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19/06/2019 By admin

The Ultimate Guide to ISO 9001 Audits

Achieving a good result at an ISO 9001 Audit should be a walk in the park for a well designed, developed and implemented Quality Management System. During the audit, the Certification Auditor will sight objective evidence to support conformity with each of the sub-clauses (clause numbers 4-10) of ISO 9001. This will mean an ISO 9001 audit result of either:

  1. Satisfactory – all is well
    Internal Auditing
  2. Improvement Opportunity – the auditor is recommending improvements (take them or leave them)
  3. Observation – things may be going off the tracks
  4. Minor Non-conformity – isolated minor deficiency identified
  5. Major Non-conformity – major deficiency identified

Note: If you have received a dreaded ISO 9001 Quality Management System major non-conformity it means there has been a significant deficiency identified in the structure and/or the implementation of the quality management system but don’t panic! Read on. 

What is the difference between a non-conformity and a non-compliance?

Before we go into the details of the various audit codes it is worth reflecting on the terminology used (incorrectly at times) around ISO Audits.

  • A Non-compliance is typically used when there is a breach of externally imposed requirements, for example, when you have not complied with the law (Acts, Regulations, etc) – Noncompliance.
  • A Non-conformity (also known as a Non-conformance) is normally used in situations where there has been a failure or non-fulfillment to conform with internally imposed requirements such as ISO Standards (eg ISO 9001 Quality Management Systems).

So when talking about ISO Audits you would normally say audit Non-conformity as opposed to audit Non-compliance. On the flip side (where you want to be), you would conform with ISO standards and comply with legal requirements.

Government Funding Grants for ISO 9001 Certification

Did you know that many Australian businesses are actually eligible for help with ISO 9001 Certification through a government-funded Business Growth Grant? Click HERE for more information.

ISO 9001 Audit Codes

A note about ISO Audit codes: Under JAS-ANZ, Certification Bodies are not obliged to use specific Audit Codes so these may vary somewhat depending upon which Certification Body conducts the audit. For example (with reference to the definitions below), some Certification Bodies will raise an Improvement Opportunity as their Observation, a Minor Non-conformity as an Improvement Request, and a Major Non-conformity as a Non-conformity. So much for standardisation! That said the following definitions will largely apply.

Satisfactory

Satisfactory (SAT) objective evidence was sighted to demonstrate conformance with ISO 9001:2015 Quality Management Systems. No further action required here – keep up the good work and well done!

Improvement opportunity

If the ISO Certification auditor identifies an Improvement Opportunity (IO) then it means they think things could be done better and they are making a recommendation to try and add value to your Quality Management System through their audit service. Bear in mind that there are many ways to skin a cat and some ISO 9001 Certification auditors may be used to seeing systems set up in a way that may not necessarily be the best solution for your business. You aren’t required to action IO recommendations made in the audit report however it is a good idea to address them in either the Improvement Register or QMS Management Review Minutes, even if it is just to say that you have reviewed the recommendations and aren’t going to proceed with them.

Observation

If the Auditor gives you an Observation (OBS) it means that things aren’t going to plan and there are some issues that need addressing before they escalate to a Minor or Major Nonconformity. Observations should be registered in your improvement framework and action taken to address the recommendations made prior to the next surveillance audit from the Certification Body.

Minor nonconformity

An isolated failure to conform with the requirements of the ISO standard or implement the Quality Management System is generally classified as a minor nonconformity and as a minimum should be addressed within the next 12 months prior to the next surveillance audit.

A Corrective Action Plan is not usually required as long as the non-conformity is registered into the improvement framework and addressed in a timely manner (maximum of 12 months). Corrective action taken to address a Minor Non-conformity will be reviewed at the following surveillance audit and if appropriate action has not been taken then the Minor will likely escalate into a major Non-conformity.

Major nonconformity

A Major Non-conformity means the auditor has determined that there is a complete or significant absence of any objective evidence to support conformance to the clause, or a complete failure to implement the Quality Management System to requirements.

