The 9000 Resource

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 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!

The ISO 2007 Survey is Released

The ISO Survey of Certifications – 2007 reveals certification activity around one or more of ISO's management system standards in 175 countries, up from 170 in 2006 – "a clear demonstration", according to the survey, " that they have become essential tools of the world economy".

ISO Secretary-General Alan Bryden comments: "The survey illustrates in a very concrete manner the extent to which ISO management system standards are meeting the organization's strategic objective of 'global relevance' – in other words, adding value for the organizations that use them all over the world."

Here is a brief summary of the findings, with the complete press release available here:

ISO 9001:2000 (quality management) Up to the end of December 2007, at least 951 486 ISO 9001:2000 certificates had been issued in 175 countries and economies. The 2007 total represents an increase of 54 557 (+ 6 %) over 2006, when the total was 896 929 in 170 countries and economies. Services again accounted for 32 % of all certificates issued.

 

ISO 14001:2004 (environmental management)

Up to the end of December 2007, at least 154 572 certificates had been issued in 148 countries and economies. The 2006 total represents an increase of 26 361 (+ 21 %) over 2006, when the total was 128 211 in 140 countries and economies. The service sectors accounted for 29 % of certificates issued, up from 27 % in 2006.

 

ISO/TS 16949:2002 (quality management for automotive suppliers)

Up to the end of December 2007, at least 35 198 ISO/TS 16949:2002 certificates had been issued in 81 countries and economies. The 2007 total represents an increase of 7 199 (+ 26 %) over 2006 when the total was 27 999 certificates in 78 countries and economies.

 

ISO 13485:2003 (quality management for medical devices)

Up to the end of December 2007, at least 12 985 ISO 13485:2003 certificates had been issued in 84 countries and economies. The 2007 total represents an increase of 4 959 (+ 62 %) over 2006 when the total was 8 026 in 81 countries and economies.

 

The survey results continue to shed light on the evolution of the global economy, with newly emerging economies such as China, India, Brazil and the Russian Federation appearing among the leading countries for totals of certificates issued, or growth during 2007. Countries other than the established industrialized economies showing intensive certification activity include Bulgaria, the Czech Republic, the Republic of Korea, Mexico, Poland, Romania, Thailand and Turkey.

© 2008 ISO

ISO to Issue Comparison of 9001:2000/2008

The ISO technical committee is preparing a document which clearly shows the difference between ISO 9001:2008 and ISO 9001:2000 and when this document is approved by ISO, they will be published in the website, probably by October 2008. ISO and IAF are keen to implement a smooth transition to ISO 9001:2008 and have taken international quality system and auditor certification bodies for consultation to this effect.

It is proposed by ISO that the ISO 9001:2008 not to have any major changes but will only introduce some clarifications to the existing terms of ISO 9001:2000. It is estimated that about a million certificates have been issued for companies in about 170 countries. It has been decided by ISO that no certification will be issued to the companies till the ISO 9001:2008 is published and audit conducted in accordance with the terms of ISO 9001:2008.

It has also been declared that all certifications issued after the release of ISO 9001:2008 will be ISO 9001:2008 certificates and two years after the publication of ISO 9001:2008, certification of ISO 9001:2000 will not be considered valid.

Does ISO 9001 = AS/NZS 9001?

The short answer is Yes, ISO 9001:2000 = AS/NZS 9001:2000, they are the same.

Each country (or at least many of them) has their own entity that is licensed to manage the Copyrighted material from ISO, and ISO provides a list of them here: http://www.iso.org/iso/about/iso_members.htm

In the US it’s ANSI (American National Standards Institute) and some people in the US call it ANSI 9001:2000, but ISO 9001:2000 is an international Standard. For our 'mates' down under it’s AS. But they are both the same ISO 9001:2000 document.

We (The 9000 Store) are not allowed to sell an actual copy of the standard, as we are not licensed, but there are 3rd party webstores that sell them. We refer people to various organizations depending on their location.  In the US, we've found Tech Street very easy to deal with.

ISO 9001 vs CMM (Softare Industry)

Organizations concerned with ISO 9001 certification often question its overlap with the Capability Maturity Model (CMM). Let’s compare the two and answer a few questions.



>ISO 9001 targets the manufacturing process, although it also includes manufacturing services and software development.

>CMM offers a model for judging the software processes of an organization and for identifying key practices required to increase the maturity of these processes. It establishes a successful means for modeling, defining, and measuring the maturity of the processes used by software professionals.

>ISO 9001 and the whole ISO process approaches software from a manufacturing standpoint.

>CMM approaches it from a development standpoint.

The CMM model was designed with five levels of maturity. ISO does not have them.

>CMM standards are more stringent than ISO standards.

>ISO does not say you have to have certain standards, but CMM says you must meet the prescribed standards.

>CMM was designed to ensure bug-free development.

>ISO is designed to put quality into the manufacturing process.

Their purposes are different. However, some versions of CMM and ISO have been merged together.

ISO plans to release ISO 9001:2008 in Oct/Nov 08

well I guess it's final...The "TAGs" aligned and the long awaited release of ISO 9001:2008 is coming together.  The proposal doesn't add requirements compared to the 2000 revision, and does not change the intent of ISO 9001:2000.  So it appears that you won't need to change anything in your QMS.Read the ISO press release here: http://www.iso.org/iso/pressrelease.htm?refid=Ref1138

Did you know? ISO 9001 in the IT Industry

Trends in IT industry

Until recently, ISO 9000 has been used primarily by the manufacturing industry but now more and more large IT companies are demanding that their business partners become ISO 9000 certified. The use of ISO 9000 standards is growing exponentially, especially in Europe.

ISO 9000 is important because it certifies that management is controlling a large set or sets of processes that deal with every function inside the business. It is not just about service or product quality; it's about management quality. Although ISO 9000 is designed to help companies run smoothly and efficiently, companies don't always implement ISO 9000 standards by choice. Many large companies are requiring their smaller business partners to comply with the standard. The standard is used primarily in Europe, as well as in certain states, including technology hot spots California and Texas.

ISO and IEEE

ISO and IEEE (Institute of Electrical and Electronics Engineers, Inc) have signed agreement to cooperate in developing international standards to serve the global market place.. The initial focus would be on information technology, transport systems and health informatics to provide “new opportunities to adopt and jointly develop international standards to serve the global marketplace.” The aim of this agreement is to optimize the resources to develop the standards and to shorten time-to-market.  It also focuses on joint development of standards and to adopt each other’s standards. The ISO secretary is optimistic that this kind of partnership is its strategic objective and will help in reinforcing the collection of ISO international standards in a consistent manner. The Managing Director of IEEE opines that this will provide innovative solutions for the benefit of the community.