QMS Specimine Exam Paper

 

CONFIDENTIAL APPROVED TRAINING PARTNERS

CQI and IRCA Specimen Examination Paper QMS Quality Management Systems Lead Auditor Training Courses (PR328 ISO 9001)

Please write your name and the date in the space provided Name: Date: THESE SPACES ARE FOR OFFICIAL USE ONLY  Section

Marker 1

Marker 2

Pass mark

Maximum

1

5

10

2

10

20

3

15

30

4

15

30

63

90

Total Name of Marker

Confirmed

Result

This examination is closed book. 



A clean copy of o f ISO 9001 and a nd a bilingual bilingual dictionary are the only items permitted for reference. Electronic Electron ic devices, including laptops and mobile phones, are no nott permitted into the examination room. Exceptions may be granted to delegates

with

CQI and IRCA IRCA QMS Specimen examina examination tion paper, paper, January 2017. Amended for use on certified course 18019 operated by Resource Inspections Canada Incorporated (01199941).  

 

special spe cial need needs. s. Any Any such such arr rra angem gement must ust be wi witth the pri prior writ ittten agreeme agre ement nt of the IRCA Approved Approved Training Training Organisat Organisation ion and shall include include a record of appropriate precautions that will be taken to ensure the fairness and security of the examination examination process and examination questions.

 

Information for delegates The examination paper is in four sections. Attempt all sections and all questions. The time allowed allowed is two hours. hours. There There is no addition additional al time allowed allowed for reading reading the examination paper. 90 marks are available. To pass you must achieve at least 63 marks (70%), and you must achieve at least 50% in each of the four sections. The maximum marks for each question, or part of a question, are shown in brackets. Your answers must be written on the sheets supplied. Please avoid writing in the margins; these are for the markers. Write on the reverse side of a page if  necessary. Additional Additional loose sheets will not be accepted. All references to ISO 9001 refer to the latest issue.

Examination technique Time management time available is: is very important in the examination. For guidance, the average 

Reading the examination instructions instructions – five minutes

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Section one – fifteen minutes

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Section two – twenty minutes

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Section three three – forty minutes

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Section four – forty minutes

Total time available – two hours (120 minutes) Allow enough time to read each question properly. properly. Make sure you understand what is being asked for before starting starting to write your answer. Where appropriate, the action verb that indicates the depth of answer required by the questio question n – exp expla lain, in, list, list, descr describ ibe e – is pr print inted ed in bold. You should ensure you understand the meaning of these terms (see below). Full marks will not be awarded for a list if an explanation is required. Conversely, it is a waste of time to provide a detailed explanation explanation if the question asks for a list.

Action verb Meaning describe

depict in words

explain

give a clear account of  

outline

give the most important features of (less depth than explain or

 

describe) give list identify defin fine

provide wi without ex explanation (u (used no normally wi with th the in instruction to to  ‘give  ‘giv e an example example (or (or example examples) s) of ....’) ....’) provide a lliist without explanation (b (bullet po points) select and name prov provid ide e a gen generally lly reco cogn gniise sed d or acce accept pte ed defi defini nittion

state a less dem demanding fo form of ‘define’ or where th there is no no recognised definition

generally

 

Section one – Five questions worth two marks each – maximum 10 marks 1.1

ISO 9001:2015 9001:2015 requires requires that internal internal audits audits are objective objective and impartial. impartial. Describe the difference between objectivity and impartiality in this context. (2 marks)

1.2

Explain, in the context of auditing, the difference between being argumentative and being assertive. (2 marks)

 

1.3

The orga organis nisati ation on needs needs to to monit monitor or custo customer mer satisf satisfact action ion.. List two two metho methods ds an organisation can use to determine the degree of customer satisfaction. (2 marks)

1.4

Cla Clause 8.3.4 of ISO 9001:2015 requires design and developme pment verification to be carried out. List two verification activities that may be used by the design function of an organisation. (2 marks)

CQI and IRCA IRCA QMS Specimen examina examination tion paper, paper, January 2017. Amended for use on certified course 18019 operated by Resource Inspections Canada Incorporated (01199941).  

