iqa learning session-01

7/27/2019 IQA Learning Session-01

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Internal Quality Auditors

Learning Sessions


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Table of Content

1. Auditing the Design and DevelopmentProcess

2. Auditing Customer Communication

3. Auditing Competence and Effectiveness ofActions Taken

4. Audit Finding Evaluation


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Auditing the Design and Development ProcessISO 9001:2008 clause 7.3

Meaning:

refers only to design and development ofproducts and services.

not design and development of processes,although it can be beneficial to apply the

methodology of clause 7.3 to the latter.


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What isProduct Design and Development?

Product RequirementSpecified Product

Characteristics

i.e. specifications, statutoryrequirements and specific orimplied customer requirements

distinguishing features of theproduct

Transform

into


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Examples of product characteristics ISO 9000:2005 clause 3.4.1

1. Physical (e.g. mechanical, electrical, chemical orbiological characteristics)

2. Sensory (e.g. related to smell, touch, taste, sight,hearing)

3. Behavioral (e.g. courtesy, honesty, veracity)4. Temporal (e.g. punctuality, reliability, availability)5. Ergonomic (e.g. physiological characteristic, or

related to human safety)6. Functional (e.g. maximum speed of an aircraft)


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How to evaluate if exclusion of 7.3 iscorrect?

Establish who is responsible for defining thecharacteristics of product or servicetogether with how and when it is carried out.

ISO 9001:2008 Clause 1.2 Application

are not acceptable unless these exclusions are limited

w/in Clause 7, and such exclusionsdo not affect theorganizations ability, or responsibility, to provideproduct that meets customer and applicable statutoryand regulatory requirements.


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Each stage has specific deliverables that cover both the commercial and technical aspects of

design and development of a product. In some cases, organizations might be able to justify the

exclusion of certain sub-clauses or individual requirements from their QMS without necessarily

excluding the entire clause.


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How to start?

Establish what design and developmentprojects have been, and are currently being

undertaken.= select a sufficient number of projects to be able to audit all stages ofthe design process


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How to evaluate if there is on-goingD&D activity?

Validate by:

Ensuring that no changes have been effected to theprevious design

Reviewing relevant documents and records such as:1. Relevant document to find out whether any amendment has

been issued during the review period.

2. Customer feedback to find out whether any design-relatedcomment has been received and auditee has takenappropriate action.

3. Nonconformity reports to find out whether any design-related NCs have been recorded.


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Records that we can take a look at

7.3.2 Design and development inputs relating to productrequirements

7.3.4 Results of design and development reviews and any necessaryactions

7.3.5 Results of design and development verification and anynecessary actions

7.3.6 Results of design and development validation and any

necessary actions

7.3.7 Results of the review of design and development changes andany necessary actions


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Auditing the need for design & development

Triggering factors:

the organizations strategic planning; market intelligence and research; service reports; customer feedback and demand; new or changed statutory and regulatory

requirements;

process changes; new technology; suppliers.


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(7.3.1) Auditing design and development planning

ISO 9001:2008 Clause 7.3.1

The organization shall plan and control the design and development ofproduct.

During the design and development planning, the organization shalldetermine

a. The design and development stages,b. The review, verification and validation that are appropriate to each

design and development stage, andc. The responsibilities and authorities for design and development.

The organization shall manage the interfaces between different groupsinvolved in design and development to ensure effective communication andclear assignment of responsibility.

Planning output shall be updated, as appropriate, as the design and

development progresses.


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ISSUES to CONSIDER:

what is the overall flow of the design planning process? how is it described? what resources and competencies are required? what part of the design will be outsourced? who is responsible and are the authorities defined? how are (internal and external) interfaces between various

groups identified and managed? are the required verification, validation and review points

defined?

are the main milestones and timelines identified? is the implementation and effectiveness of the plan monitored? is the plan updated and communicated to all relevant functions

as necessary?


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(7.3.2) Auditing design and development inputs

ISO 9001:2008 Clause 7.3.2

Inputs relating to product requirements shall be determined andrecords maintained. These inputs shall include

a) Functional and performance requirementsb) Applicable statutory and regulatory requirementsc) Where applicable, information derived from previous similar

designs, and

d) Other requirements essential for design and development.

The inputs shall be reviewed for adequacy. Requirements shall becomplete, unambiguous and not in conflict with each other.


