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‫الصدار الجديد‬

ISO DIS 9001:2015

‫ هشام احمد بركان‬. ‫ م‬: ‫اعداد‬

218925826468 +
haburkan@yahoo.com
LIBYA

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International Organization
International Organization
for Standardization
for Standardization

www.iso.org
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‫مقدمة‬

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The ISO System
164 national members
98% of world GDP*
97% of world population

Collection of 19 573 1 280 standards


ISO Standards produced in 2012
• IT tools
• Standards
224 active TCs development
3 368 technical procedures
bodies Central
• Consensus Secretariat
100 000 building in Geneva
experts • Dissemination 153 FTE
18 meeting/day staff
SMA/CASCO The ISO/CASCO Toolbox – 4
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‫الزيزو‬

‫عضوية اليزو مفتوحة الى مراكز المواصفات الوطنية او‬ ‫‪‬‬


‫المشابهة والتي تعتبر مسئولة على توحيد المواصفات في‬
‫بلدها ) عضو واحد لكل بلد ( ‪.‬‬
‫كل عضو له صوت واحد مهما كان حجم وقوة اقتصاد البلد ‪.‬‬ ‫‪‬‬
‫العضوية كالتي ‪- :‬‬ ‫‪‬‬
‫‪ -‬عضو عامل ( ‪ : ) member bodies‬الذي لدزيه مقعد دائم في الجمعية العمومية‪،‬‬ ‫‪‬‬
‫يشارك في اللجان وله حق التصويت ‪.‬‬
‫‪-‬عضو مراسل ( ‪ : ) correspondent member‬الدول التي لمتمتلك أجهزة‬ ‫‪‬‬
‫للمواصفات ول متشارك في إصدار المواصفات‪ .‬وزيعمل بصفة مراقب في اللجان ‪ ,‬و‬
‫ليس له حق التصويت ‪.‬‬
‫‪-‬عضو مشارك ( ‪ : ) Subscriber member‬للدول ذات القتصاديات الضعيفة‬ ‫‪‬‬
‫) القل نموا ( ولكن يمكن لهم متابعة تطور المعايير والحضور للجمعية العامة بصفة‬
‫مراقب‪.‬‬
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‫مهمة الزيزو‬

‫وضع المواصفات الدولية التختيارزية بغرض‪:‬‬

‫متسهيل التبادل الدولي للسلع والمنتجات والخدمات‬

‫متسهيل التعاون الدولي والمتصالت في جميع المجالت‬

‫دعم النمو التقتصادي وحمازية الصحة والسلمة والبيئة‬

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‫مبادئ منظمة التجارة العالمية لعداد المواصفات الدولية‬
‫الشفافية )برنامج العمل والتقتراحات والمواصفات( ‪.‬‬ ‫‪‬‬

‫العضوزية متاحة لكل هيئة مواصفات وطنية من جميع أعضاء‬ ‫‪‬‬


‫منظمة التجارة العالمية ‪.‬‬
‫الحياد والمتفاق ‪.‬‬ ‫‪‬‬

‫الفعالية والمناسبة لحتياجات السوق ‪.‬‬ ‫‪‬‬

‫الترابط )ل متناتقض بين المواصفات(‪.‬‬ ‫‪‬‬

‫البعد التنموي ‪.‬‬ ‫‪‬‬

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‫حقائق حول الزيزو‬
‫المواصفات مبنية اساسا على الجماع الدولي‬
‫)‪( INTERNATIONAL CONSENSUS‬‬ ‫‪‬‬

‫زيتم متطوزير المواصفات عن طرزيق لجان فنية رئيسية وفرعية وفرق عمل ‪.‬‬ ‫‪‬‬

‫اللجنة ‪ (ISO/TC176/SC2 (Quality Systems‬هي المسئولة على‬ ‫‪‬‬


‫متطوزير المواصفة القياسية الدولية ‪. ISO 9001‬‬
‫متم متطوزير المواصفة القياسية الدولية ‪ ISO 9001:2015‬عن طرزيق فرزيق‬ ‫‪‬‬
‫العمل )‪ ( WG24‬التابع للجنة الفرعية )‪. ( SC2‬‬
‫زيتكون فرزيق العمل )‪ ( WG24‬من مجموعة من تخبراء متم مترشيحهم من‬ ‫‪‬‬
‫هيئات المواصفات الوطنية او من المؤسسات المشاركة في الزيزو ‪-‬‬
‫‪ ) - liaison member‬مثل امتحادات الصناعة وغيرها ( ‪.‬‬

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ISO Development Process - ‫مراحل اعداد المواصفات‬

: ‫الخطوات الرئيسية لعداد ومتحدزيث المواصفات بمنظمة الزيزو‬
. ( ( Proposal stage : New work item proposal (NP or NWIP ) ‫مرحلة التقتراح‬ 1.
. (( Preparatory stage : working draft(s) (WD ) ‫مرحلة العداد‬ 2.
. (( Committee stage : committee draft(s) (CD) ‫مرحلة اللجنة‬ 3.
(( Enquiry stage: draft international standard (DIS ) ‫مرحلة استطلع الرأي‬ 4.
. ( ( Approval stage : final draft international standard (FDIS ) ‫مرحلة العتماد‬ 5.
. ( ( Publication stage : international standard (IS ) ‫مرحلة الصدار‬ 6.
‫ فإما ان زيتم اعتمادها او سحبها او‬, ‫ ضرورة مراجعة المواصفات دورزيا‬: ‫مرحلة المراجعة‬ 7.
. ‫متعدزيلها‬
‫ من مجموع‬%75 ‫لكي متصبح المواصفة دولية فإنه زيتطلب ان زيجيزها على التقل‬ 8.
. ‫العضاء‬

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Development Process

New Work Formal Working


Item Proposal Ballot
Draft

Vote to
Release

Draft Inter- Formal Committee


national Std Ballot Draft

Formal
Ballot

Final Draft Formal Internation


Int’l Standard Ballot
al Standard

International Consensus Process


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ISO 9001

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‫معلومات هامة‬
‫متحدد المواصفة متطلبات نظام ادارة الجودة والتي متهدف لضمان‬ ‫‪‬‬
‫استمرار متقدزيم المنتج أو الخدمة ضمن شروط معينة متضمن متحقيق‬
‫ومتحسين رضا العملء ‪.‬‬
‫متم اصدار أكثر من ‪ 1,101,272‬شهادة مطابقة لنظام الزيزو‬ ‫‪‬‬
‫‪ 9001‬ضمن ‪ 184‬بلدا في العالم ‪ ,‬محققا أكثر من ‪ %2‬ززيادة في‬
‫عدد الشهادات مقارنة بعام ‪ 2011‬اي بمعدل ‪ 21,625‬شهادة‬
‫إضافية ‪.‬‬
‫الدول الثل ث الكبر من حيث عدد الحصول على الشهادات هي ‪:‬‬ ‫‪‬‬
‫الصين ‪ ,‬ازيطاليا ‪ ,‬اسبانيا ‪.‬‬
‫الدول الثل ث الولى ضمن الززيادة في عدد الشهادات لعام ‪2012‬‬ ‫‪‬‬
‫هي ‪ :‬اسبانيا ‪ ,‬الصين ‪ ,‬ورمانيا ‪.‬‬
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‫الجودة ‪ :‬هي الدرجة التي متستوفى عندها مجموعة من الخصائص‬
‫‪.‬الكامنة للمتطلبات‬
‫الخاصية ‪ :‬هي سمة مميزة ‪.‬‬ ‫‪‬‬

