# 02 - A SYNOPSIS ON ISO 9001:2015 - What is the approach of ISO 9001:2015?

# 02 - A SYNOPSIS ON ISO 9001:2015

What is the approach of ISO 9001:2015?

Instead of certifying the end product or service, ISO 9001:2015 focuses on the system having the process approach and PDCA by which the product or service is produced. The framework underlying ISO 9001:2015 QMS is intended to provide assurance to customers that the product or service they receive from the organization will be consistent in the way in which it addresses enhancement of customer satisfaction. ISO 9001:2015 QMS is based on seven quality management principles, namely customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making and relationship management. ISO 9001:2015 provides a strong base for the effective application of the system. Designing and implementing a system as per ISO 9001:2015 QMS standard can result in more satisfied customers and more productive staff.

- Keshav Ram Singhal

# 01 - A SYNOPSIS ON ISO 9001:2015 - What does ISO 9001:2015 offer?

# 01 - A SYNOPSIS ON ISO 9001:2015

What does ISO 9001:2015 offer?

ISO 9001:2015 offers some important benefits:
- A single standard applicable to all organizations, regardless of their type or size, or the products and services they provide,
- An internationally consistent standard that supports global trade,
- An standard that requires meeting customer requirements,
- An standard that requires meeting applicable legal requirements,
- An standard that facilitates opportunities to enhance customer satisfaction,
- An standard that addresses risks and opportunities to achieve improved results and preventing negative effects,
- An standard that supports process approach and PDCA
- An opportunity for continual improvement

ISO 9001:2015 can help an organization to improve its overall performance and provide a sound basis for sustainable development initiatives.

ISO 9001:2015 standard can be used by internal and external parties, so an objective third-party verification of the system provides confidence to the organization and its interested parties including customers.

ISO 9001:2015 standard provides a strong base on which an organization can build TQM culture with focus on the customer involving all employees and carrying out continual improvement.

- Keshav Ram Singhal

OPERATION PLANNING AND CONTROL IN ISO 9001:2015 QMS

OPERATION PLANNING AND CONTROL IN ISO 9001:2015 QMS


Operation is the action of functioning of the organization to achieve its objectives.

Clause 8.1 of the standard stipulates requirements to plan, implement and control the operation processes necessary to meet the requirements for organization's products and services, and also consider the actions determined while addressing risks and opportunities, quality objectives and planning of changes as mentioned in clause 6 . Clause 4.4 of the standard also states to determine and implement processes needed for the quality management system. Most of the requirements mentioned in clause 4.4 of the standard support the requirements of clause 8.1.

In order to meet the requirements of clause 8.1, organizations are required to
- plan, implement and control processes,
- implement actions determined (i) to address risks and opportunities, (ii) to achieve quality objectives, and (iii) need for changes,
- determine requirements for products and services,
- establish the criteria for evaluating the processes in order to ensure that organization's processes are performing as expected and producing the intended outputs,
- establish the criteria for acceptance of products and services, so that products and services produced are further checked for meeting requirements for products and services,
- determine the resources needed in order to support operation,
- implement control as per established criteria (during in-process monitoring and measurement and final inspection, monitoring and measurement of the output of the process that may include inspection, test activities etc.,
- control changes planned and outsource processes, if any,
- review consequences of unintended changes and take necessary action to mitigate any adverse effect,
- determine documented information to maintain and retain to the extent necessary, maintain as determined and retained as determined.

What documented information can be determined to maintain?

Although the standard has left this on the organization to determine, however it is suggested to maintain documented information for organization's operational processes, procedures, product/service specifications, work instructions, monitoring and measurement criteria, workflow chart etc., to ensure desired results.

Outsourced processes

Outsourced processes needs to be controlled. In this regard requirements mentioned in clause 8.4 are relevant.


- Keshav Ram Singhal

For details on the Training Handbook on 'ISO 9001:2015 QMS Awareness', please CLICK HERE.

For details on 'Checklist for ISO 9001:2015 QMS', please CLICK HERE.

For Preview of Training Handbook on ISO 9001:2015 QMS Awareness for Management/Engineering Students, please CLICK HERE.

Preview of Training Handbook on ISO 9001:2015 QMS Awareness for Management / Engineering Students

To see the Preview, please CLICK HERE.

TRAINING HANDBOOK ON 'ISO 9001:2015 QMS AWARENESS' FOR MANAGEMENT / ENGINEERING STUDENTS

TRAINING HANDBOOK ON 'ISO 9001:2015 QMS AWARENESS' FOR MANAGEMENT / ENGINEERING STUDENTS

Trainer, Editor and Publisher
KESHAV RAM SINGHAL

Contents

# 01 - An introduction on 'ISO 9001:2015 QMS Awareness' Training to Management / Engineering Students
# 02 - Introduction - Historical background, Standard Development Timeline for ISO 9001:2015
# 03 - Overview of ISO 9001:2015 - Foreword, Introduction, QMS - Requirements Clauses, Scope, Normative references, Terms and definitions
# 04 - Understanding requirements of ISO 9001:2015 QMS standard - Context of the organization (Clause 4), Leadership (Clause 5), Planning (Clause 6), Support (Clause 7), Operation (Clause 8), Performance evaluation (Clause 9), Improvement (Clause 10)
# 05 - Transition Planning
# 06 - Developing and Implementing ISO 9001:2015 QMS
# 07 - ISO 9001:2005 - Quality Management Principles
# 08 - Post-training Test

To see the Preview of the Handbook, please send an email to keshavsinghalajmer@gmail.com.