If you receive a Major Nonconformity then you will not receive certification (if it is your initial audit) until the Non-conformity has been closed out, and if you are already certified then the Certification Body will not renew your certification if the Non-conformity has not been actioned within three months (ie certification suspended). But again – don’t panic!

When a Major Nonconformity is raised, simply complete the following five steps:

  1. Complete a Corrective Action Plan (including Root Cause Analysis).
  2. Submit the Corrective Action Plan to the Certification Body for review and approval within one month of the audit date.
  3. Action the items detailed in the Corrective Action Plan within three months.
  4. Update the Corrective Action Plan when the action items have been completed to indicate they have been closed out.
  5. Send the completed CAP to the Certification Body, along with any other evidence required to support the completion of the action items.

Based on the information provided the Certification Body may decide a follow-up audit is required to verify the effectiveness of action taken.

Note: CLICK HERE for an example Corrective Action Plan  

Corrective Action Plan

How to Avoid ISO 9001 Audit Non-conformity

Consider engaging an ISO 9001 Consultant to undertake a comprehensive internal audit prior to certification, surveillance or recertification audit from a Certification Body. A thorough Internal Audit will ensure any deficiencies are identified and an action plan established before non-conformities are picked up by the ISO 9001 Certification Auditor.

Outsourcing your internal auditing to Streamline provides independence, objectivity and eliminates the requirement for employee training and diversion from normal work activities – both of which cost time and money. Our Certified ISO Auditors provide experience, professionalism, and the high level of diplomacy required to facilitate effective internal audits.

Your business will receive highly objective and impartial audits that will add real value to your management system and ensure any problems with the QMS are identified and actioned before you receive a Non-conformity at the external audit.

Benefits of ISO 9001 Internal Auditing

ISO Audit
  • Receive highly objective and impartial audits that will add real value to your management system,
  • Reduced requirements for internal auditor training and logistical costs,
  • Allow your employees to focus on their core jobs so there is minimal disruption to normal business operations,
  • Avoid internal political issues that may arise due to internal departments cross-auditing,
  • Meet the requirements of management system standards,
  • Ensure your management system is effectively implemented,
  • Identify opportunities for improvement, and
  • Reduced non-conformance findings from certification bodies.

Contact Us Today

If you’d like more information on ISO 9001 Internal Auditing, or to request a Quick Quote please use the form to the right and one of our ISO Consultants will contact you within one business day.

If you would like to speak with someone straight away feel free to call us on the numbers below – we look forward to hearing from you and answering any questions you may have. 

  • Brisbane ISO Consultants 07 3667 8280
  • Sydney ISO Consultants 02 8315 7780
  • Melbourne ISO Consultants 03 9034 3990

Remember to take into account the ISO 9001 Certification Costs and understand the risks of cheap ISO 9001 Certification.

Filed Under: Articles, Featured, Ultimate Tagged With: #9001QMS, #certification, #howmuchdoesitcosttogetiso9001certified, #howtoimplementiso9001, #howtotransistionfromiso9001, #iso9001, #ISO9001:2015, #ISO90012015, #iso9001consultant, #iso9001context, #iso9001policies, #iso9001procedures, #iso9001scope, #ISO9001sections, #iso9001successfactors, #iso9001version2008, #isoaudit, #qasinternational, #QMSConsultant, #QualityAssurance, #QualityManagementSystems, #risksofiso9001, #startingiso9001, #theimportanceofiso9001, #whatarethesuccessfactorsofiso9001, #whatisiso9001, #whatisiso90012015, #whatisiso9001training, #whatisiso9001version2008, #whatisthelatestversionofiso9001, #whyisiso9001important, #whyiso9001isimportant

13/06/2019 By admin

What is required for ISO 9001 Certification?

There are a number of articles online that provide long-winded explanations on what is required for ISO 9001 Certification however in this blog we will try and keep things as short and to the point as possible.

