COMPARISON BETWEEN ISO

9001:2008 & ISO 9001:2015

SUBMITTED TO: Sir.Usman

Awan

SUBMITTED BY: Wajeeha Farooq 08 Narmeen Haroon 74 Samreen Fatima Naila Ghani 22 MS TQM Session 2013 to 2015

Introduction:

The ISO 9000 series of quality standards is by far the best selling and most extensively used management system worldwide. Like all ISO standards ISO 9001 generally undergoes a revision every five years.

The International Organization for Standardization (ISO) is currently undertaking a process for updating the ISO 9001:2008 Quality Management System standard. The process is well underway and a Committee Draft has been published (ISO/CD 9001:2015).

The process involves a number of draft releases and interested parties are invited to comment at various stages of the standard production. Once the draft has been finalized and accepted it is expected to be published and will become ISO 9001:2015.

Reason for changes:

The main reasons for the change is to keep ISO 9001 relevant, reflect changes in its environment and ensure it continues to deliver “confidence in the organization’s ability to consistently provide product that meets customer and applicable statutory and regulatory requirements”.

The current focus on effective process management is to be maintained but greater emphasis will be placed on producing desired outputs and providing confidence in product.

Structure of the proposed revision ISO/CD 9001:2005

The structure of the new standard will be significantly changed in accordance with Annex SL which was issued by ISO in 2012 to define the framework for a generic Management System Standard.

All new ISO management system standards will adhere to this framework and all current ISO management system standards (MSSs) will migrate at their next revision.

In future, all ISO MSSs should be consistent with this format and will all have the same look and feel.

The 2015 version of ISO 9001 will therefore be based on this Annex SL framework.

Other standards which will change include:

ISO/IEC 27001:2013 Information security management systems, will be the next ISO standard to be based on Annex SL

ISO 14001:2015 Environmental Management, will be the next published shortly before ISO 9001:2015 Quality management

ISO 23001: 2012 Business Continuity Management, based on an early version of Annex SL (Guide 83)

The following clause structure and proposed changes are included in the ISO/CD 9001:2015

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

Summary of Main Changes

The term “product” will be replaced by “goods & services” and the word “continual” will be dropped from “continual improvement.”

“Purchasing” and “outsourcing” will be replaced by “external provision of goods and services”

CD/9001:2015 puts a greater emphasis on the definition of scope, which has always been the most important and critical aspect of a quality management system.

It is proposed to replace preventive action in the current edition of the standard. References are made to risk, identification of risks and opportunities and planning actions to address risks and opportunities identified.

CD/9001 will take a risk-based approach to determine the type and extent of controls appropriate to each external provider and all external provision of goods and services. The proposed standard addresses risks which can affect conformity of goods and services as well as customer satisfaction.

Senior management will be required to take a more active involvement in the quality management system.

There will be general requirements for documentation, with no reference to documented quality manual, documented procedures or to quality records. The Committee Draft refers to “Documented Information.”

The need for exclusions may not be considered to be necessary in the new version of the standard but feedback on this is being sought as part of the revision process.

Publication Programmed:

June 2013 – Committee Draft Issued – ISO/CD 9001 September 2013 – Cut-off Date for Comments & Votes – ISO/CD 9001 April 2014 – Draft International Standard (DIS) – Ballot opens August 2014 – Draft International Standard (DIS) – Ballot closes July 2015 – Final Draft International Standard (FDIS) – Ballot opens August 2015 – Final Draft International Standard (FDIS) – Ballot opens September 2015 – Target date for publication of International Standard (ISO

9001:2015)

Impact of the changes:

The impact of this revision will be similar to, if not greater than the 2000 edition, which was a major change for accreditation bodies, certification bodies, and training organizations, implementing organizations, procurement organizations, consultants and customers.

Organizations may have to align their management systems with the structure of the revised standard, for example:

1. As an example the organization’s quality manual may need to be amended. 2. A risk management processes may need to be developed to determine the

level and extent of control for “external provision of goods and services”, if not already in place. This will have implications for the organizations procurement and outsourcing activities and therefore has implications for suppliers.

3. Auditors will need to become familiar with the revised ISO 9001:2015 standard and so training may need to be considered.

