Mar 12 2010

What is a Quality Manual for ISO 13485?

Category: Business and Industry — Mark Kaganov @ 4:20 pm

Well, formally there are a number of definitions of what a quality manual is. These definitions are in ISO 10013, ISO 13485 and other standards. In fact, a quality manual is a top-level document defining your quality management system. A quality manual establishes the policy level position of your organization in the area of quality management system. There are two principal definitions of what a quality manual for an ISO 13485:2003 QMS should be:

ISO 10013, Guidelines for Developing Quality Manuals, element 4.2, gives detailed suggestions for creating a quality manual. It defines a quality manual, among other requirements, as a document that should “consist of, or refer to, the documented quality system procedures intended for planning and administration of activities which impact on quality”. ISO 13485:2003, element 4.2.2 requires a quality manual to include:

1 – the scope of the quality management system

2 – details of and justification for any exclusion or non-application;

3 – quality management system procedures or reference to them;

4 – specified interaction between the processes of your QMS.

5 – description of the QMS documentation.

Typically, companies state the scope of their QMS in the Scope or Introduction sections of their quality manuals, similar to “XYZ Corporation assembles, packages and distributes personal hygiene product packs to hospitals and doctors’ offices”

After we defined the scope and exclusions, let’s describe used processes and references to the corresponding procedures. As I found through my consulting and auditing work, the best way to start this step is to transform ISO 13485 standard from a set of applicable requirements into your company’s commitments to satisfy those requirements. For example: If element 7.1 requires that the company shall establish “?documented requirements for risk management?” our manual will state: “ABC Medical, Inc. has established and maintains documented procedure for risk management?. This process is documented in the Risk Analysis Procedure.”

As you can see, a reference to a specific procedure satisfies the third requirement for a quality manual (above). Following this approach by addressing all applicable elements of the standard and referencing corresponding procedures, we will establish a manual that meets the requirements of ISO 13485:2003 standard.

Various methods are used to document process interactions. Some companies utilize Figure 1 from ISO 9001:2000 standard to document relations between main processes. Use of such an illustration and references to your procedures, will define interactions between your processes. You can find additional models for process interactions on the Internet. Just, type “process interaction matrix” into your browser and you will find your answers.

The last requirement of the element 4.2.2 is to outline of the structure of the documentation. Very often I see companies defining their structures as four- or five-level documentation structure in the documentation management section of the manual.

After completion of your quality manual, think about other benefits a well prepared quality manual may bring you. It can communicate to your prospects, customers and vendors that your business is not only a quality-conscious organization, but that it also understands benefits of a well-documented commitment to QMS through your quality manual.

I always wonder what companies achieve by stamping their quality manuals in bold capitol red letters “CONFIDENTIAL”. As far as I am concerned, a quality manual is a company’s resume for quality, and if you hide your resume, there is a very good chance that you will never get a job! All our customers are encouraged to make their quality manuals public!

If you are working on your your ISO 13485 quality management system, and want to avoid common mistakes, take a look at our ISO 13485 Quality Management consulting services.

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Mar 07 2010

Bring the Tradition of an Elegant Lenox Wedding Cake Topper to Your Special Day

Category: 1 — Alison Tomi @ 12:02 am

Everybody desires their wedding day to be the perfect occasion with a elegant wedding dress, beautiful weather, a wonderful view at the location and much more. It is a once in a lifetime (for most!) day where you have the chance to be the princess and have everything just the way you like it.

One of the most important pieces of planning that has to be done is choosing your wedding cake design. Not only is the cake devoured by all your guests at the end of the night, it is also on display during the reception for everyone to see and the wedding cake is an expression of your own tastes and desires.

A wedding cake topper is a perfect way to put your personality on show for all of your guests to see. For every personality that exists, you can be assured to find wedding cake toppers in that theme from Cinderella to Mickey Mouse!

A name that is synonymous with quality and is a well known and trusted American brand is Lenox. Lenox’s range of wedding cake toppers will ensure your wedding cake is elegant and stunning.

Lenox has been around for over 100 years and has become synonymous with excellence in the tableware market. They are well renowned for their quality craftsmanship and artistry of all their products.

For a wedding cake that is the epitomy of elegance and style a Lenox Wedding Cake Topper will ensure all those requirements are fulfilled.