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When auditing the design and developmentinputs, auditors should develop an understandingof how the organization identifies its owninputs based on:

the organizations products and processes; financial, environmental, health and safety issues; organizational risks and impacts;

customers requirements and expectations; statutory and regulatory requirements applicableto the product .


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Auditors should

evaluate the risks,

the possible implications for customersatisfaction, and

issues that the organization may encounter if

some relevant inputs are not considered.


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(7.3.3) Auditing design and development outputs

ISO 9001:2008 Clause 7.3.3

The outputs of design and development shall be in a form suitablefor verification against the design and development input and shallbe approved prior to release.

Design and development outputs shall

a) Meet the input requirements for design and developmentb) Provide appropriate information for purchasing, production and

service provision,

c) Contain or reference product acceptance criteria, andd) Specify the characteristics of the product that are essential for

its safe and proper use.

Note: Information for production and service provision can include detailsfor the preservation of products.


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D&D outputs should comply with the identifiedneeds in order to ensure that the resulting productcan fulfil its intended use. Outputs can include

information relevant to the following: marketing, sales and purchasing;

production;

quality assurance;

information for service provision and maintenance ofthe product after delivery

and, should be provided in a form that enablesverification and validation activities to be performed.


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Auditors should obtain evidence from theprojects selected to confirm that:

information regarding the completion of design anddevelopment stages is available;

the design and development process has beencompleted for the stage under review;

design and development outputs have beenconfirmed


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(7.3.4) Auditing the design and developmentprocess and design reviews

ISO 9001:2008 Clause 7.3.4

At suitable stages, systematic reviews of desig and developmentshall be performed in accordance with planned arrangement (see7.3.1)

a) To evaluate the ability of the results of the design anddevelopment to meet requirements, and

b) To identify any problems and propose necessary actions.

Participants in such reviews shall include representatives offunctions concerned with the design and development stage(s)being reviewed. Records of the results of the reviews and anynecessary actions shall be maintained.


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(7.3.4) Auditing the design and development process anddesign reviews

Auditors should

verify that the overall design and development

process is controlled in accordance with theorganizations original plan being reviewed

the design and development reviews take place

at appropriate planned stages

Participated by representatives fromconcerned/related functions


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(7.3.4) Auditing the design and developmentprocess and design reviews

The following issues should be considered by auditors whenexamining the review process:

do reviews occur at planned stages throughout the design process? are the reviews carried out in a systematic way involving

representatives of the functions concerned with the stage(s) beingreviewed?

have all original and any new inputs been considered ? are the original outputs still relevant or have revised outputs been

identified? have revised inputs and outputs been reviewed and approved by

those with the relevant responsibility and authority (including the

customer where appropriate)? does the output demonstrate the suitability, adequacy andeffectiveness of the designed product?

are the relevant design objectives being achieved? are there adequate records of reviews?


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(7.3.5) Auditing design and developmentverification

ISO 9001:2008 clause 7.3.5

Verification shall be performed in accordance

with planned arrangements (see 7.3.1)to ensurethat the design and development outputs havemet the design and development inputrequirements. Records of the results of theverification and any necessary actions shall bemaintained (see 4.2.4)


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Design and development verification is aimed at providingassurance that the outputs of a design and development activityhave met the input requirements for this activity as shown inFigure 2 below.


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Verification can comprise activities such as:

performing alternative calculations;

comparing a new design specificationwith asimilar proven design specification; undertaking demonstrations including

prototypes, simulations or tests; and, reviewing documents prior to issue.


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Auditors should determine that the design and development verificationactivities should provide confidence that:

required verifications are planned and that verification is performed asappropriate during the design and development process;

the completed design or development is acceptable and the results are

consistent with and traceable to the initial requirements; the completed design or development is the result of implementation ofa proper sequence of events, inputs, outputs, interfaces, logic flow,allocation of timing, etc;

the design or development provides safety, security, and compliancewith other requirements and design inputs;

evidence is available to demonstrate that the verification results andany further actions have been recorded and confirmed when actions arecompleted.

Auditors should determine that only verified design and developmentoutputs have been submitted to the next stage, as appropriate.


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(7.3.6) Auditing design and developmentvalidation

ISO 9001:2008 Clause 7.3.6

Design and development validation shall be performed in

accordance with planned arrangements (see 7.3.1) toensure that the resulting product is capable of meetingthe requirements for the specified application orintended use, where known. Wherever applicable,validation shall be completed prior to the delivery or

implementation of the product. Records of the resultsof validation and any necessary actions shall bemaintained (see 4.2.4).