‫الخاصية زيمكن ان متكون ضمنية او محددة ‪.‬‬ ‫‪‬‬

‫زيوجد انواع مختلفة من الخصائص مثل التالي ‪:‬‬ ‫‪‬‬

‫طبيعية ) مثال ‪ :‬الخصائص الميكانيكية ‪ ,‬الكهربية ‪ ,‬الكيميائية او البيولوجية ( ‪.‬‬ ‫‪‬‬

‫حسية ) مثال ‪ :‬المتعلقة باللمس والشم والتذوق والرؤزية والسمع ( ‪ - .‬سلوكية ) مثال ‪ :‬الدب ‪ ,‬المانة ‪ ,‬الصدق (‬ ‫‪‬‬

‫زمنية ) مثال ‪ :‬الموتقومتية ‪ ,‬الوثوتقية ‪ ,‬المتاحية ( ‪ .‬عضوزية ) مثال ‪ :‬الخصائص الفوسيولوجية ‪ ,‬او المتعلقة بأمان الفراد (‬ ‫‪‬‬
‫وظيفية ) مثال اتقصى سرعة للسيارة ( ‪.‬‬ ‫‪‬‬

‫تخاصية الجودة ‪ :‬تخاصية كامنة في المنتج او العملية او النظام متتعلق بأحد المتطلبات‬ ‫‪‬‬

‫كامنة ‪ :‬متعني موجودة في شيء ما على التخص في تخاصية دائمة ‪.‬‬ ‫‪‬‬

‫متطلب ‪ :‬هو احتياج او متوتقع متم النص عليه بشكل عام ضمني او الزامي ‪.‬‬ ‫‪‬‬

‫عبارة ) بشكل عام ضمنيا ( متعني انه عادة او امر مألوف للمنشأة والزبائن والطراف‬ ‫‪‬‬
‫التخرى ‪ ,‬ان الحتياح او التوتقع التخود في العتبار هو ضمني ‪.‬‬
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‫نظام ادارة الجودة‬
‫الدارة ‪ :‬أنشطة منسقة لتوجيه ومراتقبة المنشأة ‪.‬‬ ‫‪‬‬

‫نظام ادارة الجودة ‪ :‬هو نظام لتوجيه وضبط منشأة فيما‬ ‫‪‬‬
‫زيتعلق بالجودة ‪.‬‬
‫زيساهم في متقييم العمليات وتقياسها في نفس الوتقت ‪.‬‬ ‫‪‬‬

‫زيعتبر نطام ادارة الجودة اطار عمل ودليل ارشادي للمنظمات‬ ‫‪‬‬
‫لمراتقبة ومتطوزير ادائها ‪.‬‬
‫‪‬‬

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‫الحاجة الى الجودة‬
‫كل منظمة متود ان متتحسن ومتتطور بطرق مختلفة ‪:‬‬ ‫‪‬‬

‫متحسين رضا الزبون ‪.‬‬ ‫‪‬‬

‫متحسين أداء عمليامتها النتاجية او الخدمية ‪.‬‬ ‫‪‬‬

‫ززيادة حصتها التسوزيقية ‪.‬‬ ‫‪‬‬

‫تخفض التكاليف ‪.‬‬ ‫‪‬‬

‫ادارة المخاطر بفاعلية اكبر ‪.‬‬ ‫‪‬‬

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‫أفضل‬
‫تنافسية أفضل‬
‫مكانة تنافسية‬
‫مكانة‬

‫لنظمة‬
‫اطار عمل لنظمة‬ ‫بالقوانين‬
‫التزام بالقوانين‬
‫الرخرى‬
‫الدارة الرخرى‬
‫الدارة‬ ‫والتشريعات‬

‫توجه نحو البيئة‬ ‫الزبائن‬


‫ثقة ورضاء الزبائن‬
‫والمجتمع‬

‫العائـــــــد‬
‫اداء المؤسسة‬
‫تحسن اداء‬
‫تحسن‬ ‫من تطبيـــق‬ ‫فـــاقد أقــل‬
‫فـــاقد‬

‫نظام إدارة الجودة‬


‫اللتزام‬
‫إظهار اللتزام‬
‫إظهار‬ ‫واسواق جديدة‬
‫عروض واسواق‬
‫وتحسين السمعة‬
‫وتحسين‬

‫رضاء و تطوير‬
‫رضاء‬
‫للموارد‬
‫مستمر للموارد‬ ‫أربــاح أكثـــر‬
‫البشرية‬

‫أقــوى‬
‫اقتصاديات أقــوى‬
‫اقتصاديات‬
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ISO TC 176
QUALITY MANAGEMENT
&
QUALITY ASSURANCE -TC

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ISO TC 176
ISO TC 176
Quality Mgmt. &
Quality Assurance

SC1 SC2 SC3


Fundamental & Quality system Supporting Technology
Vocabulary (ISO 9000 ) ((ISO 9001 ,ISO 9004) ( ISO 10011 )

WG 24
WG 22 WG 23 Revision of
Communication &
interpretation product support ISO 9001

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ISO TC 176

P' and 25'O') 120'95) – ‫عدد اعضاء اللجنة‬ 

1979 : ‫تاريخ الشنشاء‬ 

ISO/TC 176 - Secretariat ( SCC) ‫السكرتارية – كندا‬ 

‫ ) اصدار المواصفات في مجال إدارة الجودة )شنظم إدارة الجودة عامة‬: ‫مجال العمل‬ 
‫ وكذلك إدارة الجودة في قطاعات محددة بناء‬،(supporting technologies - ‫والتقنيات الداعمة‬
.( .ISO Technical Management Board) ‫ ومجلس الدارة الفنية‬, ‫على طلب القطاع المختص‬

 Total number of published ISO standards related to the TC and its SCs (number
includes updates): 24
 Number of published ISO standards under the direct responsibility of ISO/TC
176 (number includes updates): 3

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 Standards and projects under the direct responsibility of ISO/TC 176
Secretariat Standard and/or project (3)
 ISO/TS 16949:2009
Quality management systems -- Particular requirements for the application of ISO 9001:2008
for automotive production and relevant service part organizations
 ISO/TS 17582:2014
Quality management systems -- Particular requirements for the application of ISO 9001:2008
for electoral organizations at all levels of government
 ISO 18091:2014
Quality management systems -- Guidelines for the application of ISO 9001:2008 in local
government

 Standards and projects under the direct responsibility of ISO/TC 176/SC 1


Secretariat
 Standard and/or project ISO 9000:2005

 Standards and projects under the direct responsibility of ISO/TC 176/SC 2


Secretariat
 ISO 9001:2008 Quality management systems
 ISO 9004:2009 Managing for the sustained success of an organization -- A quality management
approach
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Standards and projects under the direct responsibility of
ISO/TC 176/SC 3 Secretariat
 ISO 10001:2007
Quality management -- Customer satisfaction -- Guidelines for codes of conduct for organizations
 ISO 10002:2014
Quality management -- Customer satisfaction -- Guidelines for complaints handling in organizations
 ISO 10003:2007
Quality management -- Customer satisfaction -- Guidelines for dispute resolution external to organizations
 ISO 10004:2012
Quality management -- Customer satisfaction -- Guidelines for monitoring and measuring
 ISO 10008:2013
Quality management -- Customer satisfaction -- Guidelines for business-to-consumer electronic commerce transactions
 ISO 10012:2003
Measurement management systems -- Requirements for measurement processes and measuring equipment
 ISO/TR 10013:2001
Guidelines for quality management system documentation
 ISO 10014:2006
Quality management -- Guidelines for realizing financial and economic benefits
 ISO 10014:2006/Cor 1:2007
 ISO 10015:1999
Quality management -- Guidelines for training
 ISO/TR 10017:2003
Guidance on statistical techniques for ISO 9001:2000
 ISO 10018:2012
Quality management -- Guidelines on people involvement and competence
 ISO 10019:2005
Guidelines for the selection of quality management system consultants and use of their services
 ISO 19011:2011
Guidelines for auditing management systems