One of the most popular Lenox cake toppers is the stunning, First Dance Cake Topper which portrays the married couple taking their first dance. It is made from quality ivory fine China and is completed with fine platinum decorations.

After the big wedding day has come and gone, your beautiful Lenox Wedding cake topper can then be used as a quality ornament to put on display in your house. So you can forever remember your romantic day, where you declared your love forever for your partner.

With personalized Elegant Unique Wedding Cake Toppers, you can have your personality on show for everyone to see. At wedding-caketopper.com there are many quality Lenox Elegant Unique Wedding Cake Toppers available.

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Mar 01 2010

ISO 9001 Documentation

Category: Business and Industry — Mark Kaganov @ 6:15 pm

A guideline for Developing Quality Manuals, ISO 10013 Standard, suggests a documentation structure for ISO 9001 QMS. This model in the standard proposes use of a three-level arrangement. Most companies I worked with utilize four-level structures instead to include records, A typical four-level documentation structure consists of:

Quality Manual – level 1

Procedures – level 2

Instructions – level 3

Records – level 4

Interestingly, how are we going to start our quality manual without knowing what standard this manual is for? The quality policy supposes to define it. The policy defines what standard or standards, a company wants to comply with. If you like this idea, your QMS will contain five levels as in the following list:

Quality Policy – level 1

Quality Manual – level 2

Procedures – level 3

Instructions – level 4

Records – level 5

Naming your documents

Companies use various approaches to titling their manuals, procedures, instructions, etc. For example, one of my customers titled their quality manual as \”Quality Management System Quality Manual.\” This very descriptive title does define the document, but does not appear to be efficient.

This tendency to use long titles and document identifiers like \”Standard Operating Procedure\” most likely comes from regulated industries. Even though I could not find a requirement for such title formats, many companies still use these apparently outdated and ineffective conventions. If a short name sufficiently describes a document, let\’s use it. I suggest streamlining all elements of management systems. Consider this and do not make your system more complicated than it can be.

ISO 9001 – document No\’s

No standard prescribes to give a part or a document its number. It is an industry standard to give a document or a component its name, number and a revision level. Similar to part titles that we discussed above, document numbering conventions are often also may be optimized and simplified.

A company had some 130 employees. They had two part number formats: one for procedures, another for drawings. Procedures used XX-XXX number format. Drawings were numbered as XXXXXXX-XXX. One of the drawings had a number 000022-003. Assemblers simplified the system and called it \”twenty two.\”

Is it acceptable to have long and difficult-to-read and remember numbers? Yes, of course! Is it practical? I do not believe so! In the example above, the procedure number, without the tab, contained seven digits. This meant that the system was prepared to handle almost 10 million document or part numbers (PN). The company had approximately 250 documents and probably would never go beyond 300. If nothing else, just reading these numbers with five sequential zeros may give one a headache. Surprisingly, this is not the worst case I have experienced! The company that won my \”The Worst Part Number\” Grand Prize assigned 12 (!) digits to their part numbers in the alphanumeric format.

I hope it is clear that only when extensive part numbers are justified, we do not have other options. If you build helicopters or satellites, you, no doubt, will need millions of parts and therefore will need long part numbers. If not, make your life easy and stay away from all those zeros. The most practical system I worked with used a three-digit format for their part numbers. 202, 203, 204, and so on. Worked just fine!

So far we explored opportunities for improvements in the area of document titles and numbers. Yet, there is another issue with part numbers. Many companies relate a document number to a document type. For example, 20-xxxx indicates a procedure, 30-xxxx indicates a drawing, POP-xxxx indicates a Production Operating Procedure, etc. My practice with a few QMS that used designation approaches showed that \”no designation\” systems are more practical. Several QMS that used designation I have worked with have failed. Not long ago, one of my clients mentioned that they ran out of range in their document numbering format. The QMS initially permitted for identifying suppliers through a two-digit extension within the part number. While the company grew, the number of supplier increased beyond expectations and eventually the company needed more than 99 suppliers. This resulted in the document number format not being able to support new needs.

