Quality Management System Preliminary Gap Analysis

Quality Management System Preliminary Gap Analysis

Decide on a number from 0 to 5 for each item below. The scoring criteria are given in a table at the end. 1 to 5 Make notes to explain your score for future reference.

1. Have you established, documented, implemented and now maintain a Quality Management System (QMS) to any system including ISO 9001?

2. Have you identified the processes needed for your QMS and

a. the sequence of your production and service delivery processes,

b. the criteria and methods needed to ensure the processes are effective, and3. Do you have

c. have the resources and the information you need to support the processes?

d. a Quality Manual including your Quality Policy and quality objectives, and

e. written procedures and work instructions?

4. Do your records provide evidence that your business processes are effective?6. Has your Top Management communicated the importance of meeting customer and other business requirements to all the employees?9. Are your quality objectives measurable?

5. Is your Top Management committed to the development and implementation of a new QMS (i.e. based on the 2008 version of ISO 9001)?

7. Has your Top Management made a commitment to ensure your customers’ requirements are top priority?

8. Do your quality objectives include requirements for production and delivery?

10. Have the responsibilities and authorities of managers and employees been defined and communicated to them?

11. Does your management have the drive and resources needed

a. to implement, and maintain a QMS and continually improve its effectiveness, and

b. to enhance customer satisfaction by meeting customer requirements?

12. Does your organization have procedures to select competent personnel for work activities?

13. Does your organization provide training or take other action to help develop your people?

14. Does your organization provide adequate:

a. buildings, workspace and utilities,

b. process equipment, and

c. supporting services such as transport or communication?

15. When you receive a customer order do you review it for

a. requirements specified by the customer, including the delivery and post-delivery activities,

b. requirements not stated by the customer but necessary for specified use or known and intended use, and

c. statutory and regulatory requirements related to the product?

16. Do you inform your customers concerning

a. product information,

b. enquiries, contracts or order handling, including changes, and

c. channels for customer feedback and complaints?

17. Does your organization plan and control product design and development activities?

18. Does your organization maintain records of design or development review, verification and validation activities and resulting action?

19. Does your organization inspect or otherwise confirm that purchased products, materials, components and services conform to your specified purchase requirements?

20. Does your organization select suppliers depending on how important the purchased product is for production?

21. Does your organization evaluate suppliers (subcontractors or vendors) based on their ability to satisfy your requirements?

22. Do you ensure production has

a. the information that describes the characteristics of the product,

b. the necessary work instructions,

c. suitable equipment, and

d. the monitoring and measuring devices needed?

23. Does your organization regularly confirm that your production and service processes are capable of consistently meeting your requirements?

24. Are parts, components, subassemblies and products identified throughout production or service delivery?

25. Are monitoring and measurement requirements clearly shown with the status of the product?

26. Where traceability is a requirement, does production keep records of unique product identification?

27. Do you care for and protect customers’ property under your control or being used by your people?

28. Do you look after your product (including the parts or components) during both production and delivery to the customer, by providing suitable identification, packaging, storage, preservation and handling?

29. Do you have instructions needed to identify inspection or monitoring activities to be done during production or service delivery and the devices to be used?

30. Is your measuring equipment:

a. Calibrated or verified at specified intervals, or prior to use?

b. Adjusted or re-adjusted as necessary?

c. Identified to enable the calibration status to be determined?

d. Safeguarded from adjustments that would invalidate the measurement result?

e. Protected from damage and deterioration during handling, maintenance and storage?

31. Does your organization monitor customer information that shows you have satisfied customer requirements?

32. Does your organization conduct internal quality audits at planned intervals?

33. Does your organization use suitable methods to monitor and, where practical, measure the performance of your processes?

34. Does your organization inspect or measure the characteristics of finished products and record the results?

35. Does your organization identify nonconforming products and review them for disposition?

36. Does your organization collect and analyze data to assess the suitability and effectiveness of the QMS?

37. Does your organization use data to evaluate or identify where continual improvement of the QMS can be made?

38. Does your organization continually improve the effectiveness of the QMS?

39. Does your organization take corrective action to eliminate the causes of problems and to prevent their recurrence?

40. Does your organization determine and eliminate potential nonconformities in order to prevent their occurrence?

To score this table:

0 – You do not understand what is required or believe it is necessary

1 – Your organization does not perform this activity

2.- You understand this activity is a good thing to do but do not do it

3 – You do this sometimes

4 – You do this but not very well

5 – You do this quite well.

