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Timothy Macenroe's Blog


Posts from: QualityManualChat.com

 

Preventive Action Request- Ambiguous? Ever done one?

One of the six required procedures in an ISO9001:2000 quality system is regarding preventive action requests. You gotta have a procedure, but have you ever done a preventive action request? Ever seen one? Would you know one if it hit you in your face?

ISO9001:2000 section 5.5 Responsibility, Authority, Communication

The ISO9001:2000 quality standard requires that appropriate communication processes are established and documented, and that you’re actually communicating within your organization regarding the effectiveness of the quality system. How are you going to do this?

Do you post ISO9001:2000 related signs around your office?

Do you post signs around your building stating your company’s quality policy, as written in your ISO9001:2000 quality system manual? Do you think this is a good idea, or a complete waste of time?

Who is the best management representative to your ISO9001:2000 quality system?

You’ve got to decide who’s going to be the management representative to your ISO9001:2000 quality management system. Your choice here can make or break the success of your quality system? Who’s the best choice?

How to satisfy section 8.4 Analysis of Data in ISO9001:2000

How do you deal with ISO9001:2000 section 8.4? What kind of data must you gather and analyze? This is the one area of ISO that is probably the most confusing to people trying to implement a new quality management system.

In an ISO9001:2000 quality system, how do you write work instructions?

How should you write your work instructions? Is there a standard format? Are work instructions a requirement of your ISO9001:2000 quality management system?

The 21 records required by ISO9001:2000

For those about to implement an ISO9001:2000 quality management system, here’s a handy little list of the 21 records required by the standard.

How do you get people to cooperate with ISO9001:2000?

You’re trying to implement an ISO9001:2000 quality system. You can’t do it alone. How do you get others in the organization to get on board? Whips? Threats? Cursing? If these sound good to you, you need to read this.

Management Responsibility in an ISO9001:2000 Quality Management System

What, exactly, is your top management responsible for in your ISO9001:2000 quality management system? Clue: its not just writing a check to pay for the audit.

Review of product requirements in an ISO9001:2000 Quality Management System

Quality Manual Templates for ISO9001:2000 CertificationThe ISO9001:2000 quality standard says that you must review product requirements prior to your organization commiting to supply the product to your customer. Different companies handle this in wildly different ways, it all depends on what kind of company you are, and what your product is.
For some companies this […]

Control of Monitoring and Measuring Devices in an ISO9001:2000 Quality Management System

Do you have measuring devices as part of your quality control system? Ever wonder how you need to control them if you want to get ISO9001:2000 registered?

Does Your Company Take Its Quality Policy Seriously?

ISO9001:2000 section 4.2 states the requirement to have a documented quality policy. Cynical people might look at the quality policy as a bunch of horse dung. And lord knows I’ve seen quite a few companies that don’t take any part of their quality system seriously. So its not surprising that some folks […]

Control of Nonconforming Product in an ISO9001:2000 Quality

What is nonconforming product? Do you really have to deal with it? How would YOU deal with it?

How to live with ISO9001:2000 when customer requirements are poorly defined?

How can you meet the requirements of ISO9001:2000 Section 7.2 when your customer gives you poor product requirements?

Thinking of “buying” your ISO9001:2000 quality manual and procedures?

Numerous websites are out there claiming you can fork over your hard earned cash….or credit card number….and receive a ready-to-roll, plug-and-play ISO9001:2000 quality management system. Nothing could be further from the truth. Do such websites offer anything of value? Probably they do. But don’t think you’re getting off without having to do any work on your own.

More on Document Control for an ISO9001:2000 Quality Management System

There are so many nuances to document control within an ISO9001:2000 quality management system. Here’s some more to chew on.

Should you buy an ISO9001:2000 quality manual on the internet?

Thinking about doing ISO9000 yourself? Ever wonder if you should buy one of those do-it-yourself manuals online? Read more here.

What is Product Realization in an ISO9001:2000 quality system?

One of the somewhat nebulous and confusing terms in ISO is “product realization”. It took me a while to understand this concept, and I know I’m not alone. The reality is that it is an extremely simple concept.
Product Realization is simply realizing your product. OK, maybe that’s a little too simple.
Here is […]

Root analysis for someone who makes repeated mistakes

One question that I’ve struggled with over the years…and still struggle with…is how to properly address the problem of an employee who makes the same mistake over and over. Sure, in the magical fairy tale land of ISO9001:2000, it’s easy to blame it on “insufficient training” and be done with it. But there […]

When is the next revision to the ISO 9001 quality standard?

