Changes to ISO 9001 Quality management systems – Requirements

Changes to ISO 9001 Quality management systems – Requirements Updated Ed. 2, see list of changes at the end of this document The purpose of this document is to demonstrate the changes between ISO 9001:2015 (published in September 2015) and ISO 9001:2008. Due to the applicable copyright laws this has to be done without including large extracts from the standard documents. This is a concentrated and edited extract from the original documented information which constitutes a PowerPoint presentation, approximately 90 min. in duration, where the restrictions with respect to including standard text do not apply. This document replaces another document with the same title, published 2015-09-09, which was prepared when the final draft ISO/FDIS 9001:2015 was available but not the finished standard. List of contents STANDARDS FOR QUALITY MANAGEMENT SYSTEM. HISTORY STANDARDS AND OTHER DOCUMENTS ISSUED BY ISO/TC 176. THE SITUATION TODAY THE ISO 9000-SERIES: ISO 9000, 9001 AND 9004. SPECIAL CONNECTIONS DEVELOPMENT OF ISO 9001 AND OTHER STANDARDS COMMON HIGH LEVEL STRUCTURE AND IDENTICAL CORE TEXT CONTENTS OF ISO 9001:2015 IN A GRAPHICAL STRUCTURE THE CHANGES IN ISO 9001:2015 IN COMPARISON WITH ISO 9001:2008 REQUIREMENTS/STATEMENTS IN ISO 9001:2008 WHICH HAVE NO CORRESPONDENCE IN ISO 9001:2015 TRANSITION: VALIDITY OF CERTIFICATIONS TO ISO 9001:2008 SUPPORTING LITERATURE STANDARDS FOR QUALITY MANAGEMENT SYSTEM. HISTORY The 1950's Requirements on suppliers in addition to product requirements begin to be made. MIL-Q-9858:1959 is issued by the U. S. Army, Navy and Air Force (together). The 1960's and 1970's Standards for different product categories are being issued. National standards are being issued in several countries. Series with 3 different levels of requirements are usual. There is a need for a common standard. ISO's Technical Committee No. 176 is established in 1979. The 1980's ISO 9001, 9002 and 9003 are issued in 1987. Will replace the majority of older standards from different publishers. Approved as, for instance, European standards and National standards in many countries. Application becomes usual also for products which do not belong to the most qualified. The 1990's Certification (registration) of quality management systems begins to be usual. The 2nd editions of ISO 9001, 9002 and 9003 are issued in 1994. No fundamental changes to the requirements. ISO/TC 176 publishes several other quality related standards. The standard for Environmental management systems ISO 14001 issued in 1996 by ISO/TC 207. The 200x years The 3rd edition of ISO 9001 is issued in 2000. ISO 9002 and 9003 are cancelled. Instead ISO 9001 offers the possibility to make "exclusions". Terms which are usual within mechanical workshops are replaced. More general terms are introduced. The structure is made "process oriented" without any drastical changes to the very requirements. Sector specific standards are being issued, e. g. ISO/TS 16949 (automotive). International management system standards for a range of new areas are being issued. The 4th edition of ISO 9001 is issued in 2008. Some minor adjustments of the requirements. The 2010's All International management system standards shall have common high level structure and identical core text. The 5th edition of ISO 9001 is issued in 2015. 1 Series of standards with different levels of requirement At the beginning, ISO standards for quality management systems are issued representing 3 different levels of requirement. ISO 9001:1987 Quality systems – Model for quality assurance in design/development, production, installation and servicing ISO 9002:1987 Quality systems – Model for quality assurance in production and installation ISO 9003:1987 Quality systems – Model for quality assurance in final inspection and test Responsible: ISO Technical committee No. 176 Quality management and quality assurance, Sub-commitee 2 Quality Systems STANDARDS AND OTHER DOCUMENTS ISSUED BY ISO/TC 176. THE SITUATION TODAY Standards under the direct responsibility of ISO/TC 176 Secretariat and its SCs (Now they include standards in addition to those belonging to the “ISO 9000 Family”) ISO 9000:2015 Quality management systems -- Fundamentals and vocabulary The ISO ISO 9001:2015 Quality management systems -- Requirements 9000 ISO 9004:2009 Managing for the sustained success of an organization -series A quality management approach 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 10005:2005 Quality management systems -- Guidelines for quality plans ISO 10006:2003 Quality management systems -- Guidelines for quality management in projects ISO 10007:2003 Quality management systems -- Guidelines for configuration management ISO 10008:2013 Quality management -- Customer satisfaction -- Guidelines for business-toconsumer 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 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/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 ISO 19011:2011 Guidelines for auditing management systems TS = Technical Specification TR = Technical Report Source: (September 2015): http://www.iso.org/iso/home/store/catalogue_tc/catalogue_tc_browse.htm?commid=53882&published=on&inclu desc=true ISO 9001 leading in sales ISO 9001 is the standard which has the largest number of sales, by far superior to all other standards. 