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‫‪Looking to the Future‬‬
‫‪ISO/TC 176/SC 2’s vision is looking a head to the needs of future.‬‬
‫‪ ‬ان زيتم العتراف بإصدارات اللجنة )‪ (SC2‬وان متحضى بالقبول وال حترام في جميع أنحاء العالم‪،‬‬
‫ومتستخدم من تقبل المنظمات كجزء ل زيتجزأ من مبادرات التنمية المستدامة الخاصة بها "‪.‬‬
‫‪“SC2’s products are recognized and respected worldwide, and used by‬‬
‫‪organizations as an integral component of their sustainable development‬‬
‫‪initiatives”.‬‬

‫كثيرا ما زيغفل عن هذا الدور المحوري‬ ‫‪‬‬


‫لنظم إدارة الجودة كأساس للنمو‬
‫التقتصادي ودوره كركيزة واساس للتمنية‬
‫المستدامة‪ ،‬بسبب التركيز السنوات‬
‫التخيرة زيجري على العناصر التخرى‬
‫كسلمة ومتكامل البيئية والعدالة‬
‫الجتماعية ‪.‬‬

‫‪Three aspects of sustainable development‬‬


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Looking to the Future
 As we look to the future, however, it is important to ensure
that quality management is seen as much more than
certification to ISO 9001 and that it really helps
organizations to achieve long-term success.
 It’s about more than just “certification”
“Certification to ISO 9001” should be a result of a well-
implemented quality management system!
 Other ISO/TC 176 products are aimed to assist
organizations in improving their quality management
system.

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TC176/SC2 Mission

 To develop, maintain and support a portfolio of products


that enable organizations to improve their performance and
to benefit from the implementation of a robust quality
management system.
 To establish generic quality management system
requirements that provide the foundations to build
confidence in products and services delivered throughout the
supply chain to organizations and people worldwide.
 To provide guidance and support, where needed, to ensure
the continued credibility of our products.

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‫الزيزو ودورها في تحقيق التنمية المستدامة‬

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‫التنمية المستدامة ‪Sustainable Development‬‬

‫هي الستغل ل المثل للموارد والمكانات المتاحة سواء كانت بشرزية أو مادزية أو‬ ‫‪‬‬

‫طبيعية بشكل فعا ل ومتوازن بيئاًيا واجتماعيا واقتصادزيا لضمان استمرارزية التنمية‬
‫بما زيخدم آما ل وتطلعات السكان بعدالة و بدون إسراف أو إهدار لمكتسبات الجيا ل‬
‫القادمة ‪.‬‬

‫"التنمية المستدامة هي التنمية التي تلبي احتياجات الحاضر من دون النيل من قدرة‬ ‫‪‬‬

‫الجيال القادمة على تلبية إحتياجاتها"‪.‬‬

‫حصل تطوزير لمفهوم الستدامة وتعرزيفها كفرصة للمسستقبل‪" :‬بأن تتاح للجيا ل‬ ‫‪‬‬

‫القادمة الفرص والتختيارات التي أتيحت لنا‪ ،‬إن لم تزد"‬

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‫ابعاد التنمية المستدامة‬

‫البعد البيئي‬ ‫البعد الجتماعي‬ ‫البعد القتصادي‬

‫‪-‬‬ ‫‪ .‬العدالة في التوززيع ‪-‬‬


‫النظم البيئية ‪.‬‬ ‫‪-‬‬ ‫النمو القتصادي المستدزيم ‪-‬‬
‫‪ -‬الحراك الجتماعي ‪.‬‬
‫التنوع البيولوجي‪.‬‬ ‫‪-‬‬ ‫‪ -‬كفاءة رأس الما ل ‪.‬‬
‫‪ -‬المشاركة الشعبية‬
‫النتاج الصدزيق للبيئة‬ ‫‪-‬‬ ‫‪ -‬اشباع الحاجات الساسية ‪.‬‬
‫والتنوزيع الثقافي ‪.‬‬ ‫‪-‬‬
‫القدرة على التكيف ‪.‬‬ ‫‪-‬‬ ‫العدالة الجتماعية‬
‫‪ -‬استدامة المؤسسات‬

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‫هناك ارتباط متباد ل مسا بيسن التنميسة القتصسادزية والبيئيسة والجتماعيسة حيسث انسه ل زيمكن‬ ‫‪‬‬
‫اعداد او تطبيق ازية استراتيجية او سياسة مستدامة دون دمج هذه المكونات معا ‪.‬‬

‫فاجتماعيا ) البعد الجتماعي ( ‪ :‬زيكون النظام مستداما في حا ل حققت العدالة في التوززيع‬ ‫‪‬‬
‫‪ ،‬وثم ازيصا ل الخدمات الجتماعية كالصحة والتعليم الى محتاجها وتحقيق المساواة في‬
‫النوع الجتماعي والمحاسبة السياسة والمشاركة الشعبية لكافة فئات المجتمع في عملية‬
‫صنع القرار‪.‬‬

‫واقتصادزيا ) البعد القتصادي ( ‪ :‬النظام المستدام هو النظام الذي زيتمكن من انتاج السلع‬ ‫‪‬‬
‫والخدمات بشكسل مسستمر والذي زيحافسظ علسى مسستوى معيسن قابسل للدارة من التوازن‬
‫القتصادي ما بين الناتج العام والدزين ‪ ،‬وان زيمنع حدوث اتختللت اجتماعية ناتجة عن‬
‫السياسات القتصادزية ‪.‬‬
‫وبيئيسا ) البعسد السبيئي ( ‪ :‬النظام المسستدام بيئيسا زيجسب ان زيحافسظ علسى قاعدة ثابتسة من‬ ‫‪‬‬
‫الموارد الطبيعية وزيتجنب الستنزاف الزائد للموارد المتجددة وزيشمل ذلك انتاجية التربة‬
‫والتزان الجوي والنظمة البيئية الطبيعية التي ل تصنف عادة كموارد اقتصادزية ‪.‬‬

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‫التحدزيات‬
‫إن القضايا التي أفرزتها التنمية المستدامة‪ ،‬أخرجت المؤسسة القتصادية من عزلتها‬ ‫‪‬‬
‫الداخلية كنظام مغلق‪ ،‬ودورها القتصادي البحت‪ ،‬إلى نظرة حديثة‪ ،‬وبيئة خارجية‬
‫ضا وتداخل‪ .‬فالتطور الحاصل في البيئة الخارجية ولد أطرااًفا أخرى‬ ‫أكثر تعقياًدا وغمو اً‬
‫طا وتؤثر في نشاطها‪ ،‬وأفرز أدواًرا جديدة‬ ‫للمؤسسة القتصادية‪ ،‬تمارس ضغو اً‬
‫إجتماعية وسياسية وبيئية كانت مهملة ساباًقا‪ ،‬مما يضع حدواًدا جديدة‪ ،‬ويزيد من‬
‫التحديات‪ ،‬ويضيف معطيات أخرى إلى التزامات المؤسسة‪.‬‬
‫ويعتبر التغلب على هذه التطورات والتحديات أماًرا في غاية الهمية والصعوبة‪ ،‬ليس‬ ‫‪‬‬
‫فقط لتتمكن المؤسسة من المنافسة بل هدف البقاء والستمرارية‪ .‬ومن هذا المنطلق‬
‫أصبحت المؤسسات القتصادية تعرف إقبال كبياًرا وإيجاباًيا على ادماج التنمية‬
‫المستدامة في رؤيتها الستراتجية‪ ،‬وضمن سياساتها وأهدافها واهتماماتها التسييرية‪،‬‬
‫من أجل تحقيق أفضل الممارسات القتصادية والجتماعية والبيئية التي تضمن التكيف‬
‫اليجابي مع تغيرات وضغوطات المحيط‪ ،‬ومواجهة تزايد حدة المنافسة التي تواجهها‬
‫في أسواقها المحلية والعالمية‪ ،‬بما يكفل إستمرارية المؤسسة وتفوقها‪.‬‬
‫‪‬‬

