The proposed additional clauses for ISO9001:2015 are as follows:
9. Performance evaluation
- Monitoring, measurement, analysis & evaluation
- Internal audit
- Management review
- Non conformity and corrective action
- Continual Improvement
“Documentation Requirements” has been changed to “Documented Information”. We will need to think carefully about that one!
This Qualidoc agenda has proved its worth for many years quality system management in aerospace, marine freight forwarding, ship repair, IT, among others.
Used with a disciplined set of Minutes it is a reliable tool for monitoring the requirements of the ISO9001:2015 and the revisions to AS9100 that will result from the new ISO standard. It will also prepare for audits against the auditing standard AS9101 Revision E, due out later this year. See my blog AS9100 and Aerospace Manufacturing magazine article, April 2013 issue.
Who should attend? CEO and other top management executives. How often do you need this review? I recommend three to six month intervals while quality system is settling down. Thereafter annual review is sufficient, depending on the nature of your business. It is IMPORTANT to follow through on the corrective action arising from this review.
A. QMR report – status of quality system:
• results from internal audits
• corrective and preventive action
• regulatory, industrial and international standard compliance
• customer complaints
• quality objectives
B. Risk assessment and management
C. Quality objectives (strategies for continuous improvement)
D. Cost of quality system
E. Benefits of quality system
G. Customer satisfaction levels (implied needs)
H. Changes in processes and business strategies that could affect the quality system
QMR is Quality Management Representative, aka Quality Assurance Manager
WATCH FOR THE QUALIDOC QUALITY POLICY MANUAL AVAILABLE SHORTLY FROM THIS WEB SITE WITH SAMPLE MANAGEMENT AUTHORITY AND RESPONSIBILITY FOR A QUALITY MANAGEMENT SYSTEM.
CONTROL OF QUALITY RECORDS: a major task for quality system development.. Ask the following questions, preferably at contract stage:
Which documents are critical for the quality system and must be controlled? (contract to delivery stage)
Who will control the MASTER DOCUMENT LIST (one authorised person)?
How will authorised persons access the List?
Who will have “read only” access?
Who will have authorised access for review, revision? (usually the Quality Management Representative (QMR)
Have the documents been subjected to the severest scrutiny before issue? e.g.,
- verification of content
- identity of reader (who needs to know)?
- logical sequence of processes with the reader in mind (policies, procedures, working instructions, forms)
- grammar, spelling, vocabulary
Where do the documents begin to appear in the design and production process?
Are user documents included (customer, regulatory bodies, other interested parties)?
What is the distribution? (Please, no uncontrolled copies!)?
What are the intra- and interdepartmental connections for each document, with authority for receipt and distribution?
Are other interested parties involved?
Where will hard copy documents be kept (secure from damage or other deterioration)
Who will be in charge of the documents at point of use?
Has documentation development been included in the quality plan?
See also Documentation Requirements section in the Quality System Internal Audit Checklist available FREE from this web site.
Numbers are growing daily – it’s good to see so many brave souls checking their quality systems with the Qualidoc Quality System Internal Audit Checklist!
Watch the website for the issue of the Quality Policy Manual where you can make a good start on your quality system or smarten up the current system. This will be available shortly.
Not clear how ISO standards would apply to your everyday operations?
Not sure you can commit the required resources and energy?
Fear the perceived bureaucracy and paperwork that could be involved?
BUT you might need an ISO standard for
a new contract requirement
entry to a new (to you) or emerging market
more disciplined approach to your business
Check your current status via the QUALIDOC internal audit checklist – a really good place to start.
Available FREE at www.qualidoc.co.uk
The ISO quality standards are not techniques which can be learned and dropped if not convenient. They are concepts which must be converted into techniques to reflect the processes of each organisation.
The techniques are company-specific and the consultant’s job (as I see it) is
- to help the customer develop those techniques
- to make sure the ISO requirements are met without creating a gridlock in the organisation
- to discover the unknowns which cannot always be accounted for by management strategies
This development can be a huge culture shock. People are not used to describing and recording what they do as a logical sequence of events.This has to happen if you want a quality system that will pass muster with the assessor and benefit the organisation.
To see how your company or organisation is doing, download the FREE INTERNAL AUDIT CHECKLIST from www.qualidoc.co.uk – a really good place to start improving your business.
A word of caution: make sure your Purchase Orders or Standing Orders contain the complete specifications against which you want the product delivered. If you require Certificates of Compliance or Conformity. make sure they accompany the product when you receive it. When you have placed a Standing Order with a supplier they should submit updated certificates or some other confirmation of compliance each time they make a delivery against that order.
During an ISO9001 assessment at which I was present the audit revealed a certificate that was ten years old, issued for infrequent, long-term delivery of items needed in production. My customer had not asked for certificates of compliance after the first purchase, on the grounds that the supplier was always dependable and the items would be delivered a batch at a time, based on the original Purchase Order. Unfortunately, the assessor did not take this view, and we got a minor non-conformance (the only one, much to my chagrin).
I have it on the latest, highest authority that the revision contains:
- more emphasis on non-manufacturing sectors
- a new common ISO format.
This is still at committee stage, but so far this is how ISO9001:2015 will look:
4. Context of the organization
9. Performance evaluation
Available shortly from the QUALIDOC website – Quality Policy Manual for ISO9001:2008 and AS9100C
IN THE QUALIDOC PIPELINE: QUALITY ASSURANCE PROCEDURES TO SUPPORT THE QUALITY POLICY MANUAL.
WATCH THIS SPACE FOR INFORMATION ON AS9100 REVISIONS BASED ON ISO9001:2015
THE FIRST IMPRESSION IS VERY IMPORTANT. THE FIRST MEETING IN AN ASSESSMENT (MANAGEMENT RESPONSIBILITY AND AUTHORITY) IS LIKELY TO BE IN THE ADMINISTRATION AREA.
BE AWARE OF
PILES OF DOCUMENTS WAITING TO BE PROCESSED OR FILED
DOCUMENTS IN UNAUTHORISED LOCATIONS
FILES AND FILING CABINETS WITHOUT CORRECT IDENTIFICATION (MASTER DOCUMENT LIST REFERENCE)
OBSOLETE DOCUMENTS NEGLECTED ON SHELVES AND DARK CORNERS.
DUST, DIRT AND TRASH
OVERCROWDING (STAFF, FURNITURE)
INAPPROPRIATE WORKING CONDITIONS
INCOMING QUALITY-CRITICAL ITEMS IN UNAUTHORIZED SPARE SPACES
I HAVE IT ON THE BEST AUTHORITY THAT:
Proposed issue date for the revision is October, 2015
ISO has completed revising one draft, but has neither completed editing the new version nor is releasing it publicly yet.
The ISO committee has just completed the “Working Draft” stage, and is expected to release the “Committee Draft” in early June.
WATCH THIS SPACE FOR MORE INFO ON THIS REVISION.