2 THE ISO 9000-SERIES: ISO 9000, 9001 AND 9004. SPECIAL CONNECTIONS ISO 9000:2015 Quality management systems — Fundamentals and vocabulary The largest part of the contents of ISO 9000:2015 consists of definitions of terms. Other major parts carry the headings: Fundamental concepts Quality management principles Developing the QMS using fundamental concepts and principles The new editions of ISO 9000 and ISO 9001 have been developed in parallel. ISO 9004:2009. Managing for the sustained success of an organization — A quality management approach ISO 9001 and ISO 9004 have had a position as "a consistent pair". ISO 9004 is a guidance document - not a requirement standard. Adds guidelines on quality management where the range of the requirement standard (ISO 9001) ceases. Was thought to serve as a possible bridge between the requirement standard and, e. g., the critera for quality awards. The method to illustrate the connection with ISO 9001 has varied between different editions. ISO 9004 has never obtained a real sales success. DEVELOPMENT OF ISO 9001 AND OTHER STANDARDS Gates to pass before start of work on an international standard: Name New Work Item Proposal NWIP Systematic review Comment All new standards before start. Purpose: Decide whether the work shall start. Members of the concerned Sub-committee vote. Simple majority is sufficient for acceptance. All published standards after 5 years. Purpose: Decide about the future of the standard: confirmed, revised/amended, converted to another form of deliverable, or withdrawn. Members of the concerned Technical committee vote. Justification Management system standards before start of work on new standard or on revision. study Purpose: Among other things to evaluate the need for the standard in question and different aspects of risk. Approval by the ISO Technical Management Board is necessary. Design Management system standards, optional. Purpose: Make sure that the result of the specification Justification study is observed and that no conflicts with other Management system standards are created. To be carried out by the Technical committee concerned. Details can be studied in ISO/IEC Directives, Part 1, Consolidated ISO Supplement – Procedures specific to ISO, Annex SL, Appendix 2 (normative). Available on the Internet, see http://isotc.iso.org/livelink/livelink?func=ll&objId=4230452&objAction=browse&sort=subtype The process for development of ISO 9001:2015 Organizational levels within ISO ISO International Organization for Standardization TC 176 Technical committee 176 Quality management and quality assurance SC 2 Sub-committee 2 Quality systems WG 24 Working group 24. Arranges meetings with the international experts Document prepared by WG 24 WD Working Draft CD Committee Draft DIS Draft International Standard FDIS Final Draft International Standard ISO 9001 International Standard Document ready when? 2012 2013 June 2014 July 2015 July 2015 September Participants in different countries Experts nominated for WG 24 + the national organization, member of ISO/TC 176 + other interested parties within the country The national organization, member of ISO/TC 176 Authorized sales organization What is done in the countries when the document is ready? Review, write comments (base for work on the CD) Review, write comments (base for work on the DIS) Review. Vote about advancement. Write comments (base for work on the FDIS) Vote yes/no Translate (probably started earlier). Sell 3 Organizational levels within the countries (typical but not everywhere identical) Nominated national expert for WG 24 Working Group set up for working on ISO 9001 (and possibly other standards) Technical committee (member of ISO/TC 176/SC 2 as representative of the National standardization organization) National standardization organization (member of ISO) COMMON HIGH LEVEL STRUCTURE AND IDENTICAL CORE TEXT Background After the publication of the 1st edition of ISO 14001 in 1996, thoughts have arisen within the central ISO organization that organizations may run into difficulties when implementing ISO 9001 and ISO 14001 contemporaneously. The situation is influenced by the appearance of management system standards within several new areas. The ISO organization made contacts on the highest management level within industry, governments and other organizations in order to get views. A conclusion was made that co-ordination between management system standards is needed. Nomination of the Joint Technical Coordination Group JTCG (2006-2011) Around 2006, the ISO Technical Management Board appointed a ”Joint Technical Coordination Group” (JTCG) consisting of people representing the different areas for which Management System Standards (MSS) had been published by ISO or were under preparation. The task of the JTCG was to prepare the following: "High Level Structure and Identical Text for MSS and for the common MS terms and core definitions". Members of the JTCG The JTCG included representatives of different Technical committees: ISO/TC 8 Ships and marine technology ISO/TC 34 Food products ISO/TC 176 Quality management and quality assurance ISO/TC 207 Environmental management ISO/TC 223 Societal security ISO/TC 241 Road-Traffic Safety Management System ISO/TC 242 Energy Management ISO/IEC Joint project on Risk Management ISO/IEC JTC 1/SC 27 IT Security techniques The JTCG result is laid down in ISO/IEC Directives The result of the JTCG work is published in ISO/IEC Directives, Part 1, Consolidated ISO Supplement – Procedures specific to ISO, Annex SL, Appendix 2 (normative). Available on the Internet, see http://isotc.iso.org/livelink/livelink?func=ll&objId=4230452&objAction=browse&sort=subtype The revised ISO 9001 was required strictly to observe the mentioned directive. Combination of common and discipline specific text. Example from ISO 9001:2015 5.3 Organizational roles, responsibilities and authorities Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood throughout the organization. Top management shall assign the responsibility and authority for: a) ensuring that the quality management system conforms to the requirements of this International Standard; b) ensuring that the processes are delivering their intended outputs; c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1) to top management; d) ensuring the promotion of customer focus throughout the organization; e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. Blue text: common. Black text: specific to quality management system. Red text: actual discipline stated Please observe that everything will be written in black text in the finished standard 4 CONTENTS OF ISO 9001:2015 IN A GRAPHICAL STRUCTURE THE CHANGES IN ISO 9001:2015 IN COMPARISON WITH ISO 9001:2008 Different types of changes The changes in ISO 9001:2015 in comparison with