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‫التوجه‬
‫لذا إلتجأت معظم المؤسسات القتصادزية في العالم إلى الستعانة بجملة من الساليب‬ ‫‪‬‬
‫والنظم الدارزية الحدزيثة‪ ،‬التي تعتبر بمثابة مرجعيات زيستد ل بها‪ ،‬تعمل وفق نمط‬
‫تسييري إستراتيجي زيخدم العتبارات الجتماعية والبيئية علوة عن القتصادزية في‬
‫إطار الستدامة‪ .‬ومن أبرز هذه الساليب والدوات ما هو مستمد من تبني وتطبيق‬
‫المؤسسات لهم المواصفات والمعازيير القياسية الصادرة عن منظمة الزيزو بصورة‬
‫متكاملة‪.‬‬
‫تستخدم الشركات والحكومات نشاط التقييس بصفة عامة بهدف التوصل الى‬ ‫‪‬‬
‫مستوزيات مثلى من النتاج والصحة وحمازية المستهلك والبيئة والمن والجودة حيث‬
‫ان التطبيق الفعا ل لهذه النشاطات زيدعم مسيرة التنمية المستدامة والرفاه الجتماعى‬
‫وزيعمل على تسهيل التجارة‪.‬‬
‫لذلك اعتبر ) التقييس‪ ،‬والمترولوجيا‪ ،‬وتقييم المطابقة( المرتكزات الساسية الثلثة‬ ‫‪‬‬
‫للتنمية المستدامة ‪.‬‬

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‫التجارة‬
‫الممارسات‬ ‫تسهيل التباد ل‬
‫اللكترونية‬ ‫النمو‬
‫الجيدة‬ ‫التجاري‬
‫القتصادي‬
‫‪ISO 22000‬‬
‫‪ISO 27001‬‬
‫نشر التقنيات‬ ‫الحد من‬
‫الجدزيدة‬ ‫‪ISO 29001‬‬ ‫‪ISO 9001‬‬ ‫الفقر‬
‫‪ISO 2000‬‬
‫‪Economic‬‬ ‫‪ISO 9004‬‬

‫الدارة‬
‫‪Growth‬‬ ‫حمازية‬
‫‪ISO 14001‬‬ ‫& ‪Health‬‬
‫البيئية‬ ‫‪safety‬‬
‫‪ISO 45001‬‬ ‫المستهلك‬

‫‪ISO 14004‬‬ ‫‪Social‬‬


‫‪Resp. req.‬‬ ‫‪SA 8000‬‬
‫سلمة اماكن‬
‫تقييم دورة الحياة‬ ‫‪Social‬‬
‫والبطاقات الخضراء‬
‫‪Resp. Guide‬‬ ‫العمل‬
‫‪ISO 14040‬‬
‫‪ISO 26000‬‬
‫‪Road‬‬
‫‪Environmental‬‬ ‫‪Societal‬‬ ‫‪safety‬‬

‫انبعاثات الغازات‬ ‫‪Integrity‬‬ ‫‪Equity‬‬


‫الدفيئة‬
‫‪ISO 14064‬‬
‫‪Business‬‬ ‫‪ISO 39001‬‬
‫الخدمات‬
‫والتغير المناتخي‬ ‫‪Sustain‬‬
‫‪continuity‬‬
‫الصحية‬
‫‪Events‬‬
‫‪ISO 50001‬‬
‫‪ISO 22301‬‬
‫ترشيد الطاقة‬
‫والطاقات‬ ‫‪ISO 20121‬‬ ‫المن‬
‫المتجددة‬

‫جودة التربة والماء‬


‫والهواء‬
‫ادارة‬ ‫اتخلقيات‬
‫التجارة‬
‫المخلفات‬ ‫العادلة‬
‫المهنة‬
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ISO DIS 9001 :2015

A Free sample
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‫أسباب التغيير‬
‫مواكبة التغييرات والمتطلبات الجدزيدة للقطاعات المختلفة منذ عام ‪ 2008‬وقت‬ ‫‪‬‬
‫اصدار النسخة الحالية ) التكنولوجيا الحدزيثة ‪ ,‬ادارة المعلومات ‪ ,‬ادارة سلسل‬
‫القيمة ‪ ,‬التنتافسية ‪ ,‬ادارة المععرفة ‪ ,‬ادارة التغيير ‪ ,‬ادارة المخاطر‪ ,‬وغير ذلك من‬
‫المتغيرات العالمية (‪.‬‬
‫مع الستمرار في الهدف الصلي وهو توفير المنتج او الخدمة التي تتوافق مع‬ ‫‪‬‬
‫متطلبات العملء مع التوافق مع القوانين والتشرزيعات المطبقة‬
‫إعطاء المواصفة مرونة أكبر للتكامل مع أنظمة الدارة التخرى ) البيئة ‪ ,‬السلمة‬ ‫‪‬‬
‫المهنية ‪ ,‬وغيرها ( ‪.‬‬
‫وضع أسس ثابتة للعوام العشر القادمة ‪.‬‬ ‫‪‬‬

‫عكس متطلبات بيئة العمل المعقدة والمتغيرة ومواكبة سرعة التغير المطلوبة ‪.‬‬ ‫‪‬‬

‫ضمان تغطية متطلبات مستخدمي المواصفة الجدد والمؤسسات التي ستطبق‬ ‫‪‬‬
‫المواصفة مستقبل ‪.‬‬
‫تعززيز قدرة المؤسسة على تطوزير وتحسين الداء ‪ ,‬وإدارة المخاطر وتحقيق رضا‬ ‫‪‬‬
‫العملء ‪.‬‬
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‫ماالذي تم أتخذه بالعتبار للدفع بعملية التغيير ؟‬
‫نتائج استطلعات الرأي لمستخدمي المواصفة ‪.‬‬ ‫‪‬‬

‫مخرجات فريق العمل )‪Joint SC1/SC2 Task Group ) -‬‬ ‫‪‬‬


‫‪. ((Future Concepts‬‬
‫التنوع المتزايد لمستخدمي اليزو ‪. 9001‬‬ ‫‪‬‬

‫التطور الحاصل في المعرفة والتقنيات المستخدمة ‪.‬‬ ‫‪‬‬

‫مصالح واهتمامات المستخدمين الخدة بالتساع ‪.‬‬ ‫‪‬‬

‫التغييرات في الصناعة والقطاعات المختلفة ‪.‬‬ ‫‪‬‬

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World-wide Survey - Key User Inputs
 ISO 9001, as it is, must change to
continue be relevant
 Integrate with other MSS (EMS etc.)
 Provide one integral approach to the
management of the organization for
Leadership commitment &
understanding, strategic planning,
management .
Analyzing data from a  Need to work with ISO/CASCO and
Web-based survey of
users and potential users
IAF to ensure efficiency/effectiveness
of ISO 9001 and ISO of audits and address problems in
9004, conducted in 10 certification audits
languages, with a total of(  Include tools and risk management
11 722 responses from
122 countries.
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‫ما الجدزيد؟‬

‫التركيز على القيمة‬ ‫التركيز على ادارة‬


‫هيكلية جدزيدة طبقا‬ ‫تحقيق مرونة أكبر‬
‫والفائدة المتحققة‬ ‫المخاطر لتحقيق‬
‫للملحق ) ‪( SL‬‬ ‫فيما زيتعلق بالتوثيق‬
‫للمؤسسة والعملء‬ ‫الهداف‬

‫العمل على جعل المواصفة أقرب وأسهل‬


‫مفاهيم جدزيدة اتخذت في العتبار‬
‫للتطبيق لقطاع الخدمات‬

‫المحافظة على كون الزبون محور الهتمام‬

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Significant Changes:
1. 1. New Structure - The new standard has 10 clauses
2. The term "product" has been replaced by “products and
services".

