Posts tagged #qms

What is required as an absolute minimum for ISO 9001:2015 certification?

It is a common misconception that every process within an organisation (business) must be documented in order to gain ISO 9001 certification. This is simply not the case. With the shift towards risk based thinking, the 2015 revision of the standard is more adaptable than ever before. We’ve put together a list of the required documents for ISO 9001 below

Policies and Records required by ISO 9001:2015

Policies

Clause

Scope of the Quality Management System

4.3

Quality Policy

5.2

Quality Objectives and Plans for Achieving Them

6.2

Procedure for Control of Externally Provided Processes, Products and Services (outsourced processes)

8.4.1

Records

Clause

Record of Maintenance and Calibration of Monitoring and Measuring Equipment

7.1.5.1

Competence Records

7.2

Product/Service Requirements Review Record

8.2.3.2

Record of New Requirements for Product or Service

8.2.3.2

Design and Development Inputs Record

8.3.3

Record of Design and Development Controls

8.3.4

Design and Development Outputs Record

8.3.5

Record of Design and Development Changes

8.3.6

Record of Evaluation of External Provider (supplier)

8.4.1

Record of Product/Service Characteristics

8.5.1

Record of Changes on Customer’s Property

8.5.3

Record of Changes in Production/Service Provision

8.5.6

Evidence of Product/Service Conformity

8.6

Record of Nonconformity

8.7.2, 10.2.2

Monitoring Performance Information

9.1.1

Internal Audit Program and Results

9.2.2

Management Review Results

9.3

Nonconformities and Corrective Action

10.2.2

Feeling overwhelmed?

Contact ISOsafe for help with your ISO 9001 project on 1300 789 132. Don’t risk a failed ISO audit

ISO 9001:2015—An Introduction

ISO 9001 is an internationally recognised quality management system (QMS) standard. It comprises fundamental quality assurance practices that can be applied by any business. In the past ISO9001 has been hugely successful within the manufacturing sector, however, the latest iteration (version 5) has seen the standard heavily revised to appeal to businesses in all sectors.

Without a QMS, businesses have little chance of sustaining any improvements or innovations they might realise. ISO 9001:2015 helps organisations standardise operational functions from input, through to output whether a good or service is being delivered. With the inclusion of risk based thinking, it takes into consideration exogenous and isolated events that many businesses would not usually plan for.

The ISO 9001 standard leaves a great deal of discretion to the business in terms of how it will design its processes and procedures. This enables businesses to customize it to ensure individual success, instead of just blindly following a rigid set of rules.

If you are looking for better overall performance in your business, ISO 9001 is the key. Contact ISOsafe today at enquiries@isosafe.com.au to unlock your business’ true potential.

Proof ISO 9001 gears your business for rapid growth

When contracting to large businesses or the public sector (government) ISO 9001 acts as a prequalification tool. It lets others know your business has its affairs in order. This is particularly the case for Aussie businesses exporting to the world.

A recent client satisfaction survey conducted by ISOsafe highlighted the benefits of achieving certification to ISO 9001. Here is a summary of the results.

•    The respondents from the survey are most likely to be small or medium enterprises (SME). However, the industries covered are wide and varied; the construction, oil and gas, retail, and technology sectors are just a handful of many found within the survey’s sample.

•    We found that 38 percent of respondents said that they had won business (everyone loves getting more clients/customers right?) as a result of certification

•    The survey also showed that 76 percent of ISOsafe clients found that ISO 9001 certification had helped them to be more competitive. Breaking down that figure, 22 percent of respondents said that ISO 9001 certification allowed them to bid for more contracts, 31 percent said they had won contracts, 20 percent said they had raised their profile, and 3 percent said they now have an advantage over their competitors.

•    Of course, fundamentally ISO 9001 is aimed at providing a framework for organisations to help bring greater consistency and traceability to what they do. This wasn’t lost, with 55 percent of respondents saying that implementation had led to internal improvement.

Anecdotally, our survey has shown that clients tend to fit in one of two camps: those looking for business improvement and those looking to win new business. From an industry perspective, the fear is that if the latter reason continues to dominate, ISO 9001 will be viewed as a tick-box exercise rather than a business improvement tool.