ISO 9001:2008 are of different types, and these types can, as a rule, be described in the following way: sub-clause re-located to another place in the standard editorial changes which are not noted as changes a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements addition of “new” requirements which may, however, be understood even in ISO 9001:2008 without being expressly stated addition of new requirements which may, however, be considered as natural, complementary additions in comparison with what ISO 9001:2008 requires new requirements which have no correspondence in ISO 9001:2008 This is not intended to be a scientific way of description of the changes and the interface between the types is not always absolutely clear. List of clauses/sub-clauses and comments with respect to changes for each Due to applicable copyright laws, extracts of the text in ISO 9001:2015 cannot be included here Clause/sub-clause Corresp in ISO Comments with respect to the changes in comparison with in ISO 9001:2015 9001:2008 ISO 9001:2008 1 Scope 1.1 Scope, The word “continual” in b) before “improvement” is deleted. Thus General all kinds of improvement are included 1.2 Application 2 Normative 2 Normative The changes mean that a new word or a new mode of expression references references is used, which does not essentially or not at all change the meaning of the requirements 3 Terms and 3 Terms and The changes mean that a new word or a new mode of expression definitions definitions is used, which does not essentially or not at all change the meaning of the requirements 4 Context of the organization 4.1 Understanding No New concept in management system standards – new the organization correspondence requirements that have no correspondence in ISO 9001:2008 and its context in ISO 5 4.2 Understanding the needs and expectations of interested parties 9001:2008 No correspondence in ISO 9001:2008 4.3 Determining the scope of the quality management system No direct correspondence but partly an obvious relationship with requirements in 1.2 Application and 4.2.2 Quality manual 4.4 Quality management system and its processes, 4.4.1 4.1 Quality management system, General requirements 5.5.1 Responsibility and authority 8.5.1 Continual improvement 4.4 Quality management system and its processes, 4.4.2 4.2.1 Documentation requirements, General 5 Leadership 5.1 Leadership and commitment 5.1.1 General 5.1 Management commitment New requirements. Compare with ISO 9000, 3.2.3, definition of “interested party”: person or organization (3.2.1) that can affect, be affected by, or perceive itself to be affected by a decision or activity EXAMPLE Customers (3.2.4), owners, people in an organization, providers (3.2.5), bankers, regulators, unions, partners or society that can include competitors or opposing pressure groups 1) The new requirements with respect to the scope of the quality management system has no correspondence in ISO 9001:2008. However, that standard explains the scope of the standard itself 2) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all constitute a statement of a new requirements 3) Part of the changes mean addition of “new” requirements which may, however, be understood even in ISO 9001:2008 without being expressly stated 4)-5) References are made in the 2nd paragraph a) and b) to, respectively: 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 6) The new requirement in the 4th paragraph with respect to specification of ”types of products and services covered” has no correspondence in ISO 9001:2008 7) The new reference in the last paragraph to “enhancement of customer satisfaction” in this context has no correspondence in ISO 9001:2008 1) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2) Part of the changes mean addition of “new” requirements which may, however, be understood even in ISO 9001:2008 without being expressly stated 3) The new requirement in a) with respect to determination of “inputs” and “outputs” of processes has no correspondence in ISO 9001:2008 4) The new requirement in f) with respect to “risks and opportunities” has no correspondence in ISO 9001:2008 . Reference is made to 6.1 “Actions to address risks and opportunities” 1) Part of the changes mean addition of “new” requirements which may, however, be understood even in ISO 9001:2008 without being expressly stated 2) The nearest corresponding requirement in ISO 9001:2008 includes the qualifier “determined by the organization to be necessary” (Please note that 7.5.1 in ISO 9001:2015 contains a similar requirement which includes the qualifier ”determined by the organization as being necessary”) 1) Part of the changes mean addition of “new” requirements which may, however, be understood even in ISO 9001:2008 without being expressly stated 2) The new requirement in d) with respect to “process approach and risk-based thinking” has no correspondence in ISO 9001:2008 3) See separate slides about the concept “process approach” 4) The new requirement in f) on communication with respect to quality management has no correspondence in ISO 9001:2008 6 What is ”The process approach”? ISO 9001:2015, Clause 0 ”Introduction” includes a sub-clause 0.3 ”Process approach”. It refers, in principle, to the following: - applying the steps in ISO 9001:2015, sub-clause 4.4 “Quality management system and its processes” under 4.4.1 a) – h) - applying the Plan-Do-Check-Act cycle (PDCA) - applying Risk-based thinking. Reference is made to Annex A.4 ”Risk-based thinking”, which includes more details See figure! Please note: This is not a requirement! A guidance document on the Process Approach has been issued by ISO. See the list of supporting literature on the last page!  NOTE Numbers in brackets refer to the clauses in this International Standard. Representation of the structure of this International Standard in the PDCA cycle Please note: This is not a requirement! 