2.exercises & Workshops
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Delegate Hand-out Hand-out
Exercise and and Workshops
Bureau Veritas Certification
EXERCISES
Dec’19
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
Page 1 of 51
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Bureau Veritas Certification
EXERCISE No. 0: DELEGATE INTRODUCTION- MINI INTERVIEW Learning Objectives: The purpose of the exercise is: To achieve audit understanding the interview process and and evidences, why it is important the context of process to obtain on appropriate information how to inevaluate this information and then present to the organization. Duration: Refer to the time table for overall time duration and and follow follow instructions by the Trainers for break up Nature of the Activity Delegates in team of 2 work on this exercise. Material and Equipment -
Check list format Blue Blue// W Whi hite te Ta Tack ck or pin pin b boa oard rd..
Delegates Tasks and Deliverables Delegates are divided into pairs of 2 each. Each team (pair) will conduct this exercise. Initially, one member of the team will interview the other (max time allowed is 5 minutes per delegate) and collect all relevant information in the checklist template provided to them. Subsequently the 2nd member of the team will repeat the exercise. After the delegate exercise trainer will explain how to use this information.
Dec’19
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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Delegate Hand-out Hand-out Exercise and and Workshops
Bureau Veritas Certification
Delegate Introduction Checklist Template Interviewee Name: Employer name: Position: Education: Career background:
Quality management experience: Knowledge of ISO 9001:2015 grade from 1 (low) to 10 (high)
Auditing experience: (Please write the numbers in respective columns)
Type: 1st party
2nd party
3rd party
(Internal)
(Supplier)
(Certification)
No. of audits:
Nil Up to 5 5 – 10 10 & more Personal objectives in attending the course
Other information about interviewee that may be useful for auditor to know
Date:
Dec’19
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
Page 3 of 51
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Bureau Veritas Certification
Auditor name:
EXERCISE No.1: Preparation prior to Audit - Case Study Review The purpose of the exercise is: 1. To achi achieve eve an und understa nding g and familia familiarity rity abou aboutt of thetheir organ organizatio ization n to be audited so that auditors canerstandin objectively evaluate all aspects QMS and processes 2. To en enab able le th the e st stud uden ents ts to ca carry rry ou outt fu furt rthe herr ex exer erci cise ses s an and d wo work rksh shop ops s in an informed manner Duration: Refer to the time table for overall time duration and and follow follow instructions by the Trainers for break up Nature of the Activity
Team work on gathering a quick overview of the organization being audited, similar to pre audit visit/discussion with a client organization before planning stage 1 & stage 2 audit Material and Equipment -
All All d doc ocum umen enta tatio tion no off B Bet eta aT Tra rain inin ing. g. No Note te b boo ooks ks// p pla lain in w whi hite te s she heet ets sa and nd pe pens ns
Delegates Tasks and Deliverables
Delegates are divided into teams (see exercise 0) and expected to work in team to carry out a quick reading of all provided documented information by Beta Training in order to achieve familiarity about the organization. Delegate Instructions
Read individually/or in team the documented information provided by Beta Training as part of pre visit preparation by the audit team The outcome of the exercise is to be written down by the team in note pad / white papers as important information/ questions questions to be asked to seek further information
Dec’19
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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EXERCISE No. 2: Auditing Terminology Learning Objectives: The purpose of the exercise is: To achieve the required understanding on and be able to explain the terminology and concepts related to auditing a Quality Management System and apply them in real life audits Duration: Refer to the time table for overall time duration and and follow follow instructions by the Trainers for break up Nature of the Activity Team work on analysis of concepts and terminology related to auditing. Material and Equipment -
Cards. Blue Blue// W Whi hite te Ta Tack ck or pin pin b boa oard rd..
Delegates Tasks and Deliverables Delegates are divided into teams (see exercise 0) and expected to work in team to match correctly the cards with terms (printed on coloured card paper and cut into the shape of a card) with their definitions (differently coloured cards).
DELEGATE INSTRUCTIONS Delegates as a team receive packs of cards that include: -
One set of c cards ards in one colou colourr with printe printed d te text xt g giving iving vario various us terms relat related ed to auditing Anoth Another er se sett of c cards ards (diffe (differentl rently y col coloure oured) d) co contain ntaining ing printe printed d tex textt givi giving ng de definit finitions ions of those terms.
Teams are required to match the terms with their definitions (there may be more than one definition for a term) and prepare a display by: -
Us Usin ing gb blu lue e (w (whi hite te)) ta tack ck an and d bo boar ard d Using pin board
Dec’19
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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Delegate Hand-out Hand-out Exercise and and Workshops - Plac Placin ing g th the ec car ards ds iin no ord rder er o on n th the e ttab able le..
Bureau Veritas Certification
EXERCISE No 3. COMMUNICATION
FACT OR INFERENCE?
“Jones, a buyer with the XYZ Company, was scheduled for a 10 o’clock meeting in Mr Smith’s office to discuss discuss the terms of a llarge arge order. On the way to tha thatt office the buyer slipped slipp ed on a freshly wax waxed ed floor, and as a result rec receive eived d a badly bruise bruised d leg. By the time Smith was notified of the accident, Jones was on the way to the hospital for X-rays. Smith called the hospital to enquire and no one there seemed to know anything about Jones. It’s possible tha thatt Smith called the wrong hospital.”
Having read the above paragraph, please classify each of the following statements as “fact” or “inference”. “inference”. Use the following as descriptions:
FACT = truth; somethin FACT something g that has actually happ happened. ened. INFERENCE = May be a truth; something th INFERENCE that at may or may not have happened. happened.
Statement
1.
Jo Jone nes s was supp ppos ose ed to meet wit ith h Sm Smit ith. h.
2.
Jo Jone nes sw was as sche hedu dule led d ffo or a 1 10 0o o’c ’clo lock ck meet etin ing. g.
3.
The acc ccid ide ent oc occ cur urre red da att tth he X XY YZ C Com omp pany ny..
4.
Jo Jone nes sw was as ta tak ken to th the eh ho ospita pitall ffor or X-r -ray ays s.
Fact
Inference
5. No one at the ho hospita spitall which Mr Smit Smith h called knew knew anything about Jones. 6.
Smith ith h ha ad c ca alled tth he w wrrong h ho ospital.
7.
Mr Jones is a buyer.
Dec’19
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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EXERCISE 4. Reviewing Corrective Actions Format :Individual exercise by delegates Purpose : To enable delegates to understand the challenges in evaluating the corrections and corr co rrec ecti tive ve ac acti tion ons s prop propos osed ed / pres presen ente ted d by or orga gani niza zatio tions ns in re resp spon onse se to th the e No Non n rd Conformities reported during a 3 party audit Duration: Refer to the time table for overall time duration and and follow follow instructions by the Trainers for break up Exercise Material Exercise 04- Delegate hand-out Delegate Instructions Now th Now that at as an au audi dito torr yo you u ha have ve issu issued ed no non n co conf nfor ormi miti ties es,, th the e or orga gani niz zat atio ion’ n’s s representatives submit proposed corrective action plan to you. As an auditor you are expected to review these actions and advice the organization whether they can go ahead with implementation. Review in team the case studies allocated by the Trainer and comment as follows: -
Are the they ac acc cept ptab able le? ?
-
If tthe hey ya are re n not ot a acc ccep epta tabl ble, e, jjus usti tify fy why why
-
If the they y are are ac acce cept ptab able le,, wh what at evi evide denc nce e wi will ll you look fo forr ac acce cept ptin ing g th the e pr prop opos osed ed corrective action?
The outcome of the discussions and group work can be written on the hand-out against the case study (NCR) allocated to you.
