QM Unit 2

Question 1

Remember the paths to quality, the third step ‘Assurance’, what does it mean?

Answer 1

You organize activities and functions to aim for high quality according to the requirements. This will require a QMS to be implemented.

Question 2

What was the evolution fining out was needed in the assurance-step?

Answer 2

That we cannot only evaluate the final product, we must control the whole process and prevent defects from happening. Good for both internal efficiency and external trust - compliance to customer. ISO 9001 was initiated.

Question 3

Standardization

Answer 3

Developing norms for repeating situations, not law but regulation you should follow.

Question 4

ISO

Answer 4

International Organization for Standardization. They are making the norms on the international level. Not a certification body.

Question 5

CEN

Answer 5

European Committee for Standardization - the european level for these norms.

Question 6

AENOR

Answer 6

Spanish Association for Standardization and Certification. National level.

Question 7

Standard/norm:

Answer 7

Document establishing requirements, specifications and guideline to ensure that materials, products, processes and services are fit for their purpose. These must be approved on either the national, european or international level.

Question 8

Certification

Answer 8

Action by an independent party stating that the product or business is in conformance with a specific standard/document.

Question 9

Accreditation

Answer 9

Formal declaration issued by a body (ex Ministry) to make another body approved to do certificates.

Question 10

The hierarki of the bodies making the certification possible:

Answer 10

1. Public administration - ex Ministry of Industry
2. Accreditation body - approved by the ministry, ex ENAC (national)
3. Certification body - have got their license from the a- body and can therefore do certificates.
4. Certified organization - Organization XYZ, a company gets the certificate IF their QMS is good enough for the ISO standards.

Question 11

Definition of “system”

Answer 11

Set of interrelated or interacting elements

Question 12

Management System (MS)

Answer 12

Same as system but now within an org to establish policies and objectives and processes to reach goals. A MS within a company can contain many different systems such as QMS, environmental MS, financial MS etc.

Question 13

Quality management system (QMS)

Answer 13

The part of a MS that is related to improve quality. Here, most of the companies are using the ISO standards.

Question 14

Definition of “requirement”

Answer 14

The need or expectation that is stated for example in a norm/standard.

Question 15

Definition of “process”

Answer 15

Interrelated or interacting activities which uses inputs to provide an expected result. Ps. inputs to a process is generally outputs of processes. Processes in an org is often planned and carried out under controlled conditions to add value.

Question 16

Def of “procedure”

Answer 16

Specified way to carry out an activity or process.

Question 17

Three important steps in QMS

Answer 17

It must be planned, controlled and improved.

Question 18

6 common dimensions of standards

Answer 18

1. Geographical scope
2. Standardizing body
3. Activity sector
4. Organizational scope
5. Certifiability
6. Content

Question 19

Is ISO a serie of product standards or a guarantee of a product quality?

Answer 19

No, ISO is not focusing on the product itself or ensuring a level of quality, is it just standards and requirements for a quality MS that companies can implement to increase internal efficiency and meet the customer needs better.

Question 20

ISO 9004

Answer 20

A MS for managing and sustain the success of an org (an approach to QM).

Question 21

ISO 9000

Answer 21

Is stating all the terms and principles to the ISO 9000 family. Like a basic floor that you can build systems upon. The 7 QM Principles are listed here.

Question 22

The 7 principles of QM:

Answer 22

1. Customer focus - meet their expectations.
2. Leadership - managing the employees.
3. Involvement of people - involve all your competent and committed people, they are important for the process.
4. Process approach - most efficient results will be achieves if all processes/activities are interrelated.
5. Improvement - continuous focus.
6. Fact-based approach to decision-making - decisions based on analysis of data.
7. Relationships management - stakeholder relations for sustained success.

Question 23

Fewer principles in 2015 version?

Answer 23

Yes from 8 to 7, where the process approach became one instead of two similar.

Question 24

ISO 9001

Answer 24

The body of the main MS of the ISO 9000 family. Setting the standards and requirements that the company must comply with to achieve the certificate.