5.1.2 Customer 5.1 1) Most of the changes mean addition of “new” requirements focus Management which may, however, be understood even in ISO 9001:2008 without being expressly stated commitment 2) The new requirement in b) with respect to “risks and 5.2 Customer opportunities” has no correspondence in ISO 9001:2008 focus 5.2 Policy 5.2.1 Establishing 5.1 1) Most of the changes mean that a new word or a new mode of the quality policy Management expression is used, which does not essentially or not at all change commitment the meaning of the requirements 5.3 Quality 2) The references in a) to “context” and “strategic direction” mean policy addition of “new” requirements which may, however, be understood even in ISO 9001:2008 without being expressly stated 5.2.2 4.2.1 1) The changes in a) and b) mean addition of “new” requirements Communicating the Documentation which may, however, be understood even in ISO 9001:2008 quality policy requirements, without being expressly stated General 2) The new requirement in c) with respect to “interested parties” 5.3 Quality has no correspondence in ISO 9001:2008 policy 5.3 Organizational 5.4.2 Quality 1) Most of he changes mean addition of “new” requirements which roles, management may, however, be understood even in ISO 9001:2008 without responsibilities system planning being expressly stated and authorities 5.5.1 2) In ISO 9001:2008 the responsibility for ”reporting” in c) is laid Responsibility on the management representative 7 and authority 6 Planning 6.1 Actions to address risks and opportunities, 6.1.1 6.1 Actions to address risks and opportunities, 6.1.2 6.2 Quality objectives and planning to achieve them, 6.2.1 6.2 Quality objectives and planning to achieve them, 6.2.2 6.3 Planning of changes 7 Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes No direct correspondence in ISO 9001:2008 but certain details are covered by 8.4 Analysis of data and 8.5.3 Preventive action 1) Most of the changes refer to new requirements with respect to risks and opportunities and need to be considered 2) References are made to: 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties. 3) The following standard can be consulted: ISO 31000:2009 Risk management – Principles and guidelines No direct correspondence in ISO 9001:2008 but some details are covered by 8.5.3 Preventive action 4.2.1 Documentation requirements, General 5.4.1 Quality objectives 1) Most of the requirements have no correspondence in ISO 9001:2008 2) Reference is made to 4.4 “Quality management system and its processes” No correspondence in ISO 9001:2008 No direct correspondence in ISO 9001:2008 but certain details are covered by 5.4.2 Quality management system planning 6.1 Provision of resources 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment 1) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2) Part of the changes mean addition of “new” requirements which may, however, be understood even in ISO 9001:2008 without being expressly stated 3) The new requirement in the 1st sentence with respect to quality objectives for “processes” has no correspondence in ISO 9001:2008 4) The new reference in d) to “enhancement of customer satisfaction” has no correspondence in ISO 9001:2008 The requirements with respect to details to be determined during planning are new 1) Reference is made to 4.4 “Quality management system and its processes” 2) Most of the new requirements on details to be considered during planning of changes have no correspondence in ISO 9001:2008 1) Part of the changes mean addition of “new” requirements which may, however, be understood even in ISO 9001:2008 without being expressly stated 2) The new reference in b) to “external resources” has no correspondence in ISO 9001:2008. The changes mean addition of “new” requirements which may, however, be understood even in ISO 9001:2008 without being expressly stated The changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 1) The changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2) The NOTE includes new examples of possible environmental factors (not part of the requirements) 8 7.1.5 Monitoring and measuring resources 7.1.5.1 General 7.6 Control of 1) The requirements on “Monitoring and measuring resources” monitoring and have been moved from the clause “Product realization” to the measuring clause “Support” equipment 2) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 3) Part of the changes mean addition of “new” requirements which may, however, be understood even in ISO 9001:2008 without being expressly stated 7.1.5.2 7.6 Control of 1) Most of the changes mean that a new word or a new mode of Measurement monitoring and expression is used, which does not essentially or not at all change traceability measuring the meaning of the requirements equipment 2) The new reference to a situation where traceability is a “requirement” has no correspondence in ISO 9001:2008 7.1.6 No direct Most of the requirements are “new” although they may be Organizational correspondence understood even in ISO 9001:2008 without being expressly stated knowledge in ISO 9001:2008 but certain details are covered by 6.2.2 Competence, training and awareness 7.2 Competence 6.2.2 1) Most of the changes mean that a new word or a new mode of Competence, expression is used, which does not essentially or not at all change training and the meaning of the requirements awareness 2) The new requirement in a) with respect to determination of the necessary competence due to its importance for the quality management system has no correspondence in ISO 9001:2008 7.3 Awareness No direct 1) Most of the changes mean addition of “new” requirements correspondence which may, however, be understood even in ISO 9001:2008 in ISO without being expressly stated 9001:2008 but Comment 2-3: The new requirements in a) and b) with respect to certain details awareness of the “quality policy” and “objectives” have no are related with correspondence in ISO 9001:2008 6.2.2 Competence, training and awareness 7.4 No direct ISO 9001:2008, 5.5.3 contains certain requirements on top Communication correspondence management with respect to internal communication. However, in ISO the concept “external communication” and the details in a) – e) 9001:2008 but have no correspondence in ISO 9001:2008 certain details are related with 5.5.3 Internal communication 7.5 Documented information A special method is applied for comparison of requirements on “documented information”. In ISO 9001:2008, the requirements on “documents” and “records” are separated and mainly different. In ISO 9001:2015 both categories are referred to as “documented information”, and the requirements are the same. Therefore the comparison is made here partly with respect to “documents” and partly with respect to “records”. 