ISO 9001 Guidance DocumentV1

8/12/2019 ISO 9001 Guidance DocumentV1

1/16


2/16

2

DNV Business Assurance. All rights reserved

FACTS

4 QUALITY MANAGEMENT SYSTEMS

4.1 General requirements

The general requirements outline what

constitutes the basis of a quality managementsystem, a broad view of what needs to be done.The aim of which is to facilitate developmentof a system that will achieve the business qualityobjectives. Items a) through to f) provide asystematic approach to building such a system.One made up of processes, which should bemanaged in accordance with the requirementsof the standard.

It should be recognised that the system shouldinclude all processes needed to achieve theobjectives. That means processes needed for;managing the organisation, managing resources,making and/or delivering product or serviceand measurement.

Any process that is outsourced also needs tobe identied within the Quality ManagementSystem (QMS) and controlled by theorganisation. A classic example of this ismaintenance of process equipment andorganisational infrastructure. Organisationscannot simply pass activities on to subcontractorsor suppliers and not exert some controls overthem.

DOCUMENTATION AND RECORDS REQUIREDWITHIN THIS CLAUSE

There are no specic documentaryrequirements in this clause. It merely reectsthe fact that the system will be documented. Theextent of that documentation will be determinedby the organisation according to need.

FACTS

4.2 Documentation requirements

4.2.1 General

Formal quality management systems aresometimes perceived as nothing but largecollections of documents. This is a greatmisconception. Documentation is there as anaid to manage risk.

This general requirement outlines whatconstitutes the quality system documentationrequired by the standard. Whilst somedocumentation is mandatory, a great deal ofexibility is given to the organisation in deciding

what documents it requires to ensure adequateplanning, operation and control of its processes.

This will greatly depend upon; the size of

the organisation and type of activities; thecomplexity of processes and their interactions;the competencies of personnel.

Another point to note is that a record is adocument. However, as we will see in the nextfew clauses, records are controlled in a different

way to other documents.

DOCUMENTATION AND RECORDS REQUIRED

WITHIN THIS CLAUSE

Quality policy and objectives must bedocumented and there must be a qualitymanual, which by denition is a document.Other documentation such as procedures andrecords are indicated as being necessary but arenot determined or specied in this clause.

4.2.2 Quality manual

A quality manual must be produced. Its purposeis to provide an over- view of the system andallow users to nd information.

There is no dened format for a qualitymanual. The choice of format and content ispurely a matter for the organisation. However,it must contain; the scope of the QMS (e.g.the manufacture of wooden doors), including

justication for any exclusions (e.g. where there


3/16


is no design process); documented procedures,or reference to them; a description of processinteraction (e.g. an in-sequence ow chart of thequality system processes).

It should be noted that outsourcing an activity is

not justication for exclusion. The organisationis still responsible for the results and must placecontrols on such an activity.DOCUMENTATION AND RECORDS REQUIREDWITHIN THIS CLAUSE

Quality manual and possibly records of itrevision and distribution.

4.2.3 Control of documentsSystem documentation needs to be controlled.That includes documents received as well asdocuments produced internally.

The aim is to ensure that the right documentis in the right place at the right time. Onlythrough controlling documentation can it beensured that the right information is beingcommunicated to the right people.

Control should ensure that those reviewingdocuments are competent and that revisionstatus is identied and traceable. Distributionshould ensure that those that need thedocuments have access to them, and thatobsolete documents are dealt with correctly.


A documented procedure is required and therewould also be records of review and approval,distribution and recall. There may also be amaster list of all documentation and a revisionhistory.

4.2.4 Control of recordsRecords are those documents that provideevidence of conformance. They can beregarding product, process and/or system.

Forms, once complete, often become records(e.g. checklists, inspection reports, etc.).

It is up to the organisation to determine exactlywhich records are required and how long theyshould be retained for. However, requirements

for some records are stipulated in the standardand may further be stipulated in; procedures,contracts, legislation, etc.

