No Quality Manual, now what?

We have a single document that serves a the manual..most of it is not value added. It does serve to point to the documents that really serve as the basis on the QMS

At a past employer, we choose to have multiple documents that served as the manual...it essence our highest level documents were the manual.

 

We have a pretty lean manual that we'll probably keep and just tighten up even more over time. But honestly since getting our ISO certification a few months ago, other than quick edits for slight changes, I've opened our QA manual zero times. But I open things like department procedures, ERP software (traveler/router), docs and records from the master lists, and other things many times every day. Not having a manual requirement won't change anything we do on a day to day basis.

 

Great uses for a quality manual:
1. A marketing brochure that you show potential/current customers or suppliers of this is our organization, this is how we operate, etc. (which is a big reason to reference the procedures you need rather than having them in the quality manual)
2. Excellent for onboarding new employees to show them this is our organization, this is how we operate, etc.

I would say to keep the quality manual. To say it's useless doesn't make sense to me, although after seeing several manuals that just regurgitate the 2008 standard I can certainly empathize with that complaint because those are fairly useless manuals missing the point.

The requirements to show your organization's context and interested parties exists in the 2015. Where to keep this information? How about in a document called the quality manual?

 

Very true.

 

The Quality Manual has a very important role in the implementation of a quality management systems. The manual introduces the organisation to the standard for people and employees to understand what the company says or is going to do about the specific clause requirements in the standard,

The manual also introduces the standard to the company identifying the relevance of each clause and requirement within the organisation. Some have no relevance and can be excluded as a result.

Once the standard has been introduced to the company it is mainly relevant to external authorities and customers who need to understand how the standard has been adopted and deployed.

It is correct to observe that there is no specified requirement for a Quality Manual in the ISO9001:2015, but the contents of the manual are specified as a requirement, and must be maintained. The standard is leaving the method of hosting the contents of a Quality Manual to the organisation hence its apparent omission. Most organisation are now also registering for Environment, H&S and Corporate Governance as well as quality and as such these are all being hosted in a single company systems manual. It would not be appropriate to call it a Quality Manual as this is only one of its constituent parts.

 

Though a Quality Manual is no longer required but documenting the scope including justification for any exclusion is still a requirement of the 2015 version, I'm thinking of having a document that contains information on the company's:

• organizational profile
• purpose and strategic direction (i.e. vision and mission)
• system policy statements (e.g. Quality, Environmental, HS)
• description of the products and services
• description of the scope of the established system
• justification for any requirement of the subscribed standard/s that don't apply to the scope
• description of the sequence and interaction of the processes employed within the system (e.g. high-level process map)
• description of each process by a brief 1 to 2 paragraphs narrative or by describing each using the Figure 1 of FDIS 9001:2015 (ala SIPOC)
• and referencing the documented information being maintained to support operation of each process.

and instead of calling it a "Quality Manual", I'll name it "Context of the Organization". What's your take on this?

 

I'm not sure I completely agree with you Andy. Our engineering team has decided to go over CFR 820 step by step, so we can understand some of the requirements. We read a section then discuss it in our meetings, and talk about if it applies to us, and how we comply or don't comply, and what we need to do in the future to get better.

Maybe we should be jumping up and down to do these things without standards. However, these exist for a reason and discussing what the requirements are and the reasoning behind them, helps us understand why we do what we do. All of a sudden Q&R isn't the big enemy making our work harder than it needs to be. They are a resource to refining our work.

I think this expanded learning applies to everyone in a plant. Done on different levels of course, and with different terminology and context. However, a starting point is helpful.

 

I can smell "context of organization" getting stereotyped to standard verbatim already to negate any possible perception or opinion of deviation from the standard requirements, just like how Quality Manual ended up, by and large.

 

Salamat (Thanks) Andy for your straightforward answer. But should you maintain one, what do you prefer to call it?

 

I agree with you. However, with my experience with CBs here, most would be asking a "Quality Manual" that has sections describing each clause of the ISO 9001 standard . They tend to go beyond the requirements of clause 4.2.2. Though it should be a relief for us that the 2015 version removed the requirement for having a quality manual, but I doubt CBs here will be able to let go of their old ways and most probably would still look for an equivalent "manual".

"Context of the Organization" could be "a rose by any other name". Thanks for the caution. Thus, maintaining documented information can be in any form suitable to an organization, as long as it "would smell as sweet" as the intent of the standard.

 

Following Andy's advice, I am not changing the current Quality Manual. I am just putting an appendix of strategy, and a risk register table to demonstrate RBT. If the auditor ask where's this and that we will bring out records that we have done this and that. We will bring out the word "barrier thinking" and "mitigation".