Question 25

The evolution of ISO 9001:

Answer 25

First published in 1987 and were at first 3 different 9001, 9002 and 9003 which were very specific ones. So in 2000 the 9000 family was created and these are more generic ones that all types of companies can implement. In 2008 they did a new review, increasing compatibility with ISO 14001 (environment). AAAANNNDDD then at last the 2015 fourth revision: - HLS - PDCA + process map - Risk management (SWOT) + preventative actions.

Question 26

Were the preventative actions taken away?

Answer 26

No, they were just relocated and infused into the risk management part instead of being a part alone.

Question 27

Why is leadership an important aspect of the implementation if ISO 9001?

Answer 27

It is important because the leaders are the ones managing the company and they must take responsibility for internalizing the system throughout the whole org. and make sure that the employees understand it, are trained and motivated.

Question 28

How is the auditing done?

Answer 28

The auditor looks at the company's documentation and evidences of what is done and evaluate this objectively. Then decides if the ISO-requirements are met.

Question 29

Three main actors in the auditing:

Answer 29

1. The auditee - receiving the audit. 2. Client of the audit - the one asking for the audit to be done. 3. Auditor - the part that performs the audit/evaluation.

Question 30

3 different types of audit:

Answer 30

1. First party: internal audit where the org decides to do it and also performs it by themselves. Just to improve internal efficiency. 2. Second party audit: another org ask for my company to do an audit (ex to see if they can work/trade with me) and it is the other org that performs it. 3. Third ,party audit: A company reach out to an external auditor (certification body) to make an audit, and then ask for a certificate.

Question 31

What is the auditing searching for? (both internal/external)

Answer 31

It is searching for non-conformities so that the company can make corrective actions in these areas. But the external also aim to provide evidence of the org commitment to quality.

Question 32

Auditing steps:

Answer 32

1. Preparing audit 2. Audit execution 3. Audit report 4. Final report, levels: - unconditionally approved (get the certificate) - conditionally approve (need to do some corrective actions) - unconditionally disapproves - need to go through the whole system again.

Question 33

For how long will the certificate last?

Answer 33

3 years, then you have to ask for a new one, renew it.

Question 34

Describe the whole implementation process step by step: (9)

Answer 34

1. Analysis: Q evaluation (consultant maybe) 2. Data gathering and activities planning 3. Declare the org's Q. 4. Elaborating specific procedures. 5. Elaborating manual. 6. Elaborating technical instructions. 7. QMS implementation. 8. Evaluation: Quality audit. 9. Certification by an accredited certification body (this last step is not included in the implementation process).

Question 35

Motivations to implement:

Answer 35

* External factors: clients, competitors, society. | * Internal factors: culture and organizational structure.

Question 36

Is economic performance a benefit that comes with the implementation of ISO?

Answer 36

No, there is no such evidences. There are a lot benefits regarding customer satisfaction but improving the economic performance is not proven.

Question 37

What is the S-curve model trying to say?

Answer 37

It is a model (that is true for the ISO 9001 certificates) stating that there are four different stages in the evolution of a standard. 1. Initial stage - the standard is initiated and not so known yet. 2. Taking-off stage - certificates are increasing due to diffusion. 3. Saturation stage - it stagnates most already have it. 4. Decertification stage - the benefit of renewing it is not as big as before and the internalization is already done so many companies save that extra cost. Also, they might want to implement a more sector specific standard instead.

Question 38

Diffusion analysis in three views:

Answer 38

1. Factors - reasons why ISO has been spread over the world such as FDI, exports, governmental support etc. 2. Scope: the ISO can spread from being only a national standard to become international. 3. Model: S-curve showing the life of a standard.

Question 39

How deep the internalization of the standard is done is dependent on?

Answer 39

The main driving motivation to implement the standard - if it is mostly internal factors - then the internalization will be very sophisticated.

Question 40

ISO 10 000 family

Answer 40

A family of standards concerning the customer satisfaction, ex complaints handling (10002).