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02/03/2013

ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

QualityGurus.com ISO 9001:2008 Forums ISO 9001:2008 Forum How to first begin implementing ISO 9001 into my organisation?Search forums Display replies in nested form

This forum has a limit to the number of forum postings you can make in a given time period - this is currently set at 2 posting(s) in 1 day How to first begin implementing ISO 9001 into my organisation?by Emily Shimell - Tuesday, March 29, 2011, 09:51 AM

I am looking for suggestions to start implementing ISO 9001 into my small organisation (8 employees).Reply

Count of Likes: 2

Re: How to first begin implementing ISO 9001 into my organisation?by Benjamin Carruthers - Tuesday, March 29, 2011, 08:32 PM

Emily, the first thing you should decide is whether or not you will use the services of a consultant to assist in identifying your key processes that affect product/service quality and then creating and implementing the quality control processes as required. Should you want to try and do it all in-house, there are a number of starter packages/kits and guides available to assist with the above and may be a good place to start. After reviewing the scope of work involved for your particular organisation, then you can make the decision to implement yourself based upon the guides, or to refer to employ the services of a consultant who has worked with small organisations previously. Good Luck!Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by NIAZ HUSSAIN - Tuesday, July 17, 2012, 10:43 AM

First u give internal training ur employees and make strong communication internal as well externalShow parent | Reply

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Re: How to first begin implementing ISO 9001 into my organisation?by Jaroslaw Richert - Wednesday, March 30, 2011, 07:28 AM

First of all you should identify a mgmt. representative who will be responsible for implementation of ISO9000 compliant QMS and prepare the organization to be certified on ISO9000. One of his first steps should be an ISO9000 assessment, identifying the gaps between the ISO9000 requirements and the current status of your organization. Based on the outputs, an action plan should be identified to mitigate the gaps detected.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Deena Singh - Wednesday, April 6, 2011, 02:41 PM

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by Deena Singh - Wednesday, April 6, 2011, 02:41 PM

ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

Hi Emily, Firstly, I would like to congratulate you for thinking about implementing ISO 9001 in your organisation even though there are just 8 members. Not many understand its requirement & feel its okay to omit such quality mgmnt systems as their units are small.But fail to see the big picture without it. Now coming to your query,you can obtain a copy of ISO 9001:2008.Its a 30-page document with list of necessary business requirements needed to improve a company's management system. I also recommend you to get an Internal Audit done to get good understanding & strong foundation of ISO. STEPS TO FOLLOW: GAP Analysis Planning and Development Develop processes and Prepare documentation System Implementation CIAO!Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Maria Tereza - Thursday, May 12, 2011, 02:11 AM

Does that mean that you can go a head implementing the processes and conduct internal audits without formal application for cerfication or employee trainings, based on the qualification of you Quality Manager?Show parent | Reply

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Re: How to first begin implementing ISO 9001 into my organisation?by Christian Ezeala - Wednesday, April 6, 2011, 11:40 PM

I am satisfied with most of the responses so far, and agree that where to start is needs assessment to find the gaps. It would also be helpful to examine the type of business of your organization to know if ISO 9001 suffice or you will require industry specific quality system standard such as ISO/IEC 17025, and ISO/DIS 15189. ChristianShow parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by abraham lagat - Saturday, April 16, 2011, 02:32 AM

Congratulation for that very useful idea that shows the nature of your quality concerning to the customers. In whatever one is doing whether as a company or individual, the focus is the customer. The service or product provision to the customer determines the customer growth of the given company. Although in the short-run, i have seen companies opting for certification with the aim of just showing that they are seen to be quality yet in real sense they only struggle to achieve it and then go back to the poor service provision just with the tag of ISO certification especially in most governmental organizations. for small companies, to me it is very expensive process but depending on the nature and growth of the company it might be fruitful if you invest (which i know it will give negative balance in the beginning). So if you are sure that the future is green you can go ahead and show that you are purely quality oriented and be certified. or you can still plan for it by providing the quality and grow to be certified later. The norm is be qualified to be certified.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Rambhatla.V.S.S.L. Revathi - Saturday, April 30, 2011, 04:33 AM

www.qualitygurus.com/courses/mod/forum/discuss.php?d=7178

hello I am Revathi, I have joined the forum newly and very glad to meet a person like you trying to be a quality oriented person. "In my view let not something is done only to get certified but let things be done in the way they get certified".It is not the size of the company whether to be certified or not it is just an attitude to go systematically therve by improving the quality. In fact as it is your small organisation it will be quite easy in operating and controlling the procedures, where by

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ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

quality. In fact as it is your small organisation it will be quite easy in operating and controlling the procedures, where by documentation may be little bit difficult but you can manage it and once if the company turn over increases additional staff may be engaged. for example if you observe unicellular organism the cell alone performs all the functions as a multicellular organism performs ,division of work among the cells increased only when number of cells increased considerably but the quality of work if observed is equally good in both unicellular organisms and the well developed organisms like us.therefore be confident, identify a person first to maintain the documentation perfectly,later approach a Lead auditor consultancies for getting ISO cetifications in this regard .Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by NOOR MUSTAFA - Sunday, May 15, 2011, 02:04 PM

According to ISO.... first u have two things in ur mind that is VISION..AND MISSION... AND TRY TO , "DO WHAT U SAY" AND " SAY WHAT U DO " AND IN LAST YOU SHOULD DOCUMENTED IT", EVERY THING SHOULD BE IN WRITTEN FORM, IN OTHER SENSE DOCUMENTED.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Maung Maung Than - Monday, May 23, 2011, 04:29 AM

Firstly,before we begin implementing the ISO 9001:2008 into organisation, all member of the organisation must realize the quality manual,quality policy and quality objectives.Management representative must train the employee to improve their role in QMS requirements.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by ZAK MAHMOUD - Wednesday, November 9, 2011, 06:41 AM

Hi i am zak First you should follow that : - Define customer requirements - Define the policy & opjectives of your company - Define the processes wish should be done and determine the relation between them - then choose the qulified team to help you for implimentation such as: - preparing the quality manual ,procedures and internal audits teamShow parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by cyril obruche - Wednesday, June 15, 2011, 04:08 PM

First familiarize yourself with the requirement of the iso 9001 standard and decide if certification to this standard make good business senses for you organization. the two main objective organizations only deal suppliers that are certified to iso 9001 or similar business standard.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Amat Bittaye - Tuesday, October 16, 2012, 04:19 AM

Hello, I am Amat Bittaye. Frstly, thank you very much and congratulations for raising such an important question. To me I quite agree with the previous participants to employ the GAP analysis, Internal Audits as well as the quality hand book as a reference. However, the involvement of the entire management and staff is key in implementing ISO 9001:2008. Therefore, the implementation of such standards is supposed to be everyone's business. More importantly, continuous sensitisation and on the job training should be a prerequisite.www.qualitygurus.com/courses/mod/forum/discuss.php?d=7178 3/28

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and on the job training should be a prerequisite.

ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

Management and staff should be motivated to embrace the idea of ISO 9001:2008. They should ensure that staff do the job right the first time, thereby avoiding rework, rejection and waste which are all cost. In imlementing quality standards, the idea of being proactive should be inculcated in the staff rather than reactive.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Azaarudeen Dadamiyan - Thursday, August 4, 2011, 01:37 AM

ISO 9001 certification today essential one for every business neither big concern nor small. So you have to first understand what ISO 9001 with ISO manual is and approach some internal auditors or visit ISO 9001 registered firms to understand what are all the practical things are going on based on the business. Follow the following steps... Create the quality manual, policy, objectives based on your business and your customer requirements. Create the document control from the input to output make the all process with inline. Make process control Corrective action report for the non conformities both internal and customer end. Preventive actions like poke yoke, process correction, fixture correction validation , new process implementation, working procedure display , training , awareness given etc., based on business . I would also recommend you combine Corrective Actions and Preventive Actions, since they are so similar. You can use one form for both procedures, with just a check box on the form to denote whether it is a corrective or preventive action request. You may find that you can streamline other forms in a similar manner. Without knowing your particular operation it is difficult to give any more specific recommendations. If you have a question about a specific area of your business, please feel free to post it here.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Lakshmi Venugopal - Monday, August 22, 2011, 06:32 PM

Need to Assign a person to implement the ISO 9001 To purchase the procedures need to evaluate and approve your suppliers and continually monitor their performance and also need to review and approve the purchasing the documents before release. and to obtain the ISO 9001 need to implement a documented quality management systems that meets the requirements of ISO 9001 run that system and they have a registrar audit the system . if the system complies with the requirements , the registrar will grant the registration .Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by John Ahern - Thursday, August 25, 2011, 04:13 AM

I am involved with the implementaion of ISO 9001, within my organisation. From the early experiences I have gained, the company must be clear on its intentions and why it wants to implement the ISO 9001. We ;aquired' the system following the MD anouncing it had ben purchased and it fell at my door to implement!. Despite this I have been able to delay assessment as I needed to become familar with ethe expectations, underastand our current processes and link them to the framework of ISO 9001. My message is then plan and review and have an understanding of why amd what you are expecting from ISO before committing to the system.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Irene Lord - Tuesday, December 27, 2011, 05:22 AM

I must agree with John, the FIRST thing that you need to do is to understand ISO 9001. This will help you to plan, review and implement ISO 9001 in to you company with greater ease. I feel the key to implementing ISO into a company is understanding. Don't forget that everything MUST also be documented. Good luck to you.www.qualitygurus.com/courses/mod/forum/discuss.php?d=7178Show parent | Reply 4/28

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Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Rawia Abdalla - Monday, September 5, 2011, 09:58 PM

hi Emily .. simply you can implementing ISO 9001 into your small organization by determining quality objective of your business and determine customer requirements of your products or services then set a suitable processes to conform those requirements and select the suitable employee to determine , implement and control these processes , then you must make internal audits to auditing your work and results and make any corrective and preventive action to insure that your services or products met the customer requirements .Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Einstein Emeka Benson Nwachukwu - Tuesday, September 13, 2011, 08:31 AM

To start implementing ISO 9001 into your company you need to first develop product quality policy in line with the statutory and regulatory standards.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Violet Mugalavai - Wednesday, September 21, 2011, 01:24 AM

The process is of implementing ISO is the same. Your aim is to look at the customer requirements, input the resources, output the product to satisfy the customer. Thus you will need a manager who will lay down the processes and procedures and establish the controls. Your small company will also require documentation.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by sudhir Barve - Wednesday, September 21, 2011, 02:27 PM

you first study the 8 clauses of ISO 9001 and it implement in your organisation, after implemention if your perfect in iso 8clauses then you take internal audit in your organisation and also you can give the internal training to your 8 employees, by internal audit you can easily find & clear your non conformities and then for certificaton purpose you can take external audit.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Dhruva Sreenivasa Chakravarthi - Monday, September 26, 2011, 09:38 AM

hi, implementing ISO9001 should be an easier job as the team is less. since your organisation has only 8 employees and you the senior management there is a flexibility in decision making. hence sinmply follow the basic steps of implementing iso 9001 as preparing a quality manual as per the standards and as per your organisation structure ->iso 9001 procedures needs to be designed and drafted -> above all your quality policy need to be decided - > and also your quality objectives need to be achieved. finally, implementing iso for a small organisation necessarily need not be difficult as other are quoting. i feel it is easy to implement in a small organisation. the auditing process will be easy for you. regardsShow parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by zulfihar Ahamed - Monday, October 3, 2011, 06:49 AM

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First step is top management commitment for establishing ISO in the organization. Organization must appoint a MR for the implementation process.

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ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

Organization must appoint a MR for the implementation process. Begin with a team from the company / outsourced 3rd party auditor have to perform a GAP analysis, to evaluate the company's present standard procedure by comparing ISO clause.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by NISHANT MISRA - Tuesday, October 4, 2011, 07:29 PM

For organizations to function, they have to define and manage numerous inter-linked processes. Often the output from one process will directly form the input into the next process. The systematic identification and management of the various processes employed within an organization, and particularly the interactions between such processes, may be referred to as the process approach to management.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Willem Barend Cloete - Thursday, October 6, 2011, 07:10 AM

Implementing ISO 9001 for your company would be the same as for a large company. The process must still be followed; however you will take advantage of the following: 1. Smaller team to train 2. Easier to develop a quality culture 3. Competency confirmation should be easier and quicker You would still have all the mandatory procedures, objectives and policies.

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Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Saya-Braide Ebi. - Monday, October 10, 2011, 01:13 PM

My organisation is fast growing, therefore, the need to put in place standards is highly recommended. But it will require the management to identify and or accept recommendations for the establishment of ISO 9001:2008. I know that a consultant is required, and a collection of few staff with basic knowledge of ISO 9001. Document control is an area my organisation need to work on seriously. I think a stage by stage introduction of the whole standards will go a long way in helping management appreciate the importance of the standard.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Denis Obeng - Monday, October 10, 2011, 03:48 PM

Hello Emilly, It is an applaudable decision which needs to be emulated by similar sized companies. Small and medium-sized enterprises (SMEs) play a critical role in economies around the world. To remain competitive, SMEs must be capable of delivering high quality products and services on-time at a reasonable cost. The implementation of an ISO 9001 conformant system must recognize that it is but a step in a long-term development of a continually improving QMS. However it is unfortunate that often ISO 9001 is taken as a means to an end where the implementation of the QMS is not the objective rather the certification.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Antony George - Sunday, October 23, 2011, 07:04 AM

It is the chain of process. first of all study ISO standards very well then consult with other ISO standard other organizations how they implimented. Consider it is a service. at that time can maintaine the quality. After the production collect the feed back of customers, then the requirments full fill. self audit and then internal audit can found out the correction needed. Take preventive action. again consider the customer feed back. This way can Impliment ISO standard. can incres the production can establishwww.qualitygurus.com/courses/mod/forum/discuss.php?d=7178 6/28

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ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

the organisation. if need more training and refresher training to the employees that must be do.And aware of new technology and impliment.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Arif Ashfaque - Tuesday, November 8, 2011, 10:25 PM

To implement quality in organization just follow the mentioned steps. 1.Define the goal and objective for quality 2.Provide the work perfermance 3.Provide benchmark and references 4.enable the cause of poor performance. 5.Record the result of all work. 6.document what you do.Show parent | Reply

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Re: How to first begin implementing ISO 9001 into my organisation?by ZAK MAHMOUD - Thursday, November 10, 2011, 03:07 AM

Hi I am Zak first you have to persuade your top manegement how is the application of ISO 9001 benefit .Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by BOUIDERIANE HICHAM - Tuesday, November 15, 2011, 03:39 PM

Hi, You can, at very little expense, setup an ISO 9001:2008 compliant Quality Management System, and this, by using a generic Quality Management System that can be customised to suit your company without having to rely on a specialist or a consultant to complete the task. There are many generic quality management systems included with ISO 9001 books, i recommand this one : ISO 9001: 2000 for small business by Ray Tricker. Good Luk,Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Yolanda Smith - Tuesday, November 29, 2011, 02:14 PM

First see what you have already documented and how you do things. Make sure you get others involved, this is a team effort. There are tons of examples of work procedures and policies out there. Do your homework and piece together in what fits best for your company. Make sure that you don't over document things. Over documenting can get you in trouble in an audit. There are websites out there that you can get advice on how to do things or what you need. I found Elsmar Cove very useful. Make sure you have your quality manual (everything required for it) this will include your 6 documents that this training course and ISO call for. Have a copy of ISO standard is very helpful. The biggest thing is getting all of management on the same page and get your floor team members involved.Show parent | Reply

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ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?by Lisa Ramoutar - Sunday, December 4, 2011, 08:56 PM

Hi Emily, Implementation of ISO 9001 is commendable for a new company of 8 persons. I must say its a bit small but I have seen organizations with just as many people who have also tried to do same. I encourage the inclusion of a external party who is familiar with the business of your company to become involved as either a consultant or a change manager for this change. Assigning tasks to already overworked employees without establishing which is priority will not allow for a steady progress in the direction you intend. Secondly I encourage you to involve all employees in the discussions and allow all the opportunity to become familiar with ISO 9001 whilst highlighting the benefits to them individually and the benefits to the company of implementing this change. I hope my contribution proves to be of some assistance to you.

