This table is a comparison of the chages from ISO 9001:2000 to ISO 9001:2008 (published on 15th Sep 2008).
For a summary and information on how we assess against ISO 9001:2008 see our news release.
Last up-dated on 24 Sep 2008.

ISO 9001:2000 Clause No.	Paragraph Figure Table Note	Addition (A) or Deletion (D)	Amended text	TÜV UK interpretation of the changes, and possible actions for Clients, their Consultants and Assessors
Foreword	Para 2	D + A	International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3 Part 2.	No action required
Foreword	Para 3 Sentence 1	A	The main task of technical committees is to prepare International Standards.	No action required
Foreword	Para 4 Sentence 1	D + A	Attention is drawn to the possibility that some of the elements of this International Standard document may be the subject of patent rights.	No action required
Foreword	Para 5	D	International Standard ISO 9001 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems.	No action required; more information about and from ISO/TC 176 can be found on their website: www.tc176.org (opens in a new window).
Foreword	Para 6	D	This third edition of ISO 9001 cancels and replaces the second edition (ISO 9001:1994) together with ISO 9002:1994 and ISO 9003:1994. It constitutes a technical revision of these documents. Those organizations which have used ISO 9002:1994 and ISO 9003:1994 in the past may use this International Standard by excluding certain requirements in accordance with 1.2.	No action required
Foreword	Para 6	A	This fourth edition cancels and replaces the third edition (ISO 9001:2000) which has been amended to clarify points in the text and to enhance compatibility with ISO 14001:2004.	No action required
Foreword	Para 7	D	The title of ISO 9001 has been revised in this edition and no longer includes the term “Quality assurance“. This reflects the fact that the quality management system requirements specified in this edition of ISO 9001, in addition to quality assurance of product, also aim to enhance customer satisfaction.	No action required
Foreword	Para 8	D	Annexes A and B of this International Standard are for information only.	No action required
Foreword	New Para 7	A	Details of the changes between the third edition and this fourth edition are given in Annex B.	No action required; this table is a reproduction of Table B.1 in Annex B of ISO 9001:2008
0.1	Para 1 Sentence 2	D	The design and implementation of an organization‘s quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization.	No action required
0.1	Sentence 2	A	The design and implementation of an organization's quality management system is influenced by     a) its organizational environment, changes in that environment, and the risks associated with that environment,     b) its varying needs,     c) its particular objectives,     d) the products it provides,     e) the processes it employs,     f) its size and organizational structure.	Action required by clients (and their consultants) to ensure that their Quality Management System is adapted, appropriate, and suitable to the clients specific needs and environment.
0.1	Sentence 3	Now a new para	It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.	No action required
0.1	Para 4	A	This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization's own requirements.	No action required; provides clarification to what the legal requirements apply (see also new "Note 2" in Clause 1.1)
0.2	Para 2	D + A	For an organization to function effectively, it has to identify determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process.	No action required; the use of the word "determine" here (and also in other clauses) implies that the activities need to be actively influenced.
0.2	Para 3	A	The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach“.	No action required; provides clarification that the "process approach" needs to focus on the desired outcome of the processes rather than on the Quality Management System only
0.3	Para 1	D + A	The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of are quality management system standards which have been designed to complement each other, but can also be used independently. Although the two International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair.	No action required
0.3	Para 3	D	ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organization's overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.	No action required
0.3	Para 3	A	At the time of publication of this International Standard, ISO 9004 is under revision. The revised edition of ISO 9004 will provide guidance to management for achieving sustained success for any organization in a complex, demanding, and ever changing, environment. ISO 9004 provides a wider focus on quality management than ISO 9001; it addresses the needs and expectations of all interested parties and their satisfaction, by the systematic and continual improvement of the organization’s performance. However, it is not intended for certification, regulatory or contractual use.	No action required
0.4	Para 1	D	This International Standard has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community.	No action required
0.4	Para 1	A	During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community. Annex A shows the correspondence between ISO 9001:2008 and ISO 14001:2004.	No action required
1.1	Bullet a)	A	a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and	Action required to make sure you know what legal requirements, both statutory and regulatory, apply to your company and your products or services, and how you keep up to date with them.
1.1	Bullet b)	A	b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.	Action required to make sure you know what legal requirements, both statutory and regulatory, apply to your company and your products or services, and how you keep up to date with them.
1.1	Note	D + A	NOTE In this International Standard, the term “product“ applies only to the product intended for, or required by, a customer. NOTE 1 In this International Standard, the term "product" only applies to:     a) product intended for or required by a customer     b) any intended output resulting from the product realisation processes	No action required; now specifically excludes any (by-, waste-, or accidental) products not intended for or required by a customer.
1.1	New Note 2	A	NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.	No action required; "Statutory Requirements" are those defined by Parliament, whereas "Regulatory Requirements" are those defined by a public admistrative Agency, e.g. HSE.
