Archive for April, 2009

Identifying Environmental Aspects for ISO 14001

Tuesday, April 28th, 2009

During ISO 14001 implementation, the most important exercise a company will go through is identifying all possible environmental aspects. Without a proper and thorough examination of all processes, functions and grounds of a facility, the rest of the environmental management system (EMS) is an exercise in meaningless documentation.

Once all aspects are identified, a determination must be made as to what aspects are significant and if they are within the organizations ability to control. This is best conducted through some type of risk analysis format such as a failure mode and effects analysis (FMEA) type review of the aspects.

If the process of identifying all environmental aspects of your company’s activities is becoming a daunting task due to limited or stretched resources, contact the experts at G3 Solutions today!

ISO 9001 – It is time to put the “document nightmare” perception away! (Part 3 of 3)

Saturday, April 25th, 2009

In Part 2, the definition of objective evidence was clarified and examples were given. The ISO/TC 176 guidance document on ISO 9001:2008 continues to clarify and explain how conformity with the standard can be achieved. It goes on to state:

“Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d) Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.

Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.”

By examining the intent of the standard, it is clear to see that a good amount of flexibility was built in to allow a company to make the standard work for them. A big fear of ISO implementation is the phobia of having to change an organization from top to bottom to have it meet requirements. The guidance document put out by ISO/TC 176 does a great job of putting these fears to rest.

For more help with ISO standards, contact G3 Solutions today!

ISO 9001 – It is time to put the “document nightmare” perception away! (Part 2 of 3)

Thursday, April 23rd, 2009

As we stated in Part 1, documentation for ISO 9001 does not need to be complex. With that being said, the next question that we are usually asked is “How do I show conformance to the standard when I don’t have a document for everything?”

In the ISO 9001 guidance document “Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008”, it states the following:

“To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines ‘objective evidence’ as ‘data supporting the existence or variety of something’ and notes that ‘objective evidence may be obtained through observation, measurement, test, or other means.”

This suggestion provides an amazing amount of flexibility in showing conformance to the standard. If you need assistance with your ISO 9001 system, contact the ISO 9001 experts at G3 Solutions today!

ISO 9001 – It is time to put the “document nightmare” perception away! (Part 1 of 3)

Wednesday, April 22nd, 2009

Although it is true that ISO 9001 does require documented evidence for many requirements, this should not be interpreted as needing a new document for everything you do. Many times companies can modify existing documents to provide evidence of conformity to ISO 9001 requirements. Standards such as ISO/TS 16949, AS9100, ISO 13485, ISO 14001 and others have additional requirements for added documents, but the same strategy of modifying existing documents can be used for a majority of those additional demands.

In the ISO 9001 guidance document “Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008 Document: ISO/TC 176/SC 2/N525R2, October 2008″, it states “For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS. Organizations may be able to demonstrate conformity without the need for extensive documentation.

There are other recommendations for document control which we will list in future posts. Just remember that the standard gives you an incredible amount of flexibility in putting together your documentation. If you would like additional ideas on how you can control your ISO documentation, contact the experts at G3 Solutions today!

During an internal audit, get honest feedback from employees

Tuesday, April 21st, 2009

The internal audit process is an extremely important part of any ISO-based quality or environmental management system. It can be the “make it or break it” process that will determine just how effective your system will be based on the proper input from employees. Unfortunately, as part of the natural human tendency to avoid anyone with the title of “auditor”, people will often treat the internal auditor as someone to avoid in fear of being singled out or used as an example.

“I have a theory that the truth is never told during the nine-to-five hours.” – Hunter S. Thompson

This is why companies must give some good thought as to the audit team they will select. Not only must the auditor be a good communicator and data analyzer, the auditor must be able to get people to want to talk about what they do and how they do it.

Sure, there is plenty of guidance as to what makes a good auditor in ISO 19011. In fact, some of the terms used to describe auditor qualities in 19011 sound like a scouts honor pledge – honest, trustworthy, loyal, brave, etc… (Well, OK, maybe not those last three!) Certain stated qualities are important, but there are some things that just go by feel – is the person approachable, enthusiastic, and positive? Can they express themselves well and “message” people who are overly sensitive to anything that may seem like criticism, like a minor nonconformance?

If it is becoming a real chore getting the right people in your organization to perform internal audits, consider the option of an expert and true auditing professional conducting your audits – it may be the smart choice. Contact G3 Solutions today to find out just how affordable and value-added contracting/outsourcing your internal audits can be!

Is your ISO quality system still effective or has it lost its relevance?

Monday, April 20th, 2009

The scenario of a company hurriedly preparing for the surveillance audit happens more than it should. During times of reorganization, downsizing and prioritization of resources, the quality system will sometimes be given a backseat to other issues that tend to be more reactive than proactive. Losing sight of the preventive benefits of maintaining the quality system happens for a number of reasons, but some stand out more than others.