7.5.1 General 4.2.1 1) The requirements on “documented information” have been Documentation moved from the clause “Quality management system” to the requirements, clause “Support” General 2) The changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements A guidance document on Documented Information has been issued by ISO. See the list of supporting literature on the last page! 9 7.5.2 Creating and updating Comparison with requirements for “documents” (not “records”) 7.5.2 Creating and updating Comparison with requirements for “records” 4.2.3 Control of documents 7.5.3 Control of documented information, 7.5.3.1 Comparison with requirements for “documents” (not “records”) 7.5.3 Control of documented information, 7.5.3.1 Comparison with requirements for “records” 7.5.3 Control of documented information, 7.5.3.2 Comparison with requirements for “documents” (not “records”) 7.5.3 Control of documented information, 7.5.3.2 Comparison with requirements for “records” 4.2.3 Control of documents 8 Operation 8.1 Operational planning and control 4.2.4 Control of records 4.2.4 Control of records 4.2.3 Control of documents 4.2.4 Control of records 1) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2)-3) The requirements in a) with respect to “identification and description” and in b) with respect to “format” have no correspondence in ISO 9001:2008 1)-3) The new requirements with respect to “description” in a), “format” in b) and “review and approval” in c) have no correspondence in ISO 9001:2008 4) The changes mean addition of new requirements which may, however, be considered as natural, complementary additions in comparison with what ISO 9001:2008 requires 1) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2) Part of the changes mean addition of new requirements which may, however, be considered as natural, complementary additions in comparison with what ISO 9001:2008 requires 1) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2) Part of the changes mean addition of new requirements which may, however, be considered as natural, complementary additions in comparison with what ISO 9001:2008 requires 1) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2) Part of the changes mean addition of new requirements which may, however, be considered as natural, complementary additions in comparison with what ISO 9001:2008 requires 1) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2) Part of the changes mean addition of new requirements which may, however, be considered as natural, complementary additions in comparison with what ISO 9001:2008 requires 3) Part of the changes refer to requirements that use to be typically applicable to other kinds of document but not to “records” 4.1 Quality management system, General requirements 7.1 Planning of product realization 1) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2) Part of the changes mean addition of new requirements which may, however, be understood even in ISO 9001:2008 without being expressly stated 3) Reference is made in the 1st paragraph to: 4.4 Quality management system and its processes 6 Planning 4)-5) The new general requirements in b) 1) and d) on details with respect to criteria for and control of processes have no correspondence in ISO 9001:2008 6) The new requirements in the 3rd paragraph with respect to changes have no correspondence in ISO 9001:2008 7) Reference is made in the last paragraph to 8.4 “Control of externally provided products and services” 8.2 Requirements for products and services 8.2.1 Customer 7.2.3 Customer 1) Most of the changes mean that a new word or a new mode of communication communication expression is used, which does not essentially or not at all change 7.5.4 Customer the meaning of the requirements property 2) The new requirement in e) with respect to “contingency actions” has no correspondence in ISO 9001:2008 (contingency = unexpected event) 10 8.2.2 Determination of requirements for products and services 8.2.3 Review of requirements for products and services, 8.2.3.1 7.2.1 Determination of requirements related to the product 7.2.2 Review of requirements related to the product 7.2.1 Determination of requirements related to the product 7.2.2 Review of requirements related to the product 7.2.2 Review of requirements related to the product The changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements The changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 8.2.3 Review of The changes mean that a new word or a new mode of expression requirements is used, which does not essentially or not at all change the related to products meaning of the requirements and services, 8.2.3.2 8.2.4 Changes to 7.2.2 Review of Some editorial changes exist, which are not noted as changes requirements for requirements products and related to the services product 8.3 Design and development of products and services, 8.3.1 General No This is actually a summary of the requirements stated in the subcorrespondence sequent sub-clauses and it contains no specific new requirements in ISO 9001:2008 8.3.2 Design and 7.3.1 Design 1) Part of the changes mean that a new word or a new mode of development and expression is used, which does not essentially or not at all change planning development the meaning of the requirements planning 2)-3) The new requirements on items to consider in a) with respect to “nature, duration and complexity of the … activities” and in e) with respect to “resource needs” have no correspondence in ISO 9001:2008 4)-7) The new requirements on items to consider with respect to “involvement of customers” in g), “subsequent