According to reliable sources, it looks like ISO9001:2009 will be the next revision. The ISO Quality Standard has been undergoing much debate over how much to change it, and what kind of changes to make. There was a lot of speculation that 2008 would be the year, but it has been delayed until, […]

ISO9001:2000 Registration

Here are some useful tips on what you and your organization should do, and NOT do, during your ISO9001:2000 registration audit:
1. Make sure everyone has been trained and knows as much as possible about what their areas of responsibility.
2. Don’t lie.
3. If you don’t know the answer to a question, tell the […]

Do you really need ISO9001:2000?

Do you really need to have ISO9001:2000? If you don’t have a customer requirement for such a quality management system, what benefits are there to going thru the time and expense of creating and maintaining an ISO quality system?

ISO9001:2000 minimum requirements for one person shop

Let’s say you own a small shop that manufactures spare parts. It is a sole proprietorship with you as the sole full time employee. You want to streamline your manual and procedures as much as possible, to include only the bare essentials to conform to ISO9001:2000. You’re the only person there, you […]

Quality Manual Prep: How Long Does It Take?

The time needed for preparing your quality manual and quality management system can vary greatly. It largely depends upon the pressures you have to deal with.

4.1 General Requirements of an ISO9001:2000 Quality Management System

The ISO9001:2000 quality standard requires that you ensure control over outsourced processes that affect your product’s quality. How are you going to do that?

ISO9001:2000 Section 4.1 General Requirements Part 2

This is part 2 of a series on the General Requirements of an ISO9001:2000 quality management system, which is section 4.1 in the standard.

ISO9001:2000 Section 4.1 General Requirements Part 1

This is part one of a primer on the general requirements of the ISO9001:2000 quality management system. You can find the general requirements in section 4.1 of the standard.

Can you have defined objectives that are not measurable?

Can you have quality objectives that are not measurable?

How would you implement an ISO9001:2000 quality system for your website?

Does ISO9001:2000 apply to every type of business? What about a website that’s a forum, with advertising? What’s your product? Who are your customers? Does ISO apply here?

Customer Related Processes

Customer Related Processes are particular to your company, but some may be pretty common. Here we discuss how to handle customer sales order changes to prevent the wrong items from being shipped.

Alchohol and the Audit

Politics and schmoozing — a last resort for a poor quality manual.

I Learned a Lot from this Guy

Working with Dale Baldwin, ISO consultant.

Do you need a formal purchase order to satisfy ISO9001:2000?

It’s a really good idea to have a written purchase order, but if you’ve had a long lasting relationship with your customers, and have done business for years verbally or by e-mail, there are ways to continue such business while still satisfying the requirements if ISO9001:2000

He Just Wouldn’t Shut Up!!!

When some auditors get close to retirement, tracking orders might seem more like tracking game; docks aren’t for receiving packages, but for watching the sun go down; and scales aren’t for weighing packages, they’re what fish wear.

Would you let a customer observe an internal audit? ISO9001:2000

Would you let a good customer observe one of your internal audits for ISO9001:2000?

Incorporating your Employee Manual into your Quality Manual?

Is it necessary to incorporate your employee manual into your ISO9001:2000 quality manual? Would you want to do this? What are the pros and cons?

Quality Manual Motivation

What’s your motivation to get ISO certified? I’ve seen the gamut of reasons.

Incoming Inspection Reduces Production Delays

But how will the guy on the receiving dock like it?

Measuring Top Management Committment to your ISO9001:2000 Quality Management System

You don’t really have to measure top management’s commitment to your Quality Management System. This is a topic that quality people often discuss, it can reveal a lot about the potential for success…or disaster…for a company’s quality system.

Controlling external documents in your ISO9001:2000 Quality Management System

Does your organization use externally generated documents? Do you wonder if you have to control these? How should you control these?

Vendor Evaluations

Do you really need to do a vendor evaluation on your janitor? This has been suggested.

Customer Focus

Does your quality management system have a section devoted to customer satisfaction?

Is Design and Development a part of your QMS?

Does Design and Development belong in your quality management system? Some say yes.

Competence, Awareness and Training

ISO Training: availability and responsibility.

Teamwork versus Personal Responsibility

The ever present friction between the slackers and the cheerleaders … I’d love to hear your comments.

TQM Losing Ground

Total Quality Management, so popular in the early 90’s, how is TQM faring today? How many implementations are there?

Provision of Resources in an ISO9001:2000 Quality Management System

Will your organization provide the required resources necessary for implementation of a quality management system? Should you include such a section in your quality manual?

Inputs to Management Review in an ISO9001:2000 Quality Management System

Setting up and laying the format for your management review. Example inputs.

Quality Policy Statement and Quality Objectives

Plotting a course and setting measurable goals.

Controlling Electronic Records and Documents

Paper or electronic record keeping?

 
 

 

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