Gap Analysis Services: ISO 9001 Quality, ISO 45001 Safety, ISO 14001 Environmental Management Systems

Does your ISO 9001, 14001, 45001 Management System meet the requirements of the Standards? Is your System ready for Certification Audit?

An ISOsafe Gap Analysis can help to set your business up for Certification Audit Success. Our detailed Gap Analysis process can identify and help you fix issues before your Audit.

Our Gap Analysis Report offers peace of mind.

Call ISOsafe to Fast Track 🚀 your Business ISO Certification on 1300 789 132

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ISOsafe Specialists can conduct a Gap Analysis to identify areas for improvement your organisations ISO Management System. We can also provide guidance and training to assist in the close out the identified Gaps to ensure your ISO Management System is Certification ready.

Call ISOsafe to schedule your ISO 9001 Management System Gap Analysis 1300 789 132

ISO 9001 Basics: Complete Beginner’s Guide to ISO 9001:2015 Quality management systems — Requirements

ISO 9001 Quality Management Systems (QMS) is an international standard that helps organizations ensure they meet customers and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9001 is held by thousands of businesses in Australia, we’ve helped them get Certified with minimal disruption, reducing project costs and raising revenues.

In this guide to ISO 9001 Quality Management Systems (QMS) for beginners, you’ll learn:

·       What is ISO 9001 and why it is important?

·       Reasons for use?

·       ISO 9001 QMS Policy Best Practices

·       ISO 9001 Certification Best Practices   

·       How to best Prepare for ISO 9001 : 2015 Certification

·       Common Technical ISO 9001 QMS Issues

·       How to Track & Measure ISO 9001 QMS Performance Evaluation, Compliance Evaluations and Report Results at Management Review Meetings.

·       Additional ISO 9001 Considerations (such as industry specific applications of the standard and ISO Best Practices)

ISO 9001 Certification - Fast Tracked. Serving All Industries, Australia-Wide

What is ISO 9001 and why it is important?

Over one million organizations worldwide are independently certified to ISO 9001, making it one of the most widely used management tools globally.

Contents of ISO 9001:2015 are as follows:

·       Section 1: Scope

·       Section 2: Normative references

·       Section 3: Terms and definitions

·       Section 4: Context of the organization

·       Section 5: Leadership

·       Section 6: Planning

·       Section 7: Support

·       Section 8: Operation

·       Section 9: Performance evaluation

·       Section 10: Continual Improvement

Similar to its predecessor, ISO 9001:2008, the layout of the current version of the standard follows PDCA (plan–do–check–act or plan–do–check–adjust) principles. PDCA is an iterative four-step management method used in business for the control and continuous improvement of processes and products.

The ISO 9001:2015 management system standard helps ensure that consumers get reliable, desired quality goods and services. This further increases benefits for a business.

Over time, various industry sectors have wanted to standardise their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them. Some examples include:

·       The TickIT guidelines

·       AS9000 is the Aerospace Basic Quality System Standard

·       PS 9000, QS 9000, ISO/TS 16949 now referred to as IATF 16949:2016 are the various Automotive Quality Management Systems

·       TL 9000 is the Telecom Quality Management and Measurement System Standard

·       ISO 13485:2016 Medical devices

·       ISO/IEC 90003:2014 Software engineering

·       ISO/TS 29001 is quality management system requirements for the design, development, production, installation, and service of products for the petroleum, petrochemical, and natural gas industries

·       ISO 22000 Food Safety Management Systems

·       ISO 17025:2017 is the Quality Management System applicable only to Testing and Calibration Laboratories

Call ISOsafe to Fast Track 🚀 your Business ISO Certification on 1300 789 132

Reasons for use?

Proper quality management can improve business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation.

We've got the answers - Call our ISO 9001 Certification helpline now

ISO 9001 QMS Policy Best Practices

The ISO 9001:2015 Quality management systems standard requires the development a Quality Policy. A Quality Policy is a document developed by management to express the commitment of top management with respect to quality.

Section 5.2 of the ISO 9001:2015 standard requires a written, well-defined quality policy that is communicated and understood by all stakeholders and interested parties. Need help developing a Quality Policy for your business? Call ISOsafe 1300 789 132.

ISO 9001 Certification Best Practices

Before the certification body can issue or renew a certificate, the auditor must be satisfied that the company being assessed has implemented the requirements of sections 4 to 10. Sections 1 to 3 are not directly audited against, but because they provide context and definitions for the rest of the standard, not that of the organization, their contents must be taken into account.

Common Technical ISO 9001 QMS Issues

An organization applying for ISO 9001 certification is audited based on an extensive sample of its sites, functions, products, services, and processes. The auditor presents a list of problems (defined as "non-conformities", "observations", or "opportunities for improvement") to management. If there are no major non-conformities, the certification body issues a certificate. Where major non-conformities are identified, the organization presents an improvement plan to the certification body (e.g. corrective action reports showing how the problems will be resolved); once the certification body is satisfied that the organization has carried out sufficient corrective action, it issues a certificate. The certificate is limited by a certain scope (e.g., production of golf balls) and displays the addresses to which the certificate refers.

