ISO 9001:2015 – A reality check by an ISO 9001 Consultant

ISO 9001:2015 – A reality check by an ISO 9001 Consultant

“ISO 9001”, “ISO 9001 Auditor”, “ISO 9001 Certificate”…

These are the most common terms which you might have heard within your surroundings. What is in your mind about ISO 9001? Have you understood it or still have some misconception? Let me luxate your current understanding and enhance your knowledge.

I am new to ISO 9001:2015? Really???

You may have the first question, what is ISO 9001 all about?

ISO 9001 is the international standard that describe requirements for a quality management system (QMS). Companies like yours, can implement QMS, to express the ability to provide products and services that meet customer and regulatory requirements.

It is the most generic standard for certification, comprising of the minimum best practices to run an effective organisation.

There are over one million companies and organisation in over 170 countries certified to ISO 9001. Are you one of them? If yes, then think about this, “Is your implemented system delivering the expected results?” “Do you have best ever work culture and concrete system in place?” Ok! But I have something for you which will definitely drive you toward.

So what is next? Why should I go for it?

The problem with many of the firms is that they’re looking for a short-term payoff. Isn’t it? Short term gains cannot ignore the long-term benefits. Many companies are demanding ISO 9001:2015 certification to qualify as their supplier. Check, whether your customer is wanting you to get certified? Deprived of implementing ISO 9001:2015, your workforce will not have tools to do their work effectively and expect good performance. ISO 9001:2015 hold you to become competent and grow in a qualitative way to sustain business.

Are you facing performance issues like?

  • Rejection/rework rate,
  • Material and time losses,
  • Customer complaints,
  • Setup cost etc.?

Or facing behavioral issues like,

  • Poor work culture,
  • High attrition rate,
  • Fail to tapping full potential of resources,
  • Poor communication etc.?
  • Do you have your process non-standardised and adhoc?

Then this is the best time to go for practical implementation ISO 9001:2015. Consider ISO 9001:2015 certification as a value adding proposition with the best ISO 9001:2015 consultants, instead of, a mere customer requirement.

Am I eligible? Yes…

You may thinking if it applicable to your organisation or not? Yes, ISO 9001:2015 does apply to any organisation who are,

  • Seeking sustained success,
  • Seeking confidence in their supply chain.
  • Performing conformity assessment against the requirements of ISO 9001:2015 and
  • Aiming to improve performance
  • Achieve Operational Excellence or business excellence, using lean concepts

The requirements of ISO 9001:2015 are applicable to both production and service based industry. The standard will let you put in place the minimum necessary requirements.

Want to unfold structure? Let’s do it.

The new ISO 9001:2015 is framed into High Level Structure (HLS). ISO believes that this communal approach will surge the value of such standards to users. I hope you are aware about PDCA or deming cycle. Not? Don’t worry. Let me brief it to you. The plan–do–check–act cycle is a four–step model for carrying out change. As said, it’s a cycle, so it has no end, the PDCA cycle should be repeated again and again for continuous improvement. Plan-Do-Check-Act (PDCA) is the operational principle of ISO 9001. It’s applied to all processes and the QMS as a whole. The ISO 9001 requirements are generally alienated into sections which are called clauses. Clause one to three include no requirements. but instead deal with the scope of the standard, and terms and definitions. Seven of which comprises compulsory requirements for a QMS:

  • Context of the organization (Clause-4),
  • Leadership (Clause-5),
  • Planning (Clause-6),
  • Support (Clause-7),
  • Operation (Clause-8),
  • Performance evaluation (Clause-9) and
  • Improvement (Clause-10).

What is novel in it? Revealing the secret!

If you already certified with previous ISO 9001:2008, then you may thinking that why should I go for ISO 9001:2015? Or what NEW is being incorporated in this latest ISO 9001:2015? No doubt, there are few interesting concepts are there in latest 9001:2015 edition. Let’s understand all them. I am sure you will like it.

As compare to ISO 9001:2008, the new ISO 9001:2015 has various new and important concepts in it. Which help organization to evolve and establish a concrete quality management system. The concept of risk-based thinking has been implicit in earlier editions of ISO 9001:2015.

One of the key purpose of a quality management system is to act as a preventive tool. The concept of preventive action is stated through the use of risk-based thinking in framing QMS requirements. Concept of interested party is also adopted in newer version. It means that any person or organisation that can affect, be affected by or perceive itself to be affected by a decision or activity.

But what is there in ISO 9001:2015? Summary of Clauses!

Clause 4: Context of the Organisation

Set a clear vision for your organisation.

This clause requires to consider various internal and external issues and interested party needs & expectations, to achieve organisation’s strategic goal.

It could be difficult to plan your business process without understanding the interested party needs and expectations. Understanding context of your organisation in a comprehensive manner will help you know your strategic goals and the risks involved, therein.

Clause 5: Leadership

Leadership makes or breaks, system. Onus of performance lies on the leadership.

It requires that the top management have to ensure that the QMS requirements are integrated into the organisation’s processes. Also ensure that, the policy and objectives are aligned with the strategic business goals.

Clause 6: Planning

Plan to avoid risks & achieve results

It focuses on how an organisation plans actions to address both risks and opportunities. Actions to address risks and opportunities must be,

  • Monitored,
  • Accomplished, and
  • Communicated across the organization.

Organization must establish measurable quality objectives which should be aligned to quality policy.