 

1.5

Identify two ways in which an auditor can verify that agreed corrective actions have been effectively implemented. (2 marks)

CQI and IRCA IRCA QMS Specimen examina examination tion paper, paper, January 2017. Amended for use on certified course 18019 operated by Resource Inspections Canada Incorporated (01199941).  

 

Section two – Four questions worth five marks each – maximum 20 marks 2.1

ISO 9000:2 9000:2015 015 identi identifie fies s ‘evide ‘evidence nce-ba -based sed decisi decision on maki making’ ng’ as one one of of the the 7 Qualit Qua lity y Manage Managemen mentt Princi Principle ples s that that facili facilitat tate e achiev achieveme ement nt of Qualit Quality y Objectives. a) Explain your understanding of what is meant by “evidence-based decision making”. (2 marks)

b) Identify six ISO 9001:2015 clauses that support such an approach. (3 marks)

CQI and IRCA IRCA QMS Specimen examina examination tion paper, paper, January 2017. Amended for use on certified course 18019 operated by Resource Inspections Canada Incorporated (01199941).  

 

2.2

ISO 9001:2 9001:2015 015 requir requires es Top Top Manag Manageme ement nt to to demon demonstr strate ate leader leadershi ship p and and commitment with respect to the QMS. a) Describe briefly a method you could use to evaluate Top Management leadership and commitment (2 marks)

b) Give three examples of audit evidence you would gather as part of your evaluation of Top Management leadership and commitment. (3 marks)

CQI and IRCA IRCA QMS Specimen examina examination tion paper, paper, January 2017. Amended for use on certified course 18019 operated by Resource Inspections Canada Incorporated (01199941). Page 9 of 36

 

2.3 2.3

A posi positi tive ve aud audit itor or attr attrib ibut ute e is is to be di dipl plom omat atic ic.. a) State the meaning of ‘diplomatic’ ‘diplomatic’ and give an example to to demonstrate how an auditor could be diplomatic. (3 marks)

b) Describe briefly the effect that not being diplomatic could have on an CQI and IRCA IRCA QMS Specimen examina examination tion paper, paper, January 2017. Amended for use on certified course 18019 operated by Resource Inspections Canada Incorporated (01199941).  

 

audit. (2 marks)

2.4

At the the open opening ing meetin meeting g of an exte extern rnal al audi audit, t, you you are are info informe rmed d that that a recent internal audit has found many nonconformities relating to the inhouse purchasing department. Corrective action has already been planned. It is therefore suggested that to audit this department again would add no value and asks if you could delete this department from the audit plan and spend more time in the production area.

Outline five issues you would include in the response you would give to this request. (5 marks)

 

Section three – three questions worth ten marks each – maximum 30 marks 3.1

During During a routi routine ne surve surveill illanc ance e visit, visit, the the orga organis nisati ation on you you are are audit auditing ing informs you that they no longer carry out any design and development work. This activity is now outsourced to an external provider (contractor).

Give four examples of audit evidence you would look for to determine the conf confor orma manc nce e of the the curr curren entt syste system m with with IS ISO O 9001 9001:2 :201 015, 5, gi give ven n th the e information you have just received. AND For each of your examples, identify the clause(s) of ISO 9001:2015 that relate to this situation. (10 marks)

 

3.2 3.2

Takin Taking g into into accou account nt the the requi require reme ment nts s of claus clause e 10. 10.2 2 of ISO 9001 9001:2 :201 015, 5, describe in terms of a sequence or illustrate using a diagram the corrective action process starting from a non-conformance being raised by an auditor through to close out of the finding.

Identify who is responsible for each element of the process and identify where in the corrective action process decisions need to be taken. (10 marks)

 

3. 3.3 3

You You are are co cond nduc ucti ting ng an ISO 9001: 9001:20 2015 15 audit audit in an in inje ject ctio ion n moul mouldi ding ng company (a process by which plastic components are manufactured). The next activity on your audit plan is the organisation organisation’s ’s final product product testing testing laboratory.

