ISO 9001 What Records Does My Business Need To Keep?
Which documents must I keep for ISO 9001? In addition to the legislative requirement for your business to keep certain records ISO 9001 2000 requires your business to retain other records to demonstrate compliance with its various clauses. From an ISO 9001 2000 viewpoint records are documents generated whilst operating your Quality Management System. Typical examples are records of management reviews, purchase orders, sales orders, test results and internal quality system audits. An ISO 9001 2000 consultant can be very helpful to your business in deciding which records are required and those that are not. The standard is not specific about how long your business must retain each record but in order not to fall foul of your own Quality Management System, or the law, you might like to consider the following. If your business offers a period of (x) years guarantee with its product you must keep associated records for at least (x) years. If your business sells products that have legislative requirements for product testing you must keep associated records for the life of the product and sometimes longer. Any legislative requirement for you to keep records associated with your product or service. Records can be in many formats including computer generated records such as those maintained by the Easy ISO 9001 2000® software package. It would be wise to remember when keeping computer based records for long periods (say 10 - 30 years) the medium upon which the data is stored will deteriorate and therefore you must periodically validate its integrity.
Another factor to consider with long term data storage is will a device still be available in 30 years time to read the media upon which the data is stored?
I still have computer programs on punch tape but I no longer have a punch tape reader!
If you do not know what I am talking about here take it as validation of this advice. (Punch tape was a medium for storing computer programs and data in the 1960's and 1970's) The following table identifies the specific records required by ISO 9001 2000. The list does not include records that your business might choose to retain voluntarily or those required by legislative requirements for your product or service. Clause Document to retain, (Record) 5.6.1 Minutes from your Quality Management Review meetings, including any actions raised. 6.2.2 Education, training, skills and experience.(Sub clause-e) 7.1 Evidence that the realization processes and resulting product fulfill requirements. (Sub clause-d) 7.2.2 Results of the review of the requirements relating to the product and actions arising from the review. 7.3.2 Design and development inputs. 7.3.4 Results of design and development reviews and any necessary action. 7.3.5 Results of design and development verification and any necessary action. 7.3.6 Results of design and development validation and any necessary action. 7.3.7 Results of the review of design and development changes and any necessary action. 7.4.1 Results of supplier evaluations and actions arising from evaluations. 7.5.2 As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring and measurement. (Sub clause-d) 7.5.3 The unique identification of the product, where traceability is a requirement. 7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use. 7.6 Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist. (Sub clause-a) 7.6 Validity of previous results when measuring equipment is found not to conform with its requirements. 7.6 Results of calibration or verification of measuring equipment. 8.2.2 Internal audit results. 8.2.4 Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product. 8.3 Nature of the product non-conformities and any subsequent actions taken, including concessions obtained. 8.5.2 Results of corrective actions. 8.5.3 Results of preventive actions. Driso provide ISO 9001 2000 consultancy, auditing, software, and training Services.
They also supply Easy ISO 9001 2000® software for initially setting up an ISO 9001 2000 compliant Quality Management System or improving upon an existing one.
To contact Driso Consultancy Services visit the web site below and see what they can do for you and your business.
Contact: http://www.driso.co.uk for more details.
Related News
|
 |
|
|
RELATED ARTICLES
Negative Self-talk is Too Expensive
I'm always fascinated by the people who lift huge weights,
particularly in competitions like the Olympic Games. There
are events for men and women and they get up on stage to
lift a bar with huge weights attached.
I often wonder what sort of things they're saying to
themselves as they pace up and down, rubbing their hands
with resin powder and taking huge breaths.
Ringing Doorbells Without Howitzers
Many operations leaders have been there, done that with re-engineering. And they report, in effect, that the process is like ringing a doorbell with a howitzer shell.
What is the Most Difficult Part of an Improvement Program?
Answer: Starting one.
Why and How to Work with a Consultant
A good consultant provides specialist abilities and experience, innovative ideas, second opinions (reality checks), unbiased appraisals, and new approaches.
CRM ...The Emperors New Clothes
The story of the emperor's new clothes is a fairy tale about men who fooled the emperor into believing that they had made him a beautiful suit of clothes. In fact they had not made anything. The emperor went out in public wearing nothing but his underwear because he didn't want to appear stupid since they had told him only the wisest people could see the fine fabrics.When the emperor went out in public a little child yelled..."The emperor isn't wearing any clothes!" Today I am that child.
Manage Your Time - Save Your Business.
If you work from home, chances are you already know that you're really pulling "double duty". You probably work on your business while doing the laundry, corralling the kids, or fixing dinner... and let's not forget all the phone calls from family and friends expecting you to run errands or just "go out" for an afternoon of fun.
Giving a Good Appraisal Interview
Although this performance discussion is an opportunity for you to discuss your employee's work during a given period of time, it is also, and importantly, a time for you and your employee to check perceptions and reach mutual understandings and agreements about the purposes and priorities of their jobs. This discussion can positively influence your mutual working relationship. For the performance appraisal process to fulfill its purposes, both of you need to actively participate. If you find that your ideas about the job are different from those of your employee, you should not be reluctant to encourage your employee to explain their perceptions. In preparing your employees to participate fully and productively, have them consider their job and their performance in terms of the following questions. Have them plan to provide feedback about what is going well and what could be done differently that would be beneficial for them and their job.
