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

How to quickly migrate from ISO/TS 16949:2009 to IATF 16949

On 1 October 2016, The International Organization for Standardization  (ISO) and International Automotive Task Force (IATF), released the first edition of the new standard for the automotive sector IATF 16949:2016

The new standard will replace ISO/TS 16949 and outline the quality management system requirements for organizations working in automotive production, service and/or accessory parts of the automotive industry

The new standard has been developed to bring it into alignment with the recently overhauled ISO 9001:2015

If your customers require you to maintain ISO/TS 16949 certification, start planning your transition. Here are some timelines to work to:
Organisations certified to ISO/TS 16949:2009 will need to transition to IATF 16949, through a transition audit in line with the current audit cycle for ISO/TS 16949:2009

After October 1, 2017 no audits (initial, surveillance, re-certification or transfer) will be conducted to ISO/TS 16949:2009

ISO/TS 16949:2009 certificate will only be valid until 14 September 2018

ISOsafe have helped many businesses successfully and seamlessly transition. Get in touch with us today for a free quote in five minutes, email us at: enquiries@isosafe.com.au or why not speak to one of our friendly consultants on 1300 789 132

Grow your business with an ISO 9001 certification

Many smaller businesses grow very slowly with the capacity to serve a limited customer base, delivering limited volumes and operating within a defined area. Potential customers outside this immediate demographic are sceptical when higher value contracts are on the line. For any business to grow, it must offer it’s customers consistent, reliable results. Keeping existing business, is as important as, winning new business. It has been tried and tested millions of times over, an ISO 9001 Quality Management System is the best way to grow confidence among your customers.
What is ISO 9001? It is the international standard that defines the key parameters that demonstrate the certified organisation is capable of consistently delivering on its stated customer promises. It is the language that businesses and the supply chain understand. It gives confidence to those who deal with your business that you can deliver.
What does ‘certified’ to ISO 9001 mean? This means a recognised independent and accredited organisation has assessed your business against the requirements of the standards and verifies that the organisation meets those requirements.
What is the process for ISO 9001 certification? It is a 3 stage process; the use of an experienced consultancy can make this a painless and seamless process.
1. Gap Analysis– This is an assessment of the current position of the organisation against the requirements of ISO 9001
2. Implementation of ISO 9001– This process involves a range of activities to close the gaps identified in the gap analysis.
3. Certification Audit– An accredited certification body will conduct an onsite audit to independently verify that your organisations’ operations meet the requirements of ISO 9001. An (annual) regime of surveillance audits will be put in place by the certification body to verify continuing compliance.
Following certification, your business' newly acquired credentials should be at the heart of your sales and marketing strategy. It is important that everyone in your supply chain is made aware that your business is certified.
With an ISO 9001 certification your business can confidently apply for both public and private sector tenders/contracts directly, rather than as a subcontractor.
ISOsafe is Australia’s leading supplier of ISO consultancy services supporting SMEs in their effort to be more competitive; by improving quality performance, customer satisfaction and, ultimately, their market share. Get in touch today on 1300 789 132 to learn more about our services for your business. 

Transition to ISO 9001:2015 - What to expect

Preparation is key when it comes to avoiding non-conformances. So we’ve collated the top three questions auditors ask during ISO 9001 transition audits, as well as, some suggestions on how your quality management system could address each of these questions.

1. How have you determined the external and internal issues that are relevant to your business and its strategic direction? (Understanding the organization and its context – clause 4.1)
Big businesses will typically have a strategic business plan. It is important to refer the auditor to the sections of your plan that cover the external forces, internal strengths and weaknesses.
On the other hand, small businesses should refer to their Vision and Mission statements to demonstrate where the business is heading – its strategic direction. Further, a SWOT analysis is a simple and effective tool used to identify the external and internal issues. “SWOT” stands for Strengths, Weakness, Opportunities, and Threats. With Strengths and Weakness being internal issues and Opportunities and Threats being external issues. 
Useful tip: ISO 9001:2015 does not require any of this to be documented the term it uses is “determined”, however, we’ve found that many auditors want written evidence. Remember, we are here to help with SWOT analysis and all other ISO 9001 transition requirements – get in touch today.

2. How have you determined the quality risks and opportunities that need to be addressed? (Actions to address risks and opportunities – clause 6.1)
Many big businesses already have a risk manager or risk department, and it is quite common for them to be fixated on the big picture risks to the business. Further, they may not be concerned with the opportunities for the business – where it could be growing. And because quality is about the customer, some of these risks and opportunities will need to be related to the customer. The quality management system should include all identified risks and opportunities, so any actions and quality objectives should be aligned. 
For small businesses we recommend the use of a risk register. If your business has a safety system, you almost certainly will have one. If you don’t have one – create one (or leave it to ISOsafe). Your risk register should identify quality risks and opportunities, this involves looking at your business through the eyes of your customer - what you would not like if you were a customer (risk), and what would you like the business to be doing if you were a customer (opportunity). Once you have a list of customer risks and opportunities, identify how you can reduce the negative risks and build on the opportunities.
Useful tip: ISO 9001:2015 requires documented information as evidence of management reviews and these reviews should include the effectiveness of actions taken to address risks and opportunities.

3. How have you determined the inputs required and outputs expected from your quality management system processes? (Quality management system and its processes – clause 4.4.1)
Any organization that is certified to ISO 9001:2008 should have the interaction of processes already described in their quality manual. ISO 9001:2015 requires more detail on process interaction, calling for the identification of all inputs and outputs relating to each process. 
Large businesses, managing a number of different projects should have process maps in place. This could be an arduous task identifying the inputs and outputs of each of these individual processes. Warning: Auditors could have a field day here! Simplify and streamline your processes to make identifying inputs and outputs easier. 
Small businesses will also need to draw up a process map. However, ISO 9001:2015 does not require a quality manual. This is a good thing. Many small business can meet the requirements without bulky, and impractical manuals.
Useful tip: There is a lot of talk about the process approach in this version of ISO 9001:2015 however, it was very clearly spelled out as a requirement in ISO 9001:2000 so it’s been around for at least 15 years. If your consultant, quality person or auditor doesn’t know this – get a new one!

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