08 SOLUTION - Exercise Workbook - ISO 9001-QMS LATC - V 1.5

 

 

SOLUTION TO  TO EXERCISES   SOLUTION

ISO 9001:2015 Lead Auditor ( Management System) Training Course

DELEGATES TO NOTE: 1)  Exercises carried out by each delegate is to be submitted latest by end of the day, so that the Tutor can review the exercises, exercises, and provide feedback next training day 2)  Pl include YOUR NAME in each exercise you share with MSME 3)  Delayed submission of exercises will impact the Internal/Continual Assessmentt related to the delegate Assessmen 4)  Delegates to submit, to the Tutor, a ‘consolidated Exercises booklet’ (a single document) consisting of all the exercises ex ercises carried out by them on last day of the training

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IMPORTANT INSTRUCTION   INSTRUCTION  All Exercises should refer to the Apex Manual of model company, company, unless otherwise stated.

Exercises Format: Individual Exercise Exercises that are marked ‘Individual exercises’ to be performed individually by each delegate.

Exercises Format: Group Exercise Exercises that are marked ‘Group exercises’ should be performed by the following method. 1.  Tutor will divide the total number number of delegates in the sess session ion into requ requisite isite

groups. Depending on the number of delegates in a session, some group might not have the same number of delegates as other ot her groups 2.  Once the group is formed on Day-1, the sam same e group will continue to

collaborate on all the Exercises throughout the training course exercises require ‘Group ‘Group Leader’ role. In such cases, group 3.  Some exercises members can follow rotation method wherein, so that each delegate will get an opportunity to act as a ‘Group ‘ Group Leader’ in different Exercises 4.  For auditing exercises, ‘Tutor’ will act as the  the  ‘Auditee’ ‘Auditee’  

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TABLE OF CONTENTS   Sr. No.  No. 

Title of Exercise  Exercise 

Exercise - 1

Mapping Terms and Definitions of ISO I SO 9001:2015

Exercise - 2

Understanding Context of organization

Exercise - 3

Auditing QMS Policy and QMS objectives

Exercise - 4

 Auditing “Clause 6.1 Actions Actions to address risks and opportunities” opportunities”  

Exercise – Exercise  – 5  5

Mapping of ‘Terms & Definitions’ of ISO 19011:2018

Exercise - 6

Responsibilities of Audit Teams (Auditor and Auditee)

Exercise - 7

Understanding of Audit Criteria, Audit Objective and Audit Scope

Exercise - 8

Preparation of Audit Plan for Stage-1Audit

Exercise - 9

Preparation of Audit Checklist: Stage-1 audit

Exercise - 10

 Auditor’s competence requirements requirements  

Exercise - 11

Preparation of Audit Checklist to audit Top Managem Management ent

Exercise - 12

Preparation of Audit Plan for Stage-2 audit

Exercise - 13

Preparation of Agenda for Opening Meeting

Exercise - 14

Conducting Stage-2 audit (Simulated Role-Play)

Exercise - 15

Generation of NCR, Nonconform Nonconformity ity Report

Exercise - 16

Preparation of Agenda for Closing meeting

Exercise - 17

Corrective action review, and Audit Follow-up 

Exercise - 18

Documented Information (Maintained and Retained)

1.4c  QMSMLAV 1.4c 

ISO 9001:2015 Lead Auditor Training Course  Course  

 

Exercise No. 1

Title

Mapping Terms and Definitions of ISO 9001:2015

Learning

To achieve clear understanding of various ‘Terms and Definitions’

Outcome

under Clause 3 of ISO 9001:2015

Duration

45 Minutes (Delegate 30 Minutes | Review 15 Minutes)

Method

Individual Exercise

Exercise

ISO 9001:2018 Standard

Material Delegates to review the ISO 9001 > Clause 3 > Terms and Delegate Instruction

1.0  QMSLAV 1.0 

definitions. course tutor.Delegates to present their findings as directed by the

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#

TERM

MAPPING

#

1

Requirement

e

a

2

Risk

h

b

3

Continual Improvement

i

4

Grade

a

5

Monitoring

b

c

d

DEFINITION Category or rank given to different requirements for products, processes or systems having the same functional use Determining the status of a system, a process or an activity  activity  Overall intentions and direction of an organization related to as formally expressed by top management  management   Extent to which planned activities are realized and planned results achieved  achieved   Need or expectation that is stated, generally implied or obligatory  obligatory 

6

Objective

g

e f

7

Performance

f

g

achieved   Result to be achieved

 j

h

d

i

Effect of Uncertainty  Uncertainty  Recurring activity to enhance performance   performance

Measurable result result  

Competence 8 9

Effectiveness

 j 10

Policy

1.0  QMSLAV 1.0 

c

Demonstrated ability to apply knowledge and skills or  Ability  Ability to apply knowledge and skills to achieve intended results  results 

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Exercise No. 2

Title

Learning Outcome

Understanding Context of organization

To achieve understanding of the Clause 4- Context of organization of ISO 9001:2015

Duration

30 Minutes

Method

Individual Exercise

Exercise



Material



  ISO 9001:2015 Standard   Company Profile/Apex Manual

Delegates to review sub clauses of Clause 4 allocated to you by the tutor and brief the requirement of the clause; the objective and Delegate Instruction

the evidence of conformity that the delegate would expect to witness in an audit. Delegates to present their findings as directed by the course tutor.

1.  Read through in the ISO 9001:201 9001:2015 5 standard clause 4 2.  Explain the m meaning eaning and intent of clauses clauses 3.  Explain what ev evidence idence to look for in relation to each que query ry 4.  Present findin findings gs for discussion

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Tutor to provide one sub clause to each delegate. Each delegate is required to use about 10 minutes to review the clause/s in the Standard, and start preparing their findings.

Tutor Instruction

 At the end of the Presentations by all delegates, Tutor will highlight any key points. Tutor will explain the concept and hand-hold the delegates by demonstrating the exercise for Clause 4.1. The same pattern is to be used by the delegates to understand all other clauses in the entire standard. Clause No.