Three simple steps required for ISO 9001 Certification

  1. Develop and implement a Quality Management System that meets the requirements of ISO 9001:2015 Quality Management Systems.
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  2. Complete an internal audit to ensure the quality management system conforms with clauses 4 -10 of ISO 9001 and is effectively implemented and hold a QMS Management Review Meeting.
  3. Engage a JAS-ANZ Accredited Certification Body – they will complete the ISO 9001 audit in two stages:
    • Stage 1 is a documentation audit to ensure your system meets the requirements of ISO 9001, and
    • Stage 2 is an implementation audit to ensure you have implemented the system as documented.

That is it – provided you pass the audit and action any major non-conformances then you are certified!

If you haven’t developed a Quality Management System before then it may pay to engage an ISO 9001 Consultant to assist with the process – if they do their job properly then the Certification Body audit should be a tick in the box process.

If you think that you may be partway there, but would like to know how you are tracking then consider engaging a Streamline ISO Consultant to undertake a Gap Analysis Audit. Gap Audits are a great way to have an external party complete an independent assessment of your quality management system and provide you with a detailed action list with recommendations prior to completing Stage 1 of your certification audit. Also, note that there are some risks associated with Cheap ISO 9001 Certification, click here for more information.

How Streamline can help

Streamline consultants can design, develop and implement a certification-ready Quality Management System from the ground up to meet ISO 9001 requirements. If you already have an existing management system in place we will help you integrate ISO 9001:2015 into your current management system (eg ISO 45001 Safety or ISO 14001 Environmental) to form an Integrated Management System (IMS).

ISO 9001 2015

Our trained and experienced consultants have a 100% track record achieving certification for our clients and we guarantee your ISO 9001:2015 quality management system will get certified by a JAS-ANZ accredited Certification Body.

Contact Us Today

If you’d like more information, or to request a Quick Quote please use the form to the right and one of our consultants will contact you within one business day. Alternatively, you are welcome to contact us by phone or by emailing [email protected]

We look forward to hearing from you and answering any questions you may have.

External Link: To purchase a copy of ISO 9001:2015 Click Here

Filed Under: Articles Tagged With: #9001QMS, #certification, #howmuchdoesitcosttogetiso9001certified, #howtoimplementiso9001, #howtotransistionfromiso9001, #iso9001, #ISO9001:2015, #ISO90012015, #iso9001certificationaustralia, #iso9001context, #iso9001policies, #iso9001procedures, #ISO9001QualityManagementSystems, #iso9001scope, #ISO9001sections, #iso9001successfactors, #iso9001version2008, #ISOConsultant, #qasinternational, #QMSConsultant, #QualityManagement, #QualityManagementSystems, #risksofiso9001, #startingiso9001, #theimportanceofiso9001, #whatarethesuccessfactorsofiso9001, #whatisiso9001, #whatisiso90012015, #whatisiso9001training, #whatisiso9001version2008, #whatisthelatestversionofiso9001, #whyisiso9001important, #whyiso9001isimportant

04/06/2019 By admin

Quality Quote by Aristotle – Greek Philospoher

aristotle

“Quality is not an act, it is a habit”.

Aristotle – Greek Philosopher (384BC – 322BC)

Filed Under: Articles, Quality Quote Tagged With: #9001QMS, #iso9001, #ISO9001:2015, #ISO9001QualityManagementSystems, #qasinternational, #QualityAssurance, #qualityquote

31/05/2019 By admin

How to use Smartsheet for ISO 9001, ISO 45001 & ISO 14001

Smartsheet is a cloud-based software solution that is extremely easy to use (same as Excel), very cost effective and provides some powerful tools such as conditional formatting and alerts/notifications, team collaboration and resource allocation. Here is our guide for Smartsheet for ISO 9001, ISO 45001 & ISO 14001.

