What are the focus after you get ISO9001 Certification

 

Once you've reached your ISO 9001 Certification you should feel a sense of relief that you accomplished something great. It is quite a project to undertake and complete.

So now what? Here are some items you should now be focusing on:
Celebrate and Promote your Certification
Once you've successfully registered your organization to ISO 9001-2008, you will want to promote this to your customers, vendors, and employees.

Want to know and find banners & more ways /Tools for promotion ? call me.

Use of ISO LOGO
ISO has guidelines on what you can/cannot do, using the ISO logo, etc.:
Don’t use ISO’s logo or say you are "ISO Certified" - ISO didn't certify you, your Registrar did.
Your Registrar (CB or Certification Body) can provide you with a logo. This logo will typically show the certification date, standard, and length
Use the full designation "ISO 9001:2008" not just “ISO 9001”.
Don’t display ISO certification marks of conformity on products, product labels, or product packaging, or in any way that may be interpreted as denoting product conformity.
Clearly define scope (the extent) of your organization’s certification, for the locations, departments, and business units.
STILL HAVE QUERIES ? CALL ME.

How to keep improving ?

Once you are certified, you will need to keep improving the QMS. A good place to start is the new ISO 9004:2009 .Buy a copy and read it to improve your QMS. guide which now includes info on managing for the sustained success of an organization. The standard has had substantial changes made to its structure and contents. 

Continuing Education
Here are some helpful tools to keep the rest of your organization sharp:

• ISO 9001 Auditor Training Materials for a top-notch audit team.
• Root Cause Analysis Training to solve your process errors
• Educate all incoming (and existing) employees on ISO 9001

QMS Efficiency
Once you understand how to operate your QMS, let a Document Control System (DCS) do the paperwork! Use a Document Control System to manage your QMS to save money!

Quality must keep improving long after the certification!

I will support to select the proper tools for you to achieve and maintain ISO 9001.

Add some useful tools for consideration :

1) Document control : control your doc in calendar format

www.nemo-docs.com/

 

Just call me and be my guest in my facebook or this Blog for continuing learning.

Correction, Corrective Action and Preventive Action

 

• ISO 9000 Definition
• Expanded Definitions
• Differences between CA/PA and Correction
• Simple Example of Correction, CA, and PA
• Buy Corrective/Preventive Action Procedures & Forms

A critical requirement of ISO 9001 is corrective & preventive action (Sec. 8.5.2-3), and we are often asked the difference. Here is a quick evaluation and example to help you:

ISO 9000:2005 Sec. 3.6 defines them as follows:

• Correction - Action to eliminate a detected nonconformity
• Corrective action - Action to eliminate the cause of a detected nonconformity
• Preventive action - Action to eliminate the casue of a potential nonconformity

To expand on these definitions a bit

1. Correction: When a problem occurs, you need to keep several aspects in mind.

• Determine the magnitude of the problem.
• Determine how to prevent it from getting bigger.
• How to address current situation.

You could call this – Damage Control.  Although this correction takes steps to correct the problem it has no bearing on cause.

1. Corrective Action: Now determine if the importance of the situation requires further action:

• Was it a big deal?
• What’s the chance it will happen again?
• Estimate of any future threat

The causes need to be looked into to prevent recurrence if it was a big deal.

1. Preventive Action: First you need to assess the risk and mitigate it based upon severity. The following tools are helpful: Source: Carnegie Mellon University

• Checklists
• FMEA - Failure mode & effects analysis
• Hazard and operability analysis (HAZOP)
• Fault tree analysis (FTA)

Difference between:

• Correction & Corrective Action –
  • HIGH risk/impact/frequency - Correction fixes the CURRENT set of issues while Corrective action prevents it from happening again by looking at causes
  • LOW risk/impact actions are similar since likelihood of reoccurrence is low
• Corrective & Preventive Action - the damage is already done in corrective action

Simple Example to demonstrate the differences

A customer orders 500 parts, but only 450 are delivered.

