An audit is an expensive investment for any organization.  There is the cost of the auditor, the time that those being audited spend preparing for the audit, the cost of conducting the audit itself, and the time spent for reports and meetings to discuss audit findings.  To maximize the return on such an investment, managers must carefully consider the objectives they are trying to achieve through the quality audit.  The basic questions to be addressed are, What do you care about, and what do you want to know about? A general assignment that asks the auditors to roam about the organization and see if they can uncover any problems is ineffective and creates problems for the auditor and auditees alike.

            A well-defined audit will ask the auditor to examine how one specific practice is being conducted across a large part of an organization.  Or it will instruct the auditor to examine several specific practices in one unit of the organization.  Or it will instruct the auditor to examine several specific practices in one unit of the organization.  In either case, there is a clear definition of mission for the auditor.

            In defining the auditÕs mission, the manager should place the highest emphasis on obtaining verification that the most vital work is being performed properly.  What may be most vital will certainly vary form business to business and manager to manager.  In all cases, the value of the audit will be proportional to the value that the audited area has to the organization.

 

Communicating the Audit and Establishing Performance Expectations 

The effectiveness of the audit will be greatly influenced by how management communicates the purpose and performance of the audit.  Most people do not look forward to being audited and will probably dread the prospect.  This can lead to conflict in the auditing process and an effort by auditees to divert the auditor from observing the real conditions of a work process.  Proper communication of the audit and ethical conduct on the part of the auditors can go a long way to ensuring cooperation with the audit process.

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            Effective audits begin with a statement by management that a particular work process is extremely vital to the welfare to the organization, so vital, in fact, that the organization is willing to go to added expense to have an independent review of the work performance.  The purpose of the audit must be stated as an effort to gain a clear understanding of the status of a work situation to maintain and improve the process and to identify area of excellence in the organization.  The emphasis on understanding, continuous improvement, and identifying excellence will help create an atmosphere in which it is permissible and nonthreatening to discuss quality problems with the auditor.

            Where should the expectations of performance in the workplace come from?  Not the auditor!  When the auditors set the performance expectations, the expectations will vary from auditor to auditor. One auditor may view a particular situation as acceptable while another may consider it a disaster.  Standards for expected performance should be generated internally by the organization or through the adoption of standards agreed on within its industry.  Organizations need policies and procedures that define how vital   work functions will be performed.  These policies and procedures should serve as the standard against which auditors which auditors will measure performance.

            Professional societies have labored for years to agree on standards of performance in numerous disciplines.  Thousands of performance expectations have been codified into law.  Auditors do not need to impose their Òprofessional opinionÓ in the audit to establish performance expectations.  Many organizations are using internal adaptations of the Malcolm Baldridge National Quality Award as a standard for auditing how quality is being implemented.  The use of these types of consensus documents helps establish the unbiased nature of the audit process and helps the organization focus on continuous improvement and identification and recognition of excellence.

 

The AuditorÕs Role 

            The most important action that managers take in initiating an audit is selecting the auditor.  The auditor should know how to use effective listening and communication skills to find opportunities for improvement.  If management 

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selects a person who does not display these skills, the audit may do more harm than good.

            Ideally the auditor should be like Sergeant Joe Friday of Dragnet fame.  Through his conduct and demeanor, Sergeant Friday exhibited the characteristics of an effective auditor.  A ÒJoe FridayÓ auditor conducts the audit with a plan.  This auditor knows what is supposed to be happening in the organization because he or she has taken the time to review the procedures being audited.  ÒJoe FridayÓ prepares a checklist of specific areas to investigate and takes notes as he or she works through the list. 

            Sergeant Friday knows how to listen and asks open-ended questions to get people to loosen up and express concerns, then follows up with specific questions to nail down the details.  He or she asks to see examples of log books, files, check-sheets, or other relevant documents, and takes the time to study them to make sure they conform to requirements.