There are good news and bad news. The bed news is that designation systems can fail. The good news is that there is another way of dealing with document numbers: no designation at all! Using such systems, you give documents or parts sequential numbers. Going further, isn\’t the part title the best identifier of the part? One company I know did not use part numbers at all – their procedures and instructions were simply identified by titles and a two-digit revision level.

If you are optimizing your ISO 9001 QMS, our documentation set can help your company. Visit Quality Works Website and order your Quality Assurance system today! Quality Works provides management system consulting worldwide.

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Feb 19 2010

A Positive Mindset Is The Key To Attracting Success

Category: Health — Tim R Cooper @ 3:31 pm

Turn that frown upside down mum used to always say. Apparently she may have been absolutely right. Having a positive mindset can significantly contribute to us attracting success and other good things into our lives. Before we buy into that age old adage wholly, let us just stop and consider the impact that positivity can have on our lives.

To start off with, people with positive dispositions are generally seen as more friendly and approachable by others. This ability to create a good impression and maintain a calm perspective on issues can go a long way towards building and fostering good relationships. This equates to better friendships and personal relationships.

In the work place, a positive perspective can significantly improve the morale and climate under which a group of people work. Keeping a level head and not being swayed by setbacks means positive thinkers are well suited to leadership positions. Their ability to lead is further substantiated by social success in interacting well with people. Positivity can also improve the quality of your work and your level of productivity as you will not be bogged down by unnecessary worrying and stress.

Our personal goals and desires often get sidelined in our attempt to achieve professionally and meet social expectations. Desires to travel or an interest in pursuing writing are common examples of things that give way to more practical ambitions. This can lead to one feeling unfulfilled and disheartened. A different mindset can help us re-evaluate our goals and prioritise them instead of dwelling on lost opportunities.

Recently there has been renewed interest in the impact that a positive mindset can have on our ability to attract success. Whether marketed as the law of attraction, as it is being done now, the underlying principle remains the same. This being, that our minds have a powerful impact on our lives, decisions, successes and failures.

Ideally, this way of thinking should be instilled in our forming years when we are picking up habits and developing character traits. However all is not lost for the negatively inclined among us. By policing your thoughts and being aware of their impact, you can teach yourself to think differently.

Positive thinking allows us to improve the quality of the lives we lead. The seemingly simple act of maintaining a positive mindset can impact many different aspects of our lives and help us to attract the form of success that we desire.

If you want a home business that will succeed you need to learn the right ways to market. With the Internet marketer you have all the help you need. Go online and find out more.

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Oct 19 2009

What is a quality manual for ISO 13485?

Category: Business and Industry — Mark Kaganov @ 1:11 pm

A quality manual is the top-level document of a quality management system. It is similar to a constitution of a country or a manifesto of a party. This type of document establishes the policy-level position of a government, party or in the case of a quality manual, a company’ QMS. There are at least two definitions of what a quality manual for an ISO 13485 quality management system should be:

ISO 10013, Guidelines for Developing Quality Manuals, element 4.2, provides suggestions for creating a quality manual. This standard describes a quality manual as a document that “consists of, or refer to, the documented QMS procedures intended for planning and administration of activities which impact on quality” ISO 13485 2003, element 4.2.2 describes a quality manual as a document containing:

1 – the scope of the quality management system

2 – details of and justification for any exclusion or non-application;

3 – the documented QMS procedures or reference to them;

4 – relationships between the processes of your quality management system, and

5 – description of the QMS documentation.

Typically, companies state the scope of their QMS in the Scope or Introduction sections of their quality manuals, similar to “XYZ Corporation assembles, packages and distributes personal hygiene product packs to hospitals and doctors’ offices”

Now, when we established the scope of our ISO 13485:2003 QMS, we need to describe the processes we use to achieve the results stated in our scope. While we are doing this, we need to remember to reference corresponding procedures. Per my experience, the easiest way to do it is to transform the standard from a list of requirements into your organization’s dedication to satisfy those requirements. For example: Element 5.5.2.c of ISO 13485 2003 requires a Management Representative to ensure ” promotion of awareness of regulatory and customer requirements ” our manual will affirm: “The Management Representative ensures that regulatory and customer requirements are clearly communicated throughout the organization per the Purchasing Procedure and Regulatory Compliance Procedure.”

Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the third requirement for a quality manual. Continuing addressing all applicable elements of the standard and referencing supporting procedures, we will develop a quality manual satisfying requirements of the standard.

