QMS Resource Library - from ASR


Quality-ASR-Compliant-LibraryThis is a collection of Quality Management System articles, news and resources to help and inform your organization.  Find them by category, key word or use our search engine. 

Definition of a QMS: A quality management system is a collection of business processes focused on achieving your quality policy and quality objectives.


Featured Articles

2017 Transition Issues (Common Non-Conformances during ISO Audits)

Wednesday, 30 August 2017
ASR Editor
These have been most common non-conformances found in recent ASR client transition audits (2017). Our hope is clients can apply these NC’s as a learning tool to improve their organization’s QMS.

Online Training with a 50% discount for ISO and IATF courses.

Thursday, 20 July 2017
ASR Editor
OnlineStandardsTraining.com and ASR have agreed to offer steep discounts for ASR clients.

Because of the costs, organizations only train a few people; not everyone that needs it.  To  train the entire staff or work group, training can cost thousands of dollars. Whether you're an employee, an employer or going it alone. The money saved from travel alone can be substantial

How to change ISO Registrar

Monday, 30 January 2017
ASR Editor
Are you looking to change your ISO registrar?

These issues are most important:
  • Your Existing Contract
  • The Cost
  • The Reputation (Testimonials / Customer Service)

ISO Re-Certification Count Down

Tuesday, 25 April 2017
ASR Editor
Keep These Transition Dates Handy!

Second Party Auditing Services

Friday, 14 October 2016
ASR Editor
Did you know that ASR provides second-party auditing services?

Audit services include internal auditing, gap analysis, pre-assessments, IATF 16949 supplier audits, and the CQI customer specific audit series including 8, 9, 11, and 12. Click here for a complete list of the special process assessments.

Where’s Your Action List?

Monday, 16 February 2015
Rand Winters
change mgmtChange management is a small segment in the forthcoming revised ISO 9001 and for many organizations adjusting their system to address the 2015 version of ISO 9001 can be made a little easier with the appropriate tool.

As I audit organizations, I am amazed at the lack of action lists to monitor multiple tasks to be accomplished in the near future. An action list on a spreadsheet can be a valuable reminder of the projects and resources needed.

ISO 13485 - Revised Medical Device Standard Soon To Be Released

Monday, 25 January 2016
ASR Editor
Medical device 4Sometime in the first quarter of 2016 we will see the release of ISO 13485 for medical device manufacturers. The final voting on the ISO 13485 was concluded December 29, 2015 and now we will wait for the official release in 2016. 

Minor clerical changes are permitted but no significant technical changes should occur.  

Standards Revision: ISO 14001:2015

Wednesday, 23 September 2015
ASR Editor
Dear ASR clients:

The new ISO 14001:2015 standard was published on September 15, 2015.
Required timing for client transition: No later than September 15, 2018

American Systems Registrar (ASR) plans to begin conducting audits to ISO 14001:2015 in January of 2016.

IATF Mandates Certificate from Recognized Accreditation Body

Wednesday, 11 November 2015
ASR Editor
Effective December 31, 2017 organizations that supply to ISO/TS 16949 customers will be required to hold a certificate from a certification body (registrar) that is part of the International Accreditation Forum Multilateral Agreement (IAF MLA).    IAF manages the worldwide process for accreditation.

How to Advertize Your Registered Quality System

Thursday, 06 March 2014
ASR Editor
Advertising Your Registered Quality System
Does your organization's advertising material reflect the scope statement printed on your registration certificate?

Tool to help transition to ISO 9001:2015

Thursday, 22 October 2015
ASR Editor
This tool will help you look at the standard side-by-side.  It shows the ISO 9001:2015 standard clauses next the the related ISO 9001:2008 standard.  It also provides a commentary about the new standard.

Online Training Portal

Thursday, 28 November 2013
Training Coordinator
If you are looking to advance within your organization and become a quality expert with more authority - you need additional training.

