Archive for the ‘Medical Device’ Category

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.

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!

Risk Management in AS9100C

Friday, April 3rd, 2009

In the new revision of the AS9100 standard, an emphasis is being placed on clause 7.1.2 – Risk Management. This is a new requirement to implement a risk management process applicable to the product and organization covering responsibility, criteria, mitigation, and acceptance. The purpose of adding risk management in clause 7.1.2 is to provide additional focus on product risk during product realization.

Unlike ISO/TS 16949 which makes a reference to the Failure Mode and Effects Analysis (FMEA) process or ISO 13485 which references ISO 14971 for guidance on risk analysis, AS9100 is less prescriptive about how this should be done. This lack of specificity should not be interpreted as a simple suggestion for risk analysis, but rather as a flexible mandate that allows an organization to choose the best method of analysis appropriate to the product.

For more information on AS9100 Rev C, contact g3iso.com today!

When conducting internal audits, planning is key

Tuesday, March 31st, 2009

As consultants and trainers, we are often asked about the internal audit process and the amount of time that should be given to internal auditors to complete their audit. Obviously, there are many factors that go into the calculation of time that should be spent performing an audit. Complexity of process, number of employees, number of facilities and document review all have a big factor in audit time management.

One area that should always be given a significant amount of audit time is document review. Too often, we see companies that provide to their audit team members pre-packaged materials such as audit checklists or a few standard questions that become both predictable and repetitive, and end up providing no real value to the process.

Internal auditors should be given plenty of time to review the appropriate standard, process flow diagrams, procedures, work instructions, key metrics/measureables and previous audit data to ensure that they have a thorough understanding of what should be happening before they conduct the audit. The end result will be an effective audit that can provide real benefits and continual improvement opportunities.

Visit g3iso.com for more tips on internal audits.

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!

Is your quality or environmental management system improving or suffering because of the economy?

Friday, February 27th, 2009

You can’t avoid news about the current economic climate, whether it relates to here in the states or abroad. Despite all the reports of banks and financial institutions facing hardship, no other industry has been hit as hard as manufacturing, especially automotive.

As a result, have quality and enviromnmental efforts at your facility improved or have they been put on the back burner?

How has your company dealt with maintaining its quality and environmental goals and objectives?

Are your company’s ISO 9001, ISO/TS 16949 or ISO 14001 systems losing steam or are they becoming stronger as a means to be more competitive?

Log in and let us know what your company is doing. We want to hear your story.

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