Clause 7: Support

Unplanned resource utilisation could be counter-productive. 

It is all about utilising the right resources. Competent people and appropriate infrastructure needs to be in place to fulfill the organisational objectives. Organisational knowledge is one of the new change, incorporated into ISO 9001:2015. It’s too critical to preserve organisational knowledge.


Who cares for documentation? They are most sought, when problems occur, else they are the least, needed.

Documentation is also a key to good ISO 9001:2015 framework. Good practices to maintain & retain documentation is expected out of an ISO organisation.

Best documentation is the one which is understood by your people, be it a picture and the worst document is the one which is never read and utilised, how so-ever comprehensive, it is.

Clause 8: Operations

Provide resources and control the process, will be the most effective way of running your operations.

It is about the execution of the plans and processes that enable you to meet customer requirements. Organisation must have quality or control plan with well-defined acceptance criteria. It covers the requirements for products and service including customer requirement review. It emphasis more on design and development activities including

  • Planning,
  • Inputs,
  • Control,
  • Outputs and

Standard also focus on control over suppliers. It requires the process for supplier selection and evaluation. It focus on control overs production or service provision including

  • Preservation
  • Post-delivery activities
  • Control of changes
  • Release of product and services.

Finally it requires the control of non-conforming outputs in production or service operation only. Where one has to describe the,

  • non-conformity
  • Action taken,
  • Concession obtained and
  • Authority deciding the action where NCs got corrected.

Clause 9: Performance Evaluation

Measure to improve & Monitor to control

It is about measuring and evaluating QMS to ensure that it is effective and it aids continual improvement. You will need to consider what should be measured, the methods engaged, and when data should be analysed and reported on. You may definitely use various statistical tools and techniques to fulfil the requirement.

Clause 10: Improvement

If your organisation is not improving, continually, you are left behind in competition.

It requires organisations to determine and recognise opportunities for continual improvement. CAPA plays a better role here. You may apply various problem solving tools to minimise or cut the root cause of defects.

After you read this post, you will feel yourself ready or competent enough to implement brand new ISO 9001:2015 QMS. And why shouldn’t? But before that, I think you should focus on some interesting facts about implementation process. Which could make your implementation simple and prevent you from taking wrong decision. What? You are an experienced professional or already know how to put in place? No issue. Go ahead. Definitely you will find something which will be exciting for you.

How can I get ISO 9001:2015 certification?

The process to get certified to ISO 9001:2015 is quite simple. It is not mandatory to engage consultant for implementation. But consultant engagement has its own benefits from many aspects.

Which could be difficult to achieve by individual personnel or organisation. ISO 9001:2015 consultants are expert in implementing the QMS, expecting them to have excellent subject knowledge. Also they bring rich experience with them from several organisations.

In terms of documentation, best ISO 9001:2015 consultants are expected to have simple and effective templates. They will guide you to streamlining the processes. Standardisation & documentation go together and that should be done for establishing the best practice.

Sometimes employees value an outsider (ISO 9001 Consultant) more than an internal person. In training, individual might not deliver the content as effective as compare to consultant. Because they have detailed training modules.

Consultants will also help in selecting a third party certification body for the final audit of ISO 9001:2015.

Worried about monetary investment in hiring best ISO 9001 Consultant?

Don’t worry. If you hire a competent consultant, then you can expect to nurture a work culture which can give an RoI of five to ten times. Best ISO Consultant will bring for you

  • Comprehensive design of ISO 9001 framework, relevant to your company
  • Comprehensive, yet simple to follow documentation
  • Proactive approach in business processes, thinking Risk
  • Higher level of awareness at all levels
  • Problem solving methodology
  • Highly engaging training
  • A good quality of internal auditing
  • A complete approach for continual improvement

Finally consultants can let you see your process and system from a completely different perspective. Which can help you, adopt and practice, best ever tools, techniques and good practices.

Once you have established the system, you may invite any reputed third party certification body. Their auditor will come to your place and audit the implemented system. Audit is generally carried out in two stages ie, preparedness audit and certification audit. If your organisation is found to meet the ISO 9001 requirements, then they will certify your organisation with an ISO 9001:2015 certificate. Congrats!!

Be aware!!! This can hurt.

There are several critical factors, which you have to be consider while implementing ISO 9001:2015. Underestimating any of the factor can lead you towards an ineffective ISO implementation. Such factors could include but not limited to,

  • Poor QMS awareness,
  • Poor Employee engagement & participation,
  • Low Top management commitment,
  • Poor willingness to change,
  • Choice of a consultant,
  • Low focus on continual improvement and
  • unprepared for a proactive approach.

Still failed? Why it not delivering desired results?

Check the following

  • Roles & Responsibility of people…Is it clear?
  • Hazy focus on competence assessment
  • Fail to retain the organisational knowledge.
  • Improper data collection
  • Inappropriate use of collected data by means of analysis and evaluation.
  • Unclear quality objectives.
  • Poor awareness among the stakeholders Are your all employees aware about QMS?


Concluding this, ISO 9001:2015 is a mother standard indicating QMS for an organisations. It could be considered as one of the best ever business excellence model, which could deliver a plenty of benefits to your organisation, if practices and implemented in right manner. It is a mother of all standards for various sector specific applications like

  • ISO 13485,
  • IATF 16949,
  • ISO 18091,
  • ISO/TS 22163,
  • ISO/TS 29001 etc.

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