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(7.3.6) Auditing design and developmentvalidation

confirmation by examination, provision of evidence, that the particular

requirements for specific intended use are fulfilled.

Is the validation process capable of checking that thefinal product and/or service will meet, or does meet,the customers needs when it is in use ?

Validation methods should be specified as part of thedesign and development planning process, althoughthese could be modified during the realization ofdesign and development.


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(7.3.7) Auditing design and development changes

Changes to design and development shall be:

Identified

Reviewed Verified and validated, as appropriate

Approved before implementation

Records maintained


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Review of changes shall include:

Evaluation of the effect of the changes on

constituent parts and product and productsalready delivered

Maintain records of the results of review and

any necessary actions


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Design and development changes made during the design processneed to be controlled.

Auditors should consider the following :

are the sources and requests for changes properly identifiedand communicated? is the impact of any change evaluated? is any additional design proving or testing undertaken where

appropriate? are the effects of the changes on constituent parts and product

already delivered evaluated? has appropriate approval been given before a change is

implemented (this could include statutory or regulatory approvalor approval by the client)?

are the changes fully documented and do records includeinformation regarding any necessary additional actions?


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KEY POINTS IN SUMMARY

1) Plan design activities,

2)Determine the requirements,

3)Execute the initial design,4)Test the design to see if it met requirements,

5)Change the design if you have to until you can confirmyou met the requirements,

6)Document the process, specs and changes, and7)Get the customer to confirm it's what they wanted.


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End of Session 1


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Importance of Customer Communication


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Guidance from ISO 9004:2000(clause 7.2)

Processes related to interested parties

Management should ensure that the organization hasdefined mutually acceptable processes forcommunicating effectively and efficiently with itscustomers and other interested parties. Theorganization should implement and maintain suchprocesses to ensure adequate understanding of the

needs and expectations of its interested parties, andfor translation into requirements for theorganization


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Verifying the effectiveness of customer

communications

Verifying the effectiveness of customer communication is therefore acritical component for achieving customer satisfaction. Although thereis no specific requirement in ISO 9001:2000 for a documentedprocedure, depending on the size, complexity and culture of theorganization it may be necessary to have one in order to ensureeffective implementation of the customer communication process.

ISO 9000 defines the term customer as the recipient of the product.It further gives examples of customers including the end user.

Many organizations sell their products / services through dealers andretailers and may not be receiving orders directly from the end users.It is important for the auditor to verify how the organization

communicates about the quality of its product / service to the endusers and also the mechanism for obtaining a feedback (besidescomplaints) from the end users. It should be recognized that the needsof the dealers / retailers may at times be different from those of theend users.


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The auditors approach - 3

Verify the product information to confirm that it isreadily available to customers or potential customersand provides information that is up-to-date andaccurate.

Query/take a look into, for example, how oftenadvertising material, web sites and productcatalogues are reviewed to reflect the organizations

current product offerings and services and whatmeasures are taken if a particular product is modified,discontinued or no longer available.


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Some or all of the following means of an organizations specificcustomer communication may be observed by the auditor:

Enquiries, contracts or order handling, including amendments

quotations

order forms confirmation of order amendment to order delivery documentation invoices credit notes e-mail & general correspondence visit reports or notes to/from customer

Customer feedback and complaints management process

Letters in response to complaints

Acknowledgments


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There are also further instances where the auditorwill experience the organizations communication withthe customer:

During the ordering process where the customer provides no

documented statement of requirement, the organizationneeds to have a system in place to obtain or confirm thesecustomer requirements before the organization accepts theorder.

During the design/development process there may beconsiderable communication between the organization andthe customer.

During the process of authorizing the use of non conformingproduct by release or acceptance under concession by a

relevant authority and, where applicable, by the customer


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The auditor would use normal trace methodsto verify compliance with the customer

communications requirements of ISO 9001and whether the organization communicatedeffectively with the customer in theexecution of the enquiry, contract or order.