Title of clauses

4.1

Understanding the organisation and its context

4.2

Understanding the needs and expectations of workers and other interested parties

4.3

Determining the Scope of the Quality management management system

4.4

Quality management system

Typical solution: solution:   4.1

Understanding Underst anding the organisation and its context context  

Intent of clause 4.1: Step-1: Read Clause 4.1 in i n ISO 9001:2015 Prime focus is on ‘determination of external and internal factors/issues that factors/issues  that may affect the organization and vice-versa. Organization to determine the external and internal issues relevant to Quality management system. Internal and external issues can be positive or negative and include conditions, characteristics or changing circumstances that can affect its Quality management management system. a) Examples of external issues: issues: 1)

the cultural, social, political, legal, financial, technological, economic and natural surroundings and market competition, whether international, national, regional or local

2)

introduction of new competitors, contractors, subcontractors, suppliers, partners and providers, new technologies, technologies, new laws and the emergence of new occupations

3)

new knowledge on products and their effect on health and safety

4)

key drivers and trends t rends relevant to the industry or sector having impact on the organizati organization on

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5)

relationships relationshi ps with, as well as perceptio perceptions ns and values of, its external interested parties changes in relation to any of the above

b) Examples of internal issues: issues:  1)

governance, governanc e, organization organizational al structure, roles and accountabili accountabilities ties

2)

policies, objectives and the strategies that are in place to achieve them

3)

the capabilities, understood in terms of resources, knowledge and competence (e.g. capital, time, human resources, processes, systems and technologies)

4)

information systems, information flows and decision-making processes (both formal and informal)

5)

introduction of new products, materials, services, tools, software, premises and equipment

6)

relationships relationshi ps with, as well as perceptions and values of, workers

7)

the culture in the organization

Evidence (Examples Evidence  (Examples of Documented information to look for)  for)    List of external external and internal issues determined, and duly approved or or communicated communicated or reviewed or considered in Risk Assessment Assessment  



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parties   4.2 Understanding the needs and expectation of interested parties Intent of clause 4.2:

To determine a) Interested parties b) needs and expectation of interested parties Examples of Interested parties: Employees, Customers, Suppliers, Local, regional, state national or international or municipality legal and regulatory authorities, contractors and subcontractors, Board of directors, Investors, Insurer, stakeholders, visitors, community, and competitors.  competitors. 

Evidence (Documents for):  Evidence  (Documents and Records to look for):  Matrix including a) determined interested parties b) requirements of each interested party and c) c)  monitoring and reviewing information about determined interested parties and their requirements r equirements  

NOTES BY QMS MANAGER: Requirements related to Clause 4.2 are monitored by QMS Manager every quarter, and reviewed in Management Review twice a year

QMS Manager ddmmyyyy

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4.3 Scope of the managem management ent system  system  clause:   Meaning and intent of clause: Organisation needs to determine the “core processes (extent), and locations/plants/sites (boundaries)”” for its managem (boundaries) management ent system. system.  An organization may have more 8 offices sites; to plant’ go for certification of ISO 9001:2015 forthan Chennai plantand only4. So, only. theHowever, boundaryitisdecided ‘ Chennai ‘Chennai plant ’  Evidence  (Documents and Records to look for):  Evidence (Documents for):    Has the documented information on “S “Scope cope”” of auditee organization has considered considered  



(a) 

The external and internal issues referred to in Cla Claus use e 4.1? 4.1?  

(b) 

Requirement referred to in Claus Clause e 4.2? 4.2?  

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management ent system system   4.4 managem clause:  Intent of clause:  The organization must establish, implement, maintain and continually improve a management managem ent system, including i ncluding processes needed and their interactions.  interactions.   Organization integrates requirements of of the managem management ent system in to various business processes marketing, such etc.  as design and development, procurement, human resources, sales and etc. 

for)   Evidence (Documents and Records to look for)    Processes and their inter-relation and integration integration  



*****END *****EN D OF EXERCISE**** EXERCISE******

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Exercise No. 3

Title

Learning Objective

 Auditing QMS Policy and QMS Objectives Objectives

  To gain an understand understanding ing of QMS Policy and QMS Objectives as per ISO 9001:2015 clause requirements



  Prepare the list of requirements to be verified o orr reviewed for QMS Policy and its QMS Objectives



Duration

Total 35 Minutes

Method

Individual Exercise

Exercise Material

ISO 9001:2015 Standard  Apex Manual Manual

Delegat es to review the Delegates th e requirements of 5.2 and 6.2.1 Policy Policy,, and objectives and Programme requirements and identify what will be required to be reviewed. Delegate

Delegate’s Task: Delegate’s  Task:

Instruction

1.  Review Clauses 5.2 and 6. 6.2.1 2.1 2.  Identify the requirem requirements ents to be reviewed during the au audit dit 3.  Present your unde understanding rstanding on EAC EACH H clause

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Typical Solution: Points to be reviewed in documen documentation tation 5.2 Policy Sr. To look for No. 1. 2. 3. 4.

Has the organization established, implemented and maintained Policy? Appropriate to the purpose and context of the organization and supports its strategic direction? Includes the comm commitment itment to comply with legal and applicable requirements? Provide the framework for setting up of objectives?

5

includes a comm commitment itment to continual improvement of QMS?

6.

Documented, implemented and maintained?

7.

Communicated, understood, and applied within the organization?

8.

Available to relevant interested parties?

Evidence (Documents (Documents and Records to be verified)   Duly approved Policy meeting the requirements of Clause 5.2.1



 



policy related awareness sessions/training records

  Communication in the form of emails, emails, meetings, meetings, stand-up meetings, Tool-box talks, Notice boards etc.,



  Made available to interested parties? If yes, yes, evidence evidence of communication communication



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Points to be reviewed in documen documentation, tation, 6.2.1 Objectives Sr. What to check / ask / look for No. 1.

2. 3. 4.

S.M.A.R.T.

Has the organization organization established objectives at relevant functions and levels levels in order to maintain and continually improve improve the managem management ent system and performance? What are different objectives established?  Are the objectives in line with QMS Policy? Policy? (Policy sets the direction, Objectives Objectives enforce the Policy)  Are the objectives measurable? measurable? Can they be monitored? monitored? Are the QMS Objectives updated as appropriate? Whether the objectives cover/address legal/statutory/regulatory/other legal/statutory/regulatory/other requirements?

5. 6.

Whether the results of assessm assessment ent of risks ri sks and opportunities have been taken into account while establishing and reviewing the objectives?

7.

 Are QMS Objectives relevant to conformity conformity of products and services and to enhancement of customer satisfaction?

Evidence (Processes, Documents Documents and Records to look for)   List of objectives at various functions and levels maintained as ‘documented information’  information’   

While planning to achieve the Q. Objectives, Whether the organization has determined 1.

what will be done to achieve the objective objectives s (Approach, methodology)? methodology) ?