Add all the points together.

150 – 200

You are almost ready to complete your ISO 9001 QMS and apply for certification/

registration.

100 – 149

You are ready to implement the QMS. This will likely improve your business results.

0 – 99

You have a lot to do but should begin. You could consider seeking help from a

consultant or specialist.

ISO 9001 — a way of managing for conformance

Quality assurance, according to the Standard, is a way of managing that prevents non-conformance and thus “assures quality”. This is what makes ISO 9001 different from other standards: it is a management standard, not a product standard. It goes beyond product standardisation: it is standardising not what is made but how it is made. To use standards to dictate and control how organisations work was to extend the role of standards to new territory. To take such a step we might have firstly established that any such requirements worked — that they resulted in ways of working which improved performance.

Yet the plausibility of this Standard, and the fact that those who had an interest in maintaining it were (and still are) leading opinion, prevented such enquiries. In simple terms the Standard asks managers to say what they do, do what they say and prove it to a third party.

ISO 9000 (1994) paragraph 1: “The requirements specified are aimed primarily at achieving customer satisfaction by preventing non-conformity at all stages from design through servicing.”

To put it another way, the Standard asserts that preventing non-conformance achieves customer satisfaction. But does it? Of course it matters to customers that a product works. But there is no guarantee that the Standard will ensure even that. Furthermore, customers take a total view of an organisation — how easy it is to do business with — in respect of all things of importance to each and every customer.

ISO 9001 requires managers to “establish and maintain a documented quality system as a means of ensuring that product conforms to specified requirements”. Loosely translated this is “say what you do”. Management is supposed to “define and document its policy for quality . . . including its commitment to quality”.

What management would not declare its commitment to quality? But would they know what it means? Would they argue (as they should) that quality management is a different and better way to do business, or would they believe that ISO 9000 will take care of quality? The Standard encourages managers to think of “quality” and “business as usual” as separate and distinct. It helps managers avoid the revelation that quality means a wholly different view of management. Instead, the organisation “shall appoint a management representative who, irrespective of other responsibilities, shall have defined authority and responsibility” [for ISO 9000]. At a practical level this means only one executive might decide he or she had better learn a thing or two about quality. However, would being responsible for ISO 9001 lead to learning about quality or simply enforcing the ISO 9000 regime in an organisation?

Key to the regime is auditing. The Standard requires organisations to conduct internal quality audits to “verify whether quality activities comply with planned arrangements”. This can be loosely translated as “do you do as you say?” and the purpose of the audit is to see that you do. It was not until the 1994 review that the words were changed to “quality activities and related results”. It was a Standard which was rooted in the philosophy of inspection: fifteen years after its initial promulgation the promoters sought to extend the focus to results. But results or improvements assessed by what means? Inspection. By the time the Standard was adopted world-wide, quality thinking had moved a long way from the philosophy of inspection. It is now understood, at least by a few, that quality is achieved through managing the organisation as a system and using measures which enable managers to improve flow and reduce variation (which we explore in chapters 5 and 7). The defenders argue that there is nothing stopping a company having ISO 9000 and implementing methods for managing flow and reducing variation, but where are such companies? Few of the companies we researched, formally and informally, knew anything about this thinking. The Standard does not talk about it; moreover, the Standard effectively discourages managers from learning about it by representing quality in a different way.

According to ISO 8402 (quality vocabulary), quality is:

“The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.”

Everything we have learned about ISO 9000 suggests that the people who created this definition were thinking about the things which need to be controlled, those things which “bear on its ability . . .”. The builders of the Standard assumed that customer needs would be listed in contractual agreements between the supplier and customer. ISO 9000 has a “make” logic — procedures for “how you do what you do” — and a “control” logic — check to see that it is done. It is a relic of the era when contractual agreements were perceived to be an important device for regulating the behaviour of suppliers. In these ways, ISO 9000 encouraged “planning for quality”.

Planning for quality sounds plausible, but it assumes many things: that the plan is the right plan, that it is feasible, that people will “do it”, that performance will improve. It is an approach which, paradoxically, leads to poor decisions. Planners of quality systems, guided by ISO 9000, start with a view of how the world should be as framed by the Standard. Understanding how an organisation is working, rather than how someone thinks it should, is a far better place from which to start change of any kind.