Outline in a checklist Outline checklist how you will perform this audit by developing a series of ten audit checkpoints. For each checkpoint, identify examples of the audit evidence you would want to gather and give the appropriate ISO 9001:2015 reference (10 marks)

 

Section four – three questions worth ten marks each – maximum 30 marks Questions in this section are designed to test the student’s ability to analyse audit aud it situat situation ions, s, evaluat evaluate e audit audit eviden evidence ce and apply apply knowle knowledge dge of the audit audit criteria correctly.

Delegates are required to: Either 

Complete the nonconformity report template. Marking scheme for a nonconformity: 

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Forr co Fo correct ctlly ide ident ntiify fyiing the the sc scen enar ariio as as a no noncon confo forrmit mity

(2 mar marks) ks)

For a clear description of the nonconformity marks) For correctly quoting relevant evidence

(3

(3 marks)

For co correctly id identifying th the re relevant IS ISO 90 9001 re requirement mark) Overall clarity of the nonconformity report

(1

(1 mark)

Note: if delegates raise a nonconformity report when there is none, 0 (zero) marks will be awarded. OR  

Complete the audit investigation investigation template, clearly stating 

Their reason(s) for thinking there is not yet sufficient evidence to report their findings as a nonconformity (2 marks)

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How they would investigate to determine conformity or nonconformity, including audit trails they would follow and specific examples of audit evidence they would seek and for what purpose (8 marks)

Note: if de dele lega gate tes s comp comple lete te the the audi auditt in inve vest stig igat atio ion n te temp mpla late te for for a situation where there is evidence that a nonconformity exists, a maximum of 7 marks may be awarded as follows: 

Providing a valid reason why there is insufficient evidence for a nonconformity (2 marks)

 



Providing relevant audit trails trails as above (5 marks)

Note: Marks should only be awarded where the audit investigation trails are are rele releva vant nt to the the si situ tuat atio ion n an and d woul would d pr prov ovid ide e furt furthe herr evid eviden ence ce of  conformance or non-conformance.

 

4.1 Audit situation one: In the final inspection inspection and despatch despatch area you are examining examining the inspection inspection and despatch records for order number 1234. This relates to product XYZ that is due to be sent out to a customer. You note that in the final inspection section of the records the word ‘OK’ is written with the initials JW alongside it. The Despatch Supervisor tells you that JW is one of the junior inspectors. You ask the supervisor: ‘Who has authorised the release of the product?’ The supervisor replies that authorisation is not necessary for this type of routine product prod uct and it is clear from the records that the inspection inspection was satisfactory. satisfactory. He says: ‘If there has been any problem we get a signature from David Manvers, the Chief Inspector, but only if they had to do some rework to the product.’  You check the organisation’s documented information for the product release process proce ss and find it states states that the Chief Inspector Inspector is responsibl responsible e for authorising authorising final release of all products. If you think there is sufficient evidence to report your findings as a nonconformity: nonconformity: 

Complete the nonconformity report on the following page.

CQI and IRCA IRCA QMS Specimen examina examination tion paper, paper, January 2017. Amended for use on certified course 18019 operated by Resource Inspections Canada Incorporated (01199941).  

 

IRCA QMS AUDIT - NONCONFORMITY REPORT Description Descriptio n of the nonconformity nonconformity (Max 3 marks):

Relevant evidence (Max 3 Marks):

 

ISO 9001:2015 clause clause and requirement requirement (Max 1 Mark):

Note: For id ident entify ifyin ing g the scen scenar ario io as a nonco nonconfo nform rmity ity For overall clarity  

OR  

Complete your answer on the following page.

2 Marks Marks are are award awarded ed 1 Mark is awarded

 

Audit investigation template: Reason why there is not yet sufficient evidence for reporting nonconformity nonconformity (Max 2 marks):

Four audit trails you would follow, including, including, evidence sought and purpose. (Max 2 marks for each audit trail):

 

CQI and IRCA IRCA QMS Specimen examina examination tion paper, paper, January 2017. Amended for use on certified course 18019 operated by Resource Inspections Canada Incorporated (01199941).  