2.

what resources will be required? (Men, material, money, methods etc.,) ?

3.

who will be responsible? (One person person per objective, NOT a Team)?

4.

when it will be completed? completed? (And, (And, periodic periodic milestones milestones for review)?

5.

how the results will be evaluated, including indicators for monitoring (Mechanism, (Mechanism, frequency for evaluation)?

6.

how the actions to achieve objective objectives s will be integrate integrated d into the organization’s organization’s   business processes?

*****END *****EN D OF EXERCISE**** EXERCISE******

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Exercise No. 4 Exercise Name

Clause 6: Planning 6.1 Actions to address risks and opportunities  

To gain clear understanding of ‘6.1 Actions to address risks and



Learning Objective

opportunities of risks and opportunities’ opportunities ’   

Review of the list of ‘requirements’ ‘requirements’ (of  (of ISO 9001), and to ensure



that whether all such ‘requirements’ ‘requirements’ have  have been considered while taking actions to address risks and opportunities  

Furnish related evidences an aud auditor itor to look for ttowards owards



conformity of Clause 6.1 Duration

Total 45 Minutes

Method

Individual Exercise

Exercise Material



  ISO 9001:2015 Standard

1.  Review Review Clause  Clause 6.1 2.  LIST LIST the  the requirements of Clause 6.1.1 and 6.1.2, and Delegate Instruction

QMSLAV 1.0  1.0 

3.  LIST LIST probable  probable queries & evidences that you, as an Auditor, would look for to decide conformity conformity or otherwise

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6.1 Actions to address risks and opportunities # Requirements Requiremen ts as per ISO 9001

Probable queries and evidences an auditor to look for 6.1.1. Does the organization have a Plan 6.1.1  When planning for the 6.1.1 for QMS? Evidence: _________________ management managem ent system, the organization shall  6.1.1. When planning for QMS, are the issues referred in Clause 4.1 (External ( External and internal issues) considered? 1. consider the issues referred to in Clause 4.1  4.1  (What are issues referred in Clause 6.2?)

1

2

Evidence: ______________ __________________ ____ 6.1.1. When planning for QMS, are the issues referred in Clause 4.2 (Interested parties) considered? 2. consider the issues referred to in Clause 4.2  4.2 

3

(What are issues referred in Clause 6.2?) Evidence: QMS Plan refers to ‘determined ‘ determined requirements of Clause__________________ Has the organization determined the risks and opportunities (covering/address (covering/addressing)? ing)?

Organization shall determine the risks 4

and opportunities that need to be addressed to:  to: 

Evidence: Risk Assessment Records, Risk Register duly reviewed (Delegates to read 4) and 5) together in adjacent column):

5

a) give assurance that the management managem ent system can achieve its intended result(s)

Has the organization determined the risks and opportunities to give assurance that the QMS can achieve its intended results? Evidence: ______________ _______________________ _________ Is enhancement of desirable effects addressed while determining risks &

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6

b) enhance desirable effects

opportunities? Evidence: ______________ ________________ __

c) prevent, or reduce, r educe, undesired effects

Is the determination of risks and opportunities address prevention, reduction of undesired effects? Evidence: ______________ _______________________ _________ Is achievement of improved i mproved addressed while addressing risks & opportunities?

8

d) achieve improvem improvement ent Evidence: ______________ ________________________ __________

9

10

6.1.2: The organization shall plan a) actions to address these risks and

6.1.2. a) To achieve QMS Objectives, Has the organization planned actions to address

opportunities

determined risks & opportunities? Evidence: ______________ ______________________ ________

b) how to: 1) integrate and implement the actions 11 into its managem management ent system system processes (see 4.4)

6.1.2.b) To achieve QMS Objectives, Has the organization planned to integrate and implement the actions into its managem management ent system processes (Refer Clause 4.4)? 4.4)? Evidence: _______________ _____________________ ______

2) evaluate the effectiveness of these 12 actions

 Auditee to brief the planning (towards (towards achieving QMS Objectives) to evaluate the effectiveness of actions taken at a) and b) above. Evidence:   _____________________ Evidence:

 Actions taken to address risks risks and opportunities shall be proportionate to the 13 potential impact on the conformity of products and services

How the actions to address risks ri sks and opportunities are proportionate to the potential impact on conformity of products p roducts and/or services? Evidence: ______________ _______________________ _________

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Exercise No. 5 Title Titl e

ISO 19011:2018: MAPPING TERMS & DEFINITIONS To gain clear understanding on

Learning Objective



  Terms and related definitions for auditing m management anagement systems

Duration

Total 30 Minutes

Method

Individual Exercise

Exercise Material

  ISO 19011 standard   Course Presentation





Delegates to map the Definitions w with ith Terms Delegate Instruction

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Sl.No.

Terms (A)

Matched Serial. No. of Definition (B)

1

Audit criteria

2

Audit scope

(e)

3

Combined audit

(a) 

4

5

Audit

Audit programme

(b) 

(f) 

(j) 

Definition (C) a) Audit carried out together at a single auditee on two or more management systems b) Set of requirements used as a reference against which objective evidence is compared. c) Results of the t he evaluation of the collected audit evidence against audit criteria  Audit findings can can lead to the identification identification of of risks, opportunities for improvement or recording good practices d) Outcome of an audit, after consideration of the audit objectives and all audit findings e) Extent and boundaries of an audit; the audit scope generally includes a description of the physical and virtual-locations, functions, organizational organization al units, activities and processes, as well as the time period covered.

6

Audit plan

(g) 

7

Audit findings

(c) 

8

Audit conclusion

(d) 

9

Management system

(h) 

10

Audit team

QMSVILT v1  v1 

(i) 

f) Systematic, independent independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled g) Description of of the activities and arrangements for an audit h) Set of interrelated or interacting interacting elements of of an organization to establish policies and objectives, and processes to achieve those objectives i) One or more persons conducting conducting an audit, supported if needed by technical expert  j) Arrangements for a set of one or more more audits planned for a specific time frame and directed towards a specific purpose

ISO 9001:2015 Lead Auditor Training

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Exercise No. 6 Title Titl e

Learning Objective

RESPONSIBILITIES OF AUDIT TEAMS (AUDITOR AND AUDITEE) To gain clear understanding on 

  The roles and responsibilities of audit team players such as auditee client, aud auditors, itors, lead auditors, auditors, auditee, gu guides ides and observers

Duration

Total 30 Minutes

Method

Individual Exercise

Exercise Material

  ISO 19011 standard   Course Presentation





Delegates to LIST responsibilities of the Lead Auditor, the audit Delegate

team members, members, auditee managem management ent and auditee, as iindicated ndicated by

Instruction

the Tutor

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Typical Solution: Responsibilities of Au Audit dit Team Leader   1. Obtain background background information of Auditee Auditee Organization Organization 2. Conduct documentation Review 3. Select and and assign assign audit audit team members 4. Prepare the plan including data and duration duration of audit audit 5. 6. 7. 8.