In Australia, ISO 9001 acts as a pre-qualification tool. The idea is that it saves companies both time and money in avoiding having to audit every supplier. Certification provides a level of assurance that rigorous checks have already been done by an unbiased external body governed by JAS-ANZ. The trouble is, meeting the requirements of the standard and truly living it are two very different things.

ISO 9001:2015 - How we can help you get there

ISO 9001 is the internationally recognised standard for Quality Management Systems (QMS). It is the most widely used standard in the world, with over 1.1 million certificates issued to organisations in 178 countries.

ISO 9001 provides a framework and set of principles that ensure a common-sense approach to the management of your organisation to consistently satisfy customers and other stakeholders. In simple terms, it provides the basis for effective processes and effective people to deliver an effective product or service time after time.

ISO 9001:2015 was released on 15th September 2015. Organisations currently registered to ISO 9001:2008 will have 3 years to make the transition to the 2015 version. In support of the transition process, we wanted to answer some of the more common questions that we have received.

 Why was ISO 9001 revised?

All ISO standards are revised every five years to keep them current and relevant to the marketplace.

 

When should my organisation start the transition process and how will ISOsafe assist me through the transition?

Immediately! The first step is to contact ISOsafe – we’ll work with you on the transition timeline. The next step is to sit back while our expert consultant prepares all the necessary documents and delivers the ISO training your staff require. We will run the ISO project, on your behalf, through to issue of certificates.

 

Can our organisation upgrade in 2016 during a re-certification or surveillance audit?

Yes, providing your quality management system meets the requirements of ISO 9001:2015. Organisations may transition during a surveillance, recertification or special audit.  Transition audits will take place in 2016, 2017 and 2018.

 

My organisation is thinking of getting certified to ISO 9001 in 2016, what version should we be using?

We suggest you consider ISO 9001:2015 but this is your decision and ISOsafe will support an initial certification to ISO 9001:2008.

If you are seeking ISO 9001 certification for the first time, you can expect the following benefits: operational efficiency, customer satisfaction, process improvement, product improvement, reduced wastage, enhanced risk management at all levels in your business and new business / contracts – as this globally recognised certification will give your business a competitive edge in the market.

 

How can I get a copy of the ISO 9001:2015 Standard?

ISOsafe recommend purchasing Standards from an Australian supplier, such as SAI Global.

 

What are notable changes when transitioning to ISO 9001:2015?

The new ISO 9001 standard aligns with high-level organizational structure, requiring all new ISO management system standards to be aligned on a high-level structure with a set of common requirements. Additionally, there is a greater emphasis on risk-based thinking as a basis for the management system, more focus on achieving value for the company and its customers, increased flexibility regarding use of documentation, and a more approachable structure for service businesses.

 

ISOsafe have helped many organisations seamlessly transition to the revised Standards. Don’t wait till its late call us today on 1300 789 132

Why quality management is essential for your small business

With ever-increasing demands for small and micro-businesses to deliver on quality, price and service, the most effective way to enhance the confidence of your customers is through a structured certificated Quality Management System (QMS). For small businesses, this is not as daunting as it might appear, as it should always be based on how your business systems currently operate.

You can manage quality, whatever the size of your business, with a standard that’s recognised the world over. With ISO 9001 Quality Management you can:

•   save money

•   increase profit

•   win more business

•   satisfy more customers

The ISO 9001 Quality Management Standard is the foundation for:

•   A real opportunity for increasing business, and thereby profitability, by being able to pursue contracts with those customers for whom certification is a contractual requirement.

•   Providing you with the opportunity to gain a clearer understanding of your business through the information that the QMS gives you. A QMS will facilitate customer focus, enhanced risk management, increasing efficiency, productivity, cost savings, and reducing and overcoming product or service problems.

•   Developing a system which provides the building blocks a small or micro business needs to progress in that it enhances the recognition of your team members through involving them in considerations, development and implementation. This in turn significantly improves communication and understanding together with a faster response in resolving any issues that arise. All of this is achieved through your confidence that the system provides reliable, recorded information and data to base potential improvements on.

Adopting a QMS should be seen as a business development opportunity, regardless of your business size