Dec’19
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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CORRECTIVE ACTION REQUEST Company: Auditor:
Date:
NCR Number: 1
Auditee:
Non-conformity: The process of documentation control is not effective Objective Evidences:While auditing the Quality Department, it was discovered that three new procedures have been released onto the intranet, but there is no evidence of prior approval. Requirements:- ISO 9001:201 9001:2015 5 7.5.3.2, 7.5.3.2, For the control of document documented ed informati information, on, the organiza organization tion shall address the following activities as applicable : a) Distribu Distribution tion,, access, access, retrieval retrieval and use
Signed: Cause & Proposed Corrective Action:
Date:
Corrective Action – Approval records will be created and added on file. Recommended by – Quality Manager Proposed Completion Date:
DATE:
SIGNATURE
Corrective Action Review:
Signed:
Dec’19
Date:
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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CORRECTIVE ACTION REQUEST Company: Auditor:
Date:
NCR Number: 2
Auditee:
Non Conformity: The process of planning for the necessary documentation is not effective Objective Evidences:In the process manual established for description of the processes, there was no descri des cripti ption on of the int intera eracti ction on bet betwee ween n the pro proces cesse ses s of the qu quali ality ty man manage agemen ment t system. This according to the au auditee ditee is a requirement as determined determined by them. Requirements:ISO 9001:2015 4.4 requires “The organization shall maintain documented information to the extent necessary to support the operation of processes”. Signed: Date: Cause & Proposed Corrective Action: The Quality Manager will, together with the Production Manager, define the processes for the quality management system. system. Proposed Completion Date:
DATE:
SIGNATURE
Corrective Action Review:
Signed:
Dec’19
Date:
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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CORRECTIVE ACTION REQUEST Company: Auditor:
Date:
NCR Number: 3
Auditee:
Non Conformity: The process of evaluation and selection of suppliers is not implemented fully Objective Evidences:During the audit it was noted that there were no records in support of the names of any of the organisations listed on the ‘Approved ‘ Approved Suppliers List’. Company procedure Company procedure for Purchase Purchase (QPR/PUR/00 (QPR/PUR/001) 1) requ requires ires that records records of the results results of evaluations and any necessary actions arising from the evaluation of all suppliers shall be maintained.”
Requirements:ISO 9001:201 9001:2015-8.4 5-8.4.1 .1 The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations.
Signed: Cause & Proposed Corrective Action:
Date:
Corrective Action - From now on records will be created of all evaluations and reevaluations of suppliers, and will be maintained on file. Recommended by – Quality Manager Proposed Completion Date:
DATE:
SIGNATURE
Corrective Action Review:
Signed:
Dec’19
Date:
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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CORRECTIVE ACTION REQUEST Company: Auditor:
Date:
NCR Number: 4
Auditee:
Non Conformity: The process of managing customer property is not effectively implemented Objective Evidences:Evidence of customer owned materials was found in manufacturing – valves for incorporation into the pumps – but these were not identified as customer property. Requirements:ISO 9001:2015-8.5.3 requires “The organization shall identify, verify, protect and safeguard the customer’s or external provider’s provider’s property provided for use or incorporation into the products and services
Signed: Cause & Proposed Corrective Action:
Date:
Corrective Action - All valves will be suitably identified, protected and verified. Recommended by – Quality Manager Proposed Completion Date:
DATE:
SIGNATURE
Corrective Action Review:
Signed:
Dec’19
Date:
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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CORRECTIVE ACTION REQUEST Company: Auditor:
Date:
NCR Number: 5
Auditee:
Non Conformity: The process of creating awareness among employees not implemented effectively Objective During an audit of pump assembly in the production area the auditor established that four employees did not know the implications of not following process controls in their equipment as laid down in their process data sheets which are part of their Quality Management System Requirements:ISO 9001:2015-7.3 requires that persons doing work under the organizations control shall be aware aw are of : (d) the impli implicat cation ions s of no nott confor conformi ming ng with the quality quality manage managemen mentt system system requirements
Signed: Cause & Proposed Corrective Action:
Date:
Cause : The roles, responsibilities and authorities of employees including the implications of not conforming to QMS requirements were neither defined nor communicated within the organisation. Correc Corr ectiv tive e ac acti tion on - An em empl ploy oyee ee ha hand ndbo book ok de defi fini ning ng ro role les, s, re resp spon onsi sibi bilit litie ies s an and d authorities has been published and distributed to all employees. Training programmes were conducted covering each employee. A test was conducted and it is now ensured that all current employees, including the above stated four employees, are aware of their roles. All future recruits will be routed through a formal induction programme which will include this subject. Recommended by – Management Representative Signature
Corrective Action Review:
Signed:
Dec’19
Date:
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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CORRECTIVE ACTION REQUEST Company: Auditor:
Date:
NCR Number: 6
Auditee:
Non Conformity: The process of identification of process outputs (products) is not implemented implemented effectively Objective evidences:During the audit of packaging and despatch area of a pharmaceutical products, the auditor discover disc overed ed that there was no identific identificatio ation n of any unit leavin leaving g the company. company. The contract contract requires that every unit be uniquely identified at all stages of product realization chain and records maintained. Requirements:ISO 9001:2015 8.5.2 requires “Where necessary to ensure conformity of products and services, the organization shall use suitable means to identify the process outputs:
Signed: Date: Cause & Proposed Corrective Action: Corrective action – The Production Manager shall ensure that a suitable identification system is implemented for the next contract. Proposed Completion Date:
DATE:
SIGNATURE
Corrective Action Review:
Signed:
Dec’19
Date:
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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CORRECTIVE ACTION REQUEST Company: Auditor:
Date:
NCR Number: 7
Auditee:
Non Conformity: The process of identifying the status of measuring equipm equipment ent is not implemented implemented effectively
Objective evidence:During the audit, several items of measuring equipment were discovered in use in the production areas areas that were not not identified by any any means (e.g. micrometers, micrometers, pressu pressure re gauges etc.).
Requirements:7.1.5.2 Measurement traceability When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing conidence in the validity of measurement results, measuring equipment shall be: a) calibrated or veriied, or both, at speciied intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or veriication shall be retained as documented information; b) identified identified in order order to determi determine ne their their status; status;
Signed: Cause & Proposed Corrective Action:
Date:
Corrective Action –All items of measuring equipment equipment will be suitably identified, records raised, and their current calibration status determined. determined. Recommended by - The Quality Manager
Proposed Completion Date:
DATE:
SIGNATURE
Corrective Action Review:
Signed:
Dec’19
Date:
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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CORRECTIVE ACTION REQUEST Company: Auditor:
Date:
NCR Number: 8
Auditee:
Non Conformity: The process of Corrective actions has not been implemented effectively
Objective Evidences:During review of the internal audit programme, in many cases, actions taken in response to nonconformities nonconformi ties only corrected the immediatel immediately y identified symptom(s) without removing the cause of the problem.
Requirements:ISO 9001:2015 9.2.2 requires “The organization organization shall……take necessary correction and corrective actions...”
Signed: Cause & Proposed Corrective Action:
Date:
The quality manager will review and amend the procedures for internal audits and correc cor rectiv tive e ac actio tions ns to make make it clear clear that that root root cause cause analys analysis is is neces necessar sary y and that corrective actions must address the root causes of the problems. She will She will also also supp suppor ortt impl implem emen enta tati tion on of th the e revi revise sed d proc proced edur ures es by cond conduc ucti ting ng addi ad diti tion onal al tr trai aini ning ng fo forr th the e audi auditt te team am and and depa depart rtme ment nt mana manage gerr to cove coverr th the e nonconformity investigation, root cause analysis, developing of corrective actions and evaluation-of-effectiveness evaluation-of-ef fectiveness of corrective action.