• Correction –  Fix the current issue
  • get the customer 50 more parts
• Corrective Action – Why were we short?
  • Operator miscounted 9 boxes of 50 as 10 boxes of 50
• Preventive Action – make sure it doesn’t happen again
  • Weigh products on scale so you know if quantity is met

ISO 9001 requires the organization to have a documented procedure for corrective an preventive action.

Note: The combination of corrective action and preventive action documented procedures into a single QMS document is acceptable, but is not recommended. If these are combined, then it is important to verify that the organization understands clearly the difference between the intent of corrective and preventive actions.

Useful links for IRCA approved Lead auditor qualification

 

We have developed a list of links to organizations worldwide, to provide you with access to relevant sector information, and sector discussion forums.

NEW! Personnel Certification and Training blog spot

NEW! Emerald Group Publishing Ltd

General

Conformity Assessment - news and information

International Accreditation Forum

Quality

The Chartered Quality Institute

ISO - International Organization for Standardization

ISO 9001 Auditing Practices Group

 

Environment

ISO - International Organization for Standardization

 

Food

Food & Agriculture Organization of the United Nations

Food Safety Authority of Ireland

Global Food Safety Initiative

Just Food

World Health Organization

Information security

ISO 27000 Series Community Portal

 

Occupational health and safety

Institution of Occupational Safety & Health

International Labour Organization (ILO)

 

Discussion forums

The ISO Quality Forums

ISO 27000 Series Community Portal

The ITIL and ISO 20000 Support Group

NEW! Personnel Certification and Training blog

 

Article libraries / Publications

ISO Management Systems

NEW! Emerald Group Publishing Ltd

NEW! The Auditor magazine

對 Simon Chau 周兆祥 ：「環保」的迷思」的回應

全文 : Simon Chau 的網誌 

輯錄自《我復自在悠然》

由近年來教育工作者、公眾人物、政府官員、傳媒工作者、文化工作者所發表的言論來看，此時此地社會的各階層不但未具上述那種危機意識，還對於當前人類的處境充滿誤解與無知。以下舉出幾個最常見的錯誤，並列出事實：

(1) 污染是文明的代價

(2) 靠科技來打救

(3) 必定可以逢凶化吉

(4) 先發展後補救

(5) 越多就是越成功

(6) 危機皆因人太多

(7) 綠色思想與科學對立

(8) 綠色思想是開倒車

(9) 世界末日無可避免

(10) 環保是政府的事

(11) 應該由專家去解決

(12) 我個人無能為力

這完全是TQM (total quality management) 應用在我們生活的實例 :
T : 全球人參與綠色生活, 必須人人一起動手改善
Q : 第一次就做對 ! 質比量更重要。發明運用科技去建設可持續的文明綠色生活
M : 要管理 : 包括自我管理 及 政府做環境保育, 運用集體智慧以享用更好的、真正方便的產品, 達0 排放, 0 污染 , 均衡的簡單生活 ...... 詳全文

要明白" 垃圾是資源錯放的惡果 "
請大家運用集體智慧以善用資源 ... 簡單生活才是美 !! 互勉之 .

Improve the effectiveness of your internal audit

When we perform audits, our client always ask the same question : How can improve our own internal audit effectiveness ? the answer is here. Let's take a look and comment and share your view here as well.

Certification - DIY

Check our services to improve your QMS -> http://www.tuev-sued.de/management_systems

Get our Logo for promotion purpose:-

Download Center for Certification Marks
Welcome to the TÜV SÜD Management Service Download Center for Certfication Marks.
On the following pages, we offer you the opportunity to download the certification mark matching your certificate and thus communicate your commitment in your brochures, on the Internet, on your business cards, on posters etc. ...

Helpful Guide for ISO9001:2008 Upgrading

Dear friends,

After much delay, ISO has finally released ISO 9001:2008 on 14 Nov 2008, 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.