The organisation will also need to determinewho will keep the records and for how long, howthey should be kept and where, and what shouldbe done with them once they are no longerrequired.


There may be a master list of records. Adocumented procedure is required to controlrecords but that does not mean there will be onecontrol procedure covering all records.

FACTS

5 MANAGEMENT RESPONSIBILITY

5.1 Management commitment

No system will achieve its true potential withoutthe commitment of Top Management. Evidenceis required to demonstrate such commitment,particularly with regard to the development,

implementation and improvement of the system.

Such commitment can be demonstratedthrough creating a quality culture, providingclear direction, ensuring the availability ofadequate resources and reviewing progress.


Whilst there are no specic document

Plan


4/16

4


requirements, evidence can be providedthrough training records, policies andobjectives, budgets and plans, and meetingminutes.

5.2 Customer focus

Without knowing what our customers want,how can we expect to deliver? The aimof this requirement is to fully determinemarket/customer needs and expectations.This information then acts as one input todetermining strategy, which in turn providesdirection and facilitates development of a systemcapable of satisfying the targeted market orcustomer.

This is an on-going process, which can beachieved by many different means.


Whilst not specied, documents/recordsmight include market surveys, meetingminutes, questionnaires, and others.

5.3 Quality policy

The policy is a very important documentbecause it acts as the driver for the organisation.It provides the direction and formally establishesgoals and commitment.

It is the responsibility of Top Management toensure that policy is set and appropriate. Itshould not be some bland statement that could

apply to any organisation. It must provide cleardirection to allow meaningful objectives to beset in-line with it.

Once set, the policy needs to be communicatedto all employees that are involved in achieving it.They need to understand what part they have toplay in its deployment.


WITHIN THIS CLAUSE

Policy must be documented and some form ofdocument control would need to be applied.

5.4 Planning

5.4.1 Quality objectivesAs part of the planning process topmanagement needs to set quality objectives.These objectives are what make the policy areality. As such they should be consistent withpolicy and be capable of being measured.

When setting objectives the current and futureneeds of the organisation should be consideredas well as the market served.

There are many different types of objectives;market position and/or growth, processeffectiveness and/or efciency, awareness levels,maintenance of present position, etc. Whilstimprovement is necessary, objectives do not haveto be for improvement only.

The objectives need to be deployed throughoutrelevant parts of the organisation and must

be meaningful to those who are assignedresponsibility for achieving them and those

whose activities contribute to achievement.

They must also be measurable


Objectives must be documented and there willneed to be evidence regarding monitoring of

achievement. There will also be baseline data onwhich the objectives are bases.

5.4.2 Quality management system planningHaving established the quality objectives, theorganisation must plan how they are going toachieve them. This would involve determinationof structure, roles and responsibilities, processesand interaction, resources, information,


5/16


communication, etc.

Planning should be consistent with the systemsapproach.

It is realised that business is dynamic and as

such there will be change. Change managementprocesses must ensure that the integrity of thesystem is not damaged during change and thatthe system continues to function properly.


The output of system planning would need to bedescribed in the quality manual. The manualshould reect the system.

FACTS

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authorityFor a system to function effectively and

efciently those involved need to be fully awareof their role. Top Management must ensure thatresponsibility and authority are clearly denedand that everybody involved understands whatthey can and should do.

Dening roles is a function of planning,ensuring awareness can then be achievedthrough communication and training.


Whilst not required, it is common fororganisations to use job descriptions orprocedures. Again, these would be the subject ofdocument control. It may also be felt necessaryto have awareness training records.

5.5.2 Management representative

Within any system there is a need to channelinformation. This could be said to be theprimary role of the management representative(MR). It is not the responsibility of the MRto implement the system, but to ensureimplementation and provide feedback on

performance.


Some organisations choose to ofcially appointthe MR. There may also be compiled data forreporting purposes.

5.5.3 Internal communicationCommunication is essential to the effectivefunctioning of any system, Top Managementneed to ensure that mechanisms are in place tofacilitate this.