4. Organizations seeking ISO 9000 family certification, will still need to be registered under the existing standard, which will have the normal 3 year period. However, those who are going to recertify after that date are going to be impacted. At this time, the major changes to the standard seem to emanate from the Annex SL (ISO 22301:2012) integrated/multiple standards requirements, so becoming familiar with those will be important, particularly if a business is going for integrated standards certification. The timing of recertification may also be a factor for some organizations, since there could be more effort required to update existing ISO 9001:2008 materials and processes. Organizations whose three year term is nearly up when the new standard is adopted may wish to accelerate their recertification.

These are just some of the possible effects on the organization but until the final version is published it will not be possible to definitively know the implications of revised requirements, put in place detailed plans for revising internal processes or procedures, or plan the arrangements for transition or certification to ISO 9001:2015.

The transition period is expected to be around three years as there are over one million registered ISO 9001 organizations worldwide. The revised ISO 9001:2015 standard should provide a stable set of requirements at its core for the next 10 years or more.

Changes in ISO 9001 Revision 2015 Committee Draft (CD): 1. The term "product" has been replaced by "goods and services". 2. Two new clauses related to the context of the organization: 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties. 3. The requirement to use the process approach has been more explicit by adding a new clause. 4.4.2 Process approach 4. The standard does not include a specific clause for "Preventive Actions". 5. The terms "document" and "records" have been replaced with the term "documented information". 6. Control of external provision of goods and services address all forms of external provisions. 7. The term "continual improvement" has been replaced with "improvement".

What is Changing in ISO 9001:2015 So Far?

While two years away from scheduled publication, initial drafts of the new ISO 9001:2015 standard, the emphasis appears to be in these specific areas and concepts from the existing standard:

Changes in structure for ISO 9001-2015, expanding the number of sections to ten from the current standard’s eight with additions for performance

management and evaluation (see chart below for comparison) which is said to help with future closer alignments among different standards through a new so called “Annex SL’ model” which provides a framework for drafting standards which can be applied concurrently (integrated management systems or multiple management systems) such as such as ISO 9001, ISO 14001, ISO 27001, or ISO 22301.

Movement away from classical corrective/preventative action approach to more of a general risk management model, perhaps as embodied in ISO’s own standard ISO 31000:2009, Risk management-Principles and Guidelines, although it’s not clear how much may be “borrowed” from that management standard.

Requiring systems which take into account the “context of the organization” which implies a broader measurement, planning and implementation view perhaps taking into account areas such as “sustainability” (energy use, materials procurement, environmental impact, etc.), “corporate social responsibility,” “organizational resilience,” and “organizational health.” (This latter element seems to incorporate areas relating to business continuity, perhaps from ISO 22301:2012 Societal security -- Business continuity management systems --- Requirements standard.

Movement from “documents” (ISO 9001:2008 Clause 4.2.3) and “records” (Clause 4.2.4) to “document information,” (Clause 9.2 of ISO 9001:2015 Committee draft) which seems to be more accepting of electronic documents and document control approaches. However, the new clause language which more generally “requires organizations to: Retain documented information as evidence of the implementation of the audit program and the audit results,” has opened up some discussion about it not mandating procedures as in the past.

There are other changes being considered such as replacing the term “product” replaced with “goods and services” and consolidating the previous ISO 9001:2008 standard into seven principles for ISO 9001:2015. The main change is dropping “Principle 5: System approach to management” because it is already a component of having a quality management system (QMS).

Section changes in ISO 9001:2015

Section Number Current Standard Sections Proposed Standard Sections

Section 1: Scope Scope

Section 2: Normative Reference Normative References

Section 3: Terms and Definitions Terms and Definitions

Section 4: General Requirements Context of the Organization

Section 5: Management Responsibility Leadership

Section 6: Resource Management Planning

Section 7: Product Realization Support

Section 8: Measurement, Analysis and Improvement

Operation

Section 9: Performance Evaluation

Section 10: Improvement

Tabulated comparison:

ISO 9001:2008 ISO 9001:2015 CD Remarks

0. Introduction 0. Introduction

1. Scope 1. Scope

2. Normative references 2. Normative references

3. Term and definitions 3. Terms and definitions

4. Quality Management System 4. Context of the organization

4.1 General Requirements 4.1 Understanding the organization and its context

4.2.2 Quality Manual - Quality Manual not required

4.2.3 Control of Documents 7.5 Documented Information

Records and Documents are now "Documented Information"