CREATING AND DEVELOPING A PROCEDURE

Article - Creating and developing a procedure

CREATING AND DEVELOPING A PROCEDURE

ISO 9000:2015 standard defines the term 'procedure'. A procedure is a specified way to: (i) carry out an activity, or (ii) carry out a process that means carry out a set of interrelated or interacting activities that use inputs to deliver an intended result.

A procedure can be written (documented) or not. When a procedure is written (documented), it is usually referred to as a 'documented procedure'.

A documented procedure usually has the following description:
- Title,
- Document number,
- Reference,
- Cross-reference,
- Purpose,
- Scope,
- Responsibility - Who will do what,
- Procedure details - When, where and how to do,
- What resources (materials, equipment, document) will be used,
- How the activity or process will be controlled,
- How to retain documented information for the activity or process carried out

Steps to create and develop a procedure

Step 1 - Determine the need to create and develop a procedure.
Step 2 - Assign responsibility to someone to develop and write the procedure.
Step 3 - The author should - (i) establish the scope of the procedure, (ii) collect and document (write) all relevant information.
Step 4 - The author should prepare a draft by using a simple and easily understood language.
Step 5 - The author or QMSC should circulate the draft to persons concerned to obtain their comments.
Step 6 - The author should incorporate changes (modifications and additions) to the draft and prepare a final draft.
Step 7 - The author or QMSC should submit the final draft to the authority for approval for adequacy prior to issue.
Step 8 - The QMSC should issue the documented procedure for implementation.
Step 9 - Review of the procedure should be done after its implementation for some time (say three to six months) and amend/revise the procedure.
Step 10 - When you observe that the procedure is no longer useful, withdraw the procedure with information to persons and departments concerned.

QMSC = QMS Coordinator
QMS = Quality management system

- Keshav Ram Singhal


For details on the Training Handbook on 'ISO 9001:2015 QMS Awareness', please CLICK HERE.

For details on 'Checklist for ISO 9001:2015 QMS', please CLICK HERE.

Context of the organization - Determining external and internal issues

Context of the organization - Determining external and internal issues

Please read my earlier blog posts in this regard.

I designed a format for this purpose that may be useful.



Thanks,

Keshav Ram Singhal

Build A Risk Culture In Your Organization

Build A Risk Culture In Your Organization

If you wish to build a risk culture, organize a 'Building A Risk Culture Awareness' program (lecture series) in your organization and motivate all employees to answer the question 'What can go wrong at my desk/job function?' Compile information and address all relevant risk issues. This will facilitate in building a risk culture.

Risk-based thinking must be adopted in every organization.

Decision making should be on the basis risk-based thinking. Define unacceptable to desired in every process. Identify and critically prioritize the mechanisms that can influence the behaviour of employees to adopt risk-based thinking. Enforce risk-based thinking in the organization's activities as usual activities. Leaders (top management) need to continually live and breathe the risk-based culture values.

All the best,

Keshav Ram Singhal

ISO published 'Guidance for SMEs wishing to implement ISO 9001:2015 QMS'

ISO published 'Guidance for SMEs wishing to implement ISO 9001:2015 QMS'

International Organization for Standardization (ISO) has published its guidance handbook 'ISO 9001:2015 for Small Enterprises - What to do?' for SME’s wishing to implement ISO 9001:2015 QMS. The guidance handbook includes practical advice and concrete examples tailored specifically for small businesses.

The handbook is written by a group of experts from ISO/TC 176/SC 2, the technical subcommittee that developed ISO 9001:2015 QMS standard. The handbook includes useful information on everything from how to get started right through to guidance for those who choose to seek certification. It includes practical advice on the different ways of approaching a quality management system (QMS) as well as detailed guidance on each clause of ISO 9001:2015 standard.

The handbook can be purchased from national ISO member (BIS in India) or from the ISO Store. For more information, please visit ISO Website.

- Keshav Ram Singhal

ISO published ISO/TS 9002:2016 - Guidelines for application of ISO 9001:2015

ISO News -

ISO published ISO/TS 9002:2016 - Guidelines for application of ISO 9001:2015

International Organization for Standardization (ISO) has published ISO/TS 9002:2016 that has been developed to assist users to apply ISO 9001:2015 QMS standard's requirements.

The title of ISO/TS 9002:2016 is Quality management systems - Guidelines for the application of ISO 9001:2015. This technical specification document provides guidance on each clause of ISO 9001:2015 QMS standard. This document also provides examples of what an organization can do. The examples in this document are not definitive and only represent possibilities, not all of which are necessarily suitable for every organization.

ISO 9001:2015 QMS standard contains requirements that can be objectively audited or evaluated. ISO/TS 9002:2016 does not provide any additional requirements, but ISO/TS 9002:2016 includes examples, descriptions and options that aid both in the implementation of a quality management system and in strengthening its relation to the overall management system of an organization. While the guidelines in this document are consistent with the ISO 9001:2015 quality management system model, they are not intended to provide interpretations of the requirements of ISO 9001:2015 QMS standard or be used for audit or evaluation purposes.

As the requirements of ISO 9001:2015 QMS standard are generic, this document can be used by organizations of all types, sizes, levels of maturity and in all sectors and geographic locations. However, the way an organization applies the guidance can vary based on factors such as the size or the complexity of the organization, the management model it adopts, the range of the organization’s activities and the nature of the risks and opportunities it encounters.

ISO/TS 9002:2016 document can be purchased from national ISO member (BIS in India) or from the ISO Store. For more information, please visit ISO Website.


- Keshav Ram Singhal