Smartsheet for QMS 9001

As ISO Consultants, we find Smartsheet is our preferred platform to develop Quality 9001:2015, Safety 45001:2018 and Environmental 14001:2015 Management Systems. It streamlines administrative processes associated with the maintenance of ISO business management systems and ensures information is kept current and accessible when and where it is needed.

Typically, we establish the following registers in Smartsheet to support Quality, Safety & Environmental Management Systems:

  1. Document Register – centralised document storage with permissions to control read/write access as required. Reminders set to alert relevant personnel when document review is required.
  2. Training and Competency Register – an improved version of the standard excel Training Matrix that can store employee details, licenses, qualifications, and competencies. Conditional formatting in place to identify when qualifications have expired or Verification of Competency is due.
  3. Approved Suppliers & Approved Subcontractors – register of suppliers and subcontractors including business information, qualifications, insurances and performance history/data.
  4. Risk Register – Threats/Hazards, Risks, Inherent Risk Score, Residual Risk Score, Responsibilities and Controls.
  5. Equipment Test & Calibration Register – list of equipment requiring test, calibration, inspection including due dates, reminders and conditional formatting to provide a visual indication of status.
  6. Plant & Vehicle Register – plant and vehicle information including service, registration, and insurances. Conditional formatting and reminders to ensure key dates are monitored and renewed prior to expiry.
  7. Improvement Register – non-conformance, incidents & improvement opportunity registration, corrective action and action to prevent a recurrence. Responsibility allocation and identification of status.
  8. Quality, Safety & Environmental Objectives Register – register of Quality Objectives, Safety Objectives, and Environmental Objectives along with performance data history.
  9. Internal Audit and Inspection Register – schedule for managing all internal audit and inspection requirements. Copies of completed reports held on register and link to Improvement Register for any improvement items identified.
  10. Any other registers required to support the operation of the management system eg Enquiries Register, Tender/Contract Register, Project Register etc.

Try Smartsheet for Free

To ensure the registers are updated with current information, a combination of Smartsheet Forms and Update Requests can be utilised. We highly recommend you review the possible functionality benefits to your business and consider a Smartsheet based ISO Management System.

For more information contact us, or see below for some links to the Smartsheet Software videos.

  • Intro:  https://youtu.be/N-5ZTcKgo5c
  • Smartsheet 101: https://www.youtube.com/watch?v=w7BYs1O_XbU

Filed Under: Articles Tagged With: #9001QMS, #certification, #iso14001, #iso45001, #iso9001, #ISO9001:2015, #ISO9001QualityManagementSystems, #ISOConsultant, #qasinternational, #QualityAssurance, #QualityManagement, #Smartsheet

29/05/2019 By admin

SMARTER ISO 9001 Quality Objectives

What are Quality Objectives?

Clause 6.2 of ISO 9001:2015 Quality Management Systems Standard requires an organisation to establish ISO 9001 Quality Objectives at relevant functions, levels, and processes needed for the quality management system ie – how will the performance of the quality management system be measured and what are the objectives we are hoping to achieve through implementation of the QMS.

How SMARTER Quality Objectives can Help

Whilst it is not specified in ISO 9001, we recommend SMARTER Quality Objectives that underpin the delivery of the goals detailed the organisation’s strategic plan, support the Quality Policy, and are aligned with the SMARTER philosophy of:

  • S – Specific: quality objectives should be clearly articulate what is trying to be achieved. They should be relevant to the conformity of products and services and to enhance customer and stakeholder satisfaction.
  • M – Measurable: Quality Objectives should be quantitative and data to support performance able to be measured. This data is needed to identify baseline performance against the objectives and to allow for ongoing performance measurement.
  • A – Achievable: Quality Objectives should be realistic and attainable to be successful. There is no point in having an objective that is not achievable.
  • R – Relevant: Quality Objectives should support the Quality Policy and the organisation’s Strategic Plan.
  • T – Time-bound: When will the objective need to be achieved by? Is it an ongoing objective measured at a specified frequency or a targeted completion objective?
  • E – Evaluated: Quality Objectives are required to be evaluated at Management Review Meetings – Clause 9.3.2 of ISO 9001:2015.
  • R – Reviewed: Quality Objectives are required to be reviewed at Management Review Meetings – Clause 9.3.2 of ISO 9001:2015.
Smarter ISO9001 Objectives

