Comparison between ISO 9001:2008 and 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.

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 implementing a formal risk management process.

4. Context of the Organization:

Two new clauses have been added to the standard.
o 4.1 Understanding the organization and its context
o 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.

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.

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 Comparison between ISO 9001:2008 and ISO 9001:2015

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:

o Exclusions are allowed for the requirements which cannot be applied due to the
nature of the business.
o Exclusions are limited to clause 7 (Product Realization) of the standard.
o Such exclusions do not affect the organization's ability to provide products which
meet the customer requirements and also the applicable legal requirements.

The new standard does not make any reference to exclusions. However, in Annex A, the
standard clarifies that the organization cannot 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"

Note: 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

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 Comparison between ISO 9001:2008 and ISO 9001:2015

Clause based 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
4.3 Determining the scope of the
1.2 Application 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
4.4 Quality management system
4.1 General Requirements and its processes
4.2 Documentation Reduced requirements for
Requirements 7.5 Documented information documentation
4.2.1 General 7.5.1 General
Quality Manual not
4.2.2 Quality Manual - required

Records and Documents

are now "Documented
4.2.3 Control of Documents 7.5 Documented Information Information
Records and Documents
are now "Documented
4.2.4 Control of Records 7.5 Documented Information 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
6.2 Quality objectives and
5.4.1 Quality Objectives planning to achieve them
5.4.2 Quality Management
System Planning 6.3 Planning of changes
5.5 Responsibility, Authority, 5.3 Organizational roles,
and Communication responsibilities and authorities
5.5.1 Responsibility and 5.3 Organizational roles,
Authority responsibilities and authorities
5.5.2 Management
Representative - MR not required
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
9.3.3 Management Review
5.6.3 Review Output Outputs

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 Comparison between ISO 9001:2008 and ISO 9001:2015

ISO 9001:2008 ISO 9001:2015 Remarks

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, 7.2 Competence and 7.3
and Awareness Awareness
6.3 Infrastructure 7.1.3 Infrastructure
7.1.4 Environment for the
6.4 Work Environment operation of processes
7. Product Realization 8 Operation
7.1 Planning of Product 8.1 Operational planning and
Realization control
7.2 Customer-Related 8.2 Requirements for products
Processes and services
7.2.1 Determination of
Requirements Related to the 8.2.2 Determining of requirements
Product related to products and services
7.2.2 Review of Requirements 8.2.3 Review of requirements
Related to the Product related to products and services
7.2.3 Customer
Communication 8.2.1 Customer communication
8.3 Design and development of
7.3 Design and Development 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
8.4 Control of externally provided
7.4 Purchasing processes, products and services
7.4.1 Purchasing Process 8.4.1 General
8.4.3 Information for external
7.4.2 Purchasing Information providers
8.4.2 Type and extent of
7.4.3 Verification of Purchased control and 8.6 Release of
Product products and services

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 Comparison between ISO 9001:2008 and ISO 9001:2015

ISO 9001:2008 ISO 9001:2015 Remarks

7.5 Production and Service 8.5 Production and service
Provision provision
7.5.1 Control of Production 8.5.1 Control of production and
and Service Provision service provision
7.5.2 Validation of Processes
for Production and Service 8.5.1 Control of production and
Provision service provision
7.5.3 Identification and 8.5.2 Identification and
Traceability traceability
8.5.3 Property belonging to
7.5.4 Customer Property customers or external providers
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
Measurement 9.1.1 General
8.2.1 Customer Satisfaction 9.1.2 Customer satisfaction
8.2.2 Internal Audit 9.2 Internal Audit
8.2.3 Monitoring and
Measurement of Processes 9.1.3 Analysis and evaluation
8.2.4 Monitoring and 8.6 Release of products and
Measurement of Product services
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
Continual deleted in CD,
but is back in the revised
8.5.1 Continual Improvement 10.3 Continual improvement standard
10.2 Nonconformity and
8.5.2 Corrective Action corrective action
6.1 Actions to address risks and PA is being replaced with
8.5.3 Preventive Action opportunities risk-based thinking

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 Comparison between ISO 9001:2008 and ISO 9001:2015

Mandatory documents and records required by ISO

9001:2015

Here are the documents an organisation need to produce if it wants to be compliant with ISO
9001:2015.

Type Description of Document Clause (ISO9001:2105)

Document Scope of the QMS 4.3
Document Quality policy 5.2
Document Quality objectives 6.2
Criteria for evaluation and selection of suppliers 8.4.1
Record Records of training, skills, experience and qualifications 7.2
Record Product/service requirements review records 8.2.3.2
Record Characteristics of product to be produced and service to 8.5.1
be provided
Record Records about customer property 8.5.3
Record Production/service provision change control records 8.5.6
Record Record of conformity of product/service with acceptance 8.6
criteria
Record Record of nonconforming outputs 8.7.2
Record Monitoring and measurement results 9.1.1
Record Internal audit program 9.2
Record Results of internal audits 9.2
Record Results of the management review 9.3
Record Results of corrective actions 10.1

Mandatory records only if process not excluded

(Please note that these documents will not be mandatory if the company does not perform
relevant processes.)

Record Monitoring and measuring equipment calibration records* 7.1.5.1

Record Record about design and development outputs review* 8.3.2
Record Records about design and development inputs* 8.3.3
Record Records of design and development controls* 8.3.4
Record Records of design and development outputs * 8.3.5
Record Design and development changes records* 8.3.6

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 Comparison between ISO 9001:2008 and ISO 9001:2015

Non-mandatory documents

There are numerous non-mandatory documents that can be used for ISO 9001 implementation.
However, I find these non-mandatory documents to be most commonly used:

Type Description of Document Clause (ISO9001:2105)

Procedure Determining context of the organization and 4.1 and 4.2
interested parties
Procedure Addressing risks and opportunities 6.1
Procedure Competence, training and awareness 7.1.2, 7.2 and 7.3
Procedure Equipment maintenance and measuring 7.1.5
equipment
Procedure Document and record control 7.5
Procedure Sales procedure 8.2
Procedure Design and development 8.3
Procedure Production and service provision 8.5
Procedure Warehousing control 8.5.4
Procedure Management of nonconformities and 8.7 and 10.2
corrective actions
Procedure Monitoring customer satisfaction 9.1.2
Procedure Internal audit 9.2
Procedure Management review 9.3

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