6/19/2019 ISO 9001:2008 vs ISO 9001:2015 - Quality Handbook - Quality Gurus

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ISO 9001:2008 vs ISO 9001:2015
Created by Sandeep Kumar
Last updated Jan 25, 2017

ISO 9001:2015

ISO 9001:2015 was released 23 September 2015.

Following are the key changes in this standard from ISO 9001:2008:

1. New Structure

The new standard has 10 clauses .

ISO is in process of harmonizing all management system standards. For this a harmonized structure (Annex SL) has
been developed. Some standards such as ISO 30301:2011 (Information and documentation – Management
systems for records), ISO 22301:2012 (Societal security – Business continuity management systems), ISO
20121:2012 (Event sustainability management systems) have already been changed to this new structure and some
other are in process of being revised to this new structure.

2. Process Approach

ISO 9001:2015 promotes the process approach beyond the existing requirements of ISO 9001:2008. Clause 4.4
(Quality management system and its processes) provides specific requirements for adopting a process approach.
 

3. Preventive Action vs Risk Management

One of the key purpose of implementing a quality management system is to act as a preventive tool. As a result
the formal requirement related to preventive action is no more existing in the revised standard. This is being
replaced with risk based thinking.

Although it is required by the organization to determine and address risks, there is no requirement for
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implementing a formal risk management process.

4. Context of the Organization

Two new clauses have been added to the standard.

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

5. Quality Management Principles

So far the standard was based on eight quality management principles. In this standard the earlier existing eight
principles have been reduced to seven quality management principles . These are listed in the clause 0.2 of the

standard.

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6. Products and Services:

In 2008 version of the standard the term "product" was used. This term also included services. In the Committee
Draft issued in June 2013, this term was proposed to be changed to "Goods and Services". In the final standard the
term used is "Products and Services".

7. Documented Information:

2008 version of the standard had two separate terms: "documents" and "records". In the revised standard it was
combined together and called "documented information".

Annex A of the standard clarifies that where ISO 9001:2008 would have referred to documented procedures, it is
now expressed as a requirement to maintain documented information.
Documented procedures in ISO 9001:2008 = Maintain documented information in ISO 9001:2015

And where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain
documented information.
Records in ISO 9001:2008 = Retain documented information in ISO 9001:2015

8. No Exclusions:

ISO 9001:2008 version allows organizations to exclude the standard requirements under the following conditions:
Exclusions are allowed for the requirements which can not be applied due to the nature of the business.
Exclusions are limited to clause 7 (Product Realization)of the standard.
Such exclusions do not affect the organization's ability to provide products which meet the customer
requirements and also the applicable legal requirements.

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The new standard does not make any reference to exclusions. However in Annex A, the standard clarifies that the
organization can not decide a requirement to be not applicable if it falls under the scope of its QMS. Also non-
applicability is not allowed if that could lead to failure to achieve the conformity or to enhance customer
satisfaction.

9. Work Environment:

The term "work environment" used in ISO 9001:2008 has been replaced with "Environment for the operation of
processes".

10. Purchased Product:

The term "purchased product" has been replaced with "externally provided products and services".

11. Supplier

The term "supplier" has been replaced with "External provider".

This does not meet that organizations would need to change this term in their QMS as well. Organizations can still
maintain the term "supplier", "vendor", "contractor", "consultant" etc. as per their own need.

Comparison between ISO 9001:2008 and ISO 9001:2015

ISO 9001:2008 ISO 9001:2015 Remarks

0. Introduction 0. Introduction

1.1 General 1 Scope

1.2 Application 4.3 Determining the scope of the

quality management system

2. Normative references 2 Normative references

3. Terms and definitions 3 Terms and definitions

4. Quality Management System 4 Context of the organization

4.1 General Requirements 4.4 Quality management system and

its processes

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4.2 Documentation Requirements 7.5 Documented information Reduced requirements for

documentation

4.2.1 General 7.5.1 General

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 5.1 Leadership and commitment