Proposed Completion Date:
DATE:
SIGNATURE
Corrective Action Review:
Signed:
Dec’19
Date:
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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CORRECTIVE ACTION REQUEST Company: Auditor:
Date:
NCR Number: 9
Auditee:
Non Conformity: There was no evidence of any documented quality objective. ISO 9001:2015 -6.2.1 requires “The organization shall retain documented information on the quality objectives”
Signed: Cause & Proposed Corrective Action:
Date:
Cause – Lack of awareness/understanding awareness/understanding of QMS requirements. Correction : All identified employees and top management will undergo a detailed QMS awareness training programme and the effectiveness of the programme will evaluated by a third party. Any documentation, including quality objectives, that were not included, will be added to the QMS. QMS. Proposed Completion Date:
DATE:
SIGNATURE
Corrective Action Review:
Signed:
Dec’19
Date:
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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CORRECTIVE ACTION REQUEST Company: Auditor:
Date:
NCR Number: 10
Auditee:
Non Conformity: The process of maintaining the traceability of authority to release the products
Objective Evidence:During the audit it was noted the records did not indicate who the authority was, for the final release rele ase of the product. product. It could not be identifie identified d as to who was the one who who releas released ed the products
Requirements:ISO 90 9001: 01:20 2015 15 8.6 requi requires res “Docum “Documen ented ted infor informa matio tion n shall shall provid provide e tracea traceabil bility ity to the persons(s) authorizing authorizing release release of products products and services for delivery delivery to the customer.” customer.”
Signed: Cause & Proposed Corrective Action:
Date:
Corrective Action – The Chief Inspector is the authority to sign for release of the product. The final release form w will ill be modified to allow the Chief Chief Inspector to sign for final release. release. Recommended by – Management Representative
Proposed Completion Date:
DATE:
SIGNATURE
Corrective Action Review:
Signed:
Dec’19
Date:
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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Exercise and and Workshops
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WORKSHOPS
Dec’19
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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Workshop 1- Auditing Context, Planning and Support Format:: Format
Sk Skil illl ba base sed dP Pra ract ctic ical al Ev Eval alua uati tion on - de dele lega gate tes sw will ill be eva evalu luat ated ed on th thei eirr abil ability ity to meet the exercise objectives
Objectives: - To pre prepare pare de delegat legates es for in interpre terpretatio tation n and de develo velop p skill skills s to aud audit it partic particular ular requirements in the background of a case study organization. - To d devel evelop op tthe he s skills kills for d develo eveloping ping audit chec checklist klist - To enh nha anc nce e th the e unde ders rsta tan ndin ding of pro roc ces ess s an and d syste ystem m app ppro roa ach to management and its consequences for auditing - To be a able ble tto o dev develo elop p a proc process ess ffocu ocuse sed d Che Checkl cklist ist - To ena enable ble de deleg legate ates s to appre apprecia ciate te the “Planni “Planning ng”” part (PDC (PDCA) A) of the QMS of an organization and how to audit this segment of the PDCA Cycle Material and Equipment Documentation of Beta Training ISO 9001:2015 Standard Flipchart & Markers Duration: Refer to the time table for overall time duration and and follow follow instructions by the Trainers for break up Delegate briefing. The background scenario: Beta Training is an organization / company who is into design, development and delivery of training modulesstandard modules to industry. They have implemented implemented a quality management management system based on ISO 9001:2015 You are scheduled for conducting an on-site audit. You need to develop knowledge and skills required to carry out a detailed audit of requirements of Clauses 4, 6 & 7 of ISO 9001 Standard.
Part 1 of Workshop To start with, first prepare a set of questions related to the internal and external issues encounter enco untered ed and all poss possible ible intereste interested d parti parties es and their need needs s and expectat expectations ions related to ‘Beta Training Training’in ’in the following format : Sr No
Dec’19
Issues External
Internal
Interested parties Interested Party
Needs and expectations
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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This information is not be shared with Beta, but required for you to conduct the audit in a systematic manner when you are on site. Part 2 of Workshop: Delegates Tasks and Deliverables -
Sr No
Ba Base sed do on n th the e re rev view iew of th the e do doc cum umen enta tati tion on of tthe he o org rgan aniz izat atio ion n th the e te team ams ss sha hall ll pr prep epar are e a de deta taile iled d ch chec eckl klis istt wi with th th the e in info form rmat atio ion n co colle llect cted ed in part part 1 of th this is workshop in the background. You must cover the clauses 4, 6 & 7 What to check /ask / look for
Related evidence to look for
Related Clause No
Remarks/ Comments
Since 4, 6 and 7 Clauses would practically apply to all processes/ departments of Beta, delega del egates tes can make a gen generi eric c ch check ecklis listt kee keepin ping g in min mind d any pro proces cess(e s(es) s) of Beta Beta Training.
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CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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Workshop 2-Auditing ‘Operation’ Format:: Format
Sk Skil illl ba base sed dP Pra ract ctic ical al Ev Eval alua uati tion on - de dele lega gate tes sw will ill be eva evalu luat ated ed on th thei eirr abil ability ity to meet the exercise objectives
Objectives: - To prep prepare are del delegate egates s for appr appropria opriate te inter interpreta pretation tion an and d devel developing oping th the e skills required to audit particular requirements in the background of a case study organization. - To d devel evelop op tthe he s skills kills for d develo eveloping ping audit chec checklist klist - To enh nha anc nce e th the e unde ders rsta tan ndin ding of pro roc ces ess s an and d syste ystem m app ppro roa ach to management and its consequences on auditing - To be a able ble tto o dev develo elop p a proc process ess ffocu ocuse sed d Che Checkl cklist ist - To en enabl able e dele delega gates tes to ap appre precia ciate te the “D “DO” O” par partt (PDC (PDCA) A) of the QM QMS S of an organization and how to audit this segment of the PDCA Cycle Material and Equipment Documentation of Beta Training ISO 9001:2015 Flipchart & Markers Duration: Refer to the time table for overall time duration and and follow follow instructions by the Trainers for break up Delegate briefing. The background scenario: Beta Training is an organization / company who is into design, development and delivery of training modules to industry. industry. They have imp implemented lemented a quality ma management nagement system based on ISO 9001:2015 standard You are scheduled to conduct an onsite audit. You need to develop the knowledge and skills sets required to carry out a detailed audit of requirements of Clause ‘8 Operation’ of ISO 9001 Standard to verify conformance of their QMS.
Delegates Tasks and Deliverables -
Ba Base sed do on n th the e re rev view iew of th the e do doc cum umen enta tati tion on of tthe he o org rgan aniz izat atio ion n th the e te team ams ss sha hall ll prepare a detailed checklist to verify conformance of the QMS of Beta Training with the requirements.
The teams shall prepare the checklist in the following format
Dec’19
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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Following sub clauses of ‘8.Operation’ are allocated to teams as follows:
Team 1- Clause 8.2 Determination of requirements related to products and services & Clause 8.7 Control of non-conforming outputs Team 2- Clause 8.4 Control of externally provided processes, products and services Team 3- Clause 8.3 Design of products and services Team 4- Clause 8.5 Control of Production and Service Provision Clause 8.6 Release of products and services (Trainer may allocate the above sets of clauses to different teams, if they wish. However the combination / group of clauses must not change) Sr No
What to check /ask / look for
Related Related remarks evidence to Clause No (Leave (Le ave thi this s look for column blank)
All teams must produce the outputs outputs on flip charts. All questions and check check points must be related to Beta and not generic. Please leave the 4th column (Clause Number) blank to facilitate group work later. Discussion and Feedback : Please follow the trainer’s instructions after all the teams have finished their tasks.