Announcement of the release of ISO 9001:2008. Please visit the ISO website for more information http://www.iso.org/iso/pressrelease.htm?refid=Ref1180

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
What's Next :-

* Buy a copy of the ISO 9001:2008 Standard or download them from here
* Learn about the changes 9001:2008 brings and the new ISO 2008 guide.
* Get the comparation table in Chinese for study
* Check your Certification Body or ISO for Transition schedule :
ISO and IAF announce schedule for implementation of accredited certification to ISO 9001:2008
i.e. Validity of certifications to ISO 9001:2000
- 1 year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or recertifications) shall be to ISO 9001:2008.
- 24 months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid.


Planning for upgrading of your QMS :

- Improve your audit skill by ISO 9001 Auditing Practices Group

- Conduct Impact analysis for your company (collect and analysis all IQA audit result)

- Conduct gap analysis for your QMS

- Form the cross-functional team as the working team for transition process

- Check your CB about the transition arrangement

- Set the target for process re-engineering with documentation amendment to upgrading QMS

- Provide training and communication with all employees for upgraded QMS

Ensure to confirm their awareness / understanding after training by using our new service "ISO 9001:2008 Comprehension & Competency Evaluation Assessment"

- Conduct internal audit to confirm the updated QMS

- Follow-up the deviation / NC and confirm the effectiveness of taken actions

- Select the suitable tools / methods / IT system

- Intergrated all applied tools to QMS and keep continual improvement for QMS

~~~~~~~~~~~~~~~~~~~~~~~~~~
Useful info:-

*The ISO Survey of Certifications - 2007 has also been released, The survey shows the expansion of ISO 9001 to other countries as well asgrowth in other ISO standards (13485, 14001, TS 16949).
* ISO Releases Video on the ISO 9000 family of Standards



Our TUV SUD special Offer :-
*To help celebrate the long awaited release of this version, our ISO 9001:2008 Special Offer is as below :-




~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

TUV SUD America's on demand webinar
ISO 9001: 2008 - Introduction & Essential Changes
http://tuvamerica.com/tuvnews/seminars/seminarinfo.cfm?id=88

Summary of Webinar :
1) Impact you need to know : vary based on your maturity level of organisation
2) Next version : ISO9001:2015 => Major change involved
3) Inputs for amendment of ISO9001 to 2008 VERSION
4) Principle for this version : accept High benefit / Low impact suggestions
5) Change outlines : standard Annex B - Table B.1
6) Advantage of this upgrading : chance for enhancement of QMS
7) Reason for clarification in notes -> avoid liberal interpretation
8) Transition arrangement
9) Impact to other standards (ISO9000:2005 , ISO9004:2009 ; ISO13485 ; AS9100 ; TS16949; TL9000)
10) Summary of Changes :
a) Additional notes : 10 nos (1.1/4.1/ 6.2.1/ 6.4 / 7.2.1 / 7.3.1 / 7.3.3 / 7.6 / 8.2.1/ 8.2.3)
b) 3 nos revised notes in 4.2.1 / 7.5.4 / 8.2.2
c) Major change in outsourcing requirement & configuation of IT system

11) Our TUV IDEAL PROCESS : Info Gathering -> Discovering & Evaluation -> Audit -> Learning


*******************************************************************

*******************************************************************
ISO9001 Upgrading articles

抓住标准换版契机，促进组织经营绩效的提升

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

• Sky-high perspective on news standards for hands-on managers

~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Helpful links

- ISO 9001 http://www.the9000store.com/
-AS9100 Aerospace http://www.as9100store.com/
-TS 16949 Automotive http://www.16949store.com/
-ISO 13485 Medical Devices http://www.13485store.com/
-ISO 14001 Environmental http://www.14000store.com/
-ISO 22000 Food Safety https://owahk01.tuv-sud.hk/exchweb/bin/redir.asp?URL=http://www.22000-tools.com/cmd.asp?af=671257