3. Two new clauses related to the context of the organization:


4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested
parties.

4. The requirement to use the process approach has been more


explicit.
4.4. Quality management system and its processes

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Significant Changes
5. The standard does not include a specific clause for
"Preventive Actions". (Risk-based approach replaces the
requirements related to preventive action. )

6. The terms "document" and "records" have been


replaced with the term "documented information".

7. "work environment" used in ISO 9001:2008 has been


replaced with "Environment for the operation of
processes".
8. "purchased product" has been replaced with
"externally provided products and services".
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Significant Changes
9. The term "supplier" has been replaced with "External
provider".

10. From eight QMP to Seven Quality Management principles .


11.Quality Manual not required .
12. MR not required .
13. Harmonized : New ISO 9001 clauses will be harmonized with
other standards such as ISO 14001
14. ISO 9001:2015 does not address exclusions, but applicability.
15. Organizational knowledge : Clause 7.1.5 Organizational
knowledge addresses the need to determine and maintain the
knowledge obtained by the organization, including by its
personnel, to ensure that it can achieve conformity of products
and services.
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ISO 9001:2015 ‫مراحل اصدار المواصفة‬
‫المسودة الولى او النموذج‬ 2012 ‫ – دزيسمبر‬2012 ‫زيونيو‬
‫المبدئي للمواصفة أو التغيير‬ ‫المواصفة الدولية الجدزيدة‬
Working Draft International Std.

‫مسودة المواصفة‬
2013 ‫ابرزيل‬ ‫الخاصة باللجان‬
Committee Draft

2015 ‫سبتمبر‬
‫مسودة المواصفة الدولية‬
‫المبدئية‬
2014 ‫مارس‬
Draft Int. Std

‫مسودة المواصفة الدولية‬


‫النهائية‬
2015 ‫ – زينازير‬2014 ‫نوفمبر‬
Final Draft Int. Std

DIS ballot opens: /10/07 /2014 FDIS ballot opens: July 2015
DIS ballot closes: 10/10/ 2014 FDIS ballot closes: August 2015
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‫الجدو ل الزمن للصدار الجدزيد والفترة النتقالية للتطبيق‬

‫‪2015‬‬ ‫‪2016‬‬ ‫‪2017‬‬ ‫‪2018‬‬

‫سبتمبر ‪2015‬‬
‫تارزيخ اصدار النسخة الجدزيدة‬

‫الوقت المتوقع للمؤسسات الحاصلة على شهادة الزيزو‬


‫‪ 9001:2008‬للنتقا ل للنسخة الجدزيدة الزيزو‬
‫‪ 9001:2015‬هي ‪ 3‬سنوات من تارزيخ الصدار‬

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‫المواصفات الدارزية التخرى التي تغيرت أو قيد التغيير‬

‫مواصفة نظام إدارة البيئة ‪ ISO 14001:2004 :‬من المتوقع ان زيتم‬ ‫‪‬‬
‫اصدار النسخة الجدزيدة منتصف ‪. 2015‬‬
‫مواصفة نظام إدارة السلمة والصحة المهنية ‪OHSAS‬‬ ‫‪‬‬
‫‪ 18001:2007‬لتكون ضمن عائلة مواصفات الزيزو ‪ISO 45001‬‬
‫نهازية ‪ – 2016‬بدازية ‪. 2017‬‬
‫مواصفة نظام إدارة أمن وسلمة المعلومات ‪ISO 27001:2005‬‬ ‫‪‬‬
‫تم تغييرها فعليا في اكتوبر ‪ 2013‬وصدرت النسخة الجدزيدة ‪ISO‬‬
‫‪. 27001:2013‬‬

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The following is a list of standards that already
employ Annex SL.

 ISO 30301:2011, Information and documentation:


Management systems for records
 ISO 22301:2012, Societal security: Business
continuity management systems
 ISO 20121:2012, Event sustainability management
systems
 ISO 39001, Road-traffic safety (RTS) management
systems
 ISO 55001, Asset management 

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‫‪ .‬المحتوى الرئيسي وتقسيم اجزاء المواصفة الجدزيدة‬

‫تم تقسيم جديد موحد لجميع مواصفات نظم الدارة كالتي ‪:‬‬ ‫‪‬‬

‫هيكلية موحدة للبنود ‪.‬‬ ‫‪‬‬

‫توحيد للتعريفات المستخدمة ‪.‬‬ ‫‪‬‬

‫زيهدف هذا التغيير لتسهيل التكامل بين نظم الدارة ‪ ,‬سيمكن المؤسسات المطبقة‬
‫لنظم الجودةوالبيئة والسلمة تحقيق تكامل أكبر وأفضل‬

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Annex SL (High-level structure)

Introduction

1. Scope 4. Context of the organisation


2. Normative references 5. Leadership
3. Terms and definitions 6. Planning
7. Support
8. Operation
9. Performance evaluation
Appendix 10. Improvement
Bibliography

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MSS – Common Terms and
Definitions
Organization Process
Interested party (preferred term) Performance
Requirement Outsource (verb)
Management system Monitoring
Top management Measurement
Effectiveness Audit
Policy Conformity
Objective Nonconformity
Risk Correction
Competence Corrective action
Documented information Continual improvement

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‫البنود الرئيسية‬
( Annex SL MSS – High Level Structure of )
high-­‐ level structure and terminology of Annex SL is a unified
guideline used for the development of all new ISO standards

( Scope) . ‫ مجال التطبيق‬: 1 ‫البند رقم‬ 

. ( Normative references) . ‫ المرجع القياسي‬: 2 ‫البند رقم‬ 

. ( Terms and definition) . ‫ العبارات والتعريفات‬: 3 ‫البند رقم‬ 

( Context of Organization) . ‫ سياق )نطاق ( عمل المؤسسة‬: 4 ‫البند رقم‬ 

( Leadership ) . ‫ القيادة‬: 5 ‫البند رقم‬ 

( Planning) . ‫ التخطيط‬: 6 ‫البند رقم‬ 

( Support) . ‫ الدعم‬: 7 ‫البند رقم‬ 

( Operation) . ‫ العمليات‬: 8 ‫البند رقم‬ 

( Performance Evaluation ) . ‫ تقييم الداء‬: 9 ‫البند رقم‬ 

( Improvement) . ‫ التطوير‬: 10 ‫البند رقم‬ 


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10 Top Level Clauses
 1. Scope
 When/why should an organization adopt this standard?
 2. Normative references
 Blank clause introduced to match with other management
system standards.
 3. Terms and definitions
 Definitions of various terms referred in the standard.
 4. Context of the organization
 Determine the purpose and the direction of the organization.
 5. Leadership
 Commitment of the top management, quality policy, roles and
responsibilities.