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Auditing Competence and

Effectiveness of Actions Taken


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ISO 9001:2008 Clause 6.2.2 :Competence, training and awareness

The organization shall:

a) Determine the necessary competence for personnelperforming work affecting conformity to product requirements,

b) Where applicable, provide training or take other actions to

achieve the necessary competence,c) Evaluate the effectiveness of the actions taken,d) Ensure that its personnel are aware of the relevance and

importance of their activities and how they contribute to theachievement of the quality objectives, and

e) Maintain appropriate records of education, training, skills andexperience (see 4.2.4).


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h d d


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Things an organization needs to do tosatisfy the requirement

Identify what competencies are required by personnelperforming work which affects quality

Identify which personnel already performing the work have therequired competencies

Decide what additional competencies are required

Decide how these additional competencies are to be obtained training of personnel (external or internal), theoretical orpractical training, hiring of new competent personnel, assignmentof existing competent personnel to different work

Train, hire or reassign personnel

Review the effectiveness of actions taken to satisfycompetence needs Periodically review competence of personnel


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Other things to consider..

Throughout the process, the organisation isrequired to maintain appropriate records ofeducation, training, skills and experience.

However, ISO 9001:2000 does not specifyhow the process will be established or theexact nature of the records to be maintained.


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Issues that would be looked into

1. An organisation needs to identify what competencies are required bypersonnel performing work that affects quality.

Guidance - The objective of the auditor should be to determine whether thereis a systematic approach in place to identify these competencies and to verifythat the approach is effective. The outcome of the process may be a list,register, database, human resources plan, competencies development plan,

contract, project or product plan, etc. Discussions could initially be held with top management to ensure they

understand the importance of identifying the competencies required. These mayalso be a potential source of information regarding new or changed activities orprocesses, which may lead to different competency requirements in theorganization.

A review of competencies might also be needed when a new tender or contract is

being considered. Evidence of this could be found in related records.Competence requirements may be included in contract documents where theactivities of subcontractors can have an impact on processes and/or productquality characteristics.

Auditors need to determine whether the organisation has identified new orchanged competence needs during surveillance audits.


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2. Are competent people assigned to those work place activitiesnecessary to control the quality characteristics of its processes andproducts?

Guidance - Verify that some form of evaluation process is in place toensure that the competencies are appropriate to the organization'sactivities, and that the personnel selected as competent aredemonstrating these competencies. Also, the process should ensurethat any deficiencies are being acted upon and the effectiveness ofpersonnel is being measured. Verify that the activities that affectquality are performed by persons selected as competent.Evidence maybe obtained throughout the audit with an emphasis on those processes,activities, task and products where human intervention may have thegreatest impact. The auditor may review job descriptions, testing or

inspection activities, monitoring activities, records of managementreviews, definition of responsibilities and authorities, nonconformityrecords, audit reports, customer complaints, processes validationrecords etc.


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3. The organization needs to evaluate the effectiveness of theactions taken to satisfy the competence needs

Guidance - The organization may use a number of techniquesincluding role-play, peer review, observation, reviews of training andemployment records and/or interviews (see ISO 19011, Table 2, for

further examples). The appropriateness of a particular evaluation method will depend

on many factors. For example, training records could be viewed to verify that a training

course had been successfully completed (but note, this alone would notprovide evidence that the trainee is competent).

However, this same method would not be acceptable to evaluatewhether an auditor performed satisfactorily during an audit.

Instead, this may require observation, peer review, interviews, etc..The organization may need to demonstrate the attainment ofcompetence of its personnel through a combination of education,training and/or work experience.


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4. Maintenance of competence.

Guidance The auditor needs to verify that some form of effectivemonitoring process is in place and being acted upon.

Ways of doing this include a continuing professional development process (such as the one described in

ISO 19011),

regular appraisals of personnel and their performance, or

the regular inspection, testing or auditing of product for which individuals orgroups are responsible.

Ongoing changes in competence requirements may indicate that anorganization is proactive in maintaining personnel performance levels.


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Guidance from ISO 9004:2000

6.2.2.1 Competence

Management should ensure that the necessary competence is available forthe effective and efficient operation of the organization. Managementshould consider analysis of both the present and expected competenceneeds as compared to the competence already existing in theorganization.

Consideration of the need for competence includes sources as- Future demands related to strategic and operational plans and

objectives- Anticipated management and workforce succession needs- Changes to the organizations processes, tools and equipment,- Evaluation of the competence of individual people to perform defined

activities, and- Statutory and regulatory requirements, ad standards, affecting the

organization and its interested parties.


