iSixSigma

What are the most important procedures of the new ISO 9001 standard?

Six Sigma – iSixSigma Forums Old Forums General What are the most important procedures of the new ISO 9001 standard?

Viewing 11 posts - 1 through 11 (of 11 total)
  • Author
    Posts
  • #27754

    Fasi Javeed
    Participant

    Can someone please guide me as to which are the most important procedures to be written for ISO 9001:2000?
    I have identified 6 of them, which are,
    1. Control of documents
    2. Control of quality records
    3. Internal audit
    4. Control of nonconforming product
    5. Corrective action
    6. Preventive action
    What about the rest of the 46 elements?
    Do we need to write procedures/work instructions for the rest?
    Any suggestion will be greatly appreciated?
    Thank you in advance.
    Fasi

    0
    #68328

    kb.chin
    Participant

    Hi Fasi , you are correct where you have identified 6 procedures , which is mandatory requirements as per ISO 9001 :2000 .You can able to meet the requirements with only this 6 documented procedures , and of course these 6 documented procedures must address all the important sub-clauses spell out in the standards . 
    Beside this , you have to consider the nature of business of your company . Like example , a small manufacturing industries with porperly only < 50 employees and the manufacturing processes a rather very simple and easy to operate , it's sufficient with only 6 documented procedures . These 6 procedures definately able to demonstrate the quality management system and  met the ISO9001: 2000 requirements. .
    Likewise , for a multi-organization , you will feel that with only these 6 documented procedures might not enoungh to continually improve and maintain the documented quality management system.  To consider to document other procedures or work instruction , you need to consider below factors too,
    1) employee  – skills, experience competency and training level .
    2) process    – complexity , critical and special process .
    3) employee turn over rate , process with low yeild (high defect) due to human error (poka-yoke).
    4) etc.
    In other words , certain processes where the employee is well train/educated and with high skills , you may need less procedures  ,
    or on the other hand ,certain critical processes and  process complexity , you might need more procedures to maintain and sustain the system .
    My personnal feeling , certain operations or processes where you need top management to involve to review the quality management system , you have better to document it and put it into effect . Like example ,
    Management review procedure and design review procedure and etc.
    I hope with the above informations , you are able to figure out what type of procedures  you need to document down due to certain
    critical  processes,complexity of process and processes which affected the product quality .
    I think that’s all I can share with you .
    Regards.
     
     
     

    0
    #68329

    Wasim danish
    Member

    It depnds upon the compony environment and culture, if your company is quite mature in its operations, HR practices are built in the company (which needs employees satisfaction and low turn over) and quality is communicated though out the company, you will not need detailed procedure for the operations. A comprehensive plan can overcome the requirement of documentation.
     
     
     

    0
    #68330

    Wasim danish
    Member

    It depnds upon the compony environment and culture, if your company is quite mature in its operations, HR practices are built in the company (which needs employees satisfaction and low turn over) and quality is communicated though out the company, you will not need detailed procedure for the operations. A comprehensive plan can overcome the requirement of documentation.
     
     
     

    0
    #68332

    Greg Mack
    Participant

    Hi Fasi,
    My only advice to you is develop the procedures you actually NEED for your business and NOT the Standard.
    The new Standard is process based and focusses on your needs rather than the previous “demand and response” theory.
    If you think about it this way, I’m sure you will see what needs to be documented and what doesn’t.
    Hope this helps,
    Greg.
     

    0
    #68337

    John Darby
    Participant

    I have information from a certification body which contains their instructions to auditors on how to assess against ISO 9001:2000.
    It includes the statement “Check if the organization has deleted any previous existing documented procedures.  If so, special attention will need to be given to the new methods of control now being applied in these areas.”
    So it seems if you are starting from scratch, its up to the organization to define what procedures are needed in addition to the six, but if you are coming from ISO 9001:1994 its necessary to justify any deletions! Interesting……..?

    0
    #68342

    Beverly
    Participant

    Fasi,
    I suggest you use your organization chart as one of the ways to determine the need for additional procedures/work instructions.  What areas (processess) are critical to your operations, and who is responsible for them (functions, i.e., job titles).  Regardless of the skills and education of your employees, if the function is critical, it should be documented. You would not need a procedure or work instruction for a Nurse who gives a shot to a patient-it is understood those skills are part of the professional training. If the process includes how the operation is performed and who is responsible for performing the tasks, you may not need a separate work instuction.  For example:  to calibrate a piece of equipment, you could use the manufacturer’s reference manual/material as your “work instruction” by referencing the document in your procedure.  Implementing a quality system is simply formalizing the everyday tasks and operations of your company.  Keep it simple, clear, and manageable. 

    0
    #68347

    Joe Oglesby
    Participant

    Fasi,
    I believe all the previous responses to your questions are good ideas.  I suggest you pay particular attention to ISO 9001:2000, 4.2.1d and 4.2.1, Note 2, a,b,c.  When my company went through the certification process, I had to repeatedly remind my auditor that we were justified in having less documentation than he was accustomed to because we are small (4.2.1, Note 2, a) and competent (4.2.1, Note 2, c).  Of course, we had made sure that we controlled the documents that we needed to (4.2.1d).  I set up the system the way I would have if there was no ISO – no less documentation than needed (why be deficient?) and no more than needed (why waste?).
    By the way, we had only two minor nonconformances on our certification audit – neither related to document control.  On June 28, 2001 our quality management system was certified to ISO 9001:2000.
    Good luck and best regards,
    Joe Oglesby
    Nova Gas Technologies, Inc.

    0
    #68716

    Hitesh Shah
    Participant

    Dear Mr,
    You have just identified procedures required by International Standard ISO 9001:2000 [Ref. 4.2 (a)], what about 4.2(b)?
    Satndard says that “The QMS documantetion shall include: (b) documents required by the organisation to ensure the effective operation and control of its process”
    This you have to identified as per your organisation requirement. For example, in Cotton Textile mill on can not omite, Purchasing procedure or related work instructions for Purchasing of Cotton, as it is a basic Natural Raw material.
     

    0
    #68723

    mohanbijur
    Participant

    refence : your mentioned six procedures are mandatory otherprocedures/workinstructions may be needed to support them asand where required.
    system documentation can differ depending on the size of the company and type of activities,the complexity of processes and their interactions and the competence of personnel

    0
    #128747

    zakaria
    Member

    the ISO 9001:2000 asked only for six procedures and also you can write the preventive and corrective action procedures in one procedure(preventive and corrective action procedure).for the rest of the standard it depends on the competence of your staff, because some of the companies staff are very competent and they know what they are doing.

    0
Viewing 11 posts - 1 through 11 (of 11 total)

The forum ‘General’ is closed to new topics and replies.