Ashbrooke Quality Assurance International Limited

ISO 9000:2000 Series Foundation Training Course

        

      

 

CASE STUDY 1

ISO 9001:2008

   

Learning Objectives:

  • Understanding the ISO 9000:2000 Series,

  • Understanding structure of ISO 9001:2008.

 

Mission:        

To develop, reinforce and add focus to the delegate’s new knowledge of the ISO 9001:2008 Standard.

 

Objective of Case Study:           

  • Complete the attached Questionnaire.

 

Inputs:

STANDARDS (ISO 9001:2008)

 

Assignment:

Using the Questionnaire below, complete the following tasks:

a) read each question,  

b) click the answer at the beginning letter of the question to determine your result.

 

QUESTIONNAIRE  

Solutions

 

1.         A supplier is an

a) organization or person who owns the organization

b) organization or person who provides a service or product to the organization

c) organization who delivers products to customers

d) organization who provides at least $1000 of products or services per year

   

2.         The Standard series permits Certification Bodies / Registrars to certify organizations to

a) ISO 9000:2005

b) ISO 9001:2008

c) ISO 9002:2000

d) ISO 9004:2000

e) any of the above

 

3.         The Standard series requires organizations to

a) submit written requests to current clients before being allowed to upgrade to the  standard

b) declare precisely their scope of activities and declare precisely any relevant operational omissions

c) rewrite its documented system

d) submit to Registrars new applications for certification

 

4.         Customer satisfaction in the  standard

b) has become a formalized requirement for organizations

c) is not relevant as this is a quality management system standard only

d) can be omitted by an organization as a compliance requirement as the series permits the organization to customize its use of the Standard

  

5.         Continual improvement in the Standard

a) has become a formalized requirements for organizations

c) is not relevant as this is a quality management system Standard only

d) really means ‘say as you do, and do as you say’  

6.         Continual improvement in the Standard

a) is limited to the product service only

b) requires organizations to establish processes for understanding what their various processes are all about

c) is more a spiritual and cultural experience and phenomenon

d) is largely an understood process already

 

7.         The ‘Consistent Pair’ concept

a) is only applicable to organizations that have design activities

b) can only create confusion as nobody has ever needed it before

c) is designed to create a harmony between quality management system requirements and improvement of performance from within

d) is a name of a constellation in the night skies (Northern Hemisphere)

 

 8.        ISO 9000:2000 Series introduces for the first time

a) a list of international consultants and consultancies qualified to assist in its implementation

b) a quality management system process model

c) a platform in which true universal international recognition can be established

d) a governing body at the ISO to oversee the proper using of the standard (Note:  The ISO has given the body its authority commencing January 1, 2002)

 

9.         Top Management shall ensure that the quality policy

(NOTE: select the response below which is INCORRECT)

a) is appropriate to the purpose of the organization

b) provides a framework for establishing and reviewing quality objectives

c) is adjustable so that the needs and expectations of the customer on a customer-by-customer basis can be met

d) includes commitment to comply with requirements and continually improve the effectiveness of the quality management system

10.       The Quality Manual shall include

(NOTE: select the response below which is INCORRECT)

a) a description of the interaction of the processes of the quality management system

b) the documented procedures established for the quality management system, or reference to them

c) a description of responsibilities and authorities, including a list of sample authorized signatures

d) the scope of the quality management system, including details of and justification for any exclusions

 

11.       The Management Representative is a person

a) responsible for everything that goes wrong in the system

b) responsible for ensuring the promotion of awareness of customer requirements throughout the organization

c) responsible for personally training all persons the meaning of quality

d) responsible to no others as this individual is also the most senior level manager in the organization

 

12.       Training needs in the Standard

a) are set to increase the education levels of all employees

b) introduces a requirement for ensuring competence of personnel

c) can be satisfied through self-declaration of skills abilities (NOTE: this applies to practical skills only)

d) are defined such that persons responsible and authorized for affecting quality have direct hands-on quality experience

 