-Free Flowcharting Software: www.smartdraw.com/specials/isoflowcharting.asp?id=10472
-ISO 9000 Informational Blog https://owahk01.tuv-sud.hk/exchweb/bin/redir.asp?URL=http://www.9000resource.com/

--------------------------------------------------------------------------------
Useful Slide Shows about ISO9001:2008 :

The Differences Between ISO9001:2000 and ISO9001:2008
How to Pass an ISO9001:2008 Audit: A Case Study
Getting Equipped to Meet the Challenges of the Economic Downturn (in Chinese)
Implementation of ISO 9001:2008
ISO 9001:2008 vs ISO 9001:2000

[source http://www.hksq.org/slide.htm]

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Action Item :

Try to arrange internal auditor training to your internal auditor team first :-

Our TUV SUD IQA auditor training in GD area :

ISO9001 内部审核员培训_深圳 2009-03-23

日期： 2009年3月23日 - 2009年3月25日

城市：深圳

联系人：蒋夏 小姐（深圳）
电话：0755-88286998*207212；13760199252
电子邮件：sarah.jiang@tuv-sud.cn

点此获取详细信息
http://www.tuv-sud.cn/seminar-details_zh/events/

Others:-
e.g. Coming 2 days (20-21 Mar) IQA auditor in PRC by HKPC

Learning new tools :
e.g.
TÜV 南德意志集團大中華區- FMEA, APQP新版介紹-深圳
聯繫人：蔣夏小姐（深圳） 電話：0755-88286998*207212；13760199252 電子郵件：sarah.jiang@tuv-sud.cn. 蘇志明先生（南寧） 電話：0771-5596052；15877159496 ...
www.tuvps.com.cn/seminar-details_zh/events/fmea-apqp-.html

ISO9001:2008 -> Q&A in Outsouring................Mr. Govind Ramu

Q1 : “What is Outsouring?”

i) Outsourcing is the transfer of products, services, and business processes to an external service provider.
ii) Outsourcing involves contracting with an outsourcing partner, which may or may not involve offshoring.
iii) Other terms used in the outsourcing world are “multisourcing”, “nearshoring”, etc.

Q2: “Why Outsourcing?”

Four factors were considered:
i) Significantly reduce overall costs.
ii) Reduce “Time to Volume” (TTV) for new products.
iii) Access to an abundance of human resources, localized skills and knowledge, etc.
iv) Supply chain efficiencies when products are shipped directly to customers (Drop Ship) – which related to Lean.

Q3: “What Does Quality have to do with outsourcing?”

Quality is applicable to the overall process of creating products and/or services, which all aspects of outsourcing are considered. Without due diligence and appropriate controls, outsourcing could end up being costlier than in-house manufacturing or service, and customer dissatisfaction.


Therefore, ISO 9001:2008 version concerned the control over outsourced processes.



i) Quality in Project Management
· Scope Creep, Risk Management & Lessons Learned
· Challenges: IP Protection
ii) Quality in Team Management
· Managing multicultural team and their roles & responsibilities
· RACI or RASCI (Who responsible? Who accountable? Who to be consulted? Who to be informed? Who to be supporter?)
· Challenges: Team Attribute and Virtual Teams
iii) Quality in Communications Management
· Avoid the lost out of listening (using active listening)
· Challenges: Technical Interpretation & Virtual Teams
iv) Quality in Knowledge Management
· Structured Approach: DIKW Chain-the-metaphorical (Link, pace & node of transfer)
· Challenges: Tacit Knowledge (Encourage documenting tacit knowledge by driving out fear)
v) Quality in Supply Chain Management
· Supplier Selection, Performance, Improvement & Service Level Agreement (SLA)
· Challenges: IP Protection
vi) Quality in Engineering Management
· Business Model; Traceability-record Retention and Third Party Surveillance
· Challenges: Failure Cost

Seminar : ISO 9001:2008 & Get Equipped to meet the Challenges of the Economic Downturn

Upgrade your ISO 9001:2000 to ISO 9001:2008 & Get Equipped to meet the Challenges of the Economic Downturn on 5 Jan 2009



Panel discussion :-

1) How to manage the ISO9001:2008 upgrading process in my company ?
2) The calibration of ruler story ...
3) How to measure the training effectivenss ?