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To support the achievement of the organizations objectives andthe development of its people, planning for education andtraining should consider:

- Experience of people- Tacit and explicit knowledge- Leadership and management skills- Planning and improvement tools- Teambuilding- Problem solving- Communication skills- Culture and social behavior

- Knowledge of markets and the needs and expectations ofcustomers and other interested parties, and

- Creativity and innovation.



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Training plans should include:- Objectives,- Programmes and methods,- Resources needed,- Identification of necessary internal support,- Evaluation in terms of enhanced competence of people, and- Measurement of the effectiveness and the impact on the

organization.

The education and training provided should be evaluated in termsof expectations and impact on the effectiveness and efficiencyof the organization as a means of improving the future trainingplans.


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How do you determine the necessary competence of our staff?

How do you handle new staff? Introduction plans?

In what areas do you need to elevate competence? In what way?

How do you evaluate the effectiveness of the actions taken?

Are your staff aware of the intent of your quality policy, qualityobjectives and how they contribute to fulfilling them?

Do you have the infrastructure you need?

Is the work environment good enough? How about the moodamong the staff?


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Audit Finding Evaluation

S i 1


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Scenario 1 :Customer property (intellectual property) controlled by a bank

Situation:

A bank provides a variety of services to its customers (i.e. personaland company bank accounts), but chooses to implement a QMS onlyfor its Internet banking services. For this service the bank hasclaimed conformity to ISO 9001:2008. The bank clearly states in

its Quality Manual which services are covered by the QMS. Thebank applies all the requirements of ISO 9001:2008 for therealization of its Internet banking services, with the exception ofsub-clause 7.5.4 Customer property. The bank does not feel that ithas possession of any customer property as part of its Internetbanking services and has stated this in the justification for theexclusion of sub-clause 7.5.4 Customer propertyfrom its QMS.

Issue(s):

Can the bank exclude sub-clause 7.5.4 Customer propertyfrom itsQMS and claim conformity to ISO 9001:2008?

S i 2


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Scenario 2 :Exclusion of design and development by a contract manufacturer

Situation:

XYZ Electronics is building a new factory to perform manufacturing ofmobile phones, as a subcontractor. It has only one customer and thiscustomer maintains responsibility and authority for product design.XYZ Electronics is responsible for purchasing of all components and forperforming the manufacturing activities. The customer provides XYZ

with the manufacturing and parts specifications, and is also responsiblefor notifying XYZ of any design changes and providing the appropriatechange information.

XYZ Electronics, in the development of its QMS, has excluded therequirements of ISO 9001:2008 sub-clause 7.3 Design and development.XYZ Electronics considers the customer specifications as a customer

supplied product and therefore controls this according to ISO9001:2008 sub-clause 7.5.4 Customer property.

Issue(s):

Can the XYZ Electronics exclude sub-clause 7.3 Design and development

from its QMS and claim conformity to ISO 9001:2008?

S i 3


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Scenario 3 :

Regulators permit the exclusion of design development

Situation:

KML designs and fabricates pressure vessels for electricitygenerating stations, in accordance with various mandatory pressurevessel regulations.

The regulatory authority has not yet revised its requirements totake ISO 9001:2008 into account, but has confirmed that it willcontinue not to require manufacturers QMSs to include design. Onthis basis KML decides to exclude sub-clause 7.3 Design anddevelopment from its QMS and to claim conformity to ISO9001:2008.

Issue(s):

Can KML exclude sub-clause 7.3 Design and developmentfrom itsQMS and claim conformity to ISO 9001:2008?

Scenario 4 :


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Scenario 4 :

Outsourced design and development activities

Situation:

CDH Construction Ltd. provides engineering and construction services for variousdevelopers, but does not have in-house design capabilities. The company employsa project manager who is responsible for the management of design activities.These activities are outsourced to TPL Engineering Ltd, an engineering consultingcompany.

The activities of TPL Engineering Ltd. are managed through the application ofthe requirements of sub-clause 7.4 Purchasing. The project manager of CDHConstruction Ltd. oversees the design activities and is involved in design reviewmeetings and design verification and validation activities. In addition, theproject manager is responsible for ensuring that the design activities arecarried out in accordance with the requirements of ISO 9001:2008 sub-clause7.3 Design and development. However, CDH Construction Ltd. has excluded sub-clause 7.3 Design and developmentfrom its QMS, since the design activitieshave been outsourced.