1.2	Para 3	A	Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.	Action required to check that you do not make an exclusion claim for a clause if it affects your delivered product or service and / or its compliance to statutory and regulatory requirements.
2	Para 1	D	The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.	No action required
2	Para 1	A	The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.	No action required
2	Para 1	D + A	ISO 9000:20002005, Quality management systems — Fundamentals and vocabulary.	No action required
3	Para 1	D + A	For the purposes of this document International Standard, the terms and definitions given in ISO 9000 apply.	No action required
3	Paras 2, 3	D	The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used: supplier --> organization --> customer The term “organization“ replaces the term “supplier“ used in ISO 9001 :1994, and refers to the unit to which this International Standard applies. Also, the term “supplier“ now replaces the term “subcontractor“.	No action required
4.1	Bullet a)	D + A	a) identify determine the processes needed for the quality management system and their application throughout the organization (see 1.2),	No action required; the use of the word "determine" here (and also in other clauses) implies that the activities need to be actively influenced.
4.1	Bullet e)	A	e) monitor, measure where applicable, and analyse these processes, and	No action required
4.1	Para 4	D + A	Where an organization chooses to outsource any process that affects product conformity with to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.	Action required to make sure that any outsourced processes are defined in your QMS and how they are managed, e.g. their output is controlled or measured.
4.1	Note 1	D + A	NOTE 1 Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization, and measurement, analysis and improvement.	Action required to ensure your QMS includes analysis and improvement in how you evaluate your subcontractors.
4.1	New Notes 2 & 3	A	NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party. NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as: a) the potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements; b) the degree to which the control for the process is shared; c) the capability of achieving the necessary control through the application of clause 7.4.	Action required to define your outsourced processes and how you stay in control and check the results of those processes.
4.2.1	Bullet c)	A	c) documented procedures and records required by this International Standard, and	No action required
4.2.1	Bullet d)	A + D	d) documents, including records, needed determined by the organization to be necessary to ensure the effective planning, operation and control of its processes, and	No action required
4.2.1	Bullet e)	D	e) records required by this International Standard (see 4.2.4).	No action required
4.2.1	Note 1	A	NOTE 1 Where the term “documented procedure“ appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.	No action required; although ISO 9001:2008 now specifically references procedures "covered by more than one document", TÜV UK would not accept procedures covered by various documents, if that leads to them being "disjointed", and difficult to implement, maintain, and follow.
4.2.3	Bullet f)	A	f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and	No action required; provides clarification regarding the "documents of external origin" addressed here.
4.2.4	Para 1	D + A	Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. Records shall remain legible, readily identifiable and retrievable.The organization shall establish a documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. Records shall remain legible, readily identifiable and retrievable.	No action required
5.5.2	Para 1	A	Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes	Action required to ensure your QMS Representative is part of your Company’s Management team. Your QA Consultant cannot be your QA Rep. However your QA Rep can sub contract the work to the Consultant and oversee the results.
6.2.1	Para 1	A + D	Personnel performing work affecting conformity to product quality requirements shall be competent on the basis of appropriate education, training, skills and experience.	No action required; greater importance now placed on all "product requirements" rather than "product quality" only.
6.2.1	New Note	A	NOTE Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system.	No action required; clarifies that not only personnel "at the coal face" can affect product requirements.
6.2.2	Clause title	A + D	Competence, training and awareness and training	No action required
6.2.2	Bullets a) & b)	A + D	a) determine the necessary competence for personnel performing work affecting conformity to product quality requirements, b) where applicable, provide training or take other actions to satisfy these needs achieve the necessary competence,	No action required; greater importance now placed on all "product requirements" rather than "product quality" only, and the competencies necessary to achieve those.
6.3	Bullet c)	A	c) supporting services (such as transport, communication or information systems) .	No action required
6.4	New Note	A	NOTE The term "work environment" relates to conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting, or weather).	Action required to ensure you have considered all work environment conditions like noise, temp, humidity lighting, weather etc.
7.1	Bullet b)	A + D	b) the need to establish processes, and documents, and to provide resources specific to the product;	No action required
7.1	Bullet c)	A	c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;	Action required if you have not included measurement as part of the activities specific to the product. Most companies would have included measurement, though, as part of the monitoring, inspection and test activities.
7.2.1	Bullet c)	D + A	c) statutory and regulatory requirements related applicable to the product, and	No action required
7.2.1	Bullet d)	D + A	d) any additional requirements determined considered necessary by the organization.	No action required
7.2.1	New Note	A	NOTE Post delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.	Action required to ensure post delivery activities cover the additional note.
7.3.1	New Note	A	NOTE Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination as suitable for the product and the organization.	No action required.
7.3.2	Para 2	D + A	TheseThe inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.	No action required
7.3.3	Para 1	D + A	The outputs of design and development shall be provided in a form that enables in a form suitable for verification against the design and development input and shall be approved prior to release.	No action required
7.3.3	Bullet b)	D	b) provide appropriate information for purchasing, production and for service provision	No action required
7.3.3	New Note	A	NOTE Information for production and service provision can include details for the preservation of product.	Action required to make sure you also address preservation, packaging etc during the design process.