Its a Training Issue!
There's a common phrase used by Organizational Development and Human Resource professionals, when identifying kinks in the growth of an organization or company - "It's a training issue." The same phrase can be applied to almost any group of human beings that are working together to achieve a common goal. When progress stagnates and obstacles appear, you can retrace the path of movement and discover that things started to go wrong when someone wasn't trained properly.
Crisis Management Essentials - How to Communicate Effectively During a Crisis, Emergency or Disaster
A crisis, emergency or disaster can happen at anytime and anywhere.
Is Your Business A Dysfunctional Family?
The other day I brought my mother into an appliance store to purchase a television. By the time we left with her new television, she was completely disgusted. Unlike most of us, she comes from an older generation that actually expects salespeople and store employees to think of customers as valued visitors that represent their primary source of income. I wish that I could say that the store we visited was the exception, however, it was more the rule.
Time Management Tips for Managers
Late last year I was presenting a workshop for the senior managers of a major organisation. Whilst doing a pre-workshop survey to assess the challenges these managers were experiencing it became very apparent to me that many of them were showing the signs of business burn-out. And it was no wonder why. They were suffering from 'Priority Problems'. Quite simply they were making the mistake of doing the urgent rather than the important tasks.
Forget The Sandwich Technique
Do you remember being told to use the "sandwich" technique
when you needed to reprimand someone? Let me give you an
example:
Bye-Bye Boring Meetings! Make Yours Remarkable!
It's the middle of the night. You've woken up with a brilliant idea on how to improve the way your business product is delivered to your customers. You scribble it down and can't wait to share it with your co-workers during your morning meeting.
Delegate, Dont Abdicate
One of the key skills for the leaders of growing businesses is to 'get' the distinction between delegation and abdication.
Prioritise Your Day - Keep Focus - Win!
Whether you run your own business or manage a team, there are times when things
don't go to plan. Like:-Your key people don't show up.A
deadline shifts.Your boss turns up unexpectedly.You get really busy
beyond expectations....and more.How do you get clear on the priority
of the day?Value it - that's how!So, if you run any sort
of business, consider what the most important thing would be to your business,
if you were down to the barest of bones in personnel numbers, for just one
day, what would you do?Here are some thoughts...Be
honest with yourself, and very, very realistic - in fact, plan what you can achieve
and then less! It is far better to be great at less, than poor at too much.
Be honest with your people and get them on board - appeal to their
emotional side, "I need your help", usually works.Think damage limitation
- what would do the most harm to your business - and resolve that first
(hint - think Customer).With customers, be honest and realistic with them
- usually, they will be very understanding if you are clear about it being a bad day
- they will not forgive inadequate information and poor performance.Plan short-term solutions on the run - by making space for thinking time (see 1 above) to resolve where your problems are today, so you move on tomorrow.Celebrate success with your
people. Back to basics and succeeding against all the odds builds teams - utilise
the opportunity to let it sink in - together!Learn and make changes - so
that there will not be a next time. Your clients and your own staff have only so
much generosity when things go wrong - so make sure it doesn't happen again.
Fire-fighting happens! So, when you need to have a day doing just the top priorities for your business, let go of everything else. Have the courage to be honest with yourself, park not-necessary-now stuff and enjoy your day truly in the business. Be honest with your people and welcome them on board the firetruck! Finally, yet most importantly, be honest with your customers and clients, forging new, mutually supportive relationships with them too.If you need to do this too often for comfort, you need a rethink - then is the time for some real 'source' problem solving (see the "Solving Problems with Whys" article at www.ezinearticles.com - checkout 'Expert Authors, sort by name, Martin Haworth)
Managing Performance: Don?t Let Slackers Bring Down Your ?A? Players
As a manager, it is your job to ensure that the work gets done effectively. Coaching and discipline are unpleasant tasks. However, it must be a part of your everyday job duties. Here are some common mistakes managers make in handling poor performers.
Finding Common Ground Through Consensus Decision-Making
It's clear to me that a workplace is a better place when employees truly work in teams, but the most familiar team models we have are those that are created to win wars and games. We have a commander or a coach who gives orders, and the soldiers or the players use those instructions to defeat the opponent. Mediator Bill Ury says, "People are realizing that adversarial, win?lose attitudes in an increasingly interdependent world, where I depend on you and you depend on me, just don't work anymore. Using those tactics is like asking, 'Who's winning this marriage?'"
Organizational Structure, Creativity, Innovation
Organizational structure can inhibit or foster creativity and innovation. The problem with organizational structure though, is that it is resultant of many factors, including history, organic growth, strategy, operational design, product diversity, logistics, marketing, client base, supplier base and so forth. Therefore, what managers need, are not recipes for complete structural change, but insights into the properties of fostering structures that can be adapted into the existing structure.
Coaching Employees in the Workplace
After a full week of training, you are still a little nervous about your new job. All of the information you need to digest, the new environment you are adjusting to, and the new faces you will be getting acquainted with is just a bit overwhelming.
First Things First -- Process BEFORE Technology
Here's a brief story I encountered while leaving Newark International Airport following a recent business trip. Hard to believe, but true.
|