5.2 Customer Focus 5.1.2 Customer focus

5.3 Quality Policy 5.2 Policy

5.4 Planning 6 Planning

5.4.1 Quality Objectives 6.2 Quality objectives and planning

to achieve them

5.4.2 Quality Management 6.3 Planning of changes

System Planning

5.5 Responsibility, Authority, and 5.3 Organizational roles,

Communication responsibilities and authorities

5.5.1 Responsibility and Authority 5.3 Organizational roles,

responsibilities and authorities

5.5.2 Management - MR not required

Representative

5.5.3 Internal Communications 7.4 Communication

5.6 Management Review 9.3 Management Review

5.6.1 General 9.3.1 General

5.6.2 Review Input 9.3.2 Management Review Inputs

5.6.3 Review Output 9.3.3 Management Review Outputs

6. Resource Management 7.1 Resources

6.1 Provision of Resources 7.1 Resources

6.2 Human Resources 7.1.2 People

6.2.1 General 7.2 Competence

6.2.2 Competence, Training, and 7.2 Competence and 7.3 Awareness

Awareness

6.3 Infrastructure 7.1.3 Infrastructure

6.4 Work Environment 7.1.4 Environment for the operation

of processes

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7. Product Realization 8 Operation

7.1 Planning of Product 8.1 Operational planning and control

Realization

7.2 Customer-Related Processes 8.2 Requirements for products and

services

7.2.1 Determination of 8.2.2 Determining of requirements

Requirements Related to the related to products and services
Product

7.2.2 Review of Requirements 8.2.3 Review of requirements related

Related to the Product to products and services

7.2.3 Customer Communication 8.2.1 Customer communication

7.3 Design and Development 8.3 Design and development of

products and services

7.3.1 Design and Development 8.3.2 Design and development

Planning planning

7.3.2 Design and Development 8.3.3 Design and development inputs

Inputs

7.3.3 Design and Development 8.3.5 Design and development

Outputs outputs

7.3.4 Design and Development 8.3.4 Design and development

Review controls

7.3.5 Design and Development 8.3.4 Design and development

Verification controls

7.3.6 Design and Development 8.3.4 Design and development

Validation controls

7.3.7 Control of Design and 8.3.6 Design and development

Development Changes changes

7.4 Purchasing 8.4 Control of externally provided

processes, products and services

7.4.1 Purchasing Process 8.4.1 General

7.4.2 Purchasing Information 8.4.3 Information for external

providers

7.4.3 Verification of Purchased 8.4.2 Type and extent of control and

Product 8.6 Release of products and services

7.5 Production and Service 8.5 Production and service provision

Provision

7.5.1 Control of Production and 8.5.1 Control of production and

Service Provision service provision

7.5.2 Validation of Processes for 8.5.1 Control of production and

Production and Service Provision service provision

7.5.3 Identification and 8.5.2 Identification and traceability

Traceability

7.5.4 Customer Property 8.5.3 Property belonging to

customers or external providers

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7.5.5 Preservation of Product 8.5.4 Preservation

7.6 Control of Monitoring and 8.5.1 Control of production and

Measuring Equipment service provision

8. Measurement, Analysis, and 9.1 Monitoring, measurement,

Improvement analysis and evaluation

8.1 General 9.1.1 General

8.2 Monitoring and 9.1.1 General

Measurement

8.2.1 Customer Satisfaction 9.1.2 Customer satisfaction

8.2.2 Internal Audit 9.2 Internal Audit

8.2.3 Monitoring and 9.1.3 Analysis and evaluation

Measurement of Processes

8.2.4 Monitoring and 8.6 Release of products and services

Measurement of Product

8.3 Control of Nonconforming 8.7 Control of nonconforming

Product outputs

8.4 Analysis of Data 9.1.3 Analysis and evaluation

8.5 Improvement 10 Improvement

8.5.1 Continual Improvement 10.3 Continual improvement Continual deleted in CD, but is
back in the revised standard

8.5.2 Corrective Action 10.2 Nonconformity and corrective

action

8.5.3 Preventive Action 6.1 Actions to address risks and PA is being replaced with risk
opportunities based thinking

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