provision” in h), “control … by customers (etc.) in i) and “documented information” in j) have no correspondence in ISO 9001:2008 8.3.3 Design and 7.3.2 Design 1) Part of the changes mean that a new word or a new mode of development and expression is used, which does not essentially or not at all change inputs development the meaning of the requirements inputs 2)-3) The new requirements in d) with respect to “standards or codes of practice” and in e) with respect to “potential consequences of failure” have no correspondence in ISO 9001:2008 8.3.4 Design and 7.3.1 Design and 1) Part of the changes mean that a new word or a new mode of development development expression is used, which does not essentially or not at all change controls planning the meaning of the requirements 7.3.4 Design and 2) Part of the changes mean addition of “new” requirements which development may, however, be understood even in ISO 9001:2008 without review being expressly stated 7.3.5 Design and development verification 7.3.6 Design and development validation 8.3.5 Design and 7.3.3 Design 1) Part of the changes mean that a new word or a new mode of development and expression is used, which does not essentially or not at all change outputs development the meaning of the requirements 11 outputs 8.3.6 Design and development changes 2) The new requirement in c) with respect to inclusion of monitoring and measuring requirements in the outputs has no correspondence in ISO 9001:2008 3) The new requirement in the last sentence with respect to retaining documented information has no correspondence in ISO 9001:2008 The changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 7.3.7 Control of design and development changes 8.4 Control of externally provided processes, products and services 8.4.1 General 4.1 Quality 1) The term “outsourcing” has been eliminated in ISO 9001:2015. management The concerned requirements have been moved from 4.1 “Quality system, General management system, General requirements” to 7.4 “Control of requirements externally provided processes, products and services” 7.4.1 2) Part of the changes mean that a new word or a new mode of Purchasing expression is used, which does not essentially or not at all change process the meaning of the requirements 3) Part of the changes mean addition of “new” requirements which may, however, be understood even in ISO 9001:2008 without being expressly stated 4) The new requirement in b) with respect to products and services provided directly to the customer has no correspondence in ISO 9001:2008 5) The new requirements in the last paragraph with respect to “monitoring of performance” and specifically the ability to “provide processes” have no correspondence in ISO 9001:2008 8.4.2 Type and 4.1 Quality 1) Part of the changes mean that a new word or a new mode of extent of control management expression is used, which does not essentially or not at all change system, General the meaning of the requirements 2)-3) The new references in c) 1) to “customer and applicable requirements 7.4.1 Purchasing statutory and regulatory requirements” and in c) 2) to the “controls applied by the external provider” have no correspondence in ISO process 7.4.2 Purchasing 9001:2008 information 7.4.3 Verification of purchased product 8.4.3 Information 7.4.2 1) Part of the changes mean that a new word or a new mode of for external Purchasing expression is used, which does not essentially or not at all change providers the meaning of the requirements information 2) The new requirement in b) 2) with respect to approval of 7.4.3 “methods” has no correspondence in ISO 9001:2008 Verification of 3)-5) The new requirements in d) with respect to “interactions with purchased the organization”, in e) with respect to “control and monitoring” product and in f) with respect to “validation” have no correspondence in ISO 9001:2008 8.5 Production and service provision 8.5.1 Control of 6.2.2 1) Part of the changes mean that a new word or a new mode of production and Competence, expression is used, which does not essentially or not at all change service provision the meaning of the requirements training and 2) The new requirement in a) 2) with respect documented awareness 6.3 Infrastructure information that defines “results to be achieved” has no correspondence in ISO 9001:2008 6.4 Work 3) The new reference in c) with respect to verification that “criteria environment for control of processes“ have been met has no correspondence 7.1 Planning of in ISO 9001:2008 product 4) Please note that in d) the word “infrastructure” is used instead realization of “equipment”. 7.5.1 Control of 5) The new requirement in g) with respect to prevention of “human production and service provision error” has no correspondence in ISO 9001:2008 7.5.2 Validation of processes for production and service provision 12 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes 8.6 Release of products and services 8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product 7.5.3 Identification and traceability 7.5.4 Customer property 7.5.5 Preservation of product No direct correspondence in ISO 9001:2008 but a certain relationship with 7.2.1 “Determination of requirements related to the products” and 7.5.1 “Control of production and service provision” No correspondence in ISO 9001:2008 8.2.4 Monitoring and measurement of product 8.7 Control of nonconforming outputs, 8.7.1 8.3 Control of nonconforming product 8.7 Control of nonconforming outputs, 8.7.2 8.3 Control of nonconforming product The changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 1) The inclusion of “external providers” in the requirements has no correspondence in ISO 9001:2008 2) Most of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements The changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements A relationship exists with requirements in ISO 9001:2008, 7.2.1 “The organization shall determine … requirements for … postdelivery activities” (plus the NOTE) and 7.5.1 “Controlled conditions shall include … post-delivery activities” which, however, do not state any details New