7.3.7	Paras 1 & 2	No text change. Paras now merged	Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).	No action required
7.5.1	Bullet d)	D + A	d) the availability and use of monitoring and measuring devices equipment,	No action required;
7.5.1	Bullet f)	A	f) the implementation of product release, delivery and post-delivery activities.	No action required
7.5.2	Para 1	D + A	The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where , and as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.	No action required
7.5.3	Para 2	A	The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization.	No action required; but make sure that product status regarding monitoring & measurment requirements is maintained during the whole production / service delivery process.
7.5.3	Para 3	D + A	Where traceability is a requirement, the organization shall control and record the unique identification of the product and maintain records (see 4.2.4).	No action required
7.5.4	Para 1, Sentence 3	D + A	If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained the organization shall report this to the customer and maintain records (see 4.2.4).	No action required
7.5.4	Note	A	NOTE Customer property can include intellectual property and personal data.	Action required to ensure you include intellectual property and personal data (ref recent losses of huge amounts of personal data by various Government agencies ...) in your QMS, not just customer supplied equipment or materials
7.5.5	Para 1	D + A	The organization shall preserve the conformity of product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. This As applicable, preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.	No action required
7.6	Title	D + A	Control of monitoring and measuring devices equipment	No action required
7.6	Para 1	D + A	The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices equipment needed to provide evidence of conformity of product to determined requirements (see 7.2.1).	No action required
7.6	Bullet a)	A	a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded (see 4.2.4);	No action required
7.6	Bullet c)	D + A	c) be identified to enable the calibration status to be determined; c) have identification in order to determine its calibration status;	No action required
7.6	Para 4, Sentence 3	Now new para 5, without change.	Records of the results of calibration and verification shall be maintained (see 4.2.4).	No action required
7.6	Note	D + A	Note See ISO 10012-1 and ISO 10012-2 for guidance NOTE Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.	No action required
8.1	Bullet a)	D + A	a) to demonstrate conformity of the product to product requirements,	No action required
8.2.1	New Note	A	NOTE Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealer reports	No action required
8.2.2	Para 2 Sentence 3	A	The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process	No action required
8.2.2	New Para 3	A	A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.	No action required
8.2.2	Para 3	Now para 4 D + A	The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure. Records of the audits and their results shall be maintained (see 4.2.4).	No action required
8.2.2	Para 4 Sentence 1	Now para 5 A	The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.	No action required
8.2.2	Note	D + A	NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 ISO 19011 for guidance.	No action required
8.2.3	Para 1 Sentence 3	D	When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.	No action required
8.2.3	New Note	A	NOTE When determining suitable methods, it is advisable that the organization considers the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.	Action required if - as an example - you do not already consider which processes are crucial to your product's conformity to requirements, or the effectiveness of your QMS, which potential impact these processes have, how - depending on the importance and impact of these processes - you need to monitor and measure them, ...
8.2.4	Para 1	A	The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained.	No action required
8.2.4	Para 2	D + A	Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4).	No action required
8.2.4	Para 3	D + A	Product release and service delivery The release of product and delivery of service to the customer shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.	No action required
8.3	Para 1 Sentence 2	D + A	The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product.	No action required
8.3	Para 2	A	Where applicable, the organization shall deal with nonconforming product by one or more of the following ways:	No action required
8.3	New bullet d)	A	d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.	No action required
8.3	Para 3	Moved to be Para 4	Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).	No action required
8.3	Para 4	Moved to be Para 3	When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).	No action required
8.3	Para 5	Now new bullet d)	When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.	No action required
8.4	Bullet b)	D + A	b) conformity to product requirements (see 7.2.1) (see 8.2.4) ,	No action required
8.4	Bullet c)	A	c) characteristics and trends of processes and products including opportunities for preventive action (see 8.2.3 and 8.2.4),and	No action required
8.4	Bullet d)	A	d) suppliers (see 7.4).	No action required
8.5.2	Para 1	D + A	The organization shall take action to eliminate the cause causes of nonconformities in order to prevent recurrence.	No action required; now makes it clearer that there may be several causes for one nonconformity, and therefore also several investigations followed by several corrective actions.
8.5.2	Bullet f)	A	f) reviewing the effectiveness of the corrective action taken.	No action required
8.5.3	Bullet e)	A	e) reviewing the effectiveness of the preventive action taken.	No action required
Annex A	All	D + A	Updated to reflect ISO 9001:2008 versus ISO 14001:2004	No action required
Annex B	All	D + A	Updated to reflect ISO 9001:2008 versus ISO 9001:2000	No action required
Bibliography	New and amended References	D + A	Updated to reflect new standards (including ISO 9004, currently under revision); new editions of standards, or withdrawn standards.	No action required