Posts Tagged ‘quality management system’

Congratulations! You are now in charge of creating an ISO 9001 system – now what?

Monday, August 31st, 2009

Quite often, the G3 staff is asked to recommend a plan of action for people who find themselves in the position of “being volunteered” to put together an ISO 9001 (or any other ISO 9001-based standard) system for their company. Unfortunately, for employees that have little to no experience with quality standards, this can be an overwhelming task. We recommend the following steps:

Step 1 – Before you can plan what to do, you and the management team need to know what is required. Start with an overview training session on the standard for yourself followed by a session for top management. Strongly emphasize that the standard is process based and highlight the Plan-Do-Check-Act (PDCA) model. All parties involved in the implementation must realize that the standard has a couple of key principles that are referenced all throughout the standard – customer satisfaction and continual improvement. The ultimate goal is to make all customers happy, but the method of getting to that goal is by the continual improvement of your processes. This is where top management needs to make a little paradigm shift – customer satisfaction means more than a reduction in phone calls from the customer yelling about something that wasn’t just right. It certainly means more than assuming a customer is happy if they continue to give orders for more products and services. Remember, customers can multi-task by giving your organization a new purchase order while giving a new supplier the thumbs up for the next order. By the time some realize the customer isn’t happy, it can be too late.

This is where continual improvement comes into play. By knowing what your customers think of the level of service and value they receive from your organization, your company can initiate the proper continual improvement objectives that can reduce or eliminate the problems and issues that can make their way to the customer.

This is why you need to get all of top management involved. Everyone must get a clear view of the big picture. Having a quality management system (QMS) based on the appropriate ISO standard should become the implementation of a quality philosophy and roadmap for doing things right. Stress that it is a quality management system by which the company will operate and oh, by the way, it just happens to comply with the ISO standard. After that, don’t mention the letters “ISO” – just QMS. Companies that implement systems based on the need to meet ISO requirements often find that employees put an emphasis on doing things just to meet the standard as opposed to improving the process.

Additional steps will be discussed in future posts. Visit g3iso.com for more info.

New (or maybe rumored) Corrective and Preventive Action requirements! Make sure your system is up to speed!

Friday, May 8th, 2009

In order to accommodate the rumored additional changes to ISO 9001:2008, you will need to incorporate the following form into your organizations Corrective and Preventive Action system. It is also rumored that these requirements will affect additional standards such as ISO/TS 16949, ISO 14001, AS9100, ISO 13485, ISO 22000 and various other standards.

Free download: iso-mil-hf-car-par

The downloadable form was developed by members of the military to facilitate the documentation of key personal issues into a corrective and preventive action format. If you have any questions or require any help in the application or requirements of this form, please contact G3 Solutions. We will do our best to aid in the development of your quality management system and sense of humor.

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!

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!

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!

Is AS9100 the right standard for our organization? What about AS9110 and AS9120?

Friday, March 20th, 2009

In order to diversify product lines and reach out to new markets, many manufacturing companies are venturing into the aerospace and defense industries. To make this transition successful, an organization should consider revising their ISO 9001 quality management system to incorporate the requirements of AS9100, AS9110 or AS9120. Some companies have difficulty knowing exactly which standard is right for their product and/or service. There are key differences between the three, and each has a distinct application.

AS9100 – This is for organizations that design, develop, and/or produce aviation, space and defense products or organizations providing post-delivery support.

AS9110 – Any organization whose primary business is providing maintenance, repair and overhaul services for aviation commercial and military products is a candidate for this set of requirements.

AS9120 – Designed for organizations that procure parts, materials, and assemblies and resell products to a customer in the aviation, space and defense industries, including organizations that split these commodities into smaller quantities.

If this is still confusing or you find that your company is in a “grey” area between these choices, contact G3 Solutions today!

Visit www.g3iso.com for more info.

Moving from ISO 9001 to ISO 13485? There’s more to it than a few “add-ons”!

Friday, March 13th, 2009

An ISO 9001 quality management system is a great start for a company looking to get into the medical device industry, but it may be only the beginning. A transition to ISO 13485 could be required based on the type of product to be manufactured. It is easy to make the mistake of thinking that a transition to ISO 13485 will be an easy task since a quality system foundation is in place. When implementing the additional requirements, it is very important to be aware of (and focus on) the key differences between the two standards.

ISO 13485:2003 is a standard specifically for the medical device industry. It contains a majority of the requirements of ISO 9001, but the differences require substantial changes to an existing ISO 9001 quality management system. The standard, which was revised in 2003, supersedes earlier european and international documents such as EN 46001:1997, EN 46002:1997, ISO 13485:1996 and ISO 13488:1996.