            ÒJoe FridayÓ arrives on the scene with an open mind.  He or she is there to investigate the situation and report back to management.  Sometimes people just need a friendly reminder about requirements or a pat on the back for doing a good job.  Sometimes people need to have deviations pointed out to them.  ÒJoeÓ knows that his or her role is to give accurate feedback, not to harass suspects or to keep on investigating until the least some minor problems is uncovered.  ÒJoeÓ knows that the identification of excellence is just as important as the identifications of opportunities for improvement.

             A well-conducted audit demands that the auditor not be confined to a comfortable conference room, reading documents submitted by the auditees.  Sergeant Friday went out into the field to see firsthand what was going on.  ÒJoeÓ will play an active role in selecting documents to review instead of relying on the audited organization to feed him or her the documents that may happen to comply best with the requirements.

A good ÒJoe FridayÓ auditor will understand the difference between problems caused by special circumstances and those that are built into the system.  Competent auditors understand the concepts of statistical variation and can interpret statistical control charts to help access what types of opportunities the organization may have for improvement.

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The Problem Audit

Unfortunately, not all auditors work with ÒJoe FridayÓ proficiency.  Some act a lot more like Deputy Barney Fife from The Andy Griffith Show.  When given the opportunity, Barney Fife would swell up with authority, belittle people, and throw his weight around.  He was allowed only one bullet, and he had to keep that one in his shirt pocket so he would not shoot himself in the foot.  When managers allow a ÒDeputy FifeÓ to conduct audits in their organization, they are inviting disaster for the auditor and auditee alike.

            The purpose of the audit is to gain important information as operations are examined through the eyes of an unbiased observer.  If the auditor creates a climate of fear or intimidation, then the audit findings will be of little value of the organization.  People working in the organization will distrust management for sending in such a person.

            Auditors need to be capable of calmly collecting information in a nonthreatening manner.  If potential auditors cannot conduct themselves in this way, they should never be permitted to conduct an audit.  The underlying problem with a ÒDeputy FifeÓ auditor is that he or she is focused inwardly instead of on the people being audited.  ÒDeputy FifeÓ is interested in establishing his or her expertise and telling his or her own story.  ÒDeputy FifeÓ enjoys making people squirm under the scrutiny of an audit.  The only excellence ÒDeputy FifeÓ wants to recognize is his or her own.

            People who are going to audit need to be trained in how to organize for the audit and how to effectively gather information for management.  They need to learn how to conduct a pre-audit meeting, how to write audit findings, how to close out audits, how to write audit findings, how to close out audits, and how to write audit reports.  Auditors can be trained to develop good listening and observation skills and can be coached to become good ÒJoe FridayÓ auditors.  The audit process is too expensive for organizations to skimp on training for their auditors. A poorly trained auditor will undermine the positive attitude about continuous improvement and high quality that management desires to instill in the organization.

 

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Audit Follow-Up: An Orientation Toward Improvement and Excellence 

The most important part of the audit is not what the auditor does in collecting the data, but what the manager does with the audit information.  Managers must be prepared to take actions to correct audit deviations and to recognize excellence.  The actions taken to make improvements must not make the situation worse.  The best approach is to meet with the people involved in the deviation and ask for their ideas for improving the situation and to empower them to solve the problem.  This allows them to assume ownership for the problem and for the solution.  The manager must then seek commitment from people to resolve the problem within a certain time frame and make resources available to support improvements, if necessary.

            The worst possible scenario is for managers to use audit information to punish people.  Management must drive fear out of the organization.  Punishing people will condition the organization to resist audits and hide problems from management.  The manager must learn to receive bad news from an audit as an opportunity for improvement and then involve staff members in resolving the issue.  Often the audit will bring to light performance problems that can be solved only by upper management.  Although management alone has the authority to change the system, management can usually invite the people who work in the system to help diagnose the problem, make recommendations, and implement solutions for resolving the problem.

            The most effective resolutions of audit findings occur when the organization has systems in place that allow for employee participation and an open climate for discussion about problems and opportunities as part of the normal business environment.  Joint union-management efforts for achieving quality are ideal for addressing audit concerns.  Elected councils of salaried employees, working with managers offer another good channel for addressing issues in a participative manner.  An accepted method for creating cross-functional teams will provide a good vehicle for making improvements.