Clause 6.2.2 of ISO 9001:2015 also requires that when organisations are planning their Quality Objectives they determine:

  • what needs to be done,
  • resourcing requirements,
  • responsibilities,
  • schedules and due dates,
  • how the results of the performance will be evaluated

Government Funding Grants for ISO 9001 Certification

Did you know that many Australian businesses are actually eligible for help with ISO 9001 Certification through a government-funded Business Growth Grant? Click HERE for more information.

Who Needs to Know about the ISO 9001 Quality Objectives?

Quality Objectives should also be communicated to all personnel whose roles and responsibilities have a direct or indirect bearing on the performance of the objective. This includes the results of monitoring, review, and evaluation of performance data in order to ensure ownership and accountability of performance.

Summary

Quality Objectives and being able to measure the performance of the Quality Management System are key to identifying performance problems and also demonstrating continual improvement. Importantly, developing clear, concise SMARTER Quality Objectives also requires systems for capturing meaningful data to support performance against the objectives, and ultimately the achievement of the Quality Policy and goals as detailed in the organisation’s Strategic Plan.

Filed Under: Articles Tagged With: #9001QMS, #howmuchdoesitcosttogetiso9001certified, #howtoimplementiso9001, #howtotransistionfromiso9001, #iso9001, #ISO9001:2015, #ISO90012015, #iso9001context, #iso9001policies, #iso9001procedures, #iso9001scope, #ISO9001sections, #iso9001successfactors, #iso9001version2008, #qasinternational, #QualityAssurance, #QualityManagementSystems, #qualityobjectives, #risksofiso9001, #smarterobjectives, #smartgoals, #startingiso9001, #theimportanceofiso9001, #whatarethesuccessfactorsofiso9001, #whatisiso9001, #whatisiso90012015, #whatisiso9001training, #whatisiso9001version2008, #whatisthelatestversionofiso9001, #whyisiso9001important, #whyiso9001isimportant

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Streamline ISO Consultants set up our Quality and Environmental Management System in 2011, and still help us out today with internal auditing and management system upgrades.

Having ISO 9001 & 14001 Certification is great but their simple and practical Integrated Management System adds real value to our business - much more than just an ISO Certificate.

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Clearly experts in this field

"We worked with Streamline ISO Consultants on a gap analysis audit of both our Quality and Work, Health and Safety systems. They provided us with a detailed report and specific goals to improve our compliance. We were very happy with the recommendations. The service provided was flexible and responsive. Scott is clearly an expert in this field."

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Very professional - Streamline did a great job

Streamline ISO Consultants have a professional approach and did a great job preparing our QMS documentation and providing training. I would recommend them to anyone who is looking for assistance with their ISO Certification. Thanks once again to the Streamline Team!

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Phone: 02 8315 7780
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Funding Grants for ISO Certification
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Strategic Planning - Mystical Art?
ISO Certification Auditors
How to get ISO 9001 Certification
ISO Certification Cost
How to tell if your ISO Cert is fake
4-year-olds and Root Cause Analysis
Fast ISO 9001 Certification
The Ultimate Guide to ISO 9001 Audit
Certification - How Much and How Long?
Who's Interested in a Party?
How to use Smartsheet for ISO
Smarter Quality Objectives
Local Government QMS
Quality Assurance, Quality Control or QMS
ISO Certification in Sydney
ISO Certification in Melbourne
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QUICKLINKS TO ISO INFO

ISO 9001 Quality Management
ISO 45001 Health & Safety
ISO 14001 Environment
ISO 50001 Energy Management
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ISO 17025 Testing & Calibration
ISO 27001 Information Security
ISO 22000 HACCP Food Safety

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