Interaction between the processes may be documented in a number of ways. Some companies choose to define interaction of the top level processes by using variations of Figure 1 in ISO 9001 2008. Combining such a diagram with references to procedures, will define interactions between your processes. For more detailed process interaction tools, type “process interaction matrix” into your browser and you will find numerous examples.

The fifth requirement of the element 4.2.2 of ISO 13485 standard is to address the structure of the documentation. Many organizations I worked with defined their documentation structures as a 4- or 5-level structure in the documentation management section of the manual.

After completion of your quality manual, think about other benefits that a well prepared quality manual may bring you. It can communicate to your prospects, customers and vendors that your business is a quality-conscious organization and that it understands benefits of a well-documented commitment to quality and regulations.

I always wonder what companies achieve by stamping their quality manuals in bold capitol red letters “CONFIDENTIAL”. As far as I am concerned, a quality manual is a company’s resume for quality, and if you hide your resume, there is a very good chance that you will never get a job! All our customers are encouraged to make their ISO 13485 quality manuals public!

If you are developing or improving your ISO 13485 Quality Management System documentation, let Quality Works help you. We developed simple and esy to implement ISO 13485 Quality Assurance programs and documentation sets.

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Oct 07 2009

Is your ISO 9001 Quality Manual Complete? Checklist Will Tell

Category: Business and Industry — Mark Kaganov @ 10:14 pm
by Mark Kaganov

Some people call it “senior moments”, some people call it “spaced it out”, simply speaking, we all sometimes forget something – human nature.

Through my auditing career I found that often companies forget to include in their quality manuals various requirements of the standard.

Fortunately, there is a simple solution – use a checklist. A quality manual for ISO 9001 standard can be a somewhat complex document. It is not unusual that some of requirements may be missed and not addressed in the quality manual. Using a checklist will help you remember to address all the requirements. This is why many registrars use quality manual review checklists. If you are in the process of developing or tuning up your quality manual, you might ask your registrar for a checklist. If your registrar doesn’t have it, we will develop our own.

Creating a checklist for ISO 9001 standard is a relatively simple task. We basically need to transform the standard from its explicit set of requirements into a condensed list. Let’s start from a big picture and make sure that our manual includes all elements of the standard that we wish to address in our quality manual, such as Application (1.2), Quality management system (4), Management responsibility (5), and so on.

Obviously, there are numerous ways to design a checklist. Most typical format I have seen through my auditing career was a 3-column table allowing documentation of the number of the clause, the content of the requirement and the location of response to this particular clause. Take a look at the following example: Element 5 of the standard starts from the title: “Management responsibility”. Clause 5.1 is a title also. Numbering these titles 5 and 5.1 respectively, placing these titles in the checklist and indicating where in the QMS these titles are located will give us a starting point.

After creating this Table of contents, continue adding other requirements for the corresponding clauses of the standard. We will review element 6.2.2 as an example. The first requirement of this element is: “Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.” Depending on how detailed you want your checklist to be, you may include the entire requirement or split it into sub-elements: 6.2.2.i – Personnel performing work affecting product quality shall be competent on the basis of appropriate education; 6.2.2.ii – Personnel performing work affecting product quality shall be competent on the basis of training, etc.

When you document all applicable requirements of ISO 9001 standard in your checklist, you will be able to verify if your quality manual meets the requirement of your company and the standard.

The process above described a way to prepare a checklist for verifying quality manual for one standard. In fact, many organizations develop management systems for more than one standard. As an auditor, very often I see integrated ISO 9001 / ISO 14001 management systems. Don’t panic! The process is the same: integrate specific clauses on the second standard into your list which is based on the starting standard.

To see how easy it is to develop a checklist for ISO 9001 quality manual review, click the link below:

About the Author:
Working on your Quality Manual? Visit our ISO Checklist page to see how this publicatioon can help you writing your ISO 9001 Quality Manual.

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Aug 06 2009

ISO 9001 Corporate Manual

Category: Business and Industry — Mark Kaganov @ 10:52 pm
by Mark Kaganov

While numerous successful models of ISO 9001 quality management systems have been developed and are being used in various industries, approaches to documenting top level management systems for multi-location enterprises are limited at best. This article discusses a method for establishing an ISO 9001 top-level documentation structure that allows a business with multiple facilities to use common quality management system manual. This model significantly improves consistency of the corporate message regarding quality policies, while reducing the number of documents within the organization’s quality management system.