requirements A guidance document on Control of changes has been issued by ISO. See the list of supporting literature on the last page! 1) Please note the sub-clause title under which you find the requirements monitoring and measurement of product and service 2) Please note that ISO 9001:2015, 9.1 “Monitoring, measurement, analysis and evaluation” includes general requirements for monitoring and measurement 3) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 4) The requirement in a) that evidence of conformity with the acceptance criteria shall be “documented” has no, clearly expressed, correspondence in ISO 9001:2008 1) Please note that ISO 9001:2015, 10.2 “Nonconformity and corrective action” includes some general requirements with respect to dealing with nonconformities 2) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 3) Part of the changes mean “new” requirements which may be understood even in ISO 9001:2008 without being expressly stated 4) The new requirement in the 2nd paragraph with respect to action when nonconformities are detected during provision of services has no correspondence in ISO 9001:2008 5) The new alternatives in b) segregation, containment, return or suspension of provision have no correspondence in ISO 9001:2008 1) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 13 2) The requirement in d) that documented information shall identify the authority for decision of action has no, clearly expressed, correspondence in ISO 9001:2008 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 7.1 Planning of 1) Part of the changes mean that a new word or a new mode of product expression is used, which does not essentially or not at all change realization the meaning of the requirements 7.4.1 Purchasing 2) The requirement in b) with respect to determination of methods for ”evaluation” corresponds to requirements in ISO 9001:2008 process only for ”suppliers” and ”data” 7.6 Control of 3) The requirement in c) with respect to ”when monitoring and monitoring and measuring shall be performed” corresponds to requirements in measuring ISO 9001:2008 only for ”audit” and ”product” equipment 4) The new requirement in d) with respect to ”when the results 8.1 shall be analysed and evaluated” has no correspondence in ISO Measurement, 9001:2008 analysis and 5) The requirement in the last paragraph with respect to retention improvement, of “documented” information corresponds to (clearly expressed) General requirements in ISO 9001:2008 only for ”suppliers” and ”audit” 8.2 Monitoring and measurement 8.4 Analysis of data 9.1.2 Customer 8.2.1 Customer The changes mean that a new word or a new mode of expression satisfaction satisfaction is used, which does not essentially or not at all change the meaning of the requirements 9.1.3 Analysis and evaluation 8.4 Analysis of data. 8.5.1 Continual improvement 9.2 Internal audit, 9.2.1 8.2.2 Internal audit 9.2 Internal audit, 9.2.2 8.2.2 Internal audit 9.3 Management review, 9.3.1 General 5.6.1 Management review, General 9.3.2 Management review inputs 5.6.1 Management review, General 5.6.2 Review input 1) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2)-3) The new requirements with respect to evaluation of effectiveness of planning in d) and of actions to address risks and opportunities in e) have no correspondence in ISO 9001:2008 The changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 1) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2) The new requirement in a) with respect to consideration of ”changes” has no correspondence in ISO 9001:2008 3) The new requirement in d) with respect to reporting results to relevant management has no correspondence in ISO 9001:2008 4) Reference is made to ISO 19011 for guidance 1) The requirements on “Management review” have been moved from the clause “Management responsibility” to the clause “Performance evaluation” 2) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 3) The new reference to ”alignment with the strategic direction” has no correspondence in ISO 9001:2008 1) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2) The new requirement in b) with respect to consideration of changes both in ”external” and “internal” issues has no correspondence in ISO 9001:2008 3) The new requirement in c) with respect to consideration of ”trends” has no correspondence in ISO 9001:2008 4)-6) The new requirements with respect to information in c) 2) on ”quality objectives”, in c) 5) on ”monitoring and measurement 14 9.3.3 Management review outputs 10 Improvement 10.1 General 10.2 Nonconformity and corrective action, 10.2.1 5.6.1 Management review, General 5.6.3 Review output 5.2 Customer focus 8.1 Measurement, analysis and improvement, General 8.3 Control of nonconforming product 8.5.1 Continual improvement 8.5.3 Preventive action 8.3 Control of nonconforming product 8.5.2 Corrective action 10.2 Nonconformity and corrective action, 10.2.2 8.3 Control of nonconforming product 8.5.2 Corrective action 10.3 Continual improvement 8.5.1 Continual improvement results” and in c) 7) on ”external providers” have no correspondence in ISO 9001:2008 7)-8) The new requirements in d) with respect to ”adequacy of resources” and in e) with respect to “risks and opportunities” have no correspondence in ISO 9001:2008 1) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2) The new reference in b) with respect to ”need for changes” has no correspondence in ISO 9001:2008 1) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2) The new requirements in a) with respect to opportunities for ”improving products and services” and addressing “future needs and expectations” have no correspondence in ISO 9001:2008 1) Requirements for control of nonconformities are stated in ISO 9001:2008 only for such related to nonconforming product. 