It should be recognised that communication istwo-way and will not only need to cover what isrequired, but also what resulted. In other words,

what was planned and what was achieved?

Mechanisms for communication could include;meetings, notice boards, in-house publications,awareness raising seminars, toolbox talks,intranet, email, etc.


Some organisations see communication as beingimportant enough to warrant a documentedcommunication procedure. Whilst this is not

required there is at least likely to be somereference in procedures.

FACTS

5.6 Management review

5.6.1 General

Plan

Check


6/16

6


The main aim of management review is toensure the continuing suitability, adequacyand effectiveness of the QMS. Only throughconducting the review at sufcient intervals,providing adequate information and ensuringthe right people are involved can this aim be

achieved.

There is information that is considered essentialfor this purpose and as such the standard detailsthe minimum inputs to the review process.

Top Management should also use the review asan opportunity to identify improvements thatcan be made and/or any changes required,including the resources needed to realise this.

5.6.2 Review inputsDescribes the minimum inputs

5.6.3 Review outputs

Describes typical outputs


Records of the review are required to bemaintained. This will usually be in the form ofmeeting minutes but may also be in the form ofa report, notated with required actions after itsreview.

IMPACT

Exercise 11: Management Responsibility

Imagine that you are the skeptical ChiefExecutive of an organisation. Youre notparticularly interested in what ISO9001 has tooffer your business. You simply need a certicateto enable you to carry on trading with one of

your major customers.

In your teams discuss what is the minimumthat you feel you can get away with doing to

comply with the requirements of Clause 5 of thestandard.

Produce a list of your ndings.

FACTS

6 RESOURCE MANAGEMENT

6.1 Provision of resources

An effective and efcient QMS cannot bemaintained or improved without adequateresources. As a function of planning, such

resources should be determined, and thenprovided. This includes contract or projectspecic resources.

The standard puts resources into the followingthree categories; human, infrastructure, workenvironment.


Whilst not required, annual budgets,organisation charts, project/production plansare just some of the types of documents whichcould be utilised to demonstrate adequateplanning of resources.

6.2 HUMAN RESOURCES

6.2.1 General

The main intention behind this general

requirement is that the people working withinthe quality system are competent to full theduties of the assigned function.


See below.

6.2.2 Competence, training and awareness

Plan


7/16


In order to determine competence, competencecriteria need to be established for each functionaffecting quality. This can then be used toassess existing competence and determinefuture needs. Where criteria are not met someaction is required to ll the gap. Training or

reassignment may be necessary. Regardlessof the action taken, effectiveness will need tobe evaluated to ensure competence exists inrelation to criteria/needs.

Personnel also need to be made aware ofthe relevance of their activities and how theycontribute to organisational quality objectives.Induction programmes and staff reviews areoften used for this purpose.


Records are required to be able to demonstratecompetence. Recruitment and inductionprogrammes, training plans, skills tests and staffappraisals often provide evidence of competenceand the assessment thereof. Competencyrequirements are often included in recruitmentnotices and job descriptions.

FACTS

6.3 Infrastructure

Again, for a system or process to operateeffectively and efciently there must be

adequate buildings, equipment, transport,etc. Determining what is needed and whatmaintenance programme should be developedto ensure its continuing capability is part ofplanning. Obviously the plan should then beimplemented.


There is no specied documentationrequired but annual budgets, organisationcharts, project/production plans and thelike might indicate what was planned.Maintenance programmes and records couldalso be used to ensure optimisation.

6.4 Work environment

The work environment of an organisation hasmany human and physical factors that caninuence quality, effectiveness and efciency.Such factors that have inuence need to beidentied and managed. They can include;creative work methods, protective equipment,ergonomics, heat, noise, light, hygiene,

humidity, vibration, etc.

An example of a work environment issue wouldbe humidity in a paint shop. Compliance withacceptable humidity levels during painting

would need to be monitored.


