Frequently Asked Questions
Who or What is ISO?
ISO is from the Greek word ISOS meaning "equal"
ISO (International Organization for Standardisation) is the world's largest developer and publisher of International Standards. ISO is a network of 156 national standards bodies, based in Geneva, Switzerland. ISO is a non-governmental organisation that forms a bridge between the public and private sectors. Many of its member institutes are part of the governmental structure of their countries, or are mandated by their government, other members have their roots uniquely in the private sector, having been set up by industry associations.
I am very new to ISO 9001. Do you have any advice on where I can do some background reading?
Start with the source of the standard ISO they have lots of useful information without the hard sell – https://www.iso.org/tc176/sc2
Who wrote the ISO 9000 standard?
The ISO 9000 standard was created by the International Organization for Standardization. Visit https://www.iso.org for more information.
What is ISO 9000:2008?
ISO 9000 is a generic name given to a family of quality management standards including:
ISO 9000:2005, Quality management systems – Fundamentals and vocabulary. Covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. A guidance document, not used for certification purposes, but important reference document to understand terms and vocabulary related to quality management systems.
Note that the previous members of the ISO 9000 series, 9001, 9002 and 9003, have all been integrated into 9001.
ISO 9001:2008 Quality management systems – Requirements is intended for use in any organization regardless of size, type or product (including service). It provides a number of requirements which an organization needs to fulfil if it is to achieve customer satisfaction through consistent products and services which meet customer expectations. It includes a requirement for the continual improvement of the Quality Management System. (ISO 9004:2000 has further guidelines for improvement)
This is the only implementation for which third-party auditors may grant certification.
ISO 9001:2008, the approval standard, has 5 main sections:
- Quality Management System
- Management Responsibility
- Resource Management
- Product Realization
- Measurement Analysis and Improvement
ISO 9004:2000 Quality management systems - Guidelines for performance improvements and continual improvement. This standard very specifically states that it is not intended as a guide to implementation.
There are many more standards in the ISO 9001 series, see https://www.iso.org for details, many of them not even carrying "ISO 900x" numbers. Some standards in the 10,000 range are considered part of the 9000 group.
What is the difference between ISO 9001:2000 and ISO 9001:2008?
ISO 9001:2008 is the newest version of ISO 9001. ISO 9000:2008 was released in November 2008 as a replacement for ISO 9001:2000. The differences are highlighted in our ISO 9001:2008 Changes Summary.
Why ISO 9001?
It gives customers confidence in your ability to deliver their requirements. Approval can be pre-requisite when bidding for contracts. ISO 9001:2008 represents an accepted quality management standard.
Effective ISO 9001 certified systems have proven benefits and more and more the emphasis of Auditors is now placed on company improvement.
Is ISO 9001 Easy To Implement In A Small Business?
It can be fairly straight forward depending on the complexity of your operations and number of employees. See more details on our Small Business Manual Page. Our guide to implementing ISO 9001 included with our manuals provides guidance also.
How Much Documentation Is Needed?
See our article on documentation requirements of ISO 9001. It is often wrongly assumed that it is best to create masses of paperwork.
ISO 9001:2008 enables each individual organisation to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its Quality Management System.
ISO 9001:2008 defines a procedure as a "specified way to carry out an activity or a process", which does not necessarily have to be documented. You simply have to demonstrate that you meet the requirements. An Auditor can verify this by reviewing your records and interviewing staff to ensure consistency.
Documents may be in the form of flowcharts which make it easier to understand what is happening in the process. Flowcharts may be backed up by text if the process is complex.
How Do I Implement ISO 9001?
1. Buy ISO 9000:2008 Series and make yourself familiar with it. Although it is a formal document the clause titles in ISO 9001:2008 are self-explanatory. If you have any queries then e-mail us for advice.
2. Follow our free guide to implementing ISO 9001:2008
3. Write your Quality Manual
A Quality Manual is a high level document that outlines your quality management system. It outlines how you apply ISO 9001:2000 to your business activities.
4. Develop work instructions and other supporting documents
There is usually a work instructions manual that supports the Quality Manual. It outlines what you do to complete a task. It describes a method of operation who does what, in what order and to what standard.
5. Communicate with all employees
6. Carry out training. During the implementation phase everyone should operate to the procedures and complete the records that demonstrate you are doing what you say you do.
7. Carry out internal audits, corrective action, preventative action, management review and improvement.
If you require your system to be certified then you will need to go through the following stages:
A pre-assessment by your chosen certification body normally takes place about 6 weeks before certification. A desktop review of your management system against ISO 9001 is conducted, and any omissions or weaknesses that need resolving before formal assessment are identified. This allows you time to correct any areas of concern before assessment.