4.2.4 Control of Records 7.5 Documented Information

Records and Documents are now "Documented Information"

5. Management Responsibility 5. Leadership

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Planning 6. Planning

5.4.1 Quality Objectives

5.4.2 Quality Management System Planning

5.5 Responsibility, Authority, and Communication

5.5.1 Responsibility and Authority

5.5.2 Management Representative MR not required

5.5.3 Internal Communications

5.6 Management Review 9.3 Management Review

5.6.1 General

5.6.2 Review Input

5.6.3 Review Output

6. Resource Management 7. Support

6.1 Provision of Resources 7.1 Resources

6.2 Human Resources 7.2 Competence

6.2.1 General

6.2.2 Competence, Training, and Awareness

6.3 Infrastructure

6.4 Work Environment

7. Product Realization 8. Operation

7.1 Planning of Product Realization

7.2 Customer-Related Processes

7.2.1 Determination of Requirements Related to the Product

7.2.2 Review of Requirements Related to the Product

7.2.3 Customer Communication

7.3 Design and Development

7.3.1 Design and Development Planning

7.3.2 Design and Development Inputs

7.3.3 Design and Development Outputs

7.3.4 Design and Development Review

7.3.5 Design and Development Verification

7.3.6 Design and Development Validation

7.3.7 Control of Design and Development Changes

7.4 Purchasing

7.4.1 Purchasing Process

7.4.2 Purchasing Information

7.4.3 Verification of Purchased Product

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

7.5.2 Validation of Processes for

Production and Service Provision

7.5.3 Identification and Traceability

8.6.2 Identification and traceability

7.5.4 Customer Property

7.5.5 Preservation of Product 8.6.4 Preservation of goods and services

7.6 Control of Monitoring and Measuring Equipment

8. Measurement, Analysis, and Improvement

9. Performance evaluation

8.1 General

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

8.2.2 Internal Audit 9.2 Internal Audit

8.2.3 Monitoring and Measurement of Processes

8.2.4 Monitoring and Measurement of Product

8.3 Control of Nonconforming Product

8.4 Analysis of Data

8.5 Improvement 10. Improvement

8.5.1 Continual Improvement 10.2 Improvement Continual deleted

8.5.2 Corrective Action 10.1 Nonconformity and corrective action

Comparison between ISO 9001:2008 and ISO 9001:2015 Committee Draft (CD)

The latest update to ISO 9001 is underway, the first since ISO 9001:2008. But it is really the first major revision since ISO 9001:2000, which essentially consolidated three previous standards including ISO 9001, ISO 9002 and ISO 9003.

While still in the drafting stage (see enclosed time line for publication), this latest revision takes into account the vast changes in technology, business diversity and global commerce (which the ISO 9000 family and its spin-offs were created to support), including:

The growth of service businesses and their needs for quality management Recognition of the need to harmonize, integrate quality management into

overall business management systems, perhaps to serve as the basis of business management itself

Making it easier for companies to adopt multiple ISO series general business management standards such as ISO 14001 (environmental) and/or vertical standards such as AS9100

Helping to simplify the understanding of the standard, and make it easier (and more mandatory) to apply it more uniformly

The update/revision process is also supposed to keep the current focus on managing processes (as opposed to managing more specific program elements) as an effective method to gain a more repeatable pattern of success, and to remain more applicable to a wider array of enterprises. It is doing this to help make this standard revision more durable by "providing a stable core set of requirements for the next 10 years or more" even amid the increasingly changing business situations in which it must operate.

8.5.3 Preventive Action - No requirement related to PA

References

http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1633 http://drafts.bsigroup.com/Home/Details/5122

http://www.qualitygurus.net/dilemma/comparison-between-iso-90012008-and-iso-90012015-committee-draft-cd/

http://the9000store.com/what-is-iso-9001-2015.aspx#changing

http://www.iso-9001.biz/iso_9001_2008_changes.html

elsmar.com › ... › ISO 9001:2015 - Pre-Release Discussions

www.qualitydigest.com/inside/quality.../analysis-isodis-90012014.html

http://www.slideshare.net/talal953/summary-of-changes-between-iso-9001-2008-and-2015

http://www.aoq.org.au/DOC/Niavarani-ISO9001-290414.pdf http://www.iso9000conference.com/Resources/Documents/2014_ISOLSS%20Brochure.pdf