For my answer on above questions in Q1 & Q3, pls see my prior blog articles for my viewpoints and suggestions.

For the story of the ruler ..

The certificated client : all rulers bring to outside Lab for calibration ?

From Auditor : it is acceptable for the external calibration of master ruler , but not all. The internal rulers could be calibrated internally based on this master. The focus is not the calibration on this ruler, but the control including the verification of this ruler before use.

From Calibration Lab : It is definitely the good news for all ISO9001 certificated companies bring all their rulers for calibration , we earned a lot indeed.....

ISO9001 AUDIT - Corrective Action Acceptance Guidelines

TÜV SÜD Hong Kong Corrective Action Acceptance Guidelines:

Objective: The intent of this section is to provide a consistent set of criteria for the development and acceptance of corrective action responses. These guidelines apply to all standards (QMS and EMS). They are intended for both TÜV auditors and audited organizations to help them understand how nonconformities must be addressed.

1. Was Correction to eliminate existing nonconformity completed?

Describe actions taken under “Correction of Nonconformity.” (for example, Completed missing internal audits; Conducted supplier evaluations; Segregated nonconforming material, etc.)Provide evidence that actions were taken.


2. Have the appropriate causes been identified?
Consider the following:
·  what caused the actual nonconformity
·  what allowed the problem to occur without being detected internally
·  what part of the organization’s processes failed to address this issue or is the organization lacking a specific process, method, etc.
The cause shall not be a repeat or rewording of the nonconformity statement or the objective evidence.

3. Has corrective action been determined for each identified cause?
Each cause must have an identified action that eliminates / addresses the specific cause(s) and prevents recurrence of the nonconformity.

4. Has appropriate evidence been provided to verify that actions taken have been implemented and are effective?
It is the responsibility of the organization to provide evidence of internal verification of the corrective action(s), or a plan to do so.


The Lead Auditor will provide due dates for submitting evidence of implementation. This could vary depending on the circumstances and standards involved.

ISO9001:2008 Upgrading arrangement

* Check your Certification Body or ISO for Transition schedule

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

i.e. Validity of certifications to ISO 9001:2000

- 1 year after publication of ISO 9001:2008 all accredited certifications issued
(new certifications or recertifications) shall be to ISO 9001:2008.

- 24 months after publication by ISO of ISO 9001:2008, any existing certification
issued to ISO 9001:2000 shall not be valid.

ISO9001:2008 Auditor Transition training course

Key points in this course :-

- Confirmation of understanding for the pre-course (on-line training for the Introduction of ISO9001:2008 standard )
- Group discussion and case sharing for auditing in ISO9001:2008 QMS
- Role play for auditing to confirm your effectiveness of audit skills to meet ISO9001:2008 new requirements



Special offer for in-house training request and enquiry for the coming events (i.e. seminar , trainings in HK or PRC) , please contact Ms. Vivian Fung at vivian.fung@tuv-sud.hk for details.



Get your ISO9001:2008 auditor certifcate from TUV-SUD right now !!


--->>>>> WE PROVIDE THE TRAINING COURSE TO SUPPORT YOUR SUCCESS >>>>

Guide to ISO 9001:2008 Certification

Quoted by Joe Pfankuch at jpfankuch@the9000store.com

>> Creating Your Plan
>> Determine the current state of your quality system
>> Estimating the length of the project
>> Identify your resource budget: Tools
>> Identify your resource budget: People
>> Identify your resource budget: Registrar / Certification Body