Working as a QMS Lead Auditor for numerous international ISO registrars, I assessed numerous big multi-facility organizations that had difficulties with synchronizing their home office ISO 9001 quality manuals with the corresponding documents controlled by their sites. Designing quality manuals for companies with multiple sites, organizations develop their sites’ quality manuals as copies of the corporate quality manual; other enterprises create facility-specific manuals that are totally autonomous and do not correlate with the corporate ISO 9001 manuals.

In practice, neither one of these approaches result in a consistent result. In the 1st instance when a modified quality manual is used for a location, methods for updating local quality manuals are not defined. This disconnect arises from the fact that the corporate office manuals are controlled by the home office, while local quality manuals are facilities’ responsibility.

In the case of companies choosing their facilities to develop their own ISO 9001 manuals, discrepancies in numerous quality manuals result in visible differences between the home office and facilities’ quality manuals.

From the corporate identity and simply business consistency points of view, an organization should not find itself in a position of having different or conflicting commitments of its facilities to quality, customer satisfaction, design approaches and other requirements of ISO 9001 standard.

One of Quality Works’ clients illustrated this deficiency. The home office manual documented majority of the applicable requirements. At the same time, one of their Mexico facilities did not reference required ISO 14001 standard, another missed a commitment to customer satisfaction, yet the third one forgot to document their training program all together!

Summarizing my consulting experiences, I am convinced that these approaches to design of the corporate quality manual and sites’ manuals do not provide a solid consistent way to document organization’s quality manuals.

Fortunately, there is a solution. Let’s review an example of ISO 9001 2008 quality manual model that references procedures. Our quality manual references supporting documents within the text of the manual. For example, element 4.2.1, Documentation requirements, general, may read: Your Company, Inc.’s QMS documentation includes: documented statements of the quality policy per the Quality Policy and quality objectives per the Key Indicator Matrix,

This model proved to be effective for a single-location company. This approach will also work for a multi-site business, but only for common documents that are used at all locations. For example, such procedures as Internal Audit, Management Review, Corrective and Preventive Action, and others may be the same for your all facilities and therefore be referenced in the quality manual as shown above.

While references to common procedures in an ISO 9001 quality manual are clear, we still have to address those documents that are specific to particular locations such as incoming inspection, org charts, product verification and others. When we wish to maintain just one quality manual, we need to reference in it supporting procedures for all sites which may easily clutter the manual. To solve this problem we will examine how a common quality manual can efficiently reference facility-specific procedures to address statements of the organization’s ISO 9001 quality manual.

As with a single-location company, a business can still use the same reference structure if the number of locations or sites is small; let’s say not to exceed three. For example, element 8.5.1 Continual improvement, may read: Yellow Submarine Company has established and maintains documented procedures to continually improve its QMS through the use of its Quality Policy, Quality objectives per the Quality Objectives Matrix HO and the Quality Objectives Matrix BA This example references the common Quality Policy and site-specific Quality Objectives Matrix HO (Home Office) and Quality Objectives Matrix BA (Buenos Ares). This model serves well quality management systems with limited number of facilities, but it becomes ineffective when the number of company’s locations increases.

For companies with a large number of locations, where we need to reference numerous documents in the manual, including those controlled by satellite locations, we have another option. We can establish a document to connect corporate quality manual commitments with the site-specific supporting documents. Let’s name this document a Manual Reference Matrix and consider the following document reference structure.

Corporate ISO 9001 Quality Manual element

Manual Reference Matrix Table of Contents (ToC)

Site-specific Manual Reference Matrix

Facility-specific document

The Manual Reference Matrix is simply a list of all facilities and their Manual Reference Matrixes, as shown below:

Manual Reference Matrix Table of Contents

Corporate Office (Salt Lake City, UT USA)

Millburn (Australia)

Jacksonville, IL (USA)

Buenos Aires, (Argentina)

Port Williams (Chile)

etc,

Let’s see how this model works. We will document element 8.4, Analysis of data: Sunrise, LLP has established and maintains documented Management Review Procedure and site-specific data analysis procedures per the Manual Reference Matrix ToC to determine, collect and analyze appropriate data to determine the suitability and effectiveness of the Quality Management System to evaluate areas where continual improvements of the effectiveness of the ISO 9001 QMS can be made This element states that the company uses common Management Review Procedure and site-specific data analysis procedures. To locate a site-specific data analysis procedure, we simply need to consult the Manual Reference Matrix ToC.