For starters, it is only natural to become focused on problems that have occurred and how much they will cost in terms of time, money and resources as opposed to actions that prevent a sometimes incalculable amount of the same. It is easier to see a picture of real dollars lost than perceived dollars saved by being proactive. This is where the dangerous downward spiral of losing a grip on your quality system can begin.

Rational behavior requires theory. Reactive behavior requires only reflex action.” – W. Edwards Deming

Also, a lack of planning to schedule attention and maintenance can set up a situation that may look like the system is too burdensome to maintain and is beyond repair. Although it looks like doom and gloom, many key portions of the quality system can be easily jump-started and put back on track.

Before it gets to a dangerous point of no return for your ISO system, contact G3 Solutions to find out how easily effectiveness can be restored. In the coming weeks, we will have new posts on common issues that companies face when it comes to prioritizing continual improvement.

Records – are you keeping all that you should?

Thursday, April 16th, 2009

Many companies registered to ISO 9001:2000 are now reviewing their quality management system (QMS) along with associated forms and documents to make sure that there is a smooth, trouble free certificate upgrade to ISO 9001:2008. This is a great opportunity to make sure that all records required to maintain the business are kept in such a way to satisfy the ISO 9001 clause 4.2.4, which states “Records shall remain legible, readily identifiable and retrievable.”

Companies should consider every record needed for the business, not just the ones listed for ISO 9001. Having all important records fall under the scope of the control of records procedure helps to provide real value in the QMS. If you have a system that is based on ISO 9001 but includes other requirements (e.g. – ISO/TS 16949, AS9100, ISO 13485, etc.), the list of records for 9001 is just the beginning of what needs to be maintained.

For a complete list of ISO 9001 required records, you can download the following document:
iso-9001-2008-records

If you need additional help with ISO requirements, visit g3iso.com today!

If only all business travel was this much fun!

Saturday, April 11th, 2009

Normally we use this blog for serious (or at least semi-serious) ISO info, but we just had to pass this along. The attached video has absolutely nothing to do with ISO 9001, ISO/TS 16949, AS9100, ISO 13485, ISO 14001 or any other ISO standard – we promise! If you travel a lot for business, you will definitely appreciate the clip.

Have some fun – click on the following link and watch: rapping_flight_attendant

When it comes to training, don’t forget the follow up!

Thursday, April 9th, 2009

Most companies do a good job of providing proper employee training to ensure a qualified and competent workforce. Clause 6.2.2c in ISO 9001 clearly states that any training or other actions taken by top management to achieve competence must be evaluated for effectiveness. This also holds true for many standards such as ISO/TS 16949, AS9100, ISO 14001, ISO 13485 and others.

A common issue found during internal and external audits is the lack of evidence to demonstrate that effectiveness is evaluated. Keep in mind the standard does not prescribe how this is to be done, so there is tremendous flexibility in how this task can be completed.

Always consider that every ISO requirement does not need a new procedure, work instruction or form! Simple changes to existing process documents can, in most cases, do the job just fine. Make sure the method chosen provides a gage that is useful to the company in evaluating resource needs. Remember, the goal for any quality system is to provide value to an organization – not just fulfill standard requirements.

For more information, visit g3iso.com today!

Management Review – Are you meeting just for ISO reasons?

Monday, April 6th, 2009

The scenario is common in many companies. Quality planning meetings are held by top management on a regular basis, usually once a month or more, with discussions of key metrics, process performance, corrective actions, along with a host of other items. Notes are taken, actions are assigned and items are followed up on during the next meeting. So the question must be asked – why do we need a separate “Management Review” meeting? Just to fulfill an ISO requirement?

This is a good question. Having an official “Management Review” meeting (sometimes done by companies only once per year) just to make sure the 3rd party registrar auditor is happy can be quite an exercise in wasting time and reinforcing some unconstructive, even negative views of having a quality system in place. Employees (many of them in the ranks of top management) begin to question the value of the process.

Don’t let this happen to your organization!

Most quality standards such as ISO 9001, ISO/TS 16949, AS9100, ISO 13485, ISO 17025 and others have the requirement of management reviewing their quality system at defined intervals to ensure it is working as a catalyst for process effectiveness and/or improvement. A perfect opportunity to fulfill this requirement can be made during those normal meetings when top management is discussing various quality issues such as production scheduling or account reviews.

One method to efficiently maximize meeting time is to break down those ISO 9001-based requirements found in clauses 5.6.2 and 5.6.3 and review those topics during different meetings. Some topics such as quality metrics and measurables should be reviewed frequently while others such as the review of the quality policy can be looked once per year or as needed. Over the span of a year, all topics can be reviewed as part of the normal planning process. Providing you have the notes and objective evidence to show that all required items were part of the meetings, you have covered the management review requirement.

Remember, the whole point of having a review of the quality management system is to effectively facilitate continual improvement – not to just to fulfill a requirement.

Visit our website at g3iso.com today!