20200126-ISO 9001:2015-Eng.Dima Ayesh

‫لجنة ‪ ISO/TC 176‬اصدرت سلسلة الايـــــــزو ‪9000‬‬ ‫عام ‪ 1987‬و هي عبارة عن خمـــــــس مواصفات مستقلة وهي‪:‬‬ ‫‪ ‬اولا المواصفة الايزو ‪ 9000‬و هي مواصفة ارشــــــــادية‬ ‫تتضمن خطوات للانتقاء و الاستخدام لبقية السلسلة و بضمنها‬ ‫المواصفة ‪ 8402‬و الخاصة بالمصطلحات و علية تم تسمية‬ ‫هذه المواصفة بمواصفة المبادئ و المصطلحات‬

‫قسمت المواصفة الاولى الايزو‪9000‬‬ ‫بدورها الى اربعة ادلة ارشادية‬ ‫‪ ‬الدليل ‪ :ISO 9000/1‬و هي مواصفة إدارة الجــــــــــودة و تأكيد‬ ‫الجودة و تمثل الاختيار و الاستخدام‬ ‫‪ ‬الدليل ‪ :ISO 9000/2‬و هي مواصـــــــــفة إدارة الجودة و تأكيد الجودة‬ ‫و تمثل ارشادات التطبيق‬ ‫‪ ‬الدليل ‪ :ISO 9000/3‬و هي مواصـــــــفة إدارة الجودة و تأكيد الجودة‬ ‫و تمثل ارشادات في تطبيق برمجيات إدارة الجودة و صيانتها‬ ‫‪ ‬الدليل ‪ :ISO 9000/4‬و هي مواصــــــــفة إدارة الجودة و تأكيد الجودة‬ ‫و يمثل ارشادات في إدارة برامج الاعتمادية ‪.‬‬

‫‪ ‬ثانيا ‪ :‬الايزو ‪ 9001‬و هي مواصفة لتأكيد الجودة في مراحل‬ ‫التصميم و التطوير و الانتاج و التركيب و تقديم الخدمات‪.‬‬ ‫‪ ‬ثالثا ‪ :‬الايزو ‪ 9002‬و هي مواصفة لتأكيد الجودة في مراحل‬ ‫الانتاج و التركيب و تقديم الخدمات في الية التطبيق ‪.‬‬ ‫‪ ‬رابعا ‪ :‬الايزو ‪ 9003‬و هي مواصفة لتأكيد الجــــــــودة في‬ ‫مراحل التفتيش و الاختبار النهائي‪.‬‬ ‫تستخدم المواصفات ‪9001‬و ‪9002‬و ‪ 9003‬عند التعاقد بين‬ ‫جهتين منتجة و مشترية فقط ‪.‬‬

‫خامسا ‪:‬المواصفة ‪ 9004‬و هي نمــــوذج للإدارة النوعية الداخلية بل هي‬ ‫العنصر الاساســـــــي في الارشادات في إدارة الجودة و لا تستعمل لإغراض‬ ‫التعاقد‬ ‫‪ ‬و تقسم هذه المواصفة الى سبعة ادلة ارشادية و هي ‪:‬‬ ‫‪ ‬الدليل ‪ :ISO 9004/1‬و يمثل عناصر نظام الجودة كخطوط‬ ‫ارشادية ‪.‬‬ ‫‪ ‬الدليل ‪ :ISO 9004/2‬و يمثل ارشادات لتطبيق المواصفة في‬ ‫قطاع الخدمات ‪.‬‬ ‫‪ ‬الدليل ‪ :ISO 9004/3‬و يمثل ارشادات لتطبيق المواصفة في‬ ‫المواد المصنعة ‪.‬‬ ‫‪ ‬الدليل ‪ :ISO 9004/4‬ارشادات لتحسين الاداء في الجودة ‪.‬‬ ‫‪ ‬الدليل ‪ :ISO 9004/5‬ارشادات لتأكيد الجودة في إدارة‬ ‫المشاريع‬ ‫‪ ‬الدليل ‪ :ISO 9004/6‬ارشادات لمتطلبات الجودة في هيكلية‬ ‫الادراة ‪.‬‬ ‫‪ ‬الدليل ‪: ISO 9004/7‬ارشادات لمتطلبات نظام الجودة في‬ ‫هيكلية الادارة‪.‬‬