Dec’19
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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Workshop 3-Auditing ‘performance evaluation and improvement’ Format:: Format
Sk Skil illl ba base sed dP Pra ract ctic ical al Ev Eval alua uati tion on - de dele lega gate tes sw will ill be eva evalu luat ated ed on th thei eirr abil ability ity to meet the exercise objectives
Objectives: - To prep prepare are del delegate egates s for appr appropria opriate te inter interpreta pretation tion an and d devel developing oping th the e skills required to audit particular requirements in the background of a case study organization. - To d devel evelop op tthe he s skills kills for d develo eveloping ping audit chec checklist klist - To enh nha anc nce e th the e unde ders rsta tan ndin ding of pro roc ces ess s an and d syste ystem m app ppro roa ach to management and its consequences on auditing - To be a able ble tto o dev develo elop p a proc process ess ffocu ocuse sed d Che Checkl cklist ist - To en enab able le de dele lega gate tes s to ap appr prec ecia iate te th the e “C “CHE HECK CKIN ING” G” & “A “ACT CTIN ING” G” pa part rt (PDCA) of the QMS of an organization and how to audit these segments of the PDCA cycle. Material and Equipment Documentation of Beta Training ISO 9001:2015 Flipchart & Markers Duration: Refer to the time table for overall time duration and and follow follow instructions by the Trainers for break up Delegate briefing. The background scenario: Beta Training is an organization / company who is into design, development and deli de live very ry of tr trai aini ning ng mo modu dule les s to indu indust stry ry.. Th They ey ha have ve im impl plem emen ente ted d a qu qual alit ity y management system based on ISO 9001:2015 standard You are scheduled to conduct an onsite audit. You need to develop the knowledge and skill skills s se sets ts requ require ired d to ca carry rry ou outt a de deta tail iled ed au audi ditt of re requ quir irem emen ents ts of Cl Clau ause se ‘9 Perfor Per forman mance ce ev evalu aluati ation’ on’ and 10. 10.’Im ’Impro provem vement ent’’ of ISO 900 9001 1 Sta Standa ndard rd to ver verify ify conformance of their QMS to these requirements Delegates Tasks and Deliverables -
Ba Base sed do on n th the e re rev view iew of th the e do doc cum umen enta tati tion on of tthe he o org rgan aniz izat atio ion n th the e te team ams ss sha hall ll prepare a detailed checklist to verify conformance of the QMS of Beta Training with the requirements.
The teams shall prepare the checklist in the following format
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Sr No
What to check /ask / look for
Bureau Veritas Certification
Related Related evidence to Clause No look for
remarks
All teams must produce the outputs outputs on flip charts. All questions and check check points must be related to Beta and not generic
Discussion and Feedback : Please follow the trainers’ instructions after all the teams have finished their tasks.
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Workshop 4 - Planning for Stage 1 Audit Format:: Format
Sk Skil illl ba base sed dP Pra ract ctic ical al Ev Eval alua uati tion on - de dele lega gate tes sw will ill be eva evalu luat ated ed on th thei eirr abil ability ity to meet the exercise objectives
Objectives: - To pr prepar epare e del delegate egates s for plan planning ning for on on-site -site stag stage e one audit audit.. - To d dev evelo elop p th the e sk skills ills for a audi uditt pla planni nning ng - To enh nha anc nce e th the e unde ders rsta tan ndin ding of pro roc ces ess s an and d syste ystem m app ppro roa ach to management and its consequences for auditing - To dev develop elop th the e abili ability ty to de determin termine e the au audit dit sco scope pe and d determ etermine ine res resource ource requirements including audit day determination - To be abl able e to de devel velop op a p proc rocess ess foc focuse used d pla plan. n. Material and Equipment Material – Documentation of Beta Training ISO 9001 & 19011 Standards. Flipchart & Markers Duration: Refer to the time table for overall time duration and and follow follow instructions by the Trainers for break up Delegate briefing. The background: Delegates must remember that ‘Certification audits’ are conducted in 2 stages (Stage 1 & Stage 2). But each activity involved in audit process must be adequately planned, documented and the organisation personnel being audited must be well informed about such plans and the time scale. Delegates Tasks and Deliverables -
Ba Base sed do on n th the e re rev view iew of th the e do doc cum umen enta tati tion on of tthe he o org rgan aniz izat atio ion n th the e te team ams ss sha hall ll prepare an audit plan for a stage 1 audit of this organisation as part of the certification contract signed with Bureau Veritas Certification.
-
Based on the size of the company (No of employees) delegates must determine the number of person-days required for the audit (delegates can use the table derived from relevant IAF Mandatory Document, provided in this handout.)
-
Au Aud dit p pla lan n mu mus st in inc clud lude th the e sc scop ope e of th the e au aud dit a and nd iid dent ntif ific icat atio ion n of th the e au aud dit team.
Feedback session
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Teams in tur Teams turn n sha shallll pre prese sent nt their conc conclus lusion ions s and outp outputs uts.. moderates the discussion.
Tra Traine inerr an anima imates tes and
Guidelines on allocation of auditor days 1. Det Determ ermine ine th the e amou amount nt of work in invol volved ved an and d the time du durat ration ion that that will be req requir uired ed – size and complexity of the audit will mainly decide this – but remember, audits cost money mone y therefor therefore e try to keep the time as short as poss possible. ible. Ther There e are requireme requirements nts specified by IAF for Quality Management System audits 2. It mus mustt be und under erst stoo ood d th that at the tim time e requ requir ired ed for the audit audit dep depen ends ds on num numbe berr of factors as outlined in the text that follows the table 1 given below Table 1:G Table 1:Guid uide e for aud audito itorr tim time e for ini initia tiall ass assess essme ment nt (stage (stage 1 & sta stage ge 2 tog togeth ether) er) (Derived from IAF MD5:2019)
Effective Number of Personnel 1-5 6-10 11-15 16-25 26-45 46-65 66-85 86-125 126-175 176-275 276-425 426-625
Audit Time (Stage 1 + Stage 2) 1.5 2 2.5 3 4 5 6 7 8 9 10 11
Effective Number of Personnel 626-875 876-1175 1176-1550 1551-2025 2026-2675 2676-3450 3451-4350 4351-5450 5451-6800 6801-8500 8501-10700 >10700
Audit Time (Stage 1 + Stage 2) 12 13 14 15 16 17 18 19 20 21 22 Follow progression above
Term “effective number of personnel” has been referred to in ISO 17021 as “personnel” and is typically “person doing the work under the control of the organization”. Certain factors are to be considered while determining the effective number of employees, viz., the number of shifts of working where similar work is carried out or many persons doing the repetitive type of work (Ex: Data entry / front office work / identical products being produced on similar machines in a manufacturing set up etc) :Table 1 sets out typical number of audit days to be used in an initial assessment. Experience has shown that it is appropriate to base this upon the number of employees of the organization and the nature, scale and complexities of operations for a typical organization in that industry sector. The auditors’ time should then be adjusted based on any significant factors that uniquely apply to the organization to be audited.
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Delegate Hand-out Hand-out Exercise and and Workshops Bureau Veritas Certification The additional factors that need to be considered shall include but are not limited to:-
Increase auditor time:
Client System Complexity (Physical area of the audit site, Number of processes, Unique processes, Design Responsible Responsible etc) Complicated logistics involving more than one building or location where work is carried out. Staff speaking in more than one language (requiring interpreter(s) or preventing individual auditors from working independently); Very large site for the number of personnel (e.g., a forest); High degree of regulations (e.g., food, drugs, aerospace, nuclear power etc); System covers highly complex processes or relatively high number of unique activities; Activities that require visiting temporary sites to confirm the activities of the permanent site(s) whose management system is subject to certification.
Decreased auditor time:
Very small site for number of employees (e.g., office complex only) Very Few processes, Maturity of management system High percentage of employees doing the same, repetitive and simple tasks Work being carried out in shifts where the nature of work remains identical
Once the audit days are determined, the delegates in team shall draw out a detailed plan for conducting Stage 1 audit of the Beta Training Audit Plan shall be prepared on Flip Charts to facilitate effective presentations and group discussions
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AUDIT PLAN PROFORMA Organisation: Date(s): Team Leader: Team Members:
Location
Audit Criteria Audit scope:
Day
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Time
Area/Activity
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WORKSHOP No.5 – CONDUCTING STAGE 1 AUDIT The objectives of this workshop are to understand:
How to prepare delegates for conducting Stage 1 audit How to perform stage 1 audit of an hitherto unknown organisation in order to be able to assess their readiness with respect to all necessary documentation for a stage 2 audit in order to verify conformance with ISO 9001:2015. How to find the relation between a Quality Manual and the appropriate clauses of ISO 9001:2015. To familiarise delegates with the background scenario for the case study and further workshops. To better understand how to plan the audit in order to ensure that not only individual processes are reviewed but also their intended results, interaction and sequence. To enhance the knowledge of the standard. To create a basic understanding of the applicability of different clauses of the standard for different processes of an organisation and thus be ready to prepare the process matrix.