2) Part of the changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 3) The new requirement in b) 3) with respect to determination of whether “similar nonconformities exist or could occur” has no correspondence in ISO 9001:2008 4) The new requirement in e) with respect to updating ”risks and opportunities” has no correspondence in ISO 9001:2008 5) The new requirement in f) with respect to making “changes to the quality management system” has no correspondence in ISO 9001:2008 1) The changes mean that a new word or a new mode of expression is used, which does not essentially or not at all change the meaning of the requirements 2) Requirements with respect to retaining documented information are stated in ISO 9001:2008 only for such related to nonconforming product. 1) The new requirements in 10.3 are more specific and detailed than the corresponding requirements in ISO 9001:2008 REQUIREMENTS/STATEMENTS IN ISO 9001:2008 WHICH HAVE NO CORRESPONDENCE IN ISO 9001:2015 Due to applicable copyright laws, extracts of the text in ISO 9001:2008 cannot be included here Clause/sub-clause in Requirement/statement concerned Comment with respect to ISO ISO 9001:2008 9001:2015 1.2 Statement that it may be possible to exclude ISO 9001:2015 contains no Application requirements that are not applicable. corresponding statement about application but sub-clause 4.3 contains the following requirement: “The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system”. 15 4.1 Quality management system, General requirements The quality management system shall be documented in accordance with the requirements of the standard. Requirements are stated with respect to outsourcing of processes. 1) There is no general requirement in ISO 9001:2015 with respect to documentation of the quality management system. 2) The term "outsource" is not used in ISO 9001:2015. The related requirements are covered by the requirements in sub-clause 8.4 "Control of externally provided processes, products and services". 4.2.2 Quality manual A quality manual shall be established and maintained. Among other things it shall contain information about the scope of the quality management system and justification for exclusions, if any. There is no requirement in ISO 9001:2015 on establishing a quality manual but sub-clause 4.3 contains the following requirement: “The scope shall be available and be maintained as documented information ...”. 5.5.2 Management representative A member of the organization’s management shall be appointed to be responsible for certain specified tasks in respect of the quality management system. There is no requirement in ISO 9001:2015 that somebody shall be appointed to be a "management representative". 7.3.4 Design and development review Requirements are stated about who shall participate in the reviews. There is no requirement in ISO 9001:2015 about who shall participate in such reviews. 7.4.2 Purchasing information Purchasing information shall include quality management system requirements where appropriate. There is no requirement in ISO 9001:2015 that requirements on quality management system shall be stated in the purchasing information. 7.5.2 Validation of processes for production and service provision For the processes concerned it is stated, among other things, that criteria for review and approval of the processes shall be defined. The processes concerned are those which were earlier referred to as "special processes". There are no requirements in ISO 9001:2015 for defining criteria for approval of processes and for approval of equipment. 7.6 Records of the results of calibration and Control of monitoring verification are required to be maintained. and measuring equipment The ability of computer software shall be confirmed. 1) ISO 9001:2015 does not require clearly that records of the results of calibration and verification shall be maintained. 2) There is no requirement in ISO 9001:2015 that the ability of computer software shall be confirmed. 8.2.2 Internal audit Auditors are not allowed to audit their own work. 8.4 Analysis of data The information resulting from the analysis of There is no requirement in ISO data shall address, among other things, trends 9001:2015 that analysis of data shall of processes and products. include detection of trends of processes and products. 8.5.3 Preventive action Actions shall be determined to eliminate the The concept "preventive action" has causes of potential nonconformities in order to been deleted in ISO 9001:2015. The prevent their occurrence. specific requirements in respect of 16 There is no requirement in ISO 9001:2015 that auditors shall not audit their own work. such actions are intended to be covered by requirements on “actions to address risks and opportunities” in sub-clause 6.1. Documented procedures Where is establishing a documented procedure required in ISO 9001:2008 but not in ISO 9001:2015? 4.2.3 Control of documents 4.2.4 Control of records 8.2.2 Internal audit 8.3 Control of nonconforming product 8.5.2 Corrective action 8.5.3 Preventive action TRANSITION: VALIDITY OF CERTIFICATIONS TO ISO 9001:2008 ISO 9001:2008 certifications will not be valid after three years from publication of ISO 9001:2015. The expiry date of certifications to ISO 9001:2008 issued during the transition period needs to correspond to the end of the three year transition period. Source: Transition Planning Guidance for ISO 9001:2015. Available on the Internet, address http://www.iaf.nu/upFiles/IAFID9Transition9001PublicationVersion.pdf SUPPORTING LITERATURE A number of guidance documents are available at the official site for ISO/TC 176/SC 2 under the heading 1. Revision of ISO 9001, among others: ISO 9001:2015. The process approach (PowerPoint presentation) THE PROCESS APPROACH IN ISO 9001:2015 Guidance on the requirements for Documented Information of ISO 9001:2015 How Change is addressed within ISO 9001:2015 http://isotc.iso.org/livelink/livelink/open/tc176SC2public Available on the Internet, address Lennart Brandt Edition 1 2015-10-01, Edition 2 2015-10List of changes Edition 2, 2015-10-06 Page Where? 3 Under the table "Gates to pass ..." 3 The table "The process ...", 5th row, 5th column 4 "The JTCG result ...", 2nd line 16 7.6 17 Description Appendix 3 changed to Appendix 2 "Only editorial comments" deleted Appendix 3 changed to Appendix 2 Change with respect to computer software added