Issue(s):

Can CDH Construction Ltd. exclude sub-clause 7.3 Design and developmentfrom its QMSand claim conformity to ISO 9001:2008?


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Scenario 5 : Traceability

Situation:

AKP Corp. is a company that manufactures electric motors for saleby licensed distributors. Traceability of the component parts of theproduct is not an internal or external requirement of this company.

The organization has excluded the traceability requirement of sub-clause 7.5.3 Identification and traceabilityfrom its QMS, whileclaiming conformity to ISO 9001:2008.

Issue(s):

Can AKP Corp. exclude the traceability requirement of sub-clause7.5.3 Identification and traceabilityfrom its QMS and claimconformity to ISO 9001:2008?


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Scenario 6 : Design of services

Situation:

JWB is a consulting firm that performs internal audits for smallorganizations that have implemented quality management systemsthat conform to ISO 9001:2008. JWB developed its methodologyand tools for performing customers internal audits based on the

guidance of ISO 19011:2002. It delivers a customized service thathas as its output a written internal audit report and all thesupporting data from the audit. The organization wishes to excludeclause 7.3 Design and developmentwith the justification that, as aservice provider, it cannot have any design and developmentactivities.

Issue(s):

Can JWB exclude sub-clause 7.3 Design and developmentfrom itsQMS and claim conformity to ISO 9001:2008?


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Scenario 7 : Post delivery activities

Situation:

The ABC consultancy organization provides financial auditing services to largemanufacturing organizations. The product delivered to its customers is aninternal financial audit report. Contracts for internal financial audit servicesstate that a contract is completed when ABC has issued, clarified and reviewedits report with the customer, and that the customer has finally signed-off the

report as being fully agreed; any activity beyond that the sign-off would besubject to a supplementary contract. The consulting firm claims its QMSconforms to ISO 9001:2008 with the exclusion of post-delivery requirement (f)of sub-clause 7.5.1.Control of production and service provision.

Issue(s):

Can the ABC consultancy organization exclude the post-delivery requirement inbullet (f) of sub-clause 7.5.1.Control of production and service provisionfrom itsQMS and claim conformity to ISO 9001:2008?


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Scenario 8 : Validation of processes

Situation:

A small garment manufacturer carries out cutting work on textilesthat are delivered to an internal sewing department for the nextphase of the process. The quality of the output of the cutting work

can be checked after finalization of the work. It has implemented aQMS and claims conformity to ISO 9001:2008 , with the exclusionof sub-clause 7.5.2 Validation of processes for production andservice provision.

Issue(s):

Can the small garment manufacturer exclude sub-clause 7.5.2Validation processes for production and service provisionfrom itsQMS and claim conformity to ISO 9001:2008?

Scenario 9 :


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Scenario 9 :Monitoring and measuring devices

Situation:

A small training organization provides training to people who are notcurrently working and would like to upgrade their skills. Theorganization carries out practical skills training. In this process theparticipants practice the use of simple measuring equipment such asrulers, spirit levels and plumb lines. The organizations product isthe skills development, and not the crafted items produced by theparticipants. The training organization has implemented ISO 9001:2000 QMS and claims conformity to the standard with theexclusion of sub-clause 7.6 Control of monitoring and measuringdevices.

Issue(s):

Can the small training organization exclude sub-clause 7.6 Controlof monitoring and measuringdevices from its QMS and claimconformity to ISO 9001:2008.

Scenario 10 :


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Scenario 10 :Complex Organization (Global TV)

10.1 Introduction

This example illustrates some of the key issues a multinational organization withmultiple work centres faces when implementing ISO 9001:2008 throughout theentire organization.

Global TV (GTV) is an organization that designs, manufactures, sells, distributes

and services televisions (TVs) worldwide. GTV sells its product to retail outlets,which in-turn sell the TVs to end-user customers. Headquarters provides globalsupport for quality management, all purchasing functions and sales anddistribution contracts for its operations worldwide. GTV consists of a designcentre, a sub-assembly plant, a manufacturing centre and a distribution centre,all of which are wholly owned by GTV.

GTV management has decided to implement ISO 9001:2008 in all its facilities

worldwide, and expects all facilities of GTV to have their own qualitymanagement system (QMS). However, not all facilities are required to obtaincertification. In addition, all facilities have to comply with the contents of thecorporate quality policy, which is To provide customers of GTV with productsand services that meet their needs and expectations, and to continually improvethe QMS.