            Successful organizations are those that learn to place a high value on continuous improvement.  Everyone in the organization, from the managers in the strategic center to the individual contributors, must all share a belief in the positive discussion of problems and deficiencies as a necessary first step in achieving excellence.

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            The audit will serve as one of several tools available for identifying opportunities for improvement.  It must be part of a system that includes employee suggestions, analysis of quality data, feedback from customers, suggestions from suppliers, and benchmarking of other organizations.  An organization needs to use all these avenues to continuously improve its process, and maintain competitive position in its market.

            Along with identifying opportunities for improvement, the audit should identify opportunities for reward and recognition.  Managers should set the expectation that auditors will identify excellence as well as opportunities.  The identification of excellence must be followed up with recognition.  An effective recognition program will employ such methods as internal newsletters, cash or award incentives, and meetings or banquets that focus on recognition and praise.  When management links the audit process to the reward and recognition system, the audit becomes an exciting opportunity for people in the organization instead of a potentially negative event.

 

Improving Continuously            The audit can become a powerful tool for feeding a continuous improvement process and providing recognition for excellence in any organization.  Successful implementation of an audit process requires managers to set positive expectations about how audits will be conducted, select important areas for audits, provide positive communication about the purpose of the audit findings, and involve people in following up on the audit findings.  The audit should be seen as a method for identifying both opportunities for improvement and areas of excellence that deserve reward and recognition.

Revised Quality Management PrinciplesPosted on Oct 1, 2013 in Newsletter

The ISO 9001:2008 standard states that the eight quality management principles described in

ISO 9000:2005 were considered during the development of ISO 9001:2008. According to the

committee draft of ISO 9001:2015, the revised standard is being developed to make more explicit

use of the quality management principles.

ISO 9001:2015 includes an Annex A that introduces the seven quality management principles

upon which the revised standard is based. The annex provides a “statement” describing each

principle and a “rationale” explaining why an organization should address the principle.

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The draft seven quality management principles are listed below, followed by the eight current

principles shown in italics.  Note that current principles 4 and 5 have been merged into the

revised principle 4, reducing the total number of principles from eight to seven.

QMP 1 – Customer FocusStatementThe primary focus of quality management is to meet customer requirements and to strive to

exceed customer expectations.

RationaleSustained success is achieved when an organization attracts and retains the confidence of

customers and other interested parties on whom it depends. Every aspect of customer

interaction provides an opportunity to create more value for the customer. Understanding current

and future needs of customers and other interested parties contributes to sustained success of

an organization.

QMP1 – Customer FocusOrganizations depend on their customers and therefore should understand current and future

customer needs, should meet customer requirements and strive to exceed customer

expectations.

Change: The revised principle continues to focus on meeting customer requirements and striving

to exceed customer expectations. It adds that you need to look at every customer interaction for

opportunities to create more customer value. It also adds that sustained success is achieved

when you gain customer confidence.

QMP 2 – LeadershipStatementLeaders at all levels establish unity of purpose and direction and create conditions in which

people are engaged in achieving the quality objectives of the organization.

RationaleCreation of unity of purpose, direction and engagement enable an organization to align its

strategies, policies, processes and resources to achieve its objectives.

QMP 2 – LeadershipLeaders establish unity of purpose and direction of the organization. They should create and

maintain the internal environment in which people can become fully involved in achieving the

organization’s objectives.

Change: The revised principle continues to focus on leaders establishing unity of purpose and

direction, as well as, creating conditions to involve people in achieving quality objectives.  It adds

that this leadership approach will enable your organization to align its strategies, policies, and

resources to achieve its objectives.

QMP 3 – Engagement of People

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StatementIt is essential for the organization that all people are competent, empowered and engaged in

delivering value. Competent, empowered and engaged people throughout the organization

enhance its capability to create value.

RationaleTo manage an organization effectively and efficiently, it is important to involve all people at all

levels and to respect them as individuals. Recognition, empowerment and enhancement of skills

and knowledge facilitate the engagement of people in achieving the objectives of the

organization.