‫كما اصدرت اللجنة ‪ ISO/TC 176‬ثلاثة مواصفات في‬ ‫التدقيق و هي ‪:‬‬ ‫‪ ‬المواصفة ‪ ISO 10011/1‬تدقيق الجودة ‪.‬‬ ‫‪ ‬المواصفة ‪ ISO 10011/2‬مؤهلات مدقق الجودة ‪.‬‬ ‫‪ ‬المواصفة ‪ ISO 10011/3‬إدارة برامج التدقيق ‪.‬‬ ‫‪ ‬كما اصدرت المواصفات التالية‪:‬‬ ‫‪ ‬المواصفة ‪ISO 10005‬ارشادية في خطط الجودة‪.‬‬ ‫‪ ‬المواصفة‪ISO 10006‬ارشادية في إدارة المشاريع‪.‬‬ ‫‪ ‬المواصفة ‪ISO 10007‬ارشادية في الشكل العام للإدارة الرئيسية‪.‬‬ ‫‪ ‬المواصفة‪ISO 10008‬ارشادية بالجودة العامة للادارة الرئيسية‪.‬‬

‫كما اصدرت اللجنة ‪ISO/TC 176‬‬ ‫المواصفة التالية ‪:‬‬ ‫‪ ‬المواصفة ‪ISO 10021‬و تمثل مواصفة إدارة اجهزة‬ ‫القياس و المعايرة ‪.‬وتقسم الى ثلاثة ادلة ‪:‬‬ ‫‪ ‬الدليل ‪: ISO 10021/1‬إدارة اجهزة المعـــــــايرة و‬ ‫القياس ‪.‬‬ ‫‪ ‬الدليل ‪ :ISO 10021/2‬الية التطبيق في تأكيد جودة‬ ‫المعايرة و القياس‬ ‫‪ ‬الدليل ‪: ISO 10021/3‬ارشادات في تحسين جودة‬ ‫المعايرة و القياس ‪.‬‬

‫عند تطبيق المواصفة ‪ 9001‬مع‬ ‫المواصفة ‪ 9004‬و التي يطلق عليها‬ ‫‪CONSISTENT‬الثنائي المتوافق‬ ‫للوصول الى إدارة الجودة ‪PAIR‬‬ ‫الشاملة ‪.‬‬

‫معلومات عامة‬ ‫‪ ‬منظمة التقيس والسيطرة النوعية هي منظمة غير‬ ‫حكومية وليست جزء من الامم المتحدة وأعضاءها‬ ‫يمثلون اكثر من ‪ 120‬بلد ‪.‬‬ ‫‪ ‬كافة المواصفات الصادرة عن المنظمة اختيارية‬ ‫رغم ان اكثر الدول اعتبرتها مواصفات وطنية ‪.‬‬ ‫‪ ‬يجب التفريق بين مواصفة نظام ادارة الجودة‬ ‫والمواصفة الفنية القياسية للمنتج ‪.‬‬ ‫‪ ‬المنظمة غير مسؤولة عن التحقق بمـــــدى مطابقة‬ ‫ما ينفذه المؤهل للمواصفة مع متطلبات المواصفة‬ ‫ولكن يتم التحقق من خلال مكاتب دولية مخولة من‬ ‫قبل المنظمة ‪.‬‬

‫مراحل تطور الجودة‬ ‫المرحلة الاولى ‪:‬يفحص الشاري المنتج بعد وصوله اليه نظرا‬ ‫لاهتمامه بالكم والربح السريع ‪.‬‬ ‫المرحلة الثانية ‪:‬يقوم المصنع بفحص المنتج قبل شحنه للشاري ‪.‬‬ ‫المرحلة الثالثة ‪:‬يقوم قسم الجودة بضبط العمليات ‪.‬‬ ‫المرحلة الرابعة ‪:‬يقوم العاملون بضبط العمليات ‪.‬‬ ‫المرحلة الخامسة ‪:‬ادارة الجودة الشاملة‬

‫لماذا تسابقت الدول لهذا النظام؟‬ ‫‪ ‬المنافسة الشديدة في الاسواق العالمية ‪.‬‬ ‫‪ ‬الاهتمام العالمي الكبير للدول الصناعية المتقدمة بتطبيق‬ ‫الجودة الشاملة ‪.‬‬ ‫‪ ‬سهولة تبني وتطبيق مواصفات الايزو وشيوعها على‬ ‫المستوى العالمي ‪.‬‬ ‫‪ ‬انعكاسات تطبيق الايزو على فعالية الاداء والإنتاجية وثقافة‬ ‫الشركة ‪.‬‬ ‫‪ ‬انهيار اقتصاد الاتحاد السوفيتي بسبب عدم تطبيقه لهذا النظام‪.‬‬