Lead at all all stages including opening and closing closing meetings Resolve any issue/dispu issue/disputes tes arising Evaluation of NCR NCRs, s, evidence and results results reporting Prepare and present audit conclusion, makes makes recommendations, recommendations, and follows up, reports and recommends actions 9. Prepares Audit report, and distributes Auditor Organization (Certification body or Manager, Internal Audit)  Audit)   1. Determines Audit scope scope and objectives 2. Select the the audit audit team leader 3. Provides Audit Team resources 4. Determine competence of Auditors 5. Ownership of the audit report 6. Controls follow up action Responsibilities – Auditor  Responsibilities –  Auditor   1. Prepar Prepare e Audit Audit Plan and Audit checklist checklists s 2. Competent to conduct the audit 3. Conduct audits according to audit plan plan 4. Communicate with auditees and team 5. Record and and report Audit Audit Findings clearly 6. Check on correcti corrective ve actions for previous audit findings, if required 7. Confidentiality, Integrity, Integrity, Ethics, Ethics, Assertiveness, Assertiveness, Independence 8. Remain within within the agreed agreed audit scope 9. Support the audit team leader

Auditee Managemen Managementt  1. Inform workers about audit scope and objectives objectives of the audit 2. Provide resources, facilities and guides 3. Provide access to all all areas areas 4. Make themselves available for audit 5. Ensure auditee cooperation 6. Attend opening and and closing closing meetings meetings 7. Take corrective action

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Responsibility –  – Auditee  Auditee   Responsibility 1. Assist auditors by supplying supplying information and and documents documents as requested 2. Responding to audit queries 3. Providing evidence evidence as sought by the auditor auditor 4. 5. 6. 7.

Making themselves themselves available available as per audit audit plan Providing facilities as agreed Review and facilitate acceptance acceptance of NCRs if any Guide the auditors auditors where to go for next audit audit

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Exercise No. 7

Title

Understanding Audit Criteria, Audit Objective and Audit Scope

Learning

•  EXPLAIN Scope of audit, aud audit it Criteria and audit Objective with example

Objective Duration

Total 30 Minutes

Method

Individual Exercise

•  ISO 19011 Standard Exercise Material

•  ISO 9001:2015 •  Case study/Apex Manual Each delegate to go through ISO 19011 standard > Clause 3, and define the scope of the audit, audit criteria and audit objective for the given case study/Apex Manual.

Delegate Instruction

Delegates to a) Understand, Define, and briefly explain Audit Scope, Audit criteria and Audit Objective in their own words

b) To provide atleast ONE EXAMPLE for Audit Scope, Audit Criteria, and Audit Objective

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Solution:  Typical Solution:  Audit scope Definition: Extent and boundaries of an audit  audit   Meaning: Core processes, not processes, not all the processes + location/s for audit audit   Examples of core Processes: a) Manufacture, Supply Supply and Servicing Servicing of Air Air conditioners b) Construction, Installation Installation and commissioning commissioning of Petrochemical Petrochemical complex Scope of the Managem Management ent system as per ISO 9001:2015 9001:2015 is: “Design, development, production and Sales of precision engineering components components of  ABC Corporation, Mumbai and Riyadh” Riyadh” 

Audit criteria Audit criteria is the reference or foundation or basis against which conformity is to be determined; it may one or any combination of applicable standards, legal requirements, management system requirements, contractual requirements, industry codes of practices or other planned arrangements. Example of audit criteria: ISO 9001:2015, 9001:2015, Managem Management ent systems systems –  – Requirements  Requirements with guidelines for use

Audit objective Audit objective: ‘Objective of an audit” or “Purpose/aim of an audit”. audit”.  

Example:   Stage-1 audit



  Internal Audit



  Stage-2 audit



  Supplier audit



  Regulatory body audit



  Risk Managem Management ent



  Continual Improvem Improvement ent



*****END OF EXERCISE*****

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e

Exercise No. 8 Title

Preparation of Audit Plan for ‘Stage‘Stage-1 Audit’  Audit’ 

1.  To pre prepare pare for planning planning for Stage-1audit 2.  To enhance the understanding of process and systemapproach Learning Objective

to management auditing 3.  To develop the ability to determine the audit scope and determine resource requirements including determination of ‘number of audit days/duration’ according to IAF MD:5-2019 MD:5 -2019

Time Allocation

Total 45 Minutes

Format

Individual Exercise  

ISO 9001:2015 standard > Clause # 6.3.2

 

Case study/Apex Manual

 

IAF MD:5-2019



Exercise Material

Delegate Instruction





Task: a) To refer the Apex Manual, and LIST the process areas  areas   for which documentation audit is required to be carried out b)

Prepare the audit plan for the Stage-1 audit using the Template given below covering the documentation audit of ‘listed process areas’  areas’ 

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Typical solution AUDIT PLAN-Stage-1  Auditee Organization:

 ABC Corporation Corporation

Date(s):

DD –  –MM MM –  –YYYY YYYY

Team Leader:

Mr. Alistair Clarke (LA)

 – Auditor 1

Team Members:

Mr. Peter Sandris

 – Auditor 2

 Audit Criteria: Criteria:

ISO 9001:2015, Manageme Management ntSystem System –  – Requirements  Requirements with guidance for use

Location

Mumbai

 Audit Scope: “Manufacture “Manufacture and  and supply of Chemicals of ABC Corporation Mumbai” Mumbai”  Note: Based on the man-day calculation the Stage-1 audit of 1 day (Ref: IAF MD:5-2019) HOURS

AUDITOR 1

HOURS

09.30 to 10.30

10.30 to 11.30

AUDITOR 2

Opening Meeting

 Audit of details provided provided in the application, (Including scope, processes, work-culture)

11.30 to Documented information review 13.00 for the adequacy, Context of organisation,, Leadershi organisation Leadership p commitment 13.00 to 13.30