Clicking the hyperlink Ontario (Canada), for example, we will find a site-specific Manual Reference Matrix. Locating a specific element in the location’s Manual Reference Matrix, we will find a particular, location-specific document that corresponds with this clause of out ISO 9001 quality manual.

Quality Manual Reference Matrix may be formatted as a three-column table with the Manual Clause in the first column, HO References in the second and Location References in the third column. For example, for the element 8.4, Data Analysis, the Los Angeles plant’s Matrix indicates that the manual references Data Analysis Procedure HO for the corporate office and Data Analysis Procedure LA for the Los Angeles plant.

Looking for samples of a quality Manual Reference Matrix for ISO 9001 QMS? Check links below.

About the Author:
If you are tuning up your ISO 9001 Quality Manual for a large corporation and do not want to reinvent the wheel, check our Quality Assurance Manual Reference Matrix. If you have questions or need help with implementation of your Corporate Manual, check our Quality Management ISO 9001 consulting services and documentation sets.

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Aug 03 2009

ISO 13485 2003 Quality Manual

Category: Business and Industry — Mark Kaganov @ 1:45 pm
by Mark Kaganov

Well, formally there are a number of definitions of what a quality manual is. These definitions are in ISO 10013, ISO 13485 and other standards. In fact, a quality manual is a top-level document defining your quality management system. A quality manual establishes the policy level position of your organization in the area of quality management system. There are two principal definitions of what a quality manual for an ISO 13485:2003 QMS should be:

ISO 10013, Guidelines for Developing Quality Manuals, element 4.2, gives detailed suggestions for creating a quality manual. It defines a quality manual, among other requirements, as a document that should “consist of, or refer to, the documented quality system procedures intended for planning and administration of activities which impact on quality”. ISO 13485:2003, element 4.2.2 requires a quality manual to include:

1 – the scope of the quality management system

2 – justified exclusions or non-applicable clauses;

3 – quality management system procedures or reference to them;

4 – relationships between the processes of your quality management system.

5 – definition of the QMS structure

Typically, companies state the scope of their QMS in the Scope or Introduction sections of their quality manuals, similar to “XYZ Corporation assembles, packages and distributes personal hygiene product packs to hospitals and doctors’ offices”

Now, after we established the scope of our ISO 13485:2003 QMS, we need to describe the processes we use to achieve the results stated in our scope. While we are doing this, we need to remember to reference corresponding procedures. Per my experience, the easiest way to do it is to transform the standard from a list of requirements into your organization’s dedication to satisfy those requirements. For example: Element 5.5.2.c of ISO 13485:2003 requires a Management Representative to ensure “? promotion of awareness regulatory and customer requirements ?” our manual will affirm: “The Management Representative ensures that regulatory and customer requirements are clearly communicated throughout the organization per the Purchasing Procedure and Regulatory Compliance Procedure.”

Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the third requirement for a quality manual. Continuing in a similar way, addressing all applicable elements of the standard and referencing corresponding procedures, we will develop a quality manual satisfying requirements of the standard.

Various methods are used to document process interactions. Some companies utilize Figure 1 from ISO 9001:2000 standard to document relations between main processes. Use of such an illustration and references to your procedures, will define interactions between your processes. You can find additional models for process interactions on the Internet. Just, type “process interaction matrix” into your browser and you will find your answers.

The last requirement of the element 4.2.2 is to outline of the structure of the documentation. Very often I see companies defining their structures as four- or five-level documentation structure in the documentation management section of the manual.

Another important function of a quality manual, very often overlooked, is as a marketing tool. Well written and professionally published, a quality manual may become a powerful marketing instrument. It can communicate to your potential customers, suppliers and subcontractors that your company is not only a quality-conscious organization, but that it also knows how to document and communicate its commitment to quality and compliance with regulatory requirements.