‫متطلبات التطبيق الامثل لأنظمة ادارة الجودة‬ ‫‪ ‬تحديد سياسة الجودة وأهداف الجودة في المنظمة وتعهد الادارة ‪.‬‬ ‫‪ ‬تحديد العمليات الاساسية التي تؤثر على تحقيق اهداف الجودة ‪.‬‬ ‫‪ ‬تحديد الوسائل والمعايير اللازمة لتحسين فاعلية العمليات ‪.‬‬ ‫‪ ‬تحديد الوسائل لمنع العيوب وتخفيض الهدر وإعادة التشغيل ‪.‬‬ ‫‪ ‬التحسين المستمر للعمليات بهدف تحسين الفاعلية والمردود‪.‬‬

‫البنى الداعمة للجودة الشاملة‬ ‫‪ ‬تطوير ثقافة الجودة الشاملة وبناء ثقافة جماهيرية كشرط‬ ‫مسبق لابد منه كي تنجح المنظمات في مساعيها لتحسين‬ ‫الجودة فهو امرا حتميا للبلد ‪.‬‬ ‫‪ ‬ضرورة توفير البنى التحتية الفنية الداعمة للجودة لزيادة‬ ‫فرص التصدير من خلال تحسين منتجاتها بما يتعلق بالصحة‬ ‫والسلامة والبيئة ‪.‬‬ ‫‪ ‬تأسيس هيئات وطنية لتنسيق أنشطة الجودة وتشريع قوانين‬ ‫تختص بالية التطبيق لهذا النظام العالمي ومحاسبة المخالفين‬ ‫بشدة مع تحقيق امتيازات للشركات المنفذة لهذا النظام‪..‬‬

‫التصورات الخاطئة عن الجودة‬ ‫‪ ‬التكاليف العالية ‪:‬ان تخفيض نسب العيوب والمنتجات‬ ‫المرفوضة يعطي فائدة اكبر من تكاليف تنظيم الجودة‬ ‫‪ ‬الزيادة في العمالة ‪:‬تحديد معايير أفضل وخفض‬ ‫اعداد المفتشين‪.‬‬ ‫‪ ‬التضيق على العمال وخنق روح الابداع لان تطبيق‬ ‫نظام الجودة من وجهة نظرهم لا يتحقق الا من خلال‬ ‫تثقيف العمال به‪.‬‬

‫اهم ميزات تنظيم الجودة في المنظمة‬ ‫ارضاء اكبر لحاجات ورغبات الزبائن المتزايدة باستمرار‪.‬‬ ‫‪.1‬‬ ‫الاستغلال الامثل للموارد الوطنية على اكمل وجه ‪.‬‬ ‫‪.2‬‬ ‫تحسين الانتاج كما ونوعا ‪.‬‬ ‫‪.3‬‬ ‫خفض التكاليف ‪.‬‬ ‫‪.4‬‬ ‫ملائمة العرض للطلب ورفع وتيرة التسويق‪.‬‬ ‫‪.5‬‬ ‫الاقلال من الخصومات التجارية ‪.‬‬ ‫‪.6‬‬ ‫تحسين بيئة العمل ‪.‬‬ ‫‪.7‬‬ ‫زيادة الامان بالعمل ‪.‬‬ ‫‪.8‬‬ ‫زيادة فرص التصدير ‪.‬‬ ‫‪.9‬‬

What has Changed?  new concepts are considered - more risk based thinking  the customer remains the primary focus  a new common ISO format has been developed for use across all Management System Standards  a significant re-ordering of the key clauses.

Key Changes  increased emphasis on Achieving Value for the organisation and its customers  increased emphasis on understanding and control of Risk to the organisation  reduced emphasis on Documentation  no stated requirement for Documented Procedures  no reference to a Quality Manual.

And………  no requirement for a Management Representative  no formal requirement for Preventive Action  outsourcing is now External Provision  enhanced Leadership Requirements  Organisational Context – responsiveness to changing Business Environment  No exclusions, only Not Applicable clauses!