10.30 to 11.30

11.30 to 13.00

Brief site-visit: site-visit: To understand processes and technology used

Documentation review of Support, Documentation Operation

Lunch

13.30 to 14.30

Documentation Documentatio n review of Top

14.30 to 13.45

Internal audit process and review / status of findings and validation of Scope

Management including Management Review Process

13.30 to 14.30

Documentation review of Clause 6 and Legal and other requirements

14.30 to Performance evaluation 16.30

13.45 to 16.15

 Auditor Team Meeting Meeting (to finalize finalize Audit Findings, Findings, and decide Audit Audit Conclusion) Conclusion)

16.15 to 16.30

Debriefing to Auditee Manag Management ement

16.30 to

Closing Meeting

17.00

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Exercise No. 9 Title

Preparation of Audit Checklist: Stage-1 audit

•  Learning Objective

To understand and prepare ‘Audit checklist for StageStage-1 audit’ related to adequacy audit/documentation audit

• 

To understand the concept of ‘Audit Trail/Audit Investigation point’  point’ 

Duration

Total 45 Minutes

Method

Individual Exercise

Exercise Reference

Checkpoint/Audit

  ISO 9001:2015 standard



  Apex Manual



Delegate

Tutor will allocate requisite clause number/sub-clause number to each delegate to address in Audit Checklist.

Instruction Delegates to create audit Checklist for Stage-1 Stage-1 audit’, limiting to documentation audit.

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.

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TYPICAL SOLUTION:

Clause# Clause # 

4 

What to query?   query?

Requirements Requirements   Context organisation   organisation

of   and internal  Are the External and

Understanding Understanding the

4.1  4.1 

What to look for (as evidence)   evidence)

organisation and its context  context  issues determined determined? ?

List of external and internal issues (Approved note, email, Part of Management review?)

Determined Intereste Interested d parties?

4.2   4.2

4.3   4.3 4.4   4.4

5  5.1   5.1 5.1.2

theneeds Understanding theneeds and expectationof expectationof workers Determined Needs and and other interested parties  parties  expectations of interested parties?

Determination in the form of a matrix or otherwise, ot herwise, duly approved

monitoring and reviewin reviewing g information about these interested parties and their relevant requirem requirements ents Scope Statement Determining the scope of Is the Scope stated (covering  Approved Scope the manag management ement system  system  Core processes and Location/s)? management system   system

List of controlled documentation exists?

List of controlled documented information

Leadership Leadership commitment   commitment

and

Customer Focus

5.2   5.2

Policy Policy  

5.3  5.3 

Organizational responsibilities authorities   authorities

6 

Planning  Planning 

6.1  6.1 

 Action to address risk riskand and opportunities   opportunities

6.1.1   6.1.1

General   General

6.2  6.2 

Objectives objectives and planning to achieve them  them 

roles, and

Planning of changes

6.3 7 

Support  Support 

7.1  7.1 

Resources  Resources 

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7.2  7.2 

Competence  Competence  

7.3 7.3  

 Awareness   Awareness 

7.4  7.4 

Communication  Communication  

7.5  7.5 

Documented information   information

7.5.1  7.5.1 

General   General

7.5.2  7.5.2 

updating   Creating and updating

7.5.3  7.5.3 

Control of documented information   information

8 

Operation  Operation 

8.1

Operation planning and control

8.2

Requirements for products Requirements and services

8.3

Design and development of products and services

8.4

Control of externally provided processes, products and services

8.5

Production and service provision

8.6

Release of products and services

8.7

Control of nonconforming outputs

9

Performance evaluation

9.1

Monitoring, measurem measurement, ent, analysis, and performance evaluation

9.2

Internal audit

9.3

Management review

10

Improvement

10.1

General

10.2

Nonconformity and corrective action

10.3

Continual improvement

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Exercise No. 10

Title

Understanding Auditor’s competence requirements

Learning



  Lead auditor is responsible for evaluation and selection of auditors

Objective

  Make delegates aware of the knowledge and skills required for developing competence as a management system auditor



Time Allocation

Total 30 Minutes

Format

Individual Exercise

Exercise Material

  ISO 19011 Standard > Clause 7.2



  Training Presentation Presentation



Delegates to review guidelines of ISO 19011 carefully and to identify the competence needs for an auditor as follows: Delegate Instruction

ISO 19011 > 7.2 Determining auditor auditor competence 7.2.1 General 7.2.2 Personal behavior 7.2.3 Knowledge and skills 7.2.4 Achieving auditor competence 7.2.5 Achieving audit team leader competence

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Typical Solution: #

Competence requirement requirements s Personal behaviour;

 ethical, i.e., fair, truthful, sincere, honest and discreet  open-minded, i.e., willing to consider alternative ideas or points of view  diplomatic, i.e., tactful in dealing with people act ively observing physical surroundings and activities  observant, i.e., actively  perceptive, i.e., aware of and able to understand situations  versatile, i.e., able to readily adapt to different situations  tenacious, i.e., persistent and focused on achieving objectives  decisive, i.e., able to reach timely conclusions conclusions based on logical reasoning andanalysis and analysis  self-reliant, i.e., able to act and function independently whilst interacting effectively with

       

1



others  acting with fortitude, i.e., able to act responsibly and ethically, even though these actions may not always be popular and may sometimes result in disagreement or confrontation  open to improvement, i.e., willing to learn from situations, and striving for better audit results  culturally sensitive, i.e., observant and respectful to the culture of the auditee 

effectively interacting with others, including audit team members and  collaborative, the auditee’s personnel auditee’si.e.,  personnel

2

Generic knowledge and skills of management system

3

Sector specific knowledge and skills of management system auditors

4

Generic knowledge and skills of an audit team leader

5

Knowledge and skills for auditing management systems addressing multipledisciplines multiple disciplines

6

Formal education / training tra ining and experience that contribute cont ribute to the development develop ment of knowledge and skills in the management system discipline and sector the auditorintends auditorintends to audit

7

Training programmes that cover generic auditor knowledge and skills Experience in a relevant technical, managerial managerial or professional position involving the exercise

8

of judgement,peers, d ecision decision making, pro blem solving parties and communication communica tion with managers, professionals, customers andproblem other interested

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Exercise No. 11 Title

Learning

Preparation of Audit Checklist to audit Top Management To gain clear understanding about   The approach to audit the Top Management   Skills required to audit the top management.

