The 9000 Resource

Document Control Software

There are some posts on this blog about documentation, and our site (www.the9000store.com) gives some information on document control, but I've never felt comfortable enought to recommend a software package for electronic document control.  We've looked at several software solutions, but none seemed to match our expectations of user friendliness, cost-effectiveness, and flexibility.

Then we found a little gem called isoTracker - and they meet all our criteria: Simple and Intuitive, Flexible and User Friendly, Cost Effective (less than three dollars per day.) while being Scalable. We've played around with it, and can recommend this product 100% without any hesitation...See for yourself. I know some people who have bought it already and love it.

Some of the features and benefits of isoTracker:

• Custom folders allow you to take complete control over your document library
• Approval functionality enables collaboration: Track approvals to ensure no one is left out of the loop
• Trace document distributions to avoid lost copies of obsolete manuals
• Improve productivity by sharing approved quality policies, work instructions, and processes with employees
• Ensure compliance with ISO quality requirements with minimal pain and cost

Since isoTracker is pure web-based software you have nothing to install and can get started right away. No IT involvement is needed. It has all of the elements of a *full-featured quality management system* for ISO Certification:

• Non-Conformances
• Calibration Records
• Customer Complaints
• Supplier Quality
• Audit Management
• Corrective & Preventive Actions
• Training & Employees
• Document Management, and more

I'll let them (isoTracker) give you the details, but I recommend signing up for a free demo to see for yourself.

AS9100/AS9110/AS9120 - Aerospace Quality Management Systems

What is AS9100?

This is our fifth in a series on: Branching out - Other Standards based upon ISO 9001.  This is #1 of 3 on AS9100 - Aerospace Quality Management Systems, followed by AS9110 for Maintenance Facilities and AS9120 for Pass-Through Parts Distribution.

History:

The AS9100 family of standards was started with AS9000, which was developed as an SAE standard by a group of US aerospace manufacturers. (SAE was originally an aircraft standard organization way back when - not just automobiles.) It was similar to Boeing's D1-9000, but the goal was a more widely accepted standard  that many manufacturers could use. 

The International Aerospace Quality Group(IAQG) manages the standard development process, gathering input from industry professionals across the globe:
•Americas - Americas Aerospace Quality Group (AAQG) Sponsored by SAE
•Asia - Society of Japanese Aerospace Companies (SJAC) Sponsored by the Society of Japanese Aerospace Companies (SJAC)
•Europe - AeroSpace and Defence Industries Association of Europe (ASD) Aerospace and Defense Industries Association of Europe (ASD)

How does AS9100 compare to ISO 9001?

AS9100 is the document which defines the requirements for the QMS and provides guidance for its use. AS9100 is based on the Plan-Check-Do-Review-Improve cycle of ISO 9001.

For more information please visit the tutorial Basics of AS9100 and note the similarities

It expands upon the basic ISO 9001 standard with a growing number of additional requirements focusing on component quality and reliability:

• Configuration management
• Design phase, design verification, validation and testing processes
• Reliability, maintainability and safety
• Approval and review of subcontractor performance
• Verification of purchased product
• Product identification throughout the product’s life cycle
• Product documentation
• Control of production process changes
• Control of production equipment, tools and numerical control machine programmes
• Control of work performed outside the supplier’s facilities
• Special processes
• Inspection and testing procedures
• Methods, resources and recording
• Corrective action
• Expansion of the internal audit requirements in ISO 9001:2000
• First article inspection
• Servicing, including collecting and analyzing data, delivery, investigation and reporting and control of technical documentation
• Review of disposition of non conforming product

Current Revision:

The current revision AS9100 Rev C (01-2009) not only encompasses the relatively minor updates to the ISO 9001:2008 revision, but expands the standard to cover the defense contractors as well as additional changes in the requirements.

For more information please review the AS9100 Rev C revision details.

Who uses AS9100?

The short answer: any organization wanting to sell to the Aerospace and Defense industry.  However, the standard is broken down into three segments:
1.
Our next issue will explore these different versions of AS9100

ISO 14001: Steps to Certification

This is our fourth in a series on: Branching out - Other Standards based upon ISO 9001.  This is #2 of 2 on ISO 14001 - Environmental Systems.

Steps to ISO 14001 Certification

 What do we need to do to become ISO 14001 Registered?

You will need to get some general training on ISO 14001 so you understand what you need to do in your company to meet the requirements of the standard.

Consider Introduction to ISO 14001 presentation materials package.