It was always a mystery to me why some companies mark their quality manuals with a big red stamp “FOR INTERNAL USE ONLY”. Our clients are strongly encouraged to make their quality manuals public, assuming that your manual did not include any proprietary information.

About the Author:
Before you start working on or optimizing your ISO 13485 Quality Manual visit our ISO 13485 page to learn more about Quality Management systems for medical device manufacturers

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Jul 30 2009

Agents Expand Traditional Company To Global Network

Category: Management — Michael Eckhards @ 6:00 am
by Michael Eckhards

Even the current turbulent situation in the global market, Ningbo Xinda Group AUGUST Screw Air Compressor division, is using the opportunity to improve and upgrade the standards of their products. Being already a leader in the field of Rotary Screw Air compressors with own and independent R&D , AUGUST Screw Air Compressors will now be equipped with ASME certified pressure tank for the oil ” air exchangers.

In the beginning of the year 2009, Ningbo Xinda Screw Air Compressor AUGUST did already publish the certification for all models of the Screw Air compressor line by the famous EURO CERT official body for CE marking.

In most countries around the world CE is considered as an essential and valid requirement to ensure the safe and long lasting performance of products. In addition to the CE marking, AUGUST compressors are now also equipped with a ASME certified pressure vessel. This will ensure an even more safe working environment when using the compressor and promoting the product to clients.

These steps done by Ningbo Xinda AUGUST Screw Air compressor brand, is to ensure that you can get the best value and safety of the product at an most competitive price. In addition: All compressors come with an 5 years company warranty on the screw.

These quality , durability and safe series of rotary screw air compressors with many notable technical benefits and energy saving features and variable speed drive technology, is exported to many countries around the world with growing market shares . For experts in the field of screw compressors or qualified companies, Ningbo Xinda group is offering the opportunity to join the fast growing global network of distributors and agents. More than ever, in these difficult days and uncertainties of the markets , it is important to have the full back up of a reliable and experienced manufacturer, which will help you to maintain and even develop your business. Ningbo Xinda Group is such a supplier and manufacturer.

Please get directly in contact with Ningbo Xinda Group AUGUST Screw Air Compressor division for enquiries or more detailed information.

About the Author:
A brand build on 36 years of development and engineering .Advanced and energy saving technology are the corner stone of the success. Agents and distributors are invited to be part of this success story.

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Jul 17 2009

Documentation Structure for ISO 9001 QMS

Category: Business and Industry — Mark Kaganov @ 4:55 pm
by Mark Kaganov

ISO 10013, Guidelines for Developing Quality Manuals, gives an example of a documentation structure for ISO 9001 quality management systems. While this document suggests using a three-level structure, most companies implement four-level documentation structures to include records, as required by element 4.2.4 Control of quality records, of the ISO 9001:2000 Standard. A typical four-level documentation structure includes:

Quality Manual – level 1

Procedures – level 2

Instructions – level 3

Records – level 4

While auditing systems like the one above, I always asked clients about the position of their quality policy in this structure. If you start from a quality manual, how go you know what standard this manual should cover? The quality policy defines it and therefore it should be included into the structure:

Quality Policy – level 1

Quality Manual – level 2

Procedures – level 3

Instructions – level 4

Records – level 5

Document titles for your ISO 9001 QMS

Some companies use very “wordy” titles for their documents. One of companies I worked with named their Procurement procedure as “Standard Operating Procedure for Purchasing and Vendor Control.” While extremely descriptive, this title is not efficient.

It is a very typical convention in the medical device manufacturing and other regulated industries to call the second-level documentation Standard Operating Procedures, known as SOPs. Unless one has a level called “Non-standard Operating Procedures,” I really do not see a practical or economical reason for long titles like these. As long as the short name conveys the idea and leads us to the right place, let’s use it. I will promote this optimization and reduction of waste approach throughout this publication. Let’s not make things more complicated than they practically need to be.

Numbering your documents

No standard prescribes to give a part or a document its number. It is an industry standard to give a document or a component its name, number and a revision level. Similar to part titles that we discussed above, document numbering conventions are often also may be optimized and simplified.