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Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by D. VIJAYAKUMAR - Friday, January 13, 2012, 04:46 AM

After implementation of ISO9001-2008, really your organization will turn to good change. Hence, we should not think about the small or big type of organization while implementing the ISO 9001-2008. But if you implement the ISO 9001 with honestly defiantly your organization will become popular. Thanking you, With Best Regards, D.Vijayakumar.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Jefford Noche - Wednesday, January 25, 2012, 12:27 AM

Before anything else let your employees know at least the principles of ISO 9001. Then teach them step by step, understanding ISO 9001 will help them and the company as well to produce quality product/service for the consumers. In the long run, the small organization of yours will become huge company with good reputation in terms of producing good quality product and services.I'm looking forward in to your success.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Otgonbat Dashdarjaa - Tuesday, January 31, 2012, 06:57 AM

First of all, congratulation for you considering about implementation of ISO Quality Management System. From my point of view, a person who will be responsible for implementation of Quality management at your organization must be appointed firstly. That person has to do the activities required by the standard (ISO 9001- Requirements. Clause 4.1) At your organization, some exclusion may be occurred caused by your organizations nature. If your organization works at service sector, the Clause 7.3 may not be the needed at your Quality management system. Hopefully, your QM implementation is more easier than bigger organization. Good luck.Show parent | Reply

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Re: How to first begin implementing ISO 9001 into my organisation?by Michel Victor Frechette - Tuesday, January 31, 2012, 02:28 PM

It can be straight forward or you can make it very difficult for yourself , the key is being honest about your different processes, when writing up your manual , reflecting the reality of your business , do not try to make it more complicated than it is. From my experience , look at your budget . For a first timer , go with an outside consultant , this way , you will save time and in the end money ,they will guide you , and help you in getting certified much faster , do not make the same mistakes most do , trying to do it on their own ,resulting in failed audits , because they are making it to complicated , I have seen this before . Writing up processes , that only those building a

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audits , because they are making it to complicated , I have seen this before . Writing up processes , that only those building a submarine could conform to .... Stick to your product , how its built, keep it simple , but respecting the standards. This is the key towards getting certified , I should know , have gone thru this 3 times - get outside - helpThey will walk you thru it , and they will prevent you from making the same mistakes that most do when trying to get certified the first time around . Good luck in your endeavoursShow parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Dagogo Igah - Friday, February 10, 2012, 07:44 PM

how to first begin implementing ISO 9001 into a small organization of 8 employee. you don't need to purchase to ISO 9001 software.Because many companies think that they will need to purchase specific ISO 9001 software, for example, for document control, corrective action or for internal ISO 9001 audits. While there are many software solutions available that help with some aspects of ISO 9001, it is not necessary to use any such software.from my own point of view but most small and mid-size companies will only need the features and functionality already included with their existing word processing and computer network software. Even a simple paper-based system may work just fine for smaller companies! But note that none of our ISO 9001 products require that you purchase any specific ISO 9001 software. in other word, Achieving ISO 9001 certification does not need to be complicated or expensive. Nowadays, companies implement ISO 9001 in-house without the services of expensive consultants. Is just about using the right tools and guide, which means they are necessary steps to be taken when implementing for a small company. first step is for the company's top management to decide if the company should pursue ISO 9001 certification or not. For that, the company's top management needs to have a good understanding of ISO 9001 from a business point of view. Secondly,Going forward with the ISO 9001 implementation, one of the company's managers needs to be appointed to be the ISO 9001 Management Representative. The ISO 9001 Management Representative is the company's point-person and expert on ISO 9001. Having been appointed, the ISO 9001 Management Representative needs to learn much about ISO 9001 and its various requirements. Thirdly in order to properly plan the company's ISO 9001 implementation, you will first perform a gap analysis so that you know which ISO 9001:2008 requirements the company already meets, and where you will need to concentrate the ISO 9001 implementation efforts. After performing the gap analysis, they are able to plan the ISO 9001 implementation project, set important milestones, estimate time requirements and set a date for the ISO 9001 certification. It is important to inform all employees as early as possible of the company's plan to get ISO 9001 certified. You will need to explain the concept of ISO 9001 and how it will affect the company's employees in order to gain buy-in and support. Don't delay this simple step because once negative rumors and gossip have developed, your ISO 9001 implementation efforts will become more difficult! ISO 9001:2008 requires extensive documentation addressing all its requirements. Writing all the required documents is very difficult and extremely time-consuming if you start from scratch, but it can be quite easy and fast if you use good pre-written templates with detailed customization instructions. The selection of templates is very important because the templates will have a significant impact on both, the time and efforts you spend for the ISO 9001 implementation, and even more importantly, on how efficient and business-friendly your company's ISO 9001 quality management system will be. Please choose wisely. You need to put the new business processes contained in the ISO 9001 documentation into practice throughout the company. In this step, company management and staff are notified of new or changed work processes as formalized in the ISO 9001 documentation. This step also includes the writing of some detailed and position-specific work instructions; these work instructions are best written by those employees who perform the work. meanwhile, it all about processing following it a step by step instruction and guides with easy customize documentation and forms. wish you the very best.

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Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Claire Christison - Tuesday, February 21, 2012, 03:24 PM

We are a small company as well and implementing the process appears to be a lot easier than I would venture to guess it would be with a larger organization. First and foremost the President is 110% in support of ISO and therefore, the requirements and things that need to be done by the top management are either done or in process. This is probably one of the biggest reasons as to why the start of this entire process has been so flawless. If top management is not in support of ISO, then everything else that you need to do will be hard if not, impossible. If you have the support of top management the rest of the process will go a lot smoother. During the writing of our manuals, there were many processes that we already had in place; however, they simply needed to be written out and/or compiled and then reviewed for accuracy. Rather than re-inventing a process, ask those around you what they do and how they do it. All too often you have a lot of your procedures already in motion, they are just not documented. Do that first and then check to see where, if at all you are lacking for ISO. What I like about this standard is that it is not as rigorous as others and yet at the same time it does provide some parameters in which to follow. I do wish you well and I think that after going through this process we've streamlined a lot of things and are running more efficiently and where we run into errors, we now have a process in place in which to address items and then improve.www.qualitygurus.com/courses/mod/forum/discuss.php?d=7178Show parent | Reply 9/28

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Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by A.K.M. Salauddin - Friday, February 24, 2012, 09:37 PM

first I appreciate your idea that you want to implement ISO 9001 in your company that is going on with only 8 person. if it is service oriented company then it will give you benefit for advertisement. But if it is manufacture company then it will be very difficult for you. but you can try according to procedureShow parent | Reply

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Re: How to first begin implementing ISO 9001 into my organisation?by NEIL ROZEE - Monday, March 12, 2012, 06:18 PM

Hi Emily, I have a significant amount of expereince in implements ISO in small companies, most recently like yourself in a small company...15 strong which grew into 135 employees in a little over four years. We began the process of ISO ceretification very early in the in the comapaies life and I can only stress how important we found the procedures and processes we put in place. However I would stress caution, you need to be clear as to what you feel ISO would benift you an d if ISO can be applied to your business. Please do secure the services of an outside agency to guide you through each stage of the process because after all you will be still running your business. Finally once you begin the process make certain you are happy with the pace of implementation I remember we moved our dates forward a couple of times. We have had four audits since which we have passed...just keep an eye on employees "going off script" I remember a couple of occasions when our Supervisor introduced new procedures ...and neglected to go through the correct procedure. Best of Luck !!!Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Ajaykumar Pandey - Saturday, March 24, 2012, 12:41 AM

