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ISO 9001:2015 Resources Index

Welcome to the Relevant Business Solutions ISO 9001:2015 resources. Here you will find detailed explanations and interpretations of the revised Quality Management System standard.

The layout is in a series of articles, written on a clause by clause basis, thereby making them easy to dip in and out of as required. No clause should be read in isolation however, so clickable links are provided to other appropriate sections of the standard in order to understand the overall context of the requirements.

The intent is not to prescribe a road map to certification, as every business is different, but rather to help organisations to understand the meaning and interpretation of the requirements, in order to carry out a meaningful gap analysis against their current processes and procedures.

The Relevant Business Solutions approach to Management Systems is always to put the needs of the business first, with certification as an output.  There are also however included in many of the articles, an “Audit Check” section. These are intended to help organisations updating existing management systems from the 2008 release, or implementing ISO 9001 compliant systems for the first time, to understand what auditors will be looking for in the way of evidence of compliance during an independent systems audit.  As the standard becomes more widely adopted and certification body interpretations are refined, we will update these sections as the data becomes available, so please feel free to share and bookmark this page and re-visit as often as you wish.

If you need further help or advice to climb your own businesses “certification mountain”, please feel free to get in touch via our contacts page as we can also offer a free initial on site consultation.

 

Good luck on your journey!

Dave Barker MCQI CQP

 

ISO 9001:2015 Resources Index


Section 1, 2 & 3. 

Introduction and Overview of the revised standard, including its scope, references and definitions.


4  Context of the organization

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


 5  Leadership

5.1  Leadership and commitment

5.2  Policy

5.3  Organizational roles, responsibilities and authorities


6  Planning 

6.1  Actions to address risks and opportunities

6.2  Quality objectives and planning to achieve them

6.3  Planning of changes


7 Support 

7.1.1, 7.1.2, 7.1.3, 7.1.4  Resources including General requirements, People, Infrastructure and Environment

7.1.5  Monitoring and measuring resources

7.1.6  Organizational knowledge

7.2  Competence

7.3  Awareness

7.4  Communication

7.5.1  Documented information – General

7.5.2  Documented information – Creating and updating

7.5.3  Documented information – Control


8 Operation 

8.1  Operational planning and control

8.2.1, 8.2.2, 8.2.3, 8.2.4  Determining and review of the requirements for products and services including changes and customer communication

8.3.1, 8.3.2  Design and development of products and services

8.3.3  Design and development inputs

8.3.4  Design and development controls

8.3.5  Design and development outputs

8.3.6  Design and development changes

8.4.1  Control of externally provided products and services – General

8.4.2  Type and extent of control of externally provided processes

8.4.3  Information for external providers

8.5.1  Control of production and service provision

8.5.2  Identification and traceability

8.5.3  Property belonging to customers or external providers

8.5.4  Preservation

8.5.5  Post-delivery activities

8.5.6  Control of changes

8.6  Release of products and services

8.7  Control of nonconforming outputs


 9 Performance evaluation 

9.1  Monitoring, measurement, analysis and evaluation – General

9.1.2  Customer satisfaction

9.1.3  Analysis and evaluation

9.2  Internal audit

9.3.1, 9.3.2  Management review including General requirements, Inputs and Outputs


 10 Improvement 

10.1  Improvement – general

10.2  Nonconformity and corrective action

10.3  Continual improvement

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