The case study is based on a third party audit initiated by Beta Training. The company has signed the contract with Bureau Veritas Certification for a third party audit next month. As part of the third party registration process, the certification body will require the auditee to send them a copy of the documentation that contains their intent in respect of the standard’s requirements, in order that they can evaluate its adequacy adeq uacy.. Unde Underr the abov above e mentione mentioned d contract, Bure Bureau au Veritas Cert Certificat ification ion manage man agemen mentt has appo appoint inted ed you to aud audit it Beta Training’s Training’s quality management system against the requirements of ISO 9001:2015 standard As a firs firstt step step yo you u wi will ll be co cond nduc ucti ting ng a pa part rt of th the e st stag age e 1 au audi ditt of th the e organisation on the basis of the documentation submitted by the organisation at site. Each team will act as an audit team in this scenario and shall perform a part of the stage 1 audit (documentation part) of the Organisation. Each team is required to make a presentation on the following: 1.
The te team’ am’s s over overall all ju judge dgemen mentt abou aboutt the pre prepar paredn edness ess of th the e org organi anisat sation ion for a stage 2 audit.
2.
The te team’ am’s s jud judgem gement ent o on n the po posit sitive ives s and po poten tentia tiall areas areas of co conce ncern. rn.
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WORKSHOP No. 6 – PLANNING for Stage 2 audit The objectives of this workshop are to prepare the delegates as to: 1. How to p plan lan au audit dit time a and nd perf perform orm a sta stage ge 2 aud audit it of an or organis ganisation ation.. 2. To cove coverr approp appropriate riate cla clauses uses of ISO 900 9001:20 1:2015 15 with the proc process esses es defin defined ed in their system based on the outcome of documentation audit. Material for Workshop: Documentation of Beta Training ISO 19011 Standard Flip Charts and markers Duration: Refer to the time table for overall time duration and and follow follow instructions by the Trainers for break up Workshop Each team will act as an audit team. Each team shall prep prepare are plan for third part party y audi auditt of Beta Train Training ing base based d on time Duration and team members. The client organization has Head office which has the following processes:
Top Management. Supplier Management HR
Audit plan shall determine number of days and number of auditors. Each team shall present their plan on a flip chart in the pro-forma given below
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AUDIT PLAN PROFORMA Organisation: Date(s):
Location
Team Leader:
Specialist :
Team Members: Audit Criteria: Audit scope:
HOURS
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AUDITOR 1
HOURS
AUDITOR 2
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WORKSHOP No. 7- Auditor Competence Purpose The purpose of this workshop is to:
Make de Mak dele lega gate tes s aw awar are e of th the e kn know owle ledg dge e an and d skil skills ls re requ quir ired ed fo forr de deve velo lopi ping ng rd competence as a 3 party auditor.
Hand-outs and Material The following material must be issued to the delegates for this exercise:
ISO 19011:2018 Flip Charts and marker Additionally, CQI-IRCA Documents on Auditor certification (provided in pre course material) and PowerPoint Handout 10 (provided along with delegate manual) shall also be referred to.
Duration: Refer to the time table for overall time duration and and follow follow instructions by the Trainers for break up THE WORKSHOP Delegates in team should work on the Clause 7 of ISO 19011 Standard. The clause provides guidance on technical and auditing skills as well as soft skills required for management system auditors. Additionally they shall refer to the PowerPoint slides on Auditor Certification given as a hand out The task is to read the clause 7.Competence and evaluation of auditors (of ISO 19011) of and summarise the guidelines /their understanding on flipcharts All teams must prepare the flipcharts flipcharts covering covering all important elements of this clause. Trainers will ask each team to make a brief presentation on any one or more sub clauses
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WORKSHOP No. 8- Identification and reporting ‘Non Conformity’ Purpose The purpose of this workshop is to:
Develo Dev elop p the abi ability lity to ass assess ess the ava availa ilable ble inf inform ormati ation on to determ determine ine if suffic sufficien ientt evidence of conformance or non-conformance has been gathered; Develop the ability to identify the missing information and the ways to establish this information (audit trail); Develop the ability to prepare correct non-conformance report.
Hand-outs and Material The following material must be issued to the delegates for this exercise:
Delegate hand-outs – Workshop 8 Flip Charts and markers
Duration: Refer to the time table for overall time duration and and follow follow instructions by the Trainers for break up THE WORKSHOP The following are descriptions of incidents observed by you during the course of an external audit. They contain descriptions of situations where a nonconformity report may may be required. The delegates dele gates sho should uld read the descri description ptions s of all incid incidents. ents. The teams are then requ required ired to carefully examine the incidents allocated by the trainer, and then take one of the two following actions: a)
If you think that that there there is sufficie sufficient nt objectiv objective e evid evidence ence of nonconf nonconform ormity ity then then you should complete a nonconformity report.
b)
If you do not think that there is sufficient objective evidence of nonconformity then you should state your reasons in the space below the report. You should also state what the auditor should do next i.e. identify what must be checked before it can be determined whether or not there is any non-conformance.
The reports should then be prepared using FLIP CHARTS and markers issued by the trainer. The delegates must strictly present their reports in the format as given at the end of this hand-out in either of the situations as appropriate
Incident 1
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The XYZ Ltd. Ltd. is a ser servic vice e ins inspec pectio tion n and tes testin ting g com compan pany. y. In the Fo Food od Analysis Analysis Laboratory two operators were not wearing nylon caps, one operator had her laboratory coat undone and and was wearing jewellery. O Other ther three operators were OK. Procedure FAL 002 rev.2 (which is current version) available in area clearly describes, in clause 7, the dress code which requires that laboratory coats must be buttoned up, nylon caps must be worn and wearing jewellery is not permitted. Incident 2 The XY The XYZ Z Lt Ltd. d. is ma manu nufa fact ctur urin ing g food food prod produc ucts ts.. Wh Whils ilstt co cond nduc ucti ting ng an au audi ditt in th the e production area you are observing the reactor unit on the production line number 5 which is in normal normal op operati eration. on. The p pressu ressure re gau gauge ge sho shows ws 2.8 b bar. ar. The te tempera mperature ture ga gauge uge shows show s 128 degree cen centigrad tigrade. e. Flow mete meterr shows 1.2 cum/m cum/min. in. All instrum instruments ents have valid calibr calibration ation s sticke tickers. rs. You wis wish h to see Pr Proces ocess s Spec Specifica ification tion fo forr this sta station. tion. The operator shows the current version of specification PSC02 that stipulates the following process parameters: Pressure: Temperature: Flow:
2.5 0.1 bar 130 2 centigrade 1.15 – 1.2 cum/min
You ask the operator how how often the parameters are c checked. hecked. The operator explain explains s that this normally is done every hour hour and recorded in process chart. You check the charts for past few days and notices that the parameters reading are not recorded since last shift chang ch angeov eover er fou fourr hou hours rs ag ago. o. The oper operato atorr exp explai lains ns that he was bus busy y cle cleani aning ng the reactors reac tors on anoth another er line and did not have time to take readings readings.. You had prev previous iously ly reviewed the procedure PP16 that indeed required checking and recording the process parameters every hour. Further investigation showed that th the e whole batch produced on that shift did not meet the requirements. Incident 3 In the Quality Manager’s Manager’s off office ice you revie reviewed wed a number of intern internal al audit report reports. s. You noti no tice ce th that at regu regula larl rly y in all all au audi ditt roun rounds ds fo forr pa past st two two ye year ars s ar arou ound nd 70 70% % of no nonnconformances were noted in the design department. The procedures required auditing all all de depa partm rtmen ents ts at si six x mo mont nthl hly y inte interv rval als s an and d th this is wa was s fo follo llowe wed d stric strictly tly ev ever er sinc since e implementation of the system. Incident 4 In the production hall you noticed two weighing mac machines. hines. Weighing machine se serial rial no. 1624 had an affixed label stating due date for calibration which was over 4 months ago. Weighing machine serial no. 1636 had no calibration label attached. Incident 5 During the audit in the design department in XYZ Ltd., you reviewed the Design and Development Manual that ittion did contain for of design validation. Furthe Fur therr yo you u rev review iewed edand thenoticed doc docume umenta ntatio n not pe pertin rtinent ent toprocedures a sel select ection ion ten com comple pleted ted projects # 99/00 99/007, 7, 99/0 99/010, 10, 99/020, 99/025, 99/031 99/031,, 99/0 99/042, 42, 99/051, 99/054 99/054,, 99/062 99/062 and
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Delegate Hand-out Hand-out Exercise and and Workshops Bureau Veritas Certification 99/070 99/0 70 and were unab unable le to find any records of des design ign validation activity. Design Director explained that as every design was unique and one off kind, the requirement for design validation was not applicable to the products they were designing.