In my view, first understand the implied need of ISO standards, design a mechanism which will help to set the quality policy and objective inline with policy & then make the relevant documents including quality manual and procedures stating about effectiveness of QMS. Further conduct the internal audits to ensure the implementation & effectiveness of QMS within the organisation. Combination of all will help you to get ISO 90001:2008. Standard +Quality Manual+Departmental procedure+implementation+monitoring +Measurement + Belief on yourself (Yes we can) = ISO 9001:2008 organisation.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Pasi Hellman - Saturday, March 24, 2012, 10:26 AM

I have the following advice for you Emily! I started to consult a small business just like your (it had only three employees though). We started from the basics. I asked them to present their strategy, mission, vision and values. Next task was to identify the stakeholders. We drew a map of their stakeholders. That helped them to see the big picture and think about their most important competitors, partners and customers. I asked them to draw flowcharts of their key processes. After that I taught them the requirements of the ISO 9001 quality management standards. One of the most important things was absolutely the internal audits. That was the one one single important improvement, and they have been using a monthly audit schedule to 1. find out if the things are in order and 2. wherewww.qualitygurus.com/courses/mod/forum/discuss.php?d=7178 10/28

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ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

they could improve their business.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Mattia Fornaser - Sunday, April 1, 2012, 08:29 AM

In a small organization you may want to write the QMS yourself. I suggest you to purchase a book about QMS for small businesses (there are plenty out there), read it and adapt the example in it to your organization. We have done that in our company (6 people) and we got certified. It took one of us almost a month of work, but once the QMS is in place it is quite easy to maintain it.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Jaco Roets - Tuesday, April 3, 2012, 02:24 PMISO 9001 can be applied to any type and size of organization, regardless if its a small business or a large organisation. My personal opinion is that you should start right at the beginning and decide exactly what you are producing, and what the necessary control measures are that needs to be taken to achieve product quality conformance. This can be done by following the wonderful advice given by many of my colleagues on this thread. Once you know what you have and where you are headed you can start off by compiling a Quality Management Plan, which will help you identify what documentation you may need to prove that you have a conforming product. Secondly, take a good, hard look at your document numbering and record keeping process, as this is the snake that can bite you in the leg if you are not careful. Ensure that when you do compile document control registers, they contain the revision data, as well as a specified location, which can be updated as the document is sent through various review processes. This is done to ensure that you always know where the latest revision of the document can be found, as to prevent employees from working off old document sets. Once you have the administrative side covered it is time to turn to production. If your business provides a product, I would suggest the use of a simple 5 step Quality Control system. This system works as follows: Raw parts are received from suppliers and accepted by means of a material acceptance checklist; thereafter the production process starts with a pre-inspection of all equipment, work areas and raw products to ensure that the product can be assembled, this must be documented for proof of pre-production inspection. The person responsible for QC/QA must choose inspection points, which must be indicated on a checklist. As production flows these inspections are carried out and signed off according to the progress made. Any deviations identified must be written on a snag list, which needs to be repaired and signed off before the product can be released for final inspection. Final inspection is done through your Inspection & Test Plan, which will have you look at the quality in regard to specific standards, as applicable to your product, your inspections before and during manufacturing process, material acceptance checks & snag list signoff. These items must all be conformant before the QCP can be signed off and the product approved.

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Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Eduardo L Dimaano Jr - Sunday, April 15, 2012, 02:07 AM

Small or big, the you have to state an standard to follow, afterall every business have their own policy and standard. Identify what you need and proceed from there. It is a continues cycle until you satisfy the need of a business.Show parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Edward Nelson Pratt - Monday, April 16, 2012, 08:43 AM

first of all you must know why you are implementing or intend implementing the ISO, management must be ready to establish,document,implement and maintain a quality mangaement system. management must be able to ; state quality objectives realtion to the quality management system write down procedures document them and have them recorded.Show parent | Reply

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ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Anirban Chatterjee - Tuesday, April 17, 2012, 07:22 AM

hi As your organization is not big so better you learn the basic first. Then if possible consult with some knowledgeable person. However, the clauses are 0. Introduction 1.Scope 2.Normative Reference 3.Terms and Definitions 4.Quality Management System 5.Management Responsibility 6.Resource Management 7.Product Realization 8.Measurement, Analysis and Improvement Understand these clauses very carefully then start implementation. Best of luck

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Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Camilo Encarnacion - Thursday, April 26, 2012, 01:16 PM

The steps in implementing ISO 9001 can be found and clearly enumerated in the lessons of the course in Introduction to ISO 9001:2008. A company or organisation big or small does not matter when it comes to the implementation of ISO requirements. To be able to determine the requirements in achieving customer satisfaction would be the best first great step towards the target of the ISO. Evaluation of available resources and managing them in order to fulfill the criteria of standardization would not be so tasking on the part of the management particularly for a small company. It would be very beneficial for the company if it can achieve its quality goals at an early stage of its operation or production. A small organisation is inclined to becoming medium scale and even larger in the future depending upon its track record in the market. Within a small company we can easily identify who are competent and skilled from among the manpower. The processes and procedures of a small organisation can be documented in a short period. If the management is committed to the goals of standards and its resources capable of producing good quality, there will be no doubt in the achievement of ISO 9001 requirements.Show parent | Reply

Count of Likes: 0 Informationby Prince Seven - Monday, June 25, 2012, 03:44 AM

Visit this site http://www.easy9001.com/easy-steps-iso-9001.htm/ , If you want directly to destination click here iso 9001 implementationShow parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by JOHN ADDO - Thursday, July 5, 2012, 08:37 AM

Hi, I think is a very Good Idea to start even as the number of employees is not that much. My advice for you, it to make sure all your employees go through this site and the certification course. Then you find out their views on implementation of ISO 9001 in your business. That way way you get their maximum support to start the implementation process. Wish you the best.Show parent | Reply

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ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

Re: How to first begin implementing ISO 9001 into my organisation?by saeed GESSO - Wednesday, July 11, 2012, 09:25 AM

you to look in you area approved agent of iso 9001 and have expertise world wide technical sevices organisation. agree with the agent. fill form.. so prepare fot the internal audit. training your staff, what is iso 9001, what requirments of iso andall related iso 9001, as followShow parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by TAHIANA MARIE ELIANE RASOANAMBININA - Tuesday, July 17, 2012, 05:44 AM

As per your suggestion request, I am happy to introduce this model of: ISO 9001 implementation general guideline. for your small organization or company The ISO 9001 implementation and the ISO 9001 certification process will not only result in the desired ISO 9001 registration but prove to be one of the most valuable exercises you can do to improve virtually all aspects of your organization. Under the umbrella of ISO 9001 implementation, employees and management will be able to improve cross-functional cooperation and fine-tune business processes. The implementation of ISO 9001 is a process that, if done correctly, will unify all employees and managers into improving work processes. Everybody will have a chance to identify processes that are inefficient or otherwise inadequate. I. The best time for ISO 9001 implementation and certification If you are in the position of starting up a new organization, you should be setting up your business processes according to ISO 9001:2008 requirements and start implementing ISO 9001 before hiring your employees. Though, most organization have been long established before they start their ISO 9001 implementation. Since a complete ISO 9001 quality management system brings many benefits to a company, it's always better to start the ISO 9001 implementation sooner rather than later. First of all, you are to observe the resistance to change. This is the most efficient approach as your organization not only immediately reaps the benefits of ISO 9001 but you also don't have to overcome resistance to change when adjusting work processes later to meet the requirements of the ISO 9001:2008 standard. II. How do you start with ISO 9001, Should we use an ISO 9000 consultant ? As a first step, you should make yourself familiar with the ISO 9001:2008 standard and its requirements. It is important that you get a good understanding of the ISO 9001 requirements; - How they will affect your organization, and how much is involved in the ISO 9001 certification process before you make the final decision on starting the ISO 9001 implementation. - Find some important information on ISO 9001:2008 and links to organizations selling the standard and ISO 9001 training courses. Once you have a working knowledge of ISO 9001 and its implementation, you will need to decide on which approach to take to get more chance of effectiveness: - Use a consultant or Expert to implement ISO 9001 : 2008. Choice of Consultant to teach the Management Representative of your organization It would be better and, it may be beneficial if an expert in ISO 9001 requirements is used to train the ISO 9001 Management Representative. In fact, good ISO 9001 consultants, depending on how you use them, can be of great help, and they can also cause great damage, can add value as trainers. However, since most consultants try to sell their consulting services, pure ISO 9001 instructors are generally a better choice. These ISO 9001 Consultants can write an overly complicated and convoluted ISO 9001 quality manual and quality procedures.www.qualitygurus.com/courses/mod/forum/discuss.php?d=7178