As with any ISO 9001 based Standard, there is an initial assessment and four basic steps of Plan-Do-Check-Act (PDCA):

For the Initial Assessment: Establish your environmental goals (policy) and Conduct an Initial Environmental Review. State your environmental position, determining your organization’s current status and compare it to the goals you plan to meet. 

View the free online tutorial Initial Environmental Audit

1. PLAN: Develop and document your ISO 14001 Environmental Manual and Procedures
The biggest portion of the project is looking at your current processes, and redesigning them to address all of the requirements in the standard. Once you have modified or developed processes to meet the standard, you will need to control those processes. Documenting the processes as Quality System procedures is part of this control.

Learn about the ISO 14001 Documentation Package

2. DO: Use and improve your EMS
Once your system is developed and documented, employees will follow the procedures as part of running your organization. For approximately three months or more, your organization will run the EMS, collecting records.

Learn more about Auditing ISO 14001

3. CHECK: Checking for any problems and correcting them.
Your organization will self-audit, collect records, and make improvements to the system. This prepares the organization for a Self-Declaration of compliance and/or an Audit by a Registrar.

During these audits, the Auditor will be looking at your EMS to make sure that it meets the requirements of the standard. If they find that there are pieces of your EMS that do not meet the requirements, they will document a "Nonconformance". Your registration will be dependant on your correcting any nonconformances that are found.

4. ACT : Evaluating the effectiveness of the EMS and improving it
Your team will continually review the processes and look for areas of improvement, raising the goals once they are met.

The documented Requirements of ISO 14001 are:

• 4.1 Environmental Policy
• 4.2 Planning
• 4.2.1 Environmental Aspects
• 4.2.2 Legal and Other Requirements
• 4.2.3 Objectives and Targets
• 4.2.4 Environmental Management Program(s)
• 4.3 Implementation and Operation
• 4.3.1 Structure and Responsibility
• 4.3.2 Training, Awareness, and Competence
• 4.3.3 Communication
• 4.3.4 EMS Documentation
• 4.3.5 Document Control
• 4.3.6 Operational Control
• 4.3.7 Emergency Preparedness and Response
• 4.4 Checking and Corrective Action
• 4.4.1 Monitoring and Measurement
• 4.4.2 Corrective and Preventative Action
• 4.4.3 Records
• 4.4.4 EMS Audit
• 4.5 Management Review

The additional ISO 14000 Series Standards are really guidelines to help you achieve registration to ISO 14001.  

• ISO 14004 provides guidance on the development and implementation of environmental management systems 
• ISO 14010 provides general principles of environmental auditing (now superseded by ISO 19011) 
• ISO 14011 provides specific guidance on audit an environmental management system (now superseded by ISO 19011) 
• ISO 14012 provides guidance on qualification criteria for environmental auditors and lead auditors (now superseded by ISO 19011) 
• ISO 14013/5 provides audit program review and assessment material. 
• ISO 14020+ labeling issues 
• ISO 14030+ provides guidance on performance targets and monitoring within an Environmental Management System 
• ISO 14040+ covers life cycle issues

Note: ISO 14001 is the only ISO 14000 standard which can be certified by a Registrar.

Learn about ISO 14001

The ISO 14001 Workbook is a series of detailed checklists, exercises and instructions that take you through 30 systematic tasks for your organization to consider and complete.

The Workbook includes a set of three ISO 14001 PowerPoint training presentations designed to be a companion to the Workbook. Use these to train everyone in the organization on the ISO 14001 implementation and system. These products are all integrated to work together to help you achieve certification. This is an effective method that is well suited to small and medium size organizations.

This is #2 of 2 on ISO 14001 - Environmental Systems. Next we will address AS9100 - Aerospace Systems.

What is ISO 14001?

This is our third in a series on: Branching out - Other Standards based upon ISO 9001.  This is #1 of 2 on ISO 14001 - Environmental Management Standard.

What is ISO 14001:2004?

The International Organization of Standardization, (ISO) is a worldwide organization that develops many different kinds of Standards – not just quality standards. ISO 14000 is a series of documents relating to the implementation of an Environmental Management System (EMS).

ISO 14001 is the document which defines the requirements for the EMS and provides guidance for its use. ISO 14001 specifies the requirements of an environmental management system (EMS) for small to large organizations. An EMS is a systemic approach to handling environmental issues within an organization. The ISO 14001 standard is based on the Plan-Check-Do-Review-Improve cycle of ISO 9001 – even though it is not a Quality Management System.

To learn more we recommend this free tutorial "The Basics of ISO 14001?"

How does ISO 14001 relate to ISO 9001?