Again there are no specic documentary

requirements but work environment criteriaare often found in procedures, contracts,specications, codes of practice and the like.Organisations would need to provide evidenceof compliance through records.

FACTS

7 PRODUCT REALISATION

7.1 Planning of product realisation

Product realisation processes are those processesthat are required in order to realise the product.In other words they are a sequential series ofprocesses which determine requirements andconvert those requirements into a deliveredproduct that meets requirements.

Plan

Plan


8/16

8


The above are often referred to as core businessprocesses. However, they are reliant on otherprocesses, often referred to as support processes(e.g. training, documentation, maintenanceetc.).

Product realisation processes need to beplanned and developed. In some organisationsplanning happens infrequently because theproduct is always the same. In others it happens

with every contract or order.

Where a certain activity is not undertaken andnot necessary to fulll requirements, (e.g. wherethere is no design) the respective requirementsof the standard can be excluded.


There are no specic documentaryrequirements in this clause. The output ofplanning should be in the form most suitableto the organisation. That could be; drawings,specications, procedures, method statements,quality plans or any combination of theseand others. Planning should also include

what records will be needed as evidence ofcompliance.

FACTS

7.2 Customer related processes

7.2.1 Determination of requirements related tothe product

There must be a process to ensure that needsand expectations of customers (requirements)are determined. This should includedetermination of intended product use and anystatutory regulations that would apply to theproduct in its intended market.

Only once all requirements are identied can

they be reviewed.


See below.

7.2.2 Review of requirements related to theproduct.

Once determined, requirements need tobe reviewed by the organisation prior tocommitment to supply, to ensure that they areunderstood, that any anomalies are resolved andthat the organisation has the ability to meet therequirements. All too often offers are made andorders accepted without fully understandingneed and capability.

Review would need to be undertaken duringenquiry handling and again, albeit to a lesserdegree, during acceptance of a contract/orderand when handling amendments.


Examples of input documentation would be;enquiries, specications and clarications, whilstexamples of output documents could be

offers, tenders and contractor proposals.Also, subsequent amendments and relatedcommunication records.

7.2.3 Customer communication

The need for communication will differaccording to many factors; customer, internalneed, contract, risk, project complexity etc.Obviously it will take place as part of thedetermination and review processes detailed

above, but it will also need to take place duringproduction and possibly after delivery.

Communication needs to be planned to ensurethat all necessary information is available

when needed, from both external and internalsources. This will include feedback from thecustomer, which is further discussed under thespecic heading of customer satisfaction.

Do


9/16



No communication documents are speciedbut organisations normally determine whatdocuments need to be maintained. Typicallythey consist of contracts, specications, emails,letters, transmittals and attachments, meetingminutes, complaints etc.

IMPACT

Exercise 12: Customer-related Processes Clause 7.2

In your teams review the following scenario and

determine which, if any, of the requirements ofClause 7.2 have not been complied with.

In the production department there is a batch ofcomponents (identication number 6633)

which has recently been manufactured.The items are labelled HOLD PENDINGCONCESSION and are the rst batch to bemade for a recently received order.

The supervisor explains that these itemshave been manufactured in accordance withthe relevant process control procedures andconform to the well-known and establishedcapability of the production department but donot con- form to the customers specication.

The sales department is currently discussingwith the customer how to resolve this situation.Record your ndings below.

FACTS

7.3 Design and development

7.3.1 Design and development planning

There must be a systematic approach tocontrolling design activities and product

development. This will involve planning,which should include; stages of design, review,verication and validation activities; denedresponsibilities; and management of theinterfaces between various groups to ensureadequate communication.


Although not a specied requirement, acommon document produced is a design plan,

which outlines how the design will be managedthrough the whole design process.

7.3.2 Design and development inputs

The information required in order toproceed further with the design process mustbe determined, recorded and reviewed foradequacy.


This may include; customer specication;statutory requirements; information fromprevious designs etc., and associated review

records.