In some case, it is recommended using a specialized ISO 9001 instructor, to teach the ISO 9001 Management Representative and all of

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ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

In some case, it is recommended using a specialized ISO 9001 instructor, to teach the ISO 9001 Management Representative and all of executive management inside you organization; III. ISO 9001 documentation The required ISO 9001 documents are: a quality manual, quality procedures, a quality policy and quality objectives; in addition, ISO 9001 requires work instructions that provide detailed guidelines to employees on how to perform their work. However, the ISO 9001:2008 standard is very clear that work instructions need only be created instructions - possibly in form of pictures - For example, display instruction right on any machines, explaining how to replace a a small accessories. Some of the most typical forms are the Corrective Action Report Form, the Employee Review Form, and the Customer Survey. The Process of ISO 9001 certification. - The certification is issued by an independent and accredited ISO 9001 registrar. There are many such ISO 9001 registrars, so you can choose the one that fits your organization' s circumstances the best. It is better that you choose your ISO 9001 registrar early during the ISO 9001 implementation process as some registrars offer free support materials that help you implement ISO 9001. - Once the organization has completed all ISO 9001 documentation (including the all-important quality manual and quality procedures), the organization may apply for ISO 9001 certification. - After successful from verification that your organization has implemented an ISO 9001 quality management system and follows all its requirements in daily operations, an independent registrar will issue an ISO 9001 certificate to. Steps to ISO 9001 Certification process In order to achieve ISO 9001 certification, your organization needs to have the entire ISO 9001 quality management system implemented; this includes having written the entire ISO 9001 documentation and following all the requirements stipulated in your documentation. Before the certification audit can be performed and the ISO 9001 certification be issued,your organization needs to meet two conditions: 2. First, perform one complete internal ISO 9001 audit. Such an internal audit is performed internally by one or more company employees who verify that their company in fact follows the requirements described in the ISO 9001 documentation. Secondly, your organization needs to have a track record of operating according to ISO 9001 requirements; most registrars require about in some case 2 months of track record. How long does the ISO 9001 implementation take? The time to implement ISO 9001 and reach certification depends very much on you and your organization. if you and other managers are ready to put significant time and efforts into the ISO 9001 implementation endeavor, and if you use a really good pre-written template for your ISO 9001 quality manual and quality procedures, as well as good pre-written forms and checklists, then you may be able to get your organization certified in as short as 3-4 months. The fastest is 2-3 months because most ISO 9001 registrars require at least 2 months ISO 9001 track record before the certification audit. if you have a relatively small company less than 20 employees, if your employees are motivated and if they don't oppose change (employee buy-in is crucial, and employees must be involved from the beginning; Some organization are significantly slower, within 6-12 months, that is not being unusual. However, some organization that write their quality manual and quality procedures from scratch, rather than base them on a good template, often take as long as 2 years and longer. Certification Audit, and how to find Registrar ? Finding an accredited ISO 9001 registrar is not difficult. Once the above requirements are fulfilled, an accredited ISO 9001 registrar will have an auditor with its team to perform two audits: - A documentation audit, in which the ISO 9001 registrar verifies that the organization's quality manual and quality procedures meet the requirements of ISO 9001:2008. This audit can be passed easily if you based your ISO 9001 documentation on good templates. - An onsite audit at the organization, in which the ISO 9001 registrar verifies that the organization operates according to its ISO 9001 documentation and to ISO 9001:2008 requirements. - An "external audit" as opposed to the internal audit, the auditor will randomly check records, interview management and staff and observe employees perform their work. The goal is to establish evidence that the organization meets all ISO 9001:2008 requirements. - In case the auditor identifies problems, or so-called non-conformities, the organization will have the opportunity to correct the non-conformities. ISO 9001 Certificate deliverance - After Audit completely done, and in case of no significant gaps to the ISO 9001:2008 requirements are discovered or if any discovered gaps have been corrected, the ISO 9001 registrar issues the prestigious ISO 9001 certification. The ISO 9001 certificate that is typically valid for

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ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

have been corrected, the ISO 9001 registrar issues the prestigious ISO 9001 certification. The ISO 9001 certificate that is typically valid for three years should be issued. Then, It can then be easily renewed. - For continued validity of the ISO 9001 certification is during the periodic so-called surveillance audits which are conducted by the ISO 9001 registrar ; - Those surveillance audits show continued ISO 9001 compliance that your organization has an opportunity to correct any non-conformities still happened. Surveillance audits are usually conducted every 6 to 12 months. Although, they are much smaller in scope, time and cost than the initial certification audit. Cost of an ISO 9001 quality management system The cost of ISO 9001 implementation and achieving ISO 9001 certification varies significantly depending on the size of your organization and the implementation approach you take. - Periodic audit fees in some case may reach of about US$1,000 - US$2,000 per auditor day, the ISO 9001 implementation and ISO 9001 certification process can be rather expensive. - Large organization may spend in excess of hundred thousand dollars in consultant fees, while small organization can get by with a thousand dollars.

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Count of Likes: 0

Re: How to first begin implementing ISO 9001 into my organisation?by ADMIRE NYIKA - Friday, August 31, 2012, 07:42 AM

Thanks for this great input, would you have a pdf or word version of these implemantation guidelines. may you kindly forward to [email protected] kind regardsShow parent | Reply

Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by TAHIANA MARIE ELIANE RASOANAMBININA - Tuesday, July 17, 2012, 05:46 AM

As per your suggestion request, I am happy to introduce this model of: ISO 9001 implementation general guideline. for your small organization or company The ISO 9001 implementation and the ISO 9001 certification process will not only result in the desired ISO 9001 registration but prove to be one of the most valuable exercises you can do to improve virtually all aspects of your organization. Under the umbrella of ISO 9001 implementation, employees and management will be able to improve cross-functional cooperation and fine-tune business processes. The implementation of ISO 9001 is a process that, if done correctly, will unify all employees and managers into improving work processes. Everybody will have a chance to identify processes that are inefficient or otherwise inadequate. I. The best time for ISO 9001 implementation and certification If you are in the position of starting up a new organization, you should be setting up your business processes according to ISO 9001:2008 requirements and start implementing ISO 9001 before hiring your employees. Though, most organization have been long established before they start their ISO 9001 implementation. Since a complete ISO 9001 quality management system brings many benefits to a company, it's always better to start the ISO 9001 implementation sooner rather than later. First of all, you are to observe the resistance to change. This is the most efficient approach as your organization not only immediately reaps the benefits of ISO 9001 but you also don't have to overcome resistance to change when adjusting work processes later to meet the requirements of the ISO 9001:2008 standard. II. How do you start with ISO 9001, Should we use an ISO 9000 consultant ?www.qualitygurus.com/courses/mod/forum/discuss.php?d=7178 15/28