High Level Structure  the new standard adopts the high-level structure and terminology of Annex SL (used for the development of all new ISO standards)  High Level Structure - identical core text and common terms and core definitions for use in all Management System Standards:  purpose - enhance the consistency and alignment of different management system standards  organisations that integrate multiple standards (eg QMS, EMS, OHS) will see the most benefit  uses simplified language and writing styles to aid understanding and consistent interpretations of requirements.

Common structure for MSS Introduction 1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement.

Clause structure (4-6) 4. Context of the organization Understanding the organization and its context Understanding the needs and expectations of interested parties Determining the scope of the XXX management system XXX management system 5. Leadership Leadership and commitment Policy Organizational roles, responsibilities and authorities 6. Planning Actions to address risks and opportunities Objectives and plans to achieve them.

Clause structure (7-10) 7. Support Resources Competence Awareness Communication Documented information 8. Operation Operational planning and control 9. Performance evaluation Monitoring, measurement, analysis and evaluation Internal audit Management review 10. Improvement Nonconformity and corrective action Continual improvement.

Control External provision Documented information Outsourcing and purchasing Assigned responsibility and authority Documents and records Management representative

Top management requirements 5.1 Leadership and commitment Top management shall demonstrate leadership and commitment by: Ensuring (ie someone else can do it) • the Quality Policy and quality objectives are established for the QMS and are compatible with the context and strategic direction of the organisation • the integration of QMS requirements into the organisation’s business processes • the resources needed for the QMS are available • the QMS achieves its intended results Doing (ie they must do it themselves) • take accountability for the effectiveness of the QMS • promote the use of the process approach and risk-based thinking • communicate the importance of effective quality management and of conforming to QMS requirements • engage, direct and support persons to contribute to the effectiveness of the QMS • promote improvement • support other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

Risk-based approach  organisations are required to understand its context (Clause 4.1) and determine the risks and opportunities that need to be addressed (Clause 6.1)  one of the key purposes of a QMS is to act as a preventive tool  there is no separate clause or sub-clause titled “preventive action”  the concept of preventive action is expressed through a risk-based approach to formulating QMS requirements. 2015 – Annex A

Applicability  no specific reference to “exclusions” when determining applicability of requirements to the organisation’s QMS  an organisation will need to review the applicability of requirements due to the size of the organisation, the management model it adopts, the range of activities and the nature of the risks and opportunities it encounters. 2015 – Annex A

Document information  a common clause of “Documented Information” has been adopted  the terms “documented procedure” and “record” have both been replaced throughout the requirements by “documented information”  documented procedures (eg to define, control or support a process) are now expressed as a requirement to maintain documented information  records are now expressed as a requirement to retain documented information. 2015 – Annex A

Organisational knowledge  organisational knowledge (Clause 7.1.6) addresses the need to determine and maintain the knowledge obtained by the organisation and its personnel, to ensure that it can achieve conformity of products and services  the process for considering and controlling knowledge needs to take account the organisation’s context, its size and complexity, the risks and opportunities it needs to address and the need for accessibility of knowledge  the balance between knowledge held by competent people and knowledge made available by other means is at the discretion of the organisation. 2015 – Annex A

Control of externally provided processes, products and services  control of externally provided products and services (Clause 8.4) addresses all forms of external provision, whether by:  purchasing from a supplier  an arrangement with an associate company  the outsourcing of processes and functions of the organisation, or by any other means  now required to take a risk-based approach to determine the type and extent of controls appropriate to external providers and externally provided products and services. 2015 – Annex A

ISO 9001:2015 Quality Management Systems – requirements.

Introduction 0.1 General • introduces the rationale for the Standard 0.2 Quality management principles • more formally structured. 0.3 Process approach 0.4 Relationship with other MSS 2008 – Introduction

0.1 General • identifies potential benefits • it is not the intent of the standard to imply: ─ uniformity in the structure of different quality management systems ─ uniformity of documentation to align to the clauses of the Standard ─ impose specific terminology to be used. 2008 – Clause 0.1

0.2 Quality management principles  ISO 9001:2008 was based on eight quality management principles whereas the revised version refers to just seven  the principle of “a systems approach to management” has been dropped  the last principle is now called “Relationship management” instead of “Mutually beneficial supplier relationships”. 2008 – Clause 0.2

New Principles 1. Customer Focus 2. Leadership 1. Customer Focus 3. Engagement of People 2. Leadership 4. Process Approach 3. Involvement of People 4. Process Approach 5. Improvement 5. System Approach to 6. Evidence-based Decision Management Making 6. Continual Improvement 7. Factual Approach to 7. Relationship Management. Decision Making 8. Mutually Beneficial Supplier Relationships 2008 – Clause 0.2