Objective Time Allocation

Total 30 Minutes (Delegate 60 Mts | Feedback 30 Mts)

Format

Individual Exercise



Exercise Material



   

 

ISO 9001:2015 standard Apex Manual/Case study

Delegates to prepare an Audit checklist covering Clauses in ISO 9001:2015 related to Top Management which are a) 5.1 b) 5.2 c) 5.3, and d) 9.3 Delegate Instruction 

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added since NOTE: Clause 6.2 Objectives can also be added since Top Management need to ensure objectives are established, communicated, and maintained maintained

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Delegates to generate atleast 3 audit queries per sub-clause given below:

Clause #

What to query

Description of Description clause

What to look for? (as Objective evidence)

1.

5.1   5.1

2.

Leadership

3. 1.

5.2   5.2

2.

Policy  Policy 

3. 1. Organizational

5.3   5.3

roles,

2.

responsibilities

3.

and authorities  authorities  1.

6.2.1   6.2.1

2.

objectives  objectives 

3. 1. Planning

6.2.2   6.2.2

achieve objectives   objectives

to 2. 3. 1.

9.3

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Management review

2. 3.

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Exercise No. 12

Title

Learning Objective 

Preparation of Audit Plan for Stage-2 audit 

To enable delegates to prepare Audit Plan for Stage-2 audit

Duration

Total 30 Minutes

Method

Individual Exercise

Exercise Material

  ISO 9001:2015 standard and case study



  IAF-MD5:2019



Delegates to a) Review the A Apex pex M Manual, anual, and LIST the process areas Delegate Instruction

b) Utilize the ‘Template for Audit Plan’ used in a previous exercise  exercise   c) Include the Process areas in appropriate time time slots to com complete plete the Audit Plan for f or Stage-2 audit which is otherwise known as Conformity audit or Implementation audit or Certification audit

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TYPICAL SOLUTION AUDIT PLAN –  – Stage  Stage 2 audit  Auditee Organization

 ABC Corporation Corporation

Date(s)

DD –  –MM MM –  –YYYY YYYY

Group Leader

Mr. Thomas Roger (LA)

 – Auditor 1

Group Members

Mr. Bright Carpent Carpenter er

 – Auditor 2

 Audit Criteria:

ISO 9001:2015 Management System System –  – Requirements  Requirements with guidance for use

Location

Mumbai

 Audit Scope: “Design, development, production and Sales of precision engineering components of ABC Corporation, Mumbai and Riyadh” Riyadh” 

HOURS

AUDITOR 1

HOURS

09.30 to 10.30 10.30 to

Opening Meeting Top Managem Management ent

11.00

11.00 to 13.00

Supply Chain Management

13.00 to 13.30

13.30 to 15.30 15.30 to 17.00 

AUDITOR 2

10.30 to

Review of action status of audit

11.00

findings of previous audit/s Construction site/ Production (Includes risk assessment, legal requirements, objectives and programmes, operation controls and evaluation of complia compliance) nce)

11.00 to 13.00

Lunch

Documented information, Design 13.30 to 15.30 and Development Performance Evaluation, and continual Improvement 

15.30 to 17.00 

Support, Internal audit

Customer Focus, and Customer Satisfaction

17.00 to 17.15

 Auditors Team meeting meeting

17.15 to 17.30

Debriefing Top Management

17.30 to 18.00

Closing Meeting

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Exercise No. 13

Title

Learning Objective

OPENING MEETING: Preparation of Agenda

 

Understand the process of Opening Meeting

 

Preparing the Agenda for Opening meeting





Duration

Total 45 Minutes

Method

Individual Exercise

Exercise

  ISO 19011 standard > Clause 6.4.3



Material Delegates to a) Review the gu guidelines idelines in ISO 19011 > Clause 6 6.4.3 .4.3 Tutor Instruction

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b) Prepare an A Agenda genda for c conducting onducting an Opening Meeting c) Agenda to consist of atleast 10 p points oints

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TYPICAL SOLUTION Agenda for Opening Meeting  Meeting  .  business Introductions, Introductions, initiated by Audit Team Leader   1. Formal business 2. Auditors and Auditee Management Management to introduce introduce themselves themselves   3. Record of participation (Responsibility: (Responsibility: Audit Audit Team leader) leader)   management (Responsibility: Audit Team Team leader)  leader)  4. Thank the auditee management 5. Confirm Audit Scope, Audit Audit Criteria, and Audit Audit Objective (Responsibility: Audit Audit Team Leader)   Leader) 6. Confirm the audit plan plan (Responsibility: (Responsibility: Audit Team Team Leader) Leader)   method of conduct of audit, including including method method to resolve issues/disputes issues/disputes   7. Explain the method cooperation (Responding, (Responding, providing providing documentation documentation to auditor) auditor)   8. Confirm auditee cooperation 9. Establish lines of communications communications   audit   10. Promote auditee's participation in audit documentation  11. Confirm current status of controlled documentation  arrangements  12. Confirm the Lunch arrangements  13. Confirm any resources required  required  Closing   14. Reporting Procedure and Closing 15. Role of Guides, Technical Experts, Observers, Translators, Tr anslators, as applicable  applicable   16. Termination and Appeals Appeals   17. Assure confidentiality and security of data and information  information   facilities   18. Health and Safety Issues and Access to facilities ‘End of day briefings’ briefings’ if required  required  19. Process of ‘End Discussions  20. Private Room for Group Discussions  21. Any questions questions   *****END OF EXERCISE*****

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Exercise No. 14 Title

Simulated Role-play: Conducting Stage- 2 audit’ audit’ 

pl an ‘skills’ to implement the audit plan A)  Demonstrate the ‘skills’ to B)  Make use of Audit Audit checklist, and other documents, documents, and to follow audit trails Learning Objective

C)  Demonstrate the ability to build rapport with the aud auditee itee during the audit D)  Demonstrate the ‘skills’ to ‘skills’ to manage audit interviews effectively, including the ability to formulate effective audit queries E)  Demonstrate the ab ability ility to collect and v verify erify appropriate audit evidence, including appropriate sampling

Duration

Total 60 Minutes

Method

Team Exercise

Exercise

1. ISO 9001:2015 standard

Material

2. Prepared checklist from previous Exercise/s 3. Case study/Apex Manual 4. Site visit visuals (to be shared by the the Tutor during the Exercise)

 A. Delegates to 1) Be ready w with ith the Audit Check Checklist list that the delegate prepa prepared red 2) Decide who will play the role of Audit Team Leader/Lead  Auditor Delegate Instruction