02/03/2013

ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

As a first step, you should make yourself familiar with the ISO 9001:2008 standard and its requirements. It is important that you get a good understanding of the ISO 9001 requirements; - How they will affect your organization, and how much is involved in the ISO 9001 certification process before you make the final decision on starting the ISO 9001 implementation. - Find some important information on ISO 9001:2008 and links to organizations selling the standard and ISO 9001 training courses. Once you have a working knowledge of ISO 9001 and its implementation, you will need to decide on which approach to take to get more chance of effectiveness: - Use a consultant or Expert to implement ISO 9001 : 2008. Choice of Consultant to teach the Management Representative of your organization It would be better and, it may be beneficial if an expert in ISO 9001 requirements is used to train the ISO 9001 Management Representative. In fact, good ISO 9001 consultants, depending on how you use them, can be of great help, and they can also cause great damage, can add value as trainers. However, since most consultants try to sell their consulting services, pure ISO 9001 instructors are generally a better choice. These ISO 9001 Consultants can write an overly complicated and convoluted ISO 9001 quality manual and quality procedures. In some case, it is recommended using a specialized ISO 9001 instructor, to teach the ISO 9001 Management Representative and all of executive management inside you organization; III. ISO 9001 documentation The required ISO 9001 documents are: a quality manual, quality procedures, a quality policy and quality objectives; in addition, ISO 9001 requires work instructions that provide detailed guidelines to employees on how to perform their work. However, the ISO 9001:2008 standard is very clear that work instructions need only be created instructions - possibly in form of pictures - For example, display instruction right on any machines, explaining how to replace a a small accessories. Some of the most typical forms are the Corrective Action Report Form, the Employee Review Form, and the Customer Survey. The Process of ISO 9001 certification. - The certification is issued by an independent and accredited ISO 9001 registrar. There are many such ISO 9001 registrars, so you can choose the one that fits your organization' s circumstances the best. It is better that you choose your ISO 9001 registrar early during the ISO 9001 implementation process as some registrars offer free support materials that help you implement ISO 9001. - Once the organization has completed all ISO 9001 documentation (including the all-important quality manual and quality procedures), the organization may apply for ISO 9001 certification. - After successful from verification that your organization has implemented an ISO 9001 quality management system and follows all its requirements in daily operations, an independent registrar will issue an ISO 9001 certificate to. Steps to ISO 9001 Certification process In order to achieve ISO 9001 certification, your organization needs to have the entire ISO 9001 quality management system implemented; this includes having written the entire ISO 9001 documentation and following all the requirements stipulated in your documentation. Before the certification audit can be performed and the ISO 9001 certification be issued,your organization needs to meet two conditions: 2. First, perform one complete internal ISO 9001 audit. Such an internal audit is performed internally by one or more company employees who verify that their company in fact follows the requirements described in the ISO 9001 documentation. Secondly, your organization needs to have a track record of operating according to ISO 9001 requirements; most registrars require about in some case 2 months of track record. How long does the ISO 9001 implementation take? The time to implement ISO 9001 and reach certification depends very much on you and your organization. if you and other managers are ready to put significant time and efforts into the ISO 9001 implementation endeavor, and if you use a really good pre-written template for your ISO 9001 quality manual and quality procedures, as well as good pre-written forms and checklists, then you may be able to get your organization certified in as short as 3-4 months. The fastest is 2-3 months because most ISO 9001 registrars require at least 2 months ISO 9001 track record before the certification audit. if you have a relatively small company less than 20 employees, if your employees are motivated and if they don't oppose change (employee buy-in is crucial, and employees must be involved from the beginning;www.qualitygurus.com/courses/mod/forum/discuss.php?d=7178 16/28

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buy-in is crucial, and employees must be involved from the beginning;

ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

Some organization are significantly slower, within 6-12 months, that is not being unusual. However, some organization that write their quality manual and quality procedures from scratch, rather than base them on a good template, often take as long as 2 years and longer. Certification Audit, and how to find Registrar ? Finding an accredited ISO 9001 registrar is not difficult. Once the above requirements are fulfilled, an accredited ISO 9001 registrar will have an auditor with its team to perform two audits: - A documentation audit, in which the ISO 9001 registrar verifies that the organization's quality manual and quality procedures meet the requirements of ISO 9001:2008. This audit can be passed easily if you based your ISO 9001 documentation on good templates. - An onsite audit at the organization, in which the ISO 9001 registrar verifies that the organization operates according to its ISO 9001 documentation and to ISO 9001:2008 requirements. - An "external audit" as opposed to the internal audit, the auditor will randomly check records, interview management and staff and observe employees perform their work. The goal is to establish evidence that the organization meets all ISO 9001:2008 requirements. - In case the auditor identifies problems, or so-called non-conformities, the organization will have the opportunity to correct the non-conformities. ISO 9001 Certificate deliverance - After Audit completely done, and in case of no significant gaps to the ISO 9001:2008 requirements are discovered or if any discovered gaps have been corrected, the ISO 9001 registrar issues the prestigious ISO 9001 certification. The ISO 9001 certificate that is typically valid for three years should be issued. Then, It can then be easily renewed. - For continued validity of the ISO 9001 certification is during the periodic so-called surveillance audits which are conducted by the ISO 9001 registrar ; - Those surveillance audits show continued ISO 9001 compliance that your organization has an opportunity to correct any non-conformities still happened. Surveillance audits are usually conducted every 6 to 12 months. Although, they are much smaller in scope, time and cost than the initial certification audit. Cost of an ISO 9001 quality management system The cost of ISO 9001 implementation and achieving ISO 9001 certification varies significantly depending on the size of your organization and the implementation approach you take. - Periodic audit fees in some case may reach of about US$1,000 - US$2,000 per auditor day, the ISO 9001 implementation and ISO 9001 certification process can be rather expensive. - Large organization may spend in excess of hundred thousand dollars in consultant fees, while small organization can get by with a thousand dollars.

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Count of Likes: 0

Re: How to first begin implementing ISO 9001 into my organisation?by TAHIANA MARIE ELIANE RASOANAMBININA - Thursday, July 19, 2012, 10:23 AM

As per your suggestion request, I am happy to introduce this model of: ISO 9001 implementation general guideline. for your small organization or company ISO 9001 implementation The ISO 9001 implementation and the ISO 9001 certification process will not only result in the desired ISO 9001 registration but prove to be one of the most valuable exercises you can do to improve virtually all aspects of your organization. Under the umbrella of ISO 9001 implementation, employees and management will be able to improve cross-functional cooperation and fine-tune business processes. The implementation of ISO 9001 is a process that, if done correctly, will unify all employees and managers into improving work processes. Everybody will have a chance to identify processes that are inefficient or otherwise inadequate.www.qualitygurus.com/courses/mod/forum/discuss.php?d=7178

I. The best time for ISO 9001 implementation and certification

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ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

