Super User

Super User

Thursday, 10 September 2009 17:37

Why have a Documented Quality Management System?

Isn't it just more paperwork? Well let me ask you this...

  • Are you constantly interrupted by others’ questions?
  • Are you dreading the learning curve of a new employee or temp?
  • Have you had to fix the same problem more than once in the past 6 months?

Most of us “guess” or “figure it out” a couple of times a day (especially if the task is rare or new). But muddling through can cost time, money, focus – efficiency. What if there was a better way?

Thursday, 10 September 2009 17:35

What is ISO 14001 & why do I need it?

ISO 14001 is an international environmental management standard that companies use to certify that their businesses  have made a commitment to reducing the company’s impact on the environment.  Not only is being “green” a significant marketing advantage, but it is also a very popular commitment to employees and your neighbors.

If you are cringing at the potential cost of becoming a “green” company, think again. Unlike the quality  management standards that identify specific areas where you must meet minimum requirements for certification, this standard is a “voluntary” standard – you identify:

Friday, 10 September 2010 17:34

What is ISO 9001 & why do I need it?

For many small companies the whole concept of quality assurance, quality management systems, and especially ISO 9001 certification can seem overwhelming. But the truth is, ISO 9001 is really just good business practices written down. And all it asks is that you follow a few basic guidelines to ensure that your company’s product or service is consistent.

It doesn’t have to be big, complicated, expensive or time consuming –”The extent of the quality management system documentation can differ from one organization to another due to a) the size of organization and type of activities, b) the complexity of processes and their interactions, and c) the competence of personnel.” (Section 4.2.1 of ISO 9001:2008).

Monday, 14 September 2009 17:28

How do I get management to care about Quality?

For top managers or small business owners without a background in quality management, “quality” can mean products that customers don’t reject. After all, Quality Control’s job is to make sure that only good products go out the door. But there’s a huge difference between QC (quality control of products) and a QMS (a quality management system that identifies, controls, and improves the processes that produce those products).

So how do you get management to pay attention to quality? By showing them what it is costing to NOT have a well-functioning QMS. Present hard “cost of quality” data. Facts, figures, graphs – whatever they typically pay attention to. Then compare that to a vision of what could be.

"If I have a quality or environmental system that meets the ISO rules, what's the big deal about being certified?"

I get asked this a lot. Being “compliant” means that you are aware of and believe you comply with the requirements of the specific ISO standard in question. Being “certified” means that not only do you think you meet the rules but you’re willing to prove it by having an outside “certifying body” come in and audit you to verify that you really do meet the requirements.

When putting a quality management system in place for the first time, you need guidance through the concepts, terms and requirements. How you achieve that depends on the size and previous experience within your company – books, classes, or consultant are all viable options.

A consultant can provide valuable training and guidance for those charged with maintenance of your system. However, it is a mistake to assume that a consultant will “do it all for us”. It is, after all, your company’s system – not the consultant’s – and at the end of the day you are responsible for its maintenance.

As an alternative to hiring a consultant, make training the start of your implementation and learn together as a management team -- that way everyone is on the same page when making strategic decisions later. After all, ISO requires top management to provide evidence of their commitment by being involved in key strategic activities to direct your QMS, and requires that all employees are aware of, and understand their contribution to the management system.

Monday, 05 October 2009 17:17

Collecting and analyzing data

Collecting and analyzing data doesn't make us money - I don't have time.  Survival is a big deal in this economy. But wouldn’t you want to stop money from invisibly hemorrhaging out of the company? Many small company owners have a hard time seeing the return on investment in data collection. But those who collect even simple information about how their company is doing, and find where they are losing time or money, can stop those invisible leaks in profitability and productivity.

While ISO uses the term “certifying body” (because they certify the management systems of companies), many organizations in the USA use the term “registrar” (because they maintain a register of certified companies).  Same concept, just different words.

Choosing a relationship with a certifying body is an important decision. 

First - Always look for an accredited organization – this means that, like you, they are audited and monitored, and meet the stringent requirements of both the ISO requirements  for certifying, and the requirement of their accrediting body.  This ensures that you are being certified by an organization worth trusting.

Part of any quality management system (QMS) or environmental management system (EMS) is checking to see if you are really doing what you claim. Accountants do that for your finance department. Quality Control does that for your product. Internal auditors do that for your management system. I’m often asked “why can’t I hire someone outside to come and do audits for us?” While that sounds logical, it’s kind of like saying “why can’t I stop brushing my teeth and have the dentist clean them for me?” It would get pretty scary in between visits.

Sunday, 25 October 2009 17:05

What is ISO 13485 & why do I need it?

ISO 13485:2003 lists the International Standards Organization requirements for  quality management systems for medical devices.  Like many of ISO's 17,500 different standards, ISO 13485 takes the core quality management concepts of ISO 9001:2008 and adapts them to the medical device industry. 

The ISO technical committee for this standard took input from the Global Harmonization Taskforce and from food and drug agencies around the world, to ensure that those who pursued 13485 certification would be well-positioned to meet the requirements of a variety of medical device regulatory bodies  – a true benefit to those designing, manufacturing and marketing anything to the medical device industry.

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