13.       ISO 9001:2008 identifies work environment factors as

a) being the responsibility of ISO 14001 (Environmental Management System)

b) being not a factor for ensuring quality product

c) being needed to achieve conformity of product

d) being a compulsory by January 1, 2001 (Reference the RIO Conference recently completed on July 14, 1998)

 

14.       Product Realization disciplines in ISO 9001:2008 are

a) interpreted in ISO 9004:2000

b) precisely the same as the ISO 14001:2004 Standard

c) driven by the customer requirements

d) optional as the revised Standard permits an organization to omit components of the Standard that are not applicable (this omission is acceptable as long as the organization declares it on their registration certificate)

  

15.       The organization shall

(NOTE: select the response below which is INCORRECT)

a) determine quality objectives for the product, project or contract

b) establish processes and documentation, and provide resources and facilities specific to the product

c) permit the customer to verify that the process management controls are sound and truly representative of its needs and expectations

d) verify and validate activities, and the criteria for acceptability

16.       The process of understanding customer requirements shall include

(NOTE: select the response below which is INCORRECT)

a) overall value of the product to be provided

b) statutory and regulatory requirements related to the product

c) requirements not stated by the customer but necessary for specified use or known and intended use

d) customer requirements for delivery and post-delivery activities

 

17.       Contracts and orders must be

a) reviewed to ensure the organization has the ability to meet defined requirements

b) received in hard copy form prior to processing

c) reviewed to ensure the organization is able to profit in the contract or order assuring a process of perpetuity in customer support, services and most importantly continual improvement

d) both answers a) and c) above

 

18.       Property owned by the customer can

a) be identified as such using the Standard mandates for product identification and traceability

b) include intellectual property if so present and required

c) be released first for use by the customer (Evidence of release shall accompany the product)

d) include process controls for reporting to the customer its use and/or consumption; this includes rates of consumption, remaining product and acceptance of the end product  

 

19.       The organization shall control production and service operations through

(NOTE: select the response below which is INCORRECT)

a) the availability of information that describes the characteristics of the product

b) the availability of work instructions

c) establishing and maintaining process procedures that focus on specific customer related and improvement issues (These procedures must be approved by the customer prior to implementation)

d) the implementation of monitoring and measurement

 

20.        Product processes where the resulting output cannot be verified by subsequent measurement or monitoring

a) are not permitted as all processes can be verified somewhere

b) shall be validated to demonstrate the ability of these processes to achieve planned results

c) are validated by the Registrar at periodic surveillance visits

d) shall be validated using Certificates of Conformance forms (These forms shall be controlled through the Document and Data Control disciplines)

 

21.        Monitoring and measurement of system performance shall be

a) followed as interpreted in ISO 9004:2000

b) set up as an integral part of the system so that no specific processes are required as being defined

c) established with customer satisfaction as one measure of system output

d) established with internal audits as one measure of system output

 

22.        The organization shall

a) analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system

b) periodically invite the customer to review and comment on the processes established for meeting the customer needs and expectations

c) periodically invite the customer to audit its organization with particular focus on customer satisfaction and continual improvement issues

d) periodically rotate into its system new and improved processes designed to enhance the levels of customer satisfaction

 

23.        Monitoring and measurement activities by the organization include

 (NOTE: select the response below which is INCORRECT)

a) applying suitable methods for monitoring and measurement of quality management system processes

b) applying suitable methods for monitoring and measurement of the characteristics of the product

c) applying suitable methods for monitoring and measurement of success in meeting product provision targets including deliveries, profit margins, percentage defectives

d) using monitoring and measurement results to maintain and/or improve quality management system processes

 

24.        Improvement processes established and maintained by the organization

 (NOTE: select the response below which is INCORRECT)

a) must address corrective action for eliminating the causes of nonconformity by preventing recurrence

b) must address preventive action for eliminating the cause of potential nonconformities to prevent occurrence

c) must address continual improvement of the quality management system

d) must address customer care questionnaires ensuring required feedback activities and associated actions

 

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