Once I worked with a company of less than 100 people, manufacturing fairly simple devices. Their documentation system consisted of a few numeration systems depending on the type of document. One of the procedures had a number 0000057-001, which they simply called “fifty seven.” A drawing was numbered 327-856-99-17.

Is it acceptable to have long and difficult-to-read and remember numbers? Yes, of course! Is it practical? I do not believe so! In the example above, the procedure number, without the tab, contained seven digits. This meant that the system was prepared to handle almost 10 million document or part numbers (PN). The company had approximately 250 documents and probably would never go beyond 300. If nothing else, just reading these numbers with five sequential zeros may give one a headache. Surprisingly, this is not the worst case I have experienced! The company that won my “The Worst Part Number” Grand Prize assigned 12 (!) digits to their part numbers in the alphanumeric format.

If you are designing and building a Trident-class submarine, a MIG-27 jet fighter or an international space station, you, most likely, will need millions of parts, so a long part number format would be needed and will make sense. Otherwise, save yourself the trouble of reading all those zeros and make your numbering system practical. One of my customers, who won my “The Best Part Number” Grand Prize, numbered their documents as 101, 102, 103, and so on. Short and sweet!

There is another opportunity for improvement of many QMS – part number designation. Many companies relate a document number to a document type. For example, 20-xxxx indicates a procedure, 30-xxxx indicates a drawing, SOP-xxxx indicates a standard operating procedure, etc. My practice with a few QMS that used designation approaches showed that “no designation” systems are more practical. Several QMS that used designation I have worked with have failed. Not long ago, one of my clients mentioned that they ran out of range in their document numbering format. The QMS initially permitted for identifying suppliers through a two-digit identifier within the part number. While the company grew, the number of supplier increased beyond expectations and eventually the company needed more than 99 suppliers. This resulted in the document number format to being able to support new needs.

An alternative approach to part numbering is a “no designation” system, where parts are given sequential unique numbers within a specified format, regardless of their type, material, application or other attributes. After all, isn’t the part title the best designator? Seriously, through my entire professional career, I worked only with one company that did not use even document numbers. Their documents were simply identified by titles and a two-digit revision level, like The Prefect Manual 01.

About the Author:
If you are improving your ISO 9001 2008 QMS, our documentation set can help your company. Visit Quality Works Website and order your Quality Management System system today! Quality Works provides management system consulting worldwide.

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Jul 10 2009

The Two Most Important Things to Know When Having a Cement Step, Driveway, or Patio Installed

Category: Family — Robert Swedeen @ 5:31 pm
by Kurt D. Madigan

We’ve all seen sidewalks, driveways, or concrete steps that are crumbling away to dust much sooner than should occur. This could have been prevented simply by using the right material in the first place. There are many different brands and types designed for different applications and even different climates. Using the right material for the job and location makes all the difference in the world, especially when it comes to lasting a lifetime.

Learning which kind of concrete to use for your specific region/climate is always a good idea. Knowing what you want, or what should be used, can be helpful when getting a quote from a contractor. This knowledge will help ensure you are getting the best material for the job.

Many concrete brands vary what type of rock mixture they use, and with Minnesota’s weather extremes, the only sure choice is All Granite-Mix Redi-Mix concrete. Also in Minnesota, on driveways or other long expanses a class seven base fiber mesh additive should be used to add additional strength to the concrete.

It’s ok if you don’t know right now what all granite or fiber mesh is. Do a little research. It will help knowing these things when it comes time to get a professional contractor out to do an estimate. In laymens terms, you want the best material to be used so the finished product comes out beautiful, and stays that way for years to come.

Quality materials are just the first step; quality workmanship is next, and just as important. Take the time to research the company you are considering. Ask questions like, How long has this company been around?, Are they licensed, bonded, insured, or supported by quality control companies like the Better Business Bureau?, Are they willing to give you addresses and names of past customers?, Does it feel like they are listening to your needs, or just trying to sell a job?, and other questions along those lines. Remember, this is your home, and you want it done professionally and up to your standards.

About the Author:
Don’t mess around when it comes to selecting your cement contractor. G. Vizecky Contracting is a quality-oriented, family owned business that has been serving the Twin Cities community since 1946. Give them a call at (612) 825-6616 to set up a free, no obligation estimate, or follow these links to learn more about cement installation or to see some of their work.

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