Or towards implementing and maintaining a QMS
Where to begin is frequently a question that executives wishing to secure ISO 9001 Certification ask. In this article, we'll suggest a practical 5-Step process that you can take to get started (often the most difficult part).
The knowledge and information given here is essential if you and your colleagues are to make an informed decision as to:
a) whether ISO Certification is right for your organization at this time and
b) as to the amount of effort and resources that would be required.
Step 1: Get an Overview of a Quality Management System
Purpose of a Quality Management System
Quality is, fundamentally, about the ability of an organization to consistently provide products and services that meet customer requirements.
The adoption of a quality management system is a strategic decision for an organization that goes beyond the ability to provide a quality product or service. It can help to improve the organization’s overall performance and provide a sound basis for sustainable improvement initiatives.
Advantages of Having a Quality Management System
The potential benefits to an organization of implementing a Quality Management System (QMS) based on ISO 9001:2015 are:
- Having the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;
- Being able to facilitate opportunities to enhance customer satisfaction;
- Being able to address risks and opportunities associated with its context and objectives;
- Having the ability to demonstrate conformity to an internationally-recognised quality management system requirements.
Other ISO Standards Related to ISO 9001
ISO publishes four standards that focus directly on an organization's QMS:
- The management system standard: ISO 9001:2015. This standard is the specification for a QMS.
- The Technical Standard ISO/NP TS 9002:2016 Quality management system -- Guidelines for the application of ISO 9001:2015. This standard provides an extensive body of knowledge on all aspects of a QMS and has copious examples from which you can draw. Note: This is not a Normative Reference in ISO 9001:2015; therefore, it is not a mandatory requirement that it be applied to your QMS.
- ISO 9000:2015 Quality management system - Fundamentals and vocabulary, provides essential background for the proper understanding and implementation of ISO 9001:2015. Note: This is a Normative Reference in ISO 9001:2015; therefore, it is a mandatory requirement that should be applied to your QMS.
- ISO 9004:2016 Managing for the sustained success of an organization - A quality management approach, provides guidance for organizations that choose to progress beyond the requirements of ISO 9001:2015. This Standard is intended for organizations with mature quality management system; it is not generally used when first designing and implementing a QMS. Note: This standard also is not a Normative Reference in ISO 9001:2015; therefore, it is not a mandatory requirement that it be applied to your QMS.
These standards are copyright protected text and must be purchased. (For purchasing information, refer to section 1, "Purchase ISO standards.")
Application of ISO 9001:2015
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
These standards form the framework within which you will establish a QMS. That framework is described in the next section. This framework can be applied (with a little modification) to any of the ISO Management System Standards (ISO 14001, ISO 45001, etc.)
Your first objective is to inform yourself as to what’s involved in designing, implementing and maintaining a Management System. To begin:
Step 2: Get an Overview of the Initiation, Planning and Implementation Processes
- It’s a PDF file for you to print and/or save as you wish.
- The main headings throughout our Implementation Handbook have numbers in brackets (e.g. #12) to indicate the correspondence between the topic under consideration and the Step number in the Flowchart being addressed.
- The numbers in brackets at the bottom of each activity box (e.g. 8.1 & 10.1) is the Clause Number(s) corresponding to the requirement that is being addressed by the activity in question.
For ease of understanding, the 33 Steps have been set out in a simple sequence. In reality, you will frequently be working on several steps simultaneously. This will help reduce the overall timescale for the project. When project planning with your project team, you should seek out and document such opportunities.
Relating the 33 Steps to the Standard is not, perhaps, immediately obvious. The Implementation Model, where each of the six elements is mapped against the main parts of the Standard, may help. The 33 Steps will take you through each of the six elements in a logical sequence.
Step 3: Get Copies of relevant ISO standards
Before establishing a QMS and drafting the various documents for your QMS, you should purchase copies of the pertinent ISO standards, namely:
- The management system standard: ISO 9001:2015. This standard is the specification for a QMS. It sets out the requirements for an auditable QMS. It provides the standard against which certification audits are performed, including the required documentation. An organization that seeks certification of its QMS is examined against this standard.
- The Technical Standard ISO/NP TS 9002:2016 Quality management system -- Guidelines for the application of ISO 9001:2015. This standard provides an extensive body of knowledge on all aspects of a QMS especially for Small and Medium-sized Enterprises, and for Service Industries (which historically have had difficulty in interpreting ISO 9001). It contains copious examples from which you can draw.
You can purchase these standards from the following online stores:
- The ANSI online store: http://webstore.ansi.org
- The ISO Online Shop: http://www.iso.ch
- The Estonian Standards Shop: https://www.evs.ee/shop
- Or from your National Standards Institute/Authority.
Step 4: Get Training for Yourself
If you're not a lead auditor yet, you need to get to that level, so that the decision to be made regarding proceeding with the Project is adequately informed.
In addition to conventional Lead Auditor Training, we also offer Lead Implementer Training. Details and course content information is given in these links. …
- Course 033: ISO 9001:2015 Lead Auditor (32 hours/5.3 days)
- Course 032: ISO 9001:2015 Lead Implementer
Step 5: Make a Decision
Now you are in a position to have an informed discussion with your top management and colleagues regarding ISO 9001 Certification for your organization. Essentially, there are three Options…
Option 1: Defer or drop the ISO 9001 Certification Project. This is the easy option, but here you forego the efficiencies and increased business that implementing and maintaining the Standard can bring.
Option 2: Proceed with the Project using your own resources alone. If your team is knowledgeable about management systems and have been deeply involved previously in implementing and maintaining a management system, this may be a viable option.
Option 3: Proceed with the Project with outside support. Supplement your own resources with the services of a Consultant or, if part of a multinational, the services of experienced colleagues from other similar sites.
By the way, when choosing a consultant be selective. Engage only a consultant with experience in similar businesses to your own, and check out the references provided (a site visit or two may be useful).
We wish you the best of luck and early success in securing ISO 9001 Certification.
NoteL Originally published in Nov 2017, this post was reviewed and updated in Apr 2021.