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10 Top Level Clauses
 6. Planning
 Planning to address risks and opportunities and achieving quality
objectives.
 7. Support
 People, infrastructure, knowledge , communication, documented
information
 8. Operation
 Finding out customer requirements, designing, delivering, post
delivery support.
 9. Performance evaluation
 Customer satisfaction, analysis, internal audits and management
review.
 10. Improvement
 Nonconformity, corrective actions and continual improvement.
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‫ المجال‬-1
‫تحدد هذه المواصفة القياسية الدولية متطلبات نظام إدارة الجودة‬ 
:‫للمنشأة حينما‬
‫تحتاج إلى إثبات مقدرتها على توفير منتجات وخدمات تفي بمتطلبات‬ 
.‫الزبون والمتطلبات التنظيمية المعمول بها‬
. ‫تهدف إلى تعزيز رضاء الزبون‬ 

 The concept of “risk” in the context of ISO 9001 relates to the


uncertainty in achieving these objectives .
 risk is often thought of only in the negative sense. Risk-based
thinking can also help to identify opportunities. This can be
considered to be the positive side of risk

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4 Context of the organization
 4.1 Understanding the organization and its
context
The organization shall determine external and internal
issues, that are relevant to its purpose and its
strategic direction and that affect its ability to achieve
the intended outcome(s) of its quality management
system.
 External context : legal, technological, competitive, cultural, social,
economic and natural environment, whether international, national,
regional or local.
 internal context : perceptions, values and culture of the
organization. (policies, objectives and the strategies, resources ,
knowledge , information systems , standards, guidelines , contractual
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4.2 Understanding the needs and
expectations of interested parties
 The organization shall determine :
- the interested parties that are relevant to the quality
management system, and
- the quality management system related requirements, of these
interested parties.
 List of interested parties the organization must consider :

- Direct customers, end users .

- suppliers, distributers, retailers, partners, competitors,


- shareholders,
- employees and labour unions
- society, including regulators..
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Organisational context
Purpose: Clothing manufacturer
Intended outcome: Production of men’s 3 piece suits
Internal issues
•Automation
•Workforce
•Design secrets
•Capacity (Relevant) interested parties
•Company culture •Consumers
•Innovation •Employees
•Owners/shareholders
External issues
•Customers •Society
•Fashion •Suppliers and partners
•New markets
•Deadlines
•Competition
•Regulators
•Utilities

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4.3 Determining the scope of the
quality management system
 The organization shall determine the boundaries and
applicability of the quality management system to establish its
scope.
 The scope shall be stated in terms of products and services,
the main processes to deliver them and the sites of the
organization included.
 If any requirement(s) of this International Standard cannot be
applied, this shall not affect the organization’s ability or responsibility
to ensure conformity of products and services.
 justification for any instance where a requirement of this
International Standard cannot be applied.
 The scope shall be available as documented information.
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4.4 Quality management system and its
processes
The organization shall :
 establish,

 implement,

 maintain

and continually improve a quality management


system, including the processes needed and their
interactions .

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Process approach
Clause 4.4 includes requirements for process approach. Some
requirements are more prescriptive.
the inputs required and the outputs expected from these
processes;
the resources needed and ensure their availability;

the assignment of the responsibilities and authorities for these


processes;
the risks and opportunities in accordance with the requirements
of 6.1, and plan and implement the appropriate actions to address
them;
the methods for monitoring, measuring, as appropriate, and
evaluation of processes and, if needed, the changes to processes
to ensure that they achieve intended results; and
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0.3 Process approach
 The process approach applies systematic
definition and management of processes and
their interactions so as to achieve the intended
results in accordance with the quality policy
and strategic direction of the organization.
Management of the processes and the system
as a whole can be achieved using a “Plan-Do-
Check-Act” (PDCA) methodology (see 0.4)
with an overall focus on “Risk-based thinking"
aimed at preventing undesirable outcomes (see
0.5).
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‫‪PLAN‬‬

‫‪ . 7‬الدعم‬ ‫‪ .6‬التخطيط‬ ‫‪ .5‬القيادة‬ ‫‪ .4‬سياق ) إطار( عمل‬


‫‪Planning‬‬ ‫المؤسسة‬
‫‪Support‬‬ ‫‪Leadership‬‬
‫‪Context of‬‬
‫‪Organization‬‬

‫‪ .‬الموارد ‪7.1‬‬ ‫الرجراءات ‪6.1‬‬ ‫‪ 5.1‬القيادة‬


‫المتخدة للتعامل‬ ‫واللتزام ‪.‬‬ ‫فهم ‪4.1‬‬
‫‪ 7.2‬الكفاءات ‪.‬‬ ‫مع الطخطار‬ ‫المؤسسة واطار‬
‫‪ .‬والفرص‬ ‫العمل‬
‫‪ 5.2‬سياسة‬
‫‪ 7.3‬التدريب ‪.‬‬
‫أهداف الجودة ‪6.2‬‬ ‫الجودة ‪.‬‬ ‫فهم متطلبات ‪4.2‬‬
‫والتخطيط لتحقيقها‬ ‫الجهات ذات العلةقة‬
‫‪ 7.4‬التصال ‪.‬‬ ‫‪.‬‬ ‫الدوار‬
‫والمسئوليات‬
‫المعلومات ‪7.5‬‬ ‫‪ .‬والصليحيات‬ ‫‪ 4.3‬تحديد مجال‬
‫الموثقة‬ ‫‪ 6.3‬التخطيط‬ ‫تطبيق نظام ادارة‬
‫لمواكبة التغيرات ‪.‬‬ ‫الجودة ‪.‬‬

‫نظام ادارة ‪4.4‬‬


‫الجودة‬
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‫‪ACT‬‬ ‫‪CHECK‬‬ ‫‪DO‬‬
‫‪ . 10‬التطوير‬ ‫‪ .‬ةقياس الداء ‪9.‬‬ ‫‪ .8‬التشغيل‬
‫‪Improvement‬‬ ‫‪Performance‬‬ ‫‪Operation‬‬
‫‪Evaluation‬‬
‫‪ 8.1‬التخطيط وضبط التشغيل‬

‫يحالت عدم ‪10.1‬‬ ‫‪ 9.1‬المراةقبة ‪ ,‬القياس ‪,‬‬


‫المطابقة والفعال‬ ‫التحليل و التقييم ‪.‬‬
‫‪ 8.2‬دراسة ايحتيارجلت السوق‬
‫‪ .‬التصحيحية‬ ‫والتواصل مع العملء ‪.‬‬
‫‪ 9.2‬التدةقيق الداطخلي ‪.‬‬
‫‪ 8.3‬عملية تخطيط التشغيل ‪.‬‬
‫‪ 10.2‬التحسين ‪.‬‬ ‫‪ .‬مرارجعة الدارة ‪9.3‬‬
‫ضبط توريد الخدمات واللوازم ‪8.4‬‬

‫تطوير المنتجات والخدمات ‪8.5‬‬

‫‪ 8.6‬تحقيق المنتج والخدمة ‪.‬‬

‫اطلق المنتج والخدمة ‪8.7‬‬

‫‪ 8.8‬المنتج او الخدمة غير المطابقة ‪.‬‬


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‫‪4.3‬‬
‫‪4.3 ,, 4.2‬‬
‫‪4.2 ,, 4.1‬‬
‫‪4.1‬‬
‫المؤسسة‬
‫انشاءاطار المؤسسة‬
‫انشاءاطار‬
‫المستفيدة‬
‫الطراف المستفيدة‬
‫وتحديد الطراف‬
‫وتحديد‬ ‫التحسين المستمر ‪10‬‬
‫الجودة‬ ‫ادارة‬ ‫نظام‬ ‫ومجال‬
‫ومجال نظام ادارة الجودة‬