7.3.3 Design and development outputsHow the design is developed is a matter forthe each organisation to decide. However,the design output needs to be veried againstthe design input requirements. Thereforeoutput needs to be in a format that will enable

verication. Output also needs to; facilitatepurchasing, production and servicing processes;

show or give direction to acceptance criteria;specify characteristics essential to safe use.


Typical out puts include drawings, specications,instructions, schedules, user manuals, etc.

7.3.4 Design and development reviewReview of the design should be undertaken

Do


10/16

10


as planned, to ensure that design progressis satisfactory and to trigger solutions to anyproblems being encountered.


Results of review and necessary actions needto be recorded. Typically these would includemeeting minutes, altered drawings, sketches,approval documents etc.

7.3.5 Design and development verication

Verication is basically a process whereby thedesign is checked to ensure that what has beendesigned meets the input requirements. Forexample, checking design calculations to ensurethat an air conditioning unit has the desiredcapacity.


The results and any actions required as a resultmust be recorded. Typically these would includealternative calculations, approvals, stamps,comparison reports, etc.

7.3.6 Design and development validation

Validation needs to be performed, as planned,to ensure that the product can do what it wasdesigned for. For example, testing a prototypeair conditioning unit to ensure it can holdthe desired temperature under the denedoperating condition used as the basis for thedesign.

Validation should, where possible, be completedprior to delivery.


Results and any actions need to be recorded.Typically these would include test results,prototype user feedback, etc.7.3.7 Control of design and development

changes

Changes to design requirements can come atany time and as a result of many factors. Theycan also signicantly impact on what has alreadybeen designed. Any resulting changes in designmust be reviewed and veried and validated

where necessary.


Design changes need to be identied,documented and recorded. Typically these couldinclude internal memos, customer or legislativecorrespondence.

IMPACT

Exercise 13: Design & Development Clause 7.3 A Quiz!

In your teams you are required to reviewthe requirements of Clause 7.3 and produce5 questions to test the knowledge andunderstanding of the other participants.

A short quiz will be held between the teams. Youcan record your questions here.

FACTS

7.4 Purchasing

7.4.1 Purchasing process

In essence, the main aim of this requirementis to ensure that purchased products orservices will meet requirements. As a rst stepit is necessary to have condence in the entitysupplying the product or service. Therefore it isrequired that an evaluation process is in place.

This evaluation process should be exible,as not all suppliers have the same impact onthe purchasers nal product. The criteria

Do


11/16


for selection, evaluation and re-evaluation ofsuppliers must be determined. Controls couldthen be put in place based on the results of theevaluation and the relative impacts they couldhave (risk management).

Suppliers need to be re-evaluated periodically.This can be done through performance records.


The results of supplier evaluation and re-evaluation need to be maintained. Typicallythese would be in the form of references, trialorders, product specications, audit results,performance data etc. Whilst not required, anapproved supplier list is often compiled for easyreference.

7.4.2 Purchasing information

The second step to ensuring that purchasedproduct meets requirements is to provide allthe necessary information. The supplier shouldnot have to second guess what is needed.Clarity is essential, not just in terms of productspecication but also in terms of operatorqualication, quality control, quality assurance,documentation, delivery, etc. The purchaserequirements should also be checked foradequacy before they are communicated to thesupplier.


Typical documentation would include supplier

quotation analysis, purchase orders, contracts,and associated review records.

7.4.3 Verication of purchased product

The third step involved is verication of theproduct or service. This may be done by variousmeans at the pre-shipment stage or uponreceipt. For example, receiving inspection ortest, or through verifying a certicate of productconformance.

Verication activities that are to take place at thesuppliers premises need to be detailed in thepurchase information.


No documentation specied but couldinclude; purchase information, samplingplans, inspection/test reports, conformancecerticates, acceptance criteria etc.