ISO 9001 is a Quality Management System (QMS) which similarly gives organizations a systematic approach for meeting customer objectives (providing consistent quality). An important difference between ISO 14001 and other ISO standard is that it describes the requirements for an environmental management system that can be used for the registration of the management system and / or for the self-declaration of compliance by an organization. 

If you'd like to learn more, here is a comparison of ISO 9001 and ISO 14001

What is an Environmental Management System (EMS)?

An EMS gives an organization a systematic approach for managing their environmental impact (the consequences of their operations). The objective is for ISO 14001 to control environmental impact of the organization’s actions and continually increase the environmental performance as measured against objectives.

Why do companies want to pursue ISO 14001?

Fundamentally, it is everyone’s job to protect the environment by preventing pollution and continually improving the air we breathe, the water we drink, and the earth we inhabit.  But there are several specific reasons for implementing an EMS:

It’s the right thing to do
Organizations are becoming increasingly concerned in achieving sound environmental performance to demonstrate that you are a “Good Corporate Citizen”.
• Improved environmental performance—protect the environment
• Improved customer trust and satisfaction by conforming to ISO 14001 International Standards
• Improved public image and community relations—recognized for achieving certification
• Fewer accidents due to properly handled dangers

Reduced Liability
• Improved compliance with environmental regulations—Federal (EPA), State (State environmental agency), and Local (permits)
• Increased employee involvement—implementing ISO 14001 is perceived as “the right thing to do”
• Reduced liability and risk exposure by ensuring an environmentally safe system

Market Pressure
Many organizations decide to Implement ISO 14001 and obtain registration because it assures customers, shareholders, suppliers, regulators and the community at large that the company has a good Environmental Management System (EMS) in place. An organization with an effective EMS will typically meet customer expectations and comply with regulations better than an organization that does not have an effective EMS. Many organizations require their suppliers to have ISO 14001 Registration
• Gain competitive advantage—use environmental improvements to enhance marketing efforts

Cost Savings:
Implementing ISO 14001 often delivers cost savings:
• Reduced costs by avoiding excessive waste and associated costs
• Reduced materials and energy usage
• Increased efficiency by improving and standardizing environmental related processes

Is it right for our organization?

We've now given you a brief overview of ISO 14001, the Environmental Standard rooted in ISO 9001 Quality Standard.  Only you can decide if it is right for your organization, but it's certainly the right thing to do for our planet. If you'd like to learn more:

The Executive Overview of ISO 14001 gives more information for consideration of ISO 14001.
The Benefits and Costs of ISO 14001 will help you evaluate the advantage to your organization.

Our next issue will focus on how to implementISO 14001:2004

ISO 13485 for Medical Devices - Part 2: Who is requiring it and why should I do it?

This is our second article in a series of Articles on: Branching out - Other Standards based upon ISO 9001.  This is #2 of 2 on ISO 13485 - Medical Standards.

Who is requiring companies to be ISO 13485?

ISO 13485 is recognized in most major markets (including the EU, US, Canada, Japan, and Taiwan). It is very likely that it will be widely adopted by other regulatory authorities around the world. You can get it all with one single audit!
 
ISO 13485 it is based on ISO 9001. ISO 13485 does not include the customer satisfaction and continual improvement clauses. If an organization is certified to ISO 13485, it does not automatically meet the requirements of ISO 9001.The company should separately acquire ISO 9001 certification also. This free tutorial Compares ISO 9001 & ISO 13485.
 
ISO 13485 certification does not equate compliance with regulatory requirements, although in many cases it can facilitate the audit process for those requirements. Here is an overview of the Terms & Regulations for Medical Devices. 
 

Why should my organization become certified to ISO 13485?

ISO 13485 also incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system including:

1.     Expanded market access gives you:

• You will be able to work within many countries where ISO 13485 is a regulatory requirement and with many organizations where it is a contractual obligation or expectation.

• Your company will be able to win more business opportunities – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.

• The certification serves as a proven credential as it is an independent verification against recognized standards.

• ISO 13485 is globally recognized as the “best quality practices” from organizations within the medical device industry.

• This is quality system which satisfies the rigors of an independent, external audit and lays stress on additional safety, regulatory, and quality concerns specific to the medical device industry.

• This certification helps to create a systematic procedure using which the organizations monitor, measure, and analyze their processes and customer feedback.

• This certification gives you a Shorter Sales Cycle - less time is needed to earn your prospective customers' trust and confidence.

2. Overall performance improvement – Once you are certified QMS, it helps you to improve your products and processes. This certification is based on a uniform and widely accepted system of process control that gives you:

•  ISO 13485 certification means higher customer satisfaction .The delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements satisfies the customer.