I. The best time for ISO 9001 implementation and certification If you are in the position of starting up a new organization, you should be setting up your business processes according to ISO 9001:2008 requirements and start implementing ISO 9001 before hiring your employees. Though, most organization have been long established before they start their ISO 9001 implementation. Since a complete ISO 9001 quality management system brings many benefits to a company, it's always better to start the ISO 9001 implementation sooner rather than later. First of all, you are to observe the resistance to change. This is the most efficient approach as your organization not only immediately reaps the benefits of ISO 9001 but you also don't have to overcome resistance to change when adjusting work processes later to meet the requirements of the ISO 9001:2008 standard. II. How do you start with ISO 9001, Should we use an ISO 9000 consultant ? As a first step, you should make yourself familiar with the ISO 9001:2008 standard and its requirements. It is important that you get a good understanding of the ISO 9001 requirements; - How they will affect your organization, and how much is involved in the ISO 9001 certification process before you make the final decision on starting the ISO 9001 implementation. - Find some important information on ISO 9001:2008 and links to organizations selling the standard and ISO 9001 training courses. Once you have a working knowledge of ISO 9001 and its implementation, you will need to decide on which approach to take to get more chance of effectiveness: - Use a consultant or Expert to implement ISO 9001 : 2008. Choice of Consultant to teach the Management Representative of your organization It would be better and, it may be beneficial if an expert in ISO 9001 requirements is used to train the ISO 9001 Management Representative. In fact, good ISO 9001 consultants, depending on how you use them, can be of great help, and they can also cause great damage, can add value as trainers. However, since most consultants try to sell their consulting services, pure ISO 9001 instructors are generally a better choice. These ISO 9001 Consultants can write an overly complicated and convoluted ISO 9001 quality manual and quality procedures. In some case, it is recommended using a specialized ISO 9001 instructor, to teach the ISO 9001 Management Representative and all of executive management inside you organization; III. ISO 9001 documentation The required ISO 9001 documents are: a quality manual, quality procedures, a quality policy and quality objectives; in addition, ISO 9001 requires work instructions that provide detailed guidelines to employees on how to perform their work. However, the ISO 9001:2008 standard is very clear that work instructions need only be created instructions - possibly in form of pictures - For example, display instruction right on a machine, explaining how to replace a a small accessories. Some of the most typical forms are the Corrective Action Report Form, the Employee Review Form, and the Customer Survey. IV. The Process of ISO 9001 certification. - The certification is issued by an independent and accredited ISO 9001 registrar. There are many such ISO 9001 registrars, so you can choose the one that fits your organization' s circumstances the best. It is better that you choose your ISO 9001 registrar early during the ISO 9001 implementation process as some registrars offer free support materials that help you implement ISO 9001. - Once the organization has completed all ISO 9001 documentation (including the all-important quality manual and quality procedures), the organization may apply for ISO 9001 certification. - After successful from verification that your organization has implemented an ISO 9001 quality management system and follows all its requirements in daily operations, an independent registrar will issue an ISO 9001 certificate to. 1. Steps to ISO 9001 Certification In order to achieve ISO 9001 certification, your organization needs to have the entire ISO 9001 quality management system implemented; this includes having written the entire ISO 9001 documentation and following all the requirements stipulated in your documentation. Before the certification audit can be performed and the ISO 9001 certification be issued, your organization needs to meet two conditions: a) Perform one complete internal ISO 9001 audit. Such an internal audit is performed internally by one or more company employees who verify that their company in fact follows the requirements described in the ISO 9001 documentation.www.qualitygurus.com/courses/mod/forum/discuss.php?d=7178 18/28

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ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

b) Secondly, your organization needs to have a track record of operating according to ISO 9001 requirements; most registrars require about in some case 2 months of track record. 2. How long does the ISO 9001 implementation take? The time to implement ISO 9001 and reach certification depends very much on you and your organization. if you and other managers are ready to put significant time and efforts into the ISO 9001 implementation endeavor, and if you use a really good pre-written template for your ISO 9001 quality manual and quality procedures, as well as good pre-written forms and checklists, then you may be able to get your organization certified in as short as 3-4 months. The fastest is 2-3 months because most ISO 9001 registrars require at least 2 months ISO 9001 track record before the certification audit. if you have a relatively small company less than 20 employees, if your employees are motivated and if they don't oppose change (employee buy-in is crucial, and employees must be involved from the beginning; Some organization are significantly slower, within 6-12 months, that is not being unusual. However, some organization that write their quality manual and quality procedures from scratch, rather than base them on a good template, often take as long as 2 years and longer. 3. Certification Audit, and how to find Registrar ? Finding an accredited ISO 9001 registrar is not difficult. Once the above requirements are fulfilled, an accredited ISO 9001 registrar will have an auditor with its team to perform two audits: - A documentation audit, in which the ISO 9001 registrar verifies that the organization's quality manual and quality procedures meet the requirements of ISO 9001:2008. This audit can be passed easily if you based your ISO 9001 documentation on good templates. - An onsite audit at the organization, in which the ISO 9001 registrar verifies that the organization operates according to its ISO 9001 documentation and to ISO 9001:2008 requirements. - An "external audit" as opposed to the internal audit, the auditor will randomly check records, interview management and staff and observe employees perform their work. The goal is to establish evidence that the organization meets all ISO 9001:2008 requirements. - In case the auditor identifies problems, or so-called non-conformities, the organization will have the opportunity to correct the non-conformities. 4. ISO 9001 Certificate deliverance - After Audit completely done, and in case of no significant gaps to the ISO 9001:2008 requirements are discovered or if any discovered gaps have been corrected, the ISO 9001 registrar issues the prestigious ISO 9001 certification. The ISO 9001 certificate that is typically valid for three years should be issued. Then, It can then be easily renewed. - For continued validity of the ISO 9001 certification is during the periodic so-called surveillance audits which are conducted by the ISO 9001 registrar ; - Those surveillance audits show continued ISO 9001 compliance that your organization has an opportunity to correct any non-conformities still happened. Surveillance audits are usually conducted every 6 to 12 months. Although, they are much smaller in scope, time and cost than the initial certification audit. V. Cost of an ISO 9001 quality management system The cost of ISO 9001 implementation and achieving ISO 9001 certification varies significantly depending on the size of your organization and the implementation approach you take. - Periodic audit fees in some case may reach of about US$1,000 - US$2,000 per auditor day, the ISO 9001 implementation and ISO 9001 certification process can be rather expensive. - Large organization often spend in excess of hundred thousand dollars in consultant fees, while small companies can get by with a thousand dollars

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Count of Likes: 0 Re: How to first begin implementing ISO 9001 into my organisation?by Nisa Danan - Thursday, July 19, 2012, 10:50 PM

We are going to have an audit next month, but we are confused in revising our Quality Manual as well as the forms. Currently we have Revision A, if we want to amend some of the forms, do we need to indicate the revision in every pages as well as the date?Show parent | Reply

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ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

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Re: How to first begin implementing ISO 9001 into my organisation?by TAHIANA MARIE ELIANE RASOANAMBININA - Tuesday, July 24, 2012, 07:26 AM

Without getting a Management commitment of the Top Management inside an organization, nor having not got the prior choice of the area of activites which to be included into the QMS & ISO 9001: 2008 certification. Moreover, without getting stepped to Management Representative appointment, and defining any processes with its Responsbilble into each Department, it sodifficult to manage with succesful implement QMS & ISO 9001: 2008 even though into Small Business Management organization. Here are among the first action to be used when implmentating QMS & ISO 9001: 2008. Stage 1: MANAGEMENT COMMITMENT , The implementation a Quality Management system according to ISO 9001: 2008. Those who want to implement QMS have various perspective stages to be defined. However, there are various points of view on the subject on hown and from where to begin to implement it into an organization. Then, after, we recommend at each organization which wishes to launch out succesful steps, to adapt this planning to its own specific view points. For example, stage: To define the processes and their interactions can be carried out directly following stage : Inventory of fixtures of the organization, stage : Creation of manual quality can be begun after the defining any processes Management commitment (ISO 9001 : 2008 clause : 5.1), Discuss to the Management if they must ready to be aware of the interests and resources necessary to the implementation of a quality system I. First action to do inside of the organization : 1. Choose the area of QMS application in which the Top Management of the organization should focus on quality system if they relate to all or part of the organization. Although, try to avoid the area which cannot be taken into account in the field of certification such as selectig the area from clause those stated in ISO clause ISO 9001: 2008 - Realization of the product, Example: related to clause7.3 - Design and development are often excluded from the field of certification for the companies of distribution. In addition, the organization must however justify the non-applicability of these requirements to its organization. Management should establish the quality policy (5.3): Try to focus on that the Management must express its orientations in its quality policy and communicate the importance to satisfy these requirements. From these orientations will rise the Quality objectives (5.4.1) in adequacy with the goal of the organization. (5.5.3) The quality policy is communicated within the organization and each employee can consult it easily. They also make sure that each employee is able to find this information. Try to step on ISO 9001: customer focus (5.2): The organization must begin to implement the necessary means relating to the requirements and the customer focus. Although chapter 5.2 is very short, the concept of listening customer is redundant in the standard because it is about one of the pillars of the system of management. To appoint a Management Representative ISO 9001 (5.5.2): II. Second action to do inside of the organization : 2. Top Management should appoint a person in charge quality, member of the framing, whose role is: - To follow the operation of the processes (description, effectiveness, improvement), - to communicate the system effectiveness as well as the improvement appropriatenesses to the direction, - to ensure the taking into account, by all the collaborators, of the requirements of the customers. Stage 2: Inventory of fixtures of the organization This action does not have any requirements of the standard on this subject, but it is interesting to carry out an initial diagnosis in order to precisely plan the quality step (requirements in formation, time, responsibilities, means of communication, etc). Through discussions with the persons in charge for the organization, the diagnosis allows: - To identify the processes of the organization and its future persons in charge, - To include the relations which exist between the collaborators and to index their competences and experiments, Define the availability of the people who will take an active part in the deployment of the project,www.qualitygurus.com/courses/mod/forum/discuss.php?d=7178

