ISO 9001:2015 Intro

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ISO 9001:2015

University of Nairobi ISO 9001:2008 1 Certified http://www.uonbi.ac.ke

• The ISO 9001:2015 standard was published in September 2015

• ISO has developed a common Higher Level Structure (HLS) for management system standards

• All management system standards will use a consistent structure, common text and terminology

• Some revised and new standards have already implemented this requirement e.g. • ISO 27001:2013 Information Security Management Systems

• ISO 55001:2014 Asset Management Standard

Intro


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• There is a transition period of 3 years for full compliance

• For the University, the transition will involve Sensitization across the entire University

Revision of the University QMS

Implementation of the Revised QMS

Recertification by KEBS

Transition


• ISO 9001:2015 standard is constructed around seven principles:

1. Customer Focus

2. Leadership

3. Engagement of People

4. Process Approach

5. Improvement

6. Evidence-based Decision Making

7. Relationship Management

Quality Management Principles


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ISO 9001:2008 ISO 9001:2015

Products Products and services

Documentation, quality manual, documented procedures, records, instructions

Documented information

Work environment Environment for the operation of processes

Monitoring and measuring equipment

Monitoring and measuring resources

Purchased product Externally provided products and services

Supplier External provider

Different Terminology


0. Introduction

1. Scope

2. Normative Reference

3. Terms and Definitions

4. Context of the Organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance Evaluation

10. Improvement

Organization of ISO 9001:2015


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• The first three clauses in ISO 9001:2015 are largely the same as those in ISO 9001:2008.

• The last seven clauses are now arranged according to the PDCA cycle (Plan, Do, Check, Act). The following figure shows this.

Organization of Clauses


• ISO 9001:2015 has ten clauses instead of eight

9001:2015 Vs 9001:2008 Clauses


ISO 9001:2008 ISO 9001:2015

0. Introduction 0. Introduction

1. Scope 1. Scope

2. Normative reference 2. Normative reference

3. Terms and definitions 3. Terms and definitions

4. Quality management system 4. Context of the organization

5. Management responsibility 5. Leadership

6. Planning

6. Resource management 7. Support

7. Product realisation 8. Operation

8. Measurement, analysis and improvement 9. Performance evaluation

10. Improvement

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4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality management system

4.4 Quality management system and its processes

Clause 4 - Context of the Organization


• ISO 9001:2015 requires an organization to construct its quality management system from the specific context within which it is active.

• Internal and External Issues Key economic and market development

Technological innovations and developments

Regulatory developments

Political and other instabilities

Organizational culture and attitudes

Context of the Organization


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• In ISO 9001:2008, customers were often named as being the only interested party. This concept has been extended in ISO 9001:2015.

• Interested parties include Employees

Contractors

Clients/Customers

Suppliers

Regulators

Shareholders

Neighbours

Society

NGOs

Engagement of Interested Parties


5.1 Leadership and commitment

5.2 Policy

5.3 Organizational roles, responsibilities and authorities

Clause 5 - Leadership


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• Clause 5 contains much familiar content, but with greater emphasis on leadership and commitment and the expectation that top management will be more actively engaged with the quality management system

• The intention is to encourage integration and harmonization with business processes and business strategies. The top management now has to take more responsibility for the effectiveness of the quality management system

• The specific role of a Management Representative has been removed – the standard still contains all of the key activities and responsibilities but these now lie more directly within the core structure of the organization - including top management

Leadership and Commitment


6.1 Actions to address risks and opportunities

6.2 Quality objectives and planning to achieve them

6.3 Planning of changes

Clause - 6 Planning


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• Clause 6 is an excellent addition to ISO 9001:2015, introducing the concept of risk (and opportunity) via the HLS

• Organization are now strongly encouraged to use risk analysis in order to identify challenges in the management of business processes

• Formal risk analysis, using various familiar techniques, is now standard for every organization

• To emphasize their dominance, the concept of ’risk’ occurs forty-eight times in ISO 9001:2015, compared with only three times in ISO 9001:2008

• The addition of risk-based thinking has made the ‘preventive measures’ of ISO 9001:2008 redundant

Risk-based Thinking


7.1 Resources

7.2 Competence

7.3 Awareness

7.4 Communication

7.5 Documented information

Clause 7 - Support


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• Clause 7 gathers together in one place all the areas relating to the “people, place and procedural” aspects of the QMS

• The main intention behind the generalization of ‘resources’ requirement is that the people working within the QMS are competent to fulfill their duties, supported by equipment and infrastructure that is fit for purpose

• The work environment of an organization has many human and physical factors

• The organization must determine what monitoring and measuring has to be undertaken.

• Regular calibration and maintenance is one way to provide confidence that results are reliable

• Evidence of compliance should be available via retained documented information

Support


• ISO 9001:2015 no longer requires mandatory documented procedures or a quality manual. This is now referred to as ‘documented information’ in practically all clauses

• It is up to the organization to decide what is needed

• There is no longer any mention of ‘records’ but of ‘retaining documented information’, on a number of occasions

• There is some logical broadening to encompass electronic and web-based environments

• Documented information can be in diverse forms as long as it provide appropriate evidence to demonstrate compliance

Documented Information


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8.1 Operational planning and control

8.2 Requirements for products and services

8.3 Design and development of products and services

8.4 Control of externally provided processes, products and services

8.5 Production and service provision

8.6 Release of products and services

8.7 Control of nonconforming outputs

Clause 8 - Operation


• Clause 8 is basically represents the production and operational control parts of the standard

• There are a significant number of clauses added to the basic HLS

Operation


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9.1 Monitoring, measurement, analysis and evaluation

9.2 Internal audit

9.3 Management review

Clause 9 - Performance evaluation


10.1 General

10.2 Nonconformity and corrective action

10.3 Continual improvement

Clause 10 - Improvement


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• Clause 10 provides an overview of what improvement means in the context of ISO 9001:2015 – an overall approach requiring review of processes, products and services and QMS results

• Mechanisms for such improvements can be achieved by a variety of means: correction, corrective action, continual improvement, breakthrough change, innovation and reorganization

Improvement


•A number of activities within proposed period

March 2016 to March 2017

Sensitization at various levels

Revision of the University QMS

Training and awareness at various levels

Implementation of the Revised QMS

Recertification by KEBS

Way Forward


ISO 9001:2015 Intro

Documents

Transcript of ISO 9001:2015 Intro