3) Discuss within the team team a) who will lead, b) how to carry out Intro Introduction duction of aud audit it team members, c) who will sta start rt the audit, sequence sequence of a audit udit d) sequence of asking queries, e) how the queries queries w will ill be split between the a auditors uditors f)

who will intervene in case of disputes during the audit

g) ‘WhatWhat-if’ if’ the auditee is not providing information intentionally or auditee not understanding the query of auditor, h) ‘How-toHow-to-manage’ manage’ if the auditee engages delay-tactics delay-tactics 4) Note dow down n the deta details ils of ev evidences idences obta obtained ined v1  QMSVILT v1 

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5) Decide c conformity onformity or othe otherwise rwise 6) Communicate w with ith the auditee auditee in case of nonconform nonconformity ity 7) Obtain ack acknowledgem nowledgement/acceptance ent/acceptance of NCR NCR 8) Ready to generate NCR NCR,, Nonconformity Nonconformity Report (Delegates w will ill carry out another exercise to create NCRs) 9) Note down ‘Learnings’ out of this exercise exercise  

B. Non-participating Delegates: 1. To observe the course and sequence of audit, bottlenecks, auditor-auditee communication levels and patterns 2. To identify good practices by the auditor/auditee 3. To identify the scope for improvement in audit process 4. To high highlight light on ‘auditor cond conduct’ uct’   C. NOTE TO ALL DE DELEGATES: LEGATES:

1. 1. Audit  Audit queries to avoid terms such as ‘you, your, we, I, me, yours’ as matter of personification; ISO 9001:2015, as a Standard, does NOT contain such terminologies. t erminologies.

2. Point # 1 above might be practiced, if the auditor is familiar with auditee by interactions prior to a particular audit

3. In case an auditor identifies a nonconformity, please note an Objective Evidence is a MUST to declare the process as Nonconformity

4. In case a nonconformity is identified initially, but no evidence is available, auditor need to investigate further to a reasonable extent to decide conformity or otherwise; Not to deep-dive or focus to ‘go behind’ in making a nonconformity nonconformity  

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Typical nonconformities identified during Role-play: Audit finding –  –1 1 Pulley-guard found not available on the rotating part in the plant Audit finding –  –2 2 Welder not wearing/using appropriate PPE

*****END OF EXERCISE*****

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Exercise No. 15 Title

Generation of NCR, Nonconformity Report 

To optimize the a) skill related to evaluate nonco nonconformity nformity based on the audit audit Learning Objective

findings b) Preparation of no nonconformity nconformity report base based d on the audit findings with all relevant information

Duration

Total 30 Minutes (Delegate 30 Mts | Feedback 15 Mts)

Method

Individual Exercise

Exercise

ISO 9001:2015 standard

Material

Findings as identified during the Stage 2 audit in previous exercise

Delegates to 1.  Review the findings against the specific specific requirem requirements ents and will Delegate

conclude whether the scenario is conformity or otherwise

Instruction

2.  If nonconform nonconformity ity evidenced appropriately, Prepare no non n – conformity report in the given template

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TYPICAL SOLUTION  SOLUTION   NONCONFORMITY REPORT  Auditee Organization: ABC Corporation Corporation

Date: ddmmyy ddmmyyyy yy

Location: Mumbai  Auditor Name: Mr. Charles G 

Audit Plan No.: NCR No.

 Auditee Dept: Production Shop Shop -MX1

NCR Category: Minor

1. Description of Nonconform Nonconformity: ity: Organization  Organization failed to implement risk mitigation measures and related impact/s 2. Related evidence: evidence: One of the Pulley Guards was not in place on rotating belts and pulleys, which could be a cause for a hazard (Asset ID # 1234, Location of Pulley: Machine Shop: AP-1)

3. Audit Criteria: ISO 9001:2015 Clause No. 6.1. Action to address risks and opportunities   opportunities  Auditor Sign: Date:

 Auditee Sign:

*****END OF EXERCISE*****

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Exercise No. 16 Title

CLOSING MEETING: Preparation of Agenda Demonstrate the ability to 1. Review all tthe he audit findings of an audit,

Learning

2. Prepare audit audit conc conclusions, lusions, inc including luding the extent of co conformity nformity of

Objective

the management system 3. Identification of audit findings findings in add addition ition to nonconformity, and identification

of

potential

risks

and

opportunities

for

improvement 4. Grade nonconformity nonconformity reports 5. Present audit audit conc conclusions lusions a and nd recom recommendations mendations clearly to the

Time Allocation

auditee at a closing meeting Total 30 Minutes

Format

Individual Exercise   ISO 19011 standard > Clause 6.4.10

Exercise



Material



Delegate Instruction

  Audit Findings including Nonconform Nonconformity ity reports

The purpose of closing Meeting is to present audit conclusion and audit findings, and make suitable recommendation/s. Delegate to a) Refer ISO 19011 > Clause Clause 6.4.10 b) Prepare an Agenda for closing Meeting

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TYPICAL SOLUTION Agenda for Closing Meeting  Meeting 

1. Audit Team Leader to chair chair the Closing Meeting Meeting 2. Welcome the teams, and thank the Auditee Managem Management ent 3. Record presence presence of participants participants 4. Re –  –state state the scope, criteria, including exclusions and objectives 5. Convey recommendations recommendations as to certification or continuation of certification as applicable   applicable 6. Explain Audit conclusion, conclusion, and a Summary Summary of Audit Findings Findings   7. Explain nonconformities nonconformities defining major major and minor minor as required required   documents/samples ples used by the the auditor team team  8. Return any documents/sam 9. Invite questions questions on audit audit findings  findings  10. Make Disclaimer Statement Statement   relevant  11. Explain the procedures for complaint and appeal, if relevant  12. Invite auditee to ensure corrective action plans on time ti me   action   13. Highlight consequences of not addressing corrective action 14. Explain reporting, timelines, and follow up procedures procedures   information   15. Confidentiality of data and information 16. Thank the auditee management, management, auditees, audi tees, and the auditors auditors   17. Close Close  

*****END OF EXERCISE*****

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Exercise No. 17 Title

CORRECTIVE FOLLOW UP

ACTION

REVIEW

AND AUDIT

 

Evaluation of proposed corrective action

 

Evaluation of the evidences provided for the closure of the nonconformities



Learning Objective



Time Allocation

Total 45 Minutes (Delegate 30 Mts | Feedback 15 Mts)

Format

Individual Exercise

Exercise Material

ISO 9001:2015 standard > Clause 10.2 (Read the clause to comprehend comprehen d the requiremen requirements ts of corrective action and audit follow-up)   follow-up) Delegates to 1. Review the evidence of the corrective actions presented by the

Delegate Instruction

auditee

2.  Review whether the requirement is in conformity with ISO 9001:2015 standard towards closing out the NCR

3.  Decide whether the corrective actions are implemented, and effectiveness of corrective action has been checked by the auditee.