  • Striking improvement is noticed in stakeholder relationships – including staff, customers, and suppliers.

  • ISO 13485 helps you to understand how statutory and regulatory requirements impact an organization and its customers. Thus it helps in legal compliance.

  • Certification like ISO 13485 enhances the image of the company in the eyes of customers, employees, and shareholders and all.

  • You need this certification to provide improved performance in areas such as increasing sales, timeliness in getting products to the global marketplace, reducing costs, decreasing number of errors, lessening wastage, better utilization of time and resources, and lowering product failures.

  • Helps in improved risk management – this is done through greater consistency and traceability of products and using risk management techniques.

  • ISO 13485 is a framework for implementation of actions (where necessary) which ensures achievement of planned result and maintaining effectiveness of those processes which are applicable to customer, quality and regulatory requirements.

An ISO 13485 certification means ability of your organization to do business in the highly regulated sectors. It demonstrates your organization’s commitment to quality, customers, and your willingness to work towards improving efficiency.

Here is a "Benefits & Costs of ISO 13485" PowerPoint with additional information.

Our next issue of "Branching out - Other Standards based upon ISO 9001" will discuss ISO 14001 - Environmental Management - which isn't a quality standard but is still based upon ISO 9001 and the Plan Do Check Act structure.

ISO 13485 for Medical Devices Part 1 - What is ISO 13485?

This is our first in a series of Articles on: Branching out - Other Standards based upon ISO 9001.  This is #1 of 2 on ISO 13485 - Medical Standards.

What is ISO 13485 for Medical Devices?

ISO 13485 is an ISO Standard, published in 2003. The ISO 13485 was designed for organizations that provide medical devices or related services. It provides the requirements for a comprehensive management system for the design and manufacture of medical devices.

To learn more we recommend this free tutorial "What is ISO 13485?"

ISO 13485 is generally harmonized with the ISO 9001 standard, though it is a stand-alone document. ISO 13485 removes ISO9001's emphasis on continual improvement and customer satisfaction though it has been developed based on ISO 9001. It lays emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices.

If you'd like to learn more, here is a comparison of ISO 9001 and ISO 13485

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. To ensure this, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.

Organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 because certain points have been excluded in ISP 13485.

ISO 13485 certification does not fulfill the requirements of either the FDA or foreign regulators. This certification aligns an organization's management system to the requirements of the FDA's Quality System Regulation requirements (like CFR 21Part 820) as well as many other regulatory requirements in use throughout the world.

Here is a review of some of the Medical Terms & Definitions, Classes & Regulations

Once you get ISO 13485 certification, it will help your organization do business in this highly regulated sector. It will demonstrate that your organization is committed to quality, customers, and is willing to work towards improving efficiency.

ISO 13485 promotes harmonization of regulatory requirements for manufacturers of medical devices on an international scale. Is it right for you?

Consider this PowerPoint: ISO 13485 executive overview.

Our next issue will focus on Who is requiring ISO 13485 and why should I implement it?

Branching out - Industry Standards based upon ISO 9001

Most of the information in this blog has (obviously) been about ISO 9001, but there are several other standards which take ISO 9001 and configure it for a specific industry.  all follow the Plan-Do-Check-Act (PDCA) platform with a very similar structure.

Having "industry specific" standards raises the following questoins:

1. Don't special QMS's defeat the purpose of a uniformly accepted standard?
2. What is really different from one to the next?
3. Doesn't every vehicle need to be safe? Are Automobiles that much different than aircraft? 
4. Why doesn't ISO 9001 work for all of these industries?

These are great questions and learning about the different standards will shed some light on the reasons why.

January will begin a series of topics on what those standards are and why they came into existence. They include:

• ISO 13485 - Medical Devices Quality Managment System

• ISO 14001 - Environmental Management Systems

• AS9100/AS9110/AS9120 - Aerospace Quality Management Systems for Manufacturing/Maintenance Facilities/Pass-Through Parts Distribution

• ISO/TS 16949 - Automotive Industry Quality Management System

• ISO 17025 - Labratory Quality Management System

• and more...

Enjoy this holiday season and come back to learn from this informative series.

 

The 9000 Resource

Let's not Forget the Benefits of ISO 9001...

Let's not Forget the Benefits of ISO 9001...

With all the talk about the 2008 changes in ISO 9001 being so minor that they don't add value, sometimes people start wondering if they offer any value besides paperwork.  The answer is a resounding YES, and here are just some of the benefits of implementing a QMS:

Increased Efficiency: The companies have done extensive researches on the processes they are following, how to maximize quality and efficiency before going through the ISO 9001 Quality Management Standards certification process. Once they achieve certification, the processes are established. There are guidelines which can be easily followed by anyone, making it easy to provide training, transitions and even for trouble shooting purpose.