‫‪x‬‬
‫القيادة ‪5‬‬ ‫االزبائن‬
‫الزبائن‬
‫والطراف دات‬
‫العلةقة‬ ‫الجودة‬
‫ادارة الجودة‬
‫نظام ادارة‬
‫‪ 4.4‬نظام‬
‫‪4.4‬‬ ‫ةقياس الداء ‪9‬‬ ‫رضاء‬
‫‪(interested‬‬ ‫التخطيط ‪6‬‬ ‫العملية‬
‫ومنهج العملية‬
‫ومنهج‬
‫الزبائن‬
‫) ‪parties‬‬

‫‪x‬‬
‫المنتجات‬
‫والخدمات‬
‫لمتطلبات‬
‫االمتطلبات‬ ‫التشغيل ‪8‬‬
‫المدطخلت‬ ‫المخررجات‬

‫عمليات الدعم ‪7‬‬


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5 - Leadership
 5.1 Leadership and commitment
 5.1 Leadership and commitment
 5.1.1 Leadership and commitment to the quality
management system
 5.1.2 Customer focus

 5.2 Quality policy


 5.3 Organisation roles, responsibilities and
 authorities
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Leadership changes
5.1 Leadership and commitment
Top management shall demonstrate leadership and commitment with respect
to QMS by:

Ensuring (i.e. someone else can do it)


•the quality policy and quality objectives are established for the
quality management system and are compatible with the
strategic direction and the context of the organization;
•the quality policy is communicated, understood and applied
within the organization;
•integration of the quality management system requirements into
the organization’s business processes;
•the resources needed for the quality management system are
available;
•the quality management system achieves its intended results;
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Doing (i.e. they must do it themselves)
• taking accountability of the effectiveness of the quality management system;
• promoting awareness of the process approach;
• communicating the importance of effective quality management and of
conforming to the quality management system requirements;
• engaging, directing and supporting persons to contribute to the effectiveness of
the quality management system;
• promoting continual improvement and innovation;
• supporting other relevant management roles to demonstrate their leadership as
it applies to their areas of responsibility;
• shall demonstrate leadership and commitment with respect to customer focus .
• Shall establish, review , and maintain a quality policy.
• Top management shall assign the responsibility and authority for ( QMS
conforming ,processes , reporting to top Mgm. ….. )

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6 – Planning for the QMS
 6.1 Actions to address risks and opportunities
 When planning for the QMS, the organization shall consider the issues
referred to in 4.1 and the requirements referred to in 4.2 and determine the
risks and opportunities that need to be addressed to
 a) assure the QMS can achieve its intended result(s),
 b) prevent, or reduce, undesired effects, and
 c) achieve continual improvement.
 The organization shall plan:
 a) actions to address these risks and opportunities, and
 b) how to
 1) integrate and implement the actions into its QMS processes (see 4.4) , and
 2) evaluate the effectiveness of these actions.

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6.2 Quality objectives and planning to achieve them

 The organization shall establish quality objectives at relevant functions,


levels and processes.
 When planning how to achieve its Quality

objectives, the organization shall determine


 what will be done

 what resources will be required

 who will be responsible

 when it will be completed

 how the results will be evaluated.

 6.3 Planning of changes

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7- Support
 7.1 Resources
 The organization shall determine and provide the
resources needed for (the establishment, implementation,
maintenance and continual improvement ) of the QMS .
 Resources may include :
- 7.1.2 People
- 7.1.3 Infrastructure ( buildings, equipment ,transportation ,
information & communication technology .)
 7.1.4 environment for operation of processes.
 (can include physical, social, psychological, environmental and other factors
(such as temperature, humidity, ergonomics and cleanliness). )
 7.1.5 Monitoring and measuring recourses (fitness for their purpose,
traceability , verified or calibrated )

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7.1.6 Organizational Knowledge
 The organization shall determine the knowledge necessary for the operation
of its processes and to achieve conformity of products and services.
 This knowledge shall be maintained, and made available to the extent
necessary.
 When addressing changing needs and trends, the organization shall
consider its current knowledge and determine how to acquire or access the
necessary additional knowledge.
 NOTE 1 Organizational knowledge can include information such as
intellectual property and lessons learned.
 NOTE 2 To obtain the knowledge required, the organization can consider:
 a) internal sources (e.g. learning from failures and successful projects,
capturing undocumented knowledge and experience of topical experts
within the organization);
 b) external sources (e.g. standards, academia, conferences, gathering
knowledge with customers or providers).

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 7.2 Competence :
 The organization shall determine the necessary competence of
person(s) and ensure that these persons are competent on the
basis of appropriate education, training, or experience;
 where applicable, take actions to acquire the necessary competence,
and evaluate the effectiveness of the actions taken.
 7.3 Awareness : Person shall be aware of ( QP, Q. objectives,
their contribution to QMS).
 7.4 Communication (internal and external communications
relevant to QMS ) .

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 7.5 Documented information ( documented
information required by this International Standard, and
documented information determined by the organization ).
 7.5.2 Creating and updating
 7.5.3 Control of documented Information
 Annex A of the DIS clarifies that where ISO 9001:2008 would
have referred to :
 Documented procedures in ISO 9001:2008 = Maintain
documented information in ISO 9001:2015
 Records in ISO 9001:2008 = Retain documented information
in ISO 9001:2015

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8 - Operation
 The organization shall plan implement and control the processes,
as outlined in 4.4 needed to meet requirements for the provision of
products and services and to implement the actions determined in
6.1 by :
 establishing criteria for the processes and for the acceptance of
products and services; .
 determining the resources needed to achieve conformity to
product and service requirements.
 implementing control of the processes in accordance with the
criteria
 retaining sufficient documented information to have confidence
that the processes have been carried out as planned and to
demonstrate conformity of products and services to requirements.
 The organization shall ensure that outsourced processes are
controlled in accordance with 8.4.
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Operation clauses – ‫بنود التشغيل‬
8.7 8.2
nonconforming
nonconforming Determination
Determination of
of requirements
requirements
process
process outputs, for
for
products
products and
and services
services products
products and
and services
services

8.1 8.3 Design and


8.6 Release of Operational development of
products and planning and products and
services services
control

8.5 Production and 8.4 Control of externally provided


service provision products and services

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9. Performance Evaluation
 9.1 Monitoring, measurement, analysis and evaluation
 9.1.1 General : The organization shall determine what
needs to be monitored and measured , the methods, when
shall be performed , when shall be analyzed and evaluated
and shall retain appropriate documented information as
evidence of the results.
 The organization shall evaluate the quality performance
and the effectiveness of the quality management system..
 9.1.2 Customer satisfaction .
 (NOTE : Information related to customer views can include customer
satisfaction or opinion surveys, customer data on delivered products or
services quality, market-share analysis, compliments, warranty claims
and dealer reports. )

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 9.1.3 Analysis and evaluation
 The organization shall analyze and evaluate appropriate data
and information arising from monitoring, measurement and
other sources.
 The output of analysis and evaluation shall be used to:
 (demonstrate conformity , enhance customer satisfaction ,
effectiveness of the QMS , planning has been successfully
implemented , performance of processes , external
provider(s); opportunities for improvements ) .
 The results of analysis and evaluation shall also be used to
provide inputs to management review.