One of the key differences between the standards is that ISO 9001 requires an organization to demonstrate continual improvement. There is a heavy emphasis on this throughout ISO 9001 which can make the transition to ISO 13485 a little difficult. In the ISO 13485 standard, the emphasis is on maintaining the effectiveness of the quality system.

Another area of focus is the promotion and awareness of regulatory requirements, such as United States Quality System Regulation (QSR) 21 CFR 820. Depending on where the device may be sold and used around the globe, additional requirements from other nations or international bodies must be examined.

Other differences include many additional procedures that must be documented and implemented. Risk analysis must be considered throughout product realization (ISO 14971 provides guidance on this subject). Product safety, sterility, inspection and traceability are emphasized along with various additional requirements for documentation, product validation and verification of the effectiveness of corrective and preventive actions.

If you need help with the transition process, contact G3 Solutions today. Visit our full website at www.g3iso.com today!

The ISO 9001 Quality Manual – how useful is it?

Friday, March 6th, 2009

It is always amazing to see how many small companies construct a lengthy quality manual and then question whether or not it provides any real value. Unfortunately, this scenario is more common than it should be and the question is quite valid – how useful is it?

The first thing that an organization should realize when constructing a quality manual is that there is no single prescribed way for it to look. The requirements are plainly stated in ISO 9001:2008 clause 4.2.2. According to the “Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008″ (Document: ISO/TC 176/SC 2/N525R2) created by ISO Techincal Committee 176:

Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS (Quality Management System).

A small organization may find it appropriate to include the description, processes and methods of its entire QMS within a single manual, including all the documented procedures required by the standard.

Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.

The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.”

Nowhere in the standard or in the guidance document does it state that the organization must regurgitate the standard and replace the word “shall” with some type of term as “we do…”.

The best quality manuals are always written specifically for the company (NOT templates) and contain the scope of the manual, reference or inclusion of procedures and SIMPLE, employee-friendly process descriptions that clearly show the sequence and interaction of key company processes.

How does your quality manual stack up? Log in and sound off!

Visit our full website at www.g3iso.com today!

ISO Implementation – Get People Involved!!

Friday, February 13th, 2009

The proper implementation of any quality management system should invole all employees in some manner, regardless of the standard. Many times it is common to see procedures and work instructions developed by personnel who do not (or have never) been part of that function or process. This can be one of the biggest mistakes a company can make in implementing a quality system.

One of the key principles that ISO 9001 and many other standards were based on is the involvement of people. People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s improvement.

The resulting output of employee involvent can provide numerous benefits, such as:

  • Motivated, committed and involved people within the organization.
  • Innovation and creativity in furthering the organization’s objectives.
  • People being accountable for their own performance.
  • People eager to participate in and contribute to continual improvement.

    Applying the principle of involvement of people typically leads to employees:

  • understanding the importance of their contribution and role in the organization.
  • identifying constraints to their performance.
  • accepting ownership of problems and their responsibility for solving them.
  • evaluating their performance against their personal goals and objectives.
  • actively seeking opportunities to enhance their competence, knowledge and experience.
  • freely sharing knowledge and experience.
  • openly discussing problems and issues.

    Let us know what you think – sign in and voice your opinion.

  • Visit our wesite at www.g3iso.com today!

    ISO 14001 implementation – worth the effort!

    Thursday, January 22nd, 2009

    Many times we often hear comments about the commonalities between ISO 14001 and ISO 9001. Both standards have such requirements as management review, corrective & preventive action, internal audits, document control, and a top level policy statement. While there are many seemingly identical components, it should not be assumed that it is easy to implement an EMS because of these similarities. Many companies make the mistake in assuming that implementing 14001 will be a walk in the park since they have a quality management system.

    Just because a company may not have an inventory of hazardous waste, there are still countless ways that an organization can have an impact on its surrounding environment, even if the organization’s site is comprised of nothing more than a few desks and computers.

    Identifying all of the potential aspects and impacts of a company can be a very challenging task regardless of the product or service created. It is also the key first step to success in implementing an effective environmental management system.

    Once these aspects and impacts are fully identified, a company can then move forward and implement programs that can be used to minimize any negative impacts on the environment. Some companies implement programs to pro-actively create positive impacts. They may even find out that helping the environment can be a profitable venture! Reductions in waste can very often show up quickly as cost savings in such areas as resources and utilities – and that’s a bonus in any type of environment!