Posts tagged #quality manual

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.

Posted on February 2, 2017 .

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.

ISO 9001 Certificate. Gain QMS Accreditation with ISOsafe

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.

Posted on December 8, 2016 .

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