0.3 Process Approach  understand and manage interrelated processes as a system  enables consistent and predictable results  PDCA cycle is fundamental  introduces risk based thinking (always been an implied requirement). 2008 – Clause 0.3

0.4 Relationship with other MSS  now a framework to improve alignment among all International Standards for management systems  better facilitates immigration. 2008 – Clause 0.4

Section 1 - Scope • consistently provide products and services to meet requirements and enhance customer satisfaction – no change • all requirements are intended to be applicable to all organisations, regardless of type, size and product provided – no change • removal of exclusions. 2008 – Clauses 1.1 & 1.2

Section 2 – Normative references • ISO 9000:2015, Quality management systems – Fundamentals and vocabulary ▫ also describes quality management principles in detail. 2008 – Clause 2

Section 3 – Terms and Definitions  no terms and definitions  reference to ISO 9000 – no change  maintains clause numbering for consistency. 2008 – Clause 3

Some Terms (docs) • document – information and the medium on which it is contained • documented information - information required to be controlled and maintained by an organisation and the medium on which it is contained • procedure – specified way to carry out an activity or a process (can be documented or not) • record – document stating results achieved or providing evidence of activities performed. 2008 – Clause 3

More Terms (improvement) • improvement – activity to enhance performance • objective – result to be achieved • nonconformity – non-fulfilment of a requirement • correction – action to eliminate a detected nonconformity • corrective action – action to eliminate the cause of a nonconformity and prevent recurrence • preventive action – action to eliminate the cause of a potential nonconformity or other undesirable situation • verification – confirmation that specified requirements have been fulfilled • validation – confirmation that requirements for a specified intended use or application have been fulfilled. 2008 – Clause 3

More Terms (product) • product – output of an organisation that can be produced without any transaction taking place between the organisation and the customer • service – output of an organisation with at least one activity necessarily performed between the organisation and the customer • performance - measurable results • risk - effect (positive or negative) of uncertainty • outsource - to make an arrangement where an external organisation performs part of an organisation’s function or process - Note: An external organisation is outside the scope of the management system although the outsourced function or process is within the scope. 2008 – Clause 3

More Terms (people) • top management – person or group of people who directs and controls an organisation at the highest level • QMS consultant – advisor on QMS realisation – can assist in realising parts of a QMS • interested party – person or organisation that can have an affect, be affected by, or perceive itself to be affected by a decision or activity • competence – ability to apply knowledge and skills to achieve intended results • infrastructure – facilities, equipment & services • work environment - conditions under which work is performed. 2008 – Clause 3

Section 4 – Context of the Organisation 2008 – No direct equivalent

Section 4 – Context of the Organisation 4.1 Understanding the • this is a new clause and organisation and its context provides a key insight into the organisation 4.2 Understanding the needs and expectations of What constitutes the interested parties organisation’s quality management system. 4.3 Determining the scope of the quality management system 4.4 Quality management system and its processes 2008 – No direct equivalent

Section 4 – Context of the organisation 4.1 Understanding the organisation 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 processes • determine external and internal issues relevant to the QMS • must monitor these issues. 2008 – No direct equivalent

Section 4 – Context of the organisation 4.1 Understanding the organisation 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 processes • determine interested parties relevant to the QMS • determine their needs and expectations • must monitor information about interested parties’ requirements. 2008 – No direct equivalent

Section 4 – Context of the organisation 4.1 Understanding the organisation 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 processes • establish scope by determining boundaries and applicability of the QMS to consider external/internal issues, requirements of interested parties and the organisation’s products and services • scope must be documented and available, justify any clauses of ISO 9001 that is not applicable • any N/A clauses must not effect conformity of products/services and customer satisfaction. 2008 – Clauses 1.2 & 4.2.2

Section 4 – Context of the organisation 4.1 Understanding the organisation 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 processes • must establish, implement, maintain and continually improve the QMS • interaction of processes required (but not documented!) • assign responsibilities and authorities for processes • retain documented information to ensure in the processes Documented procedures are not necessarily required…. except where they are needed! 2008 – Clause 4.1

Section 5 - Leadership 2008 – Clause 5

Section 5 – Leadership 5.1 Leadership and • top management to now commitment have a greater involvement in the QMS 5.2 Policy What is required by top 5.3 Organisational roles, management. responsibilities and authorities 2008 – No direct equivalent