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 9.2 Internal audit : (retain documented information as
evidence of the implementation of the audit programme and
the audit results ).
 9.3 Management review
 The management review shall be planned and carried out
taking into consideration :
 ( previous management reviews; changes in external and
internal issues , information on the quality performance, risks
and opportunities , continual improvement ) .
 outputs of the management review shall include decisions
and actions related to continual improvement opportunities;
changes to the quality management system, including
resource needs.
 (The organization shall retain documented information as
evidence of the results of management reviews. )
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10 Improvement
 10.1 General
 The organization shall determine and select opportunities for
improvement and implement necessary actions to meet
customer requirements and enhance customer satisfaction
( by : improving processes , improving products and services ,
improving QMS results.) .
 10.2 Nonconformity and corrective action
 10.3 Continual improvement
 The organization shall continually improve the suitability,
adequacy, and effectiveness of the quality management
system.

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Annexes
 Annex A (informative) : Clarification of new
structure, terminology and concepts.
 Annex B (informative) Quality management
principles.
 Annex C (informative) The ISO 10000
portfolio of quality management standards.

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Comparison
ISO 9001:2008 ISO 9001:2015
0. Introduction 0. Introduction

1. Scope 1. Scope

2. Normative References 2. Normative References

3. Terms and Definitions 3. Terms and Definitions

4. Quality Management System 4. Context of the Organization

5. Management Responsibility 5. Leadership

6. Resource Management 6. Planning

7. Product Realization 7. Support

8. Measurement, Analysis and 8. Operations


Improvement 9. Performance Evaluations

10.Improvement

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Comparison
ISO 9001:2008 ISO DIS 9001:2015
0 Introduction 0 Introduction
1 Scope 1 Scope
2 Normative references 2 Normative references
3 Terms and definitions 3 Terms and definitions
4 Quality management system 4 Context of the organization
4.1 Understanding the organization and
its context
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the quality
management system
4.4 Quality management system and its
4.1 General requirements
processes
4.2 Documentation requirements 7.5 Documented information

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Comparison
ISO 9001:2008 ISO DIS 9001:2015
5 Management responsibility 5 Leadership
5.1 Management commitment 5.1 Leadership and commitment
5.2 Customer focus 5.1.2 Customer focus
5.3 Quality policy 5.2 Quality policy
6 Planning for the QMS
6.1 Actions to address risks and
opportunities
5.4 Planning
6.2 Quality objectives and planning
to achieve them
6.3 Planning of changes
5.3 Organizational roles,
5.5 Responsibility, authority and
responsibilities and authorities
communication
7.4 Communication
5.6 Management review 9.3 Management review
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Comparison
ISO 9001:2008 ISO DIS 9001:2015
6 Resource management 7 Support
6.1 Provision of resources 7.1 Resources
7.2 Competence
6.2 Human resources 7.3 Awareness
7.4 Communication
6.3 Infrastructure 7.1.3 Infrastructure
7.1.4 Environment for the operation of
6.4 Work environment processes

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Comparison

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Comparison
ISO 9001:2008 ISO DIS 9001:2015
8 Measurement, analysis and
9 Performance evaluation
improvement
9.1 Monitoring, measurement, analysis
8.1 General
and evaluation
9.2 Internal audit
8.2 Monitoring and measurement
9.3 Management review
8.7 Control of nonconforming process
outputs, products and services
8.3 Control of nonconforming product
9.1 Monitoring, measurement, analysis
and evaluation
9.1 Monitoring, measurement, analysis
8.4 Analysis of data
and evaluation
10 Improvement
10.1 General
8.5 Improvement 10.2 Nonconformity and corrective
action
10.3 Continual improvement

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ISO 9001:2015 DIS Mandatory Documents and Records

 The organization shall maintain


documented information…..
 These are the minimum documented
procedures required to be maintained by
the organization.

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Mandatory Documents & Records
 Scope of the Quality Management System (4.3)
Scope of the QMS including the products and services
covered and the justification of the requirements that can not
be applied. ( shall be maintained ) .
 Operation of Processes (4.4)
The organization shall maintain documented Information to
support the operations of processes .
 Quality Policy (5.2.2)
Quality policy to be available as documented information
 Control of production and service provision (8.5.1)
the availability of documented information that defines
characteristics of products and services, activities to be
performed , and the results to be achieved.
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 Operation of Processes (4.4)
maintain documented Information necessary to have
confidence that processes are being carried out as planned.
 Quality Objectives (6.2)

retain documented Information on the quality objectives.


 Monitoring and Measurement Resources (7.1.5)

retain appropriate documented information as evidence of


fitness for purpose of monitoring and measurement resources.
 Competence (7.2)

retain appropriate documented information as evidence of competence .


 Operational Planning and Control (8.1)

retaining documented information necessary to have confidence that the


processes have been carried out as planned and conform to requirements .

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 Requirements Review (8.2.3)
Information describing the results of the review of requirements
related to products and services shall be retained.
 Design and Development (8.3.5)

retain the documented information resulting from the design


and development process.
 Design and Development Changes (8.3.6)

Documented Information on design and development changes shall be


retained.
 Externally Provided Products and Services (8.4.1)
retain appropriate documented information of the results of the evaluation,
monitoring of performance and re-evaluation of the external providers .
 Traceability (8.5.2)
retain any documented information necessary to maintain
traceability when required.
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 Control of Changes (8.5.6)
retain documented Information describing the results of the review of
changes, personnel authorizing the change, and any necessary actions
 Release of Products and Services (8.6)
- Evidence of conformity with the acceptance criteria shall be retained
- doc. Information providing traceability to the person(s) authorizing release
of products and services for delivery to the customer .
 Control of Nonconforming Process Outputs, Products and
Services (8.7)
retain doc. Information on actions taken on nonconforming process outputs,
products and services.
 Monitoring, measurement, analysis and evaluation - General
(9.1.1) – retain Results of monitoring and measurement activities.

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 Internal Audit (9.2)
retain documented information as evidence of the
implementation of the audit programme and the audit results.
 Management Review (9.3)
retain documented information as evidence of the
results of management reviews.
 Nonconformity and Corrective Action (10.2)

retain documented information as evidence of the


nature of the nonconformities, actions taken, and the
results of any corrective action.

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‫مبادئ ادارة الجودة‬

‫مبادئ الجودة‬
‫الجودة‬
‫مبادئالجودة‬
‫مبادئ‬ ‫سابقا‬
(7
(7)) (8 )
‫حاليا‬
‫حاليا‬

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The Revised Quality Principles

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7 Quality Management Principles

• QMP 1 - Customer Focus


Meet and exceed customer expectations

• QMP 2 - Leadership
Provide purpose, direction and engagement.

• QMP 3 - Engagement of People


Recognition, empowerment and enhancement of skills and
knowledge.

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7 Quality Management Principles
QMP 4 - Process Approach
Understand processes to optimize performance.

QMP 5 - Improvement
To maintain current performance and to create new
opportunities.

• QMP 6 - Evidence-based Decision Making


Facts, evidences and data analysis for decision making.

• QMP 7 - Relationship Management


Manage relationship with interested parties to optimize
performance.

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references
 ISO DIS 9001:2015 .
 ISO TC 176 Docs .
 ISO TC 176 ( SC & WG ) presentations.
 Dr Nigel H Croft Chairman, ISO/TC 176/SC 2 (Quality
Systems) presentations.
 CQI & IRCA WEBINAR presentation .
 Technical update on ISO 9001:2015 Colin MacNee Duncan
MacNee Limited .
‫ )تعرزيف بالدصدار الجدزيد وعملية التغيير المرتقبة‬9001:2015 ‫نظام إدارة الجودة الزيزو‬ 
Lloyd’s Register)

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‫شكرا على حسن استماعكم‬

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