IMPACT

Exercise 14: Purchasing - Clause 7.4 True/False

In your teams you are required to review therequirements of Clause 7.4 and then identify

which of the following statements are true orfalse:

Statement T/F

Organisations are required to produce a list of

Approved Suppliers

Purchase orders must be signed as evidence of

checking prior to issue to a supplier.

All items purchased by an organisation must

be subjected to the same level of checking to

confirm they meet requirements

Data about the performance of suppliers

needs to be collected and analysed

1

2

3

4

5

Everything that an organisation buys is rquired

to be purchased from a supplier who has been

evaluated


12/16


13/16


7.5.5 Preservation of product

It almost goes without saying that all productneeds to be preserved, from raw materialsduring receipt, storage and processing tonished product up to the point of delivery. Theaim is continued suitability for use.

When planning preservation one shouldconsider the needs of customers and regulatorsand identication, handling, packaging, storageand protection.

The type of product will naturally dictate theinfrastructure and controls necessary. Frozenfood for example will require cold storageand be governed by regulation, whereas other

products may just need protection from directsunlight.


No documents are stipulated in the standard butdocumentation may include; storage proceduresand criteria, records of receipt and issue legalcompliance, nonconforming product, expirydates, damaged or lost goods, returns etc.

FACTS

7.6 Control of monitoring and measuringequipment

The main aim of this requirement is to ensure

that the necessary measuring equipment isavailable and in a known state of accuracy so asto provide assurance and evidence that productmeets requirements. This includes software.

The organisation must determine whatmonitoring and measuring has to be undertakenand thereafter provide evidence that it wasunder- taken using correct and reliableequipment.

Regular calibration and maintenance is one wayto provide condence that results can be reliedupon. Others might include procedures forhandling, use and storage.


Records of calibration are required but inaddition to this there may also be calibrationmethods, calibration lists, records of validitychecks, error acceptance criteria, maintenancerecords, etc.

FACTS

8 MEASUREMENT, ANALYSIS ANDIMPROVEMENT

8.1 General

When developing a system it is necessary to planwhat needs to be measured and how the resultswill be used to identify where improvement arerequired or desired. Such checks and analysis

are an essential part of the P-D-C-A cycle.

The focus should be on what is critical; product,process, system, business goals, customer.This will avoid unnecessary measurement andanalysis.


There will inevitably be some documentedprocedures describing methodology and criteria.There will also be templates designed to capturerelevant data, which will become records. There

will also be results of analysis.

8.2 Monitoring and measurement

8.2.1 Customer satisfactionCustomer feedback is one very good indicator

Do

Do


14/16

14


of system and business performance andthere are many ways to capture such feedback.Questionnaires are not the only solution andare often ineffective. Some other methods are;interviews, meetings, market surveys.

The aim is to monitor information that willhelp determine customer perception of productand/or service and facilitate analysis so as tofocus attention where it is needed to improve orenhance satisfaction levels where necessary.


There may be completed feedback formsor questionnaires. Alternatively there maybe results of analysis of existing data (e.g.complaints, maintenance calls, meetingminutes).

8.2.2 Internal auditThe aim of the audit process is to determinethe degree of conformance, implementationand effectiveness of the QMS and provideinformation to facilitate change andimprovement.

An audit programme needs to be establishedto ensure that all processes are audited at therequired frequency, the focus being on thosemost critical to the business objectives andsuccess.

To ensure that audits are consistent andthorough, a clear objective and scope should

be dened for each audit. This will also assistwith auditor selection to ensure objectivity andimpartiality.

To get the best results, auditors should have aworking knowledge of what is to be audited.However, they must not audit their own work.Management must act upon audit results. Thisis often limited to corrective action relating tonon-conformance, but other ndings can also

be used to trigger prevention and improvement.

Follow up activities should be performed toensure that necessary action has been taken andis effective.


A documented procedure is required. There willalso need to be an audit programme and recordsof audit results not just nonconformity notices.In addition there will be follow up records andmay be other documents such as checklists andauditor training records.