QMP 3 – Involvement of People People at all levels are the essence of an organization and

their full involvement enables their abilities to be used for the organization’s benefit.

Change: The revised principle still describes the involvement of people at all levels. It adds that it

is essential for these people to be competent, empowered, and engaged to create and deliver

value.

QMP 4 – Process ApproachStatementConsistent and predictable results are achieved more effectively and efficiently when activities

are understood and managed as interrelated processes that function as a coherent system.

RationaleThe quality management system is composed of interrelated processes. Understanding how

results are produced by this system, including all its processes, resources, controls and

interactions, allows the organization to optimize its performance.

Principle 4 – Process ApproachA desired result is achieved more efficiently when activities and related resources are managed

as a process.

Principle 5 – System Approach to ManagementIdentifying, understanding and managing interrelated processes as a system contributes to the

organization’s effectiveness and efficiency in achieving its objectives.

Change: The current Process Approach principle and System Approach principle have been

combined into this one revised Process Approach principle. It continues to focus on

understanding and managing activities as interrelated processes within a system.  It clarifies that

understanding how results are produced by the processes, resources, controls, and interactions

allows your organization to optimize its performance.

QMP 5 – ImprovementStatementSuccessful organizations have an ongoing focus on improvement.

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RationaleImprovement is essential for an organization to maintain current levels of performance, to react

to changes in its internal and external conditions and to create new opportunities.

QMP 6 – Continual ImprovementContinual improvement of the organization’s overall performance should be a permanent

objective of the organization.

Change: The revised principle uses the term “improvement” instead of “continual improvement”.

ISO 9001:2015 is being developed to make more explicit use of the quality management

principles, so you would expect it to move to the term “improvement” to align with the revised

principle.

However, the text in Annex SL to be used for all management systems standards uses the term

“continual improvement”. Moving to “improvement” would result in a deviation from the required

Annex SL common text. Therefore, the committee draft of ISO 9001:2015 was prepared using

“continual improvement”, but with the “continual” being shown in strike-though text format (to

highlight the need for resolution of this issue).

The revised principle also changes from improvement of overall performance as a permanent

objective to a focus on improvement as being essential to maintain current levels of performance.

It also expands to cover the improvements needed to react to changes in internal and external

conditions and to create new opportunities.

QMP 6 – Evidence-based Decision MakingStatementDecisions based on the analysis and evaluation of data and information are more likely to

produce desired results.

RationaleDecision-making can be a complex process, and it always involves some uncertainty. It often

involves multiple types and sources of inputs, as well as their interpretation, which can be

subjective. It is important to understand cause and effect relationships and potential unintended

consequences. Facts, evidence, and data analysis lead to greater objectivity and confidence in

decisions made.

QMP 7 – Factual Approach to Decision MakingEffective decisions are based on the analysis of data and information.

Change: The revised principle still addresses decisions that are based on the analysis of data

and information. The rationale section refers to the uncertainty and subjective nature of

decisions. It adds that understanding cause and effect relationships and the potential for

unintended consequences is important.  In addition, it states that evidence-based analysis leads

to decisions with greater objectivity and confidence.

QMP 7 – Relationship Management

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StatementFor sustained success, organizations manage their relationships with interested parties, such as

suppliers.

RationaleInterested parties influence the performance of an organization. Sustained success is more likely

to be achieved when an organization manages relationships with its interested parties to optimize

their impact on its performance. Relationship management with its supplier and partner network

is often of particular importance.

QMP 8 – Mutually Beneficial Supplier RelationshipsAn organization and its suppliers are interdependent and a mutually beneficial relationship

enhances the ability of both to create value.

Change: This principle has expanded from supplier relationship to relations with interested

parties. The revised principle states the supplier and partner network is of particular importance,

but there can be other interested parties. For example, the draft ISO 9001:2015, clause 4.2,

identifies possible interested parties as direct customers, end users, suppliers, distributors,

retailers, and regulators.

Note: For more information on the current quality management principles, see our May 2013 and

June 2013 newsletters. These newsletters describe the eight principles, as well as, their benefits

and application.