How to Track & Measure ISO 9001 QMS Performance Evaluation, Compliance Evaluations and Report Results at Management Review Meetings.

The organization should determine the methods and frequency for monitoring, measurement, analysis, and evaluation of Performance Evaluation. Does this all sound like too much work? Call ISOsafe now to get help with your ISO 9001 accreditation.

Additional ISO 9001 Considerations (such as industry specific applications of the standard and ISO Best Practices)

So if you’ve gotten this far, you should know a lot of information about how ISO 9001:2015 Quality management systems.

What should you do next? Call ISOsafe on 1300 789 132 to get started on your ISO 9001 Certification.

How to transition from OHSAS 18001:2007 to ISO 45001:2016

It has been announced that OHSAS 18001 is changing into ISO 45001 next year. So far there has been an initial draft copy issued – DIS 45001. In preparation for this transition Australian businesses currently accredited with OHSAS18001:2007 will need to identify the gaps in their current systems and bring up to speed with ISO45001:2016.

WHEN WILL ISO 45001 BE AVAILABLE?

A second draft version of ISO 45001 is now available, however, this is not a public draft document and will only be available to selected people.

The final approved version of ISO 45001:2016 will be published in mid-2017.

HOW SOON CAN I TRANSITION FROM OHSAS 18001 TO ISO 45001 WITHOUT ACCESS TO THE DIS?

It may be useful to start communicating internally that OHSAS 18001 is changing to ISO 45001. You should start to look at your processes to see if they are in line with the new high-level structure; but take note that your system must remain compliant with the requirements of OHSAS 8001:2007 until the new standard has been released.

HOW LONG WILL OHSAS 18001:2007 CONTINUE TO BE RECOGNIZED?

The current standard will be recognized and can be audited until the end of the 3-year transition period for ISO 45001:2016 (expected October 2019).

WHAT ARE THE MAIN CHANGES EXPECTED IN ISO 45001?

There are now 10 clauses, which is a significant departure from OHSAS 18001. The requirements are better organised around the new 10 clause structure which all the other Management System standards will follow in the future (including ISO 9001 and ISO 14001).

    1.0    Scope  

    2.0    Normative References  

    3.0    Terms and Definitions

    4.0    Context of the Organisation

4.1 Context of the Organisation: The intention of this is to ensure that the organisation has a high-level understanding of the important issues that can affect, either positively or negatively, the way the organisation manages its responsibilities in relation to the OH&S Management System for persons working under its control.

4.2 Understanding the needs and expectations of interested parties: The organisation needs to establish whom the interested parties (such as legislative bodies, clients, the public, etc.) are and whether or not they are relevant to OH&S, and to identify the needs and expectations that those interested parties have.

    5.0  Leadership

5.0 Leadership: ISO 45001 adds an important new requirement; that top management has to demonstrate its leadership and commitment, and by taking accountability for the effectiveness of OH&S.

5.2 Policy: This now needs to make mention of the organisation’s commitment to continual improvement and has a commitment to worker participation and consultation.

    6.0    Planning

6.0 Planning: You now need to consider risk and opportunities associated to the issues you identified in 4.1 with regards to requirement(s) of the interested parties.

    7.0    Support

7.0 Support: This requirement takes into account the areas of Resources, Competence, Awareness, Communication and Documented Information. 

    8.0    Operations

8.0 Operations: This requirement takes into account the areas of Operational Planning and Control, Management of Change, Outsourcing, Procurement, Contractors and Emergency Preparedness and Response.

    9.0    Performance Evaluation

9.0 Performance Evaluation: This requirement takes into account the areas of Monitoring, Measurement, Analysis and Evaluation, Evaluation of Compliance, Internal Audit and Management Review.

    10.0Improvement

10.0 Improvement: This requirement takes into account the areas of Incident, Nonconformity and Corrective Action and Continual Improvement.

The new concepts coming from Annex SL will, for many organisations and auditors, be tried and tested because they appear also in the updated version of ISO 9001 and ISO 14001. Organisations operating an Integrated Management System (IMS) will then have the unique opportunity to more easily align and integrate the three Management Systems and standards.

If youre looking for guidance and support to transition from OHSAS 18001 to ISO45001; contact ISOsafe today on 1300 789 132, with Specialists in every State/Territory of Australia we can assist businesses of all sizes in every industry.

How to get ISO 9001

Preparing your business for certification to standards such as ISO 9001 or ISO 45001 can seem daunting. If you’re looking to get ISO 9001 certified for the first time (or recertified due to a lapsed accreditation). We can help.