Incident 6 In the the de desi sign gn de depa partm rtmen entt yo you u revi review ewed ed th the e li list st of fi five ve-q -qua ualit lity y ob obje ject ctiv ive e fo forr th that at departmen depa rtment. t. You aske asked d if the resu results lts of plannin planning g that was carried out to achie achieve ve these objectives were documented. The design d director irector replied that any such document document was not prepared, as he believed that it would suppress the creativity. Incident 7 In the material stores you noticed that there were no tags or stickers to show the inspection status of the materials. You previous previously ly visited the as assembly sembly line and noticed that tags or stickers were were being used to identify the inspectio inspection n status. The storekeepe storekeeper r explained that there was no need to use stickers or tags as all incoming material was kept in the receiving area until until verified and accepted. Only accepted mate material rial was being allowed into designated areas. Incident 8 In the Qua Quality lity Manag Manager’ er’s s off office ice yo you u rev review iew the intern internal al aud audit it rep report orts s and note the following: Report Repo rt 0 03 3s sho hows ws ttwo wo co corr rrec ecti tive ve a act ctio ions ns ou outs tsta tand ndin ing g Repo Re port rt 05 sh show ows so one ne co corr rrec ecti tive ve ac acti tion on ou outs tsta tand ndin ing g Repo Re port rt 07 sh show ows so one ne co corr rrec ecti tive ve ac acti tion on ou outs tsta tand ndin ing g There is no evidence of follow-up action.
(d (due ue tten en mon month ths sa ago go)) (d (due ue si six xm mon onth ths s ag ago) o) (d (due ue fo four ur mont month ha ago go))
Incident 9 The hospital, hospital, XYZ plc, operates eme emergenc rgency y ambulan ambulance ce service services. s. Whils Whilstt auditing the Ambulance Department Department you ask if there were any documented procedures procedures or instructions for paramed paramedics ics cove coverin ring g fir first st aid aid,, res resusc uscita itatio tion, n, etc. The hea head d of the dep depart artmen mentt explained that as all paramedics are highly competent there was no need to have any such instructions in writing. Incident 10 XYZ plc manufacture manufactures s various cosm cosmetics etics.. In the despatc despatch h area you are reviewing reviewing the products released for shipment and notice that the quantity of anti-wrinkle night cream “Gloria” (Production Order Number 99/6802) which was kept on three pallets and marked ‘ready for shipment’, did not have the following marked on the boxes:
Batch number. Production date. Expiry date.
Procedure FP 001, clause 7.8 requires that the above-mentioned information must be printed on the boxes for all creams and lotions
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Incident 11 In the organization ABC, while auditing Purchase function for Risk Process, the Purchase Manager replied that he has only one risk identified due to the external issue related to a single supplier for a key input material PA 6. When asked how they have planned to address this risk she informed that they have decided to always maintain 180 days of inventory to face any potential crisis situations due to the supply chain issues arising out of this single supplier. On further investigation, it was found that during the past 12 months period after this decision was implemented, there are several occasions when the inventory levels were found to be much lower than stipulated level. When questioned, the Manager said it is always not possible to maintain this level of inventory. In fact, in the production line that you had visited earlier, it was indeed found that production had been stopped due to shortage of this key input. Incident 12 During an audit of multidiscipline engineering design, consulting and project management firm you review the project control process. process. The process invo involves lves number of gateways at which approval approvals s by authorise authorised d personn personnel el are required required.. Gatew Gateway ay 3 – autho authorisat risation ion to submit fee proposal involves a risk assessment where number of questions related to financ fin ancial ial,, com comme mercia rcial, l, qua quality lity,, OH& OH&S, S, env enviro ironme nmenta ntall and oth other er iss issues ues nee need d to be answer ans wered. ed. The soft softwar ware e the then n ca calcu lculat lates es the lev level el of ris risk k (lo (low, w, mediu medium m an and d hig high). h). Depe De pend ndin ing g on th the e ri risk sk,, ga gate tewa way y ap appr prov oval al wo woul uld d re requ quire ire au auth thor oris isat atio ion n at di diff ffer ered ed organisational level (Low Risk – Project Manager; Medium Risk – Regional Director; High Risk - Technical Technical Dire Director. ctor. You revie reviewed wed a sample of ten large pro projects jects an and d noted the following: a) Proje Project ct numb number er 20XX 20XX/0078 /0078 – th the e fee propo proposal sal was is issued sued to the c client lient on 16th of June 20XX, the clients purchase order was received on 28 th of June 20XX and the work on the project work commenced on the 1 st of August August 2 20XX. 0XX. Gate Gateway way 3 th approval was signed off on the 30 of November (ten days before the audit). b) Pro Projec jectt num number ber 20XX 20XX/01 /0137 37 – The proj project ect cont control rol proce process ss recor records ds sh showe owed d tha thatt project was classed as high risk, yet gateway 3 approval was authorised by the regional Director. c) Proje Project ct numb number er 20XX 20XX/0162 /0162 – Th The e projec projectt contro controll records s showe howed d that 17 out of 42 questions included in the risk assessment questionnaire were not answered.But the project found to have been completed
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Bureau Veritas Certification If you think there is sufficient evidence to report your findings as a nonconformity, complete
the following nonconformity report.
Incident Number..... Number.......
NONCONFORMITY REPORT
Description of the nonconformity:
Objective Evidence
ISO 9001:2015 clause and requirement:
OR Give your reason(s) for thinking there is not yet sufficient evidence to report your findings as a nonconformity.
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Describe how you would investigate further to determine conformity or nonconformity. Include audit trails you would follow and specific examples of audit evidence you would seek and for what purpose .
Incident Number......
Audit invesgaon template:
Reason why there is not yet sufcient evidence or reporng nonconormity
Audit trails you would ollow, including, evidence sought and purpose Audit Trail
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Evidence Sought
Purpose
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Delegate Hand-out Hand-out Exercise and and Workshops Bureau Veritas Certification WORKSHOP No.9 – AUDIT PLAN MATRIX
The objectives of this workshop are to prepare the delegates to:
How to develop a workable and useful audit plan to perform third party audit in an auditee organisation in the context of certification process. To cover appropriate clauses of ISO 9001:2015 with their processes.