Scenario 10 :


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NOTE:

For the purpose of simplifying the example for a complex organization, thenumber of centres and plants has been reduced to one of each (design centre,sub-assembly plant, manufacturing centre and distribution centre).

ISO 9001:2008 allows for the exclusion of any requirement(s) within clause 7,

where such exclusions do not affect the organizations ability orresponsibility to consistently provide product that meets customer andapplicable statutory and regulatory requirements.

When applying clause 1.2 Application to a complex organization (Global TV) wehave to take into consideration the organizations customer. Global TVs ultimatecustomer is the end user who purchases the product from a retaildistributor. The customer of the individual centres and plants is the centre or

plant that receives its product (i.e., the design centres customers are the sub-assembly plant and the manufacturing centre).

Scenario 10 :


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Scenario 10 2:


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Scenario 10.2:Manufacturing Centre (MC)

Situation:

MC receives orders from headquarters and delivers products to thedistribution centre. It has established its QMS guided by, and inconformity with, the quality policy of GTV. All aspects of qualitymanagement required by ISO 9001:2008 are performed within the MC,with the sole exception of product design and development. The MCdecided to exclude Sub-Clause 7.3 Design and developmentfrom thescope of its QMS since it performs no design activities. The MC doesinclude a statement and justification in its quality manual that it isexcluding the product design and development process and furtherindicates that a) its customer is Global TV headquarters who provideorders to the manufacturing plant, and b) Global TV headquarters isresponsible for ensuring the Design Centre conforms to ISO 9001:2008.

Issue(s):

Can the MC exclude Sub-Clause 7.3 Design and developmentfrom itsQMS and claim conformity with ISO 9001:2008?


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Scenario 10.3 : Global TV

Situation:

Global TV Headquarters distributes its products through retailoutlets to the end user customer. The organization has implementedISO 9001:2008 at it headquarters and has requested that all its

facilities implement a quality management system conforming toISO 9001:2008. To date the only facility that has not implementeda quality management system is the Design Centre. In its qualitymanagement system manual Global TV headquarters states that allof its facilities conform to ISO 9001:2008 and the organization hasnot taken any exceptions.

Issue(s):

Can Global TV claim conformity with ISO 9001:2008?


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10.4 Summary

Any complex organization (such as Global TV) has to be carefulof its claim that its quality management system conforms toISO 9001:2008. The organization has responsibility for all ISO9001:2008 requirements that can affect the organizationsability to provide products that meet its customer and statutoryand regulatory requirements. Therefore, in order to claimconformity to ISO 9001:2008 at the corporate level, it has toensure that all its relevant facilities are conforming to ISO9001:2008. The organizations individual facilities may excluderequirements within Clause 7 based on a justification making itclear that their customer is another division of the corporation,and not the end-user. The certificates of conformityreferencing internal customers are of no direct value to theexternal customers of the organization.

Mandatory records required by


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Mandatory records required byISO 9001:2008 standard

4.2.1 Records determined by theorganization to be necessary to ensureeffective planning, operation and controlof processes

5.6.1 Records of management review 6.2.2 Records of education, training, skills,

and experience 7.1 Records of evidence that realization

processes and product meet requirements 7.2.2 Records of review of customer

requirements and follow-up actions 7.3.2 Records of design and development

input 7.3.4 Records of design and development

review 7.3.5 Records of design verification

actions

7.3.6 Records of design validation actions 7.3.7 Records of design changes and

results 7.4.1 Records of the evaluation of

suppliers 7.5.2 Records of special process

validations

7.5.4 Records of lost, damaged or unsuitablecustomer property 7.6 Records of the basis of calibration used

when no traceable standards exist 7.6 Records of the results of calibration 7.6 Records of assessment of product when

calibration is out of tolerance 8.2.2 Records of internal audits 8.2.4 Records of person(s) authorizing release of

product to the customer

8.3 Records of the nature of nonconformitiesand subsequent actions8.5.2 Records of the results of corrective actiontaken

8.5.3 Records of the results of preventive actiontaken

PLUS

records the organization may choose to keep

e.g. delivery notes and copies of purchase orders arenot mentioned in that list but most organizationswould want to keep them.

iqa learning session-01

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