FAQ In ISO 9001 Standards

FAQ In ISO 9001 Standards

This list of Frequently Asked Questions (FAQs) has been prepared by ISO/TC 176/SC 2 to support the publication
of ISO 9001:2008 and the revision of ISO 9004. Input has been obtained from experts and users of the ISO 9000 standards, expressed during seminars and presentations around the world.
The list will be reviewed and updated on a regular basis to maintain its accuracy, and to include new questions where appropriate. It is intended that this list will also provide a good source of information for new users of the standards.

ISO 9000 Standards Training DVD

ISO 9000 Standards Training DVD
The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.

A company can maintain a relationship with customers, as well as get increased business through complying to the ISO 900 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.

The Introduction to ISO 9001:2008 DVD covers 3 major areas, which will help companies in the process of implementing ISO 9000 Standards. It consists of:

First, to describe some basic information on ISO 9000 Standards. It will specifically refer to ISO 9001:2008 Standards. The video will explained on topic like what is ISO 9000 Standards, The origin, history & evolution, Series of ISO 9000, version & certification in ISO 9000 Standards.

Then, the DVD will go into the introduction on quality management. It will explained on topics like what is quality, quality characteristic, quality management, Quality Management Principles, ISO 9000 vs. Quality, what is Quality Management System & etc.

Finally, the DVD will technically highlight the requirement of Quality Management System in ISO 9001:2008. It also going through in details the steps in implementing Quality Management System in ISO 9001:2008.

Why is ISO 9000 Important?

Why is ISO 9000 Important?

Origin Of ISO 9000 Standards

Origin Of ISO 9000 Standards

Document Review In ISO 9000 Standards

Document Review In ISO 9000 Standards

The ISO 9000 Standard requires that documents be reviewed.

Previously the implication was that the review was a

check by potential users that the document was fit

for purpose before it was offered for approval. It

could be construed that for a document to receive

approval it must be checked and therefore ‘review

and approval’ in this context are one and the same

and the requirement is in this instance enhanced

rather than relaxed.

A review is another look at something. Therefore

document review is a task that is carried out at any

time following the issue of a document.

This requirement responds to the Continual Improvement principle.

Reviews may be necessary when:

- Taking remedial action (i.e. Correcting an error)

- Taking corrective action (i.e. Preventing an error recurring)

- Taking preventive action (i.e. Preventing the occurrence of an error)

- Taking maintenance action (i.e. Keeping information current)

- Validating a document for use (i.e. When selecting documents for use in

connection with a project, product, contract or other application)

- Taking improvement action (i.e. Making beneficial change to the

information)

Reviews may be random or periodic. Random reviews are reactive and arise

from an error or a change that is either planned or unplanned. Periodic reviews

are proactive and could be scheduled once each year to review the policies,

processes, products, procedures, specification etc. for continued suitability. In

this way obsolete documents are culled from the system. However, if the

system is being properly maintained there should be no outdated information

available in the user domain. Whenever a new process or a modified process

in installed the redundant elements including documentation and equipment

should be disposed of.

Document Review In ISO 9000 Standards

The ISO 9000 Standard requires that documents be reviewed.

Previously the implication was that the review was a

check by potential users that the document was fit

for purpose before it was offered for approval. It

could be construed that for a document to receive

approval it must be checked and therefore ‘review

and approval’ in this context are one and the same

and the requirement is in this instance enhanced

rather than relaxed.

A review is another look at something. Therefore

document review is a task that is carried out at any

time following the issue of a document.

This requirement responds to the Continual Improvement principle.

Reviews may be necessary when:

- Taking remedial action (i.e. Correcting an error)

- Taking corrective action (i.e. Preventing an error recurring)

- Taking preventive action (i.e. Preventing the occurrence of an error)

- Taking maintenance action (i.e. Keeping information current)

- Validating a document for use (i.e. When selecting documents for use in

connection with a project, product, contract or other application)

- Taking improvement action (i.e. Making beneficial change to the

information)

Reviews may be random or periodic. Random reviews are reactive and arise

from an error or a change that is either planned or unplanned. Periodic reviews

are proactive and could be scheduled once each year to review the policies,

processes, products, procedures, specification etc. for continued suitability. In

this way obsolete documents are culled from the system. However, if the

system is being properly maintained there should be no outdated information

available in the user domain. Whenever a new process or a modified process

in installed the redundant elements including documentation and equipment

should be disposed of.