Risk Based Thinking – And ISO 9001:2015

Tuesday, 15 September 2015
ASR Editor

ISO/FDIS 9001:2015

With the release of the 2015 revision, it is important to revisit one of the major changes to the standard – developing risk based thinking.

ISO 9001:2015 moves risk based thinking from a "should" or a good idea to enhance a QMS to a "shall" requirement. Both ISO 13485:2003 and AS9100 require users to address risk in Section 7 of their respective standards.

A good way to look at risk and to address risk is by utilizing the PDCA cycle - Plan, Do, Check and Act.

Sort, Store, Shine, Standardize, Sustain (5S)

Friday, 15 May 2015
ASR Editor
Something to Think About
By Rand Winters
ASR Senior Auditor

In recent years, a number of ASR clients have started lean manufacturing programs without considering a full blown 5S program.

New for your ISO 14001 EMS - Context of the Organization

Wednesday, 24 February 2016
ASR Editor
One of the objectives of ISO 14001:2015 is the pulling together of an organization's environmental internal issues, external issues and interested parties that make up the firm's business environment or the Context of the Organization.

In the past, top management was never required to define the firm's business environment as it related to internal and external issues or any interested parties.

Standards Revision: ISO 9001:2015

Wednesday, 23 September 2015
ASR Editor
Dear ASR clients:

The new ISO 9001:2015 standard was published on September 15, 2015 (available 9/23/2015)
Required timing for client transition: No later than September 15, 2018

American Systems Registrar (ASR) plans to begin conducting audits to ISO 9001:2015 in January of 2016.

ASR will be recommending clients to transition to ISO 9001:2015 at their recertification audit if possible. Clients that transition at recertification time will not incur additional audit time. Clients may choose to transition at a surveillance audit or at a special audit at any time during the audit cycle. Additional audit time will be required to cover the review of changes to the quality management system. The additional time would be dependent on the size of the organization.

Determining Adequate 2015 Documentation

Wednesday, 29 July 2015
Rand Winters
Revision writers left it up to organizations determine how many and what procedures and work instructions to document. This vague approach to documentation opens the door for each organization to develop a system that reflects what works best for them.

Final voting on the 2015 revisions concludes in September and there may be some slight language changes.

Two types of documented information (ISO 9001:2015 4.4.2) are required. Organizations will have to maintain documented information (procedures and work instructions) and they will have to retain documented (records) information.

Changes In the New ISO 13485 Standard (DIS)

Thursday, 18 June 2015
ASR Editor
The draft standard to ISO 13485 (ISO TC 210 WG1) has added new requirements and clarifications in a number of areas.

This article covers a few areas

  • QMS
  • Management Responsibility
  • Human Resources
.

Addressing the Context of an Organization

Tuesday, 15 September 2015
ASR Editor
Central to maintaining a business is an understanding of the organization, its context as well as the needs and expectations of interested parties. Context could be expressed in an organization's existing vision, mission, policy or objectives.

Determining relevant internal and external issues is followed by the monitoring of those issues to achieve the intended results of the organization's business system. See ISO 9001:2015 or the ISO 14001:2015 for reference.

Take a look at your "Context of the Organization" and find opportunities for improvement.

What Does Your Website Say About Your Quality System?

Wednesday, 24 February 2016
ASR Editor
Your organization's web site has information that is important to your QMS. It might be advertising (communications media) your firm's capabilities and should reflect the current operating status and scope statement found on your registration certificate.

The American National Accreditation Board (ANAB) governs USA registration bodies and they have mandated certain requirements for client communications material. ANAB's objective is to ensure certificate holders don't promote a service such as design when the organization's certificate scope does not reflect that activity.
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Automotive

  • IATF 16949
  • Intl. Automotive Task Force
  • BS 25999
  • OHSAS 18001

Medical Devices

  • ISO 13485
  • Product Safety
  • Device Recalls
  • Emergency Situations

Aerospace

  • AS9100
  • AS9110
  • AS9120
  • SAE Technical Standards

Environmental

  • ISO 14001
  • EPA Regulations
  • EMS Tools
  • Emergency Preparedness