Duration: Refer to the time table for overall time duration and and follow follow instructions by the Trainers for break up Handouts and material Documented information of Beta Training Flip Charts and Markers Process Matrix Template giving in this handout ISO 9001:2015 Standard BACKGROUND In the previous workshops you have prepared a detailed audit plan covering all the processes of Beta Training to be audited during Stage 2 audit. Being a new auditor you may find it difficult to remember which clauses (and requirements of) ISO 9001:2015 would apply to the process being audit and at times you may be at a loss to realize as to how ho w to ap appr proa oach ch th the e au audi ditt or wh wher ere e to st star artt fr from om.. Th Ther eref efor ore e if yo you u ha have ve a ma matr trix ix document which identifies the applicability of various clauses of the standard to different process of the organization it would come handy to approach the audit systematically
Workshop In continuation of the preparation for the Stage 2 audit of Beta Training, the teams shall prepare an “Audit plan Matrix”. The audit plan matrix must ensure that the team will be able to able to assess individual processes but also ensure the intent and depth of audit of each process by understanding the applicability of relevant clauses of the Audit Criteria. Based on “Workshop-Planning “Workshop-Planning for for Stage 2 audit” the team shall use the information to prepare the matrix The audit plan matrix shall indicate what elements of the standards will be looked at in various departments / processes.
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ISO9001:2015 Process Matrix COMPANY:
Processes (Functions)
Scope of audit:
4.1
Understanding th the o orrganization a an nd co context
4.2 4.3
Understanding tth he n ne eeds an and e ex xpectation o off interested parties Determining the scope of the QMS
4.4
QMS and its processes
5.1
Leadership and Management commitment
5.2
Quality policy
5.3 5.3
Org rgan aniz izat atio iona nall roles oles,, re res spons ponsib ibil ilit ites es and and auth author orit itie ies s
6.1
Actions to to ad address rriisks an and o op pportunities
6.2
Quality objectives and p pla lan nning to achieve them
6.3 7.1
Planning of changes Resources
7.2
Competence
7.3
Awareness
7.4
Communication
7.5
Documented Information
8.1
Operational pl planning an and control
8.2
Determination of requiements for products and services Design and or development of products and services Control of externally provided products and services
8.3 8.4
8.5 8.6
Production and Service Provision Release of products and services
8.7
Control o off n no on conforming p prrocess o ou utputs , products and services Monitoring, measurement, analysis and evaluation Internal Audit Management Review General Non Co Conformity a an nd c co orrective a ac ction Continual Im Improvement
9.1 9.2 9.3 10.1 10.2 10.3
Workshop 10: Identification of Audit Trails Dec’19
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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The objectives objectives of of this workshop are: 1. To unders understan tand d the process process identif identifyin ying g aud audit it trails trails usin using g the knowle knowledge dge of int intera eracti ction on// interfacing of various requirements requirements of clauses with each other 2. To gain gain an insight insight into into how to identi identify fy specific, specific, promis promising ing audit audit trails trails 3. To achieve achieve an understa understandi nding ng on the question questioning ing to be done, done, evidences evidences to be sought sought and analyse the evidences in the light of the requirements
Duration: Refer to the time table for overall time duration and and follow follow instructions by the Trainers for break up Material provided for Workshop: Documented Information Information of the t he Beta Flip-chart and markers
Workshop
The trainer will allocate one clause of the standard to each team. Thus each team will have different clauses of the standard to work upon The delegates will have studied the organisation’s documentation. However they are advised to understand the organisation in more details. With this knowledge and that of ISO 9001 Standard, they are expected to work in teams and identify which other clauses of the standard interact or interface with the clause allotted to the team Teams shall prepare their presentation in the format given below with the allocated clause shown at the centre of the diagram (This diagram is known as Octopus Diagram) Make re Make refer feren ence ce to the relev relevant ant clause clauses s of the stand standard ard.. While While presen presentin ting g the infor informat mation ion,, delegates must also depict the direction of the arrows to indicate which clause gives input to the central clause and vice versa. (It must have been realised by the delegates during this workshop that each clause of the standard has one or more output(s) which become(s) input to one or more other clause(s) of the standard and vice versa. (i.e.,output of other clauses become inputs to them )
Dec’19
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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8.2 Determinatio n of requirement for products and services
Dec’19
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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Delegate Hand-out Hand-out Exercise and and Workshops Bureau Veritas Certification WORKSHOP No. 11- Developing an AUDIT CHECKLIST
The objectives of this workshop are to prepare the delegates to:
Understand how to develop a workable and useful audit checklist to perform third party audit in the auditee organisation.
To cov cover er app approp ropria riate te cla clause uses s of ISO 900 9001:2 1:2015 015 wit with h the their ir bus busine iness ss act activi ivitie ties s including processes and procedures.
Duration: Refer to the time table for overall time duration and and follow follow instructions by the Trainers for break up
Workshop Material:
The Documentation of Beta Training Flip Charts Charts and markers OR Outputs of earlier workshops
WORKSHOP The ca The case se st stud udy y is ba base sed d on a th thir ird d pa part rty y au audi ditt co cont ntra ract ct ag agre ree e be betw twee een n Be Beta ta Training and Bureau Veritas Certification for conducting Stag 2 audit of the QMS and has to ensure under contract requirements and of ISO 9001. Based on Workshop-Stage 2 Audit Planning and Workshop-Audit Plan Matrix the the team shall use the time planned for the audit. TRAINER shall allot o one ne process to e each ach team to prepare the checklist for subsequent workshop on auditing role play. The audit checklist could be based on a process matrix indicating what elements of the standards willofbethe looked the schedule audit.at in various departments and/or on process activities indicating Then prepare the checklist for the process allotted to your team by the trainer in any appropriate format, having at least the following headings: Process Activities Reference documents ISO 9001 clauses Items to check Space for notes Time allocation
Dec’19
CQI-IRCA Certified Certified PR 328 328:: QMS ISO 9001 9001:2015 :2015 Lea Lead d Auditor Tra Training ining Course (1 (17929) 7929)
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Checklist
Company: Process / Activities
Auditor:
Process: Ref Documents
ISO 9001 Cl.
Date:
Page Nº: T To o Check
Notes
Time
Signat ure:
Oct’18 CQI-IRCA Ce Certified rtified PR 328:QMS ISO 9001:2015 Lead Lead Auditor Training Course (17929) P age age 43 43 of of 51
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WORKSHOP No. 12 – CONDUCTING OPENING MEETING Purpose of this workshop: To prepare the delegates to understand and practice:
How to conduct a successful opening meeting as part of a third party audit of an auditee organisation in accordance with the requirements of ISO 19011 and ISO 17021.
Duration: Refer to the time table for overall time duration and follow instructions by the Trainers for break up Workshop Material: Documented information of Beta Training Plain Paper & pen/ Pencils Stage 2 audit preparation documents (Audit Plan, Matrix & Checklist) Workshop The ca cas se stu tud dy is bas ased ed on a th thir ird d pa parrty aud udit it in init itia iate ted d by an ext extern ernal al organisation wh organisation whic ich h Bu Bure reau au Ve Veri rita tas s Ce Cert rtif ific icat atio ion n ha has s to co cond nduc uctt un unde der r contractual requirements to verify their conformance to the requirements of ISO 9001:2015. Each team has to prepare to conduct an opening meeting with the management of the auditee organisation in line with the recommended agenda given in ISO 19011 & Pre course reading material As directed by the trainer an Opening Opening Meeting of Stage 2 audit shall be conducte conducted d
Oct’18
PR328: QMS ISO 9001:2015 Lead Auditor Training Course (17929)
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Workshop 13: Auditing Top Management The objectives objectives of of this workshop are: 1. How How to approac approach h the audit audit of the Top Manage Managemen mentt in the context context of unders understan tandi ding ng their commitment for the QMS and their overall responsibility and accountability for the QMS 2. To gain an insigh insightt into how to fram frame e right que questio stions ns and seek approp appropriate riate e evide vidences nces from Top Management to verify conformance to the requirements requirements 3. To understan understand d the auditors’ auditors’ attitude attitude and skills skills required required to be practiced practiced while while auditing auditing Top Management of any organization organization
This workshop is to be conducted in 2 parts. Part 1 - is on preparing to audit and Part 2 -is the role play of ‘auditing the Top Management’ Part 1 of the workshop workshop - Preparation for auditing auditing Top Management Materials: Documentation Documentation of the Organisation provided by the trainers Flipcharts and marker pens / acetates and pens/ plain paper Time Allocation:
Refer to the time table for overall time duration and follow instructions by the Trainers for break up Workshop Delegates Delegate s in team are required required to familiar familiarize ize themselv themselves es with the documenta documentation tion of the organization, understand who the Top Management in the company are and their specific roles and responsibilities within their organization and prepare for auditing Top Management. At the end of group work they must come out of a set of logical and sequential questions, relevant documents to be seen and records to be obtained while auditing Top Management of the organisation. organisation. Teams are expected to document the output of planning in either flip charts/ acetate sheets / plan papers Part 2 of the workshop- Auditing the Top Management Each team is assigned to audit the Top Management of this organisation. organisation. Each group will then act as an audit team and audit the Top Management. Here trainer(s) will facilitate as Top Management of the Organisation. Organisation. Time Allocation:
Refer to the time table for overall time duration and follow instructions by the Trainers for break up
Oct’18
PR328: QMS ISO 9001:2015 Lead Auditor Training Course (17929)
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WORKSHOP No. 14 – ROLE PLAY – INTERVIEWS-Proce INTERVIEWS-Process ss Audits The objectives of this workshop are to be prepare the delegates to:
How to use a workable and developed audit checklist to perform third party ‘process audit’ in the auditee organisation. To learn learn au audit dit techn techniqu iques, es, se seeki eking ng approp appropria riate te audit audit evide evidence nces s and evalu evaluati ating ng objectively objectivel y to determine conformance or otherwise to the requirements requirements Develop the art of time management and prioritization prioritization during audit Deve De velo lop p abil abilit ity y to deci decisi sion on maki making ng in diffi difficu cult lt / unex unexpe pect cted ed si situ tuat atio ions ns and and act act appropriately.