 

4.2 Audit situation two: You are auditing the design and development process in an organisation that designs and manufactures industrial equipment. They are currently dealing with a serious customer complaint relating to faulty safety mechanisms. They have sent engineers to this customer to repair some equipm equ ipment ent they they design designed, ed, manufa manufactu ctured red and suppli supplied ed two years years earlie earlierr for contract number A123. You find a recent note on file that states that the engineers are currently having diffic dif ficult ulty y in repair repairin ing g th the e equipm equipment ent.. They They have have been been issued issued with with the latest latest drawings for the equipment (serial number X134, revision 3). The drawings do not contain a modification to the safety mechanism that was made prior to delivery and installation of the equipment. You confirm with the Design Manager that revision 3 is the current version of the drawings and that revision 3 does not include the change to the safety mecha me chani nism sm.. You You ask the the Desi Design gn Mana Manage gerr why why th the e modi modifi fica cati tion on to safe safety ty mechanism was not made to the drawing and he replies that the change was reviewed revie wed and considered considered to be minor with no impact on the equipment equipment and it didn’t affect the customer’s contract specification.

If you think there there is sufficient evidence to report your findings findings as a nonconformity: 

Complete the nonconformity report on the following page.

CQI and IRCA IRCA QMS Specimen examina examination tion paper, paper, January 2017. Amended for use on certified course 18019 operated by Resource Inspections Canada Incorporated (01199941).  

 

IRCA QMS AUDIT - NONCONFORMITY REPORT Description Descriptio n of the nonconformity nonconformity (Max 3 marks):

Relevant evidence (Max 3 Marks):

 

ISO 9001:2015 clause clause and requirement requirement (Max 1 Mark):

Note: For id ident entify ifyin ing g the scen scenar ario io as a nonco nonconfo nform rmity ity For overall clarity  

OR  

Complete your answer on the following page.

2 Marks Marks are are award awarded ed 1 Mark is awarded

 

Audit investigation template: Reason why there is not yet sufficient evidence for reporting nonconformity nonconformity (Max 2 marks):

Four audit trails you would follow, including, including, evidence sought and purpose. (Max 2 marks for each audit trail):

 

CQI and IRCA IRCA QMS Specimen examina examination tion paper, paper, January 2017. Amended for use on certified course 18019 operated by Resource Inspections Canada Incorporated (01199941).  

 

4.3 Audit situation three: During an audit of an insurance company, you ask the Training Manager to show you the training records for three people who work in the Claims Department. You see from the training records that each has attended a course on customer care. You ask the Training Manager how they evaluated the training and are told “We ask every person who attends a training course to complete a questionnaire on whether they enjoyed the course, how useful they found the training and how good the tutor was. This information helps us decide whether to send other staff  on the course”. You examine the questionnaires completed by the three people who attended the customer care course. All three awarded high marks on how enjoyable they found the course and the usefulness of the course. All three also awarded a satisfactory score for the tutor.

If you think there is sufficient evidence to report your findings as a nonconformity: nonconformity: 

Complete the nonconformity report on the following page.

CQI and IRCA IRCA QMS Specimen examina examination tion paper, paper, January 2017. Amended for use on certified course 18019 operated by Resource Inspections Canada Incorporated (01199941).  

 

IRCA QMS AUDIT - NONCONFORMITY REPORT Description Descriptio n of the nonconformity nonconformity (Max 3 marks):

Relevant evidence (Max 3 Marks):

 

ISO 9001:2015 clause clause and requirement requirement (Max 1 Mark):

Note: For id ident entify ifyin ing g the scen scenar ario io as a nonco nonconfo nform rmity ity For overall clarity  

OR  

Complete your answer on the following page.

2 Marks Marks are are award awarded ed 1 Mark is awarded

 

Audit investigation template: Reason why there is not yet sufficient evidence for reporting nonconformity nonconformity (Max 2 marks):

Four audit trails you would follow, including, including, evidence sought and purpose. (Max 2 marks for each audit trail):

 

CQI and IRCA IRCA QMS Specimen examina examination tion paper, paper, January 2017. Amended for use on certified course 18019 operated by Resource Inspections Canada Incorporated (01199941).