Below you’ll find a step-by-step guide on how to get ISO 9001 certified quickly all the while benefiting from the experience by improving the goods and services your business produces.

STEP ONE: CHOOSE THE RIGHT CERTIFICATION FOR YOUR BUSINESS

The first step for any organisation is making sure that the ISO or Australian Standard (AS) you’ve chosen is the right fit for your organisation. In many instances, your potential customers or clients may require your business to hold a specific endorsement, such as ISO 9001.

STEP TWO: FAMILIARISE YOURSELF WITH THE STANDARD

Buying a copy of the standard can be useful, but isn’t necessarily required. In truth, the jargon involved may even put you off! This is where ISOsafe can add value to the process. We are able to guide you and your business through the ISO 9001 certification process from start to finish. As part of our service we are able to bring experience and professionally prepared systems to ensure your business is certified, without disruption and unnecessary costs.

STEP THREE: LEADING THE WAY

Implementing an ISO management system needs to be an organisation-wide. This can only be done with the involvement of management at each level.

ISOsafe are able to deliver training to all staff and management at your location to ensure good habits are formed.

STEP FOUR: USING A CONSULTANT

We provide consultancy services in addition to training and the documentation needed to get certified to ISO 9001.

Beware of ‘ready made’ management systems which may not suit your organisation.

STEP FIVE: SELECT A CERTIFICATION BODY

It’s important to know exactly what you’re getting when engaging a certification body. JAS-ANZ recognised certification bodies are best placed to issue ISO 9001 certificates.

ISOsafe are able to recommend the most appropriate certification body for your business based on your business’ needs.

STEP SIX: DEVELOPING A MANAGEMENT SYSTEM

The ISO management standards are designed to be generic, applicable to organisations of all sizes and industry sectors. Whilst the standards provide a framework for good management practice, they do not provide detailed steps or information the ISO 9001 auditor may be looking for.

ISOsafe’s experts are able to advise and prepare tailored documents avoiding costly failed audits; making for a faster, smoother certification process.

STEP SEVEN: THE INTERNAL AUDIT

Before any certification audit it is important to have internally audited your ISO system.

ISOsafe’s 9001 experts are able to internally audit your management system, providing a detailed report and documenting all meetings to ensure your certification audit is a success.

STEP EIGHT: GETTING ISO 9001 CERTIFIED

The process starts with what’s known as a ‘Stage 1 Audit’. This is when an certification body auditor reviews your existing systems and provides you with a gap analysis report which will identify the actions required to meet the standard. ISOsafe are able to close any gaps following this audit, making the necessary changes to satisfy the requirements of the relevant ISO standard.

At this point your organisation will be ready to proceed to ‘Stage 2 Audit’. This audit will reveal the effectiveness of your management system and whether it meets all the requirements of the specific ISO standard you wish to be certified to (e.g. ISO 9001 and/or ISO 14001). If you are fully compliant, you will be recommended for certification. The auditor’s report will then be checked via an approvals process and if no anomalies are identified, certification is officially awarded.

STEP NINE: MAINTAINING YOUR CERTIFICATION

The maintenance of your management system is where the hard work really starts. Continued buy-in from everyone is important for implementation to succeed, and for you to gain the true benefit of becoming certified.

ISOsafe are able to provide your business with the ongoing support and training needed to consistently achieve certification.

WHY ISOsafe?

ISOsafe are Australia's leading HR, Employment Law and Health & Safety consultancy firm. We have helped over 3000 businesses with expert training, advice & compliance documentation.

We also develop, implement and audit ISO Quality (ISO 9001), Safety (ISO 45001 / OHSAS 18001 / ASNZS 4801), Environmental (ISO 14001) and Integrated Management Systems (IMS).

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Looking for ISO 9001 certificate to win a new tender or contract? Find everything you need here

We have all the answers when it comes to ISO 9001 accreditation. Call us 1300 789 132.

ISOsafe understand ISO9001 Quality Management Systems certification is time consuming and sometimes confusing. This is where we can help you.

We will prepare and train your staff ensuring ISO 9001 compliance. We take the worry out of the quality process leaving you to focus on what you do best – running your business.

Why do evaluation tenders and pre-qualification questionnaires ask for ISO 9001? 

Having ISO 9001 compliant suppliers assures your customers that your business will produce good quality products and services, consistently.

And what does it mean for your business?

Your business will have established processes for everything that it does; meaning less errors and issues. By being a reliable and robust business you will gain the confidence of your customers.

How does it work?

✓ Our specialists will collect all the necessary information for preparation of your ISO 9001 system.
✓ We will complete internal audits of your Quality Management System (QMS) and provide ongoing support every step of the way until your business is certified to the globally recognised ISO 9001.

Call the ISO 9001, ISO 14001 and AS 4801 experts today on 1300 789 132 to get immediate support for your QMS certification.
 

Click here for more information about ISO 9001 – link to International Organization for Standardization.