ISO 9001 Certification
Once the areas identified in the pre-assessment have been addressed a full on-site assessment is conducted. At this point the Auditor from the Certification Body will review your Quality Management System (by interviewing staff, observing activities and checking records) to decide whether you should be recommended for certification.
How Do I Choose a Certification Body?
Do your research and find out:
Are they authorized to issue certificates in your industry? How many have they issued?
The initial assessment process.
The certification audit process.
How they carry out surveillance audits.
If they provide qualified auditors with knowledge of your industry.
What are their fees and timescales.
Do I Need a Consultant?
You can receive advice from independent consultants on how to implement your quality management system but this can be expensive and will need to be managed. Our advice is the more organising and management of the system you do yourself the more understanding and control you will have over the system. You can do it yourself using our Manual packs which are offered with or without additional support and provide a good starting point for your business.
Do your manuals cover the actual ISO 9001 requirements?
All our manuals cover all the document requirements of ISO 9001:2008: Our Quality Manual Summary specifically shows the procedures in the manual which address the requirements of each clause. This is the main reason our manuals are so easy to follow against the requirements of the standard. We have done the hard work for you!
Are your manuals and forms ISO 9001:2008 compliant?
Yes, all our manuals and forms are fully compliant with all requirements and with the new wording of ISO 9001:2008. Our Quality Manual ISO 9001 2008 Changes and Compliance Summary is included with your manual.
Do you provide support if I am not sure how to make the best use of your manual during ISO 9001implementation?
Yes we will be happy to provide you with advice whenever you need it. Please e-mail us with e-this form and we will be happy to assist you. We will try to respond within 24 hours where possible.
Do your representatives have a background in ISO 9001?
Yes we have years of experience and our manuals are written by a Qualified Lead Assessor.
Who are BRC?
The British Retail Consortium are known as BRC. In 1998 BRC developed the BRC Food Technical Standard to be used to evaluate manufacturers of retailers and own brand food products. It was designed to be used as a 'due diligence' defence for retailers and brand owners. This Standard is regarded as the benchmark for best practice in the food industry.
Its use outside the UK has seen it evolve into a Global Standard as a framework upon which many companies have based their supplier assessment programmes and manufacture of some branded products.
The majority of UK, and many European and Global retailers, and brand owners will only consider business with suppliers who have gained certification to the appropriate BRC Global Food Standard.
What is BRC Global Standard for Food Safety?
The BRC Global Standard for Food Safety has been developed to specify the safety, quality and operational standards required within a food manufacturing organisation in order to meet legal requirements and fulfil obligations to the consumer. Further information is available at www.brcglobalstandards.com
The latest BRC Global Standard for Food Safety is Issue 5 2008.
Are your manuals designed for small, medium or large companies?
We have a range of manuals tailored for different sizes of companies. Small companies should purchase the Small Business Manual and the Quality Manual is suitable for Medium size companies upwards. Food companies should purchase the Food Quality Manual.
Are your manuals specific to a particular industry?
Our standard ISO 9001 manuals are applicable to any company in any industry. Our Food Quality Manual is Food Industry specific.
Can you guarantee that we will achieve certification with your Quality Manuals?
We can assure you that the manual templates have been certified successfully many times, however, you will need to assess if you have all the required systems in place and if any other documents are deemed necessary to establish process control.
We are a service company. Can we use your manuals?
Yes our manuals are equally appropriate for the service and manufacturing industries.
We are a small company with 10 employees. Will we need many documents?
For small companies with an uncomplicated operation our Small Business Manual provides the basic ISO 9001 documentation requirements. You will probably need to add a few work instructions and records which we can guide you with if you buy the assisted package.
How long does it take to get certified?
It depends on you and your company. The minimum period is 3 months because after implementing your procedures, records and any necessary work instructions you will need to ensure that training is carried out and then all areas of your system are audited. Corrective Actions or Preventative Actions raised from these audits need to be followed up and at least some closed out to demonstrate the system is working. You will also need to review for improvement. With support from senior management and commitment from all staff you may be able to get certified in as short a period as 3 months. Larger companies tend to be more complicated and thus take more time and resource to get the system up and running.
How much does it cost to get certified?
Small companies that implement ISO 9001 using our Small Business Manual or Quality Manual without the help of expensive consultants may be able to get certified for as little as £1500 or around $2100 depending on your location.
How do we prepare for an audit?
Start with our ISO 9001 Gap Analysis tool and identify any shortfalls in your system.
How can I purchase your manuals, and how will I receive them?
All our products are available for immediate download. Select the product you want the click to buy and you will be taken to a secure Paypal payment page. Once you have paid you will automatically receive an email with download instructions. For assisted packages we will provide a support e-mail address for correspondence.