>> Project Plan Template


CREATING YOUR PLAN

To plan your project, you need to gather information so you can prepare a time line. The amount of time that it takes to get ready for registration is dependent on:

- The size and complexity of your organization

- The current state of your quality system

- The amount of resources that you can devote to the project

*****************************************

DETERMINE THE CURRENT STATE OF YOUR QUALITY SYSTEM

You can measure the current state of your quality system by scheduling a Gap Analysis Audit.

Plan enough time to go through each area of the company and compare what is being done to the requirements of the standard.

Typical Gap Analysis Audits can take anywhere from 2 to 4 days, and be done by an individual auditor or a team of auditors. Let employees know what you are doing and why, so they are informed participants during the audit.

Learn more here...
http://www.the9000store.com/cmd.asp?ad=141011

*****************************************

ESTIMATING THE LENGTH OF THE PROJECT

The results of the Gap Analysis will tell you how much work there is to be done, allowing you to estimate the time and resources needed for the project.

We have prepared 4 different time lines which you can download and use as samples or templates.

Download the time lines here...
http://www.9000resource.com/2007/11/how-long-does-i.html

*****************************************

IDENTIFY YOUR RESOURCE BUDGET: TOOLS

To complete your project you will need:

- A copy of the Standard.
http://www.the9000store.com/cmd.asp?ad=141056

- Training Programs or Tools
Training methods and resources
http://www.the9000store.com/cmd.asp?ad=14010

- Documentation
Templates to simplify design and documentation of
quality system processes, or a consultant or
internal expert to design the documentation.

- Quality Manual and Procedures
http://www.the9000store.com/cmd.asp?ad=141009


*****************************************

IDENTIFY YOUR RESOURCE BUDGET: PEOPLE

You will need internal resources in the form of employee time throughout the project.

The results of the Gap Analysis will help you estimate the time that you will need from different individuals, but you can start by identifying the individuals who will be involved in the project.

- Project Manager

- Leadership Team (Steering Team)

- People to work on Quality System Processes
(Task Teams)


Using Teams to Implement ISO 9001...
http://www.9000resource.com/2007/10/step-2-set-up-t.html

*****************************************

IDENTIFY YOUR RESOURCE BUDGET: REGISTRAR

You will need to choose a Registrar sometime during the implementation process.

You do not need to do that during this planning phase, but to estimate costs you may want to start talking to a few and getting quotes.

Find a Registrar...
http://www.the9000store.com/cmd.asp?ad=141068

*****************************************

PROJECT PLAN TEMPLATE

Schedule your audit, and identify your resources.

You are well on your way to completing your project plan. Start documenting your plan--there is a Project Plan Template in the Quickstart Kit you received, or available for download on our Project Plan information page. Visit for more detail on completing your plan.

Download Project Plan here...
http://www.9000resource.com/2007/10/step-3-develop-.html

Start your QMS from ISO 9000 Quality Principles

系統化的思想(SYSTEM THINKING)

引言 : "形象地讲,程序是假设员工是傻瓜,制度假设员工是坏蛋。中国企业现在程序的东西太少了。"

因為中國人太聰明, 事實上也沒有人自認是傻瓜或坏蛋, 因此中国企业管理中兩張皮的現像極為普遍, 也導致ISO9001的認證 在中國的失敗 ! 及所謂阳奉阴违, 执行力問題.....管理的弊病叢生...

因此, 要改變心態, 使人們明白制度及程序可有利员工的工作及其發展, 才可跟本使國人對中国企业管理的弊病加深了解. "以人為本”．．．．應以系統為依歸, 程序為附助 , 才有成功之日 !!!

在ISO9000 標準中, 系統及 程序全都是"活" 的, 可按企业實際變化以配合员工工作及其發展之需要, 最後才能滿足老板 (盈利) 及最終客人(消費者) 的需求. 現今中国企业多捨本逐末, 追求眼前獲證的喜悅及光榮, 而忘卻"以人為本" 的可貴及 ISO9000管理的真義....

沒有系統化的思想(SYSTEM THINKING) , 則只有"瞎子摸象"的惡果及"摸著石頭過河"的衝動, 對中国企业管理的弊病亳無幫助, 只能有感一言. 返回現實, 還是老老實實若按ISO9001標準执行系統之管理及持續改進, 一步一步踏實前進, 羅馬不是一晚能建成的.... 如ISO9000 言: 都是一個過程 ....