8.2.3 Monitoring and measurement of processes

Whilst the audit process measures the system,it will still be necessary to monitor and insome cases measure individual processes.

When a process is planned it should have aclear objective or purpose. The main purposeof monitoring or measuring the process is todetermine if it is achieving this objective orpurpose.

There are many different ways to monitor ormeasure a process; cycle time, waste, rejects,costs, variability, etc. Obviously those mostsuitable should be chosen.

Where the process is not effective it is anindication of a problem that needs to becorrected and as such appropriate action shouldbe taken.


Whilst no documentation is specied asrequired, there will inevitably be some processoutput information and it is this data that isused.

FACTS

8.3 Control of nonconforming product

Check


15/16


This requirement is intended to ensure thatnonconforming product is prevented fromfurther processing, use or delivery.

Once identied, and regardless of whenidentied (e.g. during processing or after

delivery) any nonconforming product shouldtrigger a process whereby an authorised andcompetent person should decide what courseof action to take. Options include scrap,concession, alternative use, product reworkor recall and others relative to the product orservice.


A documented procedure is required to controlthe process of handling non-conformingproduct, as are records of such products thatshow what action was taken.

FACTS

8.4 Analysis of data

Collection and analysis of relevant data isnecessary to measure the suitability andeffectiveness of the QMS and to identifyopportunities for improvement. As such businessgoals and objectives should considered whendeciding what to analyse.

Methods of analysis varyggreatly in termsof applicability and complexity. Simple Bar

Charts are sufcient for some activities whereasStatistical Process Controls are necessary forothers. The methods selected should only beas complex as is needed to reach the desiredconclusions relative to what is being analysed.

As a minimum, analysis should be performedin relation to customers, product conformance,processes and supplier performance. However,there are other valuable sources of information

that can be utilised e.g. employees.

The main aim is identication of prevention andimprovement opportunities.


There are no specied documentaryrequirements but there will be raw data andresulting analysis in the form of charts, graphs,percentages, distribution curves, standarddeviation etc.

FACTS8.5 Improvement

8.5.1 Continual improvement

One of the aims of any organisation should beto improve, and this should be a permanentobjective. Such a commitment will have alreadybeen indicated in the policy. The aim of thisrequirement is to drive improvement of the

systems effectiveness.

There are many ways to identify and driveimprovement. All measurement results can beanalysed to determine where improvement isrequired or desired. Policy and objectives canthen be set and deployed through preventionand improvement programmes.

Improvement does not have to take place in all

areas of the business at the same time. Focusshould be relevant to risks and benets.Improvement can be incremental (smallchanges) or breakthrough (new technology). Inreality both methods will be used at some pointin time.


There may be specic improvement objectives.

Check

Act


16/16

16

8.5.2 Corrective action

The main aim of the corrective action processis to eliminate the causes of actual problemsso as to avoid recurrence of those problems.It is a reactive process, in that it is triggeredafter an undesired event e.g. discovery of

nonconforming product.

In essence the process focuses on root causeanalysis. If we adopt the standard approachto problem solving, that being CAUSE andEFFECT, it is the cause that needs to beeliminated. The effect is handled whencontrolling the actual non-conformance.

Action taken should be appropriate to the

impact of the problem (risk). As part of thecorrective action process, the effectiveness ofaction taken must be checked to ensure itseffectiveness.

It is worth noting that corrective action by its selfwill not bring about improvement in the QMS. Itmerely brings the control level back to where itshould have been before the non-conformanceoccurred.

8.5.3 Preventive actionA similar set of requirements, but now of coursedealing with potential problems rather thanactual ones.


WITHIN THIS CLAUSE

A documented procedure is required andresults of action taken must be recorded. Other

documentation would be results of investigationin to the magnitude of the problem and thecause(s).

Date post:	03-Jun-2018
Category:	Documents
Upload:	boo-bala-saravanan
View:	225 times
Download:	0 times

ISO 9001 Guidance DocumentV1

Documents