Duration: Refer to the time table for overall time duration and follow instructions by the Trainers for break up Workshop Part 1 preparation for the Process Audit (role play) The ca The case se st stud udy y is ba base sed d on th the e th thir ird d pa part rty y au audi ditt in init itia iate ted d by an exte external rnal organisa orga nisation tion which Bureau Veritas Certification has to ensure under contract requirements and of ISO 9001:2015. Based on results of Workshops on Stage 1 audit, Stage 2 audit planning, Process Matrix and the learning achieved by the delegates and with the help of prepared checklists in Workshop 7, the team will conduct interviews with the members of the external organisation in order to verify conformity to all the relevant requirements.
Part 2 Role Play – Process audits (role play) The trainers will provide the necessary arrangements to facilitate actual conduct of audits of processes. There would be auditees representing the organisation and they would provide all answers for the auditors’ queries and also relevant documents and records. Trainers will invite each team separately the teams have to visit the meeting venue and conduct a formal audit. Trainers will observe the audit process and evaluate the team and each team members on various parameters.
Time for individual group’s role play: will be decided by the trainers on the interview spots depending on the number of teams available
Feedback and discussion Oct’18
PR328: QMS ISO 9001:2015 Lead Auditor Training Course (17929)
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WORKSHOP No. 15 – Observing an acceptable–throu acceptable–through gh Role Play by trainers. The Purpose of the Workshop The purpose of the workshop is to:
Enable delegates analyse good and bad practices in interviewing; Provide visual display to the delegates of the good practices followed in an actual audit. Relate their own auditing experience with the auditing practice demonstrated in the video.
Material Not Applicable. Duration: Refer to the time table for overall time duration and follow instructions by the Trainers for break up
Workshop: Delegates are required to keenly observe the Role Play enacted by the Trainer(s) and make notes about the whole audit process. The delegates should bring out the following points during Video presentation -
Oct’18
Intr Introd oduc ucti tion on of th the ea aud udit itor or Beg Beginn inning ing w with ith ‘‘war warm-u m-up’ p’ se sente ntence nces, s, an and d ge gener neric ic su subje bjects cts Con Conver versin sing g wit with h the au audit ditee ee an and d not ‘b ‘bom ombar bardin ding’ g’ hi him m with q ques uestio tions ns As Ask king ing ope pen n qu que est stio ion ns Pro Provid viding ing p posi ositiv tive e fe feedb edback ack to th the e au audit ditee ee w whe hen n de deser serve ved d As Aski king ng o onl nly y re rele leva vant nt q que uest stio ions ns Cla Clarify rifying ing que questi stions ons whe when n th the ea aud udite itee e is in d dou oubt bt Sho Showin wing g rea reall inte interes restt in the s sub ubjec jectt whil while e con conduc ductin ting g the in inter tervie view w Goo ood do obs bser erva vati tio on s ski kill lls s Taking notes Inf Inform orming ing the aud audite itee e wh when en n nonon-con confor formit mities ies are fou found nd Cl Clos osin ing g tthe he au audi ditt w wit ith hs sum umma mariz rizat atio ion n
PR328: QMS ISO 9001:2015 Lead Auditor Training Course (17929)
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WORKSHOP No. 16 – PREPARATION FOR CLOSING MEETING The objectives of this workshop are to prepare the delegates to:
Write nonconformity reports/corrective action requests during /after the audit in an ORGANIZATION. To practice writing an accu accurate rate summary of the audit, includin including g positive positive audit findings and opportunities for improvement. To enable delegates to understand the essential elements of a good audit report and understand how the auditee organization would evaluate their audit report and Non Conformity Reports
Hand-outs and material CAR forms as needed (Workshop ( Workshop hand-out CAR forms) forms) Blank paper for preparing the audit summary report Duration: Refer to the time table for overall time duration and follow instructions by the Trainers for break up Workshop Based on the findings of Role Play on auditing processes each team has to prepare to conduct a closing meeting with the management of the auditee organisation in line with the recommended agenda described in the pre course study material (PowerPoint Chapter on - Audit Management) and ISO 19011 standard Each team shall prepare and present any nonconformities that they have identified during the role play interviews of process audits, using the forms provided (CAR forms). The teams shall at the end prepare a formal Audit Summary Report in line with the recommendations described in Pre course study material (PowerPoint slides on – Reporting) to hand over to the Top Management (maximum one page).
CORRECTIVE ACTION REQUEST Company: Oct’18
Date:
CAR No:
PR328: QMS ISO 9001:2015 Lead Auditor Training Course (17929)
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Auditor:
Auditee:
Nonconformity:
Objective Evidence:
Requirement of the ISO 9001 standard (including Clause number):
Signed: Correction:
Date:
Root Cause
Proposed Corrective Action:
Proposed Completion Date: SIGNED
DATE:
Verification of Corrective Actions : Signed
Date:
Review of effectiveness of Corrective Action: Signed:
Date:
WORKSHOP No. 17 – Role Play- CLOSING MEETING
The objectives of this workshop are to be prepare the delegates to know: Oct’18
PR328: QMS ISO 9001:2015 Lead Auditor Training Course (17929)
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Exercises and and Workshops
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How to cond conduct uct a succ successfu essfull clos closing ing meeting durin during g a third party audit of an audite aud itee e org organ anisa isatio tion n in acc accord ordanc ance e wit with h the req requir uireme ements nts of ISO 190 19011 11 & 17021
Hand-outs and material Delegates CAR’s and Audit Summary Report prepared in Workshop 16. Duration: Refer to the time table for overall time duration and follow instructions by the Trainers for break up Workshop The ca cas se stu tud dy is bas ased ed on a th thir ird d pa parrty aud udit it in init itia iate ted d by an ext extern ernal al organisation which organisation which Bureau Veritas Certification has to ensure under contract requirements to verify conformance to ISO 9001:2015.
Based on the prepared audit findings and summary report of earlier workshop, the team tea m wil willl con condu duct ct clo closin sing g mee meetin ting g wit with h the membe members rs of the auditee auditee organisa organisation tion in order ord er to cla clarif rify y tha thatt thi third rd pa party rty aud audit it is com comple pleted ted and the audit co concl nclusi usions ons are communicated to the organization in a summarized manner
Oct’18
PR328: QMS ISO 9001:2015 Lead Auditor Training Course (17929)
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