Increased Revenue: It has been observed that ISO QMS certified companies have showed improvements in the field of productivity, financial performance as compared to the uncertified ones.

Employee Morale:  The staffs are more satisfied and motivated once there are defined roles and responsibilities, accountability of management, established training procedure and a well defined picture of how the roles of the employees affect quality and overall success of the company.
 International Recognition: The International Organization for Standardization (ISO) is recognized worldwide as the authority on quality management.

Factual Approach to Decision Making: The ISO 9001 QMS standard sets out clear instructions regarding audits and process reviews. This helps in information gathering and decision making based on data.

Supplier Relationships: ISO certification has been found beneficial regarding supplier relationships. The documentation and testing procedures helps to ensure the quality of the raw materials used for production purpose. This also helps in properly evaluating a new supplier before changing suppliers. There is procedure to check consistency with respect to how and where orders are placed.

Documentation: Since the ISO QMS standard requires proper documentation of all processes, and changes made, errors or discrepancies, it ensures consistency of the production procedure. The staffs are also more accountable. Documentation also guarantees that traceable records are available in case of non-compliant products or raw materials.

Consistency: Since all processes are documented, there is minimum scope of errors. Processes starting right from research and development, covering production, shipping are well documented. Even any small change in the process have to be documented ensuring that the changes are well planned and implemented in the best possible way to ensure maximum efficiency.

Customer Satisfaction: Companies can gain confidence of clients easily because the ISO is a universally acceptance standard. ISO 9001 QMS certification ensures efficiency, consistency and dedicated quality service by the companies thereby ensuring satisfaction of the customers.

Improvement Processes: The ISO 9001 QMS emphasizes on audit processes, management review and improved processes based on collected data. Based on facts and using a system of documentation and analysis, improvements are carefully planned and implemented. This ensures that the best decisions are made for your company.

So as we debate the significance of the revision, let's all focus on the overwhelming benefits of the ISO 9001 Quality Management System and try to improve our processes.

ISO launches video clip : "The ISO 9000 family – Global management standards"

With the publication of ISO 9001:2008 imminent, ISO has just launched a video clip in which users share their perspectives on earlier ISO 9001 editions and other standards in the ISO 9000 family which has become the global benchmark for quality management systems. The ISO 9000 family – Global management standards takes the form of a fictional television business news report on ISO 9000 in which real users speak from their personal experience in the varied contexts of multinational industry, a humanitarian aid organization and a police department, which ISO says underlines the combination of flexibility, efficiency and effectiveness of the ISO 9000 approach.

ISO Secretary-General Alan Bryden comments: "Whenever the ISO 9000 family is evoked, the emphasis is usually on ISO 9001 certification. This video is refreshing because the users emphasize the importance and benefits of ISO 9000 aspects such as management commitment, metrics, customer focus, continual improvement, knowledge transfer, cost savings and the eight quality management principles."

To view the video, please visit: http://www.iso.org/iso/pressrelease/iso9000_video.htm, and the entire ISO press release can be found here: http://www.iso.org/iso/pressrelease.htm?refid=Ref1174

ISO 9001:2008 is here...finally.

After much delay, ISO has finally released ISO 9001:2008 and you can purchase buy a copy of the ISO 9001:2008 Standard and review for yourself.  Even if you are involved with other standards, don't forget that ISO 13485, 14001, TS 16949 & AS9100 are all based upon ISO 9001 so you should be familiar with the new 9001 revision. 

ISO Organization's Introduction and support package

(© 2008 ISO)

In conjunction with the publication of ISO 9001:2008, Quality management systems - Requirements, ISO technical committee ISO/TC 176, Quality management and quality assurance, subcommittee SC 2, Quality systems, has published a number of guidance modules:

• Guidance on ISO 9001:2000 sub-clause 1.2 "Application" 
• Guidance on the documentation requirements of ISO 9001:2008
• Guide to the Terminology used in ISO 9001 and ISO 9004
• Guidance on the concept and use of the process approach for management systems
• Guidance on 'Outsourced processes'
• Implementation guidance for ISO 9001:2008
• Frequently Asked Questions

Transition schedule

• ISO and IAF announce schedule for implementation of accredited certification to ISO 9001:2008

ISO Management Systems articles

• New editions of ISO 9001 and ISO 9004
  Advice for users on implementing ISO 9001:2008

This should finally ease all of the hesitation of people waiting to implement ISO 9001 until the revision is released.  Finally.  Now get going and implement!