Talk:ISO/TC 176

Charles Corrie & Members of ISO/TC 176/SC 2-Quality Management and Quality Assurance / Quality Systems

Refereeing to ISO/CD 9001 dated 3/06/2013, I would like to present and suggest my suggestions to the new version of ISO 9001:2015 for improving and enhancement to get new standard cover all our needs and expectations in all business fields ( produce products or provide services) and also ,increase the benefits of the organizations by attracting more customers.Therefore ,the following suggestions are :-

1.Process approach in clause No.4.4.2,due to the importance of this item (element) since it is one of the main seven principles for QMS,I have an idea to add the statement " all documents and records in this clause shall be available as a documented information" at the end of that clause. 2.Clauses No.(5.1.1& 5.1.2) related to the main clause No. (5.1) named by "Leadership & Commitment",due to the same above reasons in previous one ,which is the importance of that item since it is one of the main seven principles of QMS,I would like to add the same statement "all documents and records shall be available as a documented information" at the end of that clause . 3.I think that all clauses belongs to main clause No.(6)named by "Planning" shall retain documented information due to planning item represent one of the main factors to establish effective & efficient QMS according to Deming theory which "Plan,Do,Check,Act" or "P,D,C,A" called PDCA cycle which is not stated in the draft copy of new standard and I think that adding that cycle will provide more information to new standard . 4.The clauses No.(7.1.2&7.1.3) are completely similar in the expressions,meaning and statements,for that reason,I think that it is recommended to merge these clause in one clause only and cover the requirements and add the statement " the planning for that process is one of the main requirements for infrastructure & environment " like risks in the same draft copy of standard ,besides " implementation ,monitoring,measurement,control and reporting,organization shall retain documented information for that process". 5.In clauses No.(7.1.4&7.5.2&7.5.3) there is a word called "appropriate"may be make a confusion among organizations i.e some organizations may understand that word is requirement and other organizations may not, for that reason,I think that it is better to cancel that word and add " the organization shall retain documented information for that item". 6.In clauses No.(7.1.5&7.3&7.4&8.5&9.1.2&9.1.3),I think that it is recommended to add statement "retain documented information" to these clauses to have an evidences to support top management to take decisions based on data as stated in one of main seven principles for QMS. 7.By reviewing the expressions in draft copy of new standard ,I found that many words are repeated without any value-added to the meaning for the processes for example, customer satisfaction,QMS,processes,performance and control.I think that it is better to arrange these wording in such a manner to control the activities,processes as a whole based on PDCA cycle. 8.In clause No.(8.7),I think that the evidence of conformity with the acceptance criteria shall be maintained as documented information.i.e Add the statement " retain documented information" to that paragraph at the end of that item since that evidence is important for conformity of QMS as stated in the 2nd paragraph. 9.QMS.3 named by "Engagement of people" did not take the same importance in copy draft of new standard ISO 9001:2015 like the other six principles 1,2,4,5,6,7.i.e the quantity of information covering that principle did not balance with the same weights like other principles . 10.In the current version of ISO 9001:2008 ,environment has affect on any QMS in any organization and it takes some space in the standard and we have a comparison table between the two standards for EMS,QMS. And also ,the environment enhances the performance of any QMS inside organizations when they implement an integrated management system (QMS,EMS,SMS) .I understand that you consider SMS in that draft copy but EMS did not consider .Therefore,I think that it is recommended to add clause talking about environment aspects,impacts and significant ones,as you spoken about risks in that draft copy ISO 9001:2015. 11.Preventive action process is important since when we analyze,evaluate,monitor and measure data gathering from any process, we can see and decide where is the area for improvement with taking preventive action before reaching to any deviations,complaints or non-conformity ,for that reason,I think that it is better to let that process in the standard as we have now with some modifications like,following -up the actions to get the improved value-added to the processes according to the graphs before,after the preventive actions taken. 12.The seven QMS principles did not take the equivalent weights for documents and records required as documented information in the draft copy of new standard ISO 9001:2015 since the process approach and leadership principles take the equivalent weights for example but the others like relationship management and evidence-based decision making are not.Therefore,I would like to review this standard to put each principle has an equivalent documented information to acquire best practice to implement the new standard with same balance with respect to QMS. 13.The statuary and regulatory requirements besides legal,others ones did not consider in that draft copy although it is very important when implementing the QMS inside the organizations due to these requirements are mandatory and any organization did not can deviate away from these requirements.Therefore,I think that it is better to add clause covering that item besides a method of evaluation of compliance for that requirements and shall retain documented information for that process.

I will be appreciating to your side for reading the above suggestions and sending your response to me at any way which may be helpful for updating standard and if it is not ,advise me by few words because I try to provide my suggestions to improve the standard from my point of view since I had a long experience for qualification of many organizations in different fields and also, in auditing fields in many certification bodies.

For more information,contact me at once. I will wail your response With my regards and my best wishes

Consultant and lead auditor in QMS,EMS,SMS

Eng. Medhat Abd Elaziz

Mob. 0100 966 7090