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NC 1 – 1 – NONCONFORMITY  NONCONFORMITY REPORT FORM  Auditee Organization: Location:  Auditor Name:  Auditee Dept:

PART-1: NONCONFORMITY REPORT Date of audit: ddmm ddmmyy yy NCR No. 67 NCR Grade: Major /Minor /Minor

Nonconformity: ity:  Organization failed to implement risk mitigation 1) Description of Nonconform measures and related impact/s 2) Related evidence: evidence: One of the Pulley Guards was not in place on rotating belts and pulleys, which could be a cause for a hazard (Asset ID # 1234, Location of Pulley: Machine Shop: AP-1)

3) Audit Criteria: ISO 9001:2015 Clause No. 6.1. Action to address risks and opportunities   opportunities  Auditor Signature:

 Auditee Signature:

Date:

PART-2: CORRECTIVE ACTION PLAN, and IMPLEMENTATION:  A. Correction: Correction:   Company-wide mail and verbal instructions have been given to follow strictly the machinery safety measures  measures  B. Root C Cause/s ause/s for NCR (identified by auditee): Since QMS is being implemented in the organization in recent days; awareness on machinery safety was not fully carried out due to oversight.  oversight.  C. Corrective action Plan (by auditee): machinery achinery safety shall be conducted conducted starting 3rd week Dec yyyy.    Awareness on m



  Training will also be conducted for Special PPEs, by 1st Week of Jan yyyy





  Monitoring of Dept effectiveness of machinery monitored by Heads starting 15 JAN safety yyyy  in same/similar workplaces shall be yyyy    Conformity to machinery safety will be reported by QMS Manager every fortnight starting 15 JAN yyyy  yyyy  



yyyy    Schedule for completion of Corrective Action Plan: 29 JAN yyyy 



D. CAP reviewed by Auditor & A Approved: pproved: (Auditor Signature): Date: ddmmyyyy E. Corrective action Implemented by auditee on: 10 JAN yyyy F. Effectiveness of implemen i mplemented ted corrective action checked by Management Appointee on: 15 JAN yyyy G.  G. Based on corrective action, ‘Change’ in procedures of a) PPEs and b) Risk management initiated: yyyyy initiated:  yyyyy H. Corrective action Completion Date: 27JAN yyyy yyyy   Page 44 of 64

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I. Objective evidence (available, to be produced by the auditee): a) Photos of Awareness Awareness programs b) Photos of covered/protected covered/protected machineries c) Photos of Signages for PPE PPE d) Record of effectiveness of Training Training J) Auditor informed by mail by the auditee on completion of Corrective action: action: 27JANyyyy PART-3: AUDIT FOLLOWUP Audit Follow-up (by auditor): 1) Corrective Action for NCR # 67 reviewed reviewed along with related Corrective Action Plan, and the corrective action implemented 2) Reviewed related objective evidences 3) In conformity with with Clause 6.1 4) NCR closed 5) Auditee to share the details of updates to Approved documented information w.r.t w.r.t Clause 4.4 and 6.1 by 27FEByyyy Signature of Auditor/with date:

01FEByyyy

Part-4: Further action taken Update of Processes (4.4), and ‘Actions to address Risks (6.1): Docum Documented ented information revised based on corrective action carried out, and updated procedures published by Documentt Control Officer and copy of mail dt. 27FEByyyy shared with auditor on Documen 25FEByyyy. Satisfactory : Checked and approved by: Audit Manager/ 28FEByyyy

ACTION BY DELEGATES: To review the above-process, and share their views as follows:  follows:  a) Above process is complete and correct: b) Above-process has defect or gap: (Please describe the gap, if any): any) : In Part 2-B and C above: Missing action: action: Clause 10.2.1.b “…evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere”. elsewhere”.   *****END OF EXERCISE*****

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Exercise No. 18

Title

Learning Outcome

Identification of Documen Documented ted information (MAINTAINED AND RETAINED) Understanding ‘which requirement in ISO in  ISO 9001:2015 requires MANDATORY documented information maintained and retained

Duration

30 Minutes

Method

Individual Exercise

Exercise



  ISO 9001:2015 Standard

Material 1. Delegates to review ALL clauses of ISO 9001:2015, and LIST the Delegate Instruction

requirements

that

require

mandatory

documented

information maintained and retained 2. This can be achieved by listing or by deve developing loping a matrix using a worksheet 3. Additionally, delegates may also iidentify dentify non-mandatory documented information (maintained and retained)  retained)   may help a business to establish conformity

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Template for Exercise 18: # 1 2

Clause # requiring mandatory Clause # requiring mandatory mandatory Documented  Documented Documented information MAINTAINED MAINTAINED   information RETAINED RETAINED   4.3 Scope 9.2 Internal audit 5.2 Policy 9.3 Managemen Managementt Review

SPECIMEN - ISO 9001-2015 Mandatory documented information A.

DOCUMENTED INFORMATION MAINTAINED  MAINTAINED   4.3 Scope of QMS 4.4.2 QMS and its processes 5.2.1 Policy 6.2.1 Objectives 8.1.e Operational Planning and Control C ontrol

B.

DOCUMENTED INFORMATION RETAINED INFORMATION RETAINED   4.4.2 QMS and its processes 7.1.5.1 Monitoring and measuring resources 7.2 Competence 8.2.3.2 Review of the requirements for products and services 8.3.3 Design and development inputs 8.3.5 Design and development outputs 8.3.6 Design and development changes 8.4.1 Control of externally provided processes, products and services 8.5.2 Identification and traceability 8.5.3 Property belonging to customers customers or external providers 8.5.6 Control of changes 8.6 Release of products and services 8.7.2 Control of nonconforming outputs 9.1.1 Monitoring, measurement, analysis and evaluation 9.2.2.f Internal audit 9.3.3 Management review outputs 10.2.2 Nonconformity and corrective action C. NON-MANDATORY DOCUMENTED INFORMATION - SPECIMEN

4.1 List of determined de termined 'External 'External and internal issues' - DULY APPROVED 4.2  List of determine 'Interested parties, and their needs and expectations' -DULY APPROVED 9.2 Procedure for Internal audit 9.3 Procedure for Management Review

**** End of Exercises-SOLUTION ****

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