Realise out the inventory of the existing documents and used their field , Identify the means of communication of any documents.

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Realise out the inventory of the existing documents and used their field , Identify the means of communication of any documents. Stage 3: To define the processes and their interactions ISO 9001: definition of the processes (4.1 - general Requirements) In addition to ensure the control of its externalized processes, the organization must determine: - Processes necessary to the system of management, - Interactions and means of coordination between the various processes. There are various types of process: - The trade processes : production of good or service, - the supporting processes , necessary to the correct operation of the organization. Example: human resources, accountancy, communication, data processing - Processes of management: strategy and management, management of quality. After having listed its various processes, the organization must put them according to the interactions which link them. In this way, we can obtain the general cartography from it. Stage 4: To describe a process controls, the pilot process The pilotage process is the first to be validated. It describes the method used to satisfy the requirements of the standard. Initially, it describes the real situation. The margin of progression is measured and the actions necessary are implemented thereafter, in particular, by the application of the process of continuous improvement. The best way of proceeding is to go on the place where the process proceeds (workshop, office concerned,) and to note the sequence of the various actions observed. ISO 9001: description of the processes (4.1 - general Requirements) - To define the means necessary to the control and the effectiveness of the processes. Example: To detail a stage of one process using a procedure, an instruction, a procedure - To define the resources necessary (labour, material, matter/information, of the good operation of the processes and with their availability. method) and the tools (indicator of performance, controls), to take care

Each process perhaps represented by a sequence of operations. If necessary, the interaction between the stages could be specified within the description of the process. The latter can be made by various means: - The logigramme, - the worksheet, - the data-processing tool such as software, - etc To define the documentation of the process: In a general way, it is necessary to adapt documentation to the various types of users (format: paper, data processing, written, illustration, vocabulary and language). These documents and tools can be: - Data-processing tool such as software). - Procedures: It is used for the maintenance of know-how or the description of a process. The organization can define the form which is appropriate for the description of its procedures, under condition that it is in conformity with the requirements of the documentary procedure. - Instructions: It is used for the precise description of a task, such as the use of a machine, of a data-processing tool and it is also useful for the working stations with a manpower turnover to be quickly operational and to limit the risk of error. The instruction must thus be easily readable (to avoid the abbreviations, jargon). The diagrams, photographs, films and other illustrations are often adapted to this practical documentation. - Model of documents or form: Printed or in numerical documents format, the models of documents allow all the easy data acquisition necessary, but also to standardize the internal and external communication of the organization. In order to guarantee an adequate use it is necessary to reflect well on its contents and its structure. A too complex form or too length to be supplemented will probably not be used. Example: Model of report of review of direction, of report/ratio of audit, purchase order, application form of leave, models of invoice, model of investigation of satisfaction customer. - Recordings: They are evidence to document the correct operation of the quality system, in the form of results (indicating, evaluation of the suppliers) or of reports (grid of competences, report of review of Management, certificate) This key information is used to

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ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

suppliers) or of reports (grid of competences, report of review of Management, certificate) This key information is used to guarantee the traceability and to facilitate, respectively document the decision-making process or to support decisions. The standard ISO 9001: 2008 require a certain number of recordings. For the remainder, it is at the organization to identify information likely to be recorded. Guard should however be taken not to require collaborators the production of useless documents. ISO 9001 : Records to be Maintained - 4.2.1- 5.6.1- 6.2.2 - 7.1 - 7.2.2 - 7.3.2 Reports : - 7.3.4 Design and Developpement Review and any actions which are included.. - 7.3.5- 7.3.6- 7.3.7- 7.3.7- 7.4.1 - 7.5.2- 7.5.3- 7.5.4- 7.6- 7.6- 7.6 Evaluation of the validity of the former results, if equipment of measurement and of monitoring is not declared in conformity with the requirements. - 8.2.2 Reports of internal audit. - 8.2.4 Proof of the conformity of the product to the requirements and identification of the person having authorized the release of the product for delivery to the customer. - 8.3 If a product is declared not in conformity with the requirements, the proof of this report and actions which in rise (of which exemption for the release of the product). - 8.5.2 Results of the corrective actions. - 8.5.3 Results of the preventive actions. Stage 4: Extend the other processes When the description of the pilot process is considered to be in conformity with the requirements and waitings, it is then advisable to extend methodology to the whole of the identified processes. The standard ISO 9001: 2008 comprise particular requirements relating to certain processes such as the human stock management and management of the infrastructures in order to satisfy the requirements and waitings of the customer. ISO 9001: Human resources (6.2) human resources must be managed of kind to guarantee the conformity of the products and services. Thus, the standard requires: - To determine competences necessary concerning the personnel whose activity has a direct impact on the conformity of the product. Example: To choose the working stations/ or the concerned functions and to draw up any Jobs description. - To implement the actions to acquire competences necessary and to evaluate the effectiveness of these actions. Example: Training Planing, sensitizing or promoting, coaching. Fixing of precise targets in terms of development, competences. Evaluation of the training activities (satisfaction of the participants, acquisition of the necessary qualification level). Stage 5: Creation of quality manual : is a included inside the Quality Management system of the organization. It can be possibly used at commercial purposes. ISO 9001: quality manual (4.2.2) manual quality must include: - The applicability of the system as well as the mention and the justification of exclusions, - the reference to the procedures of the quality system, - the interactions between the processes. Each organization is free to add to it the elements which it wishes. Stage 6: Planning and coordination of these steps According to the reports established following the realization of the inventory of fixtures, the person in charge for quality will propose with the Magement an action plan for the deployment of the Quality Management System. This plan must: 1. To identify the requirements in training and materials, 2. To identify the people who will be implied in the meetings of work (in particular the persons in charge process) and the composition of the teams, 3. To quantify time necessary for the achievement of the tasks allotted to each one.www.qualitygurus.com/courses/mod/forum/discuss.php?d=7178 22/28

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ISO 9001:2008: How to first begin implementing ISO 9001 into my organisation?

Once the plan is validated by Management, the person in charge of quality must follows and coordinates the closure of the project and organizes any meetings. On its side, Management must envisage the resources necessary (6.1) for the Quality Management System and achieve the quality objectives i.e.: 1. To define a budget for the staff training, the possible purchase of material or service of council, the audit of certification, 2. To release from time for the people implied in the implementation of the quality system, 3. To define the responsibilities and to communicate them within the organization (5.5.1) for : - Person in charge of quality, - Persons in charge for process per any Department, etc

To define and set up the means of